National Tuberculosis Centre, Ministry of Health and Population, Kathmandu, Nepal.
PLoS One. 2009 Dec 23;4(12):e8313. doi: 10.1371/journal.pone.0008313.
The aim of this study was to describe treatment outcomes for multi-drug resistant tuberculosis (MDR-TB) outpatients on a standardized regimen in Nepal.
Data on pulmonary MDR-TB patients enrolled for treatment in the Green Light Committee-approved National Programme between 15 September 2005 and 15 September 2006 were studied. Standardized regimen was used (8Z-Km-Ofx-Eto-Cs/16Z-Ofx-Eto-Cs) for a maximum of 32 months and follow-up was by smear and culture. Drug susceptibility testing (DST) results were not used to modify the treatment regimen. MDR-TB therapy was delivered in outpatient facilities for the whole course of treatment. Multivariable analysis was used to explain bacteriological cure as a function of sex, age, initial body weight, history of previous treatment and the region of report.
In the first 12-months, 175 laboratory-confirmed MDR-TB cases (62% males) had outcomes reported. Most cases had failed a Category 2 first-line regimen (87%) or a Category 1 regimen (6%), 2% were previously untreated contacts of MDR-TB cases and 5% were unspecified. Cure was reported among 70% of patients (range 38%-93% by Region), 8% died, 5% failed treatment, and 17% defaulted. Unfavorable outcomes were not correlated to the number of resistant drugs at baseline DST. Cases who died had a lower mean body weight than those surviving (40.3 kg vs 47.2 kg, p<0.05). Default was significantly higher in two regions [Eastern OR = 6.2; 95%CL2.0-18.9; Far West OR = 5.0; 95%CL1.0-24.3]. At logistic regression, cure was inversely associated with body weight <36 kg [Adj.OR = 0.1; 95%CL0.0-0.3; ref. 55-75 kg] and treatment in the Eastern region [Adj.OR = 0.1; 95%CL0.0-0.4; ref. Central region].
The implementation of an ambulatory-based treatment programme for MDR-TB based on a fully standardized regimen can yield high cure rates even in resource-limited settings. The determinants of unfavorable outcome should be investigated thoroughly to maximize likelihood of successful treatment.
本研究旨在描述尼泊尔使用标准化方案治疗耐多药肺结核（MDR-TB）门诊患者的治疗结果。
研究了 2005 年 9 月 15 日至 2006 年 9 月 15 日期间在经格林光灯委员会批准的国家方案中登记治疗的肺 MDR-TB 患者的数据。使用标准化方案（8Z-Km-Ofx-Eto-Cs/16Z-Ofx-Eto-Cs）治疗最多 32 个月，随访通过涂片和培养进行。药敏试验（DST）结果未用于修改治疗方案。MDR-TB 治疗在门诊设施中全程提供。使用多变量分析解释性别、年龄、初始体重、既往治疗史和报告地区与细菌学治愈之间的关系。
在最初的 12 个月中，有 175 例实验室确诊的 MDR-TB 病例（62%为男性）报告了结果。大多数病例先前曾失败过二线方案（87%）或一线方案（6%），2%为 MDR-TB 病例的先前未治疗接触者，5%为未指定。报告了 70%的患者治愈（按地区划分，范围为 38%-93%），8%死亡，5%治疗失败，17%失访。不良结局与基线 DST 时耐药药物的数量无关。死亡患者的平均体重低于存活患者（40.3 公斤对 47.2 公斤，p<0.05）。在两个地区，失访率显著较高[东部 OR = 6.2；95%CL2.0-18.9；远西部 OR = 5.0；95%CL1.0-24.3]。在逻辑回归中，治愈与体重<36 公斤呈负相关[调整后的 OR = 0.1；95%CL0.0-0.3；参考体重 55-75 公斤]，与东部地区的治疗呈负相关[调整后的 OR = 0.1；95%CL0.0-0.4；参考中央地区]。
在资源有限的情况下，即使在基于完全标准化方案的门诊基础上实施耐多药结核病治疗方案，也能获得较高的治愈率。应彻底调查不良结局的决定因素，以最大限度地提高成功治疗的可能性。
