A phase Ⅳ clinical study on Liqi Huoxue Gutta Pills for treating chronic stable angina pectoris of coronary heart disease: an analysis in diabetes subgroup
Wang Xiaofeng
Zhang Xuejuan
Wang Tian
Fan Ruihong
Xu Dongyun
Zhao Xiaohua
Xu Hui
Xu Huimei
Shen Chunfu
Xiao Changjiang
Chen Ling
Lyu Qinglian
Xu Po
Jiang Weidong
Yang Qiaogang
Liu Baoshan
Shen Anming
Xu Su＇e
Wang Zhentao
Long Mingzhi
Zhou Yabin
Liu Shurong
Li Fengchun
Wang huizhi
Deng Yue
Ye Suilin
Chen Shouqiang
Yuan Huishu
Deng Bing
Xu Xinjuan
Xia Bihua
Zhao Yingqiang
Sun Gang
Liu Sutang
Xiao Hong
Sun Jie
Zhou Rui
Xu Yong
Zhang Yongguang
Wang Xiaolong
Bi Yuxue
Sun Xu
Wu Zonggui
Abstract：clarify the safety and efficacy of Liqi Huoxue Gutta Pills in extensive administration in population with chronic stable angina pectoris (SAP) of coronary heart disease (CHD) complicated by diabetes. Methods The patients with chronic SAP of CHD (n=2433) were randomly chosen from 41 medical units including Shanghai Changzheng Hospital from Mar. 2016 to Aug. 2017. All patients were treated with Liqi Huoxue Gutta Pills 10 pills a time and 3 times a day for 4 weeks. The indexes of efficacy and safety of Liqi Huoxue Gutta Pills and quality of life (QOL) of patients were analyzed. Results After 4 weeks, the effective rate for symptoms of angina pectoris was 70.80%, stopping or reducing rate of nitroglycerin was 83.00% and effective rate of electrocardiogram curative effect was 70.30% in patients with chronic SAP of CHD complicated by diabetes. There were 208 cases with new adverse events. QOL was significantly improved after treatment for 4 weeks compared with screening period (P<0.001). Conclusion Liqi Huoxue Gutta Pills has reliable curative effect and higher safety in population patients with chronic SAP of CHD complicated by diabetes and patients’ QOL is significantly improved, which is well worth clinical application.
Keywords：Liqi Huoxue Gutta PillsPhase IV clinical studyStable angina pectorisCoronary heart diseaseDiabetes
Publication Date：2019-01-01
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：5( 1183-1187 )