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11.1BMCFamilyPracticeIF：2.032一个实用临床试验的原理和设计，以评估家庭血压监测和降压药自滴定对控制不良的高血压的影响摘要：Lackofcontrolofhypertensionisoneofthemostprevalentproblemsencounteredbygeneralpractitioners(GPs).Self-measuredbloodpressuremonitoringathome(SMBP)andself-titrationofmedicationcouldbeagoodstrategytoimprovehypertensionmanagement,however,evidenceislimitedandnotconclusive.Weaimedtoassesstheeffectiveness,intheprimarycaresetting,ofaninterventionthatincludeseducationalcomponents,SMBPandself-titrationofantihypertensivemedicationtodecreasesystolicbloodpressurecomparedtousualcare,inapopulationwithpoorlycontrolledhypertension,duringa12-monthperiod.背景:高血压控制不足是全科医生遇到的最普遍的问题之一。家庭自测血压(SMBP)和药物自滴定可能是改善高血压管理的一个好策略，然而，证据有限，没有结论性。我们的目的是评估在基层医疗机构中，在高血压控制不足的人群中，相比于常规治疗，包含教育、SMBP和自滴定降压药的干预措施在12个月内降低收缩压的效果。Methods:Pragmatic,controlled,randomized,unblindedclinicaltrialwithtwoparallelgroupsassignedinaratioof1:1toself-management(whichincludeseducationalcomponents,SBMPandself-titrationofantihypertensivemedicationbasedonapatientsGPspre-establishedadjustmentplan)ortousualcare(witheducationalcomponentstoo)方法:采用实用的、随机对照非盲的临床试验，将两平行组按1:1的比例分配给自我管理组(其中包括教育成分、SBMP和基于患者的家庭医生预先制定的调整计划自我滴定降压药）或常规护理组(也包括教育成分)。Discussion:Ifthedatafromthistrialshowpositiveresults,thestudymaycontributetoachangeofstrategyinthetreatmentofhypertension,focusingonthepatientasthemainactortoachievebloodpressurecontrol.Furthermore,thisapproachmightcontributetothefinancialsustainabilityoftheNationalHealthService讨论:如果本试验数据显示为阳性，本研究可能有助于改变高血压治疗策略，以患者为主要角色控制血压。此外，这种做法可能有助于国家卫生服务的财政可持续性。试验注册:本试验已在数据库中注册，编号EudraCT:2016-003986-25。2017年5月5日注册关键词:自我监测;血压;高血压；自我滴定；基层医疗；实用的临床试验背景：Thepresenceofhypertensionisoneofthemostimportantissuesintheglobalburdenofdisease[1].Indevelopedcountries,thedegreeofcontrolofhypertensionhasincreasedprogressivelyoverthelast15yearsandhascontributedtoadeclineincardiovascularmorbidityandmortality[28].However,arecentstudycarriedoutin12Europeancountriesshowedthatmorethan50%ofpatientstreatedforhypertensioncontinuedtohaveuncontrolledbloodpressure(BP)[9]andthatresultsarefarfromideal.Asalargepartofhypertensionmanagementiscarriedoutinprimarycare(PC)anditisoneofthemostprevalentproblemsencounteredbyGeneralPractitioners(GP),interventionsaimedatimprovingitsmanagementshouldpreferablybemadeinthissetting.Recenthypertensionclinicalguidelinesputemphasisonself-measuredbloodpressuremonitoring(SMBP)bypatientsandonteam-basedsystemstomanagethecondition[10].高血压的存在是全球疾病负担[1]中最重要的问题之一。在发达国家，高血压的控制程度在过去15年中逐步提高，心血管发病率和死亡率下降[2-8]。然而，最近在12个欧洲国家进行的一项研究表明，50%以上接受高血压治疗的患者仍然无法控制血压(BP)[9]，这一结果远非理想。由于高血压管理的很大一部分是在基层医疗(PC)中进行的，它是全科医生遇到的最普遍的问题之一，因此改善管理的干预在这种机构下进行可能更好。最近的高血压临床指南强调由患者在家庭自行测量血压(SMBP)和基于团队的系统来管理[10]。Self-measuredbloodpressuremonitoringathome(SMBP)ispracticedextensivelynowadays.IntheUnitedKingdomandCanadaitishighlyrecommendedbyGPsandusedbymorethan30%ofpatients[11,12].SystematicreviewshaveshowndisparateinformationregardingtheeffectivenessofSMBPaloneinreducingbloodpressure(BP).Ontheotherhand,self-monitoringinconjunctionwithco-interventions(includingsystematicmedicationtitrationbydoctors,pharmacists,orpatients;education;orlifestylecounseling)hasbeenshowntoleadtoclinicallysignificantBPreduction,whichpersistsforatleast12months.Nevertheless,theeffectivenessofSMBPrequiresadditionalevaluationgiventhatitsdefinitioninthosestudiesishighlyheterogeneous(differentclinicalprotocols,differentstrategiesforadditionalsupportandmanagement)andgiventhefactthatmoststudieshaveshortfollow-ups(1yearorless)[13,14].目前家庭自测血压广泛应用。在英国和加拿大，全科医生高度推荐它（家庭自测血压），超过30%的患者使用[11,12]。系统评价显示单独SMBP降低血压(BP)有效性的不同信息。另一方面，自我监测与联合干预相结合(包括医生、药剂师或患者的系统药物滴定;教育;或者生活方式咨询)已经被证明会引起显著临床意义的血压下降，至少持续12个月。然而，鉴于SMBP在那些研究中的定义高度异质性(不同的临床方案，不同的额外支持和管理策略)，并且考虑到大多数研究的随访时间较短(1年或更短)，SMBP的有效性需要额外的评估[13,14]。Regardinghometitrationofantihypertensivemedication,evidenceismorelimitedandshowsmixedresults.Twoclinicalessays,theTASMINH2[15]andtheTASMINH-SR[16],bothintheUnitedKingdomanddevelopedintheprimarycaresettingbythesameresearchteam,aresomeofthemostrecentandinterestingclinicaltrialscarriedoutinthisfield.Inthesestudies,SMBPtogetherwithself-titratemedications(accordingtoapreviouslyagreedplan),combinedwithtelemedicinecomponents,wascomparedwithusualcare.Inbothstudiessystolicbloodpressure(SBP)decreasedfrombaselineto12months,withsignificantdifferencesbetweentheinterventionandcontrolgroup(5.4and9.2mmHg,respectively).Frequencyofsideeffectswassimilarinbothgroups[15,16].TheTASMINH-SRstudyisofspecialrelevancebecauseitwascarriedoutwithhighriskpatients(withapersonalhistoryofstroke,ischemiccardiopathy,diabetesorkidneyfailure),apopulationofspecialinteresttoachieveBPtargets[16].Ontheotherhand,aclinicaltrialcarriedoutintheUSinalow-income,predominantlyminoritypopulation,aimedtodeterminewhetherhealthcoaching,SMBPandhometitrationofantihypertensivemedicationscouldimproveBPcontrolcomparedwithSMBPandhealthcoachingalone.Theresultsshowedthatboththehome-titrationarmandtheno–home-titrationarmhadareductioninSBP,withnosignificantdifferencesbetweenthemfrombaselineto6months[17].关于降压药的家庭滴定，证据更有限，结果不一。两篇临床论文，TAS