新式立体宫腔形网状宫内节育器临床试验研究-论文.pdf

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1、中国生育健康杂志2014年第25卷第4期htto：／／cirh．bimu．edu．cn·305··计划生育·新式立体宫腔形网状宫内节育器临床试验研究邱毅王磊光’于玲杨燕徐志才陈峰刘华强吴喜梅宋燕【摘要】目的观察新式立体宫腔形网状宫内节育器(3DUR-IUD)的避孕效果及不良反应。方法志愿受试者按数字表法随机分为两组，接受3DUR-IUD组和放置元宫药铜宫内节育器(2D—IUD)组，各66例。分别于术后1、3、6和12个月进行随访，了解两组放置IUD后的不良反应、带器妊娠率、IUD脱落率、因症取出率、续用率及避孕效果，B超、X光腹部平片检查3DUR—IUD位置。结果两组66例均成功放置IU

2、D，术中均无明显疼痛。3DUR—IUD组、2DIUD组不良反应发生率分别为6．1％、40．9％，差异有统计学意义。3DUR—IUD组无脱落，无带器妊娠者，续用率为100．0％，2D-IUD组终止率为13．6％，续用率86．4％，差异均有统计学意义。结论3DUR—IUD具有很好的避孕效果，术后不良反应轻微，可为育龄妇女提供新的、安全、高效的IUD。【关键词】新式立体官腔形宫内节育器；元宫药铜宫内节育器；不良反应；避孕Efficacyandsafetyofanewuterlnecavity-shaped3-dimensionalreticularintrauterinedevice：Ancl

3、inicaltrialQIUYi。WANGLeiguang．YUg，YANGYan，XUZhicai．CHENF叭g，uUHuaqiang，WUXimei，SONGYah．KeyLaboratoryforTechniquesforImprovingBirthOutcomes，ShandongProvincialFamilyPlanningInstituteofScienceandTechnology，，l口n250002，China[Abstract]ObjectiveToexploretheeficacyandsafetyofanewuterinecavity-shaped3-dime

4、nsional，reticularintrauterinedevice(3-DUR-IUD)．MethodsThe3-DUR-IUDwasmadefromnitinolandsiliconerubber．Onehundredandthirty—twowomenwererandomlydividedintothe3-DUR·IUDgroup(n=66)(3-DUR—IUDgroup)orthe2-dimensionalIUD(2-D-IUD)group(n=66)(2-D—IUDcontrolgroup)．Patientfollow-upswereperformedat1st，3rd，6t

5、h，and12thofmonthpost-operation．Sideefectssuchasabnormalleucorrhea，menstrualflowchangesinuterinebleedingprofuselyandpainwererecorded．Pregnancyrate，expulsionrate，removalrateofIUDformedicalreasonsandthecontinuationratewereevaluated．UltrasoundandpelvicX-raywereusedtoexamineIUDs．ResultsIUDsweresuccess

6、fulyplacedinallwomeninbothgroupsandtherewerenoseverepainduringtheoperation．Therateofthelumbago／abdominalpainandtheoccurrenceofleucorrheaandirregularvaginalbleedinginthe3-DUR-IUDgroup(6．1％)wassignificantlylowerthanthatofthe2-D-IUDgroup(40．9％)duringthefirst12monthsofIUDuse．Thepregnancyrate，expulsio

7、nrateandtake-ofrateduetosymptomwere0，0and0inthe3-DUR-IUDgroup，respectively．Thecontinuationratewas100．O％inthe3-DUR-IUDgroupasopposedto86．4％inthe2-D—IUDgroup．ConclusionThe3-DUR-IUDdemonstrateslong-termpatienttolerability