Fujita T, Inoue T, Morii H, Morita R, Norimatsu H, Orimo H, Takahashi H E, Yamamoto K, Fukunaga M
Calcium Research Institute, Osaka, Japan.
Osteoporos Int. 1999;9(4):296-306. doi: 10.1007/s001980050151.
To test the effect of amino-terminal peptide 1-34 of human parathyroid hormone (hPTH (1-34)) as a possible bone anabolic agent in the treatment of osteoporosis, weekly subcutaneous injection of 50 units (L group), 100 units (M group) or 200 units (H group) of hPTH (1-34) was started in 220 patients with osteoporosis at 71 institutions randomly divided into three groups in a double-masked system. Lumbar spine bone mineral density (BMD) by dual-energy X-ray absorptiometry (DXA) increased by 0.6%, 3.6% and 8.1% after 48 weeks in groups L, M and H respectively, responses in groups M and H being significantly higher than in L (p<0.05, Mann-Whitney U-test). Since the coefficient of variation for lumbar spine measurement stayed at 1-2.5%, increases of 3.6% and 8.1% appeared significant. Metacarpal BMD and cortical thickness measured by radiogrammetry did not change significantly. Serum calcium decreased in each group and serum phosphorus decreased in groups M and H. Urinary calcium/creatinine decreased at the 12th week in group H and at the 24th and 48th weeks in groups M and L. Serum 25(OH) vitamin D and 1,25(OH)(2) vitamin D decreased in each group at the 48th week (p<0.05). Serum bone-type alkaline phosphatase was increased at the fourth week in groups H and M and decreased at the 48th week in group H. Urinary hydroxyproline, pyridinoline and deoxypyridinoline declined significantly in each group. Backache improved in 30-40% of each group. No serious adverse effects were found during the test period. Intermittent weekly injection of hPTH (1-34) increased lumbar BMD in osteoporosis, suggesting usefulness in the treatment of osteoporosis.
为测试人甲状旁腺激素氨基末端肽1 - 34（hPTH(1 - 34)）作为一种可能的骨合成代谢剂在治疗骨质疏松症中的效果，将71家机构的220例骨质疏松症患者随机分为三组，采用双盲系统，分别开始每周皮下注射50单位（L组）、100单位（M组）或200单位（H组）的hPTH(1 - 34)。双能X线吸收法（DXA）测量的腰椎骨密度（BMD）在L组、M组和H组中，48周后分别增加了0.6%、3.6%和8.1%，M组和H组的反应显著高于L组（p<0.05，Mann - Whitney U检验）。由于腰椎测量的变异系数保持在1 - 2.5%，3.6%和8.1%的增加显得很显著。通过放射测量法测量的掌骨BMD和皮质厚度没有显著变化。每组血清钙均下降，M组和H组血清磷下降。H组在第12周、M组和L组在第24周和48周尿钙/肌酐下降。每组在第48周血清25(OH)维生素D和1,25(OH)₂维生素D均下降（p<0.05）。血清骨型碱性磷酸酶在H组和M组第4周时升高，在H组第48周时下降。每组尿羟脯氨酸、吡啶啉和脱氧吡啶啉均显著下降。每组30 - 40%的患者背痛有所改善。试验期间未发现严重不良反应。每周间歇性注射hPTH(1 - 34)可增加骨质疏松症患者的腰椎BMD，表明其在治疗骨质疏松症方面有用。
