Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to...Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo 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 fo r 12 weeks.The primary outcome was the Barthel Index(Bl).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 Bl 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.展开更多
目的研究并建立葛酮通络胶囊指纹图谱测定方法。方法采用RP-HPLC法以甲醇—乙腈(70∶30)和0.05%磷酸溶液进行二元梯度洗脱,流速为1.0 m L·min-1,检测波长250 nm,测定10批样品的指纹图谱。结果该方法操作简便,重现性和精密度较好,...目的研究并建立葛酮通络胶囊指纹图谱测定方法。方法采用RP-HPLC法以甲醇—乙腈(70∶30)和0.05%磷酸溶液进行二元梯度洗脱,流速为1.0 m L·min-1,检测波长250 nm,测定10批样品的指纹图谱。结果该方法操作简便,重现性和精密度较好,且各峰分离度较好,确定共有峰12个。结论建立的葛酮通络胶囊HPLC指纹图谱为其质量控制提供依据。展开更多
基金Supported by the project of Guangzhou Clinical Medical Research and Transformation Center Pilot Construction(No.20160402003)。
文摘Objective:To evaluate whether the efficacy of Getong Tongluo Capsule(葛酮通络胶囊,GTC,consisted of total flavone of Radix Puerariae)on improving patients'quality of life and lowering blood pressure are superior to the extract of Ginkgo 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 fo r 12 weeks.The primary outcome was the Barthel Index(Bl).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 Bl 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.
文摘目的研究并建立葛酮通络胶囊指纹图谱测定方法。方法采用RP-HPLC法以甲醇—乙腈(70∶30)和0.05%磷酸溶液进行二元梯度洗脱,流速为1.0 m L·min-1,检测波长250 nm,测定10批样品的指纹图谱。结果该方法操作简便,重现性和精密度较好,且各峰分离度较好,确定共有峰12个。结论建立的葛酮通络胶囊HPLC指纹图谱为其质量控制提供依据。
