Weitzenblum E, Arnaud F, Bignon J, Boutin C, Brune J, Castaing Y, Courty G, Derenne J, Duroux P, Fréour P
Service de Pneumologie, Hôpital de Hautepierre, CHRU, Strasbourg.
Rev Mal Respir. 1992;9(4):455-63.
Recent multi-centre studies have shown that high doses of Almitrine (100-200 mg per day), lead to a significant improvement in the hypoxaemia of patients presenting with chronic airflow obstruction, but that a high blood level (greater than 500 ng/ml) is often seen after 1 year, sometimes associated with signs of peripheral neuropathy. In order to maintain Almitrine blood levels in the range 200-300 ng/ml we have used an intermittent regime (with a "window" of 1 month every 3 months) and a dose limited to 100 mg per day. 102 hypoxic patients with chronic airflow obstruction, who were in a stable state were included. 65 patients were in the Almitrine group (A) and 37 patients in the placebo group (P). The treatment lasted for 1 year. In addition there was a 3 monthly follow up with arterial blood gases and spirometry, a clinical neurological examination and also electrophysiology, initially and after 6 and 12 months. 43% of patients in group A and 32% of patients in group P, left the study, most often due to poor cooperation, but sometimes as a result of side effects. After 12 months the PaO2 rose significantly in group A from 59.1 +/- 0.7 to 65.8 +/- 1.6 mmHg (p less than 0.001) whilst it was not changed in group P. The PaCO2 did not change in either group. On the other hand there was a significant fall in the subgroup of patients with hypercapnia in group A (p less than 0.001). The outcome of the neurological and electrophysiological assessments did not show any significant difference between the two groups.(ABSTRACT TRUNCATED AT 250 WORDS)
近期的多中心研究表明,高剂量的烯丙哌三嗪(每日100 - 200毫克)可显著改善慢性气流阻塞患者的低氧血症,但1年后常出现高血药水平(大于500纳克/毫升),有时伴有周围神经病变的体征。为使烯丙哌三嗪血药水平维持在200 - 300纳克/毫升范围内,我们采用了间歇给药方案(每3个月有1个月的“停药期”)且剂量限制为每日100毫克。纳入了102例病情稳定的慢性气流阻塞性低氧患者。65例患者在烯丙哌三嗪组(A组),37例患者在安慰剂组(P组)。治疗持续1年。此外,最初以及6个月和12个月后每3个月进行一次动脉血气分析和肺功能测定、临床神经学检查以及电生理学检查。A组43%的患者和P组32%的患者退出研究,多数是因为合作不佳,但有时是副作用所致。12个月后,A组的动脉血氧分压(PaO₂)从59.1±0.7显著升至65.8±1.6毫米汞柱(p<0.001),而P组未改变。两组的动脉血二氧化碳分压(PaCO₂)均未改变。另一方面,A组中存在高碳酸血症的亚组患者PaCO₂显著下降(p<0.001)。神经学和电生理学评估结果显示两组之间无显著差异。(摘要截断于250字)