Du Jian, Gao Weiwei, Ma Yan, Zhong Qiu, Liang Xuan, Fu Yanyong, Ji Binying, Xie Li, Huang Xuerui, Ge Qiping, Han Xiqin, Tian Xizhong, Shu Wei, Li Liang
Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China.
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Zhonghua Jie He He Hu Xi Za Zhi. 2015 Dec;38(12):886-91.
To analyze the therapeutic effects of the standard regimen and the optimized regimen in retreatment pulmonary tuberculosis complicated with diabetes mellitus (DM).
In a multi-center cohort study, patients with smear positive retreatment pulmonary tuberculosis (TB) with DM and those without DM [excluding multi-drug resistance (MDR), extensively drug-resistant (XDR) and non-tuberculosis Mycobacterium pulmonary disease(NTM)] were enrolled. There were a total of 178 cases, including 60 smear positive retreatment TB patients with DM and 118 without DM, who were randomly divided into 4 groups: Optimized group 1 [individualized treatment in 30 DM cases, 29 males, age (48 ± 11)], retreatment group 1 [standard retreatment regimen in 30 DM cases, 28 males, age(48 ± 10)], Optimized group 2[individual regimen in 57 non-DM cases, 37 males, age (41 ± 14)], and retreatment group 2 [standard retreatment regimen in 61 non-DM cases, 49 males, age (43 ± 13)]. Patients in the optimized group were treated with optimized individualized regimen based on DST result, with 3-4 sensitive drugs in the regimen, while those in the retreatment group were treated with national standard retreatment regimen. The therapeutic effect of different groups were recorded and the related factors of treatment outcome were analyzed with Chi-square test and multi-factor analysis.
The treatment success rates of the optimized group 1 and the retreatment group 1 were 83.3%(25/30) and 60.0%(18/30), respectively, and the difference was statistically significant (χ(2)=4.02, P=0.045<0.05). The treatment failure rate of the optimized group 1 (6.7%, 2/30) and the retreatment group 1(30.0%, 9/30) was statistically different (χ(2)=5.46, P=0.02<0.05). The outcome difference between the optimized group 2 and the retreatment group 2 showed no statistical significance. Multi-factor analysis showed that treatment regimen, DM, gender and drug resistance were the significant factors related with treatment outcome. The probability of treatment success using the individualized treatment regimen was 2.7 times higher than that using the standard regimen (P=0.025). The risk of treatment failure of the drug resistance cases was 2.8 times higher than that of the drug sensitive cases (P=0.038). The probability of treatment success in DM cases was 0.4 times that in non-DM cases (P<0.05).
The outcome of the optimized regimen group was better than that of the standard regimen group, and retreatment TB patients complicated with DM faced a higher risk of treatment failure, which should receive more attention.
分析标准方案与优化方案对复治肺结核合并糖尿病（DM）的治疗效果。
在一项多中心队列研究中，纳入涂片阳性的复治肺结核合并DM患者以及未合并DM的患者[排除耐多药（MDR）、广泛耐药（XDR）和非结核分枝杆菌肺病（NTM）]。共178例，其中涂片阳性的复治肺结核合并DM患者60例，未合并DM患者118例，随机分为4组：优化组1[30例DM患者个体化治疗，男性29例，年龄（48±11）岁]，复治组1[30例DM患者采用标准复治方案，男性28例，年龄（48±10）岁]，优化组2[57例非DM患者个体化方案，男性37例，年龄（41±14）岁]，复治组2[61例非DM患者采用标准复治方案，男性49例，年龄（43±13）岁]。优化组患者根据药物敏感性试验（DST）结果采用优化的个体化方案治疗，方案中有3 - 4种敏感药物，而复治组患者采用国家标准复治方案治疗。记录不同组的治疗效果，采用卡方检验和多因素分析对治疗转归的相关因素进行分析。
优化组1和复治组1的治疗成功率分别为83.3%（25/30）和60.0%（18/30），差异有统计学意义（χ(2)=4.02，P=0.045<0.05）。优化组1的治疗失败率（6.7%，2/30）与复治组1（30.0%，9/30）差异有统计学意义（χ(2)=5.46，P=0.02<0.05）。优化组2和复治组2的治疗转归差异无统计学意义。多因素分析显示，治疗方案、DM、性别和耐药性是与治疗转归相关的显著因素。采用个体化治疗方案的治疗成功概率比采用标准方案高2.7倍（P=0.025）。耐药病例的治疗失败风险比药物敏感病例高2.8倍（P=0.038）。DM患者的治疗成功概率是非DM患者的0.4倍（P<0.05）。
优化方案组的治疗效果优于标准方案组，复治肺结核合并DM患者面临更高的治疗失败风险，应予以更多关注。
