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金水六君煎对慢性阻塞性肺疾病患者的疗效:一项系统评价与Meta分析

Efficacy of Jinshui Liujun decoction on chronic obstructive pulmonary disease patients: a systematic review and meta-analysis.

作者信息

Huang Wanqiu, Wang Hui, Wu Di, Zhang Lu, Tong Jiabing, Yu Minghui, Li Zegeng, Yang Qinjun

机构信息

Anhui University of Chinese Medicine, Hefei, China.

The First Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, China.

出版信息

Front Pharmacol. 2025 May 21;16:1567452. doi: 10.3389/fphar.2025.1567452. eCollection 2025.

Abstract

BACKGROUND

Jin Shui Liu Jun Decoction (JSD) is a classical prescription in Traditional Chinese Medicine (TCM). In recent years, JSD has shown beneficial effects on patients with chronic obstructive pulmonary disease (COPD). However, the existing clinical research results are contradictory, and high-quality, evidence-based medical evidence is lacking. Therefore, the exact therapeutic efficacy of JSD has not been fully evaluated.

OBJECTIVES

This study aimed to ascertain the precise therapeutic efficacy of JSD in treating COPD.

DATA SOURCES AND METHOD

A search of 10 electronic databases was conducted up to 30 November 2024. The standardized mean difference (SMD) was used to assess continuous variables, while the relative risk (RR) was calculated to evaluate dichotomous variables. The Luis Furuya-Kanamori (LFK) asymmetry index, along with the Doi plot, Egger's test, and Begg's test, were used to assess publication bias. Sensitivity analysis was performed to evaluate the stability of the conclusions. Furthermore, trial sequential analysis (TSA) was used to assess the risk of false-positive results and to estimate the required sample size for the meta-analysis. Finally, single-factor and multi-factor meta-regression were conducted to analyze the sources of heterogeneity.

RESULTS

A total of 22 trials meeting the inclusion criteria were included, including 1,817 COPD participants. The meta-analysis indicated that JSD could improve overall treatment efficacy (RR = 1.15, 95% CI: 1.053-1.256, = 0.002) and pulmonary function (FEV1: SMD = 0.661, 95% CI: 0.276-1.046, = 0.001; FEV1% Predicted: SMD = 0.368, 95% CI: 0.067-0.669, = 0.017; FVC: SMD = 0.814, 95% CI: 0.392-1.235, < 0.001; FEV1/FVC Ratio: SMD = 0.602, 95% CI: 0.311-0.893, < 0.001) in COPD, potentially offering benefits in traditional Chinese medicine syndrome scores (SMD = 0.936, 95% CI: 0.301-1.571, = 0.004) and 6-min walk distance (6MWD: SMD = 0.744, 95% CI: 0.182-1.306, = 0.009). The subgroup analysis revealed a higher overall efficacy and improvement in FEV1/FVC Ratio of JLD treatment for stable chronic obstructive pulmonary disease (sCOPD) compared to the acute exacerbation of chronic obstructive pulmonary disease (AECOPD) group (SMD:0.605 v.s. 0.574, < 0.05). Additionally, compared to the simple JLD treatment plan, the conventional biomedicine (CBM)+JLD scheme showed superior overall efficacy in treating COPD patients (RR = 1.15, 95% CI: 1.043-1.268, = 0.005).

CONCLUSION

Treatment with JLD can effectively improve the overall efficacy and pulmonary function (FEV1%pred requires more research for confirmation) of COPD patients. However, the methodological quality of the included trials may limit the generalizability of the study's findings. Sources of heterogeneity were partially identified through meta-regression, but further rigorous randomized controlled trials are still required.

SYSTEMATIC REVIEW REGISTRATION

https://osf.io/msw7b.

摘要

背景

金水六君煎是中医经典方剂。近年来,金水六君煎对慢性阻塞性肺疾病(COPD)患者显示出有益作用。然而,现有的临床研究结果相互矛盾,缺乏高质量的循证医学证据。因此,金水六君煎的确切治疗效果尚未得到充分评估。

目的

本研究旨在确定金水六君煎治疗COPD的确切疗效。

数据来源与方法

截至2024年11月30日,检索了10个电子数据库。采用标准化均数差(SMD)评估连续变量,计算相对危险度(RR)评估二分变量。使用Luis Furuya-Kanamori(LFK)不对称指数以及Doi图、Egger检验和Begg检验评估发表偏倚。进行敏感性分析以评估结论的稳定性。此外,采用试验序贯分析(TSA)评估假阳性结果的风险并估计荟萃分析所需的样本量。最后,进行单因素和多因素荟萃回归分析异质性来源。

结果

共纳入22项符合纳入标准的试验,包括1817例COPD参与者。荟萃分析表明,金水六君煎可提高COPD的总体治疗效果(RR = 1.15,95%CI:1.053 - 1.256,P = 0.002)和肺功能(第一秒用力呼气容积:SMD = 0.661,95%CI:0.276 - 1.046,P = 0.001;预计第一秒用力呼气容积百分比:SMD = 0.368,95%CI:0.067 - 0.669,P = 0.017;用力肺活量:SMD = 0.814,95%CI:0.392 - 1.235,P < 0.001;第一秒用力呼气容积/用力肺活量比值:SMD = 0.602,95%CI:0.311 - 0.893,P < 0.001),可能对中医证候评分(SMD = 0.936,95%CI:0.301 - 1.571,P = 0.004)和6分钟步行距离(6MWD:SMD = 0.744,95%CI:0.182 - 1.306,P = 0.009)有益。亚组分析显示,与慢性阻塞性肺疾病急性加重期(AECOPD)组相比,金水六君煎治疗稳定期慢性阻塞性肺疾病(sCOPD)的总体疗效更高,第一秒用力呼气容积/用力肺活量比值改善更明显(SMD:0.605对0.574,P < 0.05)。此外,与单纯金水六君煎治疗方案相比,常规生物医学(CBM)+金水六君煎方案在治疗COPD患者方面显示出更好的总体疗效(RR = 1.15,95%CI:1.043 - 1.268,P = 0.005)。

结论

金水六君煎治疗可有效提高COPD患者的总体疗效和肺功能(预计第一秒用力呼气容积百分比需更多研究证实)。然而,纳入试验的方法学质量可能限制了研究结果的可推广性。通过荟萃回归部分确定了异质性来源,但仍需要进一步严格的随机对照试验。

系统评价注册

https://osf.io/msw7b。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa0e/12133822/2d74956b4134/fphar-16-1567452-g001.jpg

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