Dohn M N, Weinberg W G, Torres R A, Follansbee S E, Caldwell P T, Scott J D, Gathe J C, Haghighat D P, Sampson J H, Spotkov J, Deresinski S C, Meyer R D, Lancaster D J
Pulmonary/Critical Care Division, University of Cincinnati, OH 45267-0564.
Ann Intern Med. 1994 Aug 1;121(3):174-80. doi: 10.7326/0003-4819-121-3-199408010-00003.
To test the hypothesis that the therapeutic success rate of oral atovaquone is not worse than that of intravenous pentamidine in the primary treatment of mild and moderate Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome and to detect differences in the toxicity rates of the two treatments.
Patients were randomly assigned to receive 21 days of open-label therapy with either atovaquone, 750 mg orally with meals three times daily, or intravenous pentamidine, 3 to 4 mg per kg body weight once daily.
Multicenter study including university and community treatment facilities.
Patients with human immunodeficiency virus infection and clinical presentations consistent with mild or moderate P. carinii pneumonia were eligible. For efficacy and safety analyses, patients with histologically confirmed P. carinii pneumonia were emphasized.
Patients were monitored by clinical and laboratory evaluations for therapeutic efficacy and adverse events during the acute treatment phase and for 8 weeks after therapy was discontinued.
As initial therapy for a histologically confirmed episode of P. carinii pneumonia, 56 patients received atovaquone and 53 received pentamidine. More patients were successfully treated with atovaquone (57%) than with pentamidine (40%), a difference of 17% (95% CI, -3% to 38%; P = 0.085), but more patients failed to respond to atovaquone (29%) than to pentamidine (17%), a difference of 12% (CI, -6% to 29%; P = 0.18). Discontinuation of original therapy because of treatment-limiting adverse events was more frequent in the pentamidine group (36%) than in the atovaquone group (4%) (difference, -32%; CI, -48% to -17%; P < 0.001). Nine patients in each treatment group died during the study.
Oral atovaquone and intravenous pentamidine have similar rates for successful treatment of mild and moderate P. carinii pneumonia, but atovaquone has significantly fewer treatment-limiting adverse events.
检验以下假设，即在获得性免疫缺陷综合征患者轻度和中度卡氏肺孢子虫肺炎的初始治疗中，口服阿托伐醌的治疗成功率不低于静脉注射喷他脒，并检测两种治疗方法在毒性发生率上的差异。
患者被随机分配接受为期21天的开放标签治疗，治疗药物为阿托伐醌（每日3次，每次750毫克，与食物同服）或静脉注射喷他脒（每日每千克体重3至4毫克）。
包括大学和社区治疗机构的多中心研究。
符合人类免疫缺陷病毒感染且临床表现符合轻度或中度卡氏肺孢子虫肺炎的患者符合条件。在疗效和安全性分析中，强调组织学确诊为卡氏肺孢子虫肺炎的患者。
在急性治疗阶段及治疗停止后8周，通过临床和实验室评估对患者的治疗效果和不良事件进行监测。
作为组织学确诊的卡氏肺孢子虫肺炎发作的初始治疗，56例患者接受了阿托伐醌治疗，53例患者接受了喷他脒治疗。成功接受阿托伐醌治疗的患者（57%）多于接受喷他脒治疗的患者（40%），差异为17%（95%可信区间，-3%至38%；P = 0.085），但对阿托伐醌无反应的患者（29%）多于对喷他脒无反应的患者（17%），差异为12%（可信区间，-6%至29%；P = 0.18）。因治疗受限不良事件而停止原治疗的情况在喷他脒组（36%）比阿托伐醌组（4%）更频繁（差异为-32%；可信区间，-48%至-17%；P < 0.001）。每个治疗组各有9例患者在研究期间死亡。
口服阿托伐醌和静脉注射喷他脒在轻度和中度卡氏肺孢子虫肺炎的成功治疗率方面相似，但阿托伐醌的治疗受限不良事件明显较少。
