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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。
Aims: To evaluate the efficacy of shuanghuanglian injection in the literature. Methods: CNKI, VIP, CDDB and Pub Med databases were searched and included in the articles with the standard of 365 articles. The statistical analysis and evidence pyramid grading were used to evaluate the target documents. Results: A systematic review and meta-analysis and randomized controlled double-blind trials were included in the study. There were 1 articles in the cohort study (101 cases, 0.27%), 6 articles in the case control study (226 cases, 1.64% ). A total of 152 articles were included in the series of case-analysis articles, with 14 041 cases (41.64%), 174 case reports and 364 cases (47.67%). There were 20 opinions, comments and opinions, 425 cases (5.48%). There were 11 articles in animal research, accounting for 3.01%. There were 1 articles in vitro (“test tube”) with 20 cases (0.27%). Literature statistics show that the evidence of adverse reactions for injection Shuanghuang often case reports and a series of case-type literature, the literature on the incidence of adverse reactions and more clinical manifestations, primary disease, history of allergy, age and other general conditions were reported , Neglecting the quality of drugs that cause adverse drug reactions and the monitoring of the safety of other drugs such as irrational drug use have caused difficulties in exploring the root causes of adverse reactions. Conclusion: The level of evidence for the adverse reaction of Shuanghuanglian for injection is higher than that of the intermediate grade, lack of high-grade documentary evidence.