甲状旁腺切除术和西那卡塞治疗继发甲状旁腺功能亢进的成本效果评价
发布时间：2019-05-19 14:34
【摘要】：目的和意义:继发性甲状旁腺功能亢进(SHPT)严重影响慢性肾病患者预后及生存,本研究以SHPT患者为研究对象,评价甲状旁腺切除术(PTx)和药物西那卡塞(Cinacalcet)同时在临床应用一年的成本效果,分析其经济上的可行性和优劣,为临床决策提供个性化的科学建议。研究方法:(1)根据接受治疗的方式将患者分为PTx组和西那卡塞组,并在匹配时控制两组的基线资料和病情严重程度,使其具有可比性;(2)运用回顾性调查法提取患者随访数据库中符合研究条件的两组病例数据并整理其一般资料和临床数据;(3)运用问卷调查法进行横断面调查(现场询问、电话询问和网络调查),收集纳入研究样本的治疗成本、健康效用等资料;(4)运用T检验、卡方检验、秩和检验对两组患者数据的基本信息和治疗效果进行比较分析,获得疗效分析结果;(5)参考相关文献和临床资料建立符合SHPT疾病转归的决策树模型,运用回乘分析、增量分析进行两种方案的成本效果评价;(6)运用飓风图(Tornado diagrams)、蒙特卡洛(Monte Carlo)模拟等进行敏感度分析;(7)采用Excel2016、SPSS24.0和TreeAge2016软件进行数据录入和分析。结果:(1)基本情况:本次研究共纳入82例数据,两组各41例,除性别外其他基础资料均无统计学差异(P0.05);(2)疗效评价:两组分别在治疗后1年的血钙值(P= 0.002)、6个月的血磷值(P = 0.037)和治疗一年内的iPTH值(P0.05)有统计学差异,西那卡塞控制钙水平较稳定,PTx控制iPTH有明显优势且总体有效率(85.4%)高于西那卡塞(63.4%)且差异有统计学意义(P=0.04),Logistic回归显示西那卡塞治疗有效率的比值比(OR值)是PTx的0.297,认为PTx比西那卡塞更有效;(3)经济学评价:用PTx治疗SHPT一年的总成本(5.67万元)略高于西那卡塞(4.97万元),PTx的成本效果比(6.643万元)低于西那卡塞(7.841万元)。成本效果增量分析显示,与西那卡塞相比,使用PTx治疗SHPT患者每增加1%的治疗效果相应增加的成本为319.4元。决策树各路径分析显示PTx在发生并发症、血清钙磷指标可控状态的成本效果比(14.41万元)高于西那卡塞(8.33万元)。单因素和概率敏感度分析显示本次经济学研究结果具有稳定性,且随支付意愿的增加,PTx具有成本效果的概率增加,西那卡塞相反。故认为PTx比西那卡塞治疗更经济。结论:(1)PTx和西那卡塞对生化指标的控制均有一定效果,西那卡塞控制钙水平较稳定,PTx降iPTH快,且总体有效率有明显优势;(2)西那卡塞成本低于PTx,但因其为自费药且需长期服用,患者实际经济负担大;(3)综合各方面因素,成本效果分析显示PTx治疗一年比西那卡塞更具有成本效果优势,但在血清钙、磷正常且发生并发症的情况下,PTx的成本效果不如西那卡塞,提示接受PTx后应积极预防心血管和骨折事件的发生;(4)一维敏感度分析表明西那卡塞组无事件不可控路径的成本(CCNU)和PTx组无事件不可控路径的效果(EPNU)是影响成本效果评价稳定性的主要因素,但对结果影响不大;(5)蒙特卡洛概率敏感度模拟表明本研究的成本效果分析具有稳定性,研究结果可信;(6)但本研究在样本量和研究周期上仍有一定局限,希望有更高质量的研究数据支持以上结论。建议:本研究建议临床决策时,可参考本次经济学评价结果,根据不同患者的不同需求进行个性化选择,同时积极推广两种治疗方案在难治性SHPT治疗上的应用,做到早发现、早诊断、早治疗,提高患者生存质量。
[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.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R653;R692.5
[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.
【学位授予单位】：北京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R653;R692.5
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