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皮质类固醇作为获得性免疫缺陷综合征中重度卡氏肺孢子虫肺炎的辅助治疗。一项双盲、安慰剂对照试验。

Corticosteroids as adjunctive therapy for severe Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. A double-blind, placebo-controlled trial.

作者信息

Gagnon S, Boota A M, Fischl M A, Baier H, Kirksey O W, La Voie L

机构信息

Department of Medicine, University of Miami School of Medicine.

出版信息

N Engl J Med. 1990 Nov 22;323(21):1444-50. doi: 10.1056/NEJM199011223232103.

Abstract

BACKGROUND

Preliminary reports suggest that patients with the acquired immunodeficiency syndrome (AIDS) and Pneumocystis carinii pneumonia may benefit from the addition of corticosteroid treatment to antibiotic therapy.

METHODS

We conducted a double-blind, placebo-controlled trial to assess the efficacy of adjunctive corticosteroids in patients with AIDS and severe P. carinii pneumonia. Patients with marked abnormalities in gas exchange who had been treated with antibiotics for less than 72 hours were randomly assigned to receive either methylprednisolone (40 mg) or placebo every 6 hours for 7 days, in addition to treatment for 21 days with trimethoprim-sulfamethoxazole. The primary outcome measures were survival until hospital discharge and the development of respiratory failure.

RESULTS

Twenty-three patients were enrolled in the study; there were no significant differences in base-line clinical or laboratory measures between the two treatment groups. Of 12 patients treated with corticosteroids, 9 (75 percent) survived until hospital discharge, as compared with only 2 of 11 placebo recipients (18 percent) (P less than 0.008). Respiratory failure developed in nine placebo recipients, as compared with only three patients treated with corticosteroids (P less than 0.008). No patient required the interruption or discontinuation of corticosteroid or antibiotic treatment because of toxicity or a complicating event. Because of the marked difference in survival, it was deemed unethical to continue the trial, and the study was terminated.

CONCLUSIONS

Early adjunctive corticosteroid therapy can improve survival and decrease the occurrence of respiratory failure in patients with AIDS and severe P. carinii pneumonia.

摘要

背景

初步报告表明,获得性免疫缺陷综合征(艾滋病)合并卡氏肺孢子虫肺炎的患者,在抗生素治疗基础上加用皮质类固醇治疗可能有益。

方法

我们进行了一项双盲、安慰剂对照试验,以评估辅助使用皮质类固醇对艾滋病合并严重卡氏肺孢子虫肺炎患者的疗效。气体交换有明显异常且接受抗生素治疗少于72小时的患者,除接受三甲氧苄氨嘧啶 - 磺胺甲基异恶唑治疗21天外,还被随机分配每6小时接受一次甲泼尼龙(40毫克)或安慰剂治疗,共7天。主要结局指标为直至出院的生存率和呼吸衰竭的发生情况。

结果

23名患者纳入研究;两个治疗组在基线临床或实验室指标方面无显著差异。接受皮质类固醇治疗的12名患者中,9名(75%)存活至出院,而接受安慰剂治疗的11名患者中只有2名(18%)存活(P<0.008)。9名接受安慰剂治疗的患者发生呼吸衰竭,而接受皮质类固醇治疗的患者只有3名(P<0.008)。没有患者因毒性反应或并发事件而需要中断或停止皮质类固醇或抗生素治疗。由于生存率存在显著差异,继续试验被认为不符合伦理,该研究因此终止。

结论

早期辅助皮质类固醇治疗可提高艾滋病合并严重卡氏肺孢子虫肺炎患者的生存率,并降低呼吸衰竭的发生率。

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