健脾化痰法治疗阻塞性睡眠呼吸暂停低通气综合征的Meta分析*

作者：陈梦瑶1,2，陆勤丰1,2，陈 竹1,2，魏 瑜2

单位：1.南京中医药大学，江苏 南京 210023； 2.南京中医药大学附属医院/江苏省中医院，江苏 南京 210029

引用：引用：陈梦瑶，陆勤丰，陈竹，魏瑜.健脾化痰法治疗阻塞性睡眠呼吸暂停低通气综合征的Meta分析[J].中医药导报,2026,32(3):205-215.

DOI：10.13862/j.cn43-1446/r.2026.03.032

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摘要：

目的：从循证医学角度系统评价健脾化痰法治疗阻塞性睡眠呼吸暂停低通气综合征（OSAHS）的疗效与安全性，为OSAHS的中医诊疗提供循证医学依据。方法：本研究依据RRISMA（Preferred Reporting Itemsfor Systematic Reviewsand Meta-Analyses）指南开展，通过系统检索中国知网（CNKI）、万方数据知识服务平台（Wanfang Data）、维普中文期刊服务平台（CSTJ）、PubMed、Embase、Cochrane Library自2015年1月1日至2025年7月1日发表的有关健脾化痰法治疗OSAHS的随机对照试验（RCT），由2位研究者按照纳入、排除标准独立进行文献筛选、数据提取及交叉核对，并对纳入文献进行质量评价，运用RevMan 5.4软件进行Meta分析，并使用Stata 18进行Egger's检验确定发表偏倚的可能性。结果：共纳入15篇文献，1 280例OSAHS患者。Meta分析结果显示，与单用西药干预比较，健脾化痰法中药干预对于OSAHS患者的治疗有效率（P<0.000 1）、睡眠呼吸暂停低通气指数（AHI）（P=0.02）、最低血氧饱和度（LSaO2）（P<0.000 01）、中医证候积分（P=0.006）的改善更加显著，二者在降低Epworth嗜睡量表（ESS）评分方面的效果差异无统计学意义（P=0.54）；与持续正压通气（CPAP）+健康指导比较，在此基础上加用健脾化痰法中药干预对于OSAHS患者的治疗有效率（P<0.000 01）、AHI（P<0.000 1）、LSaO2（P<0.000 01）、ESS评分（P<0.000 01）、中医证候积分（P<0.000 01）的改善更加显著；与单用健康指导比较，在此基础上加用健脾化痰法中药干预对于OSAHS患者的治疗有效率（P=0.000 9）、LSaO2（P<0.000 01）、ESS评分（P<0.000 01）、中医证候积分（P<0.000 01）的改善更加显著，二者在降低AHI方面的效果差异无统计学意义（P=0.05）。14 d≤治疗周期＜30 d时，与无中药参与治疗比较，中药参与治疗对于治疗有效率（P<0.000 01）、AHI（P<0.000 01）、LSaO2（P<0.000 01）、ESS评分（P=0.01）、中医证候积分（P<0.000 01）的改善更加显著；30 d≤治疗周期≤60 d时，与无中药参与治疗比较，中药参与治疗对于治疗有效率（P<0.000 1）、AHI（P<0.000 1）、LSaO2（P<0.000 01）、ESS评分（P<0.000 01）的改善更加显著，二者在改善中医证候积分方面的效果差异无统计学意义（P=0.10）；60 d＜治疗周期≤90 d时，与无中药参与治疗比较，中药参与治疗对于AHI（P<0.000 01）、ESS评分（P=0.003）的改善更加显著，二者在改善治疗有效率（P=0.06）、LSaO2（P=0.09）、中医证候积分（P=0.10）方面的效果差异无统计学意义。其中4篇文献明确表明无不良反应的发生，1篇文献表明虽有不良反应的发生，但观察组与对照组之间的发生率差异无统计学意义（P＞0.05）。结论：与西药、CPAP、健康指导等常规干预比较，健脾化痰法治疗OSAHS患者具有较好的疗效，可显著提高治疗有效率、LSaO2，降低AHI、ESS评分及中医证候积分；运用健脾化痰法中药治疗相较于其他常规治疗方法，能够在较短的治疗周期内获得更好的疗效；健脾化痰法治疗OSAHS具有较好的安全性。但当前纳入文献质量水平较低，尚需更多高质量、大样本量的RCT研究来证实。

关键词：阻塞性睡眠呼吸暂停低通气综合征；中药；健脾化痰；随机对照试验；Meta分析

Abstract：

Objective: To systematically evaluate the clinical efficacy and safety of spleen-fortifying and phlegm-resolving method in the treatment of obstructive sleep apnea-hypopnea syndrome (OSAHS) from the perspective of evidence-based medicine, so as to provide evidence-based basis for the diagnosis and treatment of OSAHS with traditional Chinese medicine (TCM). Methods: This study was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Randomized controlled trials (RCTs) on spleen-fortifying and phlegm-resolving method for OSAHS published from January 1, 2015 to July 1, 2025 were systematically retrieved from China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform (Wanfang Data), VIP Chinese Journal Service Platform (CSTJ), PubMed, Embase, and Cochrane Library. Two researchers independently screened the literature, extracted data, and cross-checked them according to the inclusion and exclusion criteria, and evaluated the quality of the included literature. Meta-analysis was performed using RevMan 5.4 software, and Egger's test was conducted using Stata 18 to determine the possibility of publication bias. Results: A total of 15 articles involving 1,280 OSAHS patients were included. The results of Meta-analysis showed that compared with western medicine intervention alone, spleen-fortifying and phlegm-resolving method of Chinese medicine intervention significantly improved the treatment efficiency (P<0.000 1), apnea-hypopnea index (AHI)  (P=0.02), lowest oxygen saturation (LsaO2) (P<0.000 01), and TCM syndrome scores (P=0.006) in OSAHS patients, and there was no statistically significant difference in reducing the Epworth Sleepiness Scale (ESS) score between the two groups (P=0.54). Compared with continuous positive airway pressure (CPAP)+health guidance, the addition of Chinese medicine intervention with spleen-fortifying and phlegm-resolving method on this basis significantly improved the treatment efficiency (P<0.00001), AHI (P<0.000 1), LsaO2  (P<0.000 01), ESS score (P<0.000 01), and TCM syndrome scores (P<0.000 01) in OSAHS patients. Compared with health guidance alone, the addition of Chinese medicine intervention with spleen-fortifying and phlegm-resolving method on this basis significantly improved the treatment efficiency (P=0.000 9), LsaO2 (P<0.000 01), ESS score (P<0.000 01), and TCM syndrome scores (P<0.000 01) in OSAHS patients, and there was no statistically significant difference in reducing AHI between the two groups (P=0.05). When the treatment cycle is 14 days ≤ cycle < 30 days, compared with treatment without Chinese medicine intervention, treatment with Chinese medicine intervention leads to significantly greater improvements in treatment efficiency (P<0.000 01), AHI (P<0.000 01), LSaO2 (P<0.000 01), ESS score (P<0.01), and TCM syndrome scores (P<0.000 01). There were four articles clearly indicated that no adverse reactions occurred, and one article indicated that although adverse reactions occurred, there was no statistically significant difference in the incidence rate between the observation group and the control group (P>0.05). Conclusion: Compared with conventional interventions such as western medicine, CPAP, and health guidance, spleen-fortifying and phlegm-resolving method has a good curative effect in the treatment of OSAHS patients, which can significantly improve the treatment efficiency and LSaO2, and reduce AHI, ESS score and TCM syndrome scores. Compared with other conventional treatment methods, the use of spleen-fortifying and phlegm-resolving method of Chinese medicine can obtain better curative effect in a shorter treatment cycle. The spleen-fortifying and phlegm-resolving method has good safety in the treatment of OSAHS. However, the quality of the included literature is low at present, and more high-quality, large-sample RCTs are needed for confirmation.

Key words：obstructive sleep apnea-hypopnea syndrome; traditional Chinese medicine; spleen-fortifying and phlegm-resolving; randomized controlled trial; Meta-analysis

发布时间：2026-03-28

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