目的 本试验旨在观察种市售前列地尔注射液在治疗下肢慢性动脉闭塞症的等效性和安全性。 方法 采用 随机盲法、阳性药平行对照、多中心临床研究。试验组使用 A 药，对照组使用已上市 B 药。疗程均为 14 d 。 结果 本试验共有 7 家医院参与，随机入组 217 例受试者。对照组入选 110 人，试验组 107 人。主要疗效指标中踝肱比值，全分析集（ f ull 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 0.08 ，两组间无统计学意义，符合方案集（ p er-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 34.86 ％；试验组为 30.84 ％。相关不良事件对照组 6.42% ；试验组为 8.41% 。差别无统计学意义。 结论 临床验证表明， 2 种前列地尔注射液在治疗慢性下肢缺血性疾病的过程中，表现出相同的疗效和安全性。
Abstract
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. METHODS It was a random, blind, multicentre and control clinical pharmaceutical trial. All subjects were divided into two groups and each of group. The test and reference preparations of alprostadil injection by different companies were given via same administration route. RESULTS 7 hospitals in China and 217 volunteers were involved in the study. 110 patients received the reference preparation and 107 received test preparation. The ABI of both groups increased significantly after 14 days of treatment and the rest pain decreased. There was not significant different between two groups. The adverse drug reaction rate of reference preparation was 34.86% and the other was 30.84%. No significant different was found between two groups on adverse drug reaction. CONCLUSION The test preparation showed the same effect and safety in patients with peripheral artery occlusive disease as the reference preparation.
关键词
前列地尔注射液 /
慢性下肢缺血性疾病
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Key words
alprostadil injection /
chronic lower extremity ischemic disease
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参考文献
[1] RUTHERFORD R B. <>Vascular Surgery[M]. 5th ed. Philadelphia: W.B. Saunders, 2002: 1451-1456.
[2] NORGREN L, HIATT W R, DORMANDY J A, <>et al. Inter Society Consensus for the Management of Peripheral Arterial Disease (TASC Ⅱ )[J]. <>Eur J Vasc Endovasc Surg, 2007 ， 33(Suppl.1): 45-53.
[3] HIRSCH A T, HASKAL Z J, HERTZER N R, <>et al. ACC/AHA 2005 practice guidelines for the management of patients with peripheral arterial disease [J]. <>Circulation, 2006, 113(11):463-654.
[4] ZHAO D H, JIANG B Q. European guideline for drug clinical trial of treatment of peripheral arterial occlusive diseases [J]. <>Chin J Clin Pharmacol （中国临床药理学杂志） , 1999, 15(2) 154-157.
[5] WU Q H, TANG X B. Clinical observation of cilostazol in treatment of limb arterial ischemic disease[J]. <>Cardiovasc Pulm Dis （心脑血管病杂志） , 1997, 16(3): 211-212.
[6] DONG Z J, YU H X. Cilostazol and ticlopidine in treatment of chronic limbs arterial occlusive diseases [J]. <>Chin New Drugs J （中国新药杂志） 1996, 5(5): 348-351.
[7] MA L, JIANG L H. Clinical observation of alprostadil in treatment of senile unstable angina [J]. <>J <>Harbin Med Univ( 哈尔滨医科大学学报 ), 2003, 37(2): 170.
[8] SONG L J, FU R F. Protective effects of prostaglandin E1 on hypoxia/reoxygenation injury in cultured neonatal rat myocardial cells [J]. <>Acta Pharmacol Sin （中国药理学报） , 2003, 19(10): 1140.
[9] FAN J, LI T L. Lipo PGE1 in treatment of senile peripheral article occlusive disease [J]. <>Chin J Gerontol （中国老年学杂志） , 2002, 22(9): 341-342.
[10] WANG Z, ZHAO W G, WANG J J. Clinical observation of prostaglandin e1 in treatment of peripheral article occlusive disease [J]. <>Chin J Geriatr Cardiovas Cerebrorase Dis( 中华老年心血管病杂志 ), 2002, 4(5): 316-318.
[11] ZHAO C L, LIU J L. Clinical observation of prostaglandin e1 in treatment of peripheral article occlusive disease[J]. <>J Guangdong Med Coll( 广东医学院学报 ), 2000, 16(2) 143-144.
[12] HUANG X Z, AN Z, ZHANG B G, <>et al. Efficacy of lipo PGE1 in treatment of 47 patients with chronic arterial ischemia of leg [J]. <>J <>China Japan Friendship Hosp （中日友好医院学报） , 1999, 13(2):93-95
[13] SHU C, HE H. Advance of diagnosis and treatment of ischemic disease of lower extremity [J]. <>Chin J Gen Surg （中华普通外科杂志） , 2008, 17(6): 523-527.
[14] SHI H Y, TU G H, LI T L. Curative effect and nursing of lower extremity atherosclerosis disease patients received treatment with alprostadil [J]. <>Chin J Mod Nurs （中华现代护理杂志） , 2007, 13(26): 2466-2467.
[15] WU Q H. Progress on treatment of lower extremity vascular occlusive disease[J]. <>J <>Contin Med Educ （继续医学教育） , 2008, 20(9): 98-101.
（ 收稿日期 ： 2009-04-25 ）
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