益气活血法联合西药治疗肺纤维化疗效及安全性Meta分析＊

目的 系统评价益气活血法联合西药治疗特发性肺纤维化（idiopathic pulmonary fibrosis，IPF）的疗效及安全性。方法 系统检索中国知网、维普网、万方数据库、EMbase、PubMed、Cochrane Library图书馆等数据库，检索时限从数据库建库至2021年1月，纳入益气活血法联合西药治疗特发性肺纤维化的随机对照试验（randomized controlled trial，RCT），由2名研究人员独立筛选并交叉核对纳入结果，提取有效数据后，应用RevMan 5.3软件进行Meta分析。结果 纳入16项随机对照试验共计1160例IPF患者。分析结果显示益气活血法联合西药组可提高临床总有效率（OR= 3.71，95% CI ［2.68，5.14］，P<0.00001）；改善患者肺功能：用力肺活量（MD=0.31，95% CI ［0.23，0.38］，P<0.00001）（MD=3.59，95% CI ［1.51，5.66］，P=0.0007），一氧化碳弥散量（MD=2.54，95% CI ［1.83，3.25］，P<0.00001）；提高生活质量，降低圣乔治评分：呼吸困难（MD=-12.70，95% CI ［-21.07，-4.32］，P=0.003），活动能力（MD=-8.38，95% CI ［-13.66，-3.10］，P=0.002），疾病影响（MD=-13.87，95% CI ［-22.53，-5.22］，P=0.002）；并可降低患者中医症状积分：喘息（MD=-0.66，95% CI ［-0.84，-0.49］，P<0.00001），咳嗽（MD=-0.71，95% CI ［-1.04，-0.37］，P<0.0001）；有效提高动脉血氧分压（MD=5.92，95% CI ［4.61，7.22］，P<0.00001）；且不增加不良事件发生率（OR=0.55，95% CI ［0.27，1.14］，P=0.11）。结论 益气活血法联合西药治疗IPF可提高临床治疗有效率，改善患者生活质量，且不增加临床不良事件（便秘、嗜睡、口干、恶心呕吐、皮肤瘙痒、腹泻等）发生率。但本研究纳入文献质量参差不齐，仍需更多大样本、高质量、多中心的RCT试验验证结论。

Meta-analysis of the Efficacy and Safety of Replenishing Qi and Activating Blood Combined with Western Medicine in the Treatment of Idiopathic Pulmonary Fibrosis

Objective To systematically evaluate the efficacy and safety of the method of replenishing qi and activating blood combined with western medicine in the treatment of idiopathic pulmonary fibrosis (IPF).Methods A systematic search of databases such as CNKI, Weipu.com, Wanfang Database, EMbase, PubMed, Cochrane Library, etc., and the search time limit was from the establishment of the database to January 2021. The method of replenishing qi and activating blood combined with western medicine was included in the treatment of idiopathic pulmonary fibers in the randomized controlled trial (RCT). Two researchers independently screened and cross-checked the included results. After valid data were extracted, the RevMan 5.3 software was used for Meta analysis.Results A total of 1160 patients with IPF were included in 16 RCTs. The analysis results showed that the combination of the method of replenishing qi and activating blood combined with western medicine increased the total clinical effective rate (OR=3.71, 95% CI 2.68, 5.14], P<0.00001); improved the patient''s lung function: forced vital capacity (MD=0.31, 95% CI 0.23, 0.38], P<0.00001) (MD=3.59, 95% CI 1.51, 5.66], P=0.0007), carbon monoxide dispersion (MD=2.54, 95% CI 1.83, 3.25], P<0.00001); improved the quality of life, lower the St. George''s score: dyspnea (MD=-12.70, 95% CI -21.07, -4.32], P=0.003), activity capacity (MD=-8.38, 95% CI -13.66, -3.10], P=0.002), disease impact (MD=-13.87, 95% CI -22.53, -5.22], P=0.002); and reduced the patient''s TCM symptom score: wheezing (MD=-0.66, 95% CI -0.84, -0.49], P<0.00001), cough (MD=-0.71, 95% CI -1.04,-0.37], P<0.0001); effectively improved arterial blood Oxygen partial pressure (MD=5.77, 95% CI 4.66, 6.88], P<0.00001); and did not increase the incidence of adverse events (OR=0.55, 95% CI 0.27, 1.14], P=0.11).Conclusion The treatment of IPF with the method of replenishing qi and activating blood combined with western medicine can improve the clinical treatment efficiency and improve the quality of life of patients without increasing the incidence of clinical adverse events (constipation, lethargy, dry mouth, nausea and vomiting, skin itching, diarrhea, etc.). However, the quality of the literature included in this study is quite different, and more large-sample, high-quality, multi-center RCT are needed to verify the conclusions.