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1、·6·ChineseJournalofInformationonTCMMar.2012Vol.19No.3·临床论著·复方野菊花含片治疗外感风热咽痛症临床研究1223王勇,林友平,邓可斌,刘同祥1.三九医药股份有限公司研发事业部,广东深圳518029;2.湖北省中医院,湖北武汉430061;3.中央民族大学中国少数民族传统医学研究院,北京100081摘要:目的评价复方野菊花含片治疗外感风热引起的咽痛症(急性咽炎、急性卡他性扁桃体炎)的临床疗效和安全性。方法采用分层区组随机、盲法、阳性药平行对照、非劣效的、多中心临床试验方法,共观察病例567例。
2、试验组426例,含化服复方野菊花含片。对照组141例,含化服银黄含化片。2组均2片/次,6次/d,急性咽炎5d为1个疗程,急性卡他性扁桃体炎7d为1个疗程。结果对急性咽炎的治疗,试验组总有效率为71.4%(152/213)、对照组为59.2%(42/71);对急性卡他性扁桃体炎的治疗,试验组总有效率为70.4%(150/213),对照组为67.1%(47/70),组间疗效差异无统计学意义(P>0.05)。试验期间未见有与试验药物相关的实验室指标异常的变化,未见有严重不良事件及不良反应发生。结论复方野菊花含片能明显改善外感风热引起的咽痛、吞咽痛以
3、及咽部红肿等症状体征,治疗外感风热引起的咽痛症(急性咽炎、急性卡他性扁桃体炎)安全有效。关键词:复方野菊花含片;外感风热证;咽痛症;中医疗法DOI:10.3969/j.issn.1005-5304.2012.03.004中图分类号:R256.1文献标识码:A文章编号:1005-5304(2012)03-0006-03ClinicalStudyonCompoundYejuhuaBuccalTabletsinTreatingSoreThroatDuetoWind-heat1223WANGYong,LINYou-ping,DENGKe-bin,LIU
4、Tong-xiang(1.R&DDepartmentofSanjiuMedical&PharmacuticalCo.Ltd.,Shenzhen518029,China;2.HubeiProvinceHospitalofTraditionalMedicine,Wuhan430061China;3.InstituteofChineseMinorityTraditionalMedical,MinzuUniversityofChina,Beijing100081,China)Abstract:ObjectiveToevaluatetheefficacy
5、andsafetyofCompoundYejuhuaBuccalTabletsinthetreatmentofsorethroatduetowind-heat.MethodsArandomized,blind,positiveparallelcontrolled,multi-centerclinicaltrialwascarriedoutin567patients.Thetrialgroup(426cases)wasgivenCompoundYejuhuaBuccalTabletsandthecontralgroup(141cases)wasg
6、ivenYinhuangBuccalTabletsorally,6timesperday(2tablets/times),withthecourseofacpueipharyngitisof5daysandacutecatarrhaltonsillitisof7days.ResultsForthetreatmentofacpueipharyngitis,thetotaleffectiveratewas71.4%(152/213)inthetrialgroupand59.2%(42/71)inthecontrolgroup.Forthetreat
7、mentofacutecatarrhaltonsillitis,thetotaleffectiveratewas70.4%(150/213)inthetrialgroupand67.1%(47/70)inthecontrolgroup,thedifferencewasnotstatisticallysignificantbetweenthetwogroups(P>0.05).Therewerenosignificantchangesoflaboratoryindexesandsideeffectsrelatedtotrialdrugs.Conc
8、lusionCompoundYejuhuaBuccalTabletscanimproveexogenouswind-heat-inducedsoret