中医药治疗特发性肺纤维化有效性和安全性系统评价和Meta分析

目的]系统评价中医药治疗特发性肺纤维化(IPF)的有效性和安全性。方法]两位评价者独立进行文献检索和筛选、资料提取及质量评价,根据干预措施分为试验组(中药或中药联合西药)和对照组(安慰剂或西药),评估肺功能用力呼气量(FVC)、肺总量(TLC)、肺弥散功能(DLCO)]、动脉氧分压(PaO_2)、6 min步行试验(6MWD)、圣乔治呼吸问卷(SGRQ)评分、症状(咳嗽、呼吸困难)及不良反应发生率,采用Rev Man5.3软件进行Meta分析。结果]纳入17篇随机对照临床试验(RCTs)文献(1 113例患者),汇总分析,与对照组比较,试验组可延缓肺功能(FVC、TLC、DLCO)下降,维持PaO_2和生活质量(SGRQ评分),改善咳嗽症状,不良反应发生率低(P0.05);但不能延缓6MWD下降,改善呼吸困难症状(P0.05);亚组分析,与西药治疗比较,中药联合西药治疗可延缓FVC、TLC、DLCO下降,维持PaO_2水平和SGRQ评分,单纯中药治疗仅能延缓FVC下降。结论]观察疗程≥6月的研究结果显示,对比糖皮质激素或抗氧化剂,中药联合西药治疗≥6月可延缓IPF患者肺功能下降,维持氧合和生活质量,安全性较好,单纯中药治疗未能获益,但限于纳入试验的质量控制差异,本系统评价结论尚存在局限性。

Treatment of idiopathic pulmonary fibrosis by traditional Chinese medicine:a systematic review and Meta-analysis

Objective] To systematically evaluate the efficacy and safety of traditional Chinese medicine in treating patients with idiopathic pulmonary fibrosis (IPF).Methods] Two researchers performed literature search, data extraction, quality assessment. The interventions of experiment group included Chinese herbal medicine and integrative medicine, and of control group included placebo and western medicine. Several outcome measures were assessed, such as FVC, TLC, DLCO, PaO₂, 6MWD, SGRQ score, cough, dyspnea and adverse reaction rates. Meta-analysis was conducted by RevMan 5.3 software.Results] A total of 17 Randomized controlled trials (RCTs) involving 1 113 patients were included. The meta-analysis resulted in a increase in FVC% pred, TLC% pred, DLCO% pred, PaO₂. And there was a decrease in SGRQ score, cough score, adverse reaction rates. While no significant difference in 6MWD, dyspnea score compared to the control group. There were significant differences in FVC% pred, TLC% pred, DLCO% pred, PaO₂ and SGRQ score in integrative medicine compared with Western medicine. While only one difference in FVC% pred in Chinese herbal medicine.Conclusion] In the treatment of IPF for more than 6 months, the efficacy and safety of integrative medicine were significant, and of Chinese herbal medicine were inapparent, when compared with corticosteroids and antioxidant. However, due to the limitation of quality of included studies, this conclusion should be further confirmed by more evidence.