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地区结核病中心耐多药结核病患者直接督导下短程化疗-加强治疗的药物不良反应及治疗结果分析:一项四年回顾性研究

Adverse drug reactions and treatment outcome analysis of DOTS-plus therapy of MDR-TB patients at district tuberculosis centre: A four year retrospective study.

作者信息

Dela Arif I, Tank Nitish Kumar D, Singh Anil P, Piparva Kiran G

机构信息

Department of Pharmacology, P.D.U. Government Medical College, Rajkot, Gujarat, India.

出版信息

Lung India. 2017 Nov-Dec;34(6):522-526. doi: 10.4103/0970-2113.217569.

Abstract

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.

摘要

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,且用药时间更长。二线抗结核药物的药物不良反应(ADR)会影响依从性,进而影响治疗效果。我们着手分析接受直接观察治疗加其他疗法的耐多药结核病患者的药物不良反应及治疗效果。

材料与方法

对2010年至2014年期间在地区结核病中心登记的耐多药结核病病例进行回顾性研究。记录并评估有关社会人口统计学特征、诊断、治疗以及药物不良反应的数据。对药物不良反应进行因果关系评估、严重程度评估、管理方面评估以及对治疗效果的影响评估。

结果

72例患者中共报告了147例药物不良反应。最常观察到的药物不良反应是胃肠道反应(24.5%),其次是自述虚弱(21.23%)、心理反应(14.38%)、关节疼痛(14.38%)和呼吸道症状。36例(24.48%)事件因药物不良反应需要停药。药物不良反应与未坚持治疗及治疗失败结局显著相关。发生药物不良反应的耐多药结核病病例的治愈率(59.72%)高于未发生药物不良反应的耐多药结核病病例(30.18%)。

结论

需要注意及时识别和治疗药物不良反应,同时尽量减少治疗方案的调整。对于未发生药物不良反应的耐多药结核病病例也应给予同等关注,以提高总体治愈率。

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