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三种抗肺孢子菌药物用于晚期人类免疫缺陷病毒感染患者的随机试验。美国国立过敏与传染病研究所艾滋病临床试验组。

A randomized trial of three antipneumocystis agents in patients with advanced human immunodeficiency virus infection. NIAID AIDS Clinical Trials Group.

作者信息

Bozzette S A, Finkelstein D M, Spector S A, Frame P, Powderly W G, He W, Phillips L, Craven D, van der Horst C, Feinberg J

机构信息

University of California, San Diego, La Jolla.

出版信息

N Engl J Med. 1995 Mar 16;332(11):693-9. doi: 10.1056/NEJM199503163321101.

DOI:10.1056/NEJM199503163321101
PMID:7854375
Abstract

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, and 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.

摘要

背景

我们评估了三种治疗策略对预防感染人类免疫缺陷病毒(HIV)患者首次发生卡氏肺孢子虫肺炎的有效性。

方法

在一项开放标签试验中,843例每立方毫米CD4 +细胞少于200个的HIV感染患者接受齐多夫定加三种随机分配的预防药物之一,开始使用甲氧苄啶 - 磺胺甲恶唑、氨苯砜或雾化戊烷脒,随后在不耐受情况下按规定顺序使用其他药物。

结果

甲氧苄啶 - 磺胺甲恶唑组、氨苯砜组和雾化戊烷脒组卡氏肺孢子虫肺炎的估计36个月累积风险分别为18%、17%和21%(P = 0.22)。每立方毫米有100个或更多CD4 +淋巴细胞进入研究的患者中,治疗策略之间的风险差异可忽略不计。每立方毫米CD4 +细胞少于100个进入研究的患者中,雾化戊烷脒的风险为33%,而甲氧苄啶 - 磺胺甲恶唑为19%,氨苯砜为22%(P = 0.04)。接受甲氧苄啶 - 磺胺甲恶唑治疗的患者失败率最低,50毫克氨苯砜的失败比100毫克更常见。弓形虫病在不到3%的患者中发生。在分配到两种全身治疗的患者中,只有23%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,卡氏肺孢子虫肺炎导致的死亡率仅为1%。

结论

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有效性。每立方毫米CD4 +淋巴细胞少于100个的患者中,以甲氧苄啶 - 磺胺甲恶唑或高剂量氨苯砜而非雾化戊烷脒开始的策略更优。

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