摘要目的 评价我国优化方案和规范化方案对复治肺结核合并糖尿病的疗效.方法 本研究为多中心研究,选择国内20家医院菌阳复治肺结核合并糖尿病和无糖尿病的肺结核患者共178例,排除耐多药(MDR)、广泛耐药(XDR)肺结核和非结核分枝杆菌(NTM)肺病,其中60例合并糖尿病,118例为非糖尿病患者.采用随机数字法将患者随机分为4组:(1)糖尿病优化治疗方案组(优化l组)30例,男21例,女9例,年龄21～65岁,平均(48±11)岁;(2)糖尿病复治规范化方案组(复治l组)30例,男28例,女2例,年龄19 ～64岁,平均(48±10)岁;(3)非糖尿病优化治疗方案组(优化2组)57例,男37例,女20例,年龄19 ～75岁,平均(41±14)岁;(4)非糖尿病复治规范化方案组(复治2组)61例,男49例,女12例,年龄18 ～ 70岁,平均(43±13)岁.复治组采用国家规范化复治方案2(HREZS/6HRE,H:异烟肼,R:利福平,E:乙胺丁醇,Z:吡嗪酰胺,S:链霉素),优化组采用优化方案,即在国家规范化复治方案2HREZS/6HRE基础上,根据药敏试验结果替换耐药药物,保证同时有3～4种敏感药物.采用卡方检验比较不同组的疗效,并进行logistic多因素分析,探讨影响疗效的因素.结果 优化1组和复治1组的治疗成功率分别为83.0％(25/30)和60.0％(18/30),差异有统计学意义(x2 =4.02,P＜0.05).优化l组的失败率(2/30,6.7％)低于复治1组(9/30,30.0％),差异有统计学意义(x2 =5.46,P＜0.05).优化2组和复治2组的治疗成功率分别是为80.7％(46/57)和78.7％(48/61),差异无统计学意义(x2=0.07,P=0.79).多因素分析结果显示,治疗方案、是否有糖尿病、性别和耐药情况是影响疗效的因素,其中优化治疗方案成功率是规范化方案的2.7倍(P =0.025).耐药者的失败危险是敏感者的2.8倍(P =0.038).糖尿病患者治疗成功率是非糖尿病患者的0.4倍(P＜0.05).结论 优化治疗方案的疗效高于规范化复治方案,糖尿病是影响疗效的重要因素之一,糖尿病合并复治肺结核规范化复治方案的疗效低且失败率高.

abstractsObjective To analyze the therapeutic effects of the standard regimen and the optimized regimen in retreatment pulmonary tuberculosis complicated with diabetes mellitus (DM).Methods 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 nontuberculosis 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.Results The treatment success rates of the optimized group 1 and the retreatment group Ⅰ were 83.3％ (25/30) and 60.0％ (18/30), respectively,and the difference was statistically significant (x2 =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 (x2 =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).Conclusion 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.