茵栀黄注射液对黄疸型病毒性肝炎的退黄效果与安全性的系统评价

目的评价茵栀黄注射液对黄疸型病毒性肝炎的退黄效果与安全性.方法计算机检索MEDLINE(1966～2005),Cochrane 图书馆(2005年第1期)的临床对照试验资料库、肝病组资料库,中国生物医学文献数据库(1978～2004),中文生物医学期刊文献数据库(1994～2005),中国医学学术会议论文数据库(1994～2005),中国期刊全文数据库(1994～2005),中文科技期刊数据库(1989～2004).纳入茵栀黄注射液治疗黄疸型病毒性肝炎的随机对照试验及半随机对照试验,并对其进行质量评价.用RevMan 4.2软件进行统计分析.结果共纳入4个随机对照试验.Meta分析结果显示,对急性肝炎,单用茵栀黄注射液与西药阳性对照药相比,茵栀黄注射液的退黄效果比西药对照药更优或与西药对照药相似[WMD-19.70,95%CI(-32.69,-6.71)和WMD-1.27,95%CI(-3.08,0.54)];但对慢性肝炎,茵栀黄注射液的退黄作用要弱于思美泰[WMD-106.00,95%CI(-189.05,-22.95)];自身对照试验结果显示,大剂量茵栀黄注射液的退黄作用优于小剂量[WMD-11.50,95%CI(-16.53, -6.47)],提示加大用药剂量,可提高其退黄效率.现有资料未提示有严重不良反应发生.结论茵栀黄注射液对黄疸型病毒性肝炎可能有退黄作用,由于纳入的研究存在选择性偏倚、实施偏倚、测量性偏倚的高度可能性,尚需更多的高质量研究提供可靠的证据对其疗效及安全性予以证实.

Effect and Safety of Yinzhihuang Injection for Icteric Viral Hepatitis: A Systematic Review

Objective To evaluate the effect and safety of Yinzhihuang injection for icteric viral hepatitis.Methods We searched MEDLINE (19662005), The Cochrane Library (Issu e1,2005), CBMdisk (19782004),CMCC (19942005),CMAC (19942 005),CNKI (19942005),VIP (19892004). Data were extracted by two reviewers using a designed extraction form. The quality of included trials was critically assessed. RevMan 4.2.7 was used for data analysis.Res ults Four randomized controlled trials were included. It showed that Yinzhihuang injection could abate jaundice better than or the same as controlled western medicine in patients with hepatitis (WMD19.70,95 %CI32.69 to 6.71 and WMD1.27,95%CI 3.08 to 0 .54, respectively), but less than S-adeanosyl methionine in patients with chro nic hepatitis (WMD106.00,95%CI 189.05 to 22.95). Th ere may be a dose-effect relationship in Yinzhihuang injection, higher doses ha d better effect (WMD11.50,95%CI16.53, 6.47). No fat al side effects were reported.Conclusions It is noted that Yinzhihuang injection can abate jaundice of icteric viral hepatiti s. Due to low statistical power and high risk of selection bias, performance bi as and measurement bias of the included trials, these conclusions need to be tre ated cautiously.