Schürmann D, Bergmann F, Albrecht H, Padberg J, Grünewald T, Behnsch M, Grobusch M, Vallée M, Wünsche T, Ruf B, Suttorp N
Department of Infectious Diseases, Charité (Campus Virchow-Klinikum), Humboldt-Universität zu Berlin, Germany.
J Infect. 2001 Jan;42(1):8-15. doi: 10.1053/jinf.2000.0772.
To evaluate the safety and efficacy of a fixed 25mg pyrimethamine--500mg sulfadoxine combination plus 15mg folinic acid given twice weekly for the prevention of relapses of Pneumocystis carinii pneumonia (PCP) and primary episodes of toxoplasmic encephalitis.
Ninety-five HIV-infected patients with successfully treated PCP and without history of toxoplasmic encephalitis were enrolled between January 1990 and October 1995 in a single-arm open-label prospective study. No patient was receiving highly active antiretroviral treatment, including protease inhibitors or non-nucleoside reverse transcriptase inhibitors, while on study medication. Efficacy was analysed on an "as-treated" basis.
Five patients (5.3%) suffered a PCP relapse while on study medication, three of whom had been non-compliant. No relapse occurred in the first year. Probabilities of freedom from relapse were 0.96 after 24 months and 0.90 after 36 months. Of 69 patients positive for anti-toxoplasma IgG antibodies, one (1.5%) developed cerebral lesions compatible with toxoplasmic encephalitis after 50 months. Cutaneous allergic reactions were observed in 16 patients (16.8%) resulting in permanent discontinuation in six patients (6.3%). Two patients (2.1%) developed serious adverse reactions (Stevens-Johnson syndrome), both of whom had continued prophylaxis despite progressive hypersensitivity reactions.
The prophylactic regimen used is effective in preventing PCP relapses and toxoplasmic encephalitis. The regimen appears to be safe. Severe adverse events can likely be prevented by discontinuation of prophylaxis at the time allergic reactions are noted. Rechallenge frequently results in tolerance of the regimen. Efficacy and safety compare favourably with previously studied regimens. This simple prophylactic regimen may provide a convenient alternative for patients unable to tolerate approved regimens.
评估固定剂量的25毫克乙胺嘧啶 - 500毫克磺胺多辛联合15毫克亚叶酸每周给药两次预防卡氏肺孢子虫肺炎（PCP）复发和弓形虫脑炎初发的安全性和有效性。
1990年1月至1995年10月，95例成功治疗PCP且无弓形虫脑炎病史的HIV感染患者纳入一项单臂开放标签前瞻性研究。在研究用药期间，没有患者接受包括蛋白酶抑制剂或非核苷类逆转录酶抑制剂在内的高效抗逆转录病毒治疗。基于“实际治疗”情况分析疗效。
5例患者（5.3%）在研究用药期间发生PCP复发，其中3例未按规定用药。第一年未发生复发。24个月后无复发概率为0.96，36个月后为0.90。69例抗弓形虫IgG抗体阳性患者中，1例（1.5%）在50个月后出现符合弓形虫脑炎的脑部病变。16例患者（16.8%）出现皮肤过敏反应，6例（6.3%）因此永久停药。2例患者（2.1%）发生严重不良反应（史蒂文斯 - 约翰逊综合征），尽管出现进行性过敏反应，两人仍继续预防用药。
所用预防方案可有效预防PCP复发和弓形虫脑炎。该方案似乎安全。在发现过敏反应时停用预防用药可能预防严重不良事件。再次用药通常会产生对该方案的耐受性。与先前研究的方案相比，疗效和安全性良好。这种简单的预防方案可能为无法耐受批准方案的患者提供一种方便的替代选择。
