清解宣透肺卫方药治疗外感热病邪郁肺卫证安全性和有效性的随机双盲、阳性药平行对照、多中心临床研究

Safety and effectiveness clinical research of randomized double blinded and positive drug of parallel control and multicenter on clearing away lung heat and dispersing lung qi formula to treat lung qi stagnation syndrome due to exogenous pathogenic heat

目的:评价清解宣透肺卫方——银花平感颗粒治疗外感热病邪郁肺卫证的安全性及有效性。方法:采用随机分组、双盲单模拟、阳性药平行对照、多中心临床试验的设计方法;按临床试验3∶1随机分配至试验组与阳性药对照组,实际共入组病例416例,415例受试者进入FAS人群(试验组312例,阳性药对照组103例),409例受试者进入PPS人群(试验组307例,阳性药对照组102例)。试验组给予银花平感颗粒,对照组给予银翘解毒颗粒,疗程均为3d。结果:两组患者在基线病情等指标均具有可比性;服药依从性良好。在PPS人群中,试验组、对照组中医证候疗效愈显率分别为84.69%、72.55%;中医主要症状疗效愈显率分别为80.78%,70.59%,其差异均有统计学意义(P<0.05)。中医证候总评分和主症总评分在用药第3天,两组组内比较,差异有统计学意义(P<0.01)。试验组体温起效时间和体温解热时间显著优于阳性药对照组(P<0.01)。治疗3d后两组患者发热恶寒、头身疼痛、鼻塞流涕、咯痰、口渴等中医症状消失情况组间比较,差异有统计学意义(P<0.05);除舌质外,两组间其余差异无统计学意义。白细胞计数与分类、呼吸道病毒检测结果显示,该类疾病多属于病毒性感染疾病。结论:清解宣透肺卫方药银花平感颗料治疗外感热病邪郁肺卫证患者可显著提高疗效,具有显著解热、镇痛、止咳化痰等作用。

Objective:To evaluate the safety and effectiveness of clearing away lung heat and dispersing lung qi formula,Yinhua Pinggan Granule(YHPG),in the treatment of lung qi stagnation syndrome due to exogenous pathogenic heat.Methods:Randomized grouping,double blind single simulation,parallel control of positive drugs and multi-center clinical trial were used.The patients were randomly assigned to the experimental group and the control group according to the 3∶1 ratio of clinical trials.A total of 416 cases were actually enrolled.A total of 415 subjects entered FAS population(312 in the experimental group and 103 in the control group).A total of 409 subjects entered the PPS population(307 in the experimental group and 102 in the control group).YHPG was given to the experimental group and Yinqiao Jiedu Granule was given to the control group for 3 days.Results:The baseline condition and other indicators of the two groups were comparable,and the medication compliance was good.In PPS population,the effective rate of TCM syndromes in the experimental group and the control group was 84.69%and 72.55%,respectively(P<0.05);the effective rate of TCM symptoms in the experimental group and the control group was 80.78%and 70.59%,respectively(P<0.05).The total score of TCM syndromes and the total score of main symptoms were significantly different between the two groups on the third day(P<0.01).The onset time and antipyretic time of body temperature of the experimental group was significantly better than the control group(P<0.01).After 3 days of treatment,there were significant differences in the disappearance of TCM symptoms such as fever,chills,headache,nasal obstruction,sputum expectoration and thirst between the two groups(P<0.05).Except for tongue texture(3 days),there was no significant difference between the two groups.Leukocyte count and classification,respiratory virus detection showed that most of these diseases belong to viral infectious diseases.Conclusion:YHPG of clearing away lung heat and dispersing lung qi prescriptions can significantly improve the curative effect,which has the characteristics of obvious antipyretic,analgesic,cough relieving and expectorant effects,and so on.