上海市耐多药结核病综合防治模式实施前后主要评价指标的对照研究

Before-and-after study of a comprehensive multidrug-resistant tuberculosis control program in Shanghai, China

目的从患者督导管理、政府减免和转归等角度比较上海市耐多药结核病（multidrug-resistant tuberculosis，MDR-TB）综合防治项目实施前后患者情况，以全面评价项目效果，为推进MDR-TB防控提供依据。方法采用前后对比的研究设计，以项目纳入的248例患者（称为“项目实施后组”）及2009-2010年的87例对异烟肼、利福平耐药患者（称为“项目实施前组”）为对象开展研究。通过结核病专报系统、回顾性调查、患者减免报销记录等收集诊治督导管理、费用减免和转归等方面的数据，对其中分类变量以x^2检验比较，对连续变量以非参数方法比较。结果项目实施后组患者接受社区医师每月督导的比率增加12．0％（项目实施后组86．7％，215／248；项目实施前组74．7％，65／87；x^2=6．74，P=0．009）。无督导服药的比率降低14．5％（项目实施后组1．6％，4／248；项目实施前组16．1％，14／87；Fisher精确检验，P=0．000）。实施后患者被减免费用中位数增加4．4倍（项目实施后组1．19万元，项目实施前组0．27万元；Wilcoxon秩和检验，P=0．000）；患者自付费用比例中位数从59．7％降低至41．8％（Wileoxon秩和检验，P=0．022）；但诊疗总费用也增加2．1倍（项目实施后组中位数4．00万元，项目实施前组1．93万元；Wilcoxon秩和检验，P=0．000）。项目实施后患者治疗成功率为61．7％（153／248），诊断后1年内失败和死亡患者比率显著降低（项目实施后组2．4％，6／248；项目实施前组8．0％，7／87；x^2=5．47，P=0．019）。结论项目实施后切实提高了督导管理效果，医疗费用实现了较大幅度的减免，缓解了患者经济负担。因MDR-TB的诊疗总费用高，仍需提供更大力度和范围的减免措施。

Objective To evaluate the effect of a comprehensive multidrug-resistant tuberculosis （MDR-TB） control program in Shanghai by assessing patients＇ diagnosis, treatment management, government subsidies and treatment outcome, and to provide the basis for MDR-TB control improvement. Methods A beforehand-after study including 248 patients （post-program group） in the program since 2011, and 87 TB patients （we-program group） with drug resistance to both isoniazid and rifampicin from 2009 to 2010 was performed. Data on MDR-TB diagnosis, community follow-up, compliance, subsidies and treatment outcome were collected from TB Information Management System （TBIMS）, retrospective survey and records on subsidies. Differences of the two groups were compared using the x^2 test for categorical variables and non-parametric test for continuous variables. Results After the implementation of the program, the proportion of patients visited by community health worker monthly increased by 12.0% （86.7% （215/248） for the post-program group and 74.7% （65/87） for the pre-program group （%2 = 6.74, P= 0. 009））, the proportion of therapy without supervision decreased by 14.5 % （1.6% （4/248） for the post-program group and 16.1% （14/87） for the pre-program group （Fisher＇ s exact test, P= 0. 000））. Median government subsidies increased 4. 4 times （（11.9 thousand CNY for the post-program group and 2.7 thousand CNY /or the pre-program group （Wilcoxon two-sample test, P= 0. 000））, while median percentage of out-of-pocket expenditure decreased from 59.7% to 41.8% （Wilcoxon two-sample test, P=0. 022）, although the total expense of MDR-TB health care increased by 2.1 times （（40.0 thousand CNY for the post-program group and 19.3 thousand CNY for the pre-program group （Wilcoxon two-sample test, P= 0. 000））. The successful treatment rate after the program was 61.7% （153/248）. The proportion of treatment failure and death one year after diagnosis was significantly decreased （（2.4% （6/248） for the post-program group and 8.0% （7/87） for the pre-program group, （x^2 = 5.47, P= 0. 019））. Conclusion The comprehensive program improves the effect of supervision and management, and alleviates the patients＇ economic burden by decreasing the medical charge significantly. However, the government reimbursement should continue to be scaled-up, as the financial burden of MDR-TB is still heavy.