Gao Mengqiu, Gao Jingtao, Du Jian, Liu Yuhong, Zhang Yao, Ma Liping, Mi Fengling, Li Liang, Tang Shenjie
Beijing Chest Hospital, Capital Medical University, Tuberculosis and Thoracic Tumor Research Institute, Beijing101149, Beijing, China.
Family Health International 360 (FHI360), Beijing, 100020, China.
BMC Infect Dis. 2017 Jun 19;17(1):435. doi: 10.1186/s12879-017-2505-7.
Shortening the standard 6-month treatment for drug-susceptible pulmonary tuberculosis (DS-PTB) would be a major improvement for TB case management and disease control.
We are conducting a randomized, open-label, controlled, non-inferiority trial involving patients with smear-positive, newly diagnosed DS-PTB cases nationwide to assess the efficacy and safety of two 4.5- month regimens in comparison to the standard 6-month WHO recommended regimen. The regimen used in one experiment group is a 4.5-month fluoroquinolone-containing regimen, which consists of full course of levofloxacin, isoniazid (H), rifampin (R), parazinamid (Z) and ethambutol (E). Regimen used in the second experiment group includes 4.5-month full course of H, R, Z, E with levofloxacin removed. Patients in the control group, receive H, R, Z and E for 2 months, followed by 4 months of H and R. The primary endpoint is treatment failure or relapse within 24 month after treatment completion.
Results from this trial along with other studies will contribute to the science of constructing a shorter, effective and safe regiment for TB patients.
The protocol has been registered on ClinicalTrials.gov on 2 September,2016 with identifier NCT02901288 .
缩短药物敏感型肺结核（DS-PTB）的标准6个月治疗时间将是结核病病例管理和疾病控制方面的一项重大改进。
我们正在全国范围内开展一项随机、开放标签、对照、非劣效性试验，纳入涂片阳性、新诊断的DS-PTB患者，以评估两种4.5个月治疗方案与世界卫生组织推荐的标准6个月治疗方案相比的疗效和安全性。一个试验组使用的方案是含氟喹诺酮的4.5个月治疗方案，由左氧氟沙星、异烟肼（H）、利福平（R）、吡嗪酰胺（Z）和乙胺丁醇（E）全程组成。第二个试验组使用的方案包括去除左氧氟沙星的H、R、Z、E 4.5个月全程治疗。对照组患者接受2个月的H、R、Z和E治疗，随后4个月接受H和R治疗。主要终点为治疗完成后24个月内的治疗失败或复发。
该试验以及其他研究的结果将有助于构建更短、有效且安全的结核病患者治疗方案。
该方案于2016年9月2日在ClinicalTrials.gov上注册，标识符为NCT02901288。
