优化方案治疗复治药物敏感肺结核的疗效评价

目的 评价优化方案治疗复治药物敏感肺结核患者的临床疗效及安全性。方法 采取多中心、随机、开放、平行、对照的前瞻性队列研究,中心单位统一发放随机号随机分组,选取复治涂阳培阳或涂阴培阳肺结核患者共381例为研究对象,其中优化治疗方案组(简称“优化方案组”)244例和标准化治疗方案组(简称“标准方案组”)137例。采用SPSS 19.0软件进行数据统计,计数资料采用χ²检验,当理论频数<1时,采用Fisher确切概率法检验,以P<0.05为差异有统计学意义。比较两组方案治疗成功率及不良反应发生等情况。结果 疗程结束,优化方案组治愈175例,完成治疗30例,治疗成功率为84.0%(205/244);标准方案组治愈92例,完成治疗10例,治疗成功率为74.5%(102/137),两组比较差异有统计学意义(χ²=5.128,P=0.024)。优化方案组和标准方案组不良反应发生率分别为25.8%(63/244)和21.2%(29/137),两组比较差异无统计学意义(χ²=1.037,P=0.309);严重不良反应发生率分别为2.5%(6/244)和4.4%(6/137),两组差异无统计学意义(χ²=0.525,P=0.469)。结论 优化方案可提高复治药物敏感肺结核患者治疗成功率,且不增加药物不良反应的发生率。

Treatment effect analysis of the optimized regimen for re-treated drug-susceptible pulmonary tuberculosis patients

Objective To analyze the treatment efficacy and safety of optimized regimen for re-treated patients with drug-susceptibility pulmonary tuberculosis. Methods This was a multi-center, randomized, open, parallel, controlled prospective cohort study for retreated drug-susceptible pulmonary tuberculosis. All of 381 subjects with either positive smear and positive culture, or with negative smear but culture positive were enrolled in the study. Two hundred and forty-four cases were randomly enrolled in the optimized regimen group and 137 cases in the standard regimen. SPSS 19.0 software was used for data statistics, and chi square test was used for data analysis. When the theoretical frequency is less than 1, Fisher exact probability test was used. The difference is statistically significant (P<0.05). Treatment outcome and side effect during treatment were compared between the two groups. Results At the end of treatment, the success rate was 84.0% (205/244, 175 cases cured and 30 cases completed treatment) in the optimized regimen group and 74.5% (102/137, 92 cases cured and 10 cases completed treatment) in the standard treatment group. The treatment success rate of optimized regimen group was significantly higher than that of the standard regimen group (χ²=5.128, P=0.024). There was no significant difference between the two groups in the incidence of both side effects (25.8% (63/244) in optimized regimen group and 21.2% (29/137) in standard regimen group respectively; χ ²=1.037,P=0.309);and severe side effects (2.5% (6/244) vs. 4.4% (6/137); χ²=0.525, P=0.469). Conclusion The optimized regimen can increase treatment success patients with re-treated drug-susceptible pulmonary TB without increasing the side effects.