摘要
目的:利用快速卫生技术评估(RHTA)对速效救心丸、复方丹参滴丸、麝香保心丸、宽胸气雾剂治疗气滞血瘀型急性冠状动脉综合征(ACS)的安全性、有效性、经济性进行评价,以期为临床决策提供循证依据,为中成药的快速评估方法提供借鉴。方法:计算机检索相关数据库,检索时限为建库至2023年12月31日,按预设标准进行文献筛选、数据提取和证据质量评价,最终纳入55篇研究,包括RCT 38篇、系统评价/Meta分析17篇。结果:有效性方面,速效救心丸更适用于ACS行PCI围术期的联合治疗;复方丹参滴丸更适用于ST段抬高的心肌梗死行介入治疗/溶栓者、不稳定型心绞痛合并老年患者或合并脂质代谢异常者的联合治疗;麝香保心丸更适用于不稳定型心绞痛合并高血压或Hcy升高患者的联合治疗;宽胸气雾剂更适用于心绞痛急性发作时的单药治疗。安全性方面,59%的文献对不良反应进行报道,包括出血、胃肠道和皮肤反应、头痛乏力、口干嗜睡、心血管事件等,相对于对照组不良反应少(P<0.05)。经济学研究缺乏,日费用排序为复方丹参滴丸<麝香保心丸<速效救心丸<宽胸气雾剂。结论:4种中成药对特定人群各有治疗优势,安全性良好,但存在临床设计方案不合理、报告规范欠缺、文献质量偏低、缺乏中医药理论指导、经济学评价匮乏等问题,未来应开展更多高质量研究,同时加强经济学研究以弥补决策证据不足,从而完善中成药RHTA的规范科学性。
Objective:To evaluate the safety,efficacy,and economy of Suxiao Jiuxin pill,compound Danshen dripping pill,Shexiang Baoxin pill and Kuanxiong aerosol in the treatment of ACS with Qi stagnation and blood stasis type by RHTA,in order to provide evidence for clinical decision-making,and provide reference for RHTA of Chinese patent medicines.Methods:The relevant database was searched by computer,and the search period was from the establishment to December 31st,2023.Two evaluators screened the literature,extracted data,and evaluated the quality of evidence according to predefined criteria,55 studies were included,including 38 RCTS,17 systematic reviews/meta-analyses.Results:In terms of effectiveness,Suxiao Jiuxin pill was more suitable for combined treatment of ACS during perioperative PCI.compound Danshen dripping pill was more suitable for combined treatment of STEMI under going PCI therapy/thrombolysis,UAP combined with elderly patients or combined with abnormal lipid metabolism.Shexiang Baoxin pill was more suitable for the combined treatment of patients with UAP combined with hypertension or combined with elevated Hcy.Kuanxiong aerosol was more suitable for monotherapy in acute angina pectoris.In terms of safety,59%of the literature reported adverse reactions,including bleeding reactions,gastrointestinal reactions,skin reactions,headache,fatigue,dry mouth,drowsiness,and cardiovascular events,compared with the control group,fewer adverse reactions were reported(P<0.05).Economic research was lacking,and the daily cost of drugs was ranked as follows:compound Danshen dropping pill<Shexiang Baoxin pill<Suxiao Jiuxin pill<Kuanxiong aerosol.Conclusion:The four Chinese patent medicines each have therapeutic advantages and good safety for the specific population of ACS.However,there are still some problems such as unreasonable clinical plan design,non-standard reporting,low literature quality,lack of theoretical guidance of traditional Chinese medicine,and lack of economic evaluation.More high-quality studies should be carried out in the future,and economic research should be strengthened at the same time to make up for the lack of decision-making evidence,thus to improve the scientific standard of RHTA.
作者
黄文娟
崔梦茹
赵生俊
Huang Wenjuan;Cui Mengru;Zhao Shengjun(The Hospital of Traditional Chinese Medicine Affiliated to Xinjiang Medical University,Urumqi 830000,China)
出处
《亚太传统医药》
2025年第7期248-256,共9页
Asia-Pacific Traditional Medicine
基金
新疆维吾尔自治区药学会科研基金计划(YXH202201)
丝绸之路经济带创新驱动发展试验区、乌昌石国家自主创新示范区科技发展计划(2023LQ01002-05)。
