Teriparatide and osseous regeneration in the oral cavity.
Teriparatide and osseous regeneration in the oral cavity.
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DOI：
10.1056/nejmoa1005361
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发表时间：
2010-12-16
期刊：
影响因子：
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通讯作者：
McCauley LK
中科院分区：
文献类型：
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作者：
Bashutski JD;Eber RM;Kinney JS;Benavides E;Maitra S;Braun TM;Giannobile WV;McCauley LK
间歇性给予特立帕鲁肽（一种由甲状旁腺激素的前34个氨基酸组成的药物）对骨具有合成代谢作用。虽然特立帕替尼已被评估用于治疗骨质疏松症和骨折愈合，但缺乏评估其用于治疗人类口腔骨质疾病的临床试验。共有40名患有严重慢性牙周炎的患者接受了牙周手术，每天注射特立哌齐（20 μg）或安慰剂，沿着口服钙（1000 mg）和维生素D（800 IU），持续6周。随访1年。主要结果是牙槽骨水平的放射学线性测量。次要结果包括临床变量、血清和口腔液中的骨转换标志物、全身骨密度和生活质量。从6个月开始，特立帕曲肽治疗后骨缺损的放射学线性分辨率显著高于安慰剂治疗后，1年时骨的平均线性增益为29%，而安慰剂治疗后为3%（P<0.001）。与服用安慰剂的患者相比，服用特立派宁的患者的临床改善更大，1年时目标病变的牙周探诊深度减少了33%与20%（2.42 mm与1.32 mm），临床附着水平增加了22%与7%（1.58 mm与0.42 mm）（两项比较P = 0.02）。没有报告严重不良事件;但是，该研究的患者数量很少。在评估的其他变量方面未观察到显著差异。与安慰剂相比，特立帕鲁肽与临床结局改善、牙槽骨缺损消退更快和口腔骨伤口愈合加速相关。Teriparbital可能为颌骨局部骨缺损提供治疗潜力。（由美国国立卫生研究院和其他机构资助; ClinicalTrials.gov编号，NCT 00277706。
Intermittent administration of teriparatide, a drug composed of the first 34 amino acids of parathyroid hormone, has anabolic effects on bone. Although teriparatide has been evaluated for the treatment of osteoporosis and for the healing of fractures, clinical trials evaluating it for the treatment of osseous conditions of the oral cavity in humans are lacking. A total of 40 patients with severe, chronic periodontitis underwent periodontal surgery and received daily injections of teriparatide (20 μg) or placebo, along with oral calcium (1000 mg) and vitamin D (800 IU) supplementation, for 6 weeks. The patients were followed for 1 year. The primary outcome was a radiographic linear measurement of alveolar bone level. Secondary outcomes included clinical variables, bone turnover markers in serum and oral fluid, systemic bone mineral density, and quality of life. Radiographic linear resolution of osseous defects was significantly greater after teriparatide therapy than after placebo beginning at 6 months, with a mean linear gain in bone at 1 year of 29% as compared with 3% (P<0.001). Clinical improvement was greater in patients taking teriparatide than in those taking placebo, with a reduction in periodontal probing depth of 33% versus 20% (2.42 mm vs. 1.32 mm) and a gain in clinical attachment level of 22% versus 7% (1.58 mm vs. 0.42 mm) in target lesions at 1 year (P = 0.02 for both comparisons). No serious adverse events were reported; however, the number of patients in the study was small. No significant differences were noted with respect to the other variables that were assessed. Teriparatide, as compared with placebo, was associated with improved clinical outcomes, greater resolution of alveolar bone defects, and accelerated osseous wound healing in the oral cavity. Teriparatide may offer therapeutic potential for localized bone defects in the jaw. (Funded by the National Institutes of Health and others; ClinicalTrials.gov number, NCT00277706.)