1. 上海中医药大学针灸推拿学院,上海,201203
2. 上海中医药大学附属曙光医院生殖医学科,上海,201203
3. 南京中医药大学针灸推拿学院,南京,210023
4. 上海中医药大学科技人文研究院,上海,201203
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马杰, 严骅, 陈昊, 等. 稳心颗粒联合西药治疗心房颤动的系统评价再评价[J]. 上海中医药杂志, 2019,53(11):26-33.
MA Jie, YAN Hua, CHEN Hao, et al. Wenxin granule combined with Western medicine for atrial fibrillation,an overview of systematic review[J]. Shanghai Journal of Traditional Chinese Medicine, 2019,53(11):26-33.
马杰, 严骅, 陈昊, 等. 稳心颗粒联合西药治疗心房颤动的系统评价再评价[J]. 上海中医药杂志, 2019,53(11):26-33. DOI: 10.16305/j.1007-1334.2019.11.005.
MA Jie, YAN Hua, CHEN Hao, et al. Wenxin granule combined with Western medicine for atrial fibrillation,an overview of systematic review[J]. Shanghai Journal of Traditional Chinese Medicine, 2019,53(11):26-33. DOI: 10.16305/j.1007-1334.2019.11.005.
目的:评价稳心颗粒联合西药治疗心房颤动(简称房颤)的有效性及安全性。 方法:通过系统评价再评价的方法,系统检索Pubmed、Embase、Cochrane、中国生物医学文献数据库、中国知网、万方6个主流中英文数据库,检索收集有关稳心颗粒联合西药治疗房颤的系统评价。通过系统评价方法学质量评价工具AMSTAR 2和报告规范清单PRISMA,分别评估纳入系统评价的方法学质量和报告质量。基于定性的方法总体评价当前稳心颗粒联合西药对房颤患者转复率、复发率、窦性心律维持率、房颤发作次数、心室率改善的影响及其安全性。 结果:①共计纳入11篇系统评价,11篇文献纳入的原始研究文献中位数为24篇。②经AMSTAR 2 工具评估,纳入的系统评价整体方法学质量均为极低。11篇系统评价AMSTAR 2评估最高分为9.0,最低为3.5,平均得分为6.0。③11篇系统评价的报告质量亦存在一定缺陷,PRISMA评分最高为23.0,最低为15.0,平均得分为19.8。④定性分析显示,稳心颗粒联合西药较单纯西药治疗房颤,在转复率、复发率、窦性心律维持率方面效果更优,且安全性较好,但在心室率、房颤发作次数两个指标方面的临床疗效有限;且由于纳入系统评价的方法学质量较低,相关证据质量不高,临床使用时可能存在变异。 结论:当前已有一定数量的文献证据证明,相较于单纯西药,稳心颗粒联合西药治疗房颤可能有更优的疗效;但当前相应系统评价的方法学质量较低,疗效证据质量亦较低,对临床的指导价值也有限。故建议稳心颗粒仅可作为一种辅助用药,用于非瓣膜性、阵发性房颤患者。未来尚需要更多高质量的证据进一步评估稳心颗粒治疗房颤的有效性及安全性。
Objective: To evaluate the efficacy and safety of Wenxin granule combined with Western medicine in the treatment of atrial fibrillation. Methods Six mainstream Chinese and English databases including Pubmed,Embase,Cochrane,Chinese biological literature database,CNKI,and Wanfang were searched and collected for systematic reviews on the treatment of atrial fibrillation by using the method of overview of systematic review. Based on the methodological quality appraisal tool AMSTAR 2 and reporting checklist PRISMA statement, the methodological quality and the reporting quality of the included systematic reviews were assessed respectively. A qualitative analysis was conducted to evaluate the efficacy and safety of Wenxin granule combined with Western medicine for atrial fibrillation on the cardioversion rate, the recurrence rate, the maintenance rate of sinus rhythm, the frequency of atrial fibrillation, the improvement of the ventricular rate. Results:①A total of 11 systematic evaluations were included,and the median of the original studies included in the 11 literatures was 24. ②The overall methodological quality of the included system evaluations was extremely low,as assessed by the AMSTR 2 tool. The highest score of the 11 systematic evaluations by AMSTAR2 is 9,the lowest is 3.5,and the average score is 6.0. ③There were also some defects in the quality of the 11 systematic reports.The highest PRISMA score was 23.0,the lowest 15.0,and the average score was 19.8. ④Qualitative analysis showed that Wenxin granule combined with Western medicine was more effective and safer than Western medicine alone on cardioversion rate, recurrence rate and maintenance rate of sinus rhythm. But the clinical efficacy was limited in terms of ventricular rate and frequency of atrial fibrillation. In addition,due to the low quality of methodology included in the systematic evaluation and the low quality of relevant evidence,there may be variations in clinical use of the medicine. Conclusion: The current evidence showed that Wenxin granule combined with Western medicine may have better effect for atrial fibrillation. However, at present, the methodological quality of the corresponding systematic evaluation is low, and the quality of the curative effect evidence is also low, the guiding value for clinical use of the medicine is limited. Therefore, it is suggested that Wenxin granule can only be used as an auxiliary drug for patients with non-valvular paroxysmal atrial fibrillation. It seems that more high quality and well-designed RCT are still needed to evaluate the efficacy and safety of Wenxin granule for atrial fibrillation.
心房颤动稳心颗粒系统评价再评价
atrial fibrillationWenxin granuleoverview of systematic review
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