乌灵胶囊联合黛力新治疗脑卒中后抑郁疗效和安全性的随机对照研究

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1、乌灵胶囊联合黛力新治疗脑卒中后抑郁疗效和安全性的随机对照研究作者：付剑亮,赵玉武,孙晓江【摘要】目的：观察乌灵胶囊联合黛力新治疗脑卒中后抑郁的临床疗效和安全性。方法：采用平行对照研究方法，将卒中后抑郁病人随机分为乌灵胶囊组（n=39），给予乌灵胶囊，每次3粒，3次/d；黛力新组（n=37），给予黛力新片，每次10.5mg，2次/d，早上、中午各服1次；联合组（n=38），在黛力新治疗基础上，加服乌灵胶囊。6周为1个疗程，于治疗前，治疗后2、4、6周用汉密顿抑郁量表（HamiltonDepressionScale,HAMD）评

2、估疗效，治疗副反应量表（TreatmentEmergentSymptomScale,TESS）评定药物的不良反应，并检测血常规、尿常规、肝肾功能及心电图等。结果：乌灵胶囊组、黛力新组、联合治疗组总有效率分别为64.1%、64.9%和89.5%，乌灵胶囊组和黛力新组两组疗效差异无统计学意义（P＞0.05），联合组疗效优于另两组（P＜0.05）。单纯应用乌灵胶囊组未见不良反应，应用黛力新的两组不良反应发生率均为9%。结论：乌灵胶囊联合黛力新治疗脑卒中后抑郁疗效优于单药治疗。【关键词】脑卒中;抗抑郁药;抑郁障碍;随机对照试验　　M

3、ethods:OnehundredandfourteenpatientswithPSDwere11randomlydividedintoWulingCapsuletreatedgroup(n=39),Deanxittreatedgroup(n=37)andWulingCapsuleplusDeanxittreatedgroup(n=38).PatientsinWulingCapsuletreatedgroupwereadministeredwiththreeWulingCapsulesthreetimesaday,a

4、ndpatientsinDeanxittreatedgroupwereadministeredwithDeanxit10.5mgtwicedaily,whilepatientsintheWulingCapsuleplusDeanxittreatedgroupwereadministeredwithbothWulingCapsuleandDeanxit.Patientsinthethreegroupswerealltreatedforsixweeks.TreatmentefficacywasevaluatedwithHam

5、iltonDepressionScale(HAMD)andthesideeffectswereevaluatedwithTreatmentEmergentSymptomScale(TESS)beforetreatmentandafter2,4,and6weektreatment.Thebloodandurineroutineexaminationswereperformed,andthehepatorenalfunctionsandelectrocardiogramwereexaminedaswell.　　Result

6、s:TherewasnostatisticaldifferenceinthetotalefficacyratebetweenWulingCapsuletreatedgroupandDeanxittreatedgroup(64.1%vs64.9%,P>0.05),butthetotalefficacyrateofWulingCapsuleplusDeanxittreatedgroupwashigherthanthatofthemonotherapy(89.5%vs64.1%,89.5%vs64.9%,P<0.

7、05).Therewerenosignificantside11effectsinWulingCapsuletreatedgroup,whiletheincidenceofsideeffectswas9%inbothgroupsadministeredwithDeanxit.　　Conclusion:TheefficacyofWulingCapsuleplusDeanxitisbetterthanthatofthemonotherapyintreatingPSD.　　Keywords:apoplexy;antidepres

8、sants;depressivedisorder;randomizedcontrolledtrial　　卒中后抑郁（poststrokedepression,PSD）是脑卒中后常见的并发症，以情绪低落、兴趣减退为主要表现，患病率20%～60%［1］。PSD既能加重患者的躯体症状，又可加重