前列地尔注射液治疗下肢动脉硬化闭塞症的临床研究

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1、前列地尔注射液治疗下肢动脉硬化闭塞症的临床研究摘要目的：以前列地尔注射液(商品名：凯时，北京泰德制药有限公司生产)为阳性对照药物，评价上海福达制药有限公司生产的前列地尔注射液治疗下肢动脉硬化闭塞症的疗效与安全性。方法：全国8家医院采用随机、双盲、阳性药平行对照研究，观察试验组（前列地尔，114例）、对照组（凯时，110例）在综合疗效、间歇性跛行、静息痛、踝肱指数值的改善以及不良事件发生情况。结果：试验组总有效率为87.50%，对照组为85.45%。两组不良事件的发生率、严重程度以及与药物的相关性之间的比较，差异均无统计学意义（p＞0.05

2、）。结论：前列地尔与凯时治疗下肢动脉硬化症的有效性与安全性无差异。关键词前列腺素el下肢动脉硬化闭塞症药物治疗clinicalstudyonalprostadilinjectionforlimbarterialstenosishuangxiao-zhong1，zhangji-wei1，guoda-qiao2，lijian-xin3，chenzhong4，jinbi5，zhengqi6，huangjian-hua7，hanping8（1.departmentofvascularsurgery，renjihospitalofshanghaia

3、ffiliatedtoschoolofmedicine，shanghaijiaotonguniversity，shanghai，200001；2.departmentofvascularsurgery，zhongshanhospitalofshanghaiaffiliatedtoschoolofmedicine，fudanuniversity，shanghai，200032；3.departmentofvascularsurgery，xuanwuhospitalofbeijingaffiliatedtothecapitalmedicalu

4、niversity，beijing，100053；4.departmentofvascularsurgery，anzhenhospitalofbeijinaffiliatedtothecapitalmedicaluniversity，beijing，100029；5.departmentofvascularsurgery，xiehehospitalofwuhanaffiliatedtotongjimedicineschool，huazhonguniversityofscienceandtechnology，wuhan，430074；6.d

5、epartmentofgeneralsurgery，shanghaisixthpeople’shospitalofshanghai，shanghai，200233；7.departmentofgeneralsurgery，xiangyahospitalofchangshaaffiliatedtothezhongnanuniversity，changsha，410008；8.departmentofgeneralsurgery，shengjinghospitalofshenyangaffiliatedtothechinesemedicalu

6、niversity，shenyang，110004）abstractobjective:todeterminetheefficacyandsafetyofprostaglandine1，lipleinjectionfortreatmentofpatientswitharteriosclerosisobliterans(aso).methods:theresultsoftreatmentwereevaluatedbycomparisonofliplewithanothersimilarproduct“kaishi”.arandomized，

7、double-blind，positive-controlledparallelcontrolstudywasdesignedtotreatpatientswithasoin8hospitalsandpatientsweredividedtwogroups，oneforobservationwith114patientsandtheotherforcontrolwith110patients.thecomprehensiveefficacyandtheimprovementinclaudication，restpainandabivalu

8、ewereobserved.results:totaleffectiveratewas87.50%inobservationgroupcomparedwith85.45%incontrolgr