芪乌调脂颗粒对气虚血瘀型不稳定性心绞痛患者血清hscrp及血脂干预作用的临床研究-clinical study on intervention effect of qiwu tiaozhi granule on serum hs crp and blood lipid in patients with unstable angina pectoris of qi deficiency and blood stasis type.docxVIP

目的：中文摘要观察中药复方制剂芪乌调脂颗粒对气虚血瘀型或气虚血瘀兼痰浊型不稳定性心绞痛患者血清高敏C反应蛋白及血脂水平的干预作用和临床安全性，探索中医药治疗不稳定性心绞痛的作用机制，为新药上市及临床应用提供理论依据。方法：将气虚血瘀型或兼痰浊型不稳定型心绞痛患者65例随机分为A组(芪乌调脂颗粒组)33例，B组(阿托伐他汀钙组)32例。两组患者均分别给与阿司匹林、硝酸脂类、β受体阻断剂、ACEI/ARB、低分子肝素、氯吡格雷等UA的常规治疗药物。A组在常规UA治疗的基础上给予芪乌调脂颗粒6g/袋，日3次口服，疗程12周;B组在常规UA治疗的基础上给予阿托伐他汀钙20mg,日1次，疗程12周。分别观察两组治疗前后血清hs-CRP、TC、TG、LDL-C、AST、ALT、CK水平、症状量化评分的变化及临床总体疗效。两组在年龄、性别、病程、病情等临床一般性资料方面无显著性差异。结果：1治疗12周后，两组患者血清hs-CRP水平均较治疗前降低，与治疗前比较有统计学意义(P0.05)。A组(hs-CRP下降27.1%),B组(hs-CRP下降30.9%)组间比较无显著差异(P0.05)。两组患者血脂水平（TC,LDL-C,TG）均较治疗前降低，与治疗前比较有统计学意义(P0.05)，TG组间比较无显著差异(P0.05)。2在中医症状疗效方面，两组均能改善胸闷、胸痛、心悸、气短等气虚血瘀兼痰浊型心绞痛主次症表现，且未观察到明显不良反应。两组在症状量化各指标评分均较治疗前有好转，总积分有明显改善，差异有统计学意义(P0.01)，组间比较，气短、乏力、自汗等症状量化评分，差异有统计学意义(P0.01)。结论：中药制剂芪乌调脂颗粒对气虚血瘀或兼痰浊型不稳定性心绞痛血清CRP水平及血脂水平（TC,LDL-C,TG）有降低作用，且中药在改善气短、乏力、自汗等症状方面较阿托伐他汀有优势。关键词：芪乌调脂颗粒；超敏C反应蛋白；血脂；不稳定型心纹痛；阿托伐他汀钙；干预ABSTRACTStudyofserumlipidandhs-CRPinphlegmandbloodstasistypepatientswithunstableanginapectorisonQiwutiaozhigranuleinterventionObjective:Tostudyserumhigh-sensitivityC-reactiveprotein(hs-CRP),lipidandclinicalsafetyinphlegmandbloodstasistypepatientswithunstableanginapectoris(UA)administratedTraditionalChineseMedicine(TCM)Qiwutiaozhigranule,andexplorethemechanismontreatmentofUAwithTCM.Methods:65casesofphlegmandbloodstasistypepatientswithunstableanginaweredividedintoA(Qiwutiaozhigranulegroup),33casesandBgroup(atorvastatincalciumgroup),32casesrandomly.AandBgrouppatientswereadministratedQiwutiaozhigranule6g/bagtidandatorvastatin20mgqdfor12weeksrespectively.BothAandBgrouppatientsweregivensamebasistreatmentwithaspirin,βblockers,nitrateester,ACEI/ARB,lowmolecularheparinandclopidogrel.Twogroupswererecordedserumhs-CRP,TC,TG,LDL-C,AST,ALT,CKlevels,symptomscoresquantifyandclinicaloverallefficacybeforeandaftertreatment,whichhadnosignificantdifferenceinage,gender,diseaseduration,generalinformationontheclinicalcondition.Results:1After12weeksoftreatment,serumhs-CRPlevelswaslowerthanthosebeforetreatmentinbothAandBgroups.Itwasstatisticallysignificant(P0.01).Thedegreeso