Li Yang, Wang Fei, Wu Limin, Zhu Min, He Guiqing, Chen Xinchang, Sun Feng, Liu Qihui, Wang Xiaomeng, Zhang Wenhong
Department of Infectious Diseases, Huashan Hospital, Fudan University, Shanghai 200032, China.
Zhejiang Provincial Center for Disease Control and Prevention, Hangzhou, Zhejiang 310051, China,
Infect Drug Resist. 2019 Mar 29;12:721-731. doi: 10.2147/IDR.S195555. eCollection 2019.
Cycloserine has been used in multidrug-resistant tuberculosis (MDR-TB) treatment since the 1950s. We evaluated the efficacy and safety of cycloserine and sought to clarify the role of cycloserine for treatment of simple MDR-TB, pre-extensively drug-resistant tuberculosis (pre-XDR-TB), and extensively drug-resistant tuberculosis (XDR-TB).
A retrospective observational study was performed in Zhejiang Province, China. We enrolled 144 cycloserine-treated and 181 cycloserine-nontreated patients consecutively and determined the treatment outcome as the primary outcome. The proportion of patients with sputum culture conversion and the frequency of adverse drug reactions were also assessed.
One-hundred (69.4%) out of 144 patients in the cycloserine group successfully completed treatment. The HR of any unfavorable treatment outcome after the introduction of cycloserine was 0.58 (95% CI: 0.38-0.86, =0.008). Subgroup analysis showed that cycloser-ine could benefit simple MDR-TB cases reducing the risk of unfavorable treatment outcomes (HR: 0.43, 95% CI: 0.24-0.76, =0.004), but not pre-XDR-TB (HR: 0.65, 95% CI: 0.30-1.38, =0.263) or XDR-TB (HR: 0.73, 95% CI: 0.22-2.37, =0.589). The culture conversion rate at the intensive phase was similar whether cycloserine was administered or not (=0.703). Of the 144 patients treated with cycloserine, a total of 16 (11.1%) patients experienced side effects attributed to cycloserine.
Cycloserine is an attractive agent for the treatment of MDR-TB, and its safety profile warrants its use in most MDR-TB cases. Cycloserine significantly improved the chance of a favorable outcome for patients with simple MDR-TB but not pre-XDR-TB and XDR-TB. Thus, more aggressive regimens might be required for pre-XDR-TB or XDR-TB patients.
自20世纪50年代以来，环丝氨酸一直用于耐多药结核病（MDR-TB）的治疗。我们评估了环丝氨酸的疗效和安全性，并试图阐明环丝氨酸在单纯耐多药结核病、广泛耐药结核病（XDR-TB）前期（pre-XDR-TB）和广泛耐药结核病治疗中的作用。
在中国浙江省进行了一项回顾性观察研究。我们连续纳入了144例接受环丝氨酸治疗的患者和181例未接受环丝氨酸治疗的患者，并将治疗结果作为主要观察指标。还评估了痰培养转阴患者的比例和药物不良反应的发生率。
环丝氨酸组144例患者中有100例（69.4%）成功完成治疗。引入环丝氨酸后出现任何不良治疗结果的风险比（HR）为0.58（95%置信区间：0.38 - 0.86，P = 0.008）。亚组分析表明，环丝氨酸可使单纯耐多药结核病患者受益，降低不良治疗结果的风险（HR：0.43，95%置信区间：0.24 - 0.76，P = 0.004），但对广泛耐药结核病前期患者无效（HR：0.65，95%置信区间：0.30 - 1.38，P = 0.26）或广泛耐药结核病患者无效（HR：0.73，95%置信区间：0.22 - 2.37，P = 0.589）。无论是否使用环丝氨酸，强化期的痰培养转阴率相似（P = 0.703）。在144例接受环丝氨酸治疗的患者中，共有16例（11.1%）患者出现了归因于环丝氨酸的副作用。
环丝氨酸是治疗耐多药结核病的一种有吸引力的药物，其安全性保证了它在大多数耐多药结核病病例中的应用。环丝氨酸显著提高了单纯耐多药结核病患者获得良好治疗结果的机会，但对广泛耐药结核病前期和广泛耐药结核病患者无效。因此，广泛耐药结核病前期或广泛耐药结核病患者可能需要更积极的治疗方案。
