目的分析含环丝氨酸(Cs)化疗方案治疗耐多药肺结核患者发生药物不良反应的情况.方法选取 2013年1月至2016年6月全国11家单位纳入全球基金第五轮耐多药结核病防治项目、符合选例标准的耐多药肺结核患者作为研究对象,共计623例.所有患者均采用标准化治疗方案,即:6PZA-Am ( Cm )-Lfx ( Mfx )-Pto-Cs/18PZA-Lfx ( Mfx )-Pto-Cs;替代方案:PAS 替代 Pto, Cm 替代Am, Mfx替代Lfx(PZA:毗嗪酰胺;Am :阿米卡星;Cm :卷曲霉素;Lfk :左氧氟沙星;Mfx :莫西沙星;Pto:丙硫异烟胺;Cs :环丝氨酸;PAS:对氨基水杨酸钠).收集患者在治疗过程中的药物不良反应发生情况,分析药物不良反应的临床特征、严重程度、发生时间、持续时间、处理方法及预后,并判定其与药物之间的相关性.结果623例研究对象中有316例(50.7%)发生至少一种药物不良反应,36例(5.8%)患者由于药物不良反应停服药物或者更改治疗方案。最常见的药物不良反应为高尿酸血症(22.8%, 142/623 )和肝功能异常(18.8%, 117/623 );出现与Cs很可能相关的中枢神经系统或精神症状者有27例(4.3%),发生时间的中位数(四分位数)[M(QI,Q3)]为3 (2, 6)个月,对患者进行停用Cs或心理辅导等处理后,症状消失.结论应用含Cs的标准化疗方案进行治疗的耐多药肺结核患者中,发生中枢神经系统或精神症状与Cs有关,在对患者使用含Cs方案治疗期间需密切监测其中枢神经系统或精神系统症状.
Objective To analyze the adverse events in multidrug-resistant pulmonary tuberculosis patients treated with cycloserine-containing chemotherapy regimen. Methods A total of 623 multidrug-resistant pulmonary tuberculosis patients who were eligible for inclusion in the Global Fund' s fifth round of multidrug-resistance control program during January 2013 to June 2016 from 11 hospitals in China were selected. All patients used a standardized treatment regimen: 6PZA-Am(Cm)-Lfx(Mfx)-Pto-Cs/18PZA-Lfx(Mfx)-Pto-Cs;alternatives: PAS instead of Pto, Cm instead of Am, Mfx replacement Lfx (PZA: pyrazinamide. Am: amikacin. Cm: capreomycin, Lfx: levofloxacin, Mfx: moxifloxacin, Pto: prothionamide, Cs: cycloserine, PAS: p-aminosalicylide sodium). The adverse events during treatment were collected, their clinical characteristics, severity, occurring time, duration, treatment method and prognosis were analyzed, and the correlation between the drugs and adverse events were determined. Results Of the 623 multidrug-resistant pulmonary tuberculosis patients treated with cycloserine-containing regimen, 316 (50.7%) patients had at least one adverse event, and 36 (5.8%) patients discontinued the treatment or changed the treatment regimen due to adverse reactions. The most common adverse reactions were hyperuricemia (22.8%, 142/623) and abnormal liver function (18.8%, 117/623). Twenty-seven (4.3%, 27/623) patients developed central nervous system or psychiatric symptoms that were likely to be associated with cycloserine, and the median (interquartile range) time of occurrence was 3 (2, 6) months. After drug discontinuance or psychological counseling, the symptoms disappeared. Conclusion In multidrug-resistant pulmonary tuberculosis patients who received cycloserinecontaining regimen, the occurrence of nervous system or psychiatric symptoms was mainly related to cycloserine. Patients need to be closely monitored for these symptoms during treatment that includes cycloserine.
Tuberculosis and Thoracic Tumor
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