Montaner J S, Guillemi S, Quieffin J, Lawson L, Le T, O'Shaughnessy M, Ruedy J, Schechter M T
St Paul's Hospital, University of British Columbia, Vancouver, Canada.
Tuber Lung Dis. 1993 Jun;74(3):173-9. doi: 10.1016/0962-8479(93)90007-K.
To assess the effect of oral corticosteroids in patients with mild Pneumocystis carinii pneumonia and the acquired immune deficiency syndrome (AIDS).
Prospective, double blind, placebo controlled, randomized trial.
Included were AIDS patients having their first episode of P. carinii pneumonia, who had no other known active pulmonary pathology, who had no contraindications for corticosteroids and who had received no other anti-P. carinii medications for more than 48 h. Subjects received either prednisone, 60 mg/day for 7 days, followed by a progressive tapering over 14 days, or identical placebo. The present analysis pertains to patients with mild P. carinii pneumonia as defined by a baseline resting oxygen saturation greater than 90% and a decrease in oxygen saturation during exercise while breathing room air of not less than 5 percentage points. Early deterioration, the end-point of the trial, was defined as a 10% decrease from baseline oxygen saturation on day 3 or thereafter.
At study termination, there were 12 subjects in the placebo group and 11 in the corticosteroid group. Baseline characteristics were not statistically different between the treatment groups. Early deterioration developed in 7 and 1 patients in the placebo and corticosteroid groups respectively (P = 0.027). In addition, by day 3, a number of parameters were less favorable in the placebo group relative to the corticosteroid group including median oxygen saturation (85% vs 97%; P = 0.003), lactic dehydrogenase (1514 vs 763; P = 0.013), median respiratory rate (30 vs 22; P = 0.003), median heart rate (100 vs 81; P = 0.002), and median temperature (39 vs 37; P = 0.024). Even though patients suffering early deterioration in the placebo group were switched to corticosteroids, significant differences between the groups remained at day 30 with regard to exercise tolerance. More than half of patients assigned to the corticosteroid group exercised for a median of 6.5 min on day 30 (P = 0.017).
Oral corticosteroids prevent early deterioration and increase exercise tolerance in patients with mild AIDS-related P. carinii pneumonia as defined on the basis of pulse oximetry.
评估口服皮质类固醇对轻度卡氏肺孢子虫肺炎合并获得性免疫缺陷综合征(AIDS)患者的疗效。
前瞻性、双盲、安慰剂对照、随机试验。
纳入首次发作卡氏肺孢子虫肺炎的AIDS患者,这些患者无其他已知的活动性肺部病变,无皮质类固醇使用禁忌证,且在48小时内未接受过其他抗卡氏肺孢子虫药物治疗。受试者接受泼尼松治疗,60mg/天,共7天,随后在14天内逐渐减量,或接受相同的安慰剂治疗。本分析涉及根据基线静息氧饱和度大于90%以及在呼吸室内空气时运动期间氧饱和度下降不少于5个百分点定义的轻度卡氏肺孢子虫肺炎患者。试验终点早期病情恶化定义为第3天或之后氧饱和度较基线下降10%。
研究结束时,安慰剂组有12名受试者,皮质类固醇组有11名受试者。治疗组之间的基线特征无统计学差异。安慰剂组和皮质类固醇组分别有7名和1名患者出现早期病情恶化(P = 0.027)。此外,到第3天,安慰剂组相对于皮质类固醇组的一些参数更不理想,包括中位氧饱和度(85%对97%;P = 0.003)、乳酸脱氢酶(1514对763;P = 0.013)、中位呼吸频率(30对22;P = 0.003)、中位心率(100对81;P = 0.002)和中位体温(39对37;P = 0.024)。尽管安慰剂组中出现早期病情恶化的患者改用了皮质类固醇,但在第30天,两组在运动耐量方面仍存在显著差异。超过一半分配到皮质类固醇组的患者在第30天运动的中位时间为6.5分钟(P = 0.017)。
根据脉搏血氧饱和度定义,口服皮质类固醇可预防轻度AIDS相关卡氏肺孢子虫肺炎患者的早期病情恶化并提高运动耐量。