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特立帕肽(重组人甲状旁腺激素[1-34])增加糖尿病性慢性夏科氏神经关节病足部骨骼重塑:一项随机、双盲、安慰剂对照研究。

Teriparatide (recombinant human parathyroid hormone [1-34]) increases foot bone remodeling in diabetic chronic Charcot neuroarthropathy: a randomized double-blind placebo-controlled study.

机构信息

Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Department of Radiodiagnosis, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

J Diabetes. 2019 Sep;11(9):703-710. doi: 10.1111/1753-0407.12902. Epub 2019 Feb 13.

DOI:10.1111/1753-0407.12902
PMID:30632290
Abstract

BACKGROUND

Currently, there is no consensus regarding the medical treatment of chronic Charcot neuroarthropathy (CN) of foot, except for effective off-loading. Because tarsal bones are predominantly trabecular, teriparatide may improve the macroarchitecture of foot bones in chronic CN.

METHODS

People with diabetes and chronic CN were randomized to receive either 20 μg teriparatide or placebo subcutaneous daily for 12 months. Thirty-eight patients were screened and data were analyzed for 20. The maximum standardized uptake (SUV ) value of F-FDG PET/CT the region of interest, bone turnover markers and foot bone mineral density BMD were determined. The primary outcome measure was change in SUV g/ml.

RESULTS

Mid-foot was the most common region involved. After 12 months, SUV increased from 30.6 ± 14.7 to 37.7 ± 18.0 (P = 0.044) in the teriparatide group, but decreased from 27.6 ± 12.2 to 22.9 ± 10.4 with placebo (P = 0.148). The estimated treatment difference (ETD) was 11.9 ± 4.3 (95% CI 2.9, 20.8; P = 0.012). Similarly, P1NP increased with teriparatide (19.8 ± 5.5; P = 0.006) but decreased with placebo (-5.1 ± 3.8 ng/mL; P = 0.219); ETD was 24.8 ± 6.6 (95% CI 10.8, 38.8; P < 0.001) and CTX increased in both the teriparatide and placebo groups. Foot BMD increased by 0.06 ± 0.04 g/cm (P = 0.192) with teriparatide, but decreased by -0.06 ± 0.08 g/cm with placebo (P = 0.488; intergroup comparison, P = 0.096).

CONCLUSION

Teriparatide increases foot bone remodeling by an osteoanabolic action in people with CN.

摘要

背景

目前,除了有效减压外,对于慢性夏科氏神经关节病(CN)的足部治疗还没有共识。由于跗骨主要是松质骨,特立帕肽可能会改善慢性 CN 足部骨骼的宏观结构。

方法

患有糖尿病和慢性 CN 的患者被随机分为每天皮下注射 20μg 特立帕肽或安慰剂,持续 12 个月。对 38 名患者进行了筛选,对 20 名患者的数据进行了分析。测定感兴趣区域的 F-FDG PET/CT 的最大标准化摄取值(SUV)、骨转换标志物和足部骨密度(BMD)。主要观察指标是 SUVg/ml 的变化。

结果

中足是最常见的受累部位。12 个月后,特立帕肽组 SUV 从 30.6±14.7 增加到 37.7±18.0(P=0.044),而安慰剂组从 27.6±12.2 减少到 22.9±10.4(P=0.148)。估计治疗差异(ETD)为 11.9±4.3(95%CI 2.9,20.8;P=0.012)。同样,特立帕肽组 P1NP 增加(19.8±5.5;P=0.006),而安慰剂组减少(-5.1±3.8ng/ml;P=0.219);ETD 为 24.8±6.6(95%CI 10.8,38.8;P<0.001),CTX 在特立帕肽和安慰剂组中均增加。特立帕肽组足部 BMD 增加 0.06±0.04g/cm(P=0.192),而安慰剂组减少 0.06±0.08g/cm(P=0.488;组间比较,P=0.096)。

结论

特立帕肽通过骨形成作用增加 CN 患者的足部骨骼重塑。

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