Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.
Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study.
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中国结核病患者直接观察治疗策略治疗引起的不良反应：一项前瞻性研究。
DOI：
10.1371/journal.pone.0065037
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发表时间：
2013
期刊：
影响因子：
3.7
通讯作者：
Zhan S
中科院分区：
文献类型：
--
作者：
Lv X;Tang S;Xia Y;Wang X;Yuan Y;Hu D;Liu F;Wu S;Zhang Y;Yang Z;Tu D;Chen Y;Deng P;Ma Y;Chen R;Zhan S
中国每年有100多万结核病患者接受直接观察治疗策略（DOTS）治疗。关于DOTS治疗的药物不良反应（adr）的概况，尚未达成共识。在中国结核病人群中，没有关于直接督导下的短程化疗引起的不良反应的报道。本研究旨在确定DOTS治疗引起的不良反应的发生率和预后，并评估其对中国抗结核治疗的影响。2007-2008年进行了一项前瞻性人群队列研究。纳入中国4个地区52个县接受DOTS治疗的痰涂阳肺结核患者，随访6 ~ 9个月。中国国家食品药品监督管理局对疑似adr进行了记录和审查。本研究共纳入4304例结核病患者。649例（15.08%）患者出现至少一次不良反应，共发现766例。按脏器分类的不良反应发生率（计数）为：肝功能障碍273例（6.34%）、胃肠道疾病161例（3.74%）、关节痛108例（2.51%）、过敏反应101例（2.35%）、神经系统疾病2.04%（88例）、肾脏损害0.07%（3例）、其他0.05%（2例）。大多数adr患者（95%）临床预后良好，2例肝毒性患者和1例肾损害患者死亡。与没有不良反应的患者相比，有不良反应的患者在强化期结束时涂片检查结果阳性的可能性更大（调整OR， 2.00; 95%CI, 1.44-2.78），抗结核结果不成功的可能性更大（调整OR， 2.58; 95%CI, 1.43-4.68）。DOTS治疗不良反应发生率为15.08%。这些药物不良反应对中国的结核病控制产生了重大影响。这突出了制定战略以改善不良反应对提高患者护理质量和安全控制结核病的重要性。
More than 1 million tuberculosis (TB) patients are receiving directly observed treatment strategy (DOTS) therapy in China every year. As to the profile of adverse drug reactions (ADRs) due to DOTS therapy, no consensus has been reached. There is no report regarding ADRs due to DOTS therapy with a large Chinese TB population. This study aimed to determine the incidence and prognosis of ADRs due to DOTS therapy, and to evaluate their impact on anti-TB treatment in China. A prospective population-based cohort study was performed during 2007–2008. Sputum smear positive pulmonary TB patients who received DOTS therapy were included and followed up for six to nine months in 52 counties of four regions in China. The suspected ADRs were recorded and reviewed by Chinese State Food and Drug Administration. A total of 4304 TB patients were included in this study. 649 patients (15.08%) showed at least one ADR and 766 cases in total were detected. The incidence (count) of ADR based on affected organ was: liver dysfunction 6.34% (273), gastrointestinal disorders 3.74% (161), arthralgia 2.51% (108), allergic reactions 2.35% (101), neurological system disorders 2.04% (88), renal impairment 0.07% (3) and others 0.05% (2). Most cases of ADRs (95%) had a good clinical outcome, while two with hepatotoxicity and one with renal impairment died. Compared with patients without ADRs, patients with ADRs were more likely to have positive smear test results at the end of the intensive phase (adjusted OR, 2.00; 95%CI, 1.44–2.78) and unsuccessful anti-TB outcomes (adjusted OR, 2.58; 95%CI, 1.43–4.68). The incidence of ADRs due to DOTS therapy was 15.08%. Those ADRs had a substantial impact on TB control in China. This highlighted the importance of developing strategies to ameliorate ADRs both to improve the quality of patient care and to control TB safely.
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