Rizzardi G P, Lazzarin A, Musicco M, Frigerio D, Maillard M, Lucchini M, Moroni M
Institute of Internal Medicine, Infectious Diseases and Immunopathology, University of Milan, Italy.
J Infect. 1996 Mar;32(2):123-31. doi: 10.1016/s0163-4453(96)91312-2.
We randomized 220 HIV-1-infected subjects to receive aerosolized pentamidine (300 mg/4 weeks) or orally trimethoprim-sulfamethoxazole (320-1600 mg/day) for primary prophylaxis of Pneumocystis carinii pneumonia (PCP), and evaluated PCP and toxoplasmic encephalitis (TE) occurrence and survival. Patients developing toxicity switched to the other regimen. Analysis was on intention-to-treat. At 1 year of study, we observed in the pentamidine group a non-significant excess of PCP (4 vs. 1) and TE (7 vs. 3), and a significant increased death rate (15 vs. 2). After 2 years, no significant differences were observed: adjusted RR estimates for pentamidine vs. cotrimoxazole were 1.20 (95% CI, 0.33-4.37) for PCP (6 cases vs. 5), 1.23 (95% CI, 0.46-3.29) for TE (10 vs. 8) and 1.52 (95% CI, 0.83-2.79) for death (30 vs. 18). Crossovers were more frequent in the cotrimoxazole group (41 vs. 4, P < 0.001). Aerosolized pentamidine and cotrimoxazole were equally effective in preventing PCP, and no major differences were observed in TE occurrence and survival after 2 years follow-up.
我们将220名感染HIV-1的受试者随机分为两组，一组接受雾化喷他脒（300毫克/4周），另一组口服甲氧苄啶-磺胺甲恶唑（320 - 1600毫克/天），用于原发性预防卡氏肺孢子虫肺炎（PCP），并评估PCP和弓形虫性脑炎（TE）的发生情况及生存率。出现毒性反应的患者改用另一治疗方案。分析采用意向性治疗原则。在研究的第1年，我们观察到喷他脒组的PCP（4例对1例）和TE（7例对3例）有非显著性的过量发生，且死亡率显著增加（15例对2例）。2年后，未观察到显著差异：喷他脒与复方新诺明相比，PCP的调整相对危险度估计值为1.20（95%可信区间，0.33 - 4.37）（6例对5例），TE为1.23（95%可信区间，0.46 - 3.29）（10例对8例），死亡为1.52（95%可信区间，0.83 - 2.79）（30例对18例）。复方新诺明组的交叉换药情况更频繁（41例对4例，P < 0.001）。雾化喷他脒和复方新诺明在预防PCP方面同样有效，在2年的随访后，TE的发生情况和生存率未观察到重大差异。
