甲状旁腺激素(1-34)联合维生素K_2对绝经后骨质疏松患者疗效的临床研究

Efficacy of parathyroid hormone(1-34 ) combined with vitamin K_2 in the treatment of postmenopausal osteoporosis

目的观察甲状旁腺激素(1-34)(parathyroid hormone,PTH)联合维生素K_2(VK_2)对绝经后骨质疏松患者的临床疗效。方法选取2014年5月至2016年2月于我院治疗的120例绝经后骨质疏松患者进行研究,按照1∶1∶1比例随机分为3组:VK_2组、PTH组、联合治疗组。PTH组40例患者给予特立帕肽20μg皮下注射,每日1次,治疗6个月;VK_2组40例患者口服四烯甲萘醌软胶囊45 mg/d,每日3次,治疗12个月。联合治疗组40例给予特立帕肽联合四烯甲萘醌软胶囊治疗。药物治疗后,将3组患者的腰椎及髋部骨密度、血钙、血磷、血清骨转换指标骨碱性磷酸酶(BALP)、I型胶原N末端肽/肌酐(NTX/Cr)变化情况进行对比,同时对患者服药后的不良反应发生率进行比较。结果治疗6个月和12个月后,3组患者骨密度较治疗前都显著改善(P<0.05),且相同时间点联合治疗组均明显优于VK_2组及PTH组(P<0.05)。药物治疗12个月后,3组患者血清BALP和NTX/Cr水平较治疗前有显著改变(P<0.05),且相同时间点联合治疗组均明显优于VK_2组和PTH组(P<0.05)。3组药品不良反应发生率比较,差异无统计学意义(P>0.05)。结论甲状旁腺激素和维生素K2均对绝经后骨质疏松患者疗效显著,且联合使用效果更佳。

Objective To observe the clinical efficacy of parathyroid hormone （1-34, PTH） combined with vitamin K2 （VK2） in patients with postmenopausal osteoporosis. Methods A total of 120 patients with postmenopausal osteoporosis who were treated in our hospital from May 2014 to February 2016 were selected and divided into 3 groups according to the time of admission： VK2 group, PTH group, and combination therapy group. Forty patients in PTH group received subcutaneous injection of 20μg teriparatide, once a day, 6 months. Thirty-nine patients in VK2 group received 45mg/d soft capsule of tetranaphthalenone orally, 3 times a day, for 12 months. Forty patients in combination therapy group received teriparatide combined with tetramethylene naphthoquinone soft capsules. After the treatment, the changes of bone mineral density （BMD） of the lumbar spine and hip, blood calcium and phosphorus, changes of bone biophosphate （BALP）, type I collagen N-terminal peptide/creatinine （NTX/Cr） were compared among the 3 groups. The incidence of adverse reaction was also compared. Results After 6 and 12 months of the treatment, BMD in the 3 groups was significantly improved （P〈0.05）, and BMD in the combination therapy group was significantly better than that in the PTH and VK2 group （P〈0.05） at the same time point. After 12 months of drug treatment, serum BALP and NTX / Cr were significantly changed than those before the treatment （P〈0.05）, and those in the combination therapy group was significantly better than in VK2 and PTH group （P〈0.05） at the same time point. There was no significant difference in the incidence of adverse drug reactions among the 3 groups （P〉0.05）. Conclusion PTH and VK2 have significant effect on postmenopausal osteoporosis, and the combination therapy shows a better clinical efficacy.