2021 Volume 23 Issue 2 Published: 28 February 2021
  

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  • Zhang Yinan, Zhao Zhigang
    Abstract ( ) PDF ( )
    With the rapid development of the medical industry, patient safety has attracted more and more attention. Medication safety is an important part of patient safety. Research on medication safety of patients started earlier in the United States, a relatively perfect adverse event reporting and risk management mechanism has formed, and a lot of experience on medication safety in the research and practice has been accumulated. Britain and Australia have published their strategies and suggestions on improving medication safety on government websites and achieved certain results. At present, the problem of medication safety in China is still serious, so it is urgent to strengthen the improvement of medication safety. We should learn from the experience of the above countries and make efforts in establishing medication safety teams, making full use of information technology, strengthening the monitoring and reporting of medication risk, using self-assessment projects to improve safety management, and guiding pharmacists to go deep into clinical work, etc., so as to improve the current situation of medication safety in China.
  • Wei Juanjuan, Lin Yang, Shi Xiujin
    Abstract ( ) PDF ( )
    Objective To compare the occurrence and clinical characteristics of hypersensitivity reactions induced by 3 non-ionic iodine contrast media (NICMs) during percutaneous coronary intervention (PCI). Methods The patients who developed hypersensitivity reactions in iopromide, iohexol, and iodixanol application during PCI were screened out from adverse drug reaction reports of Beijing Anzhen Hospital from January 1, 2013 to December 31, 2018 and the total number of patients who underwent the PCI during that period and received the above NICMs was obtained by searching the hospital information system. The overall incidences of hypersensitivity reactions and severe hypersensitivity reactions and incidences of those induced by each of the 3 NICMs were calculated and their clinical characteristics were analyzed. Results The overall incidences of hypersensitivity reactions and severe hypersensitivity reactions induced by the 3 NICMs were 0.603% (422/69-955) and 0.024% (17/69-955). The incidences of hypersensitivity reactions induced by iohexol, iopromide, and iodixanol were 0.418% (109/26-097), 0.364% (83/22-787), and 1.092% (230/21-071), respectively; the incidences of severe hypersensitivity reactions were 0.023% (6/26-097), 0.039% (9/22-787), and 0.009% (2/21-071), respectively. Iodixanol had a higher incidence of hypersensitivity reactions than iopromide and iohexol (both P<0.001) but the lowest incidence of severe hypersensitivity reactions, which was significantly different from that of iopromide (P=0.047). Of the 422 patients who developed hypersensitivity reactions, 327 were male and 95 were female with an average age of 59 years (range: 27-101 years). The time of hypersensitivity reactions occurrence was recorded in 373 patients and time from NICMs injection to hypersensitivity reactions occurrence were 30-minutes to 90-hours with the median time of 5 hours; hypersensitivity reactions were immediate type (latency ≤1 hour) in 127 patients (34.0%) and delayed type (latency>1 hour) in 246 patients (66.0%). The hypersensitivity reactions induced by iopromide were mainly immediate type (79.5%, 62/78), while those induced by ioxamol were mainly delayed type (87.7%, 193/220). The proportion of patients with a previous history of allergy in the immediate type patients was significantly higher than that in the delayed type patients [15.0% (15/100) vs. 7.1% (14/197), P=0.030]. The most common clinical manifestation of hypersensitivity reactions was rash [78.0% (329/422)]. Among 17 cases of severe hypersensitivity reactions, 15 (88.2%) were anaphylactic shock, 1 was laryngeal edema, and 1 was dyspnea, all of which were immediate type. Hypersensitivity reactions were all improved after treatments, but PCI failed to be fully performed in 6 patients due to severe hypersensitivity reactions. Conclusions The safety of 3 NICMs for PCI was good and the incidence of hypersensitivity reactions was low; the incidence of severe hypersensitivity reactions due to iopromide was the highest. Severe hypersensitivity reactions such as anaphylactic shock might affect the performance of PCI and caution should be given.
  • Xie Zhenguo, Chen Lin, Yu Kun, Peng Zhe, Gong Hongmei, Liao Yunpeng, Lin Min
    Abstract ( ) PDF ( )
    Objective To explore the risk and influencing factors of atrial fibrillation (AF) due to ivabradine. Methods The database of US FDA Adverse Event Reporting System (FAERS) was searched and the drug-related adverse event (AE) reports from the 2nd quarter of 2015 to the 4th quarter of 2019 were extracted. According to the first suspicious drug, the reports were divided into ivabradine group and other drugs group, which were further divided into AF event group and non AF event group, respectively. The signal intensity of AF events related to ivabradine was screened and statistically analyzed by reporting odds ratio (ROR). If the number of AF events was more than 3 and the lower limit of 95% confidence interval (CI) of ROR was more than 1, the AF signal was positive. The stability of the results was evaluated by subgroup analysis and sensitivity analysis and the adjusted ROR value was calculated using logistic regression model in order to reduce the influence of confounding factors. The differences of clinical characteristics such as age, gender, dose, and indications between patients in the AF event group and non AF event group were compared. The clinical characteristics with significant difference (P<0.05) were enrolled in the multivariate logistic regression model to analyze the influencing factors of AF induced by ivabradine. Results A total of 6-019-954 reports were entered in the analysis, including 1-799 cases (0.03%) in the ivabradine group and 6-018-155 cases (99.97%) in the other drugs group. There were 51 cases (2.83%) of AF events in the ivabradine group and 24-266 cases (0.40%) of AF events in the other drugs group. The overall ROR of AF events induced by ivabradine was 7.21 (95%CI: 5.45-9.52) and the overall adjusted ROR was 6.81 (95%CI: 5.13-9.02). The results of subgroup analysis and sensitivity analysis were consistent with the results of overall analysis basically. Multivariate logistic regression analysis showed that the risks of AF after ivabradine administration in the 70-79 years old and ≥80 years old patients were higher than that in the <60 years old patients [odds ratio (OR)=6.525, 95%CI: 1.896-22.456, P=0.003; OR=4.948, 95%CI: 1.050- 23.315, P=0.043]. Conclusions Ivabradine has a risk of AF. Advanced age may be associated with increased risk of ivabradine related AF.
  • Liu Yan, Zhang Jingyue, Wang Yantao, Ji Rongxing, Zhang Juanjuan, Yu Xiaodong
    Abstract ( ) PDF ( )
    Objective To analyze the clinical characteristics of thrombocytopenia induced by eptifibatide. Methods Databases such as CNKI, Wanfang, VIP, PubMed, Web of Science, and Embase as of May 31st, 2020 were searched and case reports on eptifibatide-induced thrombocytopenia were collected. Clinical information including patient′s basic characteristics, eptifibatide application, the occurrence of thrombocytopenia, management and outcomes, etc. were collected and analyzed by descriptive statistical method. Results A total of 30 patients were enrolled in the study, including 17 males and 13 females, aged from 34 to 86 years with an average age of 63 years. Eptifibatide was applied because of percutaneous coronary intervention in 20 patients, acute coronary syndromes in 9 patients, and pre-operative cardiology evaluation in 1 patient. The 29 patients with combined medication records were all treated with heparins, of which 25 received aspirin and 22 received clopidogrel at the same time. The platelet count (PLT) in 30 patients was (129-398)×109/L before eptifibatide treatment and decreased to (<1-78)×109/L after treatment; 1, 2, and 27 cases were with mild, severe, and profound thrombocytopenia, respectively. Time from eptifibatide application to thrombocytopenia occurrence was 1-24-h in 29 patients (≤ 6 h in 21 patients) and 174-h in 1 patient (continuous application for 168-h). Of the 30 patients, 10 had no clinical symptoms, 14 had bleeding symptoms (5 of which were accompanied by decreased hemoglobin), 1 had only decreased hemoglobin, and 5 had other symptoms. Except 1 patient who had stopped eptifibatide 6 hours before thrombocytopenia, the other 29 patients stopped eptifibatide immediately after thrombocytopenia occurrence; 7 patients did not receive any other intervention, 1 patient was treated with glucocorticoid and caffeic acid tablets, and the other 22 patients were treated with platelet infusion and red blood cell infusion, etc. Except 1 patient with no record of time to thrombocytopenia improvement, thrombocytopenia was improved 7 hours to 12 days later in the other 29 patients. Three patients were found to have thrombosis after eptifibatide discontinuation and 1 of them died. Thrombocytopenia recurred in 2 patients after the second application of eptifibatide and was all improved after drug withdrawal and treatments but 1 patient died of septic shock and multiple organ failure finally. Conclusions Eptifibatide might cause severe thrombocytopenia, which usually occurred within 6 hours after application and were without bleeding symptoms sometimes. Thrombocytopenia could be improved if eptifibatide was stopped and platelet transfusion was given according to the patient′s condition.
  • Li Jia
    Abstract ( ) PDF ( )
    Hepatitis C virus protease inhibitors (PIs) are one of the major categories that constitute directly acting antivirals (DAA) regimen in the treatment for hepatitis C. These drugs are mainly metabolized by liver cytochrome P450 and have potential hepatotoxicity. Population pharmacokinetic study data showed that the metabolism of PIs was slower in Asians than that in White/Caucasian subjects, and the results of clinical trials and real-world studies in Asians showed that these drugs had the risk of causing liver enzyme abnormalities and bilirubin elevations. Medical workers in our country should pay full attention to the potential risks of PIs in liver safety, and should not rely too much on safety data in Europe and America. The baseline liver disease severity should be accurately assessed before selecting the DAA regimen containing PIs and the risk of disease progression should be considered. PIs are contraindicated in patients with decompensated liver disease. For patients without cirrhosis or with compensated cirrhosis, the liver function should be closely monitored during the administration of PIs and the management of liver-related adverse events should be paid attention to.
  • Jiang Yongxian, Chen Wenwen, Yang Jia, Tao Wanjun, Li Gen
    Abstract ( ) PDF ( )
    Chengdu Women and Children′s Central Hospital started the construction of a pharmacovigilance system in 2017. In August of that year, 3 venous thrombosis events related to off-label use of heamocogulase agents occurred consecutively within 1 month, which aroused the vigilance of the hospital pharmacovigilance department. And these events were designated as the risk signals of pharmacovigilance. Then the application of heamocogulase agents in the whole hospital was investigated. Intervention measures including formulation of clinical application standard of heamocogulase agents, strengthening of the prescription and medical order management, and strengthening the training of medical staff on the rational use of heamocogulase agents were formulated in connection with the medication risk links, and the pharmacovigilance system of heamocogulase agents was established. From December 2017 to February 2018 after the implementation of the intervention, the consumption of heamocogulase agents decreased by 90.8% (from 6-767 to 624) and the incidences of unreasonable medication indication, irrational course of treatment, and unjustified daily dose decreased significantly, compared with those from June to August 2017 before the intervention. As of the end of 2019, no more heamocogulase agents-related venous thrombotic events have occurred.
  • Quan Hui, Jiang Yuyong, Yu Hao, Hou Yixin
    Abstract ( ) PDF ( )
    Three patients (patient 1, a 27-years-old male with chronic hepatitis C; patient 2, a 71-years-old male with hepatitis C complicated by hepatocellular carcinoma; patient 3, a 60-years-old male with hepatitis C decompensated cirrhosis) were treated with daclatasvir-based regimens and developed drug resistance or treatment failure. Patient 1 and patient 2 received daclatasvir combined with asunaprevir. No resistance variants in the non-structural protein (NS) 5A region of HCV were detected in the 2 patients before treatment. In patient 1, HCV RNA levels were both <15 IU/ml at 4 weeks of treatment and when the drug was stopped at 24 weeks of treatment. Ten days after the drug withdrawal, virological breakthrough occurred and HCV sequence analysis showed variants at 4 sites, including S122G, L31V, Y93H, and C316N. In patient 2, HCV RNA was <15 IU/ml at 8 weeks of treatment and virological breakthrough occurred at 12 weeks of treatment. Both patients were given sofosbuvir/velpatasvir combined with ribavirin for 12 weeks and achieved sustained virologic response (SVR). Patient 3 received sofosbuvir combined with daclatasvir for 24 weeks. His HCV RNA levels were all <15 IU/ml at 4 and 12 weeks of treatment and when the drugs were stopped at 24 weeks of treatment. Virological breakthrough appeared at 12 weeks of drug withdrawal. Sofosbuvir/velpatasvir combined with ribavirin were given for 24 weeks and SVR was achieved.
  • Wang Xiao, Sun Zhenxiao, Xu Chunmei
    Abstract ( ) PDF ( )
    A 29-year-old male patient was treated with quetiapine fumarate (maintenance dose: 0.2 g twice daily) and magnesium valproate sustained release tablets (maintenance dose: 0.5 g twice daily) for bipolar affective disorder. After 9 days of treatments, the patient′s psychiatric symptoms were improved, no adverse reactions occurred, and plasma concentration of quetiapine was 379-μg/L. Clarithromycin 0.25 g orally twice daily was added because of concurrent suppurative otitis media. The next morning, the patient developed lethargy and the blood concentration of quetiapine increased to 614-μg/L, which was considered to be caused by the interaction of clarithromycin and quetiapine. Quetiapine fumarate and clarithromycin were discontinued and intravenous fluids were given to accelerate drug metabolism rate. On the 2nd day, the patient′s lethargy disappeared. Quetiapine fumarate at the original dose was given, magnesium valproate sustained-release tablets were continued, and the antimicrobial drug was switched to cefdinir capsules 0.1 g orally thrice daily. Then the symptoms above-mentioned did not recur.
  • Dong Yuan, Dong Zhiqiang
    Abstract ( ) PDF ( )
    A 74-year-old male patient with gastric body adenocarcinoma received first-line, second-line, and third-line chemotherapy for 6, 8, and 4 cycles, respectively. Because of the poor effect of chemotherapy, the patient received targeted therapy with apatinib (750-mg orally, once daily). Eighteen days later, the patient developed fatigue and dizziness, and stopped the drug by himself. Laboratory test showed that platelet count (PLT) was 41×109/L. He was diagnosed as having grade 3 thrombocytopenia. Platelet-raising therapy was given immediately. After his PLT returned to 153×109/L, the dose of apatinib was reduced to 500-mg once daily. Twenty-one days later, the symptom of dizziness recurred and facial edema appeared. Laboratory test showed that PLT was 45×109/L. It was considered that thrombocytopenia was related to apatinib and dose-dependent. Platelet-raising therapy was given again. Thirteen days later, his PLT returned to 214×109/L and an intermittent medication method with the reduced dose was applied, that is, taking apatinib 250-mg/d for 3 days and stopping for 2 days. After that, thrombocytopenia did not recur and the patient kept in stable condition.
  • Wang Baohua, Yu Dan, Zhu Xu, Zhao Limei
    Abstract ( ) PDF ( )
    A 45-year-old female patient received drospironone and ethinylestradiol tablets (Ⅱ) (containing drospirone 3-mg and ethinylestradiol 0.02-mg in each tablet) orally, once daily after endometrial polypectomy. On the 11th day of medication, the patient developed headache, movement disorder of left limb, and unclear speech without obvious inducement and CT angiography of the head showed cerebral infarction in the right parietal lobe and temporal lobe, which was considered to be related to drospironone and ethinyl estradiol. Drospirone and ethinylestradiol tablets (Ⅱ) was stopped. The treatments such as improving the symptoms of brain injury, reducing intracranial pressure, lowering blood lipids, supplementing iron and potassium, and oxygen inhalation were given. After 11 days of treatments, her movement function of the left limb was improved but the rest had no significant change.
  • Liu Bo, He Huaiwu, Long Yun
    Abstract ( ) PDF ( )
    A 48-year-old male patient with myocardial infarction received continuous intravenous pumping of propofol 1-2-mg/(kg· h) for 21 days due to delirium after cardiopulmonary resuscitation. On the 19th day after intravenous pumping of propofol, the patient developed high fever (the highest body temperature was 40.0-℃), decreased blood pressure (the lowest level was 90/60-mmHg), decreased urine volume (10-ml/h), and dark urine. The laboratory tests showed white blood cell count (WBC) 17.3×109/L, hemoglobin (Hb) 88-g/L, procalcitonin (PCT) 12.76-μg/L, cardiac troponin I (cTnI) 0.342-μg/L, serum creatinine (Scr) 239-μmol/L, creatine kinase (CK) 34-667-U/L, myoglobin (myo) 58-284-μg/L, lactic acid 2-mmol/L, and fungal (1-3)-β-D-glucan 457.9-ng/L. Candida albicans was identified from blood culture. The patient was diagnosed with propofol infusion syndrome and sepsis. Propofol was stopped immediately and replaced by continuous intravenous pumping of midazolam injection (5-mg/h). At the same time, treatments such as anti-infection and continuous bedside hemofiltration were given. After 3 days of treatments, the patient′s temperature dropped to within the normal range. After 7 days of treatments, laboratory tests showed WBC 5.6×109/L, Hb 95-g/L, PCT 0.12-μg/L, cTnI 0.023-μg/L, CK 43-U/L, myo 151-μg/L, Scr 78-μmol/L, and fungal (1-3)-β-D-glucan 88.9-ng/L. His urine volume was 90-100-ml/h.
  • Yin Huanli, Huang Yuan, Chen Zhaoyang, Xu Ting
    Abstract ( ) PDF ( )
    A 37-year-old male patient with acute myelomonocytic leukemia received cytarabine combined with idarubicin for 4 times. The patient did not develop rash or skin damage during the chemotherapy except for myelosuppression and vomiting. The patient developed slight itching on the extremities on the 4th day after the 5th intravenous infusion of idarubicin (20-mg once daily, on day 1) and cytarabine (1-900-mg once per 12-hours, on day 1 to 4), and no special treatment was given. On the 2nd day after finishing the chemotherapy, the patient developed obvious dark brown pigmentation on both cheeks and red papules on his back and bilateral waist, which was considered to be related to combination use of cytarabine and idarubicin. Chlorphenamine maleate 4-mg orally once per 12-hours, and IV infusions of 20% vitamin C injection 5-ml+0.9% sodium chloride injection 100 ml+10% calcium gluconate injection 10-ml once daily were given. Seven days later, the red papules on his back and waist disappeared; 24 days later, his facial pigmentation disappeared basically.
  • Gu Ling, Bao Wenyi, Qian Jian
    Abstract ( ) PDF ( )
    An 87-year-old male patient was scheduled for electronic laryngoscopy examination due to pharyngeal discomfort. Before the examination, he was anesthetized locally with 10-ml dyclonine hydrochloride mucilage in his mouth and vomited out 5-minutes later. After spitting out the medicine, the patient developed shortness of breath, fatigue, and dyspnea suddenly 5-minutes later; cold sweat and syncope appeared 20-minutes later; his pulse oximeter oxygen saturation (SpO2) decreased to 0.50 and unconsciousness appeared 30-minutes later. Severe allergic reaction was diagnosed, which mainly manifested as acute respiratory failure and might be related to dyclonine hydrochloride mucilage. Endotracheal intubation and ventilator assisted ventilation were performed immediately, and anti-infection, expectorant, nutritional support, stable internal environment maintaining treatments were given at the same time. After 6 days′ treatments, the endotracheal intubation was removed and the nasal tube was used for oxygen inhalation. Then the SpO2 was 0.99 and the above-mentioned symptoms disappeared.
  • Zhu Chao, Gong Chunyan
    Abstract ( ) PDF ( )
    A 26-year-old woman received laser decolorization therapy for facial freckles. After the operation, compound arbutin cream 1 g once per night was applied on the face. She developed redness, swelling, and water blisters with desquamation on her face about 12-hours after the first application of the drug. She was diagnosed as having contact dermatitis, which was considered to be related to compound arbutin cream. Then the cream was withdrawn. She received prednisone acetate 20-mg orally once daily, levocetirizine 5-mg orally once per night, and local hydropathic compress with 3% boric acid lotion. Three days later, her facial redness, swelling, and desquamation were obviously improved, and most of the water blisters disappeared. At a one-week telephone follow-up, the patient′s water blisters disappeared.