摘要
背景:中药被广泛地应用于多发性硬化(multiple sclerosis,MS)的治疗,但对其疗效和安全性尚缺乏系统的评价。目的:评价中药治疗MS的疗效和安全性。检索策略:检索中国知网数据库、中国生物医学文献数据库网络版、重庆维普中文科技期刊数据库、万方数据库、PubMed、Cochrane图书馆等数据库,检索时间从建库截止至2011年3月15日。纳入标准:纳入比较中药与西药或安慰剂治疗MS的随机对照试验。对于中药联合西药与单纯使用西药比较的随机对照试验也予以纳入。资料提取与分析:由两名评价员独立地进行文献的筛选,对纳入的研究进行质量评价及资料提取,用RevMan 5.1.0软件进行meta分析。结果的效应指标为均数差(mean difference,MD),均以95%可信区间(confidence interval,CI)表示。结果:共计纳入16项随机对照试验,涉及913例MS患者。所纳入的研究质量普遍较差。所纳入的研究中有13项研究报道了神经功能缺损,通过Kurtzke扩展残疾状态量表(KurtzkeExtended Disability Status Scale,EDSS)评分进行测评,其中2项研究显示中药组的EDSS评分低于对照组,MD及95%CI为-0.88(-1.26,-0.50),另外8项研究进行了描述性分析,显示治疗组的EDSS评分低于对照组;5项研究报道了中药治疗MS的复发率,2项研究显示,治疗组的复发率低于对照组,MD及95%CI为-0.34(-0.52,-0.16),另外3项研究进行了描述性分析,显示治疗组复发率低于对照组。次要指标如无效率、临床症状评分、神经功能评分和免疫指标的改善均优于对照组。纳入的2项研究报道了磁共振成像下的病灶数目或范围,治疗组与对照组比较有改善的趋势,但无统计学差异。中药组的药物使用不良反应低于对照组,且能减轻激素使用的不良反应。结论:根据现有证据,中医药治疗MS能改善神经功能缺损,降低复发率,改善临床症状、神经功能体征及免疫指标,且未发现明显的副作用,同时能减轻激素的副作用。但由于纳入的研究质量不高,仍需更多高质量研究以增加证据的强度。
Chinese herbal medicine （GriM） has been widely used in the treatment of multiple sclerosis （MS）. However, there is no systematic review to assess the efficacy and safety of CHM. OBJECTIVE： To systematically evaluate the efficacy and safety of CHM in the treatment of MS. SEARCH STRATEGY： Literature was searched from the China National Knowledge Infrastructure Database, the Chinese Biomedical Database （SinoMed）, the Chongqing VIP Chinese Science and Technology Periodical Database, Wanfang Data, PubMed and the Cochrane Library. The time limitation ran from the commencement of each database to March 15, 2011. INCLUSION CRITERIA： Randomized controlled trials （RCTs） testing CHM alone or in combination with Western medicine （WM） against WM or placebo used alone were included. DATA EXTRACTION AND ANALYSIS： Two authors collected the data respectively. The assessment of methodological quality was based on the Cochrane Handbook and the data were analyzed by using RevMan 5.1.0 software. The efficacy measure was mean difference （MD） with a 95% confidence interval （Cl）. RESULTS： After screening of the search results, 16 eligible RCTs with 913 cases were included. The included trials were all of low quality. Thirteen studies adopted Kurtzke Extended Disability Status Scale （EDSS） and two of them showed that EDSS in the treatment group was lower than that in the control group, and the MDand 95% Cl were --0.88 （--1.26, --0.50）. We performed descriptive analysis on the other eight studies which showed that EDSS of the treatment group was lower than that of the control group. Five studies adopted recurrent frequency and two of them showed that recurrent frequency in the treatment group was lower than that in the control group, and the MD and 95% CI were --0.34 （--0.52, --0.16）. We performed descriptive analysis on the other three studies which showed that EDSS in the treatment group was lower than that in the control group. Analyses of secondary outcomes such as clinical symptom score, neurological sign score and immune indexes showed that integrated TCM and WM was more effective than WM treatment alone. The studies displayed that the number or range of magnetic resonance imaging lesion of the treatment group was lower than that of the control group, but there was no statistical significance. The reported adverse events in the CHM group were less than those in the control group. CONCLUSION： CHM could improve neurological signs, clinical symptoms and immune indexes, and reduce recurrent frequency. The reported adverse events in the CHM group were less than those in the control group. However, further well-designed research is needed to evaluate the beneficial effects of CHM.
出处
《中西医结合学报》
CAS
2012年第2期141-153,共13页
Journal of Chinese Integrative Medicine
基金
国家自然科学基金资助项目(No.81072770)
北京中医药大学自主选题资助项目(No.2011JYBZZ-JS015)
关键词
中草药
多发性硬化
META分析
随机对照试验
drugs, Chinese herbal
multiple sclerosis
metaanalysis
randomized controlled trials
