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中药治疗特发性肺纤维化的疗效与安全性:一项荟萃分析

Efficacy and Safety of Traditional Chinese Medicine in Idiopathic Pulmonary Fibrosis: A Meta-Analysis.

作者信息

Ji Kun, Ma Jianling, Wang Liangmin, Li Niuniu, Dong Shangjuan, Shi Liqing

机构信息

Department of Respiratory Medicine, Dongfang Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100078, China.

出版信息

Evid Based Complement Alternat Med. 2020 Feb 12;2020:1752387. doi: 10.1155/2020/1752387. eCollection 2020.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of traditional Chinese medicine (TCM) on lung function and quality of life of idiopathic pulmonary fibrosis (IPF) patients by meta-analysis.

METHODS

Randomized controlled trials (RCTs) related to TCM and IPF were searched on PubMed, EMBASE Cochrane Library, ClinicalTrials, China National Knowledge Infrastructure (CNKI), Wanfang Database, Chin VIP Information (VIP), and Chinese Biomedical Database (CBM) until December 2018. Standard mean difference (SMD) and 95% CI were calculated for the measurements related to lung function (FEV1/FVC, FVC%, FEV1%, TLC%, DLCO% or DLCO, and VC%) and other parameters (PO2, 6MWD, and SGRQ) when comparing TCM treatment to the control group. Relative risk (RR) and 95% CI of adverse events (AEs) were calculated to assess the safety of TCM.

RESULTS

A total of 40 RCTs comparing TCM to western medicine (WM) and involving 3194 IPF patients were eligible for the meta-analysis. The pooled results showed that TCM treatment improved significantly PO2 (SMD = 0.80, 95% CI 0.54 to 1.06, p < 0.001), FEV1% (SMD = 0.57, 95% CI 0.42 to 0.71, p < 0.001), DLCO% (SMD = 0.38, 95% CI 0.28 to 0.48, p < 0.001), 6MWD (SMD = 0.70, 95% CI 0.56 to 0.84, p < 0.001) and other measurements and reduced SGRQ scores (SMD = −0.51, 95% CI −0.70 to −0.22, p < 0.001). Subgroup analysis of different study durations (3 months, ≥ 6 months) and comparison models (TCM vs. WM, TCM + WM vs. WM or TCM vs. placebo) showed similar results. No significant difference of risk of AEs was observed between both groups (RR = 0.66, 95% CI: 0.27–1.60, p=0.352). There was no obvious publication bias, and the pooled results were stable according to sensitivity analysis.

CONCLUSION

To the best of our knowledge, the present study had the largest sample size. Our results indicated that TCM treatment may help provide benefit to the lung function, exercise capacity, and quality of life of IPF patients, alone or combined with WM, when compared to WM. More rigorous RCTs were needed in the future.

摘要

目的

通过荟萃分析评估中药对特发性肺纤维化(IPF)患者肺功能和生活质量的疗效及安全性。

方法

在PubMed、EMBASE、Cochrane图书馆、ClinicalTrials、中国知网(CNKI)、万方数据库、维普资讯(VIP)和中国生物医学文献数据库(CBM)中检索截至2018年12月与中药和IPF相关的随机对照试验(RCT)。在比较中药治疗组与对照组时,计算与肺功能(FEV1/FVC、FVC%、FEV1%、TLC%、DLCO%或DLCO以及VC%)和其他参数(PO2、6分钟步行距离[6MWD]和圣乔治呼吸问卷[SGRQ])相关测量值的标准化均数差(SMD)及95%可信区间(CI)。计算不良事件(AE)的相对危险度(RR)及95%CI以评估中药的安全性。

结果

共有40项比较中药与西药(WM)且涉及3194例IPF患者的RCT符合荟萃分析纳入标准。汇总结果显示,中药治疗显著改善了PO2(SMD = 0.80,95%CI 0.54至1.06,p < 0.001)、FEV1%(SMD = 0.57,95%CI 0.42至0.71,p < 0.001)、DLCO%(SMD = 0.38,95%CI 0.28至0.48,p < 0.001)、6MWD(SMD = 0.70,95%CI 0.56至0.84,p < 0.001)及其他测量指标,并降低了SGRQ评分(SMD = -0.51,95%CI -0.70至-0.22,p < 0.001)。不同研究持续时间(3个月、≥6个月)和比较模型(中药与西药、中药联合西药与西药或中药与安慰剂)的亚组分析显示了相似结果。两组间AE风险无显著差异(RR = 0.66,95%CI:0.27 - 1.60,p = 0.352)。未观察到明显的发表偏倚,根据敏感性分析汇总结果稳定。

结论

据我们所知,本研究样本量最大。我们的结果表明,与西药相比,中药治疗单独或联合西药可能有助于改善IPF患者的肺功能、运动能力和生活质量。未来需要更严格的RCT。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5220/7040417/6090f2fc2086/ECAM2020-1752387.001.jpg

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