Guo Jing, Li Bin, Wu Wenbin, Wang Zhichao, Wang Fei, Guo Taipin
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan 610072, China.
School of Acupuncture, Moxibustion, Tuina and Rehabilitation, Yunnan University of Chinese Medicine, Kunming 650500, China.
Evid Based Complement Alternat Med. 2019 Jun 13;2019:5170638. doi: 10.1155/2019/5170638. eCollection 2019.
Idiopathic pulmonary fibrosis (IPF) is a major global health problem. The prevalence of the disease appears to be increasing. There is no curative therapy for IPF except lung transplantation. Chinese herbal medicines (CHMs) are showing promise for treatment of IPF. However, their effectiveness and safety are still unclear and deserve further investigation. The aim of this systematic review is to access the efficacy and safety of CHMs in treating IPF.
The protocol of this review is registered at PROSPERO. We searched seven main databases for randomized clinical trials (RCTs) on CHMs for IPF from their inception to June 4, 2018. The methodological quality of RCTs was assessed using the Cochrane risk of bias tool. All trials included were analyzed according to the criteria of the Cochrane Handbook. Review Manager 5.3, R-3.5.2 software, and Grade pro GDT web solution were used for data synthesis and analysis.
Thirteen randomized clinical trials enrolling 733 patients were included. All trials included had clear outcome indicators. The methodological quality of included trials was generally "poor." Few trials reported methods of randomization. One trial on Xuefu-zhuyu capsule assessed rate of acute exacerbation and mortality after treatment for 72 weeks and found no statistically significant difference between two groups. This meta-analysis demonstrated a significant improvement in QOL of IPF patients when CHMs was applied or combined with conventional medicine treatment. 6MWT was significantly improved in IPF patients after using CHMs or combined with conventional medicine treatment. CHMs treatment also had a certain improvement in TLC and DLCO, but the effect on FVC was not significant. Besides, CHMs failed to provide benefits in terms of PaO. The reported adverse events were not obvious and severe.
Some CHMs seem effective and safe as alternative remedies for patients with IPF, suggesting that further study of CHMs in the treatment of IPF is warranted. Although this systematic review suggests that CHMs may have positive effect on quality of life, 6-minute walk test distance, and lung function (TLC, DLOC%) and seem to be relatively safe during the course of treatment, the results must be treated with great caution because of the methodological flaws of the included trials. Long-term and high-quality trials are needed in the future to provide clear evidence for the use of CHMs.
特发性肺纤维化（IPF）是一个重大的全球健康问题。该疾病的患病率似乎正在上升。除了肺移植外，IPF没有治愈性疗法。中药在治疗IPF方面显示出前景。然而，它们的有效性和安全性仍不明确，值得进一步研究。本系统评价的目的是评估中药治疗IPF的疗效和安全性。
本评价方案已在国际前瞻性系统评价注册库（PROSPERO）登记。我们检索了七个主要数据库，以查找从建库至2018年6月4日关于中药治疗IPF的随机临床试验（RCT）。使用Cochrane偏倚风险工具评估RCT的方法学质量。所有纳入的试验均根据《Cochrane手册》的标准进行分析。使用Review Manager 5.3、R-3.5.2软件和Grade pro GDT网络解决方案进行数据合成和分析。
纳入了13项随机临床试验，共733例患者。所有纳入试验均有明确的结局指标。纳入试验的方法学质量总体“较差”。很少有试验报告随机化方法。一项关于血府逐瘀胶囊的试验评估了治疗72周后的急性加重率和死亡率，发现两组之间无统计学显著差异。本荟萃分析表明，应用中药或与传统药物联合治疗时，IPF患者的生活质量有显著改善。使用中药或与传统药物联合治疗后，IPF患者的6分钟步行试验（6MWT）有显著改善。中药治疗对肺总量（TLC）和一氧化碳弥散量（DLCO）也有一定改善，但对用力肺活量（FVC）的影响不显著。此外，中药在动脉血氧分压（PaO）方面未显示出益处。报告 的不良事件不明显且不严重。
一些中药作为IPF患者的替代疗法似乎有效且安全，这表明有必要对中药治疗IPF进行进一步研究。尽管本系统评价表明中药可能对生活质量、6分钟步行试验距离和肺功能（TLC、DLOC%）有积极影响，且在治疗过程中似乎相对安全，但由于纳入试验的方法学缺陷，结果必须谨慎对待。未来需要长期和高质量的试验为中药的使用提供明确证据。
