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双膦酸盐类药物促进胸腰椎骨折内固定术后伤椎骨修复的随机对照研究
徐海栋1,刘晓伟1,史新瑞1,杨斐1,苏佳灿2,3,许斌1*
0
(1. 解放军南京总医院骨科, 南京 210002;
2. 第二军医大学长海医院创伤骨科, 上海 200433;
3. 中韩生物医学工程中心, 上海 201802
*通信作者)
摘要:
目的 采用随机对照研究探讨在胸腰椎骨折内固定术后应用双膦酸盐抗骨质疏松进行伤椎骨修复的临床疗效。方法 2014年6月-2015年6月南京军区南京总医院骨科收治的84例胸腰椎骨折后路矫形内固定患者,按照随机数字表法分别纳入双膦酸盐治疗组和对照组,每组42例。术后除给予骨化三醇、碳酸钙D3等常规抗骨质疏松药物外,双膦酸盐治疗组服用阿仑膦酸钠维D3片(每片含阿仑膦酸钠70 mg,每周1片),对照组服用安慰剂。术后1个月、3个月、6个月、1年分别测量胸腰椎损伤区的骨密度,并进行组间比较。结果 复位后即刻两组伤椎骨密度均出现明显下降,在随访过程中两组患者的骨密度值均不断增加,术后1个月、3个月时两组骨密度值差异无统计学意义(P>0.05),术后6个月、1年时双膦酸盐组的骨密度值高于对照组,差异有统计学意义(P<0.05)。结论 采用双膦酸盐类药物进行干预,可加快胸腰椎骨折内固定术后伤椎骨质疏松的修复,具有较好的临床应用价值。
关键词:  胸腰椎骨折  内固定术  骨质疏松  应力屏蔽  双膦酸盐  临床疗效
DOI:10.16781/j.0258-879x.2017.04.0443
投稿时间:2016-12-15修订日期:2017-03-09
基金项目:南京军区医学科技创新课题(12MA080),南京军区南京总医院军事医学培育课题(YYMS2014002).
Bisphosphonates promoting repair of injured vertebrae after thoracolumbar fracture internal fixation: a randomized controlled study
XU Hai-dong1,LIU Xiao-wei1,SHI Xin-rui1,YANG Fei1,SU Jia-can2,3,XU Bin1*
(1. Department of Orthopaedics, PLA Nanjing General Hospital, Nanjing 210002, Jiangsu, China;
2. Department of Orthopaedic Trauma, Changhai Hospital, Second Military Medical University, Shanghai 200433, China;
3. China-South Korea Biomedical Engineering Center, Shanghai 201802, China
*Corresponding author)
Abstract:
Objective To explore the anti-osteoporosis effect of bisphosphonates on repairing injured vertebrae after thoracolumbar fracture internal fixation through a randomized controlled study. Methods Eighty-four patients with thoracolumbar fracture treated by orthopaedic internal fixation in Department of Orthopaedics, Nanjing General Hospital from Jun. 2014 to Jun. 2015 were included, and the patients were divided into the bisphosphonate treatment group (n=42) and control group (n=42) by random number method. The patients in both groups were given the routine anti-osteoporosis drugs such as calcitriol and calcium carbonate D3 after surgery; in addition, the patients in the bisphosphonate treatment group were also given alendronate sodium D3 tablets (each containing alendronate sodium 70 mg, 1 tablet per week), while the control group received a placebo. The bone mineral density (BMD) in thoracolumbar vertebral injury area of patients in the two groups was measured and compared at 1 month, 3 months, 6 months and 1 year after surgery. Results The BMD values of patients in two groups were significantly decreased immediately after reset compared with preoperation, and then they were increased continuously in follow-up. There was no significant difference in BMD between the two groups at 1 month or 3 months after sursery (P>0.05), while the BMD in the bisphosphonate treatment group was significantly higher than that in the control group at 6 months and 1 year after surgery (P<0.05). Conclusion Bisphosphaonate drugs can accelerate the repair of vertebral osteoporosis after thoracolumbar fracture internal fixation, showing a good clinical application value.
Key words:  thoracolumbar fractures  internal fixation  osteoporosis  stress shielding  bisphosphonates  clinical efficacy