【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(P<0.01),与阳性对照组比较差异无统计学意义(P>0.05)。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(P<0.01),与阳性对照组比较差异无统计学意义(P>0.05)。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。更多还原

【Abstract】 Objective To evaluate the clinical efficacy and safety of dimemorfan phosphate in the treatment of dry cough. Methods Three hundred seventy- eight patients with dry cough were randomly divided into experimental group( n = 216),positive control( n = 108) and placebo group( n = 54). Experimental group was taken dimemorfan phosphate20 mg,orally,tid,5- 7 d. Positive control group was taken dextromethorphan 30 mg,orally,tid,5- 7 d. Placebo group was taken dimemorfan phosphate simulation tablets 20 mg or dextromethorphan simulation tablets 30 mg,tid,5- 7 d. Comparison of the clinical efficacy,change of the total cough score after 5- 7 d treatment,and the incidence of adverse drug reactions between the three groups. Results The clinical effectiveness of cough symptom after treatment, experimental group and positive control group and placebo group were 81. 02%,84. 26% and 38. 89%,respectively. The difference between experimental group with placebo group was statistically significant( P < 0. 01),there was no statistically significant difference between experimental group with positive control group( P > 0. 05). The average decrease oftotal cough score after treatment in the experimental group,the positive control group and the placebo group were( 2. 34 ± 1. 42),( 2. 43 ± 1. 55) and( 1. 39 ± 1. 20),respectively. The decrease in the total cough score of experimental group was superior to that of placebo group( P < 0. 01),the decrease in the total cough score of experimental group was not inferior to positive control group( P > 0. 05). The incidence of adverse events were 4. 21% in experimental group,12. 04% in positive control group and 5. 66% in placebo group,respectively. Among these,the incidence of adverse events associated with drug were 1. 87%,10. 19%,5. 66%,respectively. Conclusion Dimemorfan phosphate has exact antitussive efficacy in the treatment of dry cough,has the same antitussive efficacy and similar side effect in the treatment of dry cough compared with the dextromethorphan.更多还原