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控制鸟分枝杆菌复合体的体内负荷与改善艾滋病患者的生活质量及延长生存期相关:一项使用利福布汀联合异烟肼、氯法齐明、乙胺丁醇的前瞻性试验。

Control of the body burden of M. avium complex is associated with improved quality of life and prolonged survival of patients with AIDS: a prospective trial with rifabutin combined with isoniazid, clofazimine, ethambutol.

作者信息

Olliaro P, Dautzenberg B

机构信息

R&D/Anti-infectives, Farmitalia Carlo Erba, Milan, Italy.

出版信息

J Chemother. 1994 Jun;6(3):189-96. doi: 10.1080/1120009x.1994.11741151.

Abstract

The objectives of this study were to assess whether culture conversion affects quality of life (QoL), survival and Mycobacterium avium complex (MAC)-associated morbidity in patients with AIDS. Data from an open, multicenter, noncomparative trial were analyzed to test the benefit of suppressing mycobacteria: measures of QoL, clinical outcomes and quality-adjusted survival are compared on occasion of culture-negative and positive assessments. The study was conducted at AIDS clinics in France, coordinated by the GETIM, with the participation of 51 AIDS patients with culture-proven Non-Tuberculous Mycobacteria (NTM) disease. Patients underwent a quadruple drug-regimen. The following parameters were investigated: (i) Culture conversion to a negative finding (= suppression) or on > 2 occasions, including each patient's last valid observation (= conversion); (ii) survival after treatment start; (iii) QoL by using the ECOG score, re-coded 0 to 4 for worst to best performance status; (iv) quality-adjusted survival. On treatment, > 1 negative culture was recorded for 69% of the evaluable patients, corresponding to 111 person-months of observation. Positive culture findings accounted for 42 person-months only. Patients' performance status (mean 1.8 at entry) worsened or improved according to whether culture was positive or negative (means 1.2 and 2.2; total scores 109 and 217 person-months, respectively). Similarly, MAC-attributable morbidity was significantly reduced when culture was negative. Mean survival was 195 days longer in treatment success patients. These analyses suggest that, in patients with NTM disease occurring as a late complication of AIDS, treatment was effective in improving clinical status and survival, and in suppressing bacterial growth.(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

本研究的目的是评估培养结果转阴是否会影响艾滋病患者的生活质量(QoL)、生存率以及鸟分枝杆菌复合体(MAC)相关疾病的发病率。分析了一项开放性、多中心、非对照试验的数据,以检验抑制分枝杆菌的益处:在培养结果为阴性和阳性评估时,比较生活质量指标、临床结局和质量调整生存率。该研究在法国的艾滋病诊所进行,由GETIM协调,51例经培养证实患有非结核分枝杆菌(NTM)疾病的艾滋病患者参与。患者接受四联药物治疗方案。研究了以下参数:(i)培养结果转为阴性(=抑制)或在2次以上出现这种情况,包括每位患者的最后有效观察结果(=转阴);(ii)治疗开始后的生存率;(iii)使用ECOG评分评估生活质量,重新编码为0至4分,代表从最差到最佳的表现状态;(iv)质量调整生存率。治疗期间,69%的可评估患者有1次以上培养结果为阴性,相当于111人月的观察期。培养结果为阳性的情况仅占42人月。根据培养结果为阳性或阴性,患者的表现状态(入组时平均为1.8)有所恶化或改善(平均值分别为1.2和2.2;总分分别为109和217人月)。同样,培养结果为阴性时,MAC所致疾病显著减少。治疗成功的患者平均生存期延长195天。这些分析表明,在作为艾滋病晚期并发症出现NTM疾病的患者中,治疗在改善临床状态和生存率以及抑制细菌生长方面是有效的。(摘要截断于250字)

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