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重组人生长激素与椎体增强术治疗急性骨质疏松性椎体压缩性骨折的疗效比较。

Efficacy of Recombinant Human Parathyroid Hormone versus Vertebral Augmentation Procedure on Patients with Acute Osteoporotic Vertebral Compression Fracture.

机构信息

Department of Orthopedic Surgery, The Fifth Affiliated Hospital of Shanxi Medical University, Taiyuan, Shanxi, China.

Department of Orthopedic Surgery, The Tianjin 4th Centre Hospital, Tianjin, Tianjin, China.

出版信息

Orthop Surg. 2022 Oct;14(10):2510-2518. doi: 10.1111/os.13470. Epub 2022 Aug 26.

Abstract

OBJECTIVE

Although widely used in clinical practice, vertebral augmentation procedure (VAP) for osteoporotic vertebral compression fracture (OVCF) is not supported. Recently, the effect of recombinant human parathyroid hormone (1-34) (rhPTH) has been paid great attention for its efficacy in anti-osteoporosis and bone union. This study aims to explore the outcome of rhPTH on acute OVCF and compare it with VAP to clarify its therapeutic advantages.

METHODS

The retrospective study comprised 71 acute OVCF patients from January 2015 to March 2020: 22 received rhPTH treatment (rhPTH group) and 49 underwent VAP (VAP group). The rhPTH group was 15 women and seven men with an average of 76.18 years, and the VAP group were 35 women and 14 men with an average of 73.63 years. The thoracic/lumbar vertebrae were 14/8 in the rhPTH group and 29/20 in the VAP group. The average follow-up period was 14.05 months in the rhPTH group and 13.82 months in the VAP group. The two groups were assessed regarding the visual analog score (VAS), Oswestry Disability Index (ODI), OVCF bone union, bone mineral density (BMD), kyphotic angle (KA), anterior and posterior border height (ABH and PBH, respectively), adverse events and the health-related quality of life assessed by short form-36 health survey scores (SF-36). Categorical variables were analyzed by chi-square test and continuous variables between groups were analyzed by independent samples t-test or Mann-Whitney U test according to the normality.

RESULTS

During the follow-up, the VAS was significantly lower in the rhPTH group than in the VAP group at month 3 (0.39 ± 0.6 vs 0.68 ± 0.651) (p = 0.047), month 6 (0.45 ± 0.60 vs 2.18 ± 1.22) (p < 0.001), and month 12 (0.45 ± 0.60 vs 2.43 ± 1.49) (p < 0.001). At month 12, the ODI was significantly lower in the rhPTH group (18.59 ± 3.33%) than in the VAP group (28.93 ± 16.71%) (p < 0.001). Bone bridge was detected on sagittal computed tomography images of all fractured vertebrae in the rhPTH group. The BMD was significantly higher in the rhPTH group (87.66 ± 5.91 Hounsfield units [HU]) than in the VAP group (68.15 ± 11.32HU) (p < 0.001). There were no significant differences in the changes in KA, ABH, and PBH between groups (all p > 0.05). The incidence of new OVCF was significantly lower in the rhPTH group than in the VAP group (p = 0.042). All scores of SF-36 were significantly higher in the rhPTH group than in the VAP group (all p < 0.05).

CONCLUSION

In acute OVCF patients, rhPTH was better than VAP in increasing spinal BMD to promote OVCF healing, reduce new OVCF, and improve back pain, physical ability, and health-related quality of life.

摘要

目的

椎体强化术(VAP)在骨质疏松性椎体压缩性骨折(OVCF)中的应用虽然广泛,但并未得到支持。最近,重组人生长激素(rhPTH)1-34 的作用受到了极大的关注,因为它在抗骨质疏松症和骨愈合方面具有疗效。本研究旨在探讨 rhPTH 对急性 OVCF 的疗效,并与 VAP 进行比较,以明确其治疗优势。

方法

回顾性研究纳入了 2015 年 1 月至 2020 年 3 月的 71 例急性 OVCF 患者:22 例接受 rhPTH 治疗(rhPTH 组),49 例行 VAP(VAP 组)。rhPTH 组 15 例为女性,7 例为男性,平均年龄为 76.18 岁,VAP 组 35 例为女性,14 例为男性,平均年龄为 73.63 岁。rhPTH 组胸腰椎为 14/8,VAP 组为 29/20。rhPTH 组平均随访时间为 14.05 个月,VAP 组为 13.82 个月。两组均采用视觉模拟评分(VAS)、Oswestry 功能障碍指数(ODI)、OVCF 骨愈合、骨密度(BMD)、后凸角(KA)、前后缘高度(ABH 和 PBH)、不良事件和 36 项简明健康状况调查问卷(SF-36)评估健康相关生活质量。分类变量采用卡方检验,组间连续变量采用独立样本 t 检验或 Mann-Whitney U 检验,根据正态性进行分析。

结果

随访期间,rhPTH 组在第 3 个月(0.39±0.6 比 0.68±0.651)(p=0.047)、第 6 个月(0.45±0.60 比 2.18±1.22)(p<0.001)和第 12 个月(0.45±0.60 比 2.43±1.49)(p<0.001)的 VAS 明显低于 VAP 组。在第 12 个月,rhPTH 组的 ODI(18.59±3.33%)明显低于 VAP 组(28.93±16.71%)(p<0.001)。rhPTH 组所有骨折椎体的矢状位 CT 图像上均可见骨桥。rhPTH 组的 BMD(87.66±5.91 亨氏单位[HU])明显高于 VAP 组(68.15±11.32HU)(p<0.001)。两组 KA、ABH 和 PBH 的变化无统计学差异(均 p>0.05)。rhPTH 组新发 OVCF 的发生率明显低于 VAP 组(p=0.042)。rhPTH 组的所有 SF-36 评分均明显高于 VAP 组(均 p<0.05)。

结论

在急性 OVCF 患者中,rhPTH 治疗在增加脊柱 BMD 以促进 OVCF 愈合、减少新发 OVCF、改善腰背疼痛、身体机能和健康相关生活质量方面优于 VAP。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/15f7/9531108/ad0361d6fc5b/OS-14-2510-g001.jpg

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