Shah Harsh, Yasobant Sandul, Patel Jay, Bhavsar Priya, Saha Somen, Patel Yogesh, Saxena Deepak, Sinha Anish
Department of Public Health Science, Indian Institute of Public Health, Gandhinagar, Gandhinagar, Gujarat, 382042, India.
School of Epidemiology and Public Health, Datta Meghe Institute of Medical Sciences, Wardha, Sawangi (Meghe), Wardha, Maharashtra, 442004, India.
F1000Res. 2024 Jul 23;11:1388. doi: 10.12688/f1000research.125815.2. eCollection 2022.
Background Tuberculosis (TB) continues to pose a serious threat to the public health system in India. Although the National Tuberculosis Elimination Program (NTEP) is providing a wide range of interventions from early diagnosis to complete treatment to reduce morbidity and mortality from TB, adverse drug reactions (ADR) remain a challenge in treatment adherence and completion. Methods An observational cross-sectional study was conducted in selected districts of Gujarat state. A total of 593 reported TB patients were recruited with an adjusted unified distribution based on the type of cases, site of diseases, and service facility through a simple random sampling method. A semi-structured questionnaire tool was used to collect socio-demographic, clinical, and ADR-related data from the TB patients. Data was analyzed for the frequency, percentage, chi-squared, and adjusted odds ratio to find the association between the variables. Results The majority of the study participants were male (87.2%), aged 15 to 60 (57.8%), daily laborers (22.4%), and married (64.2%). Over 75% of individuals had pulmonary TB, with 87% having experienced their first episode, 83% being new cases, and 44.7% having a history of addiction. ADR with mild symptoms was reported by more than a quarter (29%) of TB patients during the intensive phase (77%). The association between ADR experience and drug susceptibility was significant (p<0.005) and drug-resistant TB patients experience two times more ADRs than drug-sensitive TB patients (OR 2.04). Binomial logistic regression was carried out to describe the association between various variables and occurrence of ADRs. Conclusion The study highlighted a need to enhance health care providers' capacity and program structure for managing ADRs among TB patients. In order to completely eliminate TB across the country, it also emphasized the attention for a holistic and all-encompassing strategy for managing TB patients at the field level.
结核病（TB）继续对印度的公共卫生系统构成严重威胁。尽管国家结核病消除计划（NTEP）正在提供从早期诊断到完整治疗的广泛干预措施，以降低结核病的发病率和死亡率，但药物不良反应（ADR）仍然是治疗依从性和完成治疗方面的一个挑战。方法：在古吉拉特邦的选定地区进行了一项观察性横断面研究。通过简单随机抽样方法，根据病例类型、疾病部位和服务设施，对593名报告的结核病患者进行了调整后的统一分布招募。使用半结构化问卷工具从结核病患者中收集社会人口统计学、临床和ADR相关数据。对数据进行频率、百分比、卡方和调整后的优势比分析，以找出变量之间的关联。结果：大多数研究参与者为男性（87.2%），年龄在15至60岁之间（57.8%），为日工（22.4%），已婚（64.2%）。超过75%的个体患有肺结核，其中87%经历过首次发作，83%为新病例，44.7%有成瘾史。在强化期（77%），超过四分之一（29%）的结核病患者报告有轻度症状的ADR。ADR经历与药物敏感性之间的关联显著（p<0.005），耐药结核病患者经历的ADR是药物敏感结核病患者的两倍（OR 2.04）。进行了二项逻辑回归以描述各种变量与ADR发生之间的关联。结论：该研究强调需要提高医疗保健提供者管理结核病患者ADR的能力和项目结构。为了在全国范围内彻底消除结核病，它还强调了在现场层面管理结核病患者的整体和全面战略的重要性。
