摘要
目的 观察双清合剂治疗卫气同病证流行性感冒的有效性及安全性.方法 采用多中心、随机、双盲、双模拟平行对照、非劣效性试验设计,将240例卫气同病证流行性感冒患者采用分层区组随机化方法,使用SAS软件按1∶1随机分为试验组和对照组,每组120例.试验组服用双清合剂和磷酸奥司他韦胶囊模拟剂,对照组服用磷酸奥司他韦胶囊和双清合剂模拟剂,两组疗程均为5日.分别于治疗前、治疗3日、治疗5日时进行访视,评价其主要临床症状缓解时间、完全退热时间、退热起效时间、对乙酰氨基酚使用量、中医证候积分、中医证候疗效、重要临床症状缓解时间、重症/危重流感发生率及安全性.结果 试验期间,共脱落/剔除16例(试验组8例、对照组8例),最终纳入符合方案集224例,其中试验组112例,对照组112例.与对照组比较,试验组可缩短头痛缓解时间[28.00(17.75,42.99)h vs.41.00(18.75,59.00)h]、减少肌肉或关节酸痛缓解时间[37.83(12.88,52.77)h vs.38.07(13.50,69.25)h](P＜0.05).与对照组比较,试验组在主要临床症状缓解时间、完全退热时间、对乙酰氨基酚缓释片使用率及使用量、中医证候疗效显愈率方面比较,差异无统计学意义(P＞0.05).两组患者不良反应发生率,试验组为4.17％和对照组为1.67％,差异无统计学意义(x2=1.36,P＞0.05).结论 双清合剂可有效缓解卫气同病证流行性感冒的头痛、肌肉或关节酸痛症状,效果优于磷酸奥司他韦胶囊;在改善发热、咳嗽、汗出、面赤、咳黄痰临床症状,减少对乙酰氨基酚使用量,降低中医证候积分方面与磷酸奥司他韦胶囊疗效相当;安全性与磷酸奥司他韦胶囊相当.(中国临床试验注册中心注册No.ChiCTR2400087831).
Abstract
Objective To observe the effectiveness and safety of Shuangqing Mixture(SQM)in treating pattern of both defense and qi syndrome of influenza.Methods A multicenter,randomized,double-blind,double-dummy,parallel controlled,non-inferiority trial design was used.Totally 240 patients with influenza of pattern of both defense and qi syndrome were randomly assigned to the experimental group and the control group using SAS software in a 1∶1 ratio,120 in each group.The experimental group received SQM and Oseltamivir Capsules simulant,while the control group received Oseltamivir Capsules and SQM simulant.The therapeutic course for all 5 days.The main clinical symptom relief time,complete fever resolution time,fever onset time,usage of acetaminophen,Chinese medicine(CM)syndrome scores,efficacy of CM syndrome treatment,important clinical symptom relief time,incidence of severe/critical influenza,and safety were observed before treatment,and on the 3rd and 5th days of treatment.Results The trentment course,16 patients dropped out(8 in the experimental group and 8 in the control group),224 patients were finally include in analyses,with 112 individuals in each group.Compared with the control group,the experimental group showed a shorter time for headache relief[28.00(17.75,42.99)h vs.41.00(18.75,59.00)h]and reduced muscle or joint pain relief time[37.83(12.88,52.77)h vs.38.07(13.50,69.25)h](P＜0.05).There was no statistically significant difference in the main clinical symptom relief time,complete fever resolution time,usage rate and amount of acetaminophen,and the rate of marked improvement in CM syndrome efficacy(P＞0.05).The incidence of adverse reactions in the experimental group was 4.17％,and 1.67％in the control group,showing no significant difference(x2=1.36,P＞0.05).Conclusions The clinical efficacy of SQM in the treatment of headache and muscle or joint pain in patients with influenza of both defense and qi syndrome was better than use of Oseltamivir Capsules.In terms of improving fever,cough,hyperhidrosis,flushed face,productive cough of yellow sputum,reducing acetaminophen usage,and lowering CM syndrome scores,its efficacy is comparable to Oseltamivir Capsules.Its safety profile is also equivalent to that of Oseltamivir Capsules(China Clinical Trials Registry,No.ChiCTR2400087831).
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