Department of Medicine, Yenepoya Medical College, Mangalore, India; Center for Nutrition Studies, Yenepoya (Deemed to be University), Mangalore, India; Department of Medicine, McGill University, Montreal, QC, Canada.
Department of Community Medicine, Yenepoya Medical College, Mangalore, India; Center for Nutrition Studies, Yenepoya (Deemed to be University), Mangalore, India.
Lancet Glob Health. 2023 Sep;11(9):e1402-e1411. doi: 10.1016/S2214-109X(23)00324-8. Epub 2023 Aug 8.
Undernutrition is a common comorbidity of tuberculosis in countries with a high tuberculosis burden, such as India. RATIONS is a field-based, cluster-randomised controlled trial evaluating the effect of providing nutritional support to household contacts of adult patients with microbiologically confirmed pulmonary tuberculosis in Jharkhand, India, on tuberculosis incidence. The patient cohort in both groups of the trial was provided with nutritional support. In this study, we assessed the effects of nutritional support on tuberculosis mortality, treatment success, and other outcomes in the RATIONS patient cohort.
We enrolled patients (aged 18 years or older) with microbiologically confirmed pulmonary tuberculosis across 28 tuberculosis units. Patients received nutritional support in the form of food rations (1200 kcal and 52 g of protein per day) and micronutrient pills. Nutritional support was for 6 months for drug-susceptible tuberculosis and 12 months for multidrug-resistant tuberculosis; patients with drug-susceptible tuberculosis could receive an extension of up to 6 months if their BMI was less than 18·5 kg/m at the end of treatment. We recorded BMI, diabetes status, and modified Eastern Cooperative Oncology Group (ECOG) performance status at baseline. Clinical outcomes (treatment success, tuberculosis mortality, loss to follow-up, and change in performance status) and weight gain were recorded at 6 months. We assessed the predictors of tuberculosis mortality with Poisson and Cox regression using adjusted incidence rate ratios (IRRs) and adjusted hazard ratios (HRs). The RATIONS trial is registered with the Clinical Trials Registry of India (CTRI/2019/08/020490).
Between Aug 16, 2019, and Jan 31, 2021, 2800 patients (mean age 41·5 years [SD 14·5]; 1979 [70·7%] men and 821 [29·3%] women) were enrolled. At enrolment, 2291 (82·4%) patients were underweight (BMI <18·5 kg/m), and 480 (17·3%) had a BMI of less than 14 kg/m. The mean weight and BMI were 42·6 kg (SD 7·8) and 16·4 kg/m (2·6) in men and 36·1 kg (7·3) and 16·2 kg/m (2·9) in women. During the 6-month follow-up, treatment was successful in 2623 (93·7%) patients, 108 (3·9%) tuberculosis deaths occurred, 28 (1·0%) patients were lost to follow-up, and treatment failure was experienced by five (0·2%) patients. The median weight gain was 4·6 kg (IQR 2·8-6·8), but 1441 (54·8%) of 2630 patients remained underweight. At 2 months, 1444 (54·0%) of 2676 patients gained at least 5% of baseline weight. Baseline weight (adjusted IRR 0·95, 95% CI 0·90-0·99), BMI (0·88, 0·76-1·01), poor performance status (ECOG categories 3-4; 5·33, 2·90-9·79), diabetes (3·30, 1·65-6·72), and haemoglobin (0·85, 0·71-1·00) were predictors of tuberculosis mortality. A reduced hazard of death (adjusted HR 0·39, 95% CI 0·18-0·86) was associated with a 5% weight gain at 2 months.
In this study, nutritional support was provided to a cohort with a high prevalence of severe undernutrition. Weight gain, particularly in the first 2 months, was associated with a substantially decreased hazard of tuberculosis mortality. Nutritional support needs to be an integral component of patient-centred care to improve treatment outcomes in such settings.
India Tuberculosis Research Consortium, Indian Council of Medical Research.
在结核病负担较高的国家，如印度，营养不良是结核病的常见合并症。RATIONS 是一项基于现场的、整群随机对照试验，评估在印度恰尔康得为成人肺结核患者的家庭接触者提供营养支持对结核病发病率的影响。试验两组的患者队列都接受了营养支持。在这项研究中，我们评估了营养支持对 RATIONS 患者队列中结核病死亡率、治疗成功率和其他结局的影响。
我们在 28 个结核病单位招募了患有经微生物学证实的肺结核的患者（年龄 18 岁或以上）。患者接受了食物配给（每天 1200 卡路里和 52 克蛋白质）和微量营养素丸的营养支持。耐多药结核病患者的营养支持为期 12 个月，药物敏感结核病患者的营养支持为期 6 个月；如果治疗结束时 BMI 低于 18.5 kg/m，则药物敏感结核病患者可以延长 6 个月。我们在基线时记录了 BMI、糖尿病状况和改良东部合作肿瘤学组（ECOG）表现状态。在 6 个月时记录了临床结局（治疗成功率、结核病死亡率、失访和表现状态变化）和体重增加情况。我们使用调整后的发病率比（IRR）和调整后的危险比（HR），通过泊松和 Cox 回归评估结核病死亡率的预测因素。RATIONS 试验在印度临床试验注册中心（CTRI/2019/08/020490）注册。
在 2019 年 8 月 16 日至 2021 年 1 月 31 日期间，共招募了 2800 名患者（平均年龄 41.5 岁[SD 14.5]；1979 名[70.7%]男性和 821 名[29.3%]女性）。在入组时，2291 名（82.4%）患者体重不足（BMI<18.5 kg/m），480 名（17.3%）的 BMI 低于 14 kg/m。男性的平均体重和 BMI 分别为 42.6 公斤（SD 7.8）和 16.4 kg/m（2.6），女性的平均体重和 BMI 分别为 36.1 公斤（7.3）和 16.2 kg/m（2.9）。在 6 个月的随访期间，2623 名（93.7%）患者治疗成功，108 名（3.9%）患者结核病死亡，28 名（1.0%）患者失访，5 名（0.2%）患者治疗失败。中位体重增加为 4.6 公斤（IQR 2.8-6.8），但 2630 名患者中有 1441 名仍体重不足。在 2 个月时，2676 名患者中有 1444 名（54.0%）至少增加了 5%的基线体重。基线体重（调整后的 IRR 0.95，95%CI 0.90-0.99）、BMI（0.88，0.76-1.01）、较差的表现状态（ECOG 类别 3-4；5.33，2.90-9.79）、糖尿病（3.30，1.65-6.72）和血红蛋白（0.85，0.71-1.00）是结核病死亡的预测因素。体重增加 5%在 2 个月时与死亡风险降低（调整后的 HR 0.39，95%CI 0.18-0.86）相关。
在这项研究中，营养支持提供给了一个严重营养不良患病率较高的队列。体重增加，特别是在头 2 个月，与结核病死亡率显著降低有关。营养支持需要成为以患者为中心的护理的一个组成部分，以改善这种情况下的治疗结果。
印度结核病研究联盟、印度医学研究理事会。
