摘要
目的评价各种中药治疗肺间质纤维化的疗效与安全性。方法系统检索国内外相关数据库。收集比较中药与安慰剂、常规基础治疗、激素治疗肺纤维化且疗程达到3个月的随机对照试验(RCT),2名评价人员独立提取资料,参照Cochrane标准进行RCT质量评价及资料分析。结果9个RCT(共计598例肺纤维化患者)符合纳入标准。试验的方法学质量均较低。1项中西医结合治疗研究显示可以提高患者5年生存率,相对危险度(RR)4.07(95%可信区间1.28～12.95);2项中西医结合治疗研究显示可以缓解部分症状,改善部分肺功能指标;对于肺影像学病变的改善,1项中西医结合治疗研究显示优于单纯西医治疗,RR1.56(95%可信区间1.24～1.95)。2个试验报道了中医和中西医结合治疗的负性事件。结论由于试验的样本量小及质量较低,中药治疗肺纤维化疗效和安全性的证据还不足。需要进行更多高质量的临床试验以验证其疗效。
Objective To evaluate the curative effects and safety of different Chinese medical preparations for treatment of pulmonary interstitial fibrosis. Methods The related domestic and foreign databases were retrieved. The data of randomized controlled trial （RCT） was collected and compared among Chinese medical preparations and placebo, western routine treatment and hormone therapy for treating pulmonary interstitial fibrosis with a 3-month treatment course. There were 2 appraisers fetching data alone. The quality appraisal and material analysis of RCT were conducted based on the criteria of Cochrane Collaboration. Results There were 9 RCT （involving with 593 patients with pulmonary interstitial fibrosis） accorded with the collecting criteria. All of the trials were evaluated as low methodological quality. The result of one study on integrated treatment of Chinese and Western medicinals showed that the survival rate of the patient was prolonged for 5 years with RR 4.07 [confidence interval （CI） of 95 % was 1.28-12.95]. The results of two studies on integrated treatment of Chinese and Western medicinals showed that some symptoms were relieved and some indexes of lung function were improved. In the relief of lung imaging pathological changes the result of one study on integrated treatment of Chinese and Western medicinals showed that the integrated treatment was better than only Western treatment with RR 1.56 （CI of 95 % was 1.24-1.95）. There were adverse events reported in 2 trials involving with Chinese medical treatment or the integrated treatment. Conclusion Because less samples and lower quality of the trials there are not enough proofs for the curative effect and safety of Chinese medicinals for the treatment of pulmonary interstitial fibrosis. More clinical trials with higher quality are needed to confirm the potential effects of Chinese medicinals for the treatment of pulmonary interstitial fibrosis.
出处
《北京中医药大学学报（中医临床版）》
2008年第3期23-28,共6页
Journal of Beijing University of Traditional Chinese Medicine
基金
国家重点基础研究发展计划(973计划)项目资助(No.2006CB504602)
关键词
中药
肺间质纤维化
系统评价
随机对照试验
方法学评价
Chinese medicinals
pulmonary interstitial fibrosis
systematic review
randomized controlled trial
methodological appraisal
