防风通圣颗粒治疗上呼吸道感染的随机对照观察

Treatment of Upper Respiratory Infection by Fangfeng Tongsheng Granule:a Randomized Controlled Study

目的评价防风通圣颗粒治疗上呼吸道感染(表寒里热,表里俱实证)的临床有效性和安全性。方法将符合纳入标准的324例患者采用分层区组随机化方法,按中心进行分层,按2∶1比例分为2组。试验组(216例)服用防风通圣颗粒(3 g/次,2次/天),疗程3天;入组时腋下体温高于37℃者每日加服1次;对照组服用防风通圣颗粒模拟剂(用法、用量及疗程同试验组)。观察两组中医证候疗效、体温复常率、体温复常时间、单项症状疗效及不良反应。结果试验组完成203例,对照组完成101例。中医证候疗效:试验组愈显率55.67%(113/203),总有效率93.10%(189/203),中医证候积分下降(9.24±4.46)分;对照组分别为5.94%(6/101)、36.63%(37/101)、(3.27±3.29)分;试验组优于对照组(P<0.01)。体温复常率:试验组为87.50%(98/112),对照组为58.49%(31/53),试验组优于对照组(P<0.01)。体温复常时间:试验组优于对照组(P<0.01)。单项中医症状疗效:服药后试验组和对照组均获不同程度改善,两组3个主症发热、恶寒、大便秘结,治疗后积分明显下降,差异均有统计学意义(P<0.01);且试验组较对照组下降更明显(P<0.01)。无明显与药物有关的不良事件。结论防风通圣颗粒治疗上呼吸道感染(表寒里热,表里俱实证)安全、有效。

Objective To evaluate the clinical effectiveness and safety of Fangfeng Tongsheng Granule （FTG） in the treatment of upper respiratory infection （superficial cold and interior heat syndrome, exterior and interior excess syndromeS. Methods A randomized,double-blinded, multi-centered,placebo-parallel-controlled clinical trial was adopted. Totally 324 patients were enrolled and assigned to two groups ,216 patients in the treatment group and 108 patients in the control group. Those in the treatment group took FTG at the daily dose of 3 g, twice per day, the therapeutic course being 3 days. Those with axillary temperature more than 37 ℃ took one more time before medication. Those in the control group took simulated agent granules the same dose and dosage as the treatment group. The effect of Chinese medical syndrome （ECMS）,the rate of temperature-dropping-to-normal （RT）,the time of temperature-dropping-to-normal （-17-）,the curative effect of single symptom （CESS） and adverse reactions were observed. Results Totally 203 completed the trial in the treatment group and 101 in the control group. In the treatment group, the cured-effective rate was 55. 67% （1131 101 ）, the total effective rate was 93. 10% （189l101）, the ECMS score decreased by 9. 24 ±4.46, while they were 5. 94% （6l101）, 36. 63% （37l101）, and 3. 27 ±3. 29, respectively in the control group （P 〈0.01 ）. The RT was 87. 50% （98l112） in the treatment group and 58.49% （31l53） in the control group （P 〈0.01 ）. The -I-r in the treatment group was superior to that of the control group （P 〈0. 01 ）. As for CESS, all of the three primary symptoms and nine secondary symptoms were improved more obviously in the treatment group than in the control group. The integral decreased obviously, showing statistical difference （P 〈0. 01 ）. The decrease was more obvious in the treatment group than in the control group （P 〈0. 01 ）. There was no adverse event related to FTG. Conclusion FTG was effective and safe in treating upper respiratory infection （superficial cold and in- terior heat syndrome, exterior and interior excess syndrome）.