摘要
背景:慢性重型肝炎是一种病情危重、病死率高的疾病,目前尚缺乏特效的药物和治疗手段,临床主要采用综合对症支持、人工肝和肝移植治疗。中药多途径联合西医治疗慢性重型肝炎的研究已有大量报道,但对其疗效和安全性尚缺乏系统的评价。目的:评价中西医结合治疗慢性重型肝炎的有效性和安全性。检索策略:检索PubMed、Cochrane图书馆、中国知网数据库、重庆维普中文科技期刊数据库、中国生物医学文献数据库网络版和万方数据。所有数据库检索时间均从建库截止至2012年2月29日。纳入标准:纳入比较中药联合西医综合治疗或人工肝血浆置换治疗慢性重型肝炎与西医疗法的随机对照试验。资料提取与分析:由两名研究者独立提取资料,采用Cochrane协作网提供的软件RevMan5.1进行资料分析。结局的效应指标为相对危险度或均数差,均以效应值和95%置信区间表示。结果:共纳入45项随机对照试验,涉及4449例慢性重型肝炎患者,文献质量普遍偏低。在总有效率及降低病死率方面,口服中药、中药灌肠、中医综合治疗联合西医综合治疗或血浆置换均优于单纯西医治疗,差异具有统计学意义。在实验室指标方面,中西医结合治疗降低总胆红素和丙氨酸氨基转移酶、改善凝血功能的疗效优于西医对照组,降低天冬氨酸氨基转移酶活性方面两者未见显著差异;中药口服联合西医综合治疗或血浆置换在促进白蛋白合成、改善低蛋白血症方面优于单纯西医治疗;而中药灌肠对血浆白蛋白水平无显著影响。试验组的不良反应主要表现为灌肠后腹痛、腹泻等肠道症状,而对照组主要表现在血浆置换引起的不良反应。结论:中西医结合治疗慢性重型肝炎具有促进肝功能和凝血功能恢复、降低病死率的作用。但是由于中文发表的临床试验质量较低,中西医结合治疗慢性重型肝炎的优效性尚缺乏有力的证据。今后仍然需要按照国际标准,开展设计严谨、实施规范的多中心、大样本随机对照试验,进一步验证中药制剂的疗效。
BACKGROUND： Chronic severe hepatitis is a critical disease with high mortality. Currently, effective drugs and therapy still lack. Comprehensive and supportive treatment, artificial liver and liver transplantation are the main therapies. A great number of studies on traditional Chinese medicine （TCM） in many ways combined with Western medicine treatment for chronic severe hepatitis have been reported, but the efficacy and safety still lack systematic evaluation. OBJECTIVE： To evaluate the efficacy and safety of integrative medicine therapy for chronic severe hepatitis. SEARCH STRATEGY. Literature was searched from PubMed, the Cochrane Library, the China National Knowledge Infrastructure Database, the Chongqing VlP Chinese Science and Technology Periodical Database, the Chinese Biomedical Literature Database and Wanfang Database. The time limitation ran from the commencement of each database to February 29, 2012. INCLUSION CRITERIA： Randomized controlled trials （RCTs） testing Chinese herbal medicine （CHM） combined with Western medicine （comprehensive and supportive treatment or artificial liver plasma exchange） against Western medicine were included. DATA EXTRACTION AND ANALYSIS： Two authors collected and extracted data independently. The methodological quality of literature was assessed by risk of bias table from Cochrane Collaboration and the data were analyzed by RevMan 5.1 software. Heterogeneity of the included studies was checked by Chisquare test. The efficacy measure was relative risk （RR） or mean difference with a 95% confidence interval （CI）. RESULTS： A total of 45 RCTs involving 4 449 patients with chronic severe hepatitis were included. Quality of all included trials was low. The oral CHM, enema and combined TCM with either Western medicine or plasma exchange were superior to Western medicine alone in improving total effective rate and reducing mortality with significant differences. In laboratory parameters, the integrative medicine treatment group was better than Western control group in reducing the total bilirubin and alanine aminotransferase, but two groups showed equal efficacy in lowering aspartate aminotransferase activity. The oral Chinese medicine combined with Western medicine or plasma exchange was better than Western medicine used alone in improving albumin synthesis and coagulation function, but Chinese medicine enema had no significant effect on the level of plasma albumin. The main side effects of the treatment group were abdominal pain, diarrhea and other intestinal symptoms after enema, while adverse reactions of the control group were mainly due to the plasma exchange. CONCLUSION. Integrated Chinese and Western medicine can promote the recovery of liver function and coagulation function, and reduce the mortality rate of patients with chronic severe hepatitis. However, due to a lower quality of clinical trials published in Chinese journals, the evidence is insufficient to prove the superiority of integrative therapy. Further well-designed, multicenter, large-sample RCTs are still needed to evaluate the beneficial effects of CHM.
出处
《中西医结合学报》
CAS
2012年第11期1211-1228,共18页
Journal of Chinese Integrative Medicine
基金
国家自然科学基金(No.81072766)
北京市自然科学基金(No.7112066)
北京市科技计划(No.Z111107056811044)
北京市中医药科技发展基金科技提升专项(No.KJTS2011-05)
首都医学发展基金(No.SF-2007-Ⅲ-03)的支持
关键词
中西医结合疗法
中医疗法
中草药
肝炎
慢性
重型
系统评价
META分析
TCM WM therapy TCM therapy Chinese herbal medicine
hepatitis, chronic, severe review,systematic
meta-analysis
