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1、中草药ChineseTraditionalandHerbalDrugs第47卷第22期2016年11月·4043·腰痛宁胶囊治疗腰椎间盘突出症（寒湿瘀阻证）的有效性和安全性的随机、盲法、多中心临床对照研究孙庆，张玮，胡思源，钟成梁，李华南，赵娜，海兴华天津中医药大学第一附属医院，天津300193摘要：目的评价腰痛宁胶囊治疗腰椎间盘突出症（寒湿瘀阻证）的有效性和安全性。方法采用分层区组随机、盲法（第3方评价）、阳性药对照、多中心临床研究方法。根据SAS9.1.3生成的随机数字分入试验A组（4粒组）120例，试验B组（6粒
2、组）120例，对照组120例。试验组口服腰痛宁胶囊，对照组口服腰痹通胶囊，疗程4周。期间设立3个访视点进行视觉模拟（VAS）评分、Oswestry功能障碍指数（ODI）评估，并记录患者治疗疼痛的起效时间，于治疗后评价疗效及安全性。结果治疗4周ODI等级疗效显示试验A组（4粒组）的优秀率为85.83%、对照组为73.95%、试验B组（6粒组）为85.00%，试验A组优于试验B组及对照组，且不良反应最少。VAS评分和ODI的下降值试验B组优于试验A组，均优于对照组。结论腰痛宁胶囊治疗腰椎间盘突出症（寒湿瘀阻证）临床疗效确切
3、，且安全性好，能快速缓解疼痛和改善腰椎功能。关键词：腰痛宁胶囊；腰椎间盘突出症；寒湿瘀阻证；临床试验研究；视觉模拟（VAS）评分中图分类号：R285.64文献标志码：A文章编号：0253-2670(2016)22-4043-06DOI:10.7501/j.issn.0253-2670.2016.22.019EffectivityandsafetyofYaotongningCapsulesintreatmentoflumbardischerniationwithcolddampnessandbloodstasissynd
4、rome:ArandomizedblindcontrolledandmulticentertrialSUNQing,ZHANG-Wei,HUSi-yuan,ZHONGCheng-liang,LIHua-nan,ZHAONa,HAIXing-huaFirstTeachingHospitalofTianjinUniversityofTraditionalChineseMedicine,Tianjin300193,ChinaAbstract:ObjectiveToevaluatetheefficacyandsafetyofY
5、aotongningCapsulesinthetreatmentoflumbardischerniation(colddampnessandbloodstasissyndrome).MethodsThisresearchwascarriedoutusingstratifiedrandommethod,blind,positivedrugcontrolled,andmulti-centerclinical.AndtherandomnumberwasgeneratedbySAS9.1.3intotwoexperimenta
6、lgroups(4grains,120casesand6grains,120cases),andcontrolgroup(120cases).TheexperimentalgroupwastreatedwithYaotongningCapsulesfor4weeks,andthecontrolgroupwastreatedwithYaobitongCapsulesfor4weeks.At0day,2,and4weeks,theVASscore,Oswestrydysfunctionindex,andonsettimeo
7、fpainwereevaluated,andtheefficacyandsafetyofthetreatmentwereevaluated.ResultsAfter4weeksoftreatment,theefficacyofODIgradeshowedthattheexcellentratesoftheexperimentalgroup(4grains),controlgroup,andexperimentalgroup(6grains)were85.83%,73.95%,and85%,theefficacyofth
8、eexperimentalgroup(4grains)wasbetterthanothergroups,andtheadversereactionwastheleast.However,intermsofpainreliefandimprovementintheODIscale,theexperimentalgroup(6grai
