穿心莲内酯滴丸治疗急性上呼吸道感染外感风热证多中心随机对照临床试验

Andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome:a multicenter and randomized controlled trial

目的:评价穿心莲内酯滴丸治疗急性上呼吸道感染外感风热证的安全性和有效性。方法:采用随机、阳性药平行对照、多中心临床试验方法。第1阶段纳入202例,随机分为试验组(n=101)和对照组(n=101);第2阶段纳入276例,随机分为试验组(n=138)和对照组(n=138)。试验组给予穿心莲内酯滴丸,0.15g/次,3次/d;对照组给予穿心莲内酯片,0.15 g/次,3次/d。疗程均为3d。观察治疗前后症状、体征变化和有无不良反应,并进行血、粪、尿常规,肝肾功能及心电图检查。结果:第1阶段试验组和对照组治疗后的痊愈率分别为44.55%、42.57%(全分析数据集)和45.00%、43.00%(符合方案数据集),总有效率分别为94.06%、94.06%(全分析数据集)和95.00%、95.00%(符合方案数据集),两组比较,差异无统计学意义(P>0.05)。第2阶段试验组和对照组治疗后的痊愈率分别为39.13%、33.82%(全分析数据集)和38.69%、33.58%(符合方案数据集),总有效率分别为96.38%、96.32%(全分析数据集)和96.36%、96.27%(符合方案数据集),两组比较,差异亦无统计学意义(P>0.05)。在用药过程中,未发现穿心莲内酯滴丸的明显不良反应。结论:穿心莲内酯滴丸是治疗急性上呼吸道感染外感风热证安全有效的药物。

Objective： To evaluate the safety and efficacy of andrographolide drop-pill in treatment of acute upper respiratory tract infection with external wind-heat syndrome. Methods： A multicenter, randomized controlled trial was conducted. In phase 1, 202 patients with acute upper respiratory tract infection were randomly divided into two groups： trial group （n = 101） and control group （n=101）. In phase Ⅱ, 276 patients with acute upper respiratory tract infection were randomly divided into two groups： trial group （n=138） and control group （n=138）. The patients in the trial group received andrographolide drop-pill, at a dose of 1.5 g, three times a day; the patients in the control group received andrographolide tablet, at a dose of 1.5 g, three times a day. The therapeutic courses in both groups were 3 days. Clinical symptoms, physical signs, adverse effects, blood, urine and stool tests, hepatorenal function and electrocardiogram were examined before and after the treatment. Results, After treatment in the phase I , the cure rates in the trial group and the control group were 44.55%, 42.57% （full analysis set, FAS） and 45.00%, 43.00% （per protocol set, PPS）, and the total obvious rates were 94.06%, 94. 06% （FAS） and 95.00%, 95. 00% （PPS）, respectively. There were no significant differences between the two groups （P〉0. 05）. In the phase Ⅱ, the cure rates in the trial group and the control group were 39.13%, 33.82% （FAS） and 38.69%, 33.58% （PPS）, and the total obvious rates were 96.38%, 96.32% （FAS） and 96.36%, 96.27% （PPS）, respectively. There were no significa＇nt differences between the two groups （P〉0. 05） too. No adverse effects were found in the trial. Conclusion： Andrographolide drop-pill is effective and safe in the treatment of acute upper respiratory tract infection with external wind-heat syndrome.