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中国耐多药结核病防治体系现状、问题与对策研究
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摘要
耐多药结核病是指耐异烟肼和利福平两种以上抗结核药物的结核分支杆菌引起的结核病。其具有治疗时间长、治疗难度大、治疗费用高、治愈率低、死亡率高等特点,而且是重要的传染源,随着艾滋病感染者等不利因素的增加,对结核病的控制产生了很大的影响。中国耐多药结核病疫情非常严重,是全球27个耐药结核病高负担国家之一。世界卫生组织估计每年新发耐多药结核病病例约500,000起,其中印度131,000例,中国112,000例。耐多药结核病的防治已成为中国结核病防治工作的重大问题之
     针对耐药结核病带来的问题,全球范围内已开展一系列活动控制其发展。从1994年开始,WHO和国际防痨及肺部疾病联盟开始在全球开展耐药监测项目。1998年WHO提出针对耐多药结核病的DOTS-Plus策略,建议将耐多药结核病的控制纳入到国家结核病规划中。2008年出版了《耐药结核病规划管理指南:2008年紧急修订版》,提出了适用于耐药结核病管理的DOTS框架,其核心要素与非耐药结核病控制的DOTS框架基本相同。综述发现,耐多药结核病的诊断技术还需要进一步研究。对耐多药肺结核患者在药敏实验的基础上,实施标准化治疗是有效的治疗方案,但保证药物的可及性是关键。借鉴医防合作的经验,探索和建立针对耐多药肺结核患者的管理机制。研究目的
     本研究的目标是通过对耐多药结核病防治体系进行系统分析,为改善耐多药结核病防治效果,规范耐多药结核病诊疗管理措施提供依据。具体目的包括:分析耐多药结核病控制体系及筹资现状;明确耐多药结核病诊疗现状和影响因素;研究耐多药结核病管理现状及影响患者治疗效果主要因素;为建立规范化耐多药结核病防治体系提出科学的政策建议。研究方法
     研究资料来源于国家科技部重大专项课题“结核病发病模式研究”和卫生部-盖茨基金会“医院与疾控系统合作管理结核病模式研究”基线调查数据,包括患者面对面调查、机构调查、病案调查和关键人物访谈四部分。本研究采用目的抽样的方法,选择8个市(区)作为研究现场,分别是:天津市、黑龙江大庆市、浙江衢州市、重庆万州区、河南濮阳市、内蒙古呼和浩特市、河南开封市和江苏连云港市。共调查153名耐多药肺结核患者,其中实验室诊断耐多药肺结核患者87名,临床诊断耐多药肺结核患者66名。共调查140份耐多药肺结核患者的住院病案。在每个项目市都访谈了结核病防治相关工作的关键知情人,共访谈40人。课题组统一制定机构调查表,并在课题组到达现场前一周发给研究地区。
     本研究采用定量与定性相结合的分析方法。定量资料在录入计算机之前进行核对、检查,剔除不合格调查表。用EpiData3.1建立患者调查与病案调查数据库,将资料进行二次录入,全部数据导入SPSS13.0进行统计分析。定性访谈资料分析时先将其整理成文,然后导入Weft Qualitative Data Project软件,并对相关问题按主题分类后进行归纳分析。研究结果
     绝大部分耐多药肺结核患者能正确回答结核病的传播途径,但是对目前国家免费治疗政策的知晓率不高,且有近30%的耐多药肺结核患者不相信结核病能够治愈。耐多药肺结核患者心理健康状况较差,较发达地区、有借债的患者心理疾患危险性高。
     中央转移支付和结核病项目经费是支持地方开展结核病控制工作的主要经费来源。研究地区都表示结核病工作经费没问题,但缺乏相应的人员经费,即从事督导管理等工作时的激励费用。目前提供结核病诊治服务占医院业务收入的比例很少。目前城乡实施的三种医疗保险制度,都将结核病患者的住院费用纳入到补偿范围中,按照各地制定的报销方案进行报销,一般采用设定起付线和封顶线,分段报销的方法,报销比例平均在50%以上。耐多药肺结核患者自首次抗结核治疗至调查日止累计抗结核治疗时问中位数为537天,抗结核治疗总医疗费用的中位数为22500元。报销前,医疗费用占家庭非食品性支出的比例中位数为123.1%,即抗结核治疗的医疗费用是患者家庭非食品性支出的1.23倍。82.3%的患者医疗费用占家庭非食品性支出的比例超过了40%,即产生了灾难性医疗支出。70.1%的患者因治疗结核病向他人借钱,79.6%的患者表示负担较重。67.3%的患者在治疗过程中获得了医疗保险补偿,报销后医疗费用占家庭非食品性支出比例的中位数为64.1%,较补偿前的123.1%显著降低。报销后产生灾难性医疗支出的患者比例为53.7%,较补偿前的82.3%明显下降。8个市来看,大部分患者的医疗费用得到报销,但是报销费用占医疗费用的比例不高,自付费用仍然在70%以上。
     8个市的市级结核病防治人员数量从3人到71人不等。按照国家结核病防治规划指南的要求,只有万州区、呼和浩特市和开封市的人员数量达到国家要求,衢州市和连云港市结防人员数量严重不足。结防人员学历偏低,以从事结核病管理的人员为主,实验室人员比例较低。机构诊治能力分析,8个市专科医院和结防机构均配置了一定数量的结核病诊治设备,但均存在不同程度的缺失。4所医院可以通过药敏试验诊断耐多药结核病。通过访谈了解到,未开展药敏试验的主要原因是实验室硬件条件和设备不达标。市专科医院二线抗结核药品的配备状况不理想,大部分WHO建议配备的二线抗结核药品都没有配备,这必然会影响耐多药肺结核患者住院治疗方案的制定。耐多药肺结核患者就医过程分析,153名患者接受抗结核治疗的机构数不尽相同。有的患者求医过程比较简单,只在市结核病专科医院治疗;有的患者在多家医疗机构间反复多次治疗,整个求医过程较为复杂。大多数患者首次抗结核治疗机构为其他结核病防治机构,其次为综合医院和结核病专科医院。不同职业对耐多药肺结核患者选择首次治疗机构差异有统计学意义,非农民患者首次治疗机构是结核病专科医院等比较专业医疗机构。所调查耐多药肺结核患者从最早出现症状到初次就诊平均间隔36.39天;31.6%患者发生就诊延迟现象,平均延迟110.82天。大多数患者确诊医疗机构为结核病专科医院,其次为结核病防治机构和综合医院。不同文化程度对耐多药肺结核患者确诊单位差异有统计学意义,文化程度越高患者,确诊机构越是较专业医疗机构。耐多药肺结核患者从初次就诊到确诊平均间隔115.65天;33.3%患者发生确诊延迟现象,平均延迟343.83天。
     耐多药肺结核患者获得管理服务情况分析,首治期间14.7%的患者存在停药超过2周的现象。35.3%的耐多药肺结核患者首次抗结核治疗时在他人面视下服药,但大多数是在家庭成员面视下服药,医生面视下服药比例只有11.8%。首治期间35.3%的患者接受过电话或上门访视,大多数为结防人员的访视管理。以患者确诊为耐多药结核病为截点,将耐多药肺结核患者的治疗过程分为确诊前和确诊后两个阶段,结果显示,确诊前只有11.6%的患者曾在医务人员面视下服药,有42.9%的患者接受过医务人员的电话或上门访视。确诊后,仅有7.7%的患者在医生面视下服药,52.4%的患者接受过电话或上门访视。无论确诊前还是确诊后,8个市耐多药肺结核患者在治疗过程中面视下服药的比例很低,不足15%,并且在治疗过程中有近50%的患者没有接受过医务人员电话或上门访视。结论与政策建议
     结防机构在群众中的知晓和信任度不够,经费不足,设备简陋,部分地区防治人员能力低下,影响了耐多药结核病防治措施的贯彻实施。治疗耐多药结核病给绝大部分患者家庭造成了灾难性卫生支出。虽然医疗费用能够得到一定比例的报销,但报销后患者自付比例仍然在70%以上,仍有53%患者在报销后还存在灾难性医疗支出。专科医院的耐多药结核病诊断时间长,对耐多药结核病的治疗并不是按照世界卫生组织推荐的标准化治疗方案进行,只有少数的耐多药肺结核患者在专科医院住院期间规范用药。医疗机构和结防机构还没有真正建立起有效的信息交流机制,医院在患者出院后不能及时的将有关信息传递给结防机构,在耐多药肺结核患者管理上还没有真正实现“闭环管理”。耐多药肺结核患者心理健康状况差,罹患心理疾病的危险水平较高。
     针对以上结论,提出以下政策建议:1)加大地方结核病防治经费的投入,加强结防机构的人力资源建设和设备的配备,同时给予基层督导人员有效的激励和管理,提高其督导管理耐多药肺结核患者的积极性。2)进一步完善城乡3种医疗保险制度对结核病的补偿政策,在现有社会医疗保险的基础上,设计针对耐多药肺结核患者的特殊补偿措施。3)引入快速、有效的耐多药结核病诊断技术,缩短诊断时间,并辅以必要的实验室改造,提高专科医院耐多药结核病诊断能力。4)建立和推荐标准化的耐多药结核病诊疗规范,有针对性的深入开展耐多药结核病知识培训。5)进一步完善结核病控制的医防合作模式,加强专科医院与结防机构的合作。6)关注患者的心理健康,增强他们对治愈结核病的信心。
Multi-drug resistant tuberculosis (MDR-TB) has come to refer to cases in which the TB strain is resistant at least to isoniazid and rifampicin. With a long duration of treatment and high mortality rate, it's difficult and expensive to treat the disease, and the cure rates is low. Following the prevalence of AIDS and the increase of resistance to anti-tuberculosis drugs, it's a great influence for the control of TB. As one of the 27 high MDR-TB burden countries in the world, China's MDR-TB epidemic is very serious. According to WHO, emerging MDR-TB cases is 500,000, and 131,000 in India,112,000 in China every year. The prevention and treatment of MDR-TB has become the major problems in China.
     For the problems caused by MDR-TB, a series of global activities have been undertaken to control its development. Since 1994, WHO and the International Union against Tuberculosis and Lung Disease have begun to conduct drug surveillance project in the world. WHO proposed DOTS-Plus strategy for MDR-TB, and proposed MDR-TB into national TB control plans in 1998. WHO published "The drug-resistant TB planning and management guidelines:revision 2008 Emergency", and proposed for management of drug-resistant TB DOTS framework in 2008. The core elements of the framework were basically the same with control non-drug-resistant TB DOTS framework. By review, we found that MDR-TB diagnostic techniques are also needed further study. Based on the sensitivity test, the implementation of standardized treatment is an effective treatment program, but ensures availability of drugs is the key. Learn from the experience of PPM. explore and establish management for MDR-TB. AIMS
     The objective of this research is to analyze the current status of MDR-TB, in order to provide basic information for improving the treatment effectiveness and make rational recommendations for the establishment of new treatment and management model of MDR-TB. The following specific objectives are included:analyzing the current situation of MDR-TB control system and financing; identifying the factors influencing the current situation of diagnosis and treatment of MDR-TB; investigating the factors influencing the management of MDR-TB; proposing recommendations to establish standardized treatment and management model of MDR-TB. Methods
     Data was from the baseline survey data of the major special project "model of TB" of the Ministry of Science and the Ministry of Health-Gates Foundation "hospitals and disease control systems model of co-management of TB", and include household survey, organization investigation, medical record and interviews with key figures in the investigation. In this study, the purpose of sampling was adopted. The 8 cities or districts that Tianjin city, Daqing city of Heilongjiang province, Quzhou city of Zhejiang province, Wanzhou district of Chongqing city, Puyang city of Henan province. Hohhot city of Neimenggu province, Kaifeng city of Henan province and Lianyungang city of Jiangsu province. Finally, we investigated 153 MDR-TB patients in all, and 87 patients by laboratory diagnosis and 66 patients by clinical diagnosis of which.140 medical records of MDR-TB patients and 40 key figures were investigated in all. We developed the tables, and issued them a week before we arrived the city.
     Both quantitative and qualitative analysis methods were used in the study. Quantitative data was checked before input in computers, and excluded unqualified questionnaires. Investigation database of patients and medical record were established by software EpiData3.1 with second input data. The data was analysed by software SPSS 13.0 for statistical analysis. The qualitative interview data were written before analyses, and then were imported in the Weft Qualitative Data Project software, classified by subject and related issues after the inductive analysis. Results
     The vast majority of MDR-TB patients correctly answer the transmission of tuberculosis, but small knew the national free treatment policy. Nearly 30% of MDR-TB patients don't believe that MDR-TB can be cured. The MDR-TB patients are poor mental health. More developed regions, patients with debt are more likely suffer from mental disorders.
     The central transfer payments and TB project funds are major source to support the local TB control. The key figures said that the work funds were no problem, but lacked the staff resources. That is the incentive fees to engage doing supervision and management work. TB treatment services currently provide only a very small proportion of hospital revenue. In the current three medical insurance system types in the urban and rural, the hospital costs of TB patients are included into compensation range. Reimbursement is in accordance with established programs, Generally use the settings from the pay line and cap lines, sub-reimbursement method. The average reimbursement percentage is 50% or more. The median treatment time of MDR-TB patients is 537 days. The total medical cost of the MDR-TB patients is 22500 Yuan. Before reimbursement, medical expenses account for 123.1% of the annual non-food expenditure. That is the anti-TB treatment is 1.23 times of the patient's family non-food expenditure.82.3% of MDR-TB patients have catastrophic medical expenses due to treatment of tuberculosis.70.1% of patients for treatment of tuberculosis have borrowed money from others.79.6% of patients indicate that the burden is heavy.67.3% of patients obtain health insurance compensation during treatment. After reimbursement, medical expenses account for 64.1% of the annual non-food expenditure, significantly reduced than 123.1% before reimbursement. 53.7% of MDR-TB patients have catastrophic medical expenses, lower than 82.3% before reimbursement. Most patients are reimbursed for medical expenses in 8 cities. But the reimbursement proportion of medical expenses account for total cost is not high, and the patients'pay costs remain above 70%.
     The number of personnel is from 3 to 71 in the 8 Cities'municipal TB control project. According to the requirements of National TB control program guidelines, only the number of personnel of Wanzhou District, Hohhot City and Kaifeng City achieve the national requirements. The number of personnel of Quzhou City and Lianyungang City are serious short. Low TB staff qualifications, there are higher proportion of management personnel and lower proportion of laboratory personnel. Institution for treatment capability, the 8 hospitals and TB specialist agencies are equipped with a certain number of TB diagnosis and treatment equipment, but there are different degrees of loss.4 hospitals can diagnose MDR-TB with sensitivity test. Learned through interviews, the main reason not to carry out sensitivity test is that conditions and the laboratory equipment aren't qualified. The second-line anti-TB drugs are not an ideal situation in the hospitals, and most of the WHO recommended second-line anti-TB drugs aren't equipped. This will definitely affect the MDR-TB patients'treatment. The MDR-TB patients seeking medical treatment process analysis, 153 patients receive anti-TB treatment for several different agencies. Some patients seek treatment process is relatively simple and only have treatment of tuberculosis in the specialist hospitals. Some patients have repeated treatment in a number of medical institutions. Most of the patients have the first anti-tuberculosis treatment in other TB prevention and control organizations, followed by general hospitals and tuberculosis hospitals. Different occupations of MDR-TB patients take statistically significant difference to choose the first treatment agencies, and non-farmers patients choose more specialized medical institutions in the first treatment. The MDR-TB patients' interval of surveyed from the earliest onset of symptoms to first treatment is 36.39 days on average.31.6% of the patients have delay treatment, and the average delay interval is 110.82 days. Most patients were diagnosed in specialist tuberculosis hospitals, followed by tuberculosis control agencies and the general Hospitals. Degree of different cultures in patients diagnosed with professional medical units significantly, the higher the educational level of patients, diagnosed with the more professional medical units. The MDR-TB patients'average interval from the first visit to diagnosed is 115.65 days.33.3% of the patients are with diagnosed delay, the average interval is 343.83 days.
     In MDR-TB case management, there is 14.7% of patients with the phenomenon of drug withdrawal over 2 week during the first treatments.35.3% of the MDR-TB patients receive directly observed therapy in the first anti-TB treatment. But most are under family members'observation,11.8% patients take medicine under doctor's observation.35.3% patients have received telephone or home visits during the first treatment, and the majority are TB staff. Patients diagnosed with MDR-TB as cut-off point, the MDR-TB patients'treatment process are divided into two stages that are before diagnosis and after diagnosis. The results show that only 11.6% patients take medicine under doctor's observation.42.9% patients have received telephone or home visits. After diagnosis, only 7.7% patients take medicine under doctor's observation and 52.4% patients have received telephone or home visits. Confirmed either before or after diagnosis, the proportion that patients take medicine under observation is very low, less than 15%. And in the course of treatment, nearly 50% patients didn't receive medical staff telephone or home visits. Conclusions and policy implications
     The awareness and trust of TB institutions for farmers are insufficient, lack of funds, poorly equipped, low quality personnel in some areas. That affects the implementation of TB control measures.Most of the patients had a catastrophic medical expense due to treatment of tuberculosis. While medical expenses can be reimbursed a certain percentage, but the proportion of claims after reimbursed that the patient pays is still more than 70%.53% patients still had a catastrophic medical expense. Diagnoses of MDR-TB in hospitals are a long time. And the treatment of MDR-TB is not the standardized treatment program recommended by the WHO. Only a small number of the MDR-TB patients have standardized treatment in the specialist hospitals. The effective information exchange mechanism between medical institutions and CDC has not really set up. Information of the patients after discharge from hospital can not be timely relevant to CDC. The management of the patients do not truly realize the "closed-loop management." The MDR-TB patients have poor mental health, and their risk of suffering from mental disorders was high.
     To solve the above conclusions, we put forward the followed suggestions:1) Increase the local TB control input, improve human resource and equipment in CDC. provide the primary supervisors with effective incentive and management to improve them initiative to manage MDR-TB patients.2) Further improve the 3 medical insurance systems, design special compensation measures target MDR-TB patients. 3) Strengthen the capacity building of the specialist hospitals laboratories from the device inputs, technology and personnel training, and develop novel technologies for rapid detection of drug resistance gradually.4) Establish and recommend standardized MDR-TB diagnostic and treatment practices, and carry out MDR-TB training.5) Further improve the cooperation of anti-tuberculosis agencies, and strengthen the cooperation between the tuberculosis specialist hospitals and CDC.6) Concerned about the mental health of patients to increase their confidence in curing TB.
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