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磷酸二甲啡烷治療干性咳嗽的臨床療效及安全性評(píng)價(jià)

發(fā)布時(shí)間:2018-06-22 21:21

  本文選題:磷酸二甲啡烷 + 右美沙芬。 參考:《中國(guó)臨床藥理學(xué)雜志》2016年04期


【摘要】:目的評(píng)價(jià)磷酸二甲啡烷治療干性咳嗽的臨床療效和安全性。方法將378例干性咳嗽患者隨機(jī)分為試驗(yàn)組216例、陽(yáng)性對(duì)照組108例和安慰劑組54例。試驗(yàn)組予以口服磷酸二甲啡烷20 mg,tid,5~7 d;陽(yáng)性對(duì)照組予以口服氫溴酸右美沙芬30 mg,tid,5~7 d;安慰劑組予以磷酸二甲啡烷模擬片20 mg或氫溴酸右美沙芬模擬片30 mg,tid,5~7 d。比較3組患者的臨床療效、治療5~7 d后咳嗽癥狀總積分的變化,以及不良反應(yīng)發(fā)生率。結(jié)果治療后,試驗(yàn)組、陽(yáng)性對(duì)照組、安慰劑組的咳嗽癥狀臨床有效率分別為81.02%,84.26%,38.89%。試驗(yàn)組的咳嗽癥狀臨床有效率與安慰劑組比較差異有統(tǒng)計(jì)學(xué)意義(P0.01),與陽(yáng)性對(duì)照組比較差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。試驗(yàn)組、陽(yáng)性對(duì)照組、安慰劑組的咳嗽癥狀總積分相對(duì)基線的平均下降值分別為(2.34±1.42),(2.43±1.55),(1.39±1.20)。試驗(yàn)組的咳嗽癥狀總積分下降顯著優(yōu)于安慰劑組(P0.01),與陽(yáng)性對(duì)照組比較差異無(wú)統(tǒng)計(jì)學(xué)意義(P0.05)。試驗(yàn)組、陽(yáng)性對(duì)照組、安慰劑組的不良事件發(fā)生率分別為4.21%,12.01%,5.66%,其中與藥物相關(guān)的不良事件的發(fā)生率分別為1.87%,10.19%,5.66%。結(jié)論磷酸二甲啡烷在治療干性咳嗽時(shí)鎮(zhèn)咳效果確切,且磷酸二甲啡烷在治療干性咳嗽時(shí)的鎮(zhèn)咳效果與氫溴酸右美沙芬相當(dāng),兩藥的安全性相似。
[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 鹵1.42), () 2.43 鹵1.55), (1.39 鹵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.
【作者單位】: 北京大學(xué)人民醫(yī)院呼吸與危重癥科;首都醫(yī)科大學(xué)附屬安貞醫(yī)院呼吸內(nèi)科;首都醫(yī)科大學(xué)附屬友誼醫(yī)院呼吸內(nèi)科;河北省人民醫(yī)院呼吸內(nèi)科;上海肺科醫(yī)院呼吸內(nèi)科;安徽省立醫(yī)院呼吸內(nèi)科;廣州醫(yī)學(xué)院第一附屬醫(yī)院呼吸內(nèi)科;廣西壯族自治區(qū)人民醫(yī)院呼吸內(nèi)科;四川省人民醫(yī)院呼吸內(nèi)科;第四軍醫(yī)大學(xué)第二附屬醫(yī)院呼吸內(nèi)科;
【分類號(hào)】:R56

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