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目的:评估国产前列地尔注射液治疗外周动脉闭塞性疾病的疗效及安全性。方法:由首都医科大学宣武医院牵头组织的随机对照试验。2006年9月至2007年9月共207例外周动脉闭塞性血管疾病患者入选并分为2组:国产前列地尔组(101例)和非国产前列地尔组(106例)。国产前列地尔组男72例,女29例,平均年龄(63.8±9.3)岁;非国产前列地尔组男67例,女39例,平均年龄(63.7±8.4)岁。2组患者分别给予国产和非国产前列地尔各10μg入莫菲滴管静脉滴注,1次/d,连续给药2周。治疗前和治疗结束后当天进行静息痛评分,记录踝肱比值、最大无痛行走距离和缺血性溃疡面积,用药期间观察不良反应发生情况。结果:国产前列地尔组和非国产前列地尔组静息痛评分治疗2周后分别为(1.30±1.54)和(1.52±1.74),与治疗前(2.37±2.17)和(2.38±2.29)比较,差异有统计学意义(P<0.01,P<0.001),组间比较差异无统计学意义(P>0.05);踝肱比值治疗后为(0.76±0.22)、(0.74±0.22),治疗前为(0.68±0.20)、(0.66±0.21),差异有统计学意义(P<0.05,P<0.01),组间比较差异无统计学意义(P>0.05);跛行距离治疗前后改善率分别为10.34%和16.13%,组间比较差异无统计学意义(P>0.05);缺血性溃疡面积治疗前后比较差异无统计学意义(P>0.05)。国产前列地尔组9例发生不良反应包括肝脏氨基转移酶升高(3例)、静脉炎(3例),皮炎(1例)、白细胞数异常(1例)、国际标准化比率(INR)升高(1例),发生率为8.9%;非国产前列地尔组8例发生不良反应包括静脉炎(2例)、皮炎(1例)、胃肠道不适(1例)、心悸(1例)、胸闷(1例)、白细胞数异常(1例)、无力(1例),发生率为7.5%。2组不良反应发生率差异无统计学意义(P>0.05)。结论:国产前列地尔注射液是治疗外周动脉闭塞性疾病的安全有效药物。
Objective: To evaluate the efficacy and safety of domestic alprostadil injection in the treatment of peripheral arterial occlusive disease. Methods: A randomized controlled trial led by Xuanwu Hospital of Capital Medical University. From September 2006 to September 2007 a total of 207 patients with peripheral arterial occlusive vascular disease were enrolled and divided into two groups: domestic alprostadil group (101 cases) and non-domestic alprostadil group (106 cases). There were 72 males and 29 females in China, with an average age of 63.8 ± 9.3 years. There were 67 males and 39 females with a mean age of (63.7 ± 8.4) years in the non-domestic alprostadil group. Two groups of patients were given domestic and non-domestic alprostadil 10μg into the Murphy dropper intravenous infusion, 1 / d, continuous administration for 2 weeks. Rest pain scores were recorded on the day before and after the treatment, and the ankle-brachial ratio, the maximum painless walking distance and the area of ischemic ulcer were recorded. Adverse reactions were observed during the treatment. Results: After two weeks of treatment, the resting pain scores in domestic alprostadil group and non-domestic alprostadil group were (1.30 ± 1.54) and (1.52 ± 1.74), respectively, which were significantly lower than those before treatment (2.37 ± 2.17) and (2.38 ± 2.29) (0.76 ± 0.22) and (0.74 ± 0.22) respectively after treatment of ankle-brachial ratio, and the difference was statistically significant (P0.01, P0.001). There was no significant difference between the two groups (P> 0.05) (0.68 ± 0.20) and (0.66 ± 0.21) respectively, the difference was statistically significant (P <0.05, P <0.01), there was no significant difference between the two groups (P> 0.05); the improvement rate of limp distance before and after treatment were (P> 0.05). There was no significant difference in the area of ischemic ulcer before and after treatment (P> 0.05). Adverse reactions in 9 patients in the domestic alprostadil group included elevated liver aminotransferase (3 cases), phlebitis (3 cases), dermatitis (1 case), abnormal white blood cell count (1 case), international normalized ratio (INR) (1 case), the incidence was 8.9%; 8 cases of non-domestic alprostadil adverse reactions include phlebitis (2 cases), dermatitis (1 case), gastrointestinal discomfort (1 case), palpitations (1 case ), Chest tightness (1 case), abnormal white blood cell count (1 case), weakness (1 case), the incidence was 7.5%. There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). Conclusion: Domestic alprostadil injection is a safe and effective drug for the treatment of peripheral arterial occlusive disease.