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1、前列安栓治疗慢性前列腺炎临床研究作者:何学军,赵晓峰,杨峰涛,佘绍逸,邓汪东【摘要】目的评价前列安栓治疗慢性前列腺炎(CP)的有效性及安全性。方法采用随机、双盲、阳性药对照临床研究方法,通过临床症状、体征、前列腺按摩液(EPS)检查,筛选出80例CP患者,随机分为试验组(60例)和对照组(20例)。试验组应用前列安栓,对照组用野菊花栓,观察2组患者临床症状、体征、前列腺按摩液(EPS)检查结果、美国国立卫生研究院慢性前列腺炎症状指数评分(NIH-CPSI)等疗效指标,及血、尿、大便常规和心电图、肝、肾功能、药物不良反应等安全性指标。
2、结果治疗4周后,治疗组总有效率为74.14%,对照组总有效率为40.0%,治疗组优于对照组(P=0.006)。治疗组和对照组临床症状评分、NIH-CPSI评分比较,差异均有统计学意义(P<0.05,P<0.01)。2组治疗前后EPS中WBC计数比较虽有统计学意义(P<0.01),但其下降值差异却无统计学意义(P=0.121)。2组对药物的耐受性差异无统计学意义(P=0.269),无严重不良反应事件发生。结论前列安栓治疗CP有效、安全,患者依从性较好。【关键词】慢性前列腺炎;前列安栓;野菊花栓 Abstract:ObjectiveT
3、oevaluatetheefficacyandsafetyofProstantinthetreatmentofchronicprostatitis.MethodsA14randomized,double-blind,positivedrug-controlledclinicaltrialmethodwasappliedinthestudy.Throughclinicalsymptoms,signsandexpressedprostatesecretion(EPS)examination,80patientswithprostatit
4、iswererecruitedandrandomizedintoatrialgroup(60cases)andacontrolgroup(20cases).ThetrialgroupwastreatedwithProstant,andthecontrolgroupwastreatedwithwildchrysanthemumsuppository.Afterscreening,treatmentandfollow-up,inthetrialgroupandthecontrolgroup,theobservationonclinica
5、lefficacyandsafetywereevaluated,suchastheclinicalsymptoms,signs,EPSexamination,thenationalinstitutehealth-chronicprostatitssymptomindex(NIH-CPSI)andthebloodroutine,urineroutine,stoolroutine,thefunctionofliverandkindney,electrocardiographexaminationandthesideeffects.Res
6、ultsAfter4-weektreatment,thetotaleffectiveratewas74.14%inthetrialgroupand40.0%inthecontrolgroup,theefficacyofProstantwassuperiortothatofwildchrysanthemumsuppository(P=0.006).TherewassignificantdifferenceinclinicalsymptomsandNIH-CPSIbetweenpre-treatmentandpost-treatment
7、inthetrialgroupandthecontrolgroup(P<0.05,P<0.01).Thoughtherewasremarkabledifferencebetweenpre-treatmentandpost-treatmentinWBCcountintheEPS(P<0.01),nodifferenceindecrease14valueoftwogroups(P=0.121).ThetolerancetoProstantandwildchrysanthemumsuppositoryshowednosignificant
8、difference(P=0.269),andnoserioussideeffectswererecorded.ConclusionProstantiseffectiveandsafeintreatingchronicprostati