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克林霉素/伯氨喹与甲氧苄啶-磺胺甲恶唑作为艾滋病患者卡氏肺孢子虫肺炎一线治疗方案的比较:一项随机、双盲的试点试验。

Clindamycin/primaquine versus trimethoprim-sulfamethoxazole as primary therapy for Pneumocystis carinii pneumonia in AIDS: a randomized, double-blind pilot trial.

作者信息

Toma E, Fournier S, Dumont M, Bolduc P, Deschamps H

机构信息

Hôtel-Dieu de Montréal, Quebec, Canada.

出版信息

Clin Infect Dis. 1993 Aug;17(2):178-84. doi: 10.1093/clinids/17.2.178.

Abstract

The aim of this double-blind pilot trial was to compare clindamycin/primaquine with trimethoprim-sulfamethoxazole (TMP-SMZ) as primary treatment for AIDS-related Pneumocystis carinii pneumonia (PCP). The focus was on toxicity and tolerability since comparisons of efficacy were limited by the small sample size. Sixty-five individuals with a first episode of possible PCP were randomly assigned to receive clindamycin/primaquine (34 patients) or TMP-SMZ (31 patients). PCP was subsequently proven microbiologically in 27 and 22 of the patients in these respective groups. Half of the participants had an arterial partial oxygen pressure at enrollment of < or = torr. The incidence and severity of adverse reactions were lower--but not significantly lower (P = .07 and .08, respectively)--with clindamycin/primaquine. The markers of severity improved in a similar manner regardless of which regimen was administered. No significant differences were documented in outcome, duration of survival, length of the PCP-free interval, or rate of relapse. The results of this pilot study show a trend toward less toxicity with clindamycin/primaquine than with TMP-SMZ. This result must be confirmed by larger-scale clinical trials, which are also needed to better compare the efficacy of the two regimens.

摘要

这项双盲试验性研究的目的是比较克林霉素/伯氨喹与甲氧苄啶-磺胺甲恶唑(TMP-SMZ)作为艾滋病相关卡氏肺孢子虫肺炎(PCP)主要治疗方法的效果。由于样本量小,疗效比较受到限制,因此重点在于毒性和耐受性。65例首次出现可能患有PCP的患者被随机分配接受克林霉素/伯氨喹(34例患者)或TMP-SMZ(31例患者)治疗。随后,在这两组患者中分别有27例和22例经微生物学证实患有PCP。一半参与者在入组时动脉血氧分压≤ torr。克林霉素/伯氨喹治疗的不良反应发生率和严重程度较低,但差异无统计学意义(P分别为0.07和0.08)。无论采用哪种治疗方案,严重程度指标均以相似方式改善。在结局、生存时间、无PCP间期长度或复发率方面未记录到显著差异。这项试验性研究的结果显示,与TMP-SMZ相比克林霉素/伯氨喹的毒性有降低趋势。这一结果必须通过大规模临床试验加以证实,同时也需要大规模临床试验来更好地比较两种治疗方案的疗效。

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