黄七胶囊治疗中风恢复期临床用药剂量的探讨

Clinic dosage of Huangqi capsule in the treatment of the stage of stroke recovery

目的探讨黄七胶囊临床用药剂量与疗效和不良反应的关系。方法 89例中风恢复期患者随机分为高、低剂量组和安慰剂对照组,每日服3次,4周为1个周期,共服用3个周期,观察其疗效和不良反应。结果高、低剂量皆对中风恢复期患者具有明显的治疗效果,疗效与用药剂量大小成正相关。高剂量组中医证候临床基本痊愈6例,显效16例,有效6例,无效2例,显效率为73.3%,总有效率为93.3%;低剂量组中医证候临床基本痊愈2例,显效10例,有效12例,无效6例,显效率为40.0%,总有效率为80.0%。高剂量组疗效明显优于低剂量组。高剂量组神经功能缺损程度及病残程度改善率为93.3%,低剂量组为76.7%,两组比较差异有统计学意义(P<0.05)。头颅CT检查结果表明,黄七胶囊有缩小或消除脑梗死病灶的作用,且高剂量组优于低剂量组。治疗前后血液流变学及出凝血时间检查结果表明,黄七胶囊有降低血液黏稠度、改善脑梗死患者血流变状态的作用,并能延长出、凝血时间,具有防止血栓形成的作用而又无出血等不良反应,无论是高剂量组还是低剂量组,与对照组比较,差异均有统计学意义(P均<0.05)。对照组、高剂量组、低剂量组个别患者出现恶心、皮肤过敏、便秘等情况,但无剂量相关,与药物无必然联系,三组皆无肝、肾功能等损害,亦无相关死亡病例。结论黄七胶囊对气虚血瘀、脉络瘀阻型脑中风恢复期患者有较好的中医证候临床疗效,对神经功能缺损及脑梗死病灶治疗效果良好,有降低血液黏稠度、改善脑梗死患者血液流变学状态的作用,并能延长出、凝血时间,具有防止血栓形成的作用,而又无出血等不良反应,其疗效高剂量组优于低剂量组,且本品无明显不良反应。

Objective To investigate the correlation between the clinic dosage of Huangqi capsule and its efficacy and adverse reaction. Methods Eighty-nine apoplectic patients at the convalescent stage were randomly divided into three groups,the high dosage group,low dosage group and placebo-controlled group.Each subject was administered 3 times per day.Each circle of the treatment lasts for 4 weeks.The patients were administered for 3 treatment circles.The treatment efficacy and adverse reactions were closely observed.Results The drug has significant remedy effect for the high and low dosage groups.The efficacy had positive correlation with the dosage.In the high dosage group,6 patients were cured,16 patients were marked effect,6 patients were effective,2 patients were ineffective.The obvious effective rate was 73.3% and total effective rate was 93.3%.In the low dosage group,2 patients were cured,10 patients were marked effect,12 patients were effective,6 patients were ineffective.The obvious effective rate was 40.0% and the total effective rate was 80.0%.The healing effect of the high dosage group was higher than that of the low dosage group.The improvement rate for neural functional impairment and illness was 93.3% in the high dosage group and 76.7% in the low dosage group,respectively.The comparison between the two groups had statistic significance（P0.05）.Skull CT scanning showed that Huangqi capsule alleviates or eradicate cerebral infarction,and the effect for high dosage group was much better than that for low dosage group.The test results before and after treatment showed that the drug could be used to decrease blood viscosity and improve the hemorheological conditions of the cerebral infarction patients,and could prolonged the coagulation time and bleeding time,thus to prevent the development of internal clot and bleeding.Compared with the control group,both the high and low dosage groups had statistic significance（P0.05）.Drug adverse reaction observation showed that several patients in the high and low dosage groups and the control group had the symptoms of nausea,skin allergy and constipation,but all these symptoms had no correlation with the drug dosage and no necessary relation with the drug.Patients in all three groups showed no liver and kidney injury,and also had no related death.This indicated that the drug would not cause any adverse reaction. Conclusions That Huangqi capsule have effective healing function to patients with cerebral apoplexy during the recovery stage when the patients are deficient in vital energy with symptoms of blood stasis and vein stasis,the drug also has apparent effectiveness for the treatment of neural functional impairment and cerebral infarction,the drug could also be used to decrease blood viscosity and improve the hemorheological conditions of the cerebral infarction patients,and could prolonged the coagulation time and bleeding time,thus to prevent the development of internal clot and bleeding.The healing effect of the high dosage is much better than that of the low dosage.There is no adverse reaction that has been found.