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2022, 24(4)
HighLights More»   
· Incidence and influencing factors of favipiravir-associated serum uric acid elevation in patients with coronavirus disease 2019
· Efficacy and safety of aripiprazole in the treatment of antipsychotic-induced hyperprolactinemia: a meta-analysis
· Risk factors analysis and predictive value evaluation of linezolidine-induced thrombocytopenia
· Management status of suspected unexpected serious adverse reaction reports in clinical trial sites
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  Adverse Drug Reactions Journal--2022, 24 (4)   Published: 28 April 2022
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Incidence and influencing factors of favipiravir-associated serum uric acid elevation in patients with coronavirus disease 2019 Hot!
Qian Fang, Xu Yanli, Song Meihua, Tian Di, Ren Xingxiang, Ge Ziruo, Zhang Tingyu, Wang Aibin, Han Bing, Chen Zhihai
Adverse Drug Reactions Journal. 2022, 24 (4): 169-174. ;  doi: 10.3760/cma.j.cn114015-20211025-01095
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Objective To explore the occurrence and influencing factors of serum uric acid elevation in patients with coronavirus disease 2019 (COVID-19) treated with favipiravir. Methods Medical records of patients with COVID-19 who were hospitalized in Beijing Ditan Hospital between June 1, 2020 and June 30, 2021 and treated with the 5- or 10-day regimen of favipiravir were collected and retrospectively analyzed. After favipiravir withdrawal, if the elevation in serum uric acid was ≥30% of baseline level, it was defined as serum uric acid elevation. Then patients were divided into serum uric acid elevation group and non-serum uric acid elevation group. The clinical characteristics such as gender, age, body mass index, comorbidities, smoking and drinking behavior, COVID-19 grade, favipiravir regimen, and serum uric acid level and renal function before treatment in patients between the 2 groups were compared. Influencing factors of favipiravir-associated serum uric acid elevation was analyzed using multivariate logistic regression method. Results A total of 179 patients were included in the analysis, including 104 (58.1%) males and 75 (41.9%) females, aged from 19 to 70 years with a median age of 43 years. The level of serum uric acid in 179 patients after favipiravir treatment was significantly higher than before [(451±119) μmol/L vs. (332±94) μmol/L, P<0.001]. The change rate of serum uric acid from baseline level ranged from -57.1% to 157.8% with the median of 38.6%. The elevation in serum uric acid of ≥ 30% of baseline level occurred in 108 (60.3%) patients. The incidences of serum uric acid elevation in patients treated with 5-day and 10-day regimens of favipiravir were 46.8% (36/77) and 70.6% (72/102), respectively, and the difference between them was significant (P=0.001). Multivariate logistic regression analysis showed that body mass index 24.0 to <28.0-kg/m2 (OR=3.109, 95%CI: 1.209-7.994, P=0.019) and 10-day regimen of favipiravir (OR=3.017, 95%CI: 1.526-5.964, P=0.001) were independent risk factors for favipiravir-associated serum uric acid elevation. Conclusions More than half of COVID-19 patients treated with favipiravir can develop serum uric acid elevation. Overweight and 10-day regimen of favipiravir are independent risk factors for serum uric acid elevation in patients.
Efficacy and safety of aripiprazole in the treatment of antipsychotic-induced hyperprolactinemia: a meta-analysis Hot!
Ren Hao, Zhu Jianfu, Qiu Haitang
Adverse Drug Reactions Journal. 2022, 24 (4): 175-184. ;  doi: 10.3760/cma.j.cn114015-20210927-01023
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Objective To explore the efficacy and safety of aripiprazole in the treatment of antipsychotic-induced hyperprolactinemia (AIH). Methods Randomized controlled trials (RCTs) of aripiprazole in treating AIH were collected by searching relevant databases at home and abroad (up to November 29, 2020). Patients in the trial group was treated with aripiprazole on the base antipsychotic drugs, and those in the control group was treated with or without additional placebo. Outcome indicators included serum prolactin normalization rate, serum prolactin level, and the incidence of major adverse events. Meta-analysis was performed using RevMan 5.4-software. The effect size of counting data was risk ratio (RR) and its 95% confidence interval (CI), and the effect size of measurement data was standardized mean difference (SMD) and its 95%CI. Results A total of 23 RCTs were entered in the analysis, including 1-530 patients, 816 patients in the trial group and 714 patients in the control group. The meta-analysis results showed that the normalization rate of serum prolactin in the trial group was higher than that in the control group at the end of the treatment course (4-24 weeks) [73.5% (150/204) vs. 4.1% (8/194), RR=16.58, 95%CI: 8.61-31.93, P<0.001]. According to the dose of aripiprazole, the patients were divided into 5-mg/d and 10-mg/d subgroups. The analysis results showed that the serum prolactin levels in patients in the 2 trial subgroups were lower than those in their corresponding control groups at the end of the treatment, and the differences were statistically significant [SMD=-1.25, 95%CI: -1.66--0.84,P<0.001; SMD=1.93, 95%CI: -2.38--1.48, P<0.001]. There were no significant differences in the incidence of overall adverse events, extrapyramidal reactions, insomnia, somnolence, and weight gain in patients between the trial and control groups during the trial [26.5% (103/388) vs. 24.1% (94/390), RR=1.10, 95%CI: 0.90-1.36, P=0.35; 26.0% (53/204) vs. 34.0% (70/206), RR=0.77, 95%CI: 0.58-1.02, P=0.06; 8.4% (31/368) vs. 9.9% (37/372), RR=0.86, 95%CI: 0.56-1.33, P=0.50; 5.6% (19/340) vs. 4.7% (16/342), RR=1.16, 95%CI: 0.64-2.12, P=0.63; 0 vs. 7.9% (7/89), RR=0.18, 95%CI: 0.03-0.99), P=0.05]. Conclusion Aripiprazole is safe and effective in the treatment of AIH, but the long-term efficacy and safety need to be explored.
Risk factors analysis and predictive value evaluation of linezolidine-induced thrombocytopenia Hot!
Wang Binxia, Duan Lufen, Lu Jian, Zhuang Zhiwei, Yuan Yunlong, Wu Jing, Cao Fan, Shi Lu, Xu Jinhui, Li Jingjing, Zhou Qin, Tang Lian
Adverse Drug Reactions Journal. 2022, 24 (4): 185-191. ;  doi: 10.3760/cma.j.cn114015-20211125-01190
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Objective To explore the risk factors of linezolid-induced thrombocytopenia (LIT) and evaluate their predictive value. Methods Medical records of hospital acquired pneumonia (HAP) patients who admitted in Suzhou Municipal Hospital from July 2019 to October 2021 and received linezolid were collected and retrospectively analyzed. Clinical data including general information, comorbidities, linezolid application, laboratory test results, and trough concentration of linezolid was extracted. Patients were divided into LIT group and non-LIT group according to the occurrence of LIT. Clinical characteristics were compared between the 2 groups; risk factors of LIT in patients with HAP were analyzed using a binary logistic regression model, and the odds ratio (OR) and its 95% confidence interval (CI) were calculated; the predictive value of the risk factors for LIT were evaluated using receiver operating characteristic (ROC) curve. Results A total of 74 patients were included in the study, including 55 males and 19 females, aged 82 (73, 88) years. LIT occurred in 25 patients (33.8%). Compared with the non-LIT group, the age and trough concentration of linezolid in patients in the LIT group were higher [88 (81, 92) years vs. 79(70, 86) years, P=0.001; (19.6±10.3) mg/L vs. (9.8±6.4) mg/L, P<0.001], and the baseline platelet count and baseline creatinine clearance rate were lower [181(162, 212)×109/L vs. 229 (169, 289)×109/L, P=0.025; 31(19, 44) ml/(min·1.73 m2) vs. 46 (27, 65) ml/(min·1.73 m2), P=0.018]. Binary logistic regression analysis showed that the lower baseline creatinine clearance rate (OR=0.974, 95%CI: 0.951-0.998, P=0.035) and higher trough concentration of linezolid (OR=1.156, 95%CI: 1.059-1.261, P=0.001) were independent risk factors for LIT in HAP patients. ROC curve analysis showed that the threshold of the age, trough concentration of linezolid, baseline platelet count, and baseline creatinine clearance rate were 87 years (sensitivity 56.0%, specificity 83.7%), 15.4-mg/L (sensitivity 64.0%, specificity 87.8%), 189×109/L (sensitivity 67.3%, specificity 68.0%), and 45-ml/(min·1.73 m2) (sensitivity 53.1%, specificity 80.0%), respectively. Patients were respec- tively divided into 2 groups according to the thresholds and the incidences of LIT were compared. The results showed that the incidences of LIT in patients with age and trough concentration of linezolid exceeding the thresholds and in patients with baseline plate count and baseline creatinine clearance rate lower than or equal to the thresholds were significantly higher than those in the other patients (all P<0.01). Conclusions Baseline creatinine clearance rate, trough concentration of linezolid, age, and plate count are risk factors for LIT in HAP patients and their thresholds are 45-ml/(min·1.73 m2), 15.4-mg/L, 87 years, and 189×109/L, respectively. These risk factors have good predictive value for the occurrence of LIT.
Management status of suspected unexpected serious adverse reaction reports in clinical trial sites Hot!
Liao Juan, Ma Yuanji, Tang Hong
Adverse Drug Reactions Journal. 2022, 24 (4): 192-196. ;  doi: 10.3760/cma.j.cn114015-20211124-01187
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Objective To understand the management status of suspected unexpected serious adverse reaction (SUSAR) reports in clinical trial sites in China after the release of the 2020 edition of Good Clinical Practice (new GCP). Methods The serious adverse event (SAE)/SUSAR reporting requirements files in each site as of June 30, 2021 were downloaded after logging into the "summary of SAE/SUSAR reporting requirements in national sites under the new GCP" platform on an APP named Yaoyanshe (药研社). The requirements on SUSAR reporting management from above files in each site were extracted, including the acceptance process of the SUSAR reports submitted by the clinical trial sponsor and the processing process after receiving the reports (whether the investigator is required to sign for reading and evaluating the SUSAR reports, the time limit and form/format for the investigator to submit the SUSAR reports to the clinical trial institution and the ethics committee, and the processing method in the clinical trial institution and the ethics committee after receiving the SUSAR reports). The collected data were analyzed by descriptive statistics. Results The SUSAR reporting requirements files in the analysis were collected from 194-sites in 30 provincial administrative regions across the country. In the acceptance process of SUSAR reports submitted by the sponsor, 69.6% (135/194) of the sites required the investigators to sign for reading and evaluating the SUSAR reports, 24.2% (47/194) required the sponsor to submit the SUSAR reports to the clinical trial institution and/or ethics committee, and 6.2% (12/194) had no clear requirements. In the processing process after receiving the reports, 85.1% (165/194) of the sites required the investigators to submit the SUSAR reports to the clinical trial institution and the ethics committee at the same time, 13.4% (26/194) only required the investigators to submit them to the ethics committee, and 1.5% (3/194) had no clear requirements. Except that 1.0% (2/194) sites had no explicit requirements, for lethal/life-threatening SUSAR, 94.3% (183/194), 2.6% (5/194), and 2.1% (4/194) sites required investigators to submit the reports within 7 days, monthly, and quarterly, respectively. Except that 2.6% (5/194) sites had no explicit requirements, for non lethal/life-threatening SUSAR, 54.6% (106/194), 12.9% (25/194), 29.4% (57/194), and 0.5% (1/194) sites required investigators to submit the reports within 15 d, monthly, quarterly, and semiannually, respectively. Requirements on the form/format of SUSAR reports for investigators in submitting were different among sites. Only 12.9% (25/194) of the sites required the ethics committee to filing or meeting in handling of SUSAR reports, and 5.7% (11/194) required feedback on the handling opinions from the ethics committee. Conclusions Requirements on SUSAR reporting are of great differences among sites. The management of SUSAR reports in some sites does not meet the requirements in the new GCP, which may affect the risk control in clinical trials and need to be further standardized.
Domestic and foreign guideline overview on prevention and treatment of thromboembolism in patients with coronavirus disease 2019
Zhang Qingxia, Zhu Yidan, Liu Baojing, Xu Xin, Lu Yun
Adverse Drug Reactions Journal. 2022, 24 (4): 197-202. ;  doi: 10.3760/cma.j.cn114015-20211020-01081
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Coronavirus disease 2019 (COVID-19) can increase the risk of thrombosis and arterial embolism events in patients. The more serious the condition, the higher the risk. Therefore, many academic groups at home and abroad have successively issued guidelines on the prevention and treatment of throm- bosis in patients with COVID-19. Among them, American Society of Hematology 2021 guidelines on the use of anticoagulation for thromboprophylaxis in patients with COVID-19 (ASH guidelines) and its updates are newer and have more detailed recommendations on the application of anticoagulant drugs to prevent venous thromboembolism in acutely and critically ill patients with COVID-19. This review aims to provide reference for clinic through general viewing the ASH guidelines as well as other relevant guidelines at home and abroad.
Medication care of a patient with eosinophilia induced by imatinib
Chen Xiaoli, Zhang Rui, Liang Yan, Yang Zhen, Du Shuzhang
Adverse Drug Reactions Journal. 2022, 24 (4): 203-205. ;  doi: 10.3760/cma.j.cn114015-20210609-00658
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A 53-year-old male patient with small intestinal stromal tumor received imatinib 400-mg orally once daily after surgery. One month later, the patient developed eosinophilia, but it was not treated. Imatinib was continued. Four months later, edema and pain appeared in the hands, feet, and abdomen, which gradually spread to the whole body; ulcers appeared in part skin of the chest and back, and multiple maculopapular and ulcers were scattered throughout the whole body, accompanied by ulceration, exudation, itching, and pain. Eosinophil count was 2.7×109/L. Combined with the results of bone marrow aspiration and skin biopsy, it was diagnosed as eosinophilia and drug-induced rash, which were considered to be caused by imatinib. Clinical pharmacists participated in multidisciplinary consultation, analyzed the relationship between the adverse reactions and the drugs, and recommended stopping the drug, monitoring the blood concentration of imatinib for subsequent use, and adjusting its dosage. Doctors suspended imatinib treatment, and glucocorticoids and antihistamines were given. Then the patient′s rash was improved, and imatinib was continued at a reduced dose.
Bullous haemorrhagic dermatosis induced by urokinase combined with low molecular weight heparin calcium
Liu Huibo, Pei Liping, Ding Yuhong, Zhang Hongmei
Adverse Drug Reactions Journal. 2022, 24 (4): 206-208. ;  doi: 肝素, 低分子量; 皮肤疾病, 水疱大疱性; 尿激酶
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A 70-year-old female patient was treated with low molecular weight heparin calcium, levocarnitine, recombinant human erythropoietin, and ceftazidime due to end-stage renal disease, renal anemia, catheter-related infection, etc. At the same time, ceftazidime, urokinase, and low molecular weight heparin calcium was pumped into the long-term indwelling catheter to dredge the catheter because of suspected local bacterial capsule formation and long-term indwelling catheter blockage. On the 4th day of treatments, the patient developed mild pruritus. On the 5th day, it was found that the skin of her left upper limb and lower abdomen was scattered with dark red blood blisters ranging from 0.01 to 2-cm, with approximate hemispherical or irregular shape, clear boundary, and slight pain in touch. Nikolsky sign was negative. Bullous haemorrhagic dermatosis was diagnosed and it was considered to be caused by the combination use of urokinase and low molecular weight heparin calcium. The 2 drugs were stopped and heparin-free hemodialysis was given. The skin symptoms were relieved gradually. After 9 days of drug withdrawal, the blood blisters dried up and scabbed. At a 2-week follow-up, all blood scabs fell off by themselves.
Subacute thyroiditis induced by quadrivalent lytic influenza virus vaccine
Long Quanhui, Zhao Xinyi, Xiao Zhu, Yang Jia
Adverse Drug Reactions Journal. 2022, 24 (4): 208-210. ;  doi: 10.3760/cma.j.cn114015-20210811-00884
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A 48-year-old woman was vaccinated with quadrivalent lytic influenza virus vaccine. Seven days later, tenderness pain and mass with tenderness pain appeared on the left side of the thyroid gland, which was diagnosed as subacute thyroiditis. The patient received celecoxib capsules 200-mg orally twice daily, external application of Pingying powder (平瘿散), and oral administration of traditional Chinese medicine decoction. The pain and mass disappeared after 21 days of treatments. One week later, similar symptoms occurred on the right side of the thyroid gland, the same dose of celecoxib capsules was given, but it was ineffective. So, it was replaced by prednisone acetate tablets 20-mg orally once daily. Twenty-five days later, the pain was relieved and the neck mass reduced. It was considered that the patient′s subacute thyroiditis was possibly due to quadrivalent lytic influenza virus vaccine.
Immune-related adverse reactions in multiple organs due to nivolumab
Xi Qing, Li Ruirui
Adverse Drug Reactions Journal. 2022, 24 (4): 211-213. ;  doi: 10.3760/cma.j.cn114015-20210616-00683
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A 73-year-old female patient with central squamous cell carcinoma of left lung received one dose treatment of IV infusion of nivolumab 200-mg. On the 16th day after nivolumab treatment, the patient developed left eyelid ptosis and shortness of breath. Laboratory tests showed creatine kinase (CK) 21-378-U/L, CK-MB 529-U/L, N-terminal pro-B-type natriuretic peptide (NT-BNP) 8-783-ng/L, alanine aminotransferase (ALT) 350-U/L. On the 25th day after nivolumab treatment, laboratory tests showed high-sensitivity human troponin T (hs-cTnT) 1-722-ng/L, NT-BNP 2-385-ng/L, white blood cell count (WBC)was 18.5×109/L, neutrophil count was 17.9×109/L, serum free triiodothyronine (FT3) 2.66-pmol/L, thyroid stimulating hormone (TSH) 0.16 mU/L, thyroid peroxidase antibody (TPO-Ab) 61-U/ml, and thyroglobulin antibody (TG-Ab) 62-U/ml. Nivolumab-related immune myositis, myocarditis, pneumonia, and abnormal thyroid function and liver function were considered. Glucocorticoid, anti-infection, and anti-arrhythmia treatments, etc. were given. Seven days later, sinus rhythm in the patient was recovered, hs-cTnT decreased to 847-ng/L, ALT and aspartate aminotransferase were 51-U/L and 31-U/L, respectively; 34 days later, WBC was 6.8×109/L and neutrophils percentage was 0.70; 37 days later, the patient returned to spontaneous breathing; 49 days later, the patient′s muscle strength recovered significantly, NT-BNP was 185-ng/L, and hs-cTnT was 687-ng/L. Except that TSH was 16.03 mU/L, other indexes related to thyroid returned to the reference value range.
Acute pancreatitis induced by tacrolimus in a patient after kidney transplantation
Li Guangping, Wu Jiangtao, Wang Qi, Cui Bo, Wang Xu, Lu Lu, Ou Tongwen
Adverse Drug Reactions Journal. 2022, 24 (4): 213-215. ;  doi: 10.3760/cma.j.cn114015-20210510-00548
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A 38-year-old female patient with uraemia received tacrolimus 1-mg orally twice daily after kidney transplantation. The serum trough concentration of tacrolimus was 9.8-μg/L on the 15th day. On the 17th day, the patient developed abdominal pain, nausea, and vomiting. The abdominal CT showed that the volume of pancreas increased, the edge was irregular, and obvious exudation appeared around the pancreas and in the abdominal cavity. Laboratory tests showed blood amylase 430-U/L and lipase 231-U/L. The acute pancreatitis related to tacrolimus was considered. Tacrolimus was stopped and replaced by cyclosporine A 100-mg orally twice daily. Meanwhile, symptomatic and supportive treatments such as fasting, gastrointestinal decompression, lipid-lowering, acid inhibition, anti-infection, and parenteral nutrition were given. Three days later, the above symptoms were relieved. Nineteen days later, laboratory tests showed blood amylase 173-U/L and lipase 51-U/L; abdominal CT showed that the outline of the pancreas was clearer than before, and the exudation around was significantly reduced.
Stent thrombosis in coronary caused by self-withdrawal of ticagrelor
Zhang Shilin, Li Zhengrong, Lai Xiangyang
Adverse Drug Reactions Journal. 2022, 24 (4): 216-217. ;  doi: 10.3760/cma.j.cn114015-20210601-00625
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A 39-year-old male patient underwent coronary angiography due to acute extensive anterior myocardial infarction and a stent was placed in the anterior descending branch. After the operation, the patient received dual antiplatelet therapy with aspirin enteric coated tablets 100-mg orally once daily and ticagrelor 90-mg orally twice daily. Four days later, the patient stopped ticagrelor by himself. Three days after drug withdrawal, he developed chest tightness and chest pain. The coronary angiography showed stent thrombosis, which was considered to be related to discontinuation of ticagrelor. Thrombus aspiration was performed and coronary angiography showed no stenosis and unobstructed blood flow. Dual antiplatelet therapy was continued after operation. At a 2-month follow-up, the patient did not have chest tightness, chest pain, or other symptoms after taking medicine regularly according to the doctor′s advice.
Granulomatous mastitis and hyperprolactinemia caused by risperidone
Liu Jieli, Sun Ping, Zuo Ximeng, Yang Zhenrui, Wang Tangshun, Shi Xiaoguang
Adverse Drug Reactions Journal. 2022, 24 (4): 218-220. ;  doi: 10.3760/cma.j.cn114015-20211008-01034
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A 19-year-old female patient received risperidone 3-mg twice daily for schizophrenia. She did not have nipple discharge before taking the drug. After taking the drug, nipple discharge occurred intermittently. One year later, a mass with pain in the right breast was found, which could not be alleviated after treatments with Rupi Sanjie capsules (乳癖散结胶囊), cefdinir, ibuprofen, rifampicin, and isoniazid and continued to increase, accompanied by bilateral knee pain, nodular erythema and tenderness of lower limbs. Laboratory tests showed white blood cell count 18.4×109/L and serum prolactin 37.42-μg/L. Ultrasonography of the right breast showed a 13.2-cm×11.0-cm×3.0-cm area low echo with unclear boundary, local fluidity, and abundant blood flow signals around. Granulomatous lobular mastitis of right breast (abscess stage) and hyperprolactiemia was diagnosed. After excluding physiological and pathological reasons, it was considered that risperidone caused hyperprolactinemia, which then induced granulomatous mastitis. However, risperidone could not be stopped without the guidance of a specialist, so only abscess incision, drainage, debridement, anti-infection, and anti-inflammatory were given. Purulent secretions gradually decreased, pain alleviated, and erythema of lower limbs partially subsided. Then risperidone dose was adjusted to 2-mg twice daily under the guidance of her psychiatrist. The serum prolactin level decreased (28.36-μg/L). At 1 year of follow-up, granulomatous mastitis did not recur.
Rhabdomyolysis secondary to malignant syndrome caused by buspirone combined with lorazepam
Wang Bing, Zhou Guangjie, Li Jinfeng, Tang Huaying, Zhang Ailun, Huang Huixuan
Adverse Drug Reactions Journal. 2022, 24 (4): 220-222. ;  doi: 10.3760/cma.j.cn114015-20210914-00995
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A 66-year-old male patient with anxiety and depression received lorazepam 1-mg twice daily and buspirone 10-mg twice daily. Two months later, the patient developed chills, fever, drowsiness, and stiffness of limbs, etc. Laboratory tests showed white blood cell count 13.5×109/L, neutrophils 0.89,C-reactive protein 68.7-mg/L, serum creatinine 211-mmol/L, direct bilirubin 10.3-mmol/L, alanine amino- transferase 96-U/L, aspartate aminotransferase 121-U/L, creatine kinase (CK) 4-557-U/L, CK-MB 83-U/L, lactate dehydrogenase 462-U/L, α-hydroxybutyrate dehydrogenase 339-U/L, and troponin 116-ng/L. Malignant syndrome caused by buspirone was considered. The drug was stopped, lorazepam was continued, and oxygen inhalation, ECG monitoring, physical cooling, anti-infection, and other treatments were given. The patient still had fever and developed deep coma, with brown urine and myoglobin >3 000-mg/L. Secondary rhabdomyolysis was considered. Anti-infection treatment was continued and treatments such as correcting electrolyte balance, alkalizing urine, and diuresis were given. On the 10th day of drug withdrawal, the patient had normal limb activity and urine color, his creatine kinase was 246-U/L, and myoglobin was 856-mg/L. One month later, the laboratory tests showed no obvious abnormalities and no malignant syndrome releted symptoms recurred. The rhabdomyolysis secondary to malignant syndrome in the patient was considered to be possibly related to buspiron and the combination with lorazepam might promote its occurrence.
Liver injury induced by Mugua pills(木瓜丸) combined with Zhuifeng Tougu pills (追风透骨丸)
Xu Zhiyu, Zhang Aiwu
Adverse Drug Reactions Journal. 2022, 24 (4): 223-224. ;  doi: 10.3760/cma.j.cn114015-20211203-01221
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A 63-year-old female patient was treated with 30 Mugua pills and Zhuifeng Tougu pills 6 g twice daily for tenosynovitis. After taking the medicine for 10 days, the patient developed nausea and vomiting, which were aggravated gradually; after taking the medicine for 22 days, the patient had fever, nausea, retching, slight pain in the upper abdomen, systemic edema, skin pruritus, and poor spirit, appetite, and sleep. Laboratory tests showed alanine aminotransferase (ALT) 454-U/L, aspartate aminotransferase (AST) 946-U/L, alkaline phosphatase (ALP) 133-U/L, gamma glutamyltransferase (γ-GT) 170-U/L, direct bilirubin (DBil) 12.8-μmol/L, and glutamate dehydrogenase 17.3-U/L. Viral hepatitis and biliary obstruction were excluded by laboratory tests and imaging examination. Drug-induced liver injury was diagnosed, Mugua pills and Zhuifeng Tougu pills were stopped, and diisopropylamine dichloroacetate injection and compound glycyrrhizin tablets were given. Liver function was gradually improved in the patient and laboratory tests showed ALT 62-U/L, AST 49-U/L, γ-GT 38-U/L, and DBil 7.2-μmol/L 12 days later. The medication was adjusted to 3 compound glycyrrhizin tablets thrice daily for 2 weeks. After 4 weeks, laboratory tests showed ALT 31-U/L, AST 26-U/L, γ-GT 30-U/L, and DBil 5.0-μmol/L.
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