药学与临床研究
藥學與臨床研究
약학여림상연구
PHARMACEUTICAL AND CLINICAL RESEARCH
2015年
4期
337-340
,共4页
张星光%刘福平%吕肖锋%朱旅云%刘俊江%吕伯南%刘超%刘长建%王立明%虞冠锋%冉兴无
張星光%劉福平%呂肖鋒%硃旅雲%劉俊江%呂伯南%劉超%劉長建%王立明%虞冠鋒%冉興無
장성광%류복평%려초봉%주려운%류준강%려백남%류초%류장건%왕립명%우관봉%염흥무
前列地尔注射液%糖尿病%慢性下肢缺血性疾病
前列地爾註射液%糖尿病%慢性下肢缺血性疾病
전렬지이주사액%당뇨병%만성하지결혈성질병
Alprostadil injection%Diabetic%Lower Extremity Arterial Occlusive Disease (LEAOD)
目的：观察2种前列地尔注射液在治疗糖尿病下肢动脉闭塞症（糖尿病足）的等效性和安全性。方法：采用随机双盲、阳性药平行对照、多中心临床研究。试验组使用前列地尔脂微球注射液，对照组使用前列地尔注射液。疗程均为14 d。结果：随机入组235例受试者。对照组入选117人，试验组118人。主要疗效指标中踝肱比值，全分析数据集（full analysis set，FAS）人群组内比较：两组治疗14 d后踝肱比值均较基线时有所提高，且有统计学意义。组间比较：治疗14 d后对照组提高0.09；试验组提高0.10，两组间无统计学意义，符合方案数据集（per-protocol set， PPS）人群结果趋势和FAS一致。两组治疗14 d后静息痛均较基线时有所下降，且有统计学意义，组间比较无统计学差异，PPS人群结果趋势和FAS一致。最大无痛行走距离在两组间无统计学意义，PPS 结果和FAS一致。全部不良事件发生率对照组为19.33%；试验组为17.65%。相关不良事件对照组10.08%；试验组为8.4%；差别无统计学意义。结论：2种前列地尔注射液在治疗慢性下肢动脉闭塞性疾病的过程中，表现出相同的疗效和安全性。
目的：觀察2種前列地爾註射液在治療糖尿病下肢動脈閉塞癥（糖尿病足）的等效性和安全性。方法：採用隨機雙盲、暘性藥平行對照、多中心臨床研究。試驗組使用前列地爾脂微毬註射液，對照組使用前列地爾註射液。療程均為14 d。結果：隨機入組235例受試者。對照組入選117人，試驗組118人。主要療效指標中踝肱比值，全分析數據集（full analysis set，FAS）人群組內比較：兩組治療14 d後踝肱比值均較基線時有所提高，且有統計學意義。組間比較：治療14 d後對照組提高0.09；試驗組提高0.10，兩組間無統計學意義，符閤方案數據集（per-protocol set， PPS）人群結果趨勢和FAS一緻。兩組治療14 d後靜息痛均較基線時有所下降，且有統計學意義，組間比較無統計學差異，PPS人群結果趨勢和FAS一緻。最大無痛行走距離在兩組間無統計學意義，PPS 結果和FAS一緻。全部不良事件髮生率對照組為19.33%；試驗組為17.65%。相關不良事件對照組10.08%；試驗組為8.4%；差彆無統計學意義。結論：2種前列地爾註射液在治療慢性下肢動脈閉塞性疾病的過程中，錶現齣相同的療效和安全性。
목적：관찰2충전렬지이주사액재치료당뇨병하지동맥폐새증（당뇨병족）적등효성화안전성。방법：채용수궤쌍맹、양성약평행대조、다중심림상연구。시험조사용전렬지이지미구주사액，대조조사용전렬지이주사액。료정균위14 d。결과：수궤입조235례수시자。대조조입선117인，시험조118인。주요료효지표중과굉비치，전분석수거집（full analysis set，FAS）인군조내비교：량조치료14 d후과굉비치균교기선시유소제고，차유통계학의의。조간비교：치료14 d후대조조제고0.09；시험조제고0.10，량조간무통계학의의，부합방안수거집（per-protocol set， PPS）인군결과추세화FAS일치。량조치료14 d후정식통균교기선시유소하강，차유통계학의의，조간비교무통계학차이，PPS인군결과추세화FAS일치。최대무통행주거리재량조간무통계학의의，PPS 결과화FAS일치。전부불량사건발생솔대조조위19.33%；시험조위17.65%。상관불량사건대조조10.08%；시험조위8.4%；차별무통계학의의。결론：2충전렬지이주사액재치료만성하지동맥폐새성질병적과정중，표현출상동적료효화안전성。
Objective: To compare the equivalence and safety between reference preparation and test preparation of alprostadil injection in patients with chronic lower extremity arterial occlusive disease (LEAOD). Methods: It was a random, blind, multicentre and controlled clinical pharmaceutical trial. All subjects were divided into two groups and each of group. The test and reference preparations of alprostadil injections by different companies were given via the same administration route. Results: Eight hospitals in China and 235 volunteers were involved in the study, and 117 patients received the reference preparation and 118 received the test preparation. The ankle brachial index of both groups increased significantly after 14 days of treatment and the rest pain decreased, while there was no significant difference between the two groups. The adverse drug reaction rate of the reference preparation was 19.33% and that of the test was 17.65%, no significant difference was found between the two groups on adverse drug reaction. Conclusion: The test preparation showed the same effect and safety in patients with diabetic LEAOD as the reference preparation.
