摘要
目的 探究不良反应监测在耐药结核病含贝达喹啉方案治疗转归中的作用.方法 前瞻性选取2019年1月至2023年6月在上海市肺科医院接受治疗的300例耐药结核病患者作为本次研究对象,患者均使用含贝达喹啉方案治疗.分析患者在治疗期间的不良反应发生情况,并将发生不良反应的患者纳入发生组,未发生不良反应的患者纳入未发生组.分析发生组与未发生组的临床特征(性别、年龄、糖尿病、吸烟史、饮酒史)、治疗依从性及治疗转归的差异.结果 300例患者中,44.33％的患者出现不良反应,主要为胃肠道反应,占比为31.67％,其次是肝功能损伤和QT间期延长,分别占16.67％和15.00％.133例发生不良反应的患者中,91例患者仅发生1种不良反应,占比为30.33％;30例患者出现2种不良反应,占比10.00％;7例患者出现3种不良反应,占比2.33％;5例患者出现4种及以上的不良反应,占比1.67％.两组患者间性别构成比、糖尿病、吸烟史、饮酒史比较,差异均无统计学意义(P＞0.05);发生组的年龄＞35岁患者占比为66.17％,高于未发生组(53.89％),差异有统计学意义(P＜0.05).发生组患者的治疗依从率为79.70％,低于未发生组(97.01％),差异有统计学意义(P＜0.05).发生组患者的治疗有效率为54.14％,低于未发生组(78.44％),差异有统计学意义(P＜0.05).结论 接受含贝达喹啉方案治疗的300例耐药结核病患者中,133例(44.33％)的患者出现不良反应.大部分患者出现1种不良反应,少数患者出现2种及以上不良反应,且高于35岁的患者更容易发生不良反应.通过改善患者的不良反应发生情况,加强管理和患者教育,可以显著提高治疗的依从性和成功率,从而改善耐药结核病患者的治疗预后.
Abstract
Objective To explore the role of adverse reaction monitoring in the outcome of treatment of drug resistant tuberculosis contai-ning Bedaquinoline.Methods A total of 300 patients with drug-resistant tuberculosis who received treatment in Shanghai Pulmonary Hospital from January 2019 to June 2023 were selected as the subjects of this study.All patients were treated with Bedaquinoline-containing regimen.Ad-verse reactions of patients during treatment were analyzed,and patients who experienced adverse reactions were included in the occurrence group,while patients who did not experience adverse reactions were included in the non occurrence group.The differences in clinical characteristics(gen-der,age,diabetes,smoking history,drinking history),treatment compliance,and treatment outcomes between the occurrence group and the non occurrence group were analyzed.Results Among the 300 patients,44.33％had adverse reactions,mainly gastrointestinal reactions,accounting for 31.67％,followed by liver function injury and QT interval extension,accounting for 16.67％and 15.00％,respectively.Among 133 patients who experienced adverse reactions,91 patients experienced one type of adverse reaction,accounting for 30.33％;30 patients experienced two types of adverse reactions,accounting for 10.00％;7 patients experienced three types of adverse reactions,accounting for 2.33％;5 patients ex-perienced four or more types of adverse reactions,accounting for 1.67％.There were no statistically significant differences in sex composition rati-o,diabetes,smoking history and drinking history between the two groups(P＞0.05);the proportion of patients over 35 years old in the occur-rence group was 66.17％,which was higher than that in the non occurrence group(53.89％),and the difference was statistically significant(P＜0.05).The treatment compliance rate of the occurrence group was 79.70％,which was lower than that of the non-occurrence group(97.01％),and the difference was statistically significant(P＜0.05).The treatment effective rate of the occurrence group was 54.14％,which was lower than that of the non-occurrence group(78.44％),and the difference was statistically significant(P＜0.05).Conclusion Of the 300 drug-re-sistant TB patients treated with the betaquinoline-containing regimen,133(44.33％)had adverse effects.Most patients with 1 kind of adverse reactions,a few patients with 2 and more adverse reactions,and higher than 35 patients are more likely to have adverse reactions,by improving the adverse reactions of patients,strengthen management and patient education,can significantly improve the treatment compliance and success rate,to improve the prognosis of drug-resistant TB patients.
基金项目
上海市卫生健康委员会科研课题(20194Y0169)
NETL
NSTL
万方数据