【作者】 吕承菲；

【导师】 孙强；

【作者基本信息】 山东大学 ， 社会医学与卫生事业管理， 2013， 硕士

【摘要】 研究背景耐多药结核病(Multi-drug resistant tuberculosis, MDR-TB)是由至少对两种有效抗结核药物——利福平和异烟肼同时耐药的结核分支杆菌感染引起的疾病。我国是世界上22个结核病高负担国家之一,同时也是27个耐药结核病高负担国家之一。我国耐多药肺结核控制工作长期存在着发现率低、诊断和治疗不及时,治疗不规范,治疗依从性差,患者治疗疾病经济负担重等问题。由于这些问题的存在,我国耐药结核病控制面临着巨大的挑战。中国疾控中心和盖茨基金会合作的结核病控制项目试图通过在试点地区实施一系列综合干预措施,探索建立一种与医保相结合的医院及疾控系统合作新模式,为完善我国耐多药结核病控制规划提供思路及经验。改善耐多药肺结核诊疗服务的措施在其中占有很重要的地位,其中包括对耐多药肺结核患者发现、治疗管理和疾病经济负担的干预。研究目的本研究将从耐多药肺结核患者的发现、治疗管理以及疾病经济负担三个方面对综合干预措施实施后的耐多药肺结核诊疗服务进行评价,为进一步完善耐多药结核病控制规划提供建议。研究方法本研究根据全国各省耐药肺结核基线调查数据、结核病控制工作水平和社会经济条件等,选择河南开封市、江苏连云港市、重庆永川区和内蒙古呼和浩特市作为项目地区,评价各项目地区综合干预措施实施一年期间的耐多药肺结核诊疗服务。收集每个项目地区地市级结防机构、定点医院和县级结防机构有关耐多药肺结核可疑者筛查、耐多药肺结核治疗的项目常规监测资料,分析耐多药肺结核患者发现情况及影响因素,评估项目市医院治疗耐多药肺结核患者的及时性、规范性和患者治疗的依从性。在每个项目地区选择定点医院为研究现场,调查纳入项目治疗满6个月的患者。通过结构化问卷收集患者治疗信息,分析患者在项目治疗的疾病经济负担,现场共调查耐多药肺结核患者73例。此外,本研究还访谈了项目地区地市级和县级结防机构项目工作人员,定点医院负责人、医生和实验室人员,管理患者的村医等关键人物,共访谈39人。常规监测资料、机构表等定量资料在Excel中整理储存,使用SPSS18.0对资料进行描述性统计分析和统计推断,使用的统计方法包括秩和检验、卡方检验、生存分析和广义线性模型等。访谈资料根据录音整理成Word格式,使用Nvivo7软件分析。研究结果1.耐多药肺结核患者发现项目总体筛查率达到83.93%,开封、连云港和重庆三地筛查率均在90%以上。快速诊断技术检出MDR-TB患者检出率为6.22%,呼和浩特快诊MDR-TB患者检出率仅为2.95%,明显低于其他三地。总体上,结防机构来源的涂阳肺结核患者发现时间间隔为7天,呼和浩特发现时间间隔为14天,明显长于其余三地。50.19%的患者发现时间间隔在7天之内,呼市这一比例只有11.33%。送痰、快速诊断和信息反馈时间间隔分别为2、5、0天,呼和浩特的信息反馈时间为5天,明显长于其他地区。2.耐多药肺结核患者治疗管理耐多药肺结核患者总体纳入率为70.78%。快诊结果为耐多药的肺结核的患者纳入率为76.16%,高于快诊结果为耐利福平的肺结核患者的纳入率62.50%。新患者的纳入率(55.22%)低于非新患者(76.70%)。家庭年收入在5000-10000元间的患者纳入率高于家庭年收入低于5000元和家庭年收入高于10000元的患者。172例纳入项目治疗的耐多药肺结核患者治疗延迟为5天,长于规定的时间。49.42%的患者治疗延迟在4天以内。卫生系统治疗延迟和患者治疗延迟分别为0天和7天。138例耐药肺结核患者坚持治疗率由1月末的0.934下降至6月末的0.787。快速诊断结果为单耐利福平的患者坚持治疗率低于耐多药肺结核患者；无保险的患者坚持治疗率低于有保险的患者。不良反应、死亡和经济困难是影响患者治疗依从性的主要因素。3.耐多药肺结核患者疾病经济负担干预后耐多药肺结核患者次均住院费用为3819.49元,日均住院费用为97.84元,分别为干预前的52.51%和44.23%；患者住院药品费用所占比例由59.93%下降到26.59%。干预后患者的登记分类、定点医院床位数和住院天数对患者住院费用影响有统计学意义。耐多药肺结核患者治疗全疗程的总费用为23430.82元,直接医疗费用为15166.68元,直接非医疗费用为6056.00元,间接费用为437.00元。患者治疗全疗程的直接医疗费用占患者2年家庭收入的比例为65.58%,有84.90%的患者家庭的非食品支出占家庭总支出的比例超过40%,给家庭带来了灾难性医疗支出。按照目前的补偿方案,补偿后患者全疗程的总费用为7659.14元,降低了67.31%。直接医疗费用为1560.08元,降低了89.71%：直接非医疗费用为4756.00元,仅降低了21.74%。如果没有随访和注射期的项目补偿,补偿后患者全疗程的总费用为10759.14元,降低了54.08%；直接医疗费用的中位数为3360.08元,降低了77.85%；直接非医疗费用无变化,仍为6056.00元。按照目前的补偿方案,补偿后总费用占两年家庭收入的37.58%,与补偿前相比下降了74%。虽然与补偿前相比,造成灾难性医疗支出的家庭比例降低了约18%,但仍有65.75%的家庭因为治疗耐多药肺结核而给家庭带来了灾难性医疗支出。但是如果没有随访和注射期的项目补偿,补偿后患者全疗程总费用占两年家庭收入的比例为64.41%,造成家庭灾难性支出的家庭比例为82.19%。结论与建议中盖结核病控制项目从耐多药肺结核患者发现、诊断、治疗、管理和筹资等方面进行了综合性干预,改善了耐药肺结核诊疗服务。但是在项目实施过程中还存在有的地区可疑者筛查率低、患者治疗依从性差、保险政策持续性差等问题。根据以上结论,本研究提出以下建议：1.推行项目实行的耐多药肺结核患者发现策略,在医院和结防机构合作的基础上使用快速诊断技术对涂阳肺结核患者进行筛查。2.采用标准化治疗方案与个体化治疗方案相结合的治疗方法,保证定点医院药品的供应和质量,降低不良反应的发生。加强对督导员的培训,及时发现和处理不良反应。3.进一步完善定点医院和结防机构之间的合作,特别要加强合作机构间的信息沟通,在耐多药肺结核患者的发现、诊断、治疗和管理的各个环节保证信息交流的畅通和及时。4.建立完善的可持续的耐多药肺结核防治经费筹资机制,在项目结束后要保证城乡三种医疗保险制度对耐多药肺结核治疗的补偿政策继续执行。对确实贫困的患者可以介入民政部门救助,保证患者不因经济原因无法接受治疗。更多还原

【Abstract】 Background Multidrug-resistant TB (MDR-TB) is caused by bacteria that are resistant to at least isoniazid and rifampicin, the most effective anti-TB drugs. China is one of the22high tuberculosis burden countries, as well as the member of the27high MDR-TB burden countries. China is facing great challenge on MDR-TB control because of low case finding, diagnosis and treatment delay, poor treatment adherence, high economical burden and other problems. Chinese national TB control center and Bill and Melinda Gates Foundation is piloting a comprehensive intervention in four cities to improve the effects of MDR-TB control. The main contents of the intervention include:using Genetest to fast the MDR-TB patient detection; strengthening the cooperation between designated hospital and TB control department to improve the treatment; using standard treatment protocol to improve the treatment results. The intervention for improving medical service is very important.ObjectiveThe study will evaluate the multi-drug resistant tuberculosis medical services after comprehensive intervention. There will be three parts:case finding, treatment and management and economic burden of disease. The study will also explore the influential factors. There will be some advice to improve the MDR-TB control. MethodsThe study selected Kaifeng of Henan province, Lianyungang of Shandong province, Yongchuan District of Chongqing City and Hohhot of Inner Mongolia as the project cites based on the MDR-TB baseline survey data, tuberculosis control levels and socio-economic conditions.The routine records for suspect MDR-TB patients screening and MDR-TB patients treatment and management was collected and cleared up in the one year running of the program. The case finding, treatment and management will evaluate based on these data. The basic information and hospitalization of MDR-TB patients who treated in standard package was collected using structure questionnaires. These data will be used to evaluate the economic burden of disease. Also, we interviewed the key figure of the TB control departments and the municipal spcialist hospitals, the country doctors who managed patients.Quantitative data, such as the routine monitoring data were managed in Excel, using SPSS18.0for descriptive statistics and statistical inference. The transcripts of interviews data will translate into Word format, using Nvivo7software to analysis.Results1. Case finding of multidrug-resistant tuberculosis patients The screening rate in the four sites was83.98%, the rate in Kaifeng, Lianyungang, Yongchuan District were all more than90.00%. The detection rate with rapid test was6.22%, but in Hohhot the rate was only of2.95%. MDR-TB patients who came from CDC were discovered in7days, time for sputum transport, rapid test and information fed-back is2,5and0; the discovery time for MDR-TB patients coming from hospital is6.2. Management of multidrug-resistant tuberculosis patients In generally,70.78%multi-drug resistant tuberculosis patients detected by fast diagnosis participated in our project. The MDR-TB patients had a higher participate rate(76.16%) than rifampicin resistant tuberculosis patients(62.50%). The patients who had annual family income between5000-10000yuan were more likely to participate in the project.The treatment delay for172MDR-TB patients was5days.49.42%of them started their treatment in4days. Health system delay and patients delay were0days and7days.The treatment adherence declined from0.934to0.787in six months. Most patients (14) dropped out the treatment in the first two months, the default number will increase gradually after short time drop when treatment goes to the fifth month.32.26%(10/31) of the patients who dropped out the project because of side effect; and19.35%(6/31) patients died in six months treatment;9.68%(3/31) of the patients dropped out due to the economic difficulty.3. The economic burden of diseaseThe hospitalization expense after using the standard sevice package were3819.49Yuan/time and97.84Yuan/day/time, account for52.51%and44.23%of the hospitalization expense before the intervention. The drug component declined from59.93%to26.59%, at the same time, the examinations component increased from8.44%to25.62%. The register type, hospital beds and hospital days were the influence factors.The total cost of the whole treatment course was23,430.82Yuan, while the direct medical costs was15,166.68Yuan, the direct non-medical expenses was6056.00Yuan, and the indirect cost of437.00Yuan. The total cost of the whole treatment course account for65.58%of2years household income.84.90%of MDR-TB patients had a catastrophic medical expenses due to treatment of tuberculosis. According to the compensation plan, the whole course of the total cost was7659.14Yuan after compensation, reduced by67.31%. The direct medical costs was1560.08Yuan, reduced by89.71%. If there were no project compensation in follow-up and injection period, the whole course of the total cost would be7659.14Yuan, reduced by54.08%; while the direct medical costs was3360.08Yuan, reduced by77.85%. According to the compensation plan,65.75%of MDR-TB patients had a catastrophic medical expenses due to treatment of tuberculosis, reduced by18%. If there were no project compensation in follow-up and injection period,82.19%of MDR-TB patients had a catastrophic medical expenses due to treatment of tuberculosis.Conclusion and suggestionsThe comprehensive intervention strengthened the medical service of MDT-TB, especially in case finding, treatment and economic burden. However, we also faced some other difficulties in the project, such as that the patients still did not get good treatment adherence.Following are some suggestions:1. The case finding strategy that screening all the smear positive TB patients with rapid test can be replicated elsewhere.2. Standardized treatment and individualized treatment plan could be used in combination. Ensure the quality of fixed-point drug supply and reduce the occurrence of adverse reactions. Strengthen the training of the supervisor to discover and deal with adverse reactions timely.3. Improve the cooperation between the designated hospitals and CDC. Smoothly and timely communication between the partners need to be guaranteed.4. The sustainable finance mechanism need to be established. When the project finished in the sites, the finance mechanism, compensate pattern should continue to perform.更多还原