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甲狀旁腺切除術(shù)和西那卡塞治療繼發(fā)甲狀旁腺功能亢進(jìn)的成本效果評價

發(fā)布時間:2019-05-19 14:34
【摘要】:目的和意義:繼發(fā)性甲狀旁腺功能亢進(jìn)(SHPT)嚴(yán)重影響慢性腎病患者預(yù)后及生存,本研究以SHPT患者為研究對象,評價甲狀旁腺切除術(shù)(PTx)和藥物西那卡塞(Cinacalcet)同時在臨床應(yīng)用一年的成本效果,分析其經(jīng)濟(jì)上的可行性和優(yōu)劣,為臨床決策提供個性化的科學(xué)建議。研究方法:(1)根據(jù)接受治療的方式將患者分為PTx組和西那卡塞組,并在匹配時控制兩組的基線資料和病情嚴(yán)重程度,使其具有可比性;(2)運(yùn)用回顧性調(diào)查法提取患者隨訪數(shù)據(jù)庫中符合研究條件的兩組病例數(shù)據(jù)并整理其一般資料和臨床數(shù)據(jù);(3)運(yùn)用問卷調(diào)查法進(jìn)行橫斷面調(diào)查(現(xiàn)場詢問、電話詢問和網(wǎng)絡(luò)調(diào)查),收集納入研究樣本的治療成本、健康效用等資料;(4)運(yùn)用T檢驗、卡方檢驗、秩和檢驗對兩組患者數(shù)據(jù)的基本信息和治療效果進(jìn)行比較分析,獲得療效分析結(jié)果;(5)參考相關(guān)文獻(xiàn)和臨床資料建立符合SHPT疾病轉(zhuǎn)歸的決策樹模型,運(yùn)用回乘分析、增量分析進(jìn)行兩種方案的成本效果評價;(6)運(yùn)用颶風(fēng)圖(Tornado diagrams)、蒙特卡洛(Monte Carlo)模擬等進(jìn)行敏感度分析;(7)采用Excel2016、SPSS24.0和TreeAge2016軟件進(jìn)行數(shù)據(jù)錄入和分析。結(jié)果:(1)基本情況:本次研究共納入82例數(shù)據(jù),兩組各41例,除性別外其他基礎(chǔ)資料均無統(tǒng)計學(xué)差異(P0.05);(2)療效評價:兩組分別在治療后1年的血鈣值(P= 0.002)、6個月的血磷值(P = 0.037)和治療一年內(nèi)的iPTH值(P0.05)有統(tǒng)計學(xué)差異,西那卡塞控制鈣水平較穩(wěn)定,PTx控制iPTH有明顯優(yōu)勢且總體有效率(85.4%)高于西那卡塞(63.4%)且差異有統(tǒng)計學(xué)意義(P=0.04),Logistic回歸顯示西那卡塞治療有效率的比值比(OR值)是PTx的0.297,認(rèn)為PTx比西那卡塞更有效;(3)經(jīng)濟(jì)學(xué)評價:用PTx治療SHPT一年的總成本(5.67萬元)略高于西那卡塞(4.97萬元),PTx的成本效果比(6.643萬元)低于西那卡塞(7.841萬元)。成本效果增量分析顯示,與西那卡塞相比,使用PTx治療SHPT患者每增加1%的治療效果相應(yīng)增加的成本為319.4元。決策樹各路徑分析顯示PTx在發(fā)生并發(fā)癥、血清鈣磷指標(biāo)可控狀態(tài)的成本效果比(14.41萬元)高于西那卡塞(8.33萬元)。單因素和概率敏感度分析顯示本次經(jīng)濟(jì)學(xué)研究結(jié)果具有穩(wěn)定性,且隨支付意愿的增加,PTx具有成本效果的概率增加,西那卡塞相反。故認(rèn)為PTx比西那卡塞治療更經(jīng)濟(jì)。結(jié)論:(1)PTx和西那卡塞對生化指標(biāo)的控制均有一定效果,西那卡塞控制鈣水平較穩(wěn)定,PTx降iPTH快,且總體有效率有明顯優(yōu)勢;(2)西那卡塞成本低于PTx,但因其為自費(fèi)藥且需長期服用,患者實際經(jīng)濟(jì)負(fù)擔(dān)大;(3)綜合各方面因素,成本效果分析顯示PTx治療一年比西那卡塞更具有成本效果優(yōu)勢,但在血清鈣、磷正常且發(fā)生并發(fā)癥的情況下,PTx的成本效果不如西那卡塞,提示接受PTx后應(yīng)積極預(yù)防心血管和骨折事件的發(fā)生;(4)一維敏感度分析表明西那卡塞組無事件不可控路徑的成本(CCNU)和PTx組無事件不可控路徑的效果(EPNU)是影響成本效果評價穩(wěn)定性的主要因素,但對結(jié)果影響不大;(5)蒙特卡洛概率敏感度模擬表明本研究的成本效果分析具有穩(wěn)定性,研究結(jié)果可信;(6)但本研究在樣本量和研究周期上仍有一定局限,希望有更高質(zhì)量的研究數(shù)據(jù)支持以上結(jié)論。建議:本研究建議臨床決策時,可參考本次經(jīng)濟(jì)學(xué)評價結(jié)果,根據(jù)不同患者的不同需求進(jìn)行個性化選擇,同時積極推廣兩種治療方案在難治性SHPT治療上的應(yīng)用,做到早發(fā)現(xiàn)、早診斷、早治療,提高患者生存質(zhì)量。
[Abstract]:Purpose and significance: The secondary hyperparathyroidism (SHPT) has a serious effect on the prognosis and survival of patients with chronic kidney disease. The feasibility and advantage of its economy are analyzed, and the individual scientific advice is provided for clinical decision-making. Methods: (1) The patients were divided into the PTx group and the Celecoxib group according to the method of treatment, and the baseline data and the severity of the condition were controlled at the time of the match, so that they were comparable. (2) The retrospective investigation was used to extract the two groups of case data which met the study conditions in the follow-up database of the patients and to sort out the general data and clinical data; (3) the cross-sectional investigation (on-site inquiry, telephone inquiry and network investigation) was carried out by using the questionnaire method. The treatment cost, health utility and other data included in the study sample were collected; (4) The basic information and the treatment effect of the two groups of patient data were compared and analyzed by using the T-test, the chi-square test, the rank and the test, and the result of the curative effect analysis was obtained. (5) The decision tree model in accordance with the outcome of SHPT disease is established with reference to the relevant literature and clinical data, and the cost effect evaluation of the two schemes is carried out by using the regression analysis and the incremental analysis; and (6) the sensitivity analysis is carried out by using the Tornado diagms, the Monte Carlo simulation, and the like; (7) Data entry and analysis were performed using Excel2016, SPSS24.0 and TreeAge2016 software. Results: (1) Basic information: There were no statistical difference between the two groups (P0.05). The values of blood calcium (P = 0.002),6-month blood-phosphorus (P = 0.037) and iPTH (P0.05) were statistically different in the two groups after the treatment. The Ptx control iPTH had a significant advantage and the overall response rate (85.4%) was higher than that of the Cincinnati (63.4%) and the difference was statistically significant (P = 0.04). Logistic regression showed that the odds ratio (OR value) for the treatment of the sianacusser was 0.297 for PTx and that PTx was more effective than that of the Cincinnati; (3) Economic evaluation: The total cost of PTx in the treatment of SHPT for one year (RMB 5.67 million) was slightly higher than that of the West ($4.97 million), and the cost-effect ratio of PTx ($6.43 million) was lower than that of the West ($7.41 million). The incremental analysis of the cost effect showed that the corresponding increase in the treatment effect for each increase of 1% of the SHPT treated with PTx was 319.4 yuan as compared to that of the Xanacus. The results showed that the cost-effect ratio of PTx in the controllable state of serum calcium and phosphorus index (14.41 million yuan) was higher than that of Cincinnati (RMB 8.33 million). The single-factor and probability-sensitivity analysis shows that the results of this economic study are stable and, with the increase of the willingness to pay, PTx has a cost-effective increase in probability, which is the opposite of the Cincinnati. Therefore, PTx is considered to be more economical than Cincinnati. Conclusion: (1) There is a certain effect on the control of biochemical indexes of PTx and Cincinnati, and the control of calcium level is more stable, and the effect of PTx lowering iPTH is fast, and the overall effective rate has obvious advantages. (2) The cost of the cilanavir is lower than that of PTx, but it is the medicine at his own expense and needs to be taken for a long time. The actual economic burden of the patient is large; (3) the comprehensive factors and the cost effect analysis show that the PTx is more cost-effective than that of the sianacusser for one year, but in the case of normal serum calcium and phosphorus and the occurrence of complications, the cost effect of the PTx is not as good as that of the sianacus, It is suggested that the occurrence of cardiovascular and fracture events should be actively prevented after PTx is accepted. (4) One-dimensional sensitivity analysis indicates that the cost of the non-event-controllable path (CCNU) and the effect of the non-event-controlled path of the PTx group (EPNU) are the main factors that affect the evaluation stability of the cost effect. (5) Monte-Carlo probability sensitivity simulation shows that the cost effect analysis of this study has the stability and the research result is credible; (6) The present study still has some limitations in the sample size and the study period, It is hoped that higher quality research data will support the conclusions above. It is suggested that when clinical decision-making is recommended, the results of this economic evaluation can be referenced, and the individual selection can be made according to the different needs of different patients, and the application of the two treatment schemes in the treatment of the refractory SHPT is actively promoted, and the early detection, the early diagnosis and the early treatment are achieved. And the survival quality of the patients is improved.
【學(xué)位授予單位】:北京中醫(yī)藥大學(xué)
【學(xué)位級別】:碩士
【學(xué)位授予年份】:2017
【分類號】:R653;R692.5

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