Risk factors on adverse drug reactions of anti-tuberculosis treatment among smear-positive pulmonary tuberculosis patients
MA Yan1, XIE Zhong-yao1, ZHANG Li-na2, DU Jian1, LIU Yu-hong1, LI Liang1
1.Beijing Tuberculosis & Thoracic Tumor Research Institute,Beijing Chest Hospital,Capital Medical University,Clinical Center on Tuberculosis,China CDC,Beijing 101149,China; 2.National Institute for Vital Disease Control and Prevention,Beijing 102206
Abstract：To analyze the incidence and risk factors of adverse drug reactions (ADRs) among smear-positive pulmonary tuberculosis (PTB) patients and provide reference for tuberculosis prevention and control strategy, 2 142 smear-positive pulmonary tuberculosis patients who were diagnosed and treated which from 8 provinces during 2008-2010 were involved in the study. We divided smear-positive PTB patients into ADR group and non-ADR group according to the appearance of adverse reactions. Chi-square test and multivariate logistic regression analysis were used to analyze related risk factors of ADRs.Results showed that 536 cases occurred ADRs among 2 142 smear-positive PTB patients, incidence rate was 25.0%. Univariate analysis showed that there were significant statistical difference between ADRs group and non-ADRs group in age (χ2=23.815, P<0.001) and smoking (χ2=12.040, P=0.024). Multivariate logistic regression analysis revealed ADRs was significantly related to 45-64 age group, 65 and above age group, current smoker, the OR (95% CI) were 1.524 (1.159-2.422), 1.756 (1.200-2.570) and 1.620 (1.194-2.198). In conclusion, the middle-aged and elderly, smoking were independent risk factors associated with ADRs. To monitor and intervene above risk population in the process of patients? diagnosis and treatment, it is important significance to find and reduce the incidence of adverse reactions.
马艳, 谢忠尧, 张丽娜, 杜建, 刘宇红, 李亮. 涂阳肺结核患者抗结核药物不良反应发生影响因素分析[J]. 中国人兽共患病学报, 2016, 32(12): 1070-1076.
MA Yan, XIE Zhong-yao, ZHANG Li-na, DU Jian, LIU Yu-hong, LI Liang. Risk factors on adverse drug reactions of anti-tuberculosis treatment among smear-positive pulmonary tuberculosis patients. Chinese Journal of Zoonoses, 2016, 32(12): 1070-1076.
[1] Ministry of Health of the People?s Republic of China. Monitoring Regulations and Report on Drug Adverse Reaction (Order No 81of the Ministry of Health)[M]. 2011,5.04.(in Chinese) 中华人民共和国卫生部.药物不良反应报告与监测管理办法[M].2011, 5.04. [2] Ministry of health of the People?s Republic of China, China Food and Drug Administration. Monitoring Regulations and Report on Drug Adverse Reaction[M]. Beijing: Social Sciences Academic Press, 2004:3-16. (in Chinese) 中华人民共和国卫生部,国家食品药品监督管理局.药品不良反应报告和监测管理办法[M].北京:社会科学文献出版社,2004:3-16. [3] Department of Disease Control, Ministry of Health, Department of Medical Administration, Ministry of Health, Chinese Center for Disease Control and Prevention. Guidline of implementing tuberculosis control programme China[G]. Beijing: Pecking Union Medical College Press, 2008: 89. (in Chinese) 卫生部疾病预防控制局,卫生部医政司,中国疾病与反控制中心.中国结核病防治规划实施工作指南[G].北京:中国协和医科大学出版社,2008. [4] Sun BH, Zhao AG. Prospective study of adverse drug reactions monitoring in patients treated with anti-tuberculosis drugs[J]. China Med Herald, 2012, 9(19): 155-156. (in Chinese) 孙碧慧,赵安贵.常用抗结核药物不良反应监测前瞻性研究[J].中国医药导报,2012,9(19):155-156. [5] Xia YY, Zhan SY. Systematic review of anti-tuberculosis drug induced adverse reactions in China[J]. Chin J Tuberc Respir Dis, 2007, 30(6): 419-423. (in Chinese) 夏愔愔,詹思延.国内抗结核药不良反应发生率的综合分析[J].中华结核和呼吸杂志,2007,30(6):419-423. [6] Lyu X, Tang S, Xia Y, et al. Adverse reactions due to directly observed treatment strategy therapy in Chinese tuberculosis patients: a prospective study[J]. PLoS One, 2013, 8(6): e65037. (in Chinese) [7] Liang L, Xu JL, Xiao HP, et al. Retrospective analysis on anti-TB Treatment adverse effects of tuberculosis pulmonary patients with first retreatment hospitalization[J]. Chin J Antituberculosis, 2008, 30(4): 379-380. (in Chinese) 梁莉,许家琏,肖和平,等.首次复治住院肺结核病人抗结核药物不良反应回顾分析[J]. 中国防痨杂志, 2008,30(4):379-380. [8] Carroll MW, Lee M, Cai Y, et al. Frequency of adverse reactions to first-and second-line anti-tuberculosis chemotherapy in a Korean cohort[J]. Int J Tuberc Lung Dis, 2012, 16(7): 961-966. [9] Luo D, Huang MY, Liu FY, et al. Research on characteristics and related factors of adverse reactions of anti—tuberculosis among Zhuang nationality patients with smear-positive pulmonary tuberculosis[J]. Chin J Infect Dis, 2012, 30(10): 613-617. (in Chinese) 罗丹,黄敏莹,刘飞鹰,等. 壮族人群痰涂片阳性肺结核患者抗结核药物治疗的不良反应及其影响因素[J]. 中华传染病杂志2012,30(10):613-617. [10] Yang DQ. Analysis on adverse reactions of anti-tuberculosis with every other day treatment among 221 pulmonary tuberculosis patients[J]. Chin J Tuberc Respir Dis, 2008, 31(10): 773-774. (in Chinese) 杨德勤,肺结核病隔日化疗药物不良反应221例临床分析[J].中华结核和呼吸杂志,2008,31(10):773-774. [11] Chen Y, Liu Y, Wang J, et al. Risk factors on adverse reactions of anti-tuberculosis among elder pulmonary tuberculosis patients[J]. Chin J Gerontol, 2015, 35(4): 2079-2081. (in Chinese) 陈羽,刘映,王静,等.抗结核病药物治疗老年肺结核的不良反应及影响因素[J].中国老年学杂志,2015,35(4):2079-2081. [12] Marra F, Marra CA, Bruchet N, et al. Adverse drug reactions associated with first-line anti-tuberculosis drug regimens[J]. Int J Tuberc Lung Dis, 2007, 11(8): 868-875. [13] Jin T. Investigation in adverse drug reactions of plate combination anti-tuberculosis drugs[J]. Clinical Focus, 2014, 29(6): 614-616. (in Chinese) 金韬.板式抗结核组合药物不良反应调查[J].临床荟萃,2014,29(6):614-616. [14] Xie J, Ding SH, Liu LF, et al. Comparison study on adverse drug reactions of the plate combination anti-tuberculosis drugs in anti-tuberculosis chemotherapy[J]. Pract Prevent Med, 2013, 20(11): 1288-1291. (in Chinese) 谢靖,丁守华,刘林飞,等.抗结核板式药物治疗肺结核不良反应对照研究[J].实用预防医学,2013,20(11):1288-1291. [15] Przybylski G, Dabrowska A, Trzcińska H. Alcoholism and other socio-demographic risk factors for adverse TB-drug reactions and unsuccessful tuberculosis treatment-data from ten years? observation at the Regional Centre of Pulmonology, Bydgoszcz, Poland[J]. Med Sci Monit, 2014, 20: 444-453. doi:10.12659/MSM.890012 [16] Damasceno GS, Guaraldo L, Engstrom EM, et al. Adverse reactions to antituberculosis drugs in Man-guinhos, RiodeJaneiro, Brazil[J]. Clinics(SaoPaulo), 2013, 68(3): 329-337. [17] Javadi MR, Shalviri G, Gholami K, et al. Adverse reactions of anti- tuberculosis drugs in hospitalized patients: incidence, severity and risk factors[J]. Pharmacoepidemiol Drug Saf, 2007, 16(10): 1104-1110. [18] Liao CD, Zhao XL, Zhang DK. Research on adverse drug reactions of the plate combination anti-tuberculosis drugs in anti-tuberculosis treatment[J]. Chin J Antituberculosis, 2008, 30(1): 67-68. (in Chinese) 缪昌东,赵小兰, 张德坤.板式抗结核组合药物不良反应调查[J].中国防痨杂志,2008,30(1):67-68. [19] Vieira DE,Gomes M. Adverse effects of tuberculosis treatment: experience at an outpatient clinic of a teaching hospital in the city of Säo Paulo, Brazil[J]. J Bras Pneumol, 2008, 34(12): 1049-1055. [20] Gholami K, Kamali E, Hajiabdolbagh M, et al. Evaluation of anti-tuberculosis induced adverse reactions in hospitalized patients[J]. Pharm Pract, 2006, 4(3): 134-138. [21] Chhetri AK,Saha A,Verma SC, et al. A study of adverse drug reactions caused by first line anti-tubercular drugs used in Directly Observed Treatment, Short course (DOTS) therapy in western Nepal, Pokhara[J]. J Pak Med Assoc,2008, 58(10): 531-536. [22] Xie L, Gao WW, Bu JL, et al. Analysis of the adverse drug reactions of anti-tuberculosis drugs in 702 cases[J]. Chin J Antituberculosis, 2008, 30(8): 275-276. (in Chinese) 谢莉,高微微,卜建玲,等. 702例抗结核药物所致不良反应分析[J].中国防痨杂志,2008,30(8):275-276. [23] Wang XL, Zhang LP, Wang YH. Analysis and prevention of adverse reaction of anti-tuberculosis drugs in elderly patients[J].China Med, 2008, 5(3): 223-224. (in Chinese) 王秀丽,张乐平,汪远红. 抗结核药物治疗老年肺结核患者的不良反应及防治方法[J].中国医药, 2008,5(3):223-224. [24] Maciel EL, Guidoni LM, Favero JL, et al. Adverse effects of the new tuberculosis treatment regimen recommended by the Brazilian National Ministry of Health[J]. J Bras Pneumol, 2010, 36(2): 232-238. [25] Chung-Delgado K, Revilla-Montag A, Guillen-Bravo S, et al. Factors associated with anti-tuberculosis medication adverse effects: a case-control study in Lima, Peru[J]. PLoS One, 2011, 6(11): e27610. doi:10.1371/journal.pone.0027610 [26] Xiong Z, Bai LQ, Wang XJ, et al. Study on the incidence and risk factors of adverse reactions of anti-tuberculosis drugs in 115 new smear positive pulmonary tuberculosis patients[J]. Pract Prevent Med, 2015, 22(5): 537-540. (in Chinese) 雄姿,白丽琼,王孝君,等. 115例初治涂阳肺结核患者抗结核药物不良反应发生率和影响因素研究[J].实用预防医学, 2015,22(5):537-540. [27] Tost JR, Vidal R, Cayla J, et a1. Severe hepatotoxicity due to anti-tuberculosis drugs in Spain[J]. Int J Tuberc Lung Dis, 2005, 9(5): 534-540.
2016, Vol. 32 
