Paikray Elisha, Pattnaik Manoranjan, Mishra Vedvyas, Abhisek Parida Ansuman, Pradhan Shweta Supriya, Rout Anima
Department of Pharmacology, Kalinga Institute of Medical Sciences, KIIT Deemed to be University, Bhubaneswar, Odisha, India.
Department of Pulmonary Medicine, S.C.B. Medical College and Hospital, Cuttack, Odisha, India.
J Family Med Prim Care. 2024 Oct;13(10):4684-4692. doi: 10.4103/jfmpc.jfmpc_572_24. Epub 2024 Oct 18.
The foremost concern and challenge in managing drug-resistant tuberculosis is ensuring a high health-related quality of life (HRQoL). The effectiveness of pre-extensively drug-resistant (Pre-XDR) tuberculosis management hinges on patients adhering to therapy, a crucial factor in averting the development of drug-resistant strains, ultimately enhancing HRQoL.
This analytical longitudinal study spanned two years at a teaching hospital and involved collaboration between the Departments of Pharmacology and Pulmonary Medicine. A case record form was utilized to gather baseline data, encompassing patient demographics, medication details, WHO BREF HRQoL scores, and treatment adherence. Patients were classified as either adherent or nonadherent using three distinct criteria: the guidelines of the Revised National Tuberculosis Programme (RNTCP), the Morisky-Green-Levine Scale (MGLS), and the Batalla test. The sample size was determined based on 30% nonadherence rates from preliminary analysis of prior data, resulting in 86 patients included in the study. The association between the improvement of HRQoL score from the baseline with the predictor variables was assessed with a linear regression model. Comparison of nonadherence with the different predictors of the study population was assessed with binary logistic regression model.
Analysis of demographic data revealed no notable differences in age and BMI between the Bedaquiline and Delamanid groups. However, there was a gender-related difference in treatment distribution, with more men in the Bedaquiline group. Other factors, such as marital status, socioeconomic status, employment status, stigma/discrimination, comorbidity, and addiction, showed no significant differences between the groups. Comparing HRQoL scores at baseline and after six months showed substantial improvements in all domains, indicating a positive impact of the treatment. Linear regression analysis revealed a strong association between QoL improvement and adherence. Adherence patterns did not significantly differ between the two treatment groups, as assessed by various criteria. The patients with high stigma, newly diagnosed Pre-XDR cases, and the presence of adverse events had higher odds of nonadherence.
This study highlights the substantial impact of Bedaquiline and Delamanid treatment on the HRQoL of Pre-XDR TB patients in Eastern India. Adherence to treatment plays a crucial role in improving QoL, and factors like stigma, newly diagnosed Pre-XDR patients, and adverse drug reactions influence adherence adversely. The findings emphasize the importance of patient support and education to enhance treatment outcomes.
管理耐多药结核病时最主要的关注点和挑战在于确保较高的健康相关生活质量（HRQoL）。广泛耐药前（Pre-XDR）结核病管理的有效性取决于患者坚持治疗，这是避免耐药菌株产生、最终提高健康相关生活质量的关键因素。
这项分析性纵向研究在一家教学医院开展，为期两年，涉及药理学和肺病学系之间的合作。使用病例记录表收集基线数据，包括患者人口统计学信息、用药细节、世界卫生组织简明健康相关生活质量（WHO BREF HRQoL）评分以及治疗依从性。使用三种不同标准将患者分类为依从或不依从：修订后的国家结核病规划（RNTCP）指南、莫里斯基-格林-莱文量表（MGLS）和巴塔利亚测试。样本量根据先前数据的初步分析中30%的不依从率确定，最终86名患者纳入研究。使用线性回归模型评估基线时健康相关生活质量评分的改善与预测变量之间的关联。使用二元逻辑回归模型评估研究人群中不同预测因素与不依从之间的比较。
人口统计学数据分析显示，贝达喹啉组和德拉马尼组在年龄和体重指数方面无显著差异。然而，治疗分布存在性别差异，贝达喹啉组男性更多。其他因素，如婚姻状况、社会经济地位、就业状况、耻辱感/歧视、合并症和成瘾，两组之间无显著差异。比较基线时和六个月后的健康相关生活质量评分，所有领域均有显著改善，表明治疗产生了积极影响。线性回归分析显示生活质量改善与依从性之间存在密切关联。根据各种标准评估，两个治疗组的依从模式无显著差异。耻辱感高、新诊断的Pre-XDR病例以及出现不良事件的患者不依从的几率更高。
本研究强调了贝达喹啉和德拉马尼治疗对印度东部Pre-XDR结核病患者健康相关生活质量的重大影响。坚持治疗在改善生活质量方面起着关键作用，耻辱感、新诊断的Pre-XDR患者以及药物不良反应等因素对依从性有不利影响。研究结果强调了患者支持和教育对提高治疗效果的重要性。
