Podzamczer D, Salazar A, Jiménez J, Consiglio E, Santín M, Casanova A, Rufí G, Gudiol F
Infectious Disease Service, Ciutat Sanitaria de Bellvitge, Barcelona, Spain.
Ann Intern Med. 1995 May 15;122(10):755-61. doi: 10.7326/0003-4819-122-10-199505150-00004.
To evaluate the efficacy and safety of two oral, intermittent drug regimens for the simultaneous primary prophylaxis of Pneumocystis carinii pneumonia and toxoplasmosis in patients with HIV infection.
Nonblinded randomized study: Patients received either 1) trimethoprim-sulfamethoxazole (160 mg-800 mg orally twice a day on a thrice weekly regimen) or 2) 100 mg of dapsone plus 50 mg of pyrimethamine orally twice weekly.
University teaching hospital in Barcelona.
230 patients infected with HIV who had CD4 cell counts of less than 200 x 10(6)/L and who had not previously had P. carinii pneumonia or toxoplasmosis.
Clinical and biological evaluations; adverse reactions; and end points of P. carinii pneumonia, toxoplasmosis, and death.
After a median follow-up of 430 days, 6 (6.3%) of 96 evaluable patients receiving dapsone-pyrimethamine and 0 of 104 evaluable patients receiving trimethoprim-sulfamethoxazole developed P. carinii pneumonia (P < 0.0001). The cumulative rates of P. carinii pneumonia at 12 and 24 months were 0% and 0% for patients receiving trimethoprim-sulfamethoxazole and 4% and 11% for patients receiving dapsone-pyrimethamine (Mantel-Cox, P = 0.014). However, only one episode of P. carinii pneumonia developed while patients were taking these drugs. No differences were observed for toxoplasmosis (one episode in the trimethoprim-sulfamethoxazole arm and two in the dapsone-pyrimethamine arm), with cumulative rates at 12 and 24 months of 0% and 4% for the trimethoprim-sulfamethoxazole arm and 2% and 7% for the dapsone-pyrimethamine arm (P = 0.65). Similar mortality rates were observed during follow-up (P = 0.85). Nineteen patients (9.5%) discontinued therapy with the drugs because of adverse effects: Ten were in the trimethoprim-sulfamethoxazole arm and 9 were in the dapsone-pyrimethamine arm (P = 0.95).
Thrice-weekly trimethoprim-sulfamethoxazole is an effective and well-tolerated regimen for the simultaneous primary prophylaxis of P. carinii pneumonia and toxoplasmosis in patients infected with HIV. Twice-weekly dapsone-pyrimethamine appears to be a safe and effective alternative.
评估两种口服间歇性给药方案对HIV感染患者同时进行卡氏肺孢子虫肺炎和弓形虫病原发性预防的疗效和安全性。
非盲随机研究：患者接受以下两种方案之一：1）甲氧苄啶-磺胺甲恶唑（每周三次，每次口服160毫克-800毫克，每日两次）；2）每周两次口服100毫克氨苯砜加50毫克乙胺嘧啶。
巴塞罗那的大学教学医院。
230例HIV感染患者，其CD4细胞计数低于200×10⁶/L，且既往未患卡氏肺孢子虫肺炎或弓形虫病。
临床和生物学评估；不良反应；以及卡氏肺孢子虫肺炎、弓形虫病和死亡的终点指标。
中位随访430天后，96例接受氨苯砜-乙胺嘧啶治疗的可评估患者中有6例（6.3%）发生卡氏肺孢子虫肺炎，而104例接受甲氧苄啶-磺胺甲恶唑治疗的可评估患者中无一例发生（P<0.0001）。接受甲氧苄啶-磺胺甲恶唑治疗的患者在12个月和24个月时卡氏肺孢子虫肺炎的累积发生率分别为0%和0%，接受氨苯砜-乙胺嘧啶治疗的患者分别为4%和11%（Mantel-Cox检验，P=0.014）。然而，患者在服用这些药物期间仅发生1次卡氏肺孢子虫肺炎。弓形虫病方面未观察到差异（甲氧苄啶-磺胺甲恶唑组1例，氨苯砜-乙胺嘧啶组2例），甲氧苄啶-磺胺甲恶唑组在12个月和24个月时的累积发生率分别为0%和4%，氨苯砜-乙胺嘧啶组分别为2%和7%（P=0.65）。随访期间观察到相似的死亡率（P=0.85）。19例患者（9.5%）因不良反应停止药物治疗：甲氧苄啶-磺胺甲恶唑组10例，氨苯砜-乙胺嘧啶组9例（P=0.95）。
对于HIV感染患者同时进行卡氏肺孢子虫肺炎和弓形虫病的原发性预防，每周三次的甲氧苄啶-磺胺甲恶唑是一种有效且耐受性良好的方案。每周两次的氨苯砜-乙胺嘧啶似乎是一种安全有效的替代方案。
