清热祛湿颗粒治疗急性上呼吸道感染(暑湿证)的随机对照、多中心临床研究

Randomized Controlled,Multi-centre Clinical Study on Qingre Qushi Granules in Treatment of AcuteUpper Respiratory Tract Infection (Summer-heat and Dampness Syndrome)

目的评价清热祛湿颗粒治疗急性上呼吸道感染(暑湿证)的有效性和安全性。方法采用随机、双盲单模拟、阳性药平行对照、多中心临床试验方法。试验组口服清热祛湿颗粒10 g,每天3次。对照组口服藿香正气颗粒10 g,每天2次;口服清热祛湿颗粒模拟剂,10 g,每天1次。疗程均为5 d。观察患者疾病缓解时间、解热起效时间、完全解热率、中医证候积分、解热镇痛药使用情况及不良事件。结果实际入组384例,其中试验组288例、对照组96例。试验组中位疾病缓解时间为50.0 h,对照组为60.0 h,差异具有统计学意义(P<0.05)。试验组解热起效时间为(8.32±10.84)h,对照组为(15.44±19.83)h,差异具有统计学意义(P<0.01)。试验组完全解热率为92.61%(263/284),对照组为86.17%(81/94)(P>0.05)。治疗后2组中医证候积分较治疗前均显著减少(P<0.01);试验组中医证候积分明显低于对照组(P<0.05)。试验组中医证候愈显率76.39%(220/288),对照组中医证候愈显率64.58%(62/96)(P<0.05)。试验组解热镇痛药的使用率为1.74%(5/288),对照组为3.13%(3/96)(P>0.05)。2组患者试验期间生命体征和实验室检查未见有明显临床意义的改变。2组均未发生不良反应。结论清热祛湿颗粒可有效改善急性上呼吸道感染(暑湿证)患者的临床症状,起效快,能缩短缓解时间,临床使用有效、安全。

Objective To evaluate the efficacy and safety of Qingre Qushi granules in treatment of acute upper respiratory tract infection(summer-heat and dampness syndrome).Methods A randomized,double-blind single simulation,parallel control with positive drug,multi-center clinical trial was adopted.Qingre Qushi granules with a dose of 10 g was given 3 times per day to the experimental group.Huoxiang Zhengqi granules 10 g was given twice per day and the simulator of Qingre Qushi granules 10 g was given daily to the control group.The course of treatment is 5 days.In the trail,we have observed the patients’time of remission,onset time of antipyretic,complete antipyretic rate,scores of traditional Chinese medicine syndrome,the utilization of antipyretic-analgesics and adverse events.Results A total of 384 cases were actually enrolled into the trial,including 288 cases in the experimental group and 96 cases in the control group.The median disease remission time in the experimental group and control group were 50.0 h and 60.0 h with statistically significant difference(P<0.05).The onset time of antipyretic activity in the experimental group and control group were(8.32±10.84)h and(15.44±19.83)h with statistically significant difference(P<0.01).The complete antipyretic rates in the experimental group and control group were 92.62%(263/284)and 86.17%(81/94)(P>0.05).After treatment,the TCM syndrome scores of the two groups were significantly decreased(P<0.01),and the score of the experimental group was significantly lower than that of the control group(P<0.05).The TCM syndrome efficacy rates in the experimental group and the control group were 76.39%(220/288)and 64.58%(62/96)with statistically significant difference(P<0.05).The utilization rates of antipyretic-analgesic drugs in the experimental group and control group were 1.74%(5/288)and 3.13%(3/96)(P>0.05).There was no significant change of vital signs and laboratory examination in the two groups.No adverse reactions occurred in the two groups.Conclusion Qingre Qushi granules in treatment of acute upper respiratory tract infection(summer-heat and dampness syndrome)has good clinical efficacy,safety and quick effect in treatment,which can effectively improve the clinical symptoms of patients,shorten the remission time of the disease.