利塞膦酸钠胶囊治疗绝经后骨质疏松症疗效再评价

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1、利塞膦酸钠胶囊治疗绝经后骨质疏松症疗效再评价作者：郭郡浩，姚茹冰，赵智明，蔡辉【摘要】目的运用LSC校正法评定利塞膦酸钠胶囊治疗绝经后骨质疏松症(PMOP)的疗效。方法采用随机、双盲、安慰剂平行对照方法，入选的42例PMOP患者随机分为试验组(n=21)和对照组(n=21)。试验组晨起口服利塞膦酸钠胶囊，对照组口服安慰剂，2组均在晚间口服碳酸钙D咀嚼片，疗程为12个月。治疗前、治疗6个月、12个月时，测量腰椎和髋部骨密度(BMD)，用LSC校正法计算BMD的疗效，并与正态分析法比较。结果LSC校正法分析表明，试验组腰椎BMD在6个月、治疗12个

2、月时的变化与对照组比较差异均有显著性(P<0.05)，但2组髋部BMD的变化之间的差异无显著性(P>0.05)。上述结果与正态分析法对BMD的疗效评价结果一致。结论LSC校正法评价疗效的结果与正态分析法具有高度一致性，两种方法在评价疗效时各有优缺点，临床评价BMD的疗效时可视具体情况选用或同时应用。【关键词】绝经后骨质疏松症;骨密度;最小有意义变化;双能X线吸收法　　Abstract:ObjectiveToevaluateefficacyofrisedronatesodiumcapsulesinthetreatmentofpostm

3、enopausalosteoporosis11(PMOP)bytheleastsignificantchange(LSC)-adjustedmethod(LAM).MethodsThisisarandomizeddouble-blind,placebo-controlledclinicaltrial.42patientswithPMOPwererandomlydividedinto2groups:trialgroup(n=21)andcontrolgroup(n=21).During12months,patientsinthetrailgrou

4、preceivedrisedronatesodiumcapsulesorallyeverymorning,whilepatientsofcontrolgrouptookplaceboorallyeverymorning,andmeanwhileallpatientstookcalcichewDorallyeverynight.Thedouble-energybonedensitymeasurementwasusedtodeterminelumbarandhipbonemineraldensity(BMD)at3timepoints(before

5、treatment,6monthsand12monthsaftertreatment).Meanwhile,theeffectonBMDwasevaluatedbyLAMtocomparewiththeresultevaluatedbynormaldistributionanalyticalmethod(NAM).ResultsThesamplechangedataforlumbarBMDby(LAM)showedthattherewasstatisticalsignificanceinthechanges6and12monthsafterco

6、ntinuoustreatmentbetweenthetrialgroupandcontrolgrouprespectively(P<0.05),whilenostatisticalsignificanceinthechangedataforhipBMDwasobservedbetweenthetwogroups(P>0.05).TheresultsofefficacyaboutBMDbyLAMwereconsistentwiththosebyNAM.ConclusionTheresultsbyLAMandNAMhavehighco

7、ncordance.Therearebothadvantagesanddisadvantages11respectivelyintheevaluationoftheefficacyaboutBMDbyLAMandNAM.Thetwomethodsshouldbeusedaloneormeanwhilewhennecessary.　　Keywords：postmenopausalosteoporosis;bonemineraldensity;leastsignificantchange;dual-energyX-rayabsorptiometry

8、　　骨质疏松症患者治疗后疗效评价的主要观察指标包括骨密度(bonemineraldensity，BMD)的变化情况，由于BMD是定量指标，均数比较通常