双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证)的多中心双盲双模拟随机对照临床试验

A Multiple Center, Randomized Controlled, Double-blinded and Double-dummy Trial of Shuangjie Capsule (Piece) in the Treatment of the Acute Upper Respiratory Tract Infection (the Syndrome of Heat Attacking the Lung and Weifen)

目的观察双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证) 的疗效．并对其安全性作出评价。方法采用多中心随机双盲双模拟阳性药物平行对照临床试验方法,对急性上呼吸道感染(风温病热在肺卫证)患者770例,按3:3:1比例随机分为双解胶囊组(胶囊组)330例,双解片剂组(片剂组)330例,及柴黄片组(对照组)110例。胶囊组给予双解胶囊,片剂组给予双解片,对照组给予柴黄片,均每次3粒(片),每日3次。疗程均为5天。结果纳入患者770例,随机化763例,剔除28例,脱落17例,最终进入意向治疗(ITT)分析724例,符合方案集分析(PPS)718例。其中上呼吸道感染疗效:ITT分析显示胶囊组愈显率83．60％,总有效率98．39％;片剂组分别为 83．28％,99．04％;对照组分别为68．62％,98．04％。PPS分析显示胶囊组愈显率84．69％,总有效率99．02％;片剂组分别为83．22％,99．03％;对照组分别为 69．30％,99．01％。试验组(胶囊、片剂)疾病疗效优于对照组(P<0．05), ITT分析与PPS分析结果一致。中医证候疗效:ITT分析显示胶囊组愈显率 83．92％,总有效率98．07％;片剂组分别为83．92％,99．36％;对照组分别为 74．51％,98．04％。PPS分析显示胶囊组愈显率85．02％,总有效率98．70％;片剂组分别为83．87％,99．35％;对照组分别为75．24％,98．02％。试验组(胶囊、片剂)中医证候疗效优于对照组(P<0．05),ITT分析与PPS分析结果一致。观察中未发现明显不良反应。结论双解胶囊(片剂)治疗急性上呼吸道感染(风温病热在肺卫证)的疗效确切,未发现明显毒副作用。

Objective To assess the effectiveness and safety of Shuangjie Capsule （Piece） in the treatment of acute upper respiratory tract infection. Methods The multiple center, double-blinded, double-dummy and randomized controlled method was adopted to observe 770 patients who were divided into the treatment group A （n=330, treated with Shuangjie Capsule 3 pieces tid）, treatment group B （n=330, treated with Shuangjie Piece 3 pieces tid） and the control group （n=110, treated with Chaihuang Piece 3 pieces tid）. The therapeutic course for three groups was 5 days. Results Among 770 included patients, 724 and 718 were screened for intention to treat （ITT） and per-protocol population set （PPS） analysis, respectively. For the effectiveness on upper respiratory tract infection, in treatment group A, the markedly effective rate were 83.60% （ITT） and 84.69% （PPS） respectively, and effective rate were 98.39% （ITT） and 99.02% （PPS） respectively; in treatment group B, the markedly effective rate were 83.28% （ITT） and 83.22% （PPS） respectively, and effective rate were 99.04% （ITT） and 99.03% （PPS） respectively; while in the control group the markedly effective rate were 68.62% and 69.30% respectively, and effective rate were 98.04% and 99.01% respectively. The effectiveness of treatment group were significantly better than that of control group （P〈0.05）. For effects on TCM syndrome, in treatment group A, the markedly effective rate were 83.92% （ITT） and 85.02% （PPS）, and effective rate were 98.07% （ITT） and 98.70% （PPS）; in treatment group B, the markedly effective rate were 83.92% （ITT） and 83.87% （PPS）, and effective rate were 99.36% （ITT） and 99.35% （PPS）; while in the control group the markedly effective rate were 74.51% （ITT） and 75.24% （PPS）, and effective rate was 98.04% （ITT） and 98.02% （PPS）. It also showed a statistical significance between treatment and control group （P〈0.05）. ITT and PP analysis have the same results. No major adverse effect was found in the observation. Conclusion Shuangjie Capsule （Piece） shows a definite effect with no obvious toxic-adverse effects.