Efficacy and Safety of Shuangqing Mixture in the Treatment of Both Defense and Qi Syndrome of Influenza:A Multicenter,Randomized,Controlled,Non-inferiority Trial
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).
influenzasyndrome of both defense and qiShuangqing Mixturerandomized controlled trialintegrative medicine
国家科技期刊平台
NSTL
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