磷酸二甲啡烷治疗干性咳嗽的临床疗效及安全性评价

发布时间：2018-06-22 21:21

本文选题：磷酸二甲啡烷 + 右美沙芬　；参考：《中国临床药理学杂志》2016年04期

【摘要】：目的评价磷酸二甲啡烷治疗干性咳嗽的临床疗效和安全性。方法将378例干性咳嗽患者随机分为试验组216例、阳性对照组108例和安慰剂组54例。试验组予以口服磷酸二甲啡烷20 mg,tid,5~7 d;阳性对照组予以口服氢溴酸右美沙芬30 mg,tid,5~7 d;安慰剂组予以磷酸二甲啡烷模拟片20 mg或氢溴酸右美沙芬模拟片30 mg,tid,5~7 d。比较3组患者的临床疗效、治疗5~7 d后咳嗽症状总积分的变化,以及不良反应发生率。结果治疗后,试验组、阳性对照组、安慰剂组的咳嗽症状临床有效率分别为81.02%,84.26%,38.89%。试验组的咳嗽症状临床有效率与安慰剂组比较差异有统计学意义(P0.01),与阳性对照组比较差异无统计学意义(P0.05)。试验组、阳性对照组、安慰剂组的咳嗽症状总积分相对基线的平均下降值分别为(2.34±1.42),(2.43±1.55),(1.39±1.20)。试验组的咳嗽症状总积分下降显著优于安慰剂组(P0.01),与阳性对照组比较差异无统计学意义(P0.05)。试验组、阳性对照组、安慰剂组的不良事件发生率分别为4.21%,12.01%,5.66%,其中与药物相关的不良事件的发生率分别为1.87%,10.19%,5.66%。结论磷酸二甲啡烷在治疗干性咳嗽时镇咳效果确切,且磷酸二甲啡烷在治疗干性咳嗽时的镇咳效果与氢溴酸右美沙芬相当,两药的安全性相似。
[Abstract]:Objective to evaluate the efficacy and safety of dimethorphine phosphate in the treatment of dry cough. Methods 378 patients with dry cough were randomly divided into trial group (216 cases), positive control group (108 cases) and placebo group (54 cases). The experimental group was given oral dimethorphine 20 mg tidanine for 5 days, the positive control group was given oral dextromethorphan hydrobromide 30 mg tidd for 7 days, the placebo group was given 20 mg dimethorphine phosphate mimic tablet or dextromethorphan hydrobromide 30 mg tid model tablet for 57 days. The clinical efficacy, the changes of the total score of cough symptom and the incidence of adverse reaction were compared between the three groups. Results after treatment, the clinical effective rates of cough symptoms in the trial group, the positive control group and the placebo group were 81.02 and 84.26 / 38.89 respectively. The clinical effective rate of cough symptoms in the trial group was significantly higher than that in the placebo group (P0.01), but there was no significant difference compared with the positive control group (P0.05). The average decrease of the total score of cough symptom in the trial group, the positive control group and the placebo group was (2.34 卤1.42), () 2.43 卤1.55), (1.39 卤1.20). The total score of cough symptoms in the trial group was significantly lower than that in the placebo group (P0.01), but there was no significant difference compared with the positive control group (P0.05). The incidence of adverse events in the trial group, the positive control group and the placebo group was 4.21 and 12.01, respectively. The incidence of the drug-related adverse events was 1.87 and 10.19 respectively. Conclusion the antitussive effect of dimethorphine phosphate on dry cough is definite, and the antitussive effect of dimethorphine phosphate in dry cough is similar to that of dextromethorphan hydrobromide, and the safety of the two drugs is similar.
【作者单位】：北京大学人民医院呼吸与危重症科;首都医科大学附属安贞医院呼吸内科;首都医科大学附属友谊医院呼吸内科;河北省人民医院呼吸内科;上海肺科医院呼吸内科;安徽省立医院呼吸内科;广州医学院第一附属医院呼吸内科;广西壮族自治区人民医院呼吸内科;四川省人民医院呼吸内科;第四军医大学第二附属医院呼吸内科;
【分类号】：R56

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