Corsi M, Laurora G, Cesarone M R
Angiology and Vasc. Surgery, Clinical Trials Unit, Pierangeli Clinic, Pescara.
Minerva Cardioangiol. 1998 Oct;46(10 Suppl 1):59-63.
In this pilot study we selected 12 patients with short range claudication and treated, after informed consent, 6 patients (mean age 63 +/- 5; range 55-65) with severe claudication (walking distance < 100 m). Selection criteria were patent common and deep femoral artery, occluded superficial femoral artery with patent popliteal artery, with posterior tibial Doppler pressure > 50 mmHg and anterior tibial > 40 mmHg.
Patients were evaluated with a treadmill test performed to their walking limit. PGE1 was used by intramuscular injections (for a total of 80 micrograms, divided in 4 injections). The injections were about 2 cm deep in the posterior calf muscles. An exercise program was associated. Patients were required to walk 20 minutes just after the injections and to follow an exercise program (walking slowly at least 30 minutes, 3 times daily, in the following 4 weeks).
Both the PGE1 group and a comparable control group (12 patients mean age 62 +/- 4; range 56-65) were treated with ASA and pentoxyfillin (400 mg t.i.d.). In the PGE1 group the average total walking distance at inclusion was 25 +/- 16 (range 0-52); it increased to 113 +/- 55 (range 50-289) (after 1 week) and to 117 +/- 27 (range 30-1020) at 4 weeks. No important changes were observed in the control group (54 +/- 6 m at inclusion, 58 +/- 8 after one week and 63 +/- 7 after 4 weeks). There were no important side effects. One patient experienced important injection pain which disappeared in a few hours. No significant changes in tibial pressures were observed.
Intramuscular injection of PGE1 may be an interesting treatment option in patients with severe intermittent claudication but these preliminary findings should be verified in larger randomised studies.
在这项初步研究中，我们选取了12例间歇性跛行距离较短的患者，在获得知情同意后，对6例严重间歇性跛行（步行距离<100米）的患者（平均年龄63±5岁；范围55 - 65岁）进行治疗。入选标准为股总动脉和股深动脉通畅，股浅动脉闭塞但腘动脉通畅，胫后动脉多普勒压力>50 mmHg且胫前动脉>40 mmHg。
通过让患者在跑步机上行走至极限进行评估。采用肌肉注射前列腺素E1（总量80微克，分4次注射）。注射部位在小腿后侧肌肉约2厘米深处。同时进行一项运动计划。要求患者在注射后立即行走20分钟，并在接下来的4周内遵循运动计划（每天至少缓慢行走30分钟，共3次）。
前列腺素E1组和一个可比的对照组（12例患者，平均年龄62±4岁；范围56 - 65岁）均接受阿司匹林和己酮可可碱（400毫克，每日三次）治疗。在前列腺素E1组中，纳入时的平均总步行距离为25±16（范围0 - 52）；1周后增加至113±55（范围50 - 289），4周时增加至117±27（范围30 - 1020）。对照组未观察到明显变化（纳入时为54±6米，1周后为58±8米，4周后为63±7米）。未出现严重副作用。1例患者注射时出现严重疼痛，但数小时后消失。未观察到胫动脉压力有显著变化。
肌肉注射前列腺素E1可能是严重间歇性跛行患者的一种有前景的治疗选择，但这些初步结果应在更大规模的随机研究中得到验证。
