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耐多药结核病患者药物不良反应的发生率及管理:一项前瞻性研究的分析

Frequency and Management of Adverse Drug Reactions Among Drug-Resistant Tuberculosis Patients: Analysis From a Prospective Study.

作者信息

Massud Asif, Syed Sulaiman Syed Azhar, Ahmad Nafees, Shafqat Muhammad, Chiau Ming Long, Khan Amer Hayat

机构信息

Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, George Town, Malaysia.

Faculty of Pharmaceutical Sciences, Government College University, Faisalabad, Pakistan.

出版信息

Front Pharmacol. 2022 Jun 2;13:883483. doi: 10.3389/fphar.2022.883483. eCollection 2022.

Abstract

Drug-resistant tuberculosis (DR-TB) management is often linked with a higher rate of adverse drug reactions (ADRs) needing effective and timely management of these ADRs, which, if left untreated, may result in a higher rate of loss to follow-up of drug-resistant patients. The study was aimed at prospectively identifying the nature, frequency, suspected drugs, and management approaches for ADRs along with risk factors of ADRs occurrence among DR-TB patients at Nishtar Medical University, Hospital, Multan, Pakistan. The prospective study included all the DR-TB patients enrolled for treatment from January 2016 to May 2017 at the study site Patients were evaluated for the treatment-induced ADRs as per standard criteria of the National Tuberculosis Program, Pakistan. Multivariate logistic regression was used to assess the independent variables associated with the occurrence of ADRs. Out of 271 DR-TB patients included in the final analysis, it was observed that 55 patients (20.3%) experienced at least three ADRs. A total of 50 (18.5%) patients experienced zero adverse effects, while 15 (5.5%), 33 (12.2%), and 53 (19.6%) patients experienced one, two, and four ADRs, respectively. Gastrointestinal disturbances (66.7%), nervous system disorders (59.4%), and electrolyte disturbances (55.7%) remained the highest reported ADRs during therapy, followed by arthralgia (49.1%), ototoxicity (24%), pruritic reactions/rash (12.9%), dyspnoea (12.5%), and tinnitus (8.8%). Pulmonary cavitation at the baseline visit (-value 0.001, OR 3.419; 95% CI (1.694-6.902) was significantly associated with the occurrence of ADRs among DR-TB patients. The frequency of ADRs was high among the study cohort; however, these were managed effectively. Patients with recognized risk factors for ADRs occurrence need continuous clinical management efforts.

摘要

耐多药结核病(DR-TB)的管理往往与较高的药物不良反应(ADR)发生率相关,这就需要对这些不良反应进行有效且及时的处理,否则,可能会导致耐多药患者的失访率升高。本研究旨在前瞻性地确定巴基斯坦木尔坦尼什塔尔医科大学医院耐多药结核病患者药物不良反应的性质、频率、可疑药物、处理方法以及药物不良反应发生的风险因素。这项前瞻性研究纳入了2016年1月至2017年5月在研究地点登记接受治疗的所有耐多药结核病患者。按照巴基斯坦国家结核病规划的标准对患者进行治疗引起的药物不良反应评估。采用多因素逻辑回归分析评估与药物不良反应发生相关的独立变量。在纳入最终分析的271例耐多药结核病患者中,观察到55例(20.3%)患者至少出现三种药物不良反应。共有50例(18.5%)患者未出现不良反应,而15例(5.5%)、33例(12.2%)和53例(19.6%)患者分别出现1种、2种和4种药物不良反应。治疗期间报告最多的药物不良反应依次为胃肠道紊乱(66.7%)、神经系统疾病(59.4%)和电解质紊乱(55.7%),其次是关节痛(49.1%)、耳毒性(24%)、瘙痒反应/皮疹(12.9%)、呼吸困难(12.5%)和耳鸣(8.8%)。基线访视时存在肺空洞(P值0.001,OR 3.419;95%CI(1.694 - 6.902))与耐多药结核病患者药物不良反应的发生显著相关。研究队列中药物不良反应的发生率较高;然而,这些不良反应得到了有效处理。已识别出有药物不良反应发生风险因素的患者需要持续的临床管理措施。

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