Objective To investigate the types,incidence rate and related factors of adverse drug reactions(ADRs)in pa-tients with concomitant multi-drug resistant pulmonary tuberculosis(MDR-TB)and diabetes mellitus(DM)and those with only MDR-TB in an attempt to improve the surveillance of patients with both MDR-TB and DM.Methods A total of 359 MDR-TB patients who were diagnosed in the first batch of the 5th round of China Global Fund project in Wuhan city from December 1, 2006 to June 30,2014 and enrolled in the whole supervision process were retrospectively analyzed.They fell into MDR-TB(DM+)group(n=74;20.6%,74/359)and MDR-TB(DM -)group(n=285;79.4%,285/359).The incidence and the occurrence time of ADRs were compared between the two groups.The patients with MDR-TB(DM +)group were divided into two sub-groups in terms of the occurrence of ADRs.The treatment success rate and the effects of age,body mass index,plasma albumin level before treatment,fasting blood glucose level,smoking,alcohol consumption and other diseases on ADRs were investiga-ted.Results ①The incidence of ADRs in MDR-TB(DM+)group(39 cases,52.7%)was not significantly different from that in MDR-TB(DM -)group(141 cases,49.5%)(c2=0.245,P>0.05). ② The incidence of hypothyroidism(c2=6.08,P<0.05), hypokalemia(c2=12.37,P<0.05)and QT interval prolongation(c2=4.32,P<0.05)was significantly higher in MDR-TB(DM+)group than in MDR-TB(DM -)group during the treatment. ③ The lower body mass index(F=6.289,P<0.05),the de-creased level of plasma albumin(F=9.743,P<0.05),concomitant chronic liver disease(c2=6.000,P<0.05)and other chronic diseases(c2= 4.125,P<0.05)were associated with ADRs in patients with both MDR-TB and DM.No associations of sex,age, mean fasting blood glucose level,smoking,alcohol consumption,duration of diabetes,initial treatment and retreatment,number of resistant drugs was found with ADRs. ④There were 17 cases(43.6%,17/39)cured in ADRs group and 25 cases(71.4%,25/35)cured in non-ADRs group,with significant difference found(c2=5.825,P<0.05).Conclusion The patients with concomi-tant MDR-TB and DM are more likely to develop hypothyroidism,hypokalemia,and QT interval prolongation during the treat-ment,and need periodic monitoring and adjustment of medication.Those with the worse nutritional status(lower BMI and plas-ma albumin level)and other concomitant diseases(such as chronic liver disease,etc.)are more likely to have ADRs.Those with ADRs tend to have lower success rate of cure,and they are more likely to suffer treatment failure,loss to follow-up,interruption of treatment and so on.%目的 通过对耐多药结核病(multi-drug resistant tuberculosis,MDR-TB)合并与不合并糖尿病(diabetes melli-tus,DM)的患者进行比较,探讨耐多药结核病合并糖尿病患者药物不良反应的种类、发生率及相关因素,为更有效地制定耐药结核病合并糖尿病患者的全程督导治疗模式提供帮助.方法 回顾性分析了2006年12月1日至2014年6月30日期间参与武汉市首批第五轮中国全球基金项目,被确诊为耐多药结核病并被纳入全程督导管理的359例患者,其中,病例组:耐多药结核病合并2型糖尿病组[MDR-TB(DM+)组]74例(20.6%);对照组:同期耐多药结核病不合并2型糖尿病组[MDR-TB(DM -)组]285例(79.4%).分析比较两组患者各种不良反应的发生率及发生时间.MDR-TB (DM+)组按有无不良反应分组,探讨2组间治疗成功率,以及年龄、体重指数、治疗前血浆白蛋白水平、空腹血糖水平、吸烟、饮酒、基础疾病等对不良反应的影响.结果 ① MDR-TB(DM+)组不良反应发生率(39/74,52.7%)与MDR-TB (DM -)组(141/285,49.5%)之间无明显差异(c2=0.245,P>0.05).②MDR-TB(DM+)组患者治疗期间甲状腺功能减退(c2=6.08,P<0.05)、低钾血症(c2=12.37,P<0.05)及QT间期延长(c2=4.32,P<0.05)发生率明显高于MDR-TB(DM+)组.③ MDR-TB(DM+)组按有无不良反应分组发现:体重指数低(F=6.289,P<0.05)、治疗前血浆白蛋白水平低(F=9.743,P<0.05)、合并慢性肝病(c2=6.000,P<0.05)及合并其他慢性疾病(c2=4.125,P<0.05)与出现不良反应相关;性别、年龄、空腹血糖平均值、吸烟、饮酒、糖尿病病程时间、初复治、耐药数目等与不良反应无明显相关.④MDR-TB(DM+)有不良反应组治愈17例(17/39,43.6%),无不良反应组治愈25例(25/35,71.4%),两组差异有统计学意义(c2=5.825,P<0.05).结论 耐多药结核病合并糖尿病患者治疗期间容易出现甲状腺功能减退、低钾血症、QT间期延长,需定期监测、调整药物治疗.治疗前患者营养状况越差(体重指数及血浆白蛋白低)或合并有其他并存病(如慢性肝病等),越容易出现不良反应.出现不良反应的患者治愈成功率低,容易出现治疗失败、失访、中断治疗等.
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