温润辛金培本方治疗支气管哮喘慢性持续期的随机对照双盲研究

A Randomized Controlled Double-Blind Study of the Treatment of Bronchial Asthma Chronic Persistent Period by Wenrun Xinjin Peiben Prescription

目的:分析和研究温润辛金培本方药治疗支气管哮喘慢性持续期的疗效及安全性。方法:选取2009年4月至2009年11月5家三级甲等医院收治的支气管哮喘慢性持续期患者共计130例,将其随机分为观察组和对照组,每组65例。在西药常规治疗基础上,观察组口服温润辛金培本方,对照组予中药安慰剂,疗程为6周。将2组患者的疗效指标及安全性指标进行比较。结果:观察组和对照组患者的基线情况具有可比性。观察组患者在疗前、疗后的安全性指标未见明显异常,用药过程中无不良反应发生。2组患者主症+体征疗效结果显示:观察组控制2例,显效9例,有效26例,无效28例;对照组控制3例,显效1例,有效15例,无效46例,观察组疗效优于对照组,差异有统计学意义(P<0.01)。主症+体征显效率及有效率评价结果显示,观察组患者均明显高于对照组,差异有统计学意义(P<0.05,P<0.01)。观察组患者治疗后肺功能指标FEV_1/FVC明显优于对照组患者,差异有统计学意义(P<0.05),观察组患者疗后FEV_1较治疗前明显改善,差异有统计学意义(P<0.05)。结论:温润辛金培本方药治疗支气管哮喘慢性持续期疗效满意,无明显不良反应发生,用药安全较高,对促进患者症状缓解、肺功能改善及病情转归具有积极作用。

Objective： To analyze and study the curative effect and safety in the treatment of chronic persistent period asthma by Wenrun Xinjin Peiben prescription.Methods： A total of 130 patients with chronic persistent bronchial asthma from five hospitals from April 2009 to November 2009 were selected.They were randomly divided into the treatment group and the control group,with65 cases in each group.On the basis of routine treatment of western medicine,the treatment group was treated with Wenrun Xinjin Peiben prescription,and the control group was given a placebo.The treatment course was 6 weeks.The efficacy and safety indexes of the two groups were compared.Results： The baseline situation of the patients in the treatment group and the control group was comparable.There was no obvious abnormality in the safety indexes of the patients in the treatment group before and after the treatment,and no adverse reaction occurred during the medication.The results of main symptoms and signs curative effect in the two groups showed that in the treatment group 2 cases were under control,9 cases markedly effective,26 cases effective,28 cases not effective,while in the control group 3 cases were under control,1 case markedly effective,15 cases effective,and 46 cases not effective.The curative effect of treatment group was better than the control group（ P〈0.01）.The effectiveness and efficiency evaluation of main symptoms and signs showed that the patients in the treatment group were significantly higher than those of the control group（ P〈0.05,P〈0.01）.The pulmonary function index FEV_1/FVC in the treatment group was significantly better than that in the control group（ P〈0.05） after treatment.The FEV_1 in the treatment group was significantly improved after treatment compared with that before treatment（ P〈0.05）.Conclusion： Satisfactory curative effect had been showed in the treatment of chronic persistent asthma by Wenrun Xinjin Peiben prescription,with a high safety and no obvious adverse reaction.It has a positive effect on alleviating the symptoms of the patients,improving the lung function and the prognosis of the disease.