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1、还脑益聪胶囊治疗老年轻度认知损害的双盲随机对照研究作者:李浩,姚明江,赵文明,官杰,蔡琳琳,崔玲【关键词】中草药制剂;轻度认知损害;随机对照试验;双盲法;中医Objective:ToobservetheeffectandexplorethemechanismofHuannaoYicongcapsuleintreatingsenilepatientswithmildcognitiveimpairment(MCI).Methods:Theinvestigationaldrugswerepackedbyblindmethod.Arandomized,double-blind
2、andcontrolledtrialwasconductedonninetysenilepatientswithMCI.Otherforty-fivesenilehealthypersonswererecruitedtothehealthycontrolgroup.TheninetysenilepatientswererandomlydividedintotheHuannaoYicongcapsule-treatedgroup(45patientsadministeredwiththreeHuannaoYicongcapsulesandtwoaniracetamcap
3、suleanalogues)andaniracetam-treatedgroup(45patientstreatedwithtwoaniracetamcapsulesandthreeHuannaoYicongcapsuleanalogues).Patientsinthetwogroupsweretreatedthreetimesdailyfor16weeks.Memory,traditionalChinesemedicinesyndrome,cerebralbloodflow,freeradicalsandinflammatorymediators,suchassup
4、eroxidedismutase(SOD),malondialdehyde(MDA),acetylcholinesterase(AchE),interleukin-1α(IL-1α)andinterleukin-6(IL-6)weredeterminedbeforeandafterthetreatment.Bloodlipids,includingtriglyceride(TG),totalcholesterol(TC),lowdensitylipoproteincholesterol(LDL-C),highdensitylipoproteincholesterol(
5、HDL-C),apolipoproteinA-1(ApoA-1)andapolipoproteinB-100(ApoB-100),weredetectedbeforeandafterthetreatment.Thesafetyindexes,suchasroutinetestsofbloodandurine,hepaticandrenalfunctiontestsandelectrocardiogram(ECG)weretakenbeforeandafterthetreatment.Results:Indexscoreofclinicalmemoryscaleinse
6、nilehealthypeoplewassignificantlyhigherthanthatinMCIpatientsbeforetreatment(P<0.01),andthecontentofAchE,IL-1αandIL-6wasobviouslylower(P<0.01,P<0.05),theactivityofSODwashigher(P<0.05).Nosignificantdifferencewasfoundindirectionmemoryofclinicalmemoryscalebetweenthetwotreatmentgroups.Otheri
7、ndexscoresofclinicalmemoryscaleandtraditionalChinesemedicinesyndromeinpatientsofHuannaoYicongcapsule-treatedgroupweresignificantlyimprovedas8comparedwiththoseoftheaniracetam-treatedgroup(P<0.05,P<0.01).Thebloodflowparametersofanteriorcerebralartery,posteriorcerebralarteryandres