本文選題：涂陰肺結(jié)核　切入點(diǎn)：初治　出處：《北京協(xié)和醫(yī)學(xué)院》2017年碩士論文　論文類型：學(xué)位論文

【摘要】：目的通過(guò)觀察樣本地區(qū)標(biāo)準(zhǔn)抗結(jié)核藥物化療6個(gè)月與標(biāo)準(zhǔn)抗結(jié)核藥物聯(lián)合免疫制劑化療4個(gè)月兩種治療方案初治涂陰肺結(jié)核患者的臨床療效,基于兩種治療方案的臨床效果,探討樣本地區(qū)初治涂陰肺結(jié)核患者接受兩種治療方案的成本、成本-效果,為改進(jìn)初治涂陰肺結(jié)核化療方案療程提供科學(xué)的臨床決策依據(jù)。資料與方法1.資料來(lái)源:以樣本地區(qū)的初治涂陰肺結(jié)核患者為研究對(duì)象,采用多中心臨床隨機(jī)對(duì)照實(shí)驗(yàn)的研究設(shè)計(jì),將研究對(duì)象分為試驗(yàn)組和對(duì)照組,進(jìn)行為期6個(gè)月的干預(yù)實(shí)驗(yàn)。試驗(yàn)組化療周期為4個(gè)月(2個(gè)月強(qiáng)化期,2個(gè)月繼續(xù)期),對(duì)照組為6個(gè)月(2個(gè)月強(qiáng)化期,4個(gè)月繼續(xù)期)。其中試驗(yàn)組:2HRZEM15/2HRM15(H:異煙肼,R:利福平,Z:吡嗪酰胺、E:乙胺丁醇、M:免疫制劑微卡(母牛分枝桿菌)),母牛分支桿菌菌苗22.5ug/次,1次/2周、共6次、肌肉注射;對(duì)照組:2HRZE15/2HR15+2HR。按照研究方案對(duì)試驗(yàn)組和對(duì)照組進(jìn)行系統(tǒng)追蹤,利用統(tǒng)一問(wèn)卷調(diào)查研究對(duì)象的一般情況,觀察2組治療1月末、2月末、4月末、6月末的胸部X線病變吸收情況、治療費(fèi)用等方面數(shù)據(jù),通過(guò)建立相關(guān)數(shù)據(jù)庫(kù)進(jìn)行成本-效果分析。2.研究方法:采用統(tǒng)計(jì)分析和藥物經(jīng)濟(jì)評(píng)價(jià)分析方法,統(tǒng)計(jì)學(xué)方法主要涉及統(tǒng)計(jì)描述、t檢驗(yàn)、非劣效性檢驗(yàn)、χ2檢驗(yàn)、方差分析和logistic回歸分析,特別是成本-效果分析,主要指標(biāo)為成本-效果比和增量成本-效果比;利用SPSS20.0進(jìn)行數(shù)據(jù)分析。結(jié)果1.一般情況:試驗(yàn)組和對(duì)照組在年齡、性別、文化程度、婚姻狀況、職業(yè)類別上均不具有統(tǒng)計(jì)學(xué)差異,具有可比性;2.效果:斑片狀陰影、結(jié)節(jié)狀陰影及空洞影在1月末、2月末、4月末及6月末的變化上試驗(yàn)組與對(duì)照組不具有統(tǒng)計(jì)學(xué)差異;在斑片狀陰影/結(jié)節(jié)狀陰影/空洞影上的吸收有效上,試驗(yàn)組在1月末、2月末、4月末及6月末胸部X線病變吸收有效率分別為 17.3%、42.7%、60.8%、72.3%,對(duì)照組分別為 21.4%、35.3%、53.6%、66.0%,除1月末外,試驗(yàn)組在其他各月末的治療效果均不差于對(duì)照組;在斑片狀陰影/結(jié)節(jié)狀陰影/空洞影上的吸收顯效上,試驗(yàn)組在1月末、2月末、4月末及6月末胸部X線病變吸收顯效率分別為2.0%、4.5%、9.8%、28.3%,對(duì)照組分別為0.0%、2.2%、8.0%、22.9%,試驗(yàn)組各月末的治療效果與對(duì)照組的差異沒有統(tǒng)計(jì)學(xué)意義;3.成本比較:試驗(yàn)組的平均總成本為3554.6元,略高于對(duì)照組的3304.5元,且差異具有統(tǒng)計(jì)學(xué)意義;4.成本-效果分析:以胸部X線病變吸收有效率為效果指標(biāo):試驗(yàn)組比對(duì)照組具有成本效果,且值得采用,其中男性中對(duì)照組比試驗(yàn)組具成本效果,但女性中試驗(yàn)組比對(duì)照組更具成本效果;以胸部X線病變吸收顯效率為效果指標(biāo)時(shí),試驗(yàn)組比對(duì)照組具有成本效果,且值得采用,男性和女性中試驗(yàn)組均比對(duì)照組都具有成本效果。結(jié)論1.試驗(yàn)組與對(duì)照組療效相當(dāng)。以患者胸部X線病變吸收有效率作為效果指標(biāo)時(shí),試驗(yàn)組在2月末、4月末及6月的治療效果差異沒有統(tǒng)計(jì)學(xué)意義;而以患者胸部X線病變吸收顯效率作為效果指標(biāo)時(shí),試驗(yàn)組在1月末、2月末、4月末及6月末的治療效果差異沒有統(tǒng)計(jì)學(xué)意義。2.試驗(yàn)組成本高于對(duì)照組。試驗(yàn)組與對(duì)照組化療療程有所縮短,但免疫制劑母牛分枝桿菌菌苗的價(jià)格較為昂貴,導(dǎo)致試驗(yàn)組的總成本高于對(duì)照組。3.總體上試驗(yàn)組比對(duì)照組具成本效果,在女性樣本中比較突出。不論是以患者胸部X線病變吸收有效率還是顯效率作為效果指標(biāo),試驗(yàn)組均比對(duì)照組更有成本效果。而在分析不同性別下的成本-效果時(shí)發(fā)現(xiàn),以患者胸部X線病變吸收有效率為效果指標(biāo)時(shí),男性中對(duì)照組比試驗(yàn)組具有成本效果,以患者胸部X線病變吸收顯效率為效果指標(biāo)時(shí),男性中試驗(yàn)組比對(duì)照組具有成本效果;而在女性中,不論是以患者胸部X線病變吸收顯效率還是有效率作為效果指標(biāo),試驗(yàn)組均比對(duì)照組更具成本效果。
[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.

【學(xué)位授予單位】：北京協(xié)和醫(yī)學(xué)院
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R521

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