CORTICOSTEROIDS PREVENT EARLY DETERIORATION IN PATIENTS WITH MODERATELY SEVERE PNEUMOCYSTIS-CARINII PNEUMONIA AND THE ACQUIRED-IMMUNODEFICIENCY-SYNDROME (AIDS)
CORTICOSTEROIDS PREVENT EARLY DETERIORATION IN PATIENTS WITH MODERATELY SEVERE PNEUMOCYSTIS-CARINII PNEUMONIA AND THE ACQUIRED-IMMUNODEFICIENCY-SYNDROME (AIDS)
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DOI：
10.7326/0003-4819-113-1-14
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发表时间：
1990-07-01
影响因子：
39.2
通讯作者：
RUEDY, J
中科院分区：
文献类型：
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作者：
MONTANER, JSG;LAWSON, LM;RUEDY, J
目的是确定口服皮质类固醇是否可以预防获得性免疫缺陷综合征（AIDS）相关卡氏肺孢子虫肺炎患者的早期恶化。本研究设计为前瞻性、双盲、安慰剂对照、随机试验。入选患者首次发生卡氏肺孢子虫肺炎，无其他已知的活动性肺部病理，无皮质类固醇禁忌症，未接受抗卡氏肺孢子虫肺炎药物治疗超过48小时，静息时脉搏血氧饱和度≥ 85%且<90%，或呼吸室内空气时运动时血氧饱和度降低5个百分点。受试者被随机分配到泼尼松，60 mg/d，7天，然后在14天内逐渐减少或相同的安慰剂。早期恶化，试验终点定义为第3天或之后基线氧饱和度降低10%。患者出现早期恶化的病例被认为是治疗失败;然后对代码进行破盲，患者的治疗由主治医生判断。进行了序贯分析，主要变量是早期恶化的发展。在序贯分析的基础上，试验于1989年4月5日终止，当时前37例患者共发生9次早期恶化，总体显著性水平为P = 0.0136。19例安慰剂治疗患者中共有8例（42.1%）发生早期恶化，而18例皮质类固醇治疗患者中仅有1例（5.6%）发生早期恶化。两个治疗组之间的基线特征无统计学差异。治疗效果的校正比值比为5.87（95% CI，1.27 - 27.4）。安慰剂组和皮质类固醇组早期恶化概率的校正点估计值分别为43%和12%。安慰剂组所有8例发生早期恶化的患者在加用皮质类固醇治疗后迅速恢复。尸检记录显示，皮质类固醇组中1例早期恶化的患者于第6天死于压倒性卡氏肺孢子虫肺炎。皮质类固醇组在第7天的运动耐量增加，并持续到第30天。口服皮质类固醇预防中重度艾滋病相关卡氏肺孢子虫肺炎患者早期恶化并增加运动耐量
The objective was to determine whether oral corticosteroids can prevent early deterioration in patients with acquired immunodeficiency syndrome (AIDS)-related Pneumocystis carinii pneumonia. It was designed as a prospective, double-blind, placebo-controlled, randomized trial. Included patients were having their first P. carinii pneumonia episode, had no other known active pulmonary pathology, had no contraindication for corticosteroids, received no anti-P. carinii pneumonia medications for more than 48 hours, and had oxygen saturation by pulse oximetry of 85% or more and less than 90% at rest or a 5-percentage-point decrease in oxygen saturation with exercise while breathing room air. Consenting subjects were randomly assigned to prednisone, 60 mg/d for 7 days, followed by a progressive tapering over 14 days or to an identical placebo. Early deterioration, the endpoint of the trial was defined as a 10% decrease in baseline oxygen sturation on day 3 or thereafter. The cases of patients developing early deterioration were considered to be failures of treatment; the code was then broken, and the patient''s treatment was left to the judgment of the treating physician. Sequential analysis was done with the primary variable being development of early deterioration. The trial was terminated 5 April 1989 on the basis of the sequential analysis when a total of nine episodes of early deterioration had occurred in the first 37 patients at an overall significance level of P = 0.0136. A total of 8 of 19 placebo-treated patients (42.1%) developed early deterioration compared with only 1 of 18 patients (5.6%) treated with corticosteroids. Baseline characteristics were not statistically different between the two treatment groups. The adjusted odds ratio for the treatment effect was 5.87 (95% CI, 1.27 to 27.4). The adjusted point estimates for the probability of early deterioration in the placebo and corticosteroid groups were 43% and 12%, respectively. All 8 patients in the placebo group developing early deterioration recovered rapidly with addition of corticosteroid treatment. The single patient with early deterioration in the corticosteroid group died on day 6 from overwhelming P. carinii pneumonia, as documented at autopsy. The corticosteroid group had an increased exercise tolerance on day 7 that persisted at day 30. Oral corticosteroids prevent early deterioration and increase exercise tolerance in patients with moderately severe AIDS-related P. carinii pneumonia.