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1、巴戟天寡糖胶囊治疗抑郁症的临床研究摘要目的：以盐酸氟西汀片对照，评价巴戟天寡糖胶囊治疗抑郁症的临床有效性和安全性。方法：采用随机、双盲、多中心、阳性药对照设计方法。受试者分为三组：巴戟天寡糖胶囊高剂量组(200mg/d).巴戟天寡糖胶囊低剂量组(150mg/d)和阳性对照组(盐酸氟西汀片20mg/d),疗程6周。结果：对照组有效率70.34%,高剂量组有效率66.39%,低剂量组有效率68.91%,三组间比较差别无统计学意义(P>0.05)o不良事件发生率，高剂量组29.41%,低剂量19.83%,对照组24.17%,差异无统计学意义(卩>0.05)。结论：巴戟天寡糖胶囊治疗抑郁症非劣
2、于盐酸氟西汀片；不良反应轻微，安全性好。尖键词：抑郁症；巴戟天寡糖胶囊；盐酸氟西汀ClinicalStudyofMorindaOfficinalsOligoseCapsuleintheTreatmentofDepressionAbstractObjective:Fluoxetineascontroldrugs,toevaluatetheefficacyandsafetyofMorindaoflicinalisoligosecapsuleinthetreatmentofmildandmoderatedepressivedisorder(kidneydeficiencysyndrome).
3、Methods:Inarandomized,double-blind,double-dummy,multicenter,variabledoseandpositivedrugcontrolledclinicaltrial,subjectswereenrolledandrandomlydividedinto3groups.Thepatientsweretreatedwithhighdose(400or800mg/d)andlowdose(300or600mg/d)ofMorindaofficinalisoligosecapsuleorfluxetinehydrochloridetable
4、ts(20or30mg/d)forsixweeks.Results:Theeffectiverateswere70.34%(controlgroup),66.38%(highdosegroup)and68.91%(lowdosegroup),nosiginificantdifferencecanwefoundamong3groups(P>0.05).Toevaluatetheprimaryefficacy,westratifiedbycenterCMH/2test.Theresultshowthatthedifferenceamongthreegroupswasnosignifican
5、t(P>0.05).Non-inferioritytestisqualifiedamonghighdoseandlowdoseofMorindaofficinalisoligosecapsuleandfluxetinehydrochloridetablets.Theincidencesofadverseeventswere29.41%(highdosegroup),19.83%(lowdosegroup)and24.17%(controlledgroup),respectively,therewasnosignificancedifference.Conclusion：Morindao
6、flicinalisoligosecapsuleisnotinferiortothefluoxetinetabletsinthetreatmentofmildandmoderatedepression(kidneydeficiencysyndrome).Thedrugissafeinthetherapeuticdose,andadversereactionaremild・Itissuitableforthemildandmoderatedepression.Keywords:Depression;MorindaOfficinalisOligoseCapsule;FluoxetineHy
7、drochloride常用缩写词中英文对照表英文缩写英文名称中文名称5-HT5-hydroxytryptamine5■轻色胺NENorepinephrine去甲肾上腺素MAOIMonoamineOxidaseInhibitor单胺氧化酶抑制剂TCATricyclicAntidepressant三环类抗抑郁药SSRISelectiveSerotoninReuptakeInhibitor选择性5■轻色胺再摄制剂HAMDHamiltonDepress
