Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study
Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study
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DOI：
10.4103/0970-2113.217569
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发表时间：
2017-11-01
期刊：
影响因子：
1.6
通讯作者：
Piparva, Kiran G.
中科院分区：
文献类型：
--
作者：
Dela, Arif I.;Tank, Nitish Kumar D.;Piparva, Kiran G.
背景：耐多药结核病(MDR-TB)的治疗需要使用昂贵且有毒的二线抗结核药物，这些药物的疗程较长。二线抗结核药物的不良反应影响依从性，从而影响治疗结果。我们着手分析接受直接监督治疗加治疗的耐多药结核病患者的不良反应和治疗结果。材料和方法：对2010-2014年全区结核病控制中心登记的耐多药肺结核病例进行回顾性研究。记录和评估有关社会人口学资料、诊断和治疗以及不良反应的数据。评估ADRs的因果关系、严重程度评估、管理方面以及对治疗结果的影响。结果：72例患者共报告不良反应147例。最常见的不良反应是胃肠道反应(24.5%)，其次是自我报告的虚弱(21.23%)、心理反应(14.38%)、关节疼痛(14.38%)和呼吸道症状。36例(24.48%)患者因不良反应需停药。不良反应与非治疗依从性和不良结局显著相关。耐多药肺结核合并ADR的治愈率(59.72%)高于未发生ADR的MDR-TB(30.18%)。结论：应重视对ADR的及时认识和处理，尽量减少对治疗方案的修改。对无ADR病例的耐多药肺结核应给予同等重视，以提高总体治愈率。
Background: Treatment of multidrug-resistant tuberculosis (MDR-TB) requires the use of expensive and toxic second-line anti-tubercular drugs which are given for a longer duration. Adverse drug reactions (ADRs) of second-line antitubercular drugs affect compliance and thereby treatment outcome. We set out to analyze ADRs and treatment outcome of MDR-TB patients receiving directly observed treatments plus therapy. Materials and Methods: A retrospective study of registered MDR-TB cases at district tuberculosis center during 2010-2014 was performed. Data regarding sociodemographic profile, diagnosis, and treatment as well as ADRs were recorded and evaluated. ADRs were evaluated for causality, severity assessment, management aspects, and impact on treatment outcome. Results: In total 147 ADRs were reported among 72 cases. Most commonly observed ADRs were gastrointestinal (24.5%) followed by self reported weakness (21.23%), psychological (14.38%), joint pain (14.38%), and respiratory symptoms. Discontinuation of the drugs due to ADRs was required in 36 (24.48%) events. ADRs were significantly associated with nontreatment adherence and defaulter outcome. Cure rate was higher in MDR-TB cases with ADRs (59.72%) than MDR-TB cases without ADRs (30.18%). Conclusion: Attention needs to be paid for timely recognition and treatment of ADR with minimum modification of treatment regimen. Equal attention should be paid to MDR-TB without ADR cases to raise over all cure rate.