A RANDOMIZED TRIAL OF 3 ANTIPNEUMOCYSTIS AGENTS IN PATIENTS WITH ADVANCED HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION
A RANDOMIZED TRIAL OF 3 ANTIPNEUMOCYSTIS AGENTS IN PATIENTS WITH ADVANCED HUMAN-IMMUNODEFICIENCY-VIRUS INFECTION
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DOI：
10.1056/nejm199503163321101
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发表时间：
1995-03-16
影响因子：
158.5
通讯作者：
FEINBERG, J
中科院分区：
文献类型：
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作者：
BOZZETTE, SA;FINKELSTEIN, DM;FEINBERG, J
背景我们评估了三种治疗策略对预防人类免疫缺陷病毒（HIV）感染患者卡氏肺孢子虫肺炎首次发作的有效性。在一项开放标签试验中，843例CD 4+细胞少于200/mm 3的HIV感染患者接受齐多夫定联合三种随机分配的预防药物，首先是甲氧苄啶-磺胺甲恶唑、氨苯砜或喷他脒雾化，随后是用于不耐受病例的其他药物的确定顺序。甲氧苄氨嘧啶-磺胺甲恶唑、氨苯砜和喷他脒雾化组36个月卡氏肺孢子虫肺炎的累积风险分别为18%、17%和21%（P = 0.22）。在进入研究的患者中，每立方毫米100个或更多的CD 4+淋巴细胞的治疗策略之间的风险差异可以忽略不计。在那些每立方毫米少于100个CD 4+细胞的患者中，喷他脒雾化吸入的风险为33%，而甲氧苄啶-磺胺甲恶唑为19%，氨苯砜为22%（P=0.04）。最低的失败率发生在接受甲氧苄啶-磺胺甲恶唑的患者中，50 mg氨苯砜比100 mg氨苯砜更常见酸衰竭。弓形虫病在不到3%的患者中发展。在分配到两种全身治疗的患者中，只有23%的患者在完成研究时接受了分配的药物和剂量。所有三组的中位生存期约为39个月，卡氏肺孢子虫肺炎的死亡率仅为1%。在晚期HIV感染患者中，我们研究的三种治疗策略在预防卡氏肺孢子虫肺炎方面具有相似的效果。对于每立方毫米CD 4+淋巴细胞少于100个的患者，以甲氧苄啶-磺胺甲恶唑或高剂量氨苯砜而不是喷他脒雾化开始的策略上级。
Background. We evaluated the effectiveness of three treatment strategies for the prevention of a first episode of Pneumocystis carinii pneumonia in patients infected with the human immunodeficiency virus (HIV).Methods. In an open-label trial, 843 patients with HIV infection and fewer than 200 CD4+ cells per cubic millimeter received zidovudine plus one of three randomly assigned prophylactic agents, beginning with trimethoprim-sulfamethoxazole, dapsone, or aerosolized pentamidine and followed by a defined sequence of other drugs to be used in cases of intolerance.Results. The estimated 36-month cumulative risks of P. carinii pneumonia were 18 percent, 17 percent, and 21 percent in the trimethoprim-sulfamethoxazole, dapsone, and aerosolized-pentamidine groups, respectively (P = 0.22). The difference in risk among treatment strategies was negligible in patients entering the study with 100 or more CD4+ lymphocytes per cubic millimeter. In those entering with fewer than 100 CD4+ cells per cubic millimeter, the risk was 33 percent with aerosolized pentamidine, as compared with 19 percent with trimethoprim-sulfamethoxazole and 22 percent with dapsone (P=0.04). The lowest failure rates occurred in patients receiving trimethoprim-sulfamethoxazole, acid failures were more common with 50 mg of dapsone than with 100 mg. Toxoplasmosis developed in less than 3 percent of patients. Of the patients assigned to the two systemic therapies, only 23 percent were receiving their assigned drug and dose when they completed the study. The median survival was approximately 39 months in all three groups, and the mortality attributable to P. carinii pneumonia was only 1 percent.Conclusions. In patients with advanced HIV infection, the three treatment strategies we examined have similar effectiveness in preventing P. carinii pneumonia. Strategies that start with trimethoprim-sulfamethoxazole or with high-dose dapsone, rather than aerosolized pentamidine, are superior in patients with fewer than 100 CD4+ lymphocytes per cubic millimeter.