ABSTRACT
OBJECTIVE@#To evaluate whether the efficacy of Getong Tongluo Capsule (, 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 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 (P0.05). 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 (P0.05).@*CONCLUSION@#GTC exhibited significant efficacy in improving patients' quality of life as well as neurological function and controlling hypertension. (Registration No. ChiCTR1800016667).
ABSTRACT
Objective To observe the effect of hypoxemia in children with obstructive sleep apnea hypopnea syndrome (OSAHS) on erythropoietin (EPO) and hypoxia-inducible factor 1α (HIF-1α) levels in serum,and to learn the changes in endocrine and its relationship to growth in OSAHS children.Methods Seventy children with snoring were selected from Jun.2006 to Jun.2010 from the First Hospital of Hebei Medical University.Apnea hypopnea index ≥5 times/hour observed by the polysomnography,and the minimum oxygen saturation ＜ 92％ were taken as the standard,then the children were divided into OSAHS group (38 cases) and PS group (32 cases).The red blood cell count,hemoglobin,hematocrit,mean corpuscular volume,red cell distribution width,serum erythropoietin and hypoxia-inducible factors were observed and analysed statistically between the 2 groups.Results 1.Between OSAHS group and PS group,the differences of red blood cell count,hemoglobin and hematocrit were statistically significant (all P ＜ 0.01).Mean corpuscular volume and red cell distribution width showed no significant difference between both groups (all P ＞0.05).2.The EPO level in OSAHS group was higher than that in the PS group,the difference was significanty (P ＜0.01).3.The serum levels of HIF-1α showed no significant difference between the 2 groups(P ＞ 0.05).Conclusions Hypoxemia induced by OSAHS can cause the changes in endocrine and the concentration of blood formed elements.This change is one of the most important process in physiological changes in children with OSAHS,and meanwhile it can also influence the growth of children.