摘要
目的评价易善复治疗慢性肝炎的有效性与安全性。方法计算机检索EMBASE(1980～2003年5月)、MEDLINE(1966～2003年5月)、Cochrane图书馆(2003年第2期)、中国生物医学文献光盘数据库(1979～2003年5月),并手工检索8种主要的中文专业学术期刊(1989～2003年5月),纳入比较易善复与安慰剂或空白治疗慢性肝炎的随机对照试验。由两名评价者独立提取资料并进行方法学质量评估。试验数据的统计分析采用Cochrane协作网提供的RevMan4.2软件进行。结果最终纳入6个RCT,共568例患者。对其中4个RCT(451例患者)的Meta分析显示,易善复治疗慢性肝炎的有效率为52.5%,对照组的有效率为35.7%,其差异具有统计学意义[RR1.81,95%CI(1.41,2.33),Z=4.69,P<0.00001]。对其中3个RCT(100例)的Meta分析显示,与对照组相比,易善复能够改善慢性肝炎患者的病理组织学,其差异有统计学意义[RR2.58,95%CI(1.61,4.15),Z=3.91,P<0.0001]。此外,没有报道与易善复治疗慢性肝炎相关的严重不良反应。结论现有临床证据表明,与安慰剂和空白对照组相比,易善复治疗慢性肝炎有效,可改善患者的临床症状,改善患者的病理组织学,同时有利于改善患者的肝功能,且无明显药物不良反应。但本系统评价纳入的RCT和患者数量有限,其临床疗效须进一步开展大规模的高质量临床试验进行验证。
Objective To evaluate the efficacy and safety of Polyunsaturated phosphatidylcholine (PPC) for chronic hepatitis. Methods We searched EMBASE (1980May,2003), MEDLINE(1966May,2003), CBM (1979May,2003), The Cochrane Library Issue 2, 2003 and handsearched 8 related Chinese journals. Randomized controlled trials(RCT) comparing PPC versus placebo/no treatment for chronic hepatitis were included with no restrictions of blinding, language and publication. Two reviewers independently performed data extraction and assessed the quality. Data were entered and analyzed by RevMan 4.2 software supplied by the Cochrane Collaboration. Results Six high quality trials involving 568 patients were included. Four studies involving 451 patients showed the clinical effective rate of PPC for chronic hepatitis was 52.5% while the control group was 35.7% with statistical difference [RR 1.81, 95%CI (1.41,2.33), Z=4.69, P< 0.000 01 ]. A meta-analysis involving three studies with 100 patients showed PPC can statically improve histopathology of chronic hepatitis comparing with control group [RR 2.58, 95%CI (1.61,4.15), Z=3.91, P< 0.000 1 ]. No serious adverse events were reported. Conclusions PPC is a safe medicine used for treating chronic viral hepatitis and may relieve clinical symptoms and signs. At the same time, it has positive effect on hepatic histopathology for patients. However, more high quality clinical trials are required.
出处
《中国循证医学杂志》
CSCD
2005年第7期543-548,共6页
Chinese Journal of Evidence-based Medicine
关键词
易善复
多烯磷脂酰胆碱
慢性肝炎
随机对照试验
系统评价
META分析
Essentiale
Polyunsaturated Phosphatidylcholine
Chronic hepatitis
Randomized controlled trials
Systematic review
Meta-analysis
