2018 Volume 20 Issue 3 Published: 28 June 2018
  

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  • Clinical analysis of liver injury associated with edaravone in patients with acute ischemic stroke
    Song Lipo, Wang Chunmei, Chu Yanqi, Ji Xunming, Duan Jiangang, Wei Libing, Ning Yachan, Huang Ying, Zhang Jian
    2018, 20(3): 164-168. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.002
    Abstract ( ) PDF ( )
    ObjectiveTo analyze the clinical characteristics of liver injury related to edaravone in treating patients with acute ischemic stroke (AIS).MethodsAmong the AIS patients treated with edaravone in Vascular Surgery ICU of Xuanwu Hospital Capital Medical University from January 2014 to October 2017, 9 patients were diagnosed as having liver injury associated with edaravone by active monitoring. The total number of patients treated with edaravone at the same period in Vascular Surgery ICU were obtained from the hospital information system and the incidence of liver injury associated with edaravone was calculated. The clinical data of the 9 patients were collected and analyzed retrospectively.ResultsThe incidence of liver injury associated with edaravone was 8.7% (9/103). The 9 patients included 6 males and 3 females. The age of the patients was 52-83 years and their average age was (65± 6) years. The time for the occurrence of liver injury was 3-9 days and the average time was (6±2) days. The main manifestations of liver injury were increase of alanine aminotransferase (9 cases), aspartic aminotransferase (7 cases), alkaline phosphatase (4 cases), total bilirubin (2 cases), and accompanied by rash in 1 case. Using RUCAM scale, 7 patients were classified as "highly probable" and 2 patients were classified as "probable". Using  "Grade of DILI severity"" standard, all the 9 patients were diagnosed as "mild liver injury". After 4-13 days of edaravone withdrawal, 8 patients had normal liver function and 1 case improved.ConclusionsEdaravone might cause liver injury, mainly manifesting liver dysfunction. The degree of liver injury was mild, and the prognosis was good after timely intervention.
  • Drug-induced liver failure: clinical analysis of 108 cases
    Wang Lijun, Zhan Hanqiu
    2018, 20(3): 169-175. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.003
    Abstract ( ) PDF ( )
    ObjectiveTo explore the etiology, clinical features and outcome of drug-induced liver failure (DILF) for reference to safe drug use in clinical practice.MethodsThe information of patients with DILF, who were admitted to the Department of Liver Disease in Beijing Ditan Hospital Capital Medical University from January 1, 2007 to December 31, 2016 was collected using hospital information system and analyzed retrospectively.ResultsA total of 108 patients were entered investigation, including 46 males (42.6%) and 62 females (57.4%), aged 11 to 81 years with a median age 48 (35, 61) years. Of the 108 patients with DILF, 48 patients (44.4%) received Western medicines，43 patients (39.8%) received traditional Chinese medicines, 13 patients (12.0%) received Western medicines combined with traditional Chinese medicines, and 4 patients (3.7%) received medicines with no definite classifications. In 61 patients receiving Western medicines or Western medicines plus traditional Chinese medicines, the top 3 Western medicines were antituberculosis drugs (29.5%, 18/61), nonsteroidal anti-inflammatory drugs (18.0%, 11/61) and anti-infective agents except antituberculosis drugs (14.7%, 9/61). Of 56 patients receiving traditional Chinese medicines or traditional Chinese medicines plus Western medicines, 15 had osteoarthrosis, 15 had skin diseases(53.6% in total, 30/56). Ten patients had no definite diseases, who only took traditional Chinese medicine for recuperation or health care, accounting for 23.3% of the 43 patients receiving traditional Chinese medicines. Among the 108 DILF patients, 44 patients (40.7%) were diagnosed as having subacute liver failure, 41 patients(38%) as acute liver failure, 21 patients(19.4%) as acute-on-chronic liver failure, and 2 patients(1.9%) as chronic liver failure; according to their pathologic features, 66 patients(63.4%) had hepatocyte liver injury, 6 patients(5.8%) had cholestasis liver injury, and 32 patients(30.8%) had mixed type liver injury. The length of hospitalization of 108 patients was 1-183 days, and the medium length of hospitalization was 22 (10, 44) days. In addition, 33 patients (30.6%) died during their hospitalization, 3 patients (2.8%) were judged to be cured, 40 patients(37.0%) were improved, and 32 patients(29.6%) were invalid at the time of their discharge. The MELD scores of patients in the effective treatment group (cure and improvement) and ineffective treatment group (ineffectiveness and death) were (24.2±6.7) and (36.4±12.3), respectively. And the difference was statistically significant(t=-5.9245, P<0.001). A MELD score cut-off values of ≥32.3 (sensitivity 60.0%, specificity 93.0%) was determined as having invalid or death risk for patients with DILF.ConclusionsWestern medicines that might induce liver failure mainly include anti-infective drugs(especially antituberculous drugs) and nonsteroidal anti-inflammatory drugs. Traditional Chinese medicines and their preparations as well as heath care products were also an important cause of DILF. The major pathological features of DILF were hepatocyte liver injury. The prognosis of patients with DILF is poor. MELD score might be used to predict the prognosis of DILF.
  • Hepatic sinusoidal obstruction syndrome related to Tusanqi: clinical analysis of 19 cases
    Wu Dengke, Gao Jie
    2018, 20(3): 176-180. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.004
    Abstract ( ) PDF ( )
    ObjectiveTo explore the clinical characteristics of hepatic sinusoidal obstruction syndrome (HSOS) related to Tusanqi (senecio chrysanthemoides) and fully recognize the severity of the disease.MethodsMedical record data of patients who were diagnosed as having Tusanqi-related HSOS in the First Affiliated Hospital of Soochow University from January 2011 to May 2018 were collected and analyzed retrospectively.ResultsA total of 19 patients entered the study, including 12 males (63.2%), 7 females (36.8%), and the median age was 65(44-82) years. All the patients mistook Tusanqi for Sanqi (Panax notoginseng), and they themselves took Tusanqi steeping in water(13 cases), decocting in water (4 cases) or soaking in wine(2 cases). The reasons for taking Tusanqi were trauma(11 cases), hypertension (4 cases of), lumbar intervertebral disc herniation(2 cases), lumbar fracture(1 cases), and prostatitis hemorrhage(1 cases). The median time of Tusanqi use was 23(5-212) days. The median time from Tusanqi initiation to onset of HSOS was 20 (5-212) days. The RUCAM score were 4 for 1 case, 5 for 7 cases, 6 for 5 cases, 7 for 4 cases, 8 for 2 cases. The patients′ Child-Pugh was classified as follows: A (2 cases), B (8 cases) and C (9 cases). The types of liver injury were cholestasis in 5 cases, hepatocyte injury in 6 cases, and mixed type in 8 cases. The severity of HSOS was classified as super severe in 5 cases, severe in 4 cases, moderate in 7 cases, and mild in 3 cases. The clinical manifestations included abdominal distension, poor appetite, jaundice, hepatomegaly, ascites, and edema of both lower limbs. Laboratory abnormalities included elevated ALT, AST, TBil, and INR levels, prolonged prothrombin time, and decreased PLT and serum albumin levels. The imaging findings were mainly ascites, hepatomegaly, decreased density of liver parenchyma, uneven liver enhancemen, and unclear hepatic vein. The treatment measures included hepatoprotection, diuresis, anticoagulation, hormone therapy, improvement of microcirculation and plasmapheresis. The outcomes of the patients showed that 15 patients improved, and 4 died; and the mortality was 21.1%.ConclusionsTusanqi-related HSOS was a serious adverse reaction with decompensated liver disease as the main manifestation, poor prognosis and high mortality. Therefore, public education of safe drug use should be strengthen to avoid the misuse of Tusanqi.
  • Randomized controlled trial of dialysate calcium concentrations on risks of adverse reactions in hemodialysis patients during dialysis
    Chen Bin, Zhang Ping, Chen Jianghua
    2018, 20(3): 181-186. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.005
    Abstract ( ) PDF ( )
    ObjectiveTo explore the effects of dialysate calcium concentrations (DCC) on risks of adverse reactions occurred in maintenance hemodialysis patients during dialysis.MethodsThe subjects were end-stage renal disease (ESRD) patients in stable condition who were treated with maintenance dialysis in the First Affiliated Hospital, Zhejiang University from June to October 2016. According to the DCC, the patients were randomly divided into 3 groups, the 1.25 mmol/L group, the 1.35 mmol/L group, and the 1.50 mmol/L group; the observation time was 12 weeks. The urea clearance index Kt/V, urea reduction rate (URR), mean arterial pressure before and after dialysis, the serum calcium, serum phosphorus, intact parathyroid hormone (iPTH), and alkaline phosphatase (ALP) levels before and after dialysis, and the incidence of muscle spasm, nausea and vomiting, headache, chest tightness, and arrhythmia in hemodialysis patients in the 3 groups were compared.ResultsA total of 273 patients entered the study, including 159 males and 114 females with ages from 25 to 83 years and average age of (52±9) years. Each of the 1.25 mmol/L, 1.35 mmol/L, and 1. 50 mmol/L groups comprised 91 patients. The differences of baseline data in patients in the 3 groups were not statistically significant (P>0.05). After 12 weeks of hemodialysis, the differences of Kt/V and URR in patients in the 3 groups were not statistically significant (all P>0.05)；the differences of the mean arterial pressures in patients in the 1.25 and 1.35 mmol/L groups ［(102±9) and (103±11) mmHg, respectively］ were not statistically significant (all P>0.0.5); the mean arterial pressure in the patients in the 1.50 mmol/L group was higher than that before hemodialysis ［(120±12) mmHg vs. (103±9) mmHg, P<0.01］ and was higher markedly than that in 1.25 and 1.35 mmol/L groups (all P<0.01); the serum calcium level in patients in the 1.25 mmol/L group was lower than that before hemodialysis ［(1.94±0.31) mmol/L vs. (2.24±0.18) mmol/L, P<0.01］; the serum calcium level in the patients in the 1.50 mmol/L group was higher than that before hemodialysis ［(2.54±0.18) mmol/L vs. (2.24±0.17) mmol/L, P<0.01］; the iPTH and ALP levels in patients in the 1.25 mmol/L group were higher than those before hemodialysis ［(356±68) U vs. (291±49) U, (443±45) U vs. (343±58) U, all P<0.01］. During dialysis, the incidence of muscle spasm in patients in the 1.25 mmol/L group was higher than that in the 1.35 mmol/L and 1.50 mmol/L groups ［14.28%(13/91) vs. 5.49%(5/91) and 4.39%(4/91), all P<0.05］; the incidence of headache in patients in the 1.50 mmol/L group was higher than that in the 1.25 mmol/L and 1.35 mmol/L groups ［14.28%(13/91) vs. 3.30%(3/91) and 5.49%(5/91), P=0.01 and P<0.05］. The differences in incidences of chest tightness, arrhythmia, nausea and vomiting were not statistically significant (all P>0.05).ConclusionThe dialysate with calcium concentration of 1.35 mmol/L may reduce the incidence of muscle spasm, does not increase the incidence of hypertension and headache, and effectively reduce the risk of adverse reactions in maintenance hemodialysis patients, while ensuring the adequacy of dialysis.
  • Analysis on reports of medication errors with methotrexate tablets in National Monitoring Network for Clinical Safe Medication from 2012 to 2017
    Zhang Qingxia, Yan Suying, Li Xiaoling, Zeng Yan, Wang Yuqin
    2018, 20(3): 187-192. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.007
    Abstract ( ) PDF ( )
    ObjectiveTo understand and analyze the occurrence of medication errors with methotrexate tablets and their related factors in order to avoid or reduce the adverse events occurring.MethodsAll medication error reports in National Monitoring Network for Clinical Safe Medication from September 22, 2012 to September 21, 2017 were collected and the reports of medication errors with  methotrexate tablets were selected. And the grading and content of medication errors with methotrexate tablets, the persons who found medication errors, and the triggering factors for medication errors were analyzed.ResultsA total of 25 119 reports of medication errors from the 204 hospitals of 25 provinces and municipalities in our country were collected by National Monitoring Network for Clinical Safe Medication between September 22, 2012 and September 21, 2017.The reports of medication errors with methotrexate tablets accounted for 0.14% (35 /25 119) of the total reports of medication errors. The reports of serious medication errors(E-I) with methotrexate tablets accounted for 3.18%(7/220) of the total reports of serious medication errors. The reports of medication errors with methotrexate tablets involved 34 patients, including 16 males and 18 females aged 25-87 years. The 34 patients included 20 cases of rheumatoid arthritis, 6 cases of psoriasis, 2 cases of systemic lupus erythematosus, 2 cases of leukemia, 1 case of connective tissue disease, 1 case of polymyositis, 1 case of hypertension, and 1 case of toxic diffuse goiter. Of the 35 cases of medication errors, 18 cases(51.43%) were classified as class B, 9 cases(25.71%) as class C, 1 case (2.86%) as class D, 1 case(2.86%) as class E, 5 cases(14.28%) as class F, and 1 case(2.86%) as class I. The serious medication errors accounted for 20.00% of medication errors with methotrexate tablets. Four patients had both wrong dose and wrong frequency of administration. Among the medication errors with methotrexate tablets, the frequency of administration errors ranked first, accounting for 53.85%(21/39) in total. All patients mistook "once weekly" for "once daily". Wrong dose ranked the second, accounting for 30.77%(12/39) in total. Wrong drug class ranked the third, accounting for 7.69% (3/39) in total. The persons who triggered the medication errors with methotrexate tablets included doctors 74.29%(26/35), pharmacists 17.14%(6/35), and patients or their family members 8.57% (3/35). Twenty-six cases of medication errors with methotrexate tablets were triggered by doctors, of them, 24 were discovered and intercepted by pharmacists. Of the 6 cases of medication errors triggered by pharmacists, 3 cases were discovered and intercepted by pharmacists, and one case was discovered and intercepted by a doctor. These medication errors did not cause any harm to the patients. Four cases that were not intercepted and 3 cases triggered by patients or their families were all serious medication errors, of which 1 caused death. Of the persons who discovered the medication errors, pharmacists accounted for 77.14% (27/35), and doctors accounted for 22.86% (8/35). The main factors causing medication errors were lack of related pharmacologic knowledge(45.71%, 16/35), copying error(20%, 7/35), similar drug name or adjacent packing boxes (8.57%, 3/35).ConclusionsMedication errors with methotrexate tablets often occurred in patients with autoimmune diseases. The content of medication errors with methotrexate tablets mainly due to wrong frequency of administration. The incidence of serious medication errors was high, it might cause death. The main cause of medication errors with methotrexate tablets in treating non-neoplastic diseases was lack of understanding of frequency administration "once weekly". Pharmacists might play an important part in detecting and intercepting medication errors with methotrexate tablets.
  • Analysis of efficacy and safety of fosfomycin-trometamol in treatment of acute uncomplicated lower urinary tract infection
    Li Jing, Ge Yunjie, Jia shaodan, Xiao Zhixiu
    2018, 20(3): 193-197.
    Abstract ( ) PDF ( )
    ObjectiveTo evaluate the efficacy and safety of fosfomycin-trometamol (FMT) in the treatment of acute uncomplicated lower urinary tract infection (LUTI).MethodsThe medical records of acute uncomplicated LUTI patients, who had acute uncomplicated LUTI and received FMT or levofloxacin (LEV) in Qingdao Municipal Hospital from January 2015 to October 2017, were collected and analyzed retrospectively. Comparisons were made between the FMT group and the LEV group to investigate the patients' clinical efficacy, bacteriological efficacy, bacteria isolated from urine cultures, the susceptibility of isolated strains to drugs and the occurrence of adverse reactions.ResultsSeventy patients entered the FMT group, including 31 males and 39 females, aged from 29 to 68 years with an average age of (51±10) years．56 patients entered the LEV group, including 26 males and 30 females, aged from 31 to 66 years with an average age of (52±10) years．The treatment periods of patients in the two groups were 3 to 7 days. Routine blood tests and liver and renal function tests were normal before the treatment. After the treatments, 59 patients were cured, 5 patients improved, and the clinical efficacy was 91.4% (64/70) in the FMT group; while 28 patients were cured, 4 patients improved, and the clinical efficacy was 57.1% (32/56) in the LEV group. And the difference was statistically significant (χ2=20.16, P<0.001). Positive bacteria were found in urine culture of 46 patients in the FMT group, including 35 strains of Escherichia coli［17 of which were extended-spectrum β-lactamases (ESBL)-producing Escherichia coli］, 3 strains of Bacillus proteus ［1 of which was ESBL-producing Bacillus proteus］, 3 strains of Enterococous faecalis, 3 strains of Staphylococcus aureus， and 2 strains of Staphylococcus epidermidis. Positive bacteria were found in urine culture of 37 patients in the LEV group, including 29 strains of Escherichia coli (14 of which were ESBL-producing Escherichia coli), 3 strains of Bacillus proteus (1 of which was ESBL-producing Bacillus proteus), 2 strains of Enterococous faecalis, 1 strain of Staphylococcus aureus, and 2 strains of Staphylococcus epidermidis. Bacteriological efficacy were 91.3% and 56.8%, for the FMT group and the LEV group, respectively and the difference was statistically significant (χ2=13.38, P<0.001). Thirteen of the 17 ESBL-producing Escherichia coli strains isolated from patients in the FMT group were susceptible to FMT (susceptibility rate: 76.5%). Five of the 14 ESBL-producing Escherichia coli strains isolated from patients in the LEV group were susceptible to LEV (susceptibility rate: 35.7%). And the difference was statistically significant (P=0.033). The difference of the incidence of adverse reactions was not statistically significant between the FMT group and the LEV group ［11.4% (8/70) vs 16.1% (9/56), χ2=0.575, P=0.448］.ConclusionFMT was more effective and safer than LEV in the treatment of patients with acute uncomplicated LUTI.
  • Safety of dapagliflozin in Asian patients with type 2 diabetes mellitus: a Meta-analysis
    Fang Zhenwei, Shi Jia, Shi Xiujin, Tang Huilin, Lin Yang
    2018, 20(3): 198-209. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.009
    Abstract ( ) PDF ( )
    ObjectiveTo evaluate the safety of dapagliflozin in Asian patients with type 2 diabetes mellitus (T2DM).MethodsRandomized controlled trials (RCTs) which evaluated the safety of dapagliflozin in Asian patients with T2DM from related databases and clinical trial registries from establishment to July 27, 2017 were searched. The patients who treated with dapagliflozin enrolled the dapagliflozin group. The patients who received placebo or other hypoglycemic agents enrolled the control group. The primary safety endpoints included cardiovascular safety, hypoglycemia, genital tract infection and urinary tract infection. The secondary safety endpoints included tumor, pyelonephritis, renal failure, fracture, amputation, etc. Meta-analysis was conducted using RevMan 5.3 and Stata 12.1 software. Risk ratio (RR) and 95% confidence intervals (CI) were calculated for dichotomous outcomes. Mean difference (MD) and 95%CI were calculated for continuous outcomes.ResultsA total of 9 RCTs involving 1 857 Asian T2DM patients enrolled the study. Of 1 857 patients, 1 180 patients were in the dapagliflozin group and 677 patients were in the control group ［the placebo group: 619 patients; the dipeptidyl peptidase-4 (DPP4) inhibitor group: 58 patients］. The results of Meta-analysis showed that the differences of incidences of major adverse cardiovascular events (MACE), non-fatal myocardial infarction, non-fatal stroke, hypoglycemia, and urinary tract infection between the dapagliflozin group and the placebo group were all no statistical significance［0.58% (4/684) vs. 0.99% (4/406), RR=0.59, 95%CI: 0.17-2.02, P=0.40］, ［0.20% (1/510) vs. 0.63% (2/319), RR=0.43, 95%CI: 0.08-2.30, P=0.33］, ［0.52% (3/574) vs. 0.57% (2/352), RR=0.76, 95%CI: 0.18-3.24, P=0.71］, ［5.79% (65/1 122) vs. 8.08% (50/619), RR=0.92, 95%CI: 0.67-1.28, P=0.64］, and ［3.48% (39/1 122) vs. 3.39% (21/619), RR=1.03, 95%CI: 0.61-1.73, P=0.91］, respectively. The incidence of genital tract infection in the dapagliflozin group was higher than that in the placebo group, but the difference was statistically significant ［2.08% (23/1 105) vs. 0.33% (2/611), RR=3.42, 95%CI: 1.21-9.70, P=0.02］. The result of subgroup analysis showed that the incidence of genital tract infection in the dapagliflozin 10 mg group was higher than that in the placebo group, the difference was statistically significant ［2.30% (13/564) vs. 0.36% (2/551), RR=4.56, 95CI: 1.32-15.78,P=0.02］. There were no significant correlations of other major endpoint events between the dapagliflozin groups in different dosage and the placebo group. The level of serum uric acid, compared with the baseline in the dapagliflozin group, decreased more than that in the placebo group, the difference was statistically significant (MD=-15.47 μmol/L, 95%CI: -30.35--0.60, P=0.04). There were no statistical significances of the incidences of tumor, renal adverse events, fracture, and amputation between the dapagliflozin group and the placebo group (all P＞0.05). The level of estimated glomerular filtration rate, compared with the baseline in the dapagliflozin group, decreased similar to that in the DPP4 inhibitor group, the difference was not statistically significant ［MD=1.70 ml/（min·1.73 m2）, 95%CI：-7.79-11.19, P=0.73］. ConclusionsDapagliflozin is relatively safe in the treatment of Asian patients with type 2 diabetes. It should be vigilant for the probability of genital tract infection induced by dapagliflozin in the clinical practice.
  • Clinical analysis of late-onset neutropenia following rituximab
    Cong Jia, Wang Jingwen
    2018, 20(3): 210-215. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.010
    Abstract ( ) PDF ( )
    ObjectiveTo understand the incidence and clinical characteristics of late-onset neutropnia (LON) caused by rituximab.MethodsThe medical records of patients treated with rituximab from hospital information system in Beijing Tongren Hospital, Capital Medical University from December 1, 2012 to March 31, 2017 were collected and retrospectively analyzed. The criteria for neutropenia was defined as neutrophil count <1.5×109/L. ResultsA total of 166 patients were enrolled, including 94 males and 72 females, 16~90 years old and the average age was (63±11) years. Of the 166 patients, 158 had B cell lymphoma, 6 had immune thrombocytopenia, and 2 had optical neuromyelitis. The number of treatment course of rituximab was 2-16 and the median number of treatment course was 5. Among the 158 patients with B cell lymphoma, 37, 30, 22, and 66 cases were in the Ann Arbor stage I, II, III, and IV, respectively, and 27 cases had bone marrow infiltration. Of the 166 patients, 19 patients (11.4%) developed 20 cases of LON, of which 10 (6%) had grade 3-4 neutropenia(6 cases of grade 3, 4 cases of grade 4); the median time for the last use of rituximab to LON occurrence was 56 days (22-105 days), and the median number of the lowest neutrophil count was 0.95×109/L［(0.05-1.47)×109/L］. Three patients(all grade 4 neutropenia) developed complications (including 1 patient with pneumonia/bacteremia, 1 with herpes zoster, and 1 with fever) during neutropenia, and all recovered after use of granulocyte colony-stimulating factor (GCSF) and antibiotics or antiviral treatments. Of 19 LON patients, 5 patients(4 cases of grade 4 neutropenia, 1 cases of grade 3) received GCSF treatment, 14 patients did not receive special intervention, and the median duration of neutropenia was 16 days (5-42 days). The occurrence of LON was not related to age, gender, disease stages and bone marrow infiltration, but the IgM level and B lymphocyte count in LON patients were significantly lower than those in patients without-LON (P<0.001) 6 months after drug withdrawal.ConclusionsThe rate of LON induced by rituximab was 11.4% in our hospital. The 2-3 grade neutropenia caused by rituximab are mostly self limiting, and the prognosis is good.Patients with 4 grade neutropenia may be complicated with infection, so GCSF therapy is needed.
  • The current situation of setting of medication safety officer overseas
    Song Haoxin, Zeng Linan, Xu Bei, Chen Zhe, Lin Mao, Yi Qiusha, Zhang Lingli
    2018, 20(3): 216-219.
    Abstract ( ) PDF ( )
    Medication safety officer (MSO) is an expert and manager of medication safety. Management of medication safety by MSO has been popularized and plays an important role in the medical institutions of the United States (US) and the United Kingdom (UK). The results of systematic search and analysis of literature showed that the setting of MSO in US and UK was mainly based on various characteristics of the adverse drug events (for example, the large number, high possibility for patient damage and economic loss, poor quality of the reports，inadequate management and preventability)，and aimed to reduce its occurrence and then to guarantee the medication safety in patients. In US and UK, the MSOs mainly worked in large hospitals or large health care provider organizations, while the position level was not clearly defined. Responsibilities of MSOs mainly included the formulation and practice of a medication safety program, supervision and improvement of medication safety system, providing professional advice on medication safety, management and reporting of medication safety information in internal medical institution, receiving and transmitting medication safety information outside and carrying out medication safety training. In addition, the US put forward some specific qualification requirements for the position, including educational background, practicing qualification, related training experience, etc. The setting of MSO may be one of the effective measures to solve the problem of medication safety. It is suggested to set up a MSO management system in China′s medical institutions and actively explore a novel management mode of medication safety in China.
  • Cutaneous adverse reactions caused by epidermal growth factor receptor inhibitions: clinical manifestation,  prevention, and management
    Zhu Yuanchao, Chang Jianmin, Hu Xin
    2018, 20(3): 220-225. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.012
    Abstract ( ) PDF ( )
    The target of epidermal growth factor receptor inhibitor (EGFRI) is epidermal growth factor receptor (EGFR). EGFRI can block the activation and signal transduction of EGFR in tumor cells, inhibit the proliferation of tumor cells and induce apoptosis, thus having antineoplastic effect. EGFRIs are currently widely used as targeted anti-tumor drugs. EGFRI can act on skin keratinocytes, interfering with the growth, proliferation, differentiation, migration and adhesion of keratinocytes, causing growth arrest and premature differentiation of the keratinocytes in the basal layer, and often leading to adverse skin reactions. The incidence of EGFRI-related cutaneous adverse reactions was 40% to 90%. Common cutaneous adverse reactions include papulopustular rash, skin pruritus, dry skin, skin cracking, angiotelectasis, and changes of hair and nails. Most cutaneous adverse effects are reversible and dose-dependent. The incidence and severity of adverse skin reactions are closely related to the clinical efficacy of EGFRI. Therefore, the adverse skin reactions should be correctly recognized and should be managed separately  according to the severity of the reactions. In general, grade 1 and grade 2 adverse skin reactions need not withdrawal or dosage adjustment of EGFRI, but severe adverse skin reactions may affect the patients' quality of life, so EGFRI dosage should be reduced or discontinued, and EGFRI retreatment should be continued when the skin damage is improved.
  • Alteplase-induced anaphylaxis accompanied with peripheral hematoma in a patient with acute cerebral infarction
    Zhou Jingliang, Guan Xiaodong, Wu Xinjing, Peng Binbin
    2018, 20(3): 226-227. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.013
    Abstract ( ) PDF ( )
    A 74-year-old male patient with hypertension was admitted to hospital because of aphasia and movement disorder of his right limb for 3 hours. He was diagnosed as acute cerebral infarction. Thrombolytic therapy with alteplase (1 mg/ml) was given 1 hour and 17 minutes after admission. Intravenous injection of alteplase 6.48 mg was given firstly (within 1-2 minutes of completing the injection) and then 58.32 mg was administered intravenously via an infusion pump. About 10 minutes after treatment with alteplase, the patient suddenly developed pallor, drenching sweats, cold limbs, and unconsciousness; his blood pressure dropped from 169/89 mmHg to 112/68 mmHg. Alteplase-induced anaphylaxis was considered. Alteplase was immediately stopped and oxygen inhalation and liquid supplements were given. At the same time, dopamine, diphenhydramine, dexamethasone, and other anti-anaphylactic and anti-shock agents were immediately given. The next morning, the patient developed anemia, RBC 2.12×1012/L, Hb 66 g/L. That night, hematoma appeared in his deep muscle from the right hip (at the injection site) to thigh. The peripheral hematoma was considered to be induced by alteplase. On the 3rd day of admission, the patient developed cerebral palsy and was discharged by his family′s request.
  • Toxic epidermal necrolysis caused by calcium dobesilate capsules: report of 2 cases
    Gao Tingting, Qin Li, Zhou Xiaoyong
    2018, 20(3): 228-230. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.014
    Abstract ( ) PDF ( )
    Two female patients (patient 1, 63 years old; patient 2, 51 years old) with hypertension and chronic renal insufficiency received calcium dobesilate capsules 0.5 g thrice daily. Patient 1 developed red rash on her left upper limb, accompanied by high fever 15 days after medication. Patient 2 developed red rash on her trunk and both thighs, accompanied by cough and high fever 20 days after medication. They developed rash all over the body 1 day (patient 1) and 3 days (patient 2), respectively after the rash occurrence, ulceration on oral mucosa, binoculus, and pudendum 3 days (patient 1) and 9 days (patient 2), respectively after the rash occurrence. They were diagnosed as toxic epidermal necrolysis due to calcium dobesilate capsules. Calcium dobesilate capsules were stopped, and glucocorticoid, human immune globulin, supplement of potassium and calcium, etc. were given. The mucosal erosions were healed or improved on day 13 (patient 1) and 18 (patient 2) of treatments, respectively. The rash faded after 16 days (patient 1) and 25 days (patient 2) of treatments, respectively.
  • Severe diarrhea with abdominal pain caused by rectal administration of carboprost methylate suppositories
    Shen Jie, Ren Hongying, Qi Hong, Tan Fengping
    2018, 20(3): 230-232.
    Abstract ( ) PDF ( )
    A 29-year-old female patient received cervical injection of oxytocin injection 10 U twice daily because of postpartum subinvolution of uterus. On the 4th day of treatment, the patient received a transrectal administration of carboprost methylate suppositories 0.5 mg due to poor efficacy of oxytocin injection. About 20 minutes after rectal medication, the patient developed diarrhea with watery stools 4 times within 70 minutes. About 2 hours after rectal medication, the patient developed persistent abdominal colic and gradually aggravated. Intramuscular injections of metoclopramide 10 mg and pethidine 100 mg were given. However, her abdominal pain did not improve obviously and abdominal ultrasound examination showed no abnormality. Her diarrhea and abdominal pain were considered to be related to carboprost methylate. Symptomatic supportive treatments with spasmolysis, antidiarrheal, potassium supplementation, fluid replacement were given continuously. Five days later, diarrhea and abdominal pain disappeared.
  • Severe hypertension in a very-low-birth-weight infant caused by caffeine combined with cimetidine or erythromycin
    Shen Xintian, Zhou Ping, Liang Xiaoqin, Chen Yu, Zhong Ming, Fan Xiaomei, Guo Huijuan
    2018, 20(3): 232-234. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.016
    Abstract ( ) PDF ( )
    A male preterm infant, who was born at 28 weeks+2 of gestational age and diagnosed as preterm hyaline membrane disease (PHMD) 2 hours after birth, was given nasal continuous positive airway pressure (nCAPA) therapy, intratracheal instillation of poractant alfa injection, intravenous infusion of ceftazidime and penicillin for infection, and caffeine for stimulating respiration. On day 4 of treatment, the infant′s heart rate reached 160-170 beats/min. It was suspected that caffeine induced tachycardia, and the heart rate restored when caffeine was withdrawn. On day 16, the infant′s condition was improved significantly, nCAPA was changed to noninvasive positive pressure ventilation and caffeine was given again to stimulate respiration. On day 24, cimetidine was given due to bile reflux. On day 28, intravenous infusion of erythromycin was given because of positive Ureaplasma urealyticum DNA in sputum. On day 29, cimetidine was stopped. Since day 25 after treatment, the systolic pressure was higher than 83 mmHg for 9 continuous days and elevated to 106/75 mmHg on day 34. The severe hypertension was considered to be caused by caffeine. When caffeine was stopped, the blood pressure returned to normal. On day 46, the infant′s symptoms were improved significantly, high flow oxygen was given, erythromycin was stopped, and caffeine was added for the third time. Hypertension did not recur. The relationship between the hypertension and drugs was evaluated by Karch-Lasagna method, indicating that the hypertension was probably related to combined use of caffeine and cimetidine or erythromycin.
  • Extrapyramidal symptoms caused by aripiprazole
    Wang Yexin, Cheng Yuanyuan, Dong Jicheng, Sun Guoping, Lu Ying, Liang Xiaoling
    2018, 20(3): 235-236. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.017
    Abstract ( ) PDF ( )
    A 56-year-old male patient with undifferentiated type of schizophrenia received one disintegrating tablet of aripiprazole 10 mg orally once daily and the dose of the drug was increased to 30 mg once daily on day 21. Thereafter, the patient′s mental symptoms improved markedly. After receiving aripiprazole for 4 months, the patient developed difficulty in walking. Extrapyramidal symptoms (EPS) induced by aripiprazole was considered. The drug dose was reduced to 25 mg once daily, but the symptoms did not improve, subsequently, hypermyotonia, dysphagia, salivation, mask face, and urinary incontinence appeared. Although the dose of aripirazole was reduced to 5 mg once daily, it did not help to control EPS. Aripirazole was stopped, and 3 days later, the patient′s EPS became aggravated. Intravenous infusions of 0.9% sodium chloride injection 500 ml, IV vitamin C 2 g, IV vitamin B6 0.5 g as well as dextrose and sodium chloride injection 500 ml once daily were given to promote drug excretion. The next day, EPS relieved and on day 5, basically faded.
  • Anaphylactic shock due to doxapram hydrochloride injection
    Dai Chengjia, Li Hongna, Lin Xiaofeng, Lin Yan
    2018, 20(3): 237-238.
    Abstract ( ) PDF ( )
    A 40-year-old female patient was diagnosed as having left breast cancinoma and underwent modified radical mastectomy. The patient′s surgical procedure was uneventful and her vital signs were stable. After the operation, doxapram hydrochloride 100 mg injection  was given by intravenous injection (about 1 minute of completing the injection) to accelerate the patient recovering from the anesthesia. The patient developed shock about 5 minutes after the injection. Her blood pressure fluctuated between 60/46 and 74/54 mmHg, blood oxygen saturation fluctuated between 58% and 74%, and wet rales were audible over both lungs. The patient immediately received oxygen inhalation via a facemask and intravenous injection of adrenaline 40 μg, furosemide 40 mg, and dexamethasone 10 mg. In addition, dopamine 80 mg dissolved in 20 ml of 0.9% sodium chloride injection was administered intravenously via an infusion pump at a rate of 8 ml/h. Twenty minutes later, the patient′s moist rales in both lungs were significantly reduced, her blood pressure was 86/52 mmHg, and oxygen saturation fluctuated between 0.84 and 0.91. On postoperative day 2, the patient had blood pressure 110/70 mmHg, oxygen saturation 0.98, and heart rate 70-80 beats/min. Auscultation revealed the patient had coarse breath sounds in both lungs and slight moist rales were heard in her right lower lung. On postoperative day 5, the patient′s condition was stable and her wound healed well and then she was discharged.
  • L-carnitine injection induced epilepsy
    Wang Shubo, Li Yong, Guo Zhilei
    2018, 20(3): 239-240. https://doi.org/10.3760/cma.j.issn.1008-5734.2018.03.019
    Abstract ( ) PDF ( )
    A 56-year-old female patient was hospitalized because of suffering from chest discomfort for 2 days, and combined with hypertension and diabetes. She received oral valsartan capsules, metoprolol succinate sustained-release tablets, rosuvastatin calcium tablets, aspirin enteric-coated tablets, isosorbide dinitrate tablets, acarbose, and IV infusion of pantoprazole 80 mg+0.9% sodium chloride injection 100 ml and L-carnitine injection 4.0 g+0.9% sodium chloride injection 250 ml once daily. On the third day, about 2 hours after completion of pantoprazole and L-carnitine infusion, the patient presented with unresponsiveness to verbal stimuli, sudden loss of consciousness, limbs convulsion, eyes staring, trismus, and pink frothy sputum. Immediate ECG monitoring, open airway, sucking, oxygen therapy, intramuscular injection of 10 mg diazepam injection, rapid intravenous infusion of glycerol fructose sodium chloride injection 250 ml and 20% mannitol injection 125 ml were given. About 10 minutes later, the patient′s convulsion stopped but she still could not speak and she returned to normal the next day. Symptomatic epilepsy was considered. The probability of epilepsy induced by primary disease was excluded by brain CT and MRI functional imaging examinations and L-carnitine injection was suspected to be associated with the epilepsy. L-carnitine injection was discontinued and other drugs were continued and epilepsy did not recur.
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