索他洛尔对室性心律失常的疗效及安全性（双盲随机对照试验）

Eficacyandsafetyofsotalolonventriculararrhythmias:double┐blindrandomcontrolstudy

本研究系前瞻性双盲及随机试验，以安慰剂（ＰＬＡ）与索他洛尔（ＳＯＴ）进行比较，评价ＳＯＴ对室性早搏（室早）患者疗效及安全性。２９例患者依次服ＳＯＴ１６０、２４０、３２０ｍｇ／日各１周。服药前及后每周行２４小时Ｈｏｌｔｅｒ检查判定疗效。服ＳＯＴ后室早减少≥９０％者达３７．９％，减少≥７５％者达２７．６％，总有效率为６５．５％。服ＰＬＡ者总有效率２０％。ＳＯＴ组服药前、后ＱＴｃ轻度延长，心率减慢及收缩压下降，Ｐ值均＜０．０５。２例因窦缓需减量或停药。其它不良反应轻而少，两组间差异无显著性。ＳＯＴ组和ＰＬＡ组有效者（分别为１９例和６例），继续服ＳＯＴ和ＰＬＡ３个月，前者１１例、后者５例室早复发。ＳＯＴ组７例经增药量或自行好转，ＰＬＡ组仅１例自行好转。３个月服药期间未见新的不良反应。短及长期治疗中未见致心律失常作用。结果提示国人服ＳＯＴ１６０～３２０ｍｇ／ｄ较安全。

Inthisprospective,double-blind,randomizedstudy,theeficacyandsafetinessofso-talol(SOT)andplacebo(PLA)werecomparedin59patientswithprematureventricularcontractsbymeansof24-hourHoltermonitoringweekly.ThecriteriaofexcelentefectwerePVCsreductionfor≥90%,andgoodefectasPVCsreductionfor≥75%but<90%.AfteroralSOTorPLA160,240,320mg/dayweekly,therateofexcelentefectofSOTwas37.9%,andgoodeffect27.6%.ThetotaleffectofPLAwas20%.InSOTgrouptheQTcintervalincreasedfrom0.43±0.02sto0.45±0.03s(P<0.05),HRdecreasedfrom69.3±6.5beats/minto62.5±9.9beats/min(P<0.01),systolicBPdecreasedfrom117.2±13.7mmHgto110.7±12.3mmHg(P<0.01).DiastolicBPhadnosignificantdiference.TwopatientshadtodecreasethedosageordiscontinueSOTbecauseoftheserioussinusbradycardia.NineteenrespondersofSOTand6ofPLAcontinuedtherapyfor3months.PVCsrecurredin11ofthe19respondersintheSOTgroupand5of6respondersinthePLAgroup.4of5patientsintheSOTgrouphadthenumberofPVCsmarkedlyreducedbyincreas-ingdose,whilethePVCsdecreasedspontaneouslyintheother2patients.Theremaining4patientswithSOT320mg/daywerestilnotafected.Therewasnonewsideeffectsduringthelate3months′treatment.Theproarrhythmicefectswerenotobservedduringshortorlongtermtherapy.Thus,inChinesepatientswithPVCs,sotalolwasrelativelyefectiveandsafe,butBPandHRshouldbemonitored.Theefectivedosewas160 320mg/day.