Vashishtha Richa, Mohan Krishna, Singh Bhagteshwar, Devarapu Satish K, Sreenivas Vishnubhatla, Ranjan Sanjay, Gupta Deepak, Sinha Sanjeev, Sharma Surendra K
Department of Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India.
BMC Infect Dis. 2013 Oct 7;13:468. doi: 10.1186/1471-2334-13-468.
Despite the latest World Health Organization guidelines advocating daily therapy in HIV-TB co-infected individuals, there are few recent studies comparing outcomes of thrice-weekly anti-tuberculosis treatment in HIV-positive and HIV-negative patients with TB. The present study sets out to compare TB treatment outcomes in these two groups in the Indian national programme, which currently involves thrice-weekly therapy for all, regardless of HIV status.
HIV-positive and HIV-negative were consecutively screened for enrolment into this prospective observational study, carried out at the All India Institute of Medical Sciences hospital, New Delhi, India, between 2006 and 2010. Patients were given short-course thrice-weekly rifampicin-based therapy, with all HIV-positive patients being started on highly active antiretroviral therapy at least 14 days after commencing TB treatment. Patients were regularly followed-up for 24 months after completion of treatment.
150 HIV-positive, 155 HIV-negative patients were enrolled consecutively for the study. Significantly higher treatment success (93.5% vs. 76.7% at end of treatment, p < 0.001) and lower mortality (2.8% vs. 21.6% on follow up, p < 0.001) were observed in HIV-negative patients. No significant difference was found in treatment failure (p = 0.16), sputum smear (p = 0.58) and culture conversion (p = 0.55), and non-serious adverse event incidence (p = 0.851) between the two groups. Low baseline CD4 cell count (<100 cells/ mm3) was the only predictor of mortality in HIV-TB patients (odds ratio 8 · 43, p = 0 · 013).
Thrice-weekly anti-tuberculosis therapy is more effective in HIV-negative than in HIV-positive patients. However, outcomes in this HIV co-infected cohort were found to be similar to those reported previously with daily therapy, with no safety concerns. This should prompt further study into whether intermittent or daily therapy should be used universally in resource-poor settings, using large well executed randomised controlled trials.
NCT No. 00698334.
尽管世界卫生组织最新指南提倡对合并感染艾滋病毒和结核病的患者进行每日治疗，但最近很少有研究比较艾滋病毒阳性和艾滋病毒阴性结核病患者每周三次抗结核治疗的效果。本研究旨在比较印度国家项目中这两组患者的结核病治疗效果，该项目目前对所有患者，无论其艾滋病毒感染状况如何，均采用每周三次治疗。
在印度新德里全印度医学科学研究所医院于2006年至2010年进行的这项前瞻性观察研究中，对艾滋病毒阳性和艾滋病毒阴性患者进行连续筛查以纳入研究。患者接受基于利福平的每周三次短程治疗，所有艾滋病毒阳性患者在开始结核病治疗至少14天后开始接受高效抗逆转录病毒治疗。治疗结束后对患者进行24个月的定期随访。
连续招募了150名艾滋病毒阳性患者和155名艾滋病毒阴性患者进行研究。艾滋病毒阴性患者的治疗成功率显著更高（治疗结束时为93.5% 对76.7%，p<0.001），死亡率更低（随访时为2.8% 对21.6%，p<0.001）。两组在治疗失败（p = 0.16）、痰涂片（p = 0.58）和培养转阴（p = 0.55）以及非严重不良事件发生率（p = 0.851）方面未发现显著差异。低基线CD4细胞计数（<100个细胞/mm³）是艾滋病毒合并结核病患者死亡率的唯一预测因素（比值比8.43，p = 0.013）。
每周三次抗结核治疗对艾滋病毒阴性患者比艾滋病毒阳性患者更有效。然而，发现该艾滋病毒合并感染队列的治疗效果与先前每日治疗报告的效果相似，且无安全性问题。这应促使使用大规模执行良好的随机对照试验，进一步研究在资源匮乏地区是否应普遍采用间歇或每日治疗。
NCT编号00698334。
