四川地区中医药治疗轻症甲型H1N1流感的随机对照研究

A prospective, randomized controlled trial of Chinese traditional medicine on treating the mild pandemic (H1N1) 2009 influenza in Sichuan area

目的评价四川地区中医药治疗轻症甲型H1N1流感的疗效、安全性及经济性,为今后的防控工作提供客观依据。方法采用前瞻性随机对照研究。将符合纳入标准的轻症甲型H1N1流感实验室确诊患者111例随机分入对照组1(给予对症治疗/休息及安慰剂1粒/次,2次/天,共5天)、对照组2(给予磷酸奥司他韦75mg/次,2次/天,共5天)、中药治疗组(给予单付中药150ml/次,3次/天;安慰剂1粒/次,2次/天,共5天)和联合治疗组(给予单付中药150ml/次,3次/天;磷酸奥司他韦75mg/次,2次/天,共5天)。观察4组疗效、不良反应、并发症及费用的差异。结果中药治疗组(31例)、对照组1(26例)、对照组2(29例)及联合治疗组(25例)的轻症甲型H1N1流感患者完全痊愈;在各基线指标相似的情况下,中药治疗组患者入组后发热持续时间(h)及症状持续时间短于对照组1及对照组2,但尚无明显统计学差异(P>0.05);4组患者发病后发热总持续时间(h)、症状总持续时间及符合国家出院标准的住院时间无明显差异(P>0.05);中药治疗组有1例(1/31)出现轻微腹泻,对照组2有1例出现皮疹(1/29)、2例出现恶心呕吐(2/29);联合治疗组有1例出现皮疹(1/25),4组间不良反应比较无明显统计学差异(P>0.05);中药治疗组有2例(2/31)、对照组1有3例(3/26)、对照组2有3例(3/29)、联合治疗组有2例(2/25)出现并发症,4组间比较亦无明显统计学差异(P>0.05);中药治疗组治疗费用明显低于对照组2及联合治疗组,差异有统计学意义(P<0.05)。结论轻症甲型H1N1流感症状轻,预后较好,中药治疗可能有缩短热程及缓解症状的双重作用,经济有效,安全可行。中药联合磷酸奥司他韦治疗轻症甲型H1N1流感疗效并不优于中药或磷酸奥司他韦单药治疗。

Objective To evaluate the curative effect,safety economy of Chinese traditional medicine on treating the mild pandemic （H1N1） 2009 influenza,and to provide the impersonal evidence for preventing and controlling this disease.Methods A prospective,randomized controlled research was carried out.Total of 111 cases with mild pandemic （H1N1） 2009 influenza were confirmed through real-time PCR by Cheng Du or Sichuan CDC,who integrated the elimination standard along with the enrollment standard and stochastically divided all the patients into the control group one （26 cases,taking placebo a grain,two times a day for five days）,the control group two （29 cases,taking oseltamivir 75 mg,two times a day for five days）,the Chinese traditional medicine treatment group （31 cases,taking Chinese traditional medicine 150 ml,three times a day and placebo a grain twice times a day for five days）,and the united treatment group （25 cases,taking Chinese traditional medicine 150 ml,three times a day and oseltamivir 75 mg,two times a day for five days）.Differences among the four groups on curative effect,side-effects,complications and economy were analyzed.Results Although the basal condition were similar,the patients’ fever and symptom duration （h） after enrollment in Chinese traditional medicine group were shorter than those in control group one and control group two,but the difference were not significantly statistical.Total fever duration （h）,total symptom duration （h） and the hospital stay （d） among the four groups had no obvious difference.Only one case in Chinese traditional medicine group had mild diarrhea.There was one case with rash in control group two and the united treatment group,respectively.Also two cases occured vomiting in control group two.Two cases in Chinese traditional medicine group （2/31）,three cases in control group one（3/26）,three cases in control group two（3/29） and two cases in the united treatment group（2/25） occured complication.But the difference on complication among the four groups were not significant.The drug cost of each case in Chinese traditional medicine group was lower than that in control group two and the united treatment group.And the difference were significantly statistical.Conclusions The symptom of mild pandemic （H1N1） 2009 influenza is mild and the prognosis is good.Chinese traditional medicine on treating the mild pandemic （H1N1） 2009 influenza may shorten the fever duration and improve the symptom,which is safe,economic,effective and feasible.The Chinese traditional medicine combined with oseltamivir on treating mild pandemic （H1N1） 2009 influenza is no better than Chinese traditional medicine or oseltamivir alone.