益盖宁对慢性肾脏病-矿物质和骨异常的疗效观察

Efficacy of elcitonin in the treatment of chronic kidney disease-mineral and bone disorder

目的观察益盖宁(依降钙素注射液)肌肉或皮下注射对慢性肾脏病-矿物质和骨异常(chronic kidney disease-mineral and bone disorder,CKD-MBD)的有效性及安全性。方法选取维持性血液透析2年及以上,且合并不同程度骨关节疼痛、血钙升高、皮肤瘙痒及皮肤转移性钙化小结节的患者30例。首先予益盖宁注射液20U第1周肌肉或皮下注射,每日1次,以后改为3次/周,于透析后使用,疗程12周。同时予低盐低嘌呤饮食,高钙血症患者停用活性维生素D3及相应钙剂。定期复查血常规(血红蛋白、白细胞及血小板)、肝功能(直接胆红素、间接胆红素、丙氨酸氨基转移酶、天门冬氨酸氨基转移酶)、血钙、血磷、全段甲状旁腺激素(intact parathyroid hormone,i PTH)和第3、4腰椎骨密度,并采用视觉模拟评分(visual analogue scale/score,VAS)法记录骨痛程度,随访不良反应的发生情况。结果血钙浓度随治疗时间延长逐渐下降,8周后出现统计学差异(t=2.424,P=0.019);血磷呈下降趋势,12周后出现统计学差异(t=2.061,P=0.044);骨痛程度较治疗前明显减轻,VAS评分随治疗时间延长而下降,12周后亦出现统计学差异(X^2=51.463,P<0.0001);i PTH虽呈下降趋势,但与治疗前相比无统计学差异(X^2=11.120,P=0.069);治疗后骨密度增加,因患者数量较少(n=3),未进行统计学分析。结论益盖宁可降低维持性血液透析患者钙磷水平,改善骨关节疼痛,增加骨密度,对肾性骨病有显著疗效。

Objective To observe the efficiency and safety of calcitonin （elcitonin） in the treatment of chronic kidney disease-mineral and bone disorder. Methods A total of 30 patients with bone and joint pain, hypercalcemia, skin itch, and skin metastatic calcification nodules were enrolled in this study. All of them were on maintenance hemodialysis for more than 2 years. Elcitonin 20U was intramuscularly or subcutaneous- ly injected once per day for one week and then 3 times per week after dialysis for a therapeutic course of 12 weeks. They also had low salt and low purine diet. Active vitamin D3 and calcium supplement were with- drawn in patients with hypercalcemia. Blood routine examination （hemoglobin, white blood cells and platelets）, liver functions （direct and indirect bilirubin, alanine aminotransferase and aspartate aminotransferase）, serum calcium, serum phosphate, intact parathyroid hormone （iPTH）, and bone mineral density of the 3rd and 4th lumbar vertebrae were examined. Visual analogue score （VAS） was used to record the pain. Adverse reaction of elcitonin was monitored. Results After the treatment, serum calcium decreased overtime, and decreased significantly after the treatment for 8 weeks as compared with the baseline （t=-2.424, P=0.019）. Serum phosphate and VAS also decrease overtime, and decreased significantly after the treatment for 12 weeks as compared with the baseline （t=-2.061, P=-0.044 for phosphate; 2;= 51.463, P〈 0.0001 for VAS）. However, iPTH decrease after the treatment but without statistical significance （χ^2=11.120, P=0.069）. Bone mineral density was observed in 3 cases, and the density increased after the treatment. Conclusion Elcitonin can decrease se- rum calcium and phosphate, increase bone mineral density, and alleviate joint pain. Elcitonin can be used in the treatment of renal osteodystrophy.