Al-Shaer Mohammad H, Mansour Hanine, Elewa Hazem, Salameh Pascale, Iqbal Fatima
Department of Pharmacy, Al Wakra Hospital - Hamad Medical Corporation, Doha, Qatar.
Present address: Department of Pharmacotherapy and Translational Research, Infectious Disease Pharmacokinetics Laboratory, College of Pharmacy and Emerging Pathogens Institute, University of Florida, Gainesville, FL, 32610, USA.
BMC Infect Dis. 2017 Feb 2;17(1):118. doi: 10.1186/s12879-017-2231-1.
Tuberculosis is considered the second most common cause of death due to infectious agent. The currently preferred regimen for treatment of pulmonary tuberculosis (PTB) is isoniazid, rifampin, pyrazinamide, and ethambutol, which has been used either as separate tablets (ST) or as fixed-dose combination (FDC). To date, no studies have compared both regimens in Qatar. We aim to evaluate the safety and effectiveness of FDC and ST regimen for treating PTB, in addition to comparing safety and efficacy of FDC and ST regimens in patients with diabetes treated for TB.
A retrospective observational study was conducted in two general hospitals in Qatar. Patients diagnosed with PTB received anti-tuberculosis medications (either as FDC or ST) administered by the nurse. Sputum smears were tested weekly. We assessed the time to negative sputum smear and incidence of adverse events among FDC and ST groups.
The study included 148 patients. FDC was used in 90 patients (61%). Effectiveness was not different between FDC and ST regimens as shown by mean time to sputum conversion (29.9 ± 18.3 vs. 35.6 ± 23 days, p = 0.12). Similarly, there was no difference in the incidence of adverse events, except for visual one that was higher in ST group. Among the 33 diabetic patients, 19 received the FDC and had faster sputum conversion compared to those who received ST (31 ± 12 vs. 49.4 ± 30.9 days, p = 0.05). Overall, diabetic patients needed longer time for sputum conversion and had more hepatotoxic and gastric adverse events compared to non-diabetics.
ST group had higher visual side effects compared to FDC. FDC may be more effective in diabetic patients; however, further studies are required to confirm such finding.
结核病被认为是由感染因子导致的第二大常见死因。目前治疗肺结核（PTB）的首选方案是异烟肼、利福平、吡嗪酰胺和乙胺丁醇，该方案既可以采用单独片剂（ST）形式，也可以采用固定剂量组合（FDC）形式。迄今为止，卡塔尔尚未有研究对这两种方案进行比较。我们旨在评估FDC和ST方案治疗PTB的安全性和有效性，此外还将比较FDC和ST方案在接受结核病治疗的糖尿病患者中的安全性和疗效。
在卡塔尔的两家综合医院开展了一项回顾性观察研究。被诊断为PTB的患者由护士给予抗结核药物（FDC或ST形式）。每周对痰涂片进行检测。我们评估了FDC组和ST组痰涂片转阴的时间以及不良事件的发生率。
该研究纳入了148例患者。90例患者（61%）使用了FDC。FDC和ST方案的有效性并无差异，痰涂片转阴的平均时间分别为（29.9±18.3天与35.6±23天，p = 0.12）。同样，不良事件的发生率也无差异，不过视觉方面的不良事件在ST组中更高。在33例糖尿病患者中，19例接受了FDC，与接受ST的患者相比，痰涂片转阴更快（31±12天与49.4±30.9天，p = 0.05）。总体而言，与非糖尿病患者相比，糖尿病患者痰涂片转阴所需时间更长，且肝毒性和胃部不良事件更多。
与FDC相比，ST组的视觉副作用更高。FDC在糖尿病患者中可能更有效；然而，需要进一步研究来证实这一发现。
