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中成药辅助治疗冠心病心绞痛:一项前瞻性临床队列研究。

Adjuvant treatment of coronary heart disease angina pectoris with Chinese patent medicine: A prospective clinical cohort study.

作者信息

Liu Yijia, Li Zhu, Shen Dandan, Song Yanqi, Huang Mengnan, Xue Xiaoxue, Xie Jing, Jiao Ziyi, Gao Shuming, Xu Yilan, Gao Shan, Wang Xianliang, Xu Qiang, Gao Sheng, Li Chunjie, Li Lin, Niu Kaijun, Yu Chunquan

机构信息

Graduate School.

First Teaching Hospital.

出版信息

Medicine (Baltimore). 2019 Aug;98(33):e16884. doi: 10.1097/MD.0000000000016884.

Abstract

BACKGROUND

Patients with coronary heart disease (CHD) angina pectoris are in critical condition, which can cause sudden death, myocardial infarction, and other adverse events, and bring serious burden to families and society. Timely treatment should be given to improve the condition. Western medicine treatment of angina pectoris failed to meet the demand of angina symptom control.

OBJECTIVE

It is hoped that the research method with higher evidential value will be adopted to compare the short-term, medium-term, and long-term effects of Chinese patent medicine combined with conventional western medicine and conventional western medicine alone in the treatment of CHD angina pectoris, so as to tap the clinical efficacy advantages of traditional Chinese medicine (TCM) and provide reliable data support for its clinical application.

METHODS

A prospective cohort study was conducted among patients with CHD angina pectoris who were treated with oral Chinese patent medicine and conventional western medicine. The patients were divided into exposed group and nonexposed group according to whether or not the patients with CHD angina pectoris were treated with Chinese patent medicine. The exposed group was treated with TCM combined with conventional western medicine, while the nonexposed group was treated with conventional western medicine alone. Patients need to be hospitalized for 2 weeks as the introduction period and whether to enter the group is determined according to the treatment and medication conditions of the patients. The follow-up time points were 0th, 4th, 12th, 24th, and 48th weeks. The main events and secondary events were used as the evaluation criteria for clinical efficacy of CHD angina pectoris. In the experimental study, we will use strict indicators to detect standard operation procedure for multinomics and bacterial flora detection.

CONCLUSION

This study will provide evidence for the clinical efficacy advantages of Chinese patent medicine and reliable support for its clinical application through test data.

摘要

背景

冠心病心绞痛患者病情危急,可导致猝死、心肌梗死等不良事件,给家庭和社会带来沉重负担。应及时给予治疗以改善病情。西医治疗心绞痛未能满足心绞痛症状控制的需求。

目的

希望采用证据价值更高的研究方法,比较中成药联合传统西药与单纯传统西药治疗冠心病心绞痛的短期、中期和长期效果,以挖掘中医药的临床疗效优势,为其临床应用提供可靠的数据支持。

方法

对口服中成药和传统西药治疗的冠心病心绞痛患者进行前瞻性队列研究。根据冠心病心绞痛患者是否接受中成药治疗,将患者分为暴露组和非暴露组。暴露组采用中医联合传统西药治疗,非暴露组采用单纯传统西药治疗。患者需住院2周作为导入期,并根据患者的治疗和用药情况确定是否入组。随访时间点为第0、4、12、24和48周。主要事件和次要事件作为冠心病心绞痛临床疗效的评价标准。在实验研究中,我们将使用严格的指标来检测多组学和细菌菌群检测的标准操作程序。

结论

本研究将通过试验数据为中成药的临床疗效优势提供证据,并为其临床应用提供可靠支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/562f/6831431/28b26e8cc4eb/medi-98-e16884-g001.jpg

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