海南省耐多药肺结核患者治疗不良反应情况
|
摘要
目的分析耐多药肺结核患者在应用标准化方案治疗过程中不良反应发生情况,以及对治疗和转归的影响和处置对策。方法采用设计好的药物不良反应调查表,回顾性调查2014年3月至2016年12月海南省所有使用耐多药标准化治疗方案且已有治疗转归的80例耐多药肺结核患者病案,收集患者基本信息、不良反应发生情况、对治疗的影响及其治疗转归等信息。结果 80例患者不良反应发生率为31.3%(25/80),男性不良反应发生率为30.8%(20/65),女性不良反应发生率为33.3%(5/15),差异无统计学意义(P=1.000)。不良反应发生率居前3位分别为单纯尿酸升高(28.0%,7例)、胃肠道反应(20.0%,5例)、肝功能异常(16.0%,4例)、不良反应导致的更改方案患者占16.0%(4/25),发生不良反应的患者治疗成功率72.0%(18/25),未发生不良反应的患者治疗成功率50.9%(28/55),比较差异无统计学意义(P=0.077)。结论耐多药肺结核应用标准化治疗方案治疗过程中引起的不良反应,经过早期处置及调整方案,大部分患者能够继续治疗,对治疗转归未形成较明显影响。
Objective To analyze the incidence of adverse reactions and the effects on treatment and outcomes in patients with multidrug-resistant pulmonary tuberculosis treated with standardized regimens. Methods A well-designed adverse drug reaction questionnaire was used to retrospectively investigate the medical records of 80 patients with multidrugresistant tuberculosis who had been treated with multi-drug-resistant standardized treatment in Hainan Province from March2014 to December 2016. Basic information about patients, the occurrence of adverse reactions and their impact on treatment,treatment outcomes and other information were collected. Results The incidence of adverse reactions in 80 patients was31.3%(25/80), the incidence of adverse reactions in males was 30.8%(20/65), and the incidence of females was 33.3%(5/15).The difference was not statistically significant(P=1.000). The top three adverse reactions were simple uric acid increased(28.0%, 7 cases), gastrointestinal reactions(20.0%, 5 cases), abnormal liver function(16.0%, 4 cases), and adverse reactions caused by changes in protocol in patients accounted for 16.0%(4/25), the success cure rate of patients with adverse reactions was 72.0%(18/25), and the success cure rate of patients without adverse reactions was 50.9%(28/55). The difference was not statistically significant(P=0.077). Conclusion The adverse reactions caused by multi-drug resistant tuberculosis adopts standardized treatment, after early treatment and adjustment, most patients can continue treatment, which has no obvious effect on the treatment outcome.
Objective To analyze the incidence of adverse reactions and the effects on treatment and outcomes in patients with multidrug-resistant pulmonary tuberculosis treated with standardized regimens. Methods A well-designed adverse drug reaction questionnaire was used to retrospectively investigate the medical records of 80 patients with multidrugresistant tuberculosis who had been treated with multi-drug-resistant standardized treatment in Hainan Province from March2014 to December 2016. Basic information about patients, the occurrence of adverse reactions and their impact on treatment,treatment outcomes and other information were collected. Results The incidence of adverse reactions in 80 patients was31.3%(25/80), the incidence of adverse reactions in males was 30.8%(20/65), and the incidence of females was 33.3%(5/15).The difference was not statistically significant(P=1.000). The top three adverse reactions were simple uric acid increased(28.0%, 7 cases), gastrointestinal reactions(20.0%, 5 cases), abnormal liver function(16.0%, 4 cases), and adverse reactions caused by changes in protocol in patients accounted for 16.0%(4/25), the success cure rate of patients with adverse reactions was 72.0%(18/25), and the success cure rate of patients without adverse reactions was 50.9%(28/55). The difference was not statistically significant(P=0.077). Conclusion The adverse reactions caused by multi-drug resistant tuberculosis adopts standardized treatment, after early treatment and adjustment, most patients can continue treatment, which has no obvious effect on the treatment outcome.
引文
[1]王立伟,王子珍.耐多药肺结核病患者应用化疗方案的疗效分析[J].临床荟萃,2014,29(6):605-607.
[2]王宇.耐多药肺结核防治管理工作方案[M].北京:军事医学科学出版社,2012.
[3]孔雯,刘巧,陆伟,等.标准化耐多药肺结核化疗方案的不良反应及治疗转归情况分析[J].中华疾病控制杂志,2014,18(7):610-612.
[4]徐彩红,李仁忠,阮云洲,等.耐多药肺结核治疗不良反应发生情况分析[J].中华疾病控制杂志,2013,17(3):243-245.
[5]ORMEROD L P,HORSFIELD N.Frequency and type of reactions to antituberculosis drugs:Observations in routine treatment[J].Tubercle and Lung Disease,1996,77(1):37-42.
[6]PATEL A M,MCKEON J.Avoidance and management of adverse reactions to antituberculosis drugs[J].Drug Saf,1995,12(1):1-25.
[7]陈明亭,李仁忠,阮云洲.耐多药结核病防治标准化培训教程[M].北京:人民卫生出版社,2015.
[8]BAGHAEI P,TABARSI P,DORRIZ D,et al.Adverse effects of multidrug-resistant tuberculosis treatment with a standardized regimen:A report from Iran[J].Am J Ther,2011,18(2):e29-e34.
[9]SHIN S S,PASECHNIKOV A D,GELMANOVA I Y,et al.Adverse reactions among patients being treated for MDR-TB in Tomsk,Russia[J].Int J Tuberc Lung Dis,2007,11(12):1314-1320.
[10]FURIN J J,MITNICK C D,SHIN S S,et al.Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis[J].Int J Tuberc Lung Dis,2001,5(7):648-655.
[11]张广恩,符彩云,黄静静,等.海南省结核分枝杆菌耐药影响因素分析[J].公共卫生与预防医学,2017,28(1):18-22.
[12]冯地忠,何伏华,陈寿东.老年结核病患者临床特征分析[J].预防医学,2018,30(12):1255-1257.
[13]梁静,袁应鑫,魏萍.抗结核药物治疗耐多药肺结核患者的不良反应[J].热带医学杂志,2018,18(2):221-224.
[14]张广恩,符彩云,黄静静,等.海南省结核病耐药状况调查研究[J].中国热带医学,2016,16(12):1178-1182.
[15]黄静静,陈亚玲,熊昌富,等.海南省2015年结核病耐药监测结果分析[J].中国热带医学,2017,17(3):216-220.
[16]中华人民共和国卫生部.全国结核病耐药性基线调查报告(2007-2008年)[R].北京,人民卫生出版社,2010:2-3.2019-03-21
[2]王宇.耐多药肺结核防治管理工作方案[M].北京:军事医学科学出版社,2012.
[3]孔雯,刘巧,陆伟,等.标准化耐多药肺结核化疗方案的不良反应及治疗转归情况分析[J].中华疾病控制杂志,2014,18(7):610-612.
[4]徐彩红,李仁忠,阮云洲,等.耐多药肺结核治疗不良反应发生情况分析[J].中华疾病控制杂志,2013,17(3):243-245.
[5]ORMEROD L P,HORSFIELD N.Frequency and type of reactions to antituberculosis drugs:Observations in routine treatment[J].Tubercle and Lung Disease,1996,77(1):37-42.
[6]PATEL A M,MCKEON J.Avoidance and management of adverse reactions to antituberculosis drugs[J].Drug Saf,1995,12(1):1-25.
[7]陈明亭,李仁忠,阮云洲.耐多药结核病防治标准化培训教程[M].北京:人民卫生出版社,2015.
[8]BAGHAEI P,TABARSI P,DORRIZ D,et al.Adverse effects of multidrug-resistant tuberculosis treatment with a standardized regimen:A report from Iran[J].Am J Ther,2011,18(2):e29-e34.
[9]SHIN S S,PASECHNIKOV A D,GELMANOVA I Y,et al.Adverse reactions among patients being treated for MDR-TB in Tomsk,Russia[J].Int J Tuberc Lung Dis,2007,11(12):1314-1320.
[10]FURIN J J,MITNICK C D,SHIN S S,et al.Occurrence of serious adverse effects in patients receiving community-based therapy for multidrug-resistant tuberculosis[J].Int J Tuberc Lung Dis,2001,5(7):648-655.
[11]张广恩,符彩云,黄静静,等.海南省结核分枝杆菌耐药影响因素分析[J].公共卫生与预防医学,2017,28(1):18-22.
[12]冯地忠,何伏华,陈寿东.老年结核病患者临床特征分析[J].预防医学,2018,30(12):1255-1257.
[13]梁静,袁应鑫,魏萍.抗结核药物治疗耐多药肺结核患者的不良反应[J].热带医学杂志,2018,18(2):221-224.
[14]张广恩,符彩云,黄静静,等.海南省结核病耐药状况调查研究[J].中国热带医学,2016,16(12):1178-1182.
[15]黄静静,陈亚玲,熊昌富,等.海南省2015年结核病耐药监测结果分析[J].中国热带医学,2017,17(3):216-220.
[16]中华人民共和国卫生部.全国结核病耐药性基线调查报告(2007-2008年)[R].北京,人民卫生出版社,2010:2-3.2019-03-21