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中华脑科疾病与康复杂志(电子版) ›› 2023, Vol. 13 ›› Issue (04) : 205 -214. doi: 10.3877/cma.j.issn.2095-123X.2023.04.003

临床研究

机器人辅助立体定向血肿引流术治疗自发性脑出血疗效及卫生经济学评价
谭可(), 李锦平, 彭玉涛, 吴文汧, 杨子文, 汪阳, 陶立波, 刘畅   
  1. 100020 北京,首都医科大学附属北京朝阳医院神经外科
    100083 北京,北京大学医学部卫生政策与技术评估中心
  • 收稿日期:2023-05-09 出版日期:2023-08-15
  • 通信作者: 谭可

Efficacy and health economic evaluation of robot-assisted stereotactic hematoma drainage for spontaneous intracerebral hemorrhage

Ke Tan(), Jinping Li, Yutao Peng, Wenqian Wu, Ziwen Yang, Yang Wang, Libo Tao, Chang Liu   

  1. Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing 100020, China
    Center for Health Policy and Technology Evaluation, Peking University Health Science Center, Beijing 100083, China
  • Received:2023-05-09 Published:2023-08-15
  • Corresponding author: Ke Tan
  • Supported by:
    The Innovation Technology Project of Beijing Chao-Yang Hospital, Capital Medical University(22kcjjyb-4)
引用本文:

谭可, 李锦平, 彭玉涛, 吴文汧, 杨子文, 汪阳, 陶立波, 刘畅. 机器人辅助立体定向血肿引流术治疗自发性脑出血疗效及卫生经济学评价[J/OL]. 中华脑科疾病与康复杂志(电子版), 2023, 13(04): 205-214.

Ke Tan, Jinping Li, Yutao Peng, Wenqian Wu, Ziwen Yang, Yang Wang, Libo Tao, Chang Liu. Efficacy and health economic evaluation of robot-assisted stereotactic hematoma drainage for spontaneous intracerebral hemorrhage[J/OL]. Chinese Journal of Brain Diseases and Rehabilitation(Electronic Edition), 2023, 13(04): 205-214.

目的

探讨机器人辅助立体定向血肿引流术治疗自发性脑出血(SICH)的临床疗效及卫生经济学评价。

方法

收集首都医科大学附属北京朝阳医院神经外科自2019年3月至2022年3月行手术治疗的199例SICH患者的临床资料和经济数据。将所有患者按手术方式分为4组:机器人手术组77例,采用机器人辅助立体定向血肿引流术;神经内镜组65例,采用神经内镜下血肿清除术;小骨窗开颅组21例,采用小骨窗开颅显微镜下血肿清除术;硬通道组36例,采用硬通道血肿清除术。对比分析4组患者术后近期至1年的临床随访结果和医疗费用指标。选择机器人手术及内镜手术患者的数据,采用倾向性评分方法进行抽样匹配,以改良Rankin量表(mRS)评分和质量调整生命年(QALYs)指标进行卫生经济学评价。

结果

手术后出院时,4组患者的手术时间、术后血肿残余量、住院总费用、手术相关费用、ICU住院天数、呼吸机使用时间等方面比较,差异具有统计学意义(P<0.05);其中机器人手术组中再出血、颅内感染的发生率分别为2.6%、1.3%,平均住院时间15.45 d,平均住院费用46 077.90元。4组患者中mRS≤3分比例比较,差异具有统计学意义(P<0.05),其中机器人手术组术后3个月和1年的mRS≤3分的患者比例分别为55.8%和74.0%。采用倾向性评分抽样匹配,最终得到均衡可比的机器人手术组及神经内镜组,每组37例。手术后1年,机器人手术组能够人均节省36 862.14元的成本并多获得0.062个QALYs。

结论

机器人辅助立体定向血肿引流术具有成本更低且疗效更好的卫生经济学优势,更进一步的结果有待于开展多中心、扩大样本量的前瞻性随机对照研究。

Objective

To investigate the clinical efficacy and health economic evaluation of hematoma drainage for spontaneous intracerebral hemorrhage (SICH) with the assistance of neurosurgical navigation and positioning planning system (referred to as robot).

Methods

The clinical data and economic data of 199 SICH patients who underwent surgical treatment from March 2019 to March 2022 were collected. All patients were divided into 4 groups according to surgical methods: the robotic surgery group consisted of 77 patients who underwent robot assisted stereotactic hematoma drainage surgery; 65 cases in the neuro-endoscopy groups underwent hematoma removal surgery under neuroendoscopy; 21 cases in the small bone window craniotomy group underwent microscopic hematoma removal with small bone window open; 36 cases in the rigid catheter group underwent CT image-guided free-hand rigid catheter technique. Clinical follow-up outcomes and medical cost from the immediate post-operative to one year period were compared and analyzed. Data from both the robotic surgery and neuro-endoscopy groups were sampled and matched using propensity scoring methods, and health economics were evaluated using modified Rankin scale (mRS) scores and quality adjusted life years (QALYs) indicators.

Results

At the time of discharge, there were differences between the groups in terms of operation time, hematoma residual volume, total hospital costs, surgery-related costs, number of days in the ICU, and duration of ventilator use (P<0.05). In the robotic surgery group complication rate of rebleeding was 2.6%, intracranial infection was 1.3%, average hospital stay was 15.45 d, and average hospital cost was ¥46 077.90. There was difference in the proportion of mRS≤3 points between the 4 groups (P<0.05), in which the proportion of patients with mRS≤3 points at 3 months and 1 year after surgery in the robotic surgery group was 55.8% and 74.0%, respectively. Propensity score sampling was matched, resulting in 37 patients each in the balanced and comparable robotic surgery and neuro-endoscopy groups. One year after surgery, the robotic surgery group was able to save ¥36 862.14 per capita and gain 0.062 more QALYs.

Conclusion

Based on our model of SICH calculations suggest that robotic-assisted stereotactic drainage has the health economic advantage of being less costly and more effective, further results await multicenter, prospective randomized controlled trials with expanded sample size.

表1 4组患者的临床和影像学资料
Tab.1 Clinical and imaging data of 4 groups
项目 机器人手术组(n=77) 神经内镜组(n=65) 小骨窗开颅组(n=21) 硬通道组(n=36) F/χ2 P
年龄(岁,Mean±SD) 59.0±12.3 54.0±12.4 49.0±13.0 60.0±15.6 4.451 0.005
男性[例(%)] 53(68.8) 47(72.3) 12(57.1) 29(80.6) 3.772 0.287
术前合并症[例(%)]            
脑卒中史 40(51.9) 33(50.8) 7(33.3) 21(58.3) 3.421 0.335
高血压史 71(92.2) 53(81.5) 16(76.2) 36(100.0) 11.887 0.008
冠心病史 13(16.9) 7(10.8) 1(4.8) 6(16.7) 2.839 0.417
糖尿病 16(20.8) 16(24.6) 2(9.5) 12(33.3) 4.616 0.202
使用抗血小板药物[例(%)] 9(11.7) 15(23.1) 4(19) 3(8.3) 5.294 0.151
使用抗凝药物[例(%)] 5(6.5) 1(1.5) 1(4.8) 3(8.3) 2.832 0.418
发病前mRS评分[例(%)]         20.983 0.051
0分 60(77.9) 53(81.5) 18(85.7) 21(58.3)    
1分 4(5.2) 7(10.8) 3(14.3) 3(8.3)    
2分 3(3.9) 3(4.6) 0(0) 3(8.3)    
3分 6(7.8) 0(0) 0(0) 4(11.1)    
4分 4(5.2) 2(3.1) 0(0) 5(13.9)    
术前GCS评分[例(%)]         4.172 0.007
14~15分 9(11.7) 4(6.1) 1(4.8) 11(30.6)    
5~13分 61(79.2) 58(89.2) 15(71.4) 22(61.1)    
3~4分 7(9.1) 3(4.6) 5(23.8) 3(8.3)    
血肿体积[例(%)]         2.390 0.070
≥60 mL 6(7.8) 10(15.4) 0(0) 7(19.4)    
30~<60 mL 55(71.4) 52(80.0) 21(100.0) 21(58.3)    
20~<30 mL 16(20.8) 3(4.6) 0(0) 8(22.2)    
血肿部位[例(%)]         12.273 0.007
基底节丘脑 55(71.4) 31(47.7) 12(57.1) 15(41.7)    
脑叶 22(28.6) 34(52.3) 9(42.9) 21(58.3)    
术前血肿扩大[例(%)] 0(0) 12(18.5) 4(19) 6(16.7) 15.714 0.001
图1 马尔可夫模型
Fig.1 The Markov model
表2 4组患者手术及随访结果比较
Tab.2 Comparison of surgical and follow-up results among the 4 groups
项目 机器人手术组(n=77) 神经内镜组(n=65) 小骨窗开颅组(n=21) 硬通道组(n=36) F/Z/χ2 P
发病至手术时间[h,M(P25,P75)] 26.00(22.50,72.00) 6.00(5.00,9.50) 7.00(4.75,11.00) 36.00(11.75,72.00) 43.052 <0.001
手术时间(h,Mean±SD) 0.8±0.3 2.7±0.6 3.8±0.6 0.4±0.1 475.700 <0.001
术后血肿残余量[例(%)]         8.683 <0.001
<15 mL 76(98.7) 60(92.3) 20(95.2) 28(77.8)    
≥15 mL 1(1.3) 5(7.7) 1(4.8) 8(22.2)    
手术并发症[例(%)]            
再出血 2(2.6) 4(6.2) 1(4.8) 5(13.9) 5.586 0.134
颅内感染 1(1.3) 5(7.7) 3(14.3) 4(11.1) 6.901 0.075
出院时ADL评分[分,M(P25,P75)] 20.0(0,50.0) 10.0(0,52.5) 10.0(0,47.5) 2.5(0,57.5) 1.888 0.596
出院时mRS评分[例(%)]         23.245 0.079
0分 0(0.0) 0(0.0) 0(0.0) 0(0.0)    
1分 2(2.6) 0(0.0) 0(0.0) 3(8.3)    
2分 0(0.0) 3(4.6) 1(4.8) 0(0.0)    
3分 2(2.6) 5(7.7) 1(4.8) 1(2.8)    
4分 30(39.0) 23(35.4) 7(33.3) 10(27.8)    
5分 43(55.8) 32(49.2) 12(57.1) 19(52.8)    
6分 0(0.0) 2(3.1) 0(0.0) 3(8.3)    
术后3个月mRS评分[例(%)]         31.778 0.023
0~3分 43(55.8) 27(41.5) 8(38.1) 12(33.3)    
4~6分 34(44.2) 38(58.5) 13(61.9) 24(66.7)    
术后1年mRS评分[例(%)]         46.676 <0.001
0~3分 57(74.0) 44(67.7) 10(47.6) 17(47.2)    
4~6分 20(26.0) 21(32.3) 11(52.4) 19(52.8)    
住院总费用[元,M(P25,P75)] 36 268.00(28 789.00,51688.50) 71 623.00(54 838.00,118 202.00) 104 422.00(99 913.00,120 804.00) 39 041.50(27 568.75,75 880.25) 31.908 <0.001
手术相关费用[元,M(P25,P75)] 11 664.0(11 656.0,11 714.0) 26 884.0(25 561.0,29 578.5) 27 735.0(24 000.5,31 717.5) 5 767.5(4 156.5,6 604.0) 467.456 <0.001
住院时间[d,M(P25,P75)] 14.00(11.50,18.50) 14.00(12.00,19.00) 20.00(16.50,22.00) 14.00(12.00,21.75) 2.083 0.104
ICU住院天数[d,M(P25,P75)] 0(0,4) 6(2,11) 11(7,16) 5.5(0,14) 10.458 <0.001
呼吸机使用时间[h,M(P25,P75)] 0(0,0)a 48.0(0,117.5) 76.0(38.5,94.0) 0(0,0) 10.891 <0.001
图2 4组患者术后1年随访mRS评分构成比例
Fig.2 Proportion of mRS scores at one-year follow-up in the 4 groups
表3 马尔可夫模型参数设置及参数来源
Tab.3 The sources and settings of model Markov parameters
表4 成本-效果分析结果
Tab.4 The results of the cost-utility analysis
图3 单因素敏感性分析龙卷风图
Fig.3 The Tornado diagram of the single-factor sensitivity analysis
图4 概率敏感性分析散点图
Fig.4 The scatterplot of probabilistic sensitivity analysis
图5 成本-效果可接受曲线
Fig.5 The cost-effective acceptability curve
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