Kurtz D, Weitzenblum E, Krieger J, Reitzer B, Roujansky P
Rev Mal Respir. 1985;2 Suppl 1:S45-52.
In order to verify the effect of almitrine bismesylate on episodes of nocturnal oxygen desaturation, 10 patients suffering from chronic obstructive pulmonary disease had polygraphic EEG night sleep recordings with simultaneous measurement of O2 saturation. The subjects presented during nocturnal sleep a quantity of desaturation of at least 2,400 sec. X p. cent (this quantity being represented by the surface of the SaO2 curve under the desaturation level defined as the waking SaO2 less 4 p. cent) and had been included in a matched experimental protocol, double blind, almitrine bismesylate versus placebo. After administration of either placebo or almitrine bismesylate for 14 days (100 mg per day in two doses) a control night sleep recording was performed. The effect of treatment was assessed using an analysis of variance for 2 or 3 factors, completed by a Student t test in case of significant interaction between the factors. It appears that almitrine bismesylate produces: a non significant decrease in total sleep, slow wave sleep and REM sleep time; a significantly earlier awakening (p less than 0.05); a significant reduction of the total duration of desaturation episodes (p less than 0.05) without any correlation with the variations of total sleep time; a non significant decrease in the quantity of desaturation; a significant increase in PaO2 (p less than 0.001) and in SaO2 (p less than 0.01) measured two hours after the awakening. However there was no evidence of any significant change in mean SaO2 and lowest SaO2 during the night. Finally the variability of the effect of almitrine bismesylate during day or night time remains unexplained.
为了验证二甲磺酸阿米三嗪对夜间氧饱和度降低发作的影响,10例慢性阻塞性肺疾病患者进行了多导睡眠脑电图夜间记录,同时测量氧饱和度。这些受试者在夜间睡眠时呈现至少2400秒×p%的饱和度降低量(该量由低于定义为清醒时SaO2减去4%的饱和度水平下的SaO2曲线面积表示),并已被纳入一项匹配的实验方案,该方案为双盲,比较二甲磺酸阿米三嗪与安慰剂。在给予安慰剂或二甲磺酸阿米三嗪14天(每日100毫克,分两次给药)后,进行了一次对照夜间睡眠记录。使用两因素或三因素方差分析评估治疗效果,若因素之间存在显著相互作用,则通过学生t检验完成分析。结果显示,二甲磺酸阿米三嗪产生:总睡眠时间、慢波睡眠时间和快速眼动睡眠时间无显著减少;显著更早醒来(p<0.05);饱和度降低发作的总持续时间显著缩短(p<0.05),且与总睡眠时间的变化无任何相关性;饱和度降低量无显著减少;醒来两小时后测量的PaO2(p<0.001)和SaO2(p<0.01)显著增加。然而,夜间平均SaO2和最低SaO2没有任何显著变化的证据。最后,二甲磺酸阿米三嗪在白天或夜间效果的变异性仍无法解释。