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开展比较效果研究以识别治疗心绞痛的相似中成药的治疗特征。

Practice of Comparative Effectiveness Research to Identify Treatment Characteristics of Similar Chinese Patent Medicine for Angina Pectoris.

作者信息

Cao Hongbo, Wang Ping, Li Nan, Liu Dan, Ma Junshao, Fan Ruihong, Zhou Zhihuan

机构信息

Tianjin University of Traditional Chinese Medicine, Tianjin, China.

Center for Evidence-Based Medicine, Tianjin, China.

出版信息

Evid Based Complement Alternat Med. 2017;2017:7062714. doi: 10.1155/2017/7062714. Epub 2017 Aug 13.

Abstract

OBJECTIVE

Individualized application of TCM is not easy and may lead to undesirable results, such as poor effect or even adverse reactions. This trial aims to compare two common Chinese patent medicines with similar effects.

BACKGROUND OF THE RESEARCH

Four hospitals carried out the test at the same time in Tianjin city of China.

PARTICIPANTS

144 patients were involved in this study; all patients must meet the diagnostic criteria.

INTERVENTIONS

Qishen Yiqi pills, compound danshen pills, and their placebos; an efficacy analysis was conducted after the first medication and after crossover medication.

PRIMARY OUTCOME MEASURES

The primary index of end point includes Seattle Angina Questionnaire score-7 and score of 7-point Likert Scale; the curative effect was compared with minimal clinically important differences value.

RESULT

Two drugs have their respective advantages in treating SAP. In practical application, the two drugs shall be discriminated in use based on patients' specific symptoms.

TRIAL REGISTRATION

Chinese clinical trials register is ChiCTR-TTRCC-14004406 (registered 23 March 2014).

摘要

目的

中医个体化应用并非易事,且可能导致不理想的结果,如疗效不佳甚至出现不良反应。本试验旨在比较两种疗效相似的常用中成药。

研究背景

中国天津市的四家医院同时开展了该试验。

参与者

144名患者参与了本研究;所有患者均须符合诊断标准。

干预措施

芪参益气滴丸、复方丹参滴丸及其安慰剂;首次用药后及交叉用药后进行疗效分析。

主要结局指标

终点主要指标包括西雅图心绞痛问卷评分-7及7点李克特量表评分;将疗效与最小临床重要差异值进行比较。

结果

两种药物在治疗稳定性心绞痛方面各有优势。在实际应用中,应根据患者的具体症状对两种药物加以甄别使用。

试验注册

中国临床试验注册中心注册号为ChiCTR-TTRCC-14004406(2014年3月23日注册)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/14c4/5574271/9474f963e3be/ECAM2017-7062714.001.jpg

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