国产与进口脊柱内固定器械在腰椎椎间融合术治疗腰椎退行性疾病中的成本-效用分析

Cost-utility analysis of domestic and imported instruments of internal fixation of spine in treating lumbar degenerative diseases by lumbar spine fusion

目的:比较国产与进口两种脊柱内固定器械在采用腰椎椎间融合术治疗腰椎退行性疾病的成本-效用,为临床实践和卫生管理决策提供证据参考。方法:采用前瞻性队列研究选取在医院治疗的79例腰椎退行性疾病患者,按融合手术时使用的固定器械不同,将使用国产固定器械的患者纳入观察组(41例);将使用进口固定器械的患者纳入对照组(38例)。比较两组患者疼痛程度、功能障碍指数和生命质量的改善情况,并进行成本-效用分析。结果:两种脊柱内固定器械在患者疼痛程度、功能障碍指数和生命质量的改善方面差异无统计学意义,但观察组的例均器械费用为(24156.97±10298.33)元,总例均费用为(86928.54±22498.63)元。均低于对照组的例均器械费用(41259.20±11085.65)元和总例均费用(104882.10±20029.82)元,差异有统计学意义(Z=-4.592,Z=-4.062;P<0.05)。观察组手术完成后3个月和6个月的成本效用比分别为817766.13元/质量调整寿命年(QALY)和306302.11元/QALY,均低于对照组的921635.33元/QALY和366366.36元/QALY,且观察组和对照组增量成本-效用比(ICUR)分别为2393808.00元/QALY和7181424.00元/QALY,远高于2019年3倍人均GDP阈值(212676元/QALY)。结论:国产脊柱内固定器械在腰椎椎间融合术治疗腰椎退行性疾病中具有明显的成本效用优势。使用国产脊柱内固定器械有助于减轻患者疾病负担,实现价值医疗。

Objective:To compare the cost-utility of domestic and imported instruments of internal fixation of spine in treating lumbar degenerative diseases by lumbar spine fusion so as to provide reference evidence for clinical practice and health management decisions.Methods:A prospective cohort study was conducted to select 79 patients with lumbar degenerative diseases who admitted to hospital.According to the different fixed instruments used in fusion surgery,patients using domestic fixed instruments were divided into the observation group(41 cases),and patients using imported fixed instruments were divided into the control group(38 cases).And the pain degree,dysfunction index,and improvement in quality of life(QOL)between the two groups were compared.And then,a cost-utility analysis was performed.Results:There were no statistically significant differences between the two kinds of instruments of internal fixation of spine in terms of pain degree,dysfunction index and improvement of QOL.But both per capita instrument cost and total per capita cost of observation group[(24156.97±10298.33)CNY,(86928.54±22498.63)CNY]were significantly lower than those of control group[(41259.20±11085.65)CNY,(104882.1020029.82)CNY](Z=-4.592,Z=-4.062,P<0.05).And the cost-utility ratios of observation group of 3 months and 6 months after the surgeries were completed were respectively 817766.13 CNY/quality adjusted life years(QALY)and 306302.11 CNY/QALY,which were lower than those of control group(921635.33 CNY/QALY and 366366.36 CNY/QALY).And the incremental cost utility ratios(ICUR)of observation group and control group were respectively 2393808.00 CNY/QALY and 7,181,424.00 CNY/QALY,which were much stronger higher than 3 times of threshold value of per capita GDP in 2019.Conclusion:Domestic instrument of internal fixation of spine has obvious cost-utility advantages in treating lumbar degenerative diseases by lumbar spine fusion.The use of domestic instrument of internal fixation of spine is helpful to relieve the burden of disease of patients and realize value-based healthcare.