前列地尔(脂微球)冻干粉针治疗慢性下肢缺血性疾病的有效性及安全性研究  

Alprostadil lipid microsphere powder injection in the treatment of chronic lower limb ischemic disease

作　　者：何明坤[1,2] 何筱莹[1] 黄知敏[1] 李延兵[1] 

机构地区：[1]中山大学附属第一医院内分泌科,广州510080 [2]广州市第一人民医院老年科

出　　处：《新医学》2013年第3期188-192,共5页Journal of New Medicine

摘　　要：目的:评估前列地尔(脂微球)冻干粉针的临床疗效和安全性。方法:33例经踝肱指数和动脉彩色多普勒超声检查确诊的慢性下肢缺血性疾病患者,随机分为试验组[前列地尔(脂微球)冻干粉针,16例]和对照组[注射用前列地尔(凯时注射液),17例],接受每日1次的静脉注射治疗,连续2周。治疗前及治疗结束当天记录踝肱指数、评估下肢缺血症状的改善效果、血浆血栓素B2(TXB2)浓度。用药期间观察药物不良反应并检测实验室安全性指标。结果:试验组和对照组治疗前的踝肱指数分别为0.86±0.21和0.83±0.25;疼痛评分分别为2.86±1.53和2.92±1.58;麻木评分分别为4.81±1.45和4.68±1.36。治疗两周后两组的踝肱指数分别升至1.01±0.23和1.04±0.28;疼痛评分分别降至0.83±0.78和0.91±0.82;麻木评分分别降至1.88±1.71和1.75±1.59。治疗前后上述3个指标的组内改变均有统计学意义(P<0.01),但两组间治疗后比较差异无统计学意义(P>0.05)。两组患者不良反应的发生率无差异。结论:前列地尔(脂微球)冻干粉针可显著提高慢性下肢缺血性疾病患者患肢踝肱指数,缓解下肢缺血症状,其疗效和安全性与凯时注射液相似。Objective： To compare the efficacy and safety of the alprostadil lipid microsphere powder injection with alprostadil injection in the treatment of chronic lower limb isehemic disease. Methods： A total of 33 patients with chronic lower limb ischemic disease （confirmed by ABI index and vessel ultrasound） were enrolled and ran- domly assigned to a 2-week intravenous infusion of either alprostadil lipid microspheres lyophilized powder injection （16 patients, test group） or alprostadil injection （17 patients, control group）. Ankle braehial index （ABI）, symptomatic score, maximum painless walking distance, and concentration of blood Thromboxane B2 （TXB2） were obtained at baseline and after treatment. The profile of side effects was evaluated throughout the study. Re- sults： Mean value of ABI at the end of treatment （ 1.01± 0.23 and 1.04 ± 0.28 in test group and control group re- spectively） were significantly higher than that at baseline （0. 86±0. 21 and 0. 83±0. 25 respectively）. According- ly, the pain score （0. 83±0.78 vs. 0.91 ±0. 82） and the numbness score （ 1.88± 1.71 vs. 1.75 ± 1.59） at the end of treatment were significantly lower than those at baseline （ pain score 2. 86± 1.53 vs. 2.92±1.58, numb- ness score 4. 81± 1.45 vs 4.68± 1.36 in test group and control group respectively）. All changes were statistically significant （P 〈 0. 01 ）. The profile of side effects was comparable in the two groups. No serious safety issues were noted. Conclusions： Alprostadil lipid microsphere powder injection was as effective and safe as that of alprostadil injection for the treatment of chronic lower limb ischemic disease.

关 键 词：前列地尔 下肢缺血性疾病 踝肱指数 血栓素B2 

分 类 号：R543.5[医药卫生—心血管疾病]