Efficacy of Getong Tongluo Capsule ((sic)(sic)) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial
Objective To evaluate whether the efficacy of Getong Tongluo Capsule ((sic)(sic), GTC, consisted of total flavone ofRadix Puerariae) on improving patients' quality of life and lowering blood pressure are superior to the extract ofGinkgo biloba(EGB) for patients with convalescent-phase ischemic stroke and primary hypertension. Methods This randomized, positive-drug- and placebo-controlled, double-blind trial was conducted from September 2015 to October 2017. Totally 477 eligible patients from 18 hospitals in China were randomly assigned in a 2:1:1 ratio to the following interventions, twice a day for 12 weeks: (1) GTC 250 mg plus EGB-matching placebo 40 mg (237 cases, GTC group), (2) EGB 40 mg plus GTC-matching placebo 250 mg (120 cases, EGB group) or (3) GTC-matching placebo 250 mg plus EGB-matching placebo 40 mg (120 cases, placebo group). Moreover, all patients were orally administered aspirin enteric-coated tablets 100 mg, once a day for 12 weeks. The primary outcome was the Barthel Index (BI). The secondary outcomes included the control rate of blood pressure and National Institutes of Health Stroke Scale (NIHSS) scores. The incidence and severity of adverse events (AEs) were calculated and assessed. Results The BI relative independence rates, the clinical recovery rates of NIHSS, and the total effective rates of NIHSS in the GTC and EGB groups were significantly higher than the placebo group at 12 weeks after treatment (P<0.05), and no statistical significance was found between the GTC and EGB groups (P>0.05). The control rate of blood pressure in the GTC group was significantly higher than the EGB and placebo groups at 12, 18 and 24 weeks after treatment (P<0.01). There were no statistically significant differences in the incidences of AEs, adverse drug reactions, or serious AEs among the 3 groups (P>0.05). Conclusion GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667)
基金:
project of Guangzhou Clinical Medical Research and Transformation Center Pilot Construction [20160402003]
第一作者单位:[1]Beijing Univ Chinese Med, Dongfang Hosp, Dept Neurol, Beijing 100078, Peoples R China[2]Beijing Univ Chinese Med, Sch Clin Med 2, Beijing 100029, Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
Zhao Qian-yu,Tang Rong-hua,Lu Guo-xiong,et al.Efficacy of Getong Tongluo Capsule ((sic)(sic)) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial[J].CHINESE JOURNAL OF INTEGRATIVE MEDICINE.2021,27(4):252-258.doi:10.1007/s11655-020-3320-3.
APA:
Zhao, Qian-yu,Tang, Rong-hua,Lu, Guo-xiong,Cao, Xu-zheng,Liu, Lu-ran...&Chen, Zhi-gang.(2021).Efficacy of Getong Tongluo Capsule ((sic)(sic)) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial.CHINESE JOURNAL OF INTEGRATIVE MEDICINE,27,(4)
MLA:
Zhao, Qian-yu,et al."Efficacy of Getong Tongluo Capsule ((sic)(sic)) for Convalescent-Phase of Ischemic Stroke and Primary Hypertension: A Multicenter, Randomized, Double-Blind, Controlled Trial".CHINESE JOURNAL OF INTEGRATIVE MEDICINE 27..4(2021):252-258