清开灵注射液治疗病毒性肝炎引起肝功能异常的Meta分析

摘要

AIM The proofs of evidence-based medicine of Qingkailing Injection's effect on viral hepatitis are lack in spite of the wide use of Qingkailing Injection in medical practice.This study aims to use Meta-analysis to evaluate its clinical effect and safety.METHODS Such databases as CNKI,VIP and Wanfang were searched for randomized controlled trials related to Qingkailing Injection in treatment of viral hepatitis,which were published officially between 1996--2016.Revman 5.3 software was used to conduct Meta-analysis for the effective rate,rate of adverse reaction,the decrease rate of ALT,AST and TBIL of Qingkailing Injection.Meanwhile,subgroup analysis was conducted to the clinical effect of doses [＜ 0.5 mL/(kg · d),0.5-0.67 mL/(kg · d),＞0.67 mL/(kg · d)],treatment courses (≤ 14 d,＞ 14 d),manufacturers (Beijing University of Chinese Medicine Pharmaceutical Factory,Shenwei Pharmaceutical Company,Shanxi Taihang Pharmaceutical Company),year (1996 to 2002,2003 to 2009,2010 to 2016).RESULTS Fourteen studies were included according to the criterion.The results of Meta-analysis showed that the total effective rate,the decrease rate of ALT,AST and TBIL in Qingkailing Injection group were significantly higher than those in the control group (P ＜ 0.05).Whereas,no significiant differences were found between Qingkailing Injection group and the control group of its rate of adverse reaction (P ＞ 0.05).Subgroup-analysis showed that the effective rate of Qingkailing in doses subgroup,treatment courses subgroup,manufacturers subgroup and year subgroup were significantly higher than those of the control group.CONCLUSION Qingkailing Injection has obvious benefit in the treatment of viral hepatitis,which can reduce the activity of ALT and AST,also can reduce the content of TBIL.But we should pay attention to the prevention of allergic reaction in the clinical use.%目的 清开灵注射液在临床实践中常用于治疗病毒性肝炎,但缺乏一定的循证医学依据.本研究采用Meta分析方法以期评价其在临床应用的有效性和安全性.方法 计算机检索CNKI(中国期刊全文数据库)、VIP(中文科技期刊数据库)和万方数据库1996-2016年期间发表的有关清开灵注射液静脉注射治疗病毒性肝炎的临床随机对照研究,采用RevMan5.3软件对清开灵注射液的有效率、不良反应率、ALT(谷丙转氨酶)下降率、AST(谷草转氨酶)下降率以及TBIL(总胆红素)下降率进行Meta分析,同时对剂量[＜0.5 mL/(kg·d)、0.5～0.67 mL/(kg·d)、＞0.67 mL/(kg·d)]、疗程(≤14 d、＞14 d)、厂家(北京中医药大学药厂、神威药业、山西太行药业)、年份(1996-2002、2003-2009、2010-2016)的有效率进行亚组分析.结果 根据纳入和排除标准纳入文献14篇.Meta分析结果显示,其总有效率、ALT、AST和TBIL指标的下降率均明显高于对照组(P＜0.05),而其不良反应发生率与对照组相比无显著差异(P＞0.05);亚组分析结果显示,不同剂量、不同疗程、不同厂家以及不同使用年份,其中的清开灵注射液治疗组的有效率均明显高于对照组(P＜0.05).结论 清开灵注射液治疗病毒性肝炎具有明显的疗效,能降低患者ALT、AST活性和TBIL含有量.但其临床使用时应注意预防过敏样反应的发生.