中国中药杂志

2021, v.46(03) 712-721

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血必净注射液临床安全性评价不同研究类型间差异化分析
Differential analysis of different study types in clinical safety evaluation of Xuebijing Injection

李晴;金鑫瑶;周霞;庞稳泰;王可仪;李楠;郑文科;
LI Qing;JIN Xin-yao;ZHOU Xia;PANG Wen-tai;WANG Ke-yi;LI Nan;ZHENG Wen-ke;Tianjin University of Traditional Chinese Medicine;Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine;

摘要(Abstract):

根据目前已发表的血必净注射液不同临床研究类型,综合分析比较其安全性评价结果间的差异。通过计算机检索Cochrane Library、PubMed、EMbase、中国学术期刊全文数据库(CNKI)、维普数据库(VIP)、万方数据库(Wanfang)等6个文献数据库,搜索有关血必净注射液临床安全性的随机对照研究、病例对照研究、队列研究、系统评价及临床安全性(医院)集中监测的所有文献,全面、客观地评价血必净注射液安全性,并对不同研究结果进行差异性分析。共纳入211篇文献,使用血必净注射液患者共46 384例,累计发生不良反应423例。包括随机对照研究191篇、队列研究3篇、系统评价15篇、临床安全性(医院)集中监测2篇,不良反应发生率分别为随机对照研究2.54%(常见)、队列研究2.31%(常见)、系统评价0.95%(偶见)、临床安全性(医院)集中监测0.50%(偶见)。423例不良反应中超一半发生于皮肤及附件系统(151例)、心血管系统(68例)及胃肠系统(65例),表现为皮疹、皮肤瘙痒、心悸、血压下降、恶心呕吐、腹泻等,不良反应程度较轻。其中随机对照研究显示血必净注射液用于恶性肿瘤、多器官功能衰竭时ADR发生率最高,系统评价研究显示血必净注射液用于肝硬化自发性腹膜炎时ADR发生率最高。研究类型不同可导致药物安全性评价结果间的显著差异,样本量、研究目的、质量控制是造成结果偏倚的主要因素。临床安全性(医院)集中监测研究因其大样本、高质量的特点成为当前较好的药物临床安全性评价模式,而全生命周期管理更能客观反映药物安全性,指导临床合理用药。
This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.

关键词(KeyWords): 血必净注射液;安全性;不良反应;发生率;文献分析
Xuebijing Injection;safety;adverse reactions;incidence;literature analysis

Abstract:

Keywords:

基金项目(Foundation): 国家自然科学基金青年基金项目(81603493)

作者(Author): 李晴;金鑫瑶;周霞;庞稳泰;王可仪;李楠;郑文科;
LI Qing;JIN Xin-yao;ZHOU Xia;PANG Wen-tai;WANG Ke-yi;LI Nan;ZHENG Wen-ke;Tianjin University of Traditional Chinese Medicine;Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine;

Email:

DOI: 10.19540/j.cnki.cjcmm.20201015.501

参考文献(References):

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