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中西医结合与单纯西医治疗原发性高血压的疗效比较:一项随机对照试验的系统评价和荟萃分析

Integrated Chinese herbal medicine with Western Medicine versus Western Medicine in the effectiveness of primary hypertension treatment: A systematic review and meta-analysis of randomized controlled trials.

作者信息

Mohammed Shadi A D, Hanxing Liu, Fang Lu, Algradi Adnan Mohammed, Alradhi Mohammed, Safi Mohammed, Shumin Liu

机构信息

Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China; School of Pharmacy, Lebanese International University, 18644, Sana'a, Yemen.

Heilongjiang University of Chinese Medicine, Harbin, 150040, Heilongjiang, China.

出版信息

J Ethnopharmacol. 2023 Jan 10;300:115703. doi: 10.1016/j.jep.2022.115703. Epub 2022 Sep 10.

Abstract

ETHNOPHARMACOLOGICAL RELEVANCE

Integrated Chinese herbal medicine (CHM) and Western Medicine (WM) treatments have been used for primary hypertension (PHTN) patients in China. Currently, there are many randomized control trials (RCTs) published regarding the effect of CHM and WM on PHTN, which indicated that combining Chinese with WM was effective and safe for PHTN when compared with WM alone, but the quality of evidence was insufficient, and there is no clear information and summary are available for these RCTs assessing the effectiveness of CHM with WM versus WM in patients with PHTN.

OBJECTIVES

This systematic study and meta-analysis aimed to evaluate the effectiveness and safety of CHM combined with WM in comparison with WM in reducing systolic and diastolic blood pressure for patients with PHTN.

METHODS

The information of this study was searched from electronic databases (PubMed, COCHRANE, EMBASE, Ovid, CNKI, VIP, Wanfang, and CBM). The markedly effective and effective terms were according to Guiding Principles for Clinical Research of New Chinese Medicines. Two investigators independently reviewed each trial. The Cochrane risk of bias assessment tool was used for quality assessment, and RevMan 5.4 was used for meta-analysis.

RESULTS

In this study, a total of 29 studies that included 2623 patients were recorded. The study results displayed that the clinical effectiveness in the treatment of hypertension patients from the integrated medicines was considerably higher than that with WM alone, clinical effective (RR 1.23, 95% CI [1.17, 1.30], P < 0.00001), and markedly effective (ME) in the patients (RR 1.66, 95% CI [1.52, 1.80], and P < 0.00001). Random effect in SBP (MD 7.91 mmHg,[6.00, 983], P < 0.00001) and DBP (MD 5.46 mmHg, [3.88, 6.43], P < 0.00001), a subgroup analysis was carried out based on the type of intervention, duration of treatment, and CHM formulas that showed significance. Furthermore, no severe side effects were reported, and no patients stopped treatment or withdrawal due to any severe adverse events.

CONCLUSION

Compared to WM alone, the therapeutic effectiveness of CHM combined with WM is significantly improved in the treatment of hypertension. Additionally, CHM with WM may safely and efficiently lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in individuals with PHTN. However, rigorous randomized controlled trials with a large sample, high quality, long duration of treatment, and follow-up are recommended to strengthen this clinical evidence.

摘要

民族药理学相关性

在中国,原发性高血压(PHTN)患者采用中药(CHM)与西药(WM)联合治疗。目前,有许多关于CHM和WM对PHTN疗效的随机对照试验(RCT)发表,表明与单纯使用WM相比,CHM与WM联合治疗PHTN有效且安全,但证据质量不足,且尚无关于这些评估CHM与WM联合治疗PHTN患者有效性的RCT的明确信息和总结。

目的

本系统研究和荟萃分析旨在评估CHM联合WM与WM相比在降低PHTN患者收缩压和舒张压方面的有效性和安全性。

方法

本研究的信息从电子数据库(PubMed、COCHRANE、EMBASE、Ovid、CNKI、VIP、万方和CBM)中检索。显著有效和有效的术语依据《中药新药临床研究指导原则》。两名研究者独立审查每项试验。采用Cochrane偏倚风险评估工具进行质量评估,使用RevMan 5.4进行荟萃分析。

结果

本研究共记录了29项研究,包括2623例患者。研究结果显示,联合用药治疗高血压患者的临床疗效显著高于单纯使用WM,临床有效率(RR 1.23,95%CI[1.17,1.30],P<0.00001),患者显著有效率(ME)(RR 1.66,95%CI[1.52,1.80],P<0.00001)。收缩压(MD 7.91 mmHg,[6.00,983],P<0.00001)和舒张压(MD 5.46 mmHg,[3.88,6.43],P<0.00001)存在随机效应,基于干预类型、治疗持续时间和CHM配方进行的亚组分析显示有显著性差异。此外,未报告严重副作用,也没有患者因任何严重不良事件而停止治疗或退出研究。

结论

与单纯使用WM相比,CHM联合WM治疗高血压的疗效显著提高。此外,CHM联合WM可安全有效地降低PHTN患者的收缩压(SBP)和舒张压(DBP)。然而,建议进行大样本、高质量、长治疗期和随访的严格随机对照试验,以加强这一临床证据。

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