初治涂阴肺结核两种治疗方案的成本—效果研究

发布时间：2018-03-21 22:03

本文选题：涂阴肺结核　切入点：初治　出处：《北京协和医学院》2017年硕士论文　论文类型：学位论文

【摘要】：目的通过观察样本地区标准抗结核药物化疗6个月与标准抗结核药物联合免疫制剂化疗4个月两种治疗方案初治涂阴肺结核患者的临床疗效,基于两种治疗方案的临床效果,探讨样本地区初治涂阴肺结核患者接受两种治疗方案的成本、成本-效果,为改进初治涂阴肺结核化疗方案疗程提供科学的临床决策依据。资料与方法1.资料来源:以样本地区的初治涂阴肺结核患者为研究对象,采用多中心临床随机对照实验的研究设计,将研究对象分为试验组和对照组,进行为期6个月的干预实验。试验组化疗周期为4个月(2个月强化期,2个月继续期),对照组为6个月(2个月强化期,4个月继续期)。其中试验组:2HRZEM15/2HRM15(H:异烟肼,R:利福平,Z:吡嗪酰胺、E:乙胺丁醇、M:免疫制剂微卡(母牛分枝杆菌)),母牛分支杆菌菌苗22.5ug/次,1次/2周、共6次、肌肉注射;对照组:2HRZE15/2HR15+2HR。按照研究方案对试验组和对照组进行系统追踪,利用统一问卷调查研究对象的一般情况,观察2组治疗1月末、2月末、4月末、6月末的胸部X线病变吸收情况、治疗费用等方面数据,通过建立相关数据库进行成本-效果分析。2.研究方法:采用统计分析和药物经济评价分析方法,统计学方法主要涉及统计描述、t检验、非劣效性检验、χ2检验、方差分析和logistic回归分析,特别是成本-效果分析,主要指标为成本-效果比和增量成本-效果比;利用SPSS20.0进行数据分析。结果1.一般情况:试验组和对照组在年龄、性别、文化程度、婚姻状况、职业类别上均不具有统计学差异,具有可比性;2.效果:斑片状阴影、结节状阴影及空洞影在1月末、2月末、4月末及6月末的变化上试验组与对照组不具有统计学差异;在斑片状阴影/结节状阴影/空洞影上的吸收有效上,试验组在1月末、2月末、4月末及6月末胸部X线病变吸收有效率分别为 17.3%、42.7%、60.8%、72.3%,对照组分别为 21.4%、35.3%、53.6%、66.0%,除1月末外,试验组在其他各月末的治疗效果均不差于对照组;在斑片状阴影/结节状阴影/空洞影上的吸收显效上,试验组在1月末、2月末、4月末及6月末胸部X线病变吸收显效率分别为2.0%、4.5%、9.8%、28.3%,对照组分别为0.0%、2.2%、8.0%、22.9%,试验组各月末的治疗效果与对照组的差异没有统计学意义;3.成本比较:试验组的平均总成本为3554.6元,略高于对照组的3304.5元,且差异具有统计学意义;4.成本-效果分析:以胸部X线病变吸收有效率为效果指标:试验组比对照组具有成本效果,且值得采用,其中男性中对照组比试验组具成本效果,但女性中试验组比对照组更具成本效果;以胸部X线病变吸收显效率为效果指标时,试验组比对照组具有成本效果,且值得采用,男性和女性中试验组均比对照组都具有成本效果。结论1.试验组与对照组疗效相当。以患者胸部X线病变吸收有效率作为效果指标时,试验组在2月末、4月末及6月的治疗效果差异没有统计学意义;而以患者胸部X线病变吸收显效率作为效果指标时,试验组在1月末、2月末、4月末及6月末的治疗效果差异没有统计学意义。2.试验组成本高于对照组。试验组与对照组化疗疗程有所缩短,但免疫制剂母牛分枝杆菌菌苗的价格较为昂贵,导致试验组的总成本高于对照组。3.总体上试验组比对照组具成本效果,在女性样本中比较突出。不论是以患者胸部X线病变吸收有效率还是显效率作为效果指标,试验组均比对照组更有成本效果。而在分析不同性别下的成本-效果时发现,以患者胸部X线病变吸收有效率为效果指标时,男性中对照组比试验组具有成本效果,以患者胸部X线病变吸收显效率为效果指标时,男性中试验组比对照组具有成本效果;而在女性中,不论是以患者胸部X线病变吸收显效率还是有效率作为效果指标,试验组均比对照组更具成本效果。
[Abstract]:Objective: the clinical effect of antituberculosis drugs combined with immunotherapy chemotherapy 4 months two therapeutic schemes in the treatment of smear negative pulmonary tuberculosis patients by observing the sample standard anti tuberculosis drugs for 6 months with standard chemotherapy, the clinical effect of two therapeutic schemes based on the discussion of the sample area of initial smear negative TB patients received two treatments the cost, cost effectiveness, in order to improve the initial treatment of smear negative pulmonary tuberculosis chemotherapy treatment to provide clinical basis for decision-making science. Materials and methods 1. sources: the sample area of initial smear negative TB patients as the research object, the research adopts the design of multi center randomized controlled clinical trial, the subjects were divided into test group and control group. The intervention experiment lasted for 6 months. The experimental group chemotherapy cycle for 4 months (2 months of intensive period of 2 months, the control group continued period) was 6 months (2 months of intensive period of 4 months following the renewal). Test group: 2HRZEM15/2HRM15 (H: R: Li Fuping Z:, isoniazid, pyrazinamide and ethambutol E:, M: immune micro card (Mycobacterium vaccae)), 22.5ug/ time, 1 times /2 week, a total of 6 times, intramuscular injection; control group: 2HRZE15/2HR15+2HR. system to track the test group and the control group according to the research the general scheme, using the research object questionnaire survey, observation of treatment in the 2 groups at the end of 1, 2 at the end of 4 at the end of 6 at the end of the absorption of chest X-ray lesions, treatment costs and other aspects of the data,.2. by using the method of the establishment of the database for cost effectiveness analysis: using statistical analysis and economic evaluation of drug analysis method statistical methods, mainly involving descriptive statistics, t test, non inferiority, 2 test, analysis of variance and logistic regression, especially the cost-effectiveness analysis, the main indicators for the cost-effectiveness ratio and incremental cost. Fruit ratio; SPSS20.0 is used for data analysis. Results 1. general condition: the test group and the control group in age, gender, educational level, marital status, occupation category was not statistically significant, comparable effect; 2.: patchy shadows, nodular shadows and empty hole in the end of 1, at the end of 2. The change at the end of 4 and 6 at the end of the experiment group and the control group had no statistical difference; patchy shadow / nodular shadow / empty hole on the absorption of effective, in the experimental group at the end of 1, at the end of 2, at the end of 4 and 6 at the end of the chest X-ray lesions absorption effective rate respectively was 17.3%, 42.7%, 60.8%. 72.3%, the control group were 21.4%, 35.3%, 53.6%, 66%, in addition to 1 at the end, the experimental group in each other at the end of the treatment effect is not worse than the control group; the effective absorption in patchy shadow / nodular shadow / empty hole on the test group at the end of January, 2 at the end of 4, and at the end of the month at the end of 6 chest X-ray The absorption of pathological significant efficiency were 2%, 4.5%, 9.8%, 28.3%, the control group were 0%, 2.2%, 8%, 22.9%, the test group at the end of the treatment and control groups was not statistically significant difference; 3. cost comparison: the average total cost of test group is 3554.6 yuan to 3304.5 yuan, slightly higher than the control group, and the difference was statistically significant; cost effectiveness analysis of 4.: the chest X-ray absorption rate of lesions effective effect index: the experimental group has cost effectiveness than the control group, and worthy of the male control group, in the experimental group than the cost effect, but the experimental group than the control group of women is more cost-effective in the chest; the effective rate of X-ray absorption of pathological effect index, the test group has cost effectiveness than the control group, and is worth using, men and women in the test group than the control group has a cost effect. Conclusion the 1. experimental group had similar effect with control group. Patients in chest X-ray The absorption efficiency as an indicator of disease, in the experimental group at the end of 2, 4 at the end of June and the differences in treatment effect was not statistically significant; the chest X-ray lesions were the effective absorption rate as effect indicators, in the experimental group at the end of 1, 2 at the end of treatment at the end of 4 and 6 at the end of the difference was not statistically significant.2. the cost of test group was higher than the control group. The experimental group and the control group of chemotherapy has been shortened, but the immune preparation of Mycobacterium vaccae vaccine price is more expensive, resulting in the total cost of test group is higher than the control group.3. general test group than in the control group with the cost effect, in the female sample is more prominent. Whether on chest X-ray lesions the absorption efficiency and the effective rate as the performance index, the test group was higher than that of the control group. While the more cost found in the analysis of the effect of different gender cost, with chest X-ray lesions absorption The efficiency effect index, the male control group than the test group has cost effectiveness, the chest X-ray lesions were the effective absorption rate as effect indicators, test group of men has cost effectiveness than the control group; while in women, whether on chest X-ray lesions in patients with effective absorption rate or effective rate as the performance metrics, test than the control group were more cost-effective.

【学位授予单位】：北京协和医学院
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R521

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