养心开郁片治疗中、轻度抑郁症90例临床观察.pdfVIP

养心开郁片治疗中、轻度抑郁症90例临床观察

林海;王静怡;王晓燕;王开娜;刘岗;吕富荣;杨琳;查鹏洲

【摘要】Objectives:ToobserveefficacyandsafetyofYangxinKaiyutablets

onmoderateormilddepression.Method:135patientswererandomized

tothetabletarm(n=90,4tablets,3timesperday)andFluoxetinearm

(n=45,25mg/dayinthemorning);backgroundmedication:4Zaoan

capsules30minbeforebed.Efficacyandsafetyparametersincludethe

Hamiltondepressionratingscale(HAMD-17),TCMsyndromscale,

SymptomChecklist90(SCL-90),self-ratingscalefordepression(SDS),

self-ratingscaleforAnxiety(SAS),RatingScaleforSideEffects(SERS)

andrelatedlaboratoryanalysisatWEEK2andWEEK6.Results:Therewere

nostatisticalsignificanceofbeforetreatment(P＞0.05).AtWEEK2both

groupsimprovedonallparameters(P＜0.05);AtWEEK6totaleffective

rateforthetabletwas85.55％.Thetotaleffectiverateandthescoresof

variousratingscaleatthesettimepointswerenotstatisticallydifferent

betweenthetwogroups.TheSASassessmentwasbetterwiththetablet.

Palpitation,insomniaandthesymptomofdepressionimproved

significantlyinthetreatmentgroupandthecontrolgrouprespectively(P

＜0.05).Nosafetyconcernsrevealedduringthestudy.Conclusion:the

YangxinKaiyutabletscantreatmoderateormilddepressionwithout

obvioussafetyissue.%目的:观察养心开郁片治疗中-轻度抑郁症的临床疗效及安

全性.方法:将135例患者随机分为治疗组90例,对照组45例,治疗组口服养心开郁

片4片/次,3次/d;对照组口服氟西汀25mg/d,上午服用;夜间睡前30min2组均给

予枣安胶囊2～4粒.于第一次就诊及用药第2和6周末分别以HAMD-17、中医

症状量表、SCL-90、SDS、SAS、SERS量表及实验室检查评估疗效与安全性.结果:

用药前2组各类量表评分无统计学差异(P0.05);用药2周后治疗组各类评分均有

所改善(P0.05);6周后治疗组总有效率85.55%,各类评分较用药前有显著差异

(P0.05).2组间总有效率、各类量表的各时间点评分基本无统计学差异;SAS评分

治疗组优于对照组(P0.05).治疗组中医症状少寐多梦、心烦心悸改善明显,对照组

忧伤郁闷改善明显(P0.05).SERS评估、安全性评估均未发现明显不良反应.结论:

提示养心开郁片治疗中轻度抑郁症具有较好的疗效,2周即可起效,治疗6周后效果

明显,与氟西汀相当,安全性良好.

【期刊名称】《世界中医药》

【年(卷),期】2011(006)003

【总页数】3页(P201-203)

【关键词】