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目的 观察扶正剔邪搜络方治疗特发性肺纤维化(IPF)的疗效及安全性.方法 采用随机、双盲、安慰剂对照研究,选取中医辨证为气阴两虚、痰瘀互阻证的IPF轻中度患者76例,分为治疗组和对照组各38例.治疗组口服扶正剔邪搜络方,对照组口服安慰剂,疗程均为12周.分别于治疗前后行肺功能及肺部高分辨率CT(HRCT)检查,并监测症状、体征、血氧饱和度及呼吸困难的变化情况,采用临床、X线、生理综合计分法(CRP)评定病情程度.结果 治疗组总体疗效优于对照组(P<0.05).治疗组气短、咳嗽、喘息、呼吸困难等症状及肺弥散功能的改善优于对照组(P<0.05).观察期间2组均未发生不良反应.结论 扶正剔邪搜络方治疗IPF具有一定疗效且安全.“,”Objective To observe the clinical effect and safety of Fuzheng Tixie Souluo Formula in treating idiopathic pulmonary fibrosis (IPF).Methods Randomized double-blind placebo-controlled study was used in this study.76 patients with mild and moderate IPF were randomly divided into the treatment group and control group, with 38 in each.The treatment group was given Fuzheng Tixie Souluo Formula orally, while the control group was given placebo orally.The treatment lasted 12 weeks.Pulmonary function and HRCT were examined before and after treatment.Symptoms and signs were recorded as well.CRP scores were calculated for the assessment of disease severity.Results Comprehensive effect of the treatment group is superior to control group(P<0.05).Compared to the control group, symptoms of the treatment group such as shortness of breath, coughing, wheezing and dyspnea were significantly improved(P<0.05),and the diffusion function was improved as well(P<0.05).No reverse effects were found in both groups.Conclusion Fuzheng Tixie Souluo Formula has positive effect on idiopathic pulmonary fibrosis.