基于证据金字塔评估注射用双黄连不良反应证据效力  

Effectiveness evaluation on adverse reaction of Shuanghuanglian Injection based on the evidence pyramid

作　　者：唐丹丹[1] 谢晴宇[2] 胡佳卉[1] 孟庆刚[1] 王忠[2] 

机构地区：[1]北京中医药大学,北京100029 [2]中国中医科学院中医临床基础医学研究所,北京100700

出　　处：《中华中医药杂志》2016年第7期2739-2741,共3页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：中国博士后基金项目(No.2014M550133);北京中医药大学创新团队项目(No.2011-CXTD-03)~~

摘　　要：目的:评价注射用双黄连不良反应文献报道证据效力。方法:检索CNKI、VIP、CDDB和Pub Med数据库,纳入符合标准的文献365篇,应用统计分析及证据金字塔分级法,评价目标文献。结果:系统性综述和Meta分析和随机对照双盲试验类文献0篇;队列研究类文献1篇,病例数101例(0.27%);病例对照研究类文献6篇,病例数226例(1.64%);系列病例分析类文献152篇,病例数14 041例(41.64%);病例报告类文献174篇,病例数364例(47.67%);观点、评论、意见类文献20篇,病例数425例(5.48%);动物研究类文献11篇,所占比例为3.01%;离体("试管")研究类文献1篇,病例数20例(0.27%)。文献统计结果表明,注射用双黄连的不良反应证据多为病例报告类文献和系列病例分析类文献,文献多对不良发应发生的临床表现、原发疾病、过敏史、年龄等一般情况进行报道,忽视造成药物不良反应的药物质量、不合理用药等其他药品安全性问题的监测,给探究不良反应根源造成了困难。结论:注射用双黄连的不良反应证据水平在中等级别的文献较多,缺乏高等级的文献证据资料。Objective： To evaluat the evidence level of Shuanghuanglian Injection adverse reaction. Methods： CNKI, VIP, CDDB and Pub Med database were retrieved, and 365 pieces of literature were dopted following the inclusion criteria, then the literatures were evaluated by statistical analysis and evidence pyramid classification. Results： Systematic review, Meta-analysis and randomized double-blind trial class had 0 reference. Cohort study class had 1 reference, which involved the number of cases in 101 cases（0.27%）. Case-control study class had 6 references, which included 226 cases（1.64%）. Series of cases analysis class had 152 references, which included 14 041 cases（41.64%）. Case reports were 174 references, which included 364 cases（47.67%）. View comments had 20 references, and the number of cases was 425（5.48%）. Animal research had 11 references, the percentage was 3.01%. In vitro（test tube） study class had 1 reference, the number of cases were 20（0.27%）. According to the literature statistical analysis, the Shuanghuanglian＇s adverse reaction literatures were mostly the reports or cases analysis. The literatures reported the normal satuation such as the clinical feature, the primary diseases, the allergic history, the age and so on, which ignored the medicine safety issues such as the medicine＇s quality, unreasonable prescription and so on. Conclusion： There is a large amount of literature in the middle grade of evidence, however, the data of high grade of literature evidence is lacking. It was lack of levels of literature evidence.

关 键 词：注射用双黄连 文献报道 不良反应 证据金字塔 

分 类 号：R286[医药卫生—中药学]