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中药稳心颗粒治疗室性早搏的疗效与安全性:一项系统评价。

Efficacy and safety of Chinese herbal medicine Wenxin Keli for ventricular premature be ats: A systematic review.

作者信息

He Mei, Lv Zhan, Yang Zheng-Wei, Huang Jiu-Ling, Liu Fu

机构信息

Department of Pharmacy, Affiliated Hospital of North Sichuan Medical College, Wenhua Road 63, Nanchong, Sichuan 637000, PR China.

Department of Cardiology, Affiliated Hospital of North Sichuan Medical College, PR China.

出版信息

Complement Ther Med. 2016 Dec;29:181-189. doi: 10.1016/j.ctim.2016.10.007. Epub 2016 Oct 13.

Abstract

BACKGROUND

To evaluate the efficacy and safety of the Chinese herbal extract Wenxin Keli, alone or in combination with Western medicine, for ventricular premature beats.

METHODS

This systematic review was registered at PROSPERO (registration number CRD42013003200). A systematic literature search of 8 core electronic databases and 3 clinical trial registries in Chinese and English, yielded 10 trials whose randomness verified by contacting the authors. The included trials were assessed by the Cochrane risk of bias tool.

RESULTS

Wenxin Keli might be more efficacious than placebo (Change of VPBs numbers, RR, 1.61, 95%CI, 1.48-1.76, P<0.00001, I=0%;VPBs- related symptom, RR, 2.10, 95%CI, 1.91-2.30, P<0.00001, I=0%), and the dual therapy of Wenxin Keli plus amiodarone might also be more effective than the monotherapy of amiodarone (Change of VPBs numbers, RR, 1.23, 95%CI, 1.10-1.39, P=0.0005, I=0%; VPBs- related symptom, RR, 1.51., 95%CI, 1.30-1.76, P<0.00001, I=0%), whereas Wenxin Keli might be comparable to metoprolol, propafenone or mexiletine (Change of VPBs numbers: metoprolol, RR, 1.01, 95%CI, 0.91-1.11, P=0.88, I=0%; propafenone, RR, 1.05, 95%CI, 0.93-1.19, P=0.44, I=0%; mexiletine, RR, 1.06, 95%CI, 0.96-1.17, P=0.28. VPBs- related symptom: metoprolol, RR, 0.95, 95%CI, 0.87-1.04, P=0.27, I=0%, propafenone. RR, 1.10, 95%CI, 0.93-1.30, P=0.29, I=29%, mexiletine,RR, 0.94, 95%CI, 0.78-1.12, P=0.47). Participants with ventricular premature beats' numbers<360 beats/h or with coronary heart disease benefited the most of the Wenxin Keli therapy (Change of VPBs numbers:RR, 1.10, 95%CI, 1.02-1.20, P=0.02, I=44%; RR, 1.71, 95%CI, 1.18-2.49, P=0.005, I=54%, respectively). The safety analysis revealed that Wenxin Keli did not statistically significant differed from the Western medicine in respect of the incidence of total adverse drug reactions (RR, 0.59, 95%CI, 0.35-1.01, P=0.05, I=0%), but Wenxin Keli might be associated with a reduced risk of proarrhythmic reactions (P=0.007). The quality of the methodology of included trials was generally low. Several limitations existed that affected the validity of the findings, including the small sample size, insufficient randomization methods, poorly defined eligibility criteria, short duration of follow-up, absence of hard endpoints, and high risk of publication bias(P=0.013).

CONCLUSIONS

Wenxin Keli might be a promising alternative and complementary medicine for ventricular premature beats.

摘要

背景

评估中药提取物稳心颗粒单独或与西药联合治疗室性早搏的疗效和安全性。

方法

本系统评价在国际前瞻性系统评价注册平台(PROSPERO)注册(注册号CRD42013003200)。通过对8个核心电子数据库以及3个中英文临床试验注册库进行系统文献检索,获得10项试验,通过与作者联系核实其随机性。纳入的试验采用Cochrane偏倚风险工具进行评估。

结果

稳心颗粒可能比安慰剂更有效(室性早搏数量变化,RR=1.61,95%CI为1.48 - 1.76,P<0.00001,I=0%;与室性早搏相关的症状,RR=2.10,95%CI为1.91 - 2.30,P<0.00001,I=0%),稳心颗粒联合胺碘酮的双重治疗可能也比胺碘酮单药治疗更有效(室性早搏数量变化,RR=1.23,95%CI为1.10 - 1.39,P=0.0005,I=0%;与室性早搏相关的症状,RR=1.51,95%CI为1.30 - 1.76,P<0.00001,I=0%),而稳心颗粒可能与美托洛尔、普罗帕酮或美西律相当(室性早搏数量变化:美托洛尔,RR=1.01,95%CI为0.91 - 1.11,P=0.88,I=0%;普罗帕酮,RR=1.05,95%CI为0.93 - 1.19,P=0.44,I=0%;美西律,RR=1.06,95%CI为0.96 - 1.17,P=0.28。与室性早搏相关的症状:美托洛尔,RR=0.95,95%CI为0.87 - 1.04,P=0.27,I=0%,普罗帕酮,RR=1.10,95%CI为0.93 - 1.30,P=0.29,I=29%,美西律,RR=0.94,95%CI为0.78 - 1.12,P=0.47)。室性早搏数量<360次/小时或患有冠心病的参与者从稳心颗粒治疗中获益最大(室性早搏数量变化:RR=1.10,95%CI为1.02 - 1.20,P=0.02,I=44%;RR=1.71,95%CI为1.18 - 2.49,P=0.005,I=54%,分别)。安全性分析显示,在药物不良反应总发生率方面,稳心颗粒与西药无统计学显著差异(RR=0.59,95%CI为0.35 - 1.01,P=0.05,I=0%),但稳心颗粒可能与心律失常反应风险降低有关(P=0.007)。纳入试验的方法学质量总体较低。存在一些影响研究结果有效性的局限性,包括样本量小、随机化方法不足、纳入标准定义不明确、随访时间短、缺乏硬终点以及发表偏倚风险高(P=0.013)。

结论

稳心颗粒可能是治疗室性早搏的一种有前景的替代和补充药物。

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