1.Early efficacy of Jack vertebral dilator kyphoplasty bone grafting combined with minimally invasive fixation for thoracolumbar fractures
Jin FAN ; Lipeng YU ; Qirui DING ; Guoyong YIN
Chinese Journal of Trauma 2017;33(12):1087-1093
Objective To investigate the short-term clinical efficacy of Jack vertebral dilator kyphoplasty bone grafting combined with minimally invasive fixation in the treatment of thoracolumbar fracture.Methods A retrospective case series analysis was made on 34 patients with thoracolumbar fracture treated by minimally invasive transpedicular bone grafting and fixation in the injury vertebrae with Jack vertebral dilator from December 2014 to December 2015.There were 20 males and 14 females,and their age was 25-27 years (mean,46.7 years).According to the AO classification,there were 16 cases of type A1 and 18 type A3.The injured levels were at T11 in one case,at T12 in 6,at L1 in 15,at L2 in 9 and at L3 in 3.The operation time,blood loss,fluoroscopy frequency,incision length,and postoperative hospital stay duration were recorded.The visual analogue scale (VAS),Oswestry disability index (ODI),height ratio of vertebrae,Cobb angle,and complications were evaluated at follow-up.Results The operation time was (91.2 ±9.8) minutes,blood loss was (42.4 ±4.3) ml,incision length was (7.2 ± 0.4) cm,intraoperative fluoroscopy frequency were five,postoperative hospital stay was (3.9 ± 0.5) days,and follow-up time was (13.8 ± 1.7) months.All the patients showed complete healing in the injury vertebra.The VAS was (6.4 ± 0.9) points preoperatively,(4.1 ± 0.8) points,(1.2 ± 0.4) points,and (1.2 ± 0.5) points at 7 days,3 months and 12 months postoperatively.The ODI was (39.2 ± 2.3) points preoperatively,(24.5 ± 1.9) points,(13.0 ± 3.0) points,and (12.3 ± 2.0) points at 7 days,3 months and 12 months postoperatively.At postoperative 7 days,the VAS and ODI were significantly decreased compared with those preoperatively (P < 0.05) and further declined at postoperative 3 months (P < 0.05),while there was no significant difference between 3 months and 12 months postoperatively (P > 0.05).The height ratio of vertebrae was 47.8 ± 12.2 preoperatively,83.6 ±4.9,82.5 ±4.8,and 81.7 ±4.7 at 7 days,3 months and 12 months postoperatively.The Cobb angle was respective (22.4 ± 4.7) °preoperatively,(3.6 ± 2.4) °,(4.6 ± 2.6) °,and (5.0 ± 2.8) ° at 7 days,3 months and 12 months postoperatively.At postoperative 7 days,the height ratio of vertebrae was increased and Cobb angle was decreased significantly compared to those preoperatively (P < 0.05),while there was no significant difference in the indicators at 3 days,3 months and 12 months postoperatively (P > 0.05).No looseness or breakage of internal fixation was found at follow-up and all patients had fracture union at the last follow-up.Conclusion Jack vertebral dilator kyphoplasty bone grafting combined with minimally invasive fixation is safe and effective for treatment of thoracolumbar fractures,as the procedure can quickly relieve the pain,improve the function disability,effectively maintain the height of the vertebral body and restore the sagittal balance of spine.
2.Inspiration from International Experience on Risk Sharing Agreements of Medical Insurance Access for CAR-T Products
Wei LI ; Huli QIN ; Jinxi DING ; Jiaming LI ; Qirui XIA
China Pharmacy 2021;32(24):2957-2962
OBJECTIVE:To learn from the experience of foreign listed chimeric antigen receptor T lymphocyte (CAR-T) products in signing risk sharing agreements in medical insurance access ,so as to provide references for relevant decisions of medical insurance departments in China. METHODS :Taking 9 risk sharing agreements of CAR-T products marketed in the United Kingdom,France,Italy and Germany as samples ,the international experience of medical insurance payment of CAR-T products were analyzed from six dimensions ,such as agreement types ,monitoring indicators ,data collection metho ds,agreement periods , payment conditions and payment methods. Some suggestions were put forward for the medical insurance access of these products in China. RESULTS & CONCLUSIONS :Four sample countries generally signed risk sharing agreements of medical insurance access (financial agreement and performance-based agreement )with pharmaceutical enterprises ;the indicators such as progressive disease and progression-free survival were collected by using data collection system or clinical research data ,so as to monitor the efficacy and safety of CAR-T products. The agreement periods and payment conditions were determined according to different agreement types;“medical insurance advance payment ”or“pharmaceutical enterprise advance payment ”combined with “staged payments ” were adopted for risk control. Solving the risk of medical insurance funds caused by “efficacy uncertainty ”is the core issue of CAR-T product access. The induction of risk sharing agreements may be the way to solve this problem ,and the scientific design of the various elements of risk sharing agreements is a prerequisite to ensure that the agreement is operational.