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15 May 2020, Volume 17 Issue 5 Previous Issue    Next Issue

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Mechanism and Safety Risk of Anti-novel Coronavirus Pneumonia Drug-tocilizumab WANG Tao 2020, 17(5): 257-260.  DOI: 10.19803/j.1672-8629.2020.05.01 Abstract ( 1013 )   PDF (855KB) ( 884 )   ObjectiveTo analyze the risk of tocilizumab when used in China in order to provide reference for clinical rational drug use. Methods The individual adverse drug reaction cases reported by WHO Vigilyze and China adverse drug reaction database, domestic literature and risk management plans of foreign regulatory agencies were analyzed. Results The risk of hepatic dysfunction, cutaneous damage, anaphylactic reaction, gastrointestinal disorders, infection and hematological damage should be guarded against. Conclusion We should reinforce the safety monitoring of tocilizumab by focusing on such adverse reactions as serious infections and liver damage, and promote the rational application of this medicine. References | Related Articles | Metrics

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Common Adverse Drug Events due to Long-term Medication with Chloroquine / Hydroxychloroquine and Drug Interactions WEI Hongtao, SHEN Su, DI Xuan, CUI Can, LIAO Yin, SONG Yao 2020, 17(5): 261-266.  DOI: 10.19803/j.1672-8629.2020.05.02 Abstract ( 676 )   PDF (1010KB) ( 310 )   ObjectiveTo investigate the possible adverse drug reactions caused by long-term use of chloroquine/hydroxychloroquine (CQ/HCQ) and related risk factors in order to provide evidence for rational clinical applications of these drugs. Methods Electronic databases including PubMed, CNKI and Wanfang were searched for possible ADR/AE caused by CQ/HCQ administration. ADR/AE that occurred more than 3 months after medication were identified as long-term ADR/AE. Results A total of 1 280 articles were retrieved, 85 of which were adopted. Among the 85 articles, 51 involved visual impairment, including 35 cases of maculopathy, 15 cases of vision decline, 1 case of retinopathy, 1 case of color blindness, and 2 cases of blindness. There were 15 cases of improvement after drug withdrawal, but 38 patients didn't recover. Most of the cases of visual impairment could not recover with a cumulative dose >1 000 g and after more than 5 years of medication. There were also 24 articles on heart related ADR/AE involving 31 patients. These ADR/AE involved 25 cases of conduction block, 17 cases of myocardial injury and 15 cases of heart failure. There were 4 cases of death, 6 cases of implantation with pacemakers and 4 cases of heart transplantation. There were 5 articles related to skin ADR/AE and another 5 ones related to other ADR/AE. Conclusion CQ/HCQ can cause serious ADR/AE, including cardiotoxicity, maculopathy, and hypoacusis. CQ/HCQ is mainly metabolized by CYP450 enzyme, so drug interactions deserve attention. References | Related Articles | Metrics

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The Role of Renin-angiotensin System in COVID-19 and Drug Intervention LI Sizheng, HU Guang, HE Jingcheng, HU Yuchi, LI Zhiyong, JIN Hongtao 2020, 17(5): 267-271.  DOI: 10.19803/j.1672-8629.2020.05.03 Abstract ( 430 )   PDF (932KB) ( 303 )   The pathogenesis of COVID-19 is characterized by fever, dry cough and fatigue. In severe cases, it may progress to acute respiratory distress syndrome (ARDS), etc., and even death. SARS-CoV-2 can invade cells through angiotensin-converting enzyme 2 (ACE2) and cause down-regulation of ACE2 expression. The down-regulation of ACE2 expression can lead to the imbalance of renin-angiotensin system (RAS), which leads to the occurrence of subsequent pathological states. RAS also plays an important role in ARDS. This review summarized the possible roles of RAS in the pathogenesis of COVID-19, as well as treatment of COVID-19 based on RAS, hoping to optimize the treatment and provide reference information. References | Related Articles | Metrics

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Adverse Drug Reactions in 45 Patients with COVID-19 YANG Ping, LI Chanjuan, AN Wei 2020, 17(5): 272-275.  DOI: 10.19803/j.1672-8629.2020.05.04 Abstract ( 523 )   PDF (940KB) ( 183 )   ObjectiveTo analyze the adverse drug reactions (ADRs) that occurred during the treatment of patients with COVID-19 in our hospital. Methods Cases of ADRs were collected by clinical pharmacists via questionnaire survey, Kan gnet system, and disease course review. The gender, age, previous medical history, allergic history, report type, suspected drugs,usage and dosage, and clinical manifestations of adverse reactions were retrospectively analyzed. Results A total of 45 ADR cases were collected, and the incidence of ADR was 12.4%, including 44 cases in general（39 known cases, 5 new cases）, and one case of severe ADRs. ADRs occurred more frequently with antiviral drugs lopinavir / ritonavir tablets(LPV/r), glucocorticoid methylprednisolone(MP), and the antibacterial drug moxifloxacin. Conclusion During clinical use of multiple drugs for COVID-19, it is necessary to have a clear idea about indications, patients' health status, drug interactions and precautions. While efficacy is emphasized, related ADRs should also be made better-known, spotted and reported in time to ensure the safety of drug use. References | Related Articles | Metrics

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Trend Analysis of Ten-year Annual Reports on Adverse Drug Reaction Monitoring WANG Dan, REN Jingtian, DONG Duo, PENG Lili, LIU Wei 2020, 17(5): 276-283.  DOI: 10.19803/j.1672-8629.2020.05.05 Abstract ( 1364 )   PDF (1576KB) ( 898 )   ObjectiveTo analyze the pattern of change of ADR monitoring data in China over the past ten years so as to point out some issues worthy of attention. Methods The data in the annual report on ADR monitoring issued by the state drug regulatory agencies from 2009 to 2018 was analyzed, the trend of change explored and the reasons were analyzed. Results The number and quality of ADR reports in China have been improved rapidly in the past decade, the coverage of monitoring networks has been expanding, and the ability of risk identification and control has been enhanced. However, there are still some problems worthy of attention and the need for improvement. Conclusion Drug regulatory agencies and ADR monitoring centers should conduct in-depth research based on the risk highlighted by the monitoring data and on the experience accumulated over the years, shift priorities and work hard to improve the level of monitoring. References | Related Articles | Metrics

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Study on Adverse Drug Reactions Signal Early Warning of XianlingGubao Capsule and Tablet GAO Huanhuan, ZHANG Yili, XIE Yanming, GUO Zhengyi, WANG Zhifei 2020, 17(5): 284-289.  DOI: 10.19803/j.1672-8629.2020.05.06 Abstract ( 587 )   PDF (1910KB) ( 227 )   Objective To improve the safety of clinical application of Xianlinggubao oral dosage forms, a Chinese patent medicine commonly used for orthopedics by detecting early warning signals of adverse reactions (ADR) in clinical practice. Methods SRS data of Xianlinggubao oral dosage forms provided by Guizhou Tongjitang Pharmaceutical Co., Ltd. were used as the subjects of this study. The data was collected between January 1, 2004 and July 21, 2016. Early warning signals of adverse drug reactions related to Xianlinggubao oral dosage forms were analyzed. PRR and Bayesian confidence propagation neural network (BCPNN) were used to analyze the top ten frequent ADR manifestations (rash, itching, nausea, vomiting, chills, gastric dysfunction, dizziness, fever, allergic reaction and pneumothorax) in SRS data reports and background data, while the propensity score method (PS) was used to control the confounding factors. Results The early warning signals of ADR manifestations confirmed by both methods were nausea, vomiting, gastric dysfunction and dizziness. The warning signals disappeared after the tendency score brought the confounding factors under control. Conclusion Nausea, vomiting and gastric dysfunction are the early warning signals of ADRs caused by Xianlinggubao oral dosage forms. Due to the limitation of SRS data, whether this result is directly related to Xianlinggubao oral dosage forms needs to be confirmed by multiple studies to find comprehensive evidence and provide more reliable and effective guidance for rational clinical use and risk reduction. References | Related Articles | Metrics

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Comparative Analysis of Serious Adverse Drug Reactions Induced by Atypical Antipsychotic Drugs MA Minkang, LV Xiaoqin, GENG Mengchun 2020, 17(5): 290-295.  DOI: 10.19803/j.1672-8629.2020.05.07 Abstract ( 494 )   PDF (1225KB) ( 441 )   ObjectiveTo investigate the characteristics of serious adverse drug reactions (ADRs) associated with eight types of atypical antipsychotics in order to provide reference for safe and rational use of drugs in clinic. Methods There were 1 497 serious ADRs induced by clozapine, risperidone, olanzapine, quetiapine, ammonia, ziprasidone, aripiprazole and paliperidone as reported by Zhejiang ADR monitoring system from January 2015 to April 2019. These ADRs were analyzed by using Excel software. Results These serious ADRs caused by different atypical antipsychotic drugs varied, the most common of which involved damage to the liver and biliary system and to the neurological system. However, some ADRs were unique to certain drugs. For example, paliperidone led to reproductive disorders, clozapine blood disorders, ammonia damage to the endocrine system, and aripiprazole led to urinary tract disorders. Conclusion ADRs caused by atypical antipsychotic drugs are wide-spread. It’s important to strengthen the monitoring of serious ADRs by such means as a regular follow-up of liver function and B ultrasound. In addition, more attention should be paid to unique ADRs of different drugs. Doctors should prescribe drugs with reference to the patients' preexisting diseases. References | Related Articles | Metrics

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Literature Review of Baclofen-induced Adverse Reactions in Patients with Renal Insufficiency ZHAO Min, HUANG Zhenguang 2020, 17(5): 296-299.  DOI: 10.19803/j.1672-8629.2020.05.08 Abstract ( 371 )   PDF (981KB) ( 194 )   Objective To explore the regularities and characteristics of adverse reactions induced by baclofen in patients with renal insufficiency so as to provide reference for rational clinical use of this drug. Methods The CNKI, VIP, Pubmed, Wiley and EBSCO database were searched to retrieve related articles published between 1990 and 2018 . The clinical data of baclofen induced adverse reactions in patients with renal diseases was collected and statistically analyzed. Results A total of thirty-one pieces of literature involving forty-eight cases were enrolled for analysis. The patients comprised twenty-eight males (58.33%) and twenty females (41.67%). Twenty-nine of them (61.70%) were above 60 and 43 of them (89.58%) were patients with ESRD. The adverse drug reactions induced by baclofen usually started within four days (77.08%). The daily dose of baclofen ranged from 5mg to 30mg. The major clinical manifestations were drowsiness, unconsciousness and coma. Of the forty-eight patients, four (8.33%)improved after drug discontinuation, six (12.50%) improved after peritoneal dialysis, and thirty-eight (79.17%) improved after hemodialysis. Conclusion Baclofen can lead to adverse drug reactions in the central nervous system of patients with renal insufficiency. Careful assessment of risk versus benefit is required when baclofen is used for patients with kidney disease. Patients taking baclofen must be monitored. References | Related Articles | Metrics

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128 Cases of Adverse Drug Reactions Induced by Amisulpride Tablets YANG Xue 2020, 17(5): 300-304.  DOI: 10.19803/j.1672-8629.2020.05.09 Abstract ( 428 )   PDF (1064KB) ( 751 )   ObjectiveTo analyze the characteristics and patterns of adverse drug reactions (ADRs) induced by amisulpride and promote clinically rational use of this drug. Methods The clinical data on 128 cases of ADRs caused by amisulpride tablets was retrospectively analyzed. These cases were collected by Henan ADR monitoring system between January 2011 and May 2019. The patients' gender, age, medical history, medication and adverse drug reactions were analyzed. Results ADRs caused by amisulpride mostly occurred in patients aged 15 to 44 (75.78%). Most of the ADRs were neurologcial disorders , endocrine disorders, gastrointestinal disorders and cardiovascular disorders. Clinical manifestations included extrapyramidal disorders, hyperprolactinaemia, sinus bradycardia, constipation and leucopenia. Conclusion We should be alert to the occurrence of adverse reactions, strengthen the monitoring and risk management of drug use, and ensure the safety of drug use. References | Related Articles | Metrics

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One Case of Angioedema Induced by Acetylcysteine Injection WANG Xinlu, LI Yanjiao, SONG Yanqing, WANG Xiangfeng 2020, 17(5): 305-307.  DOI: 10.19803/j.1672-8629.2020.05.10 Abstract ( 533 )   PDF (820KB) ( 354 )   ObjectiveTo investigate the causes of and solutions to angioedema induced by acetylcysteine injection. Methods The possibility of and solutions to angioedema caused by acetylcysteine injection were analyzed in one patient with arteriosclerosis obliterans admitted to the Department of Vascular Surgery of the First Hospital of Jilin University in September 2018. Results A 65-year-old female patient was admitted to the hospital because her left lower limb had felt cold, numb and hurt for a year.On the first day after admission, the patient was intravenously given 8 g acetylcysteine along with 250 mL 5% glucose.After eighty minutes, such symptoms of angioedema appeared as facial edema and systemic rash.Medication was discontinued right away and antiallergic treatment was offered.The above symptoms disappeared after one hour of symptomatic treatment. On the 14th day, the patient got better and was discharged. Conclusion Acetylcysteine injection might have caused angioedema in this patient. Dripping has to be slow while this drug is injected, and it should be used with caution among patients with a history of drug allergy and asthma. At the same time, the patient has to be attended to and observed closely. References | Related Articles | Metrics

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One Case of Liver Injury Induced by Mycophenolate Mofetil Dispersible Tablets YIN Tong, WANG Yaochen, NI Xiaojun 2020, 17(5): 308-310.  DOI: 10.19803/j.1672-8629.2020.05.11 Abstract ( 766 )   PDF (813KB) ( 382 )   ObjectiveTo analyze such adverse effects of mycophenolate mofetil dispersible tablets as drug-induced liver injury. Methods The clinical data on one case of elevation of hepatic enzymes after taking mycophenolate mofetil dispersible tablets in Shanghai Renji Hospital in December 2019 was summarized. Results The patient complained about progressive vision loss of more than 2 months. She was diagnosed with neuromyelitis optica spectrum disorders. Hepatic enzymes gradually increased 5 days after taking mycophenolate mofetil dispersible tablets (0.25 g/d). The peak value was 350 U/L for alanine aminotransferase (ALT), 161 U/L for aspartate aminotransferase (AST), 126 U/L for lactate dehydrogenase (LDH), 63 U/L for alkaline phosphatase (ALP), and 25 U/L for γ-L-glutamyltranspeptidase (γ-GT). After mycophenolate mofetil dispersible tablets were discontinued, hepatoprotective treatment was given. During the revisit 5 days later, her hepatic function returned to normal. Conclusion Mycophenolate mofetil has adverse effects, such as drug-induced liver injury. References | Related Articles | Metrics

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Big Data and Pharmacovigilance: Recent Developments and Applications LI Meng, HU Hao, UNG Oi Lam Carolina 2020, 17(5): 311-314.  DOI: 10.19803/j.1672-8629.2020.05.12 Abstract ( 731 )   PDF (870KB) ( 551 )   ObjectiveTo review and summarize the recent developments and applications of big data technology in pharmacovigilance in order to shed light on possible measures for improving the identification of adverse drug events in China. Methods Official documents from developed countries and recent literature were searched to identify, analyze and summarize the status quo and future developments of big data applications in pharmacovigilance. To elucidate the findings, drug-induced liver injury was used as a case study. Results An increasing number of countries are establishing registries and databases, collaboration networks and alliances to support the big data approach to pharmacovigilance. Big data has played a big role not only in the monitoring and analysis of adverse drug events, but also in the establishment of predictive models of adjuvant pharmacovigilance to predict and prevent potential adverse reactions. Conclusion The development paradigm of pharmacovigilance has changed, and the role of big data in pharmacovigilance will become more prominent in the future. For China, we can learn from other countries to make more informed decisions on the strategies for advancing the pharmacovigilance system. References | Related Articles | Metrics