骨质疏松患者腰椎融合术后应用特立帕肽的疗效

The application and therapeutic effect of teriparatide after lumbar fusion surgery in patients with osteoporosis

中文关键词:  特立帕肽  骨质疏松  腰椎融合  骨密度

英文关键词:Teriparatide  Osteoporosis  Lumbar fusion  Bone mineral density

中文摘要:

  【摘要】 目的：探究特立帕肽在骨质疏松患者腰椎融合术后的应用价值及其临床疗效。方法：选取2022年1月~2023年12月，在我院接受后路单节段腰椎滑脱复位联合椎间植骨融合及椎弓根螺钉内固定术，并且伴有骨质疏松症的131例患者作为研究对象进行回顾性研究。按照术后是否接受特立帕肽治疗，将患者分成观察组（n=69，男37例，女32例，56.03±7.24岁，术后接受特立帕肽治疗）和对照组（n=62，男37例，女25例，58.72±7.68岁，不使用特立帕肽治疗）。采用倾向性评分匹配法（propensity score matching，PSM），以基线资料作为协同变量，卡钳值选择0.02，匹配度1∶1，共匹配成功60对。观察组与对照组在年龄、性别、身体质量指数（body mass index，BMI）等基线资料上经PSM匹配后具有可比性。比较两组的手术指标，包括手术时间、术中出血量、术后引流管拔除时间及术后住院时间。采用改良MacNab标准评估两组术后6个月的临床疗效，计算优良率。术前及术后3个月、6个月，采用视觉模拟量表（visual analog scale，VAS）评分评估患者疼痛情况，Oswestry功能障碍指数（Oswestry disability index，ODI）评估腰椎功能情况，运用双能X线吸收法测量髋部骨密度；术后3个月、6个月进行腰椎CT扫描评估术后椎间融合率，融合标准为CT矢状位、冠状位图像中融合节段椎体间有连续骨小梁形成。因果森林模型估计的个体处理效应（individual treatment effect，ITE）为应用特立帕肽患者腰椎骨融合速率的率差。应用二元Log-binomial回归模型计算两组患者术后不良反应的相对危险度（relative risk，RR）。结果：两组患者的手术指标比较无显著统计学差异（P>0.05）。观察组优良率为93.33%，对照组优良率为65.00%，两组患者临床疗效比较差异具有统计学意义（P<0.05）。与术前比较，术后3、6个月观察组和对照组腰背痛VAS、腿痛VAS评分以及ODI逐渐降低（P<0.05）；与对照组比较，观察组术后3、6个月腰背痛VAS、腿痛VAS评分以及ODI明显降低（P<0.05）。观察组术后3、6个月的髋部骨密度水平较术前逐渐升高（术前：0.58±0.16g/cm2，术后3个月：0.82±0.21g/cm2，术后6个月：0.91±0.19g/cm2，P<0.05）；与对照组比较，观察组术后3、6个月髋部骨密度明显升高（术后3个月：0.82±0.21g/cm2 vs 0.64±0.19g/cm2，术后6个月：0.91±0.19g/cm2 vs 0.66±0.21g/cm2，P<0.05）。腰背痛VAS、腿痛VAS评分、ODI以及髋部骨密度组别、时间、组别×时间交互项中差异均有统计学意义（P<0.05）。术后3、6个月，观察组椎间融合率高于对照组（81.67% vs 60%，93.33% vs 73.33%，均P<0.05）。因果森林模型结果显示，60例观察组患者的ITE值均为-0.01~-0.18（1/月），提示应用特立帕肽可使患者腰椎骨融合速率提高，融合时间最多缩短约18%。与对照组比较，观察组患者术后不良反应总发生率风险降低（RR<1，P<0.05）。结论：特立帕肽可明显改善骨质疏松患者的骨质量，提升腰椎融合术后的椎间融合成功率，通过提高腰椎骨融合速率有效缩短融合时间，且安全性良好。

英文摘要:

  【Abstract】 Objectives: To explore the application value and clinical efficacy of teriparatide in patients with osteoporosis after lumbar fusion surgery. Methods: A retrospective study was conducted on 131 patients with osteoporosis who underwent posterior single-segment lumbar spondylolisthesis repositioning combined with interbody implant fusion and pedicle screw internal fixation between January 2022 and December 2023. The patients were divided into an observation group(n=69, 37 males and 32 females, 56.03±7.24 years, treated with teriparatide after operation) and a control group(n=62, 37 males and 25 females, 58.72±7.68 years, no teriparatide treatment). Using propensity score matching(PSM) with baseline data as covariates, a caliper value of 0.02 was selected for 1∶1 matching. A total of 60 matched pairs were successfully generated. There was no statistically significant difference between the two groups in baseline characteristics such as age, gender, and BMI after PSM. The operative indexes were compared, including operative duration, intraoperative blood loss, time to the removal of postoperative drainage tube, and length of hospital stay. The modified MacNab criteria were used to evaluate clinical efficacy at 6 months postoperatively of both groups of patients. Before operation, and at 3 months and 6 months after operation, visual analog scale(VAS) score was used to assess the pain conditions, and Oswestry disability index(ODI) was adopted to evaluate lumbar function, meanwhile, hip bone mineral density(BMD) was measured by dual-energy X-ray absorptiometry. Postoperative lumbar CT scans were performed at 3 and 6 months to assess intervertebral fusion rates. The fusion criteria were defined as the presence of continuous trabecular bone formation between the vertebral bodies of the fused segment on both sagittal and coronal CT images. The individual treatment effect(ITE) estimated by the causal forest model was the rate difference in the rate of lumbar spinal fusion in patients applying teriparatide. A binary log-binomial regression model was applied to calculate the relative risk(RR) of postoperative adverse reaction in both groups. Results: There was no significant differences between the two groups in surgical indexes(P>0.05). The excellent and good rates were 93.33% in the observation group and 65.00% in the control group, and the difference between the two groups was statistically significant(P<0.05). Compared with the preoperative values, the low back and leg pain VAS scores and ODI of both groups decreased at 3 and 6 months after operation(P<0.05); Compared with the control group, the low back and leg pain VAS score and ODI of the observation group decreased significantly at 3 and 6 months after operation(P<0.05). The level of hip BMD in the observation group gradually increased at 3 and 6 months after operation compared with the preoperative levels(pre-op: 0.58±0.16g/cm2, post-op 3 months: 0.82±0.21g/cm2, post-op 6 months: 0.91±0.19g/cm2, P<0.05); Compared with the control group, hip BMD in the observation group increased significantly at 3 and 6 months after operation(post-op 3 months: 0.82±0.21g/cm2 vs 0.64±0.19g/cm2, post-op 6 months: 0.91±0.19g/cm2 vs 0.66±0.21g/cm2, P<0.05). The differences in low back and leg pain VAS scores, ODI, and hip BMD group, time, and group×time interaction items were statistically significant(P<0.05). At 3 and 6 months after surgery, the intervertebral fusion rate in the observation group was higher than that in the control group(81.67% vs 60%, 93.33% vs 73.33%, P<0.05). The results of the causal forest model indicated that the ITE values for all 60 patients in the observation group ranged from -0.01 to -0.18(per month), suggesting that the application of teriparatide could enhance lumbar spinal fusion rates, with fusion time potentially reduced by up to approximately 18%. Compared with the control group, patients in the observation group had a lower risk of total incidence of postoperative adverse reactions(RR<1, P<0.05). Conclusions: Teriparatide significantly improves bone quality in patients with osteoporosis, enhances the success rate of intervertebral fusion following lumbar fusion surgery, and effectively shortens fusion time by accelerating the rate of lumbar bone fusion, while demonstrating a favourable safety profile.