| Shenzhu Guanxin Recipe Granules (参术冠心方颗粒) for Improving Exercise Tolerance in Patients with Stable Angina (SERIES Trial): A Protocol of Multicenter,Randomized, Double-Blind,Placebo Parallel Controlled Clinical Trial |
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| 作者姓名： | MAO Shuai XU Dan-ping DANG Xiao-jing LI Winny WU Huan-lin |
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| 作者单位： | Second Clinical Medical College;Heart Center;Faculty of Medicine;Beijing University of Chinese Medicine |
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| 基金项目： | Supported by Foundation from Department of Science and Technology of Guangdong Province(No.2012A032500017);Foundation from Guangdong Provincial Academy of Traditional Chinese Medicine(No.YN2014LN07,YK2013B1N10,A2016192);Science Foundation of Guangdong Province(No.2015A030310437,2015A030306049);National Natural Science Foundation(No.81403341,81703877) |
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| 摘 要： | Background:Manypatientswithchronicanginaexperienceanginalepisodesdespitesuccessfulrecanalization,antianginalandantiischemicmedications.EmpiricalobservationssuggestedthatShenzhuGuanxinRecipeGranules(参术冠心方颗粒,SGR),aChineseherbalcompound,exertedpotentialimpactsonincreasedtreadmillexerciseperformanceandanginarelieve.However,therehasbeennosystematicstudytoclarifytheimpactofSGRonexercisetoleranceinpatientswithstableangina.TheSERIES(ShEnzhuguanxinRecipeforImprovingExercisetoleranceinpatientswithStableangina)trialisdesignedtodeterminetheeffectsofSGRonexerciseduration,electrocardiographic(ECG)evidenceofmyocardialischemia,andincidenceofmajoradversecardiacevents(MACE)instableanginalpatients.Methods:Atotalof184eligiblepatientswithstableanginawillberandomlyassignedtoreceiveplaceboorSGR(10g/dayfor12weeks)ina1:1ratio.Theprimaryoutcomewillbethechangefrombaselineintotalexercisetoleranceduration,timetoonsetofanginaandECGischemiaduringexercisetreadmilltestingperformedovera12-weekstudyperiod.ThesecondaryoutcomewillincludeECGmeasures,theoccurrenceandcompositeofMACEandtheSeattleAnginaQuestionnairescore.Moreover,thecoronarymicrocirculationwillbeevaluatedtoexplorethepossibleeffectsinresponsetotreatmentofSGR.Aftertheprocedure,allparticipantswillbefollowedupbyinterviewat3and6months,enquiringaboutanycardiacevents,hospitalizations,cardiacfunctionallevelandmedicationusage.Additionally,theoccurrenceofadverseeventswillbeevaluatedateachfollow-up.Discussion:ThisstudymayprovidenovelevidenceontheefficacyofSGRinimprovingexercisetoleranceandpotentiallyreducingclinicaladverseevents.(TrialregistrationNo.ChiCTR-TRC-14004504)
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| 关 键 词： | exercise tolerance stable angina Shenzhu Guanxin RECIPE coronary microcirculation TRIAL PROTOCOL RANDOMIZED controlled TRIAL |
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