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真元胶囊治疗慢性心力衰竭的疗效和安全性:Meta 分析和试验序贯分析。

Efficacy and safety of Zhenyuan capsule in the treatment of chronic heart failure: A meta-analysis and trial sequential analysis.

机构信息

The First Affiliated Hospital of Hunan University of Chinese Medicine, Changsha, China.

Branch of National Clinical Research Center for Chinese Medicine Cardiology, Changsha, China.

出版信息

Medicine (Baltimore). 2023 Sep 8;102(36):e35006. doi: 10.1097/MD.0000000000035006.

DOI:10.1097/MD.0000000000035006
PMID:37682146
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10489261/
Abstract

BACKGROUND

Chronic heart failure (CHF) is a common and difficult-to-treat disease in clinical practice. The efficacy and safety of Zhenyuan capsule (ZYC) in the treatment of CHF were evaluated by meta-analysis and trial sequential analysis (TSA) of published relevant data.

METHODS

Searched 8 databases for clinical literature on ZYC in the treatment of CHF, up to December 2022. Then the meta-analysis and TSA were performed on the studies that met the inclusion criteria.

RESULTS

Meta-analysis showed that compared with conventional treatment, combined use of ZYC could significantly increase the clinical effective rate (risk ratio 1.20, 95% confidence interval [CI] 1.141.26, P < .00001) by 20%, left ventricular ejection fraction (MD 8.85, 95%CI 4.5713.12, P < .0001) by 8.85%, and 6-minutes walking distance (MD 47.91, 95%CI 18.6677.17, P = .001) by 47.91 m, and significantly reduce brain natriuretic peptide (MD -247.86, 95%CI -330.62-165.09, P < .00001) by 247.86 pg/mL. TSA showed that the benefits suggested by the original results were conclusive. In terms of safety, the total adverse events in the combined group of ZYC were comparable to those in the conventional group, and TSA demonstrated that this result needed more research and demonstration.

CONCLUSION

ZYC can effectively improve the clinical efficacy of treating CHF, significantly increase left ventricular ejection fraction and 6-minute walk distance, and remarkably reduce brain natriuretic peptide. ZYC, with definite efficacy and safety, has the value of clinical application and in-depth research.

摘要

背景

慢性心力衰竭(CHF)是临床实践中一种常见且难以治疗的疾病。通过对已发表相关数据的荟萃分析和试验序贯分析(TSA),评估了真元胶囊(ZYC)治疗 CHF 的疗效和安全性。

方法

检索 8 个数据库,获取截至 2022 年 12 月有关 ZYC 治疗 CHF 的临床文献。然后对符合纳入标准的研究进行荟萃分析和 TSA。

结果

荟萃分析表明,与常规治疗相比,ZYC 联合使用可使临床有效率显著提高 20%(风险比 1.20,95%置信区间[CI] 1.141.26,P < .00001),左心室射血分数(MD 8.85,95%CI 4.5713.12,P < .0001)提高 8.85%,6 分钟步行距离(MD 47.91,95%CI 18.6677.17,P = .001)增加 47.91 m,脑利钠肽(MD -247.86,95%CI -330.62-165.09,P < .00001)降低 247.86 pg/mL。TSA 显示原始结果提示的益处具有结论性。在安全性方面,ZYC 联合组的总不良反应与常规组相当,TSA 表明这一结果需要更多的研究和论证。

结论

ZYC 能有效提高 CHF 的临床疗效,显著增加左心室射血分数和 6 分钟步行距离,显著降低脑利钠肽。ZYC 疗效确切,安全性良好,具有临床应用和深入研究的价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/41aed18b4f0d/medi-102-e35006-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/a0526ad1ae9c/medi-102-e35006-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/271344d42306/medi-102-e35006-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/d66850c98596/medi-102-e35006-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/950d0714ff90/medi-102-e35006-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/f56a954610df/medi-102-e35006-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/91d98b7b1d4c/medi-102-e35006-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/4a5b65ad5c63/medi-102-e35006-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/41aed18b4f0d/medi-102-e35006-g008.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/a0526ad1ae9c/medi-102-e35006-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/271344d42306/medi-102-e35006-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/d66850c98596/medi-102-e35006-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/950d0714ff90/medi-102-e35006-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/f56a954610df/medi-102-e35006-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/91d98b7b1d4c/medi-102-e35006-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/4a5b65ad5c63/medi-102-e35006-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fffb/10489261/41aed18b4f0d/medi-102-e35006-g008.jpg

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