【摘要】 目的　随机、开放观察国产鲑降钙素注射液对原发性骨质疏松症 (OP)的疗效和安全性。方法　收集 5 0岁以上妇女 ,自然绝经 2年以上 ,伴有骨痛的OP患者 2 7例。随机分为处理组 (13例 ) ,予肌肉注射国产鲑降钙素 5 0U/次 ,2次 /周 ;对照组 (14例 )予肌肉注射进口鲑降钙素 (密盖息 ) 5 0U/次 ,2次 /周 ;同时均补充凯思立D 1片 /d ,共 6个月。观察治疗前和治疗 6个月后骨密度 (BMD)值、治疗前和治疗后 3、6个月后血尿骨转换生化指标的变化、疼痛等症状的缓解和不良反应。结果　治疗 6个月后 ,处理组L2～ 4的BMD值增加2 .0 12 % ,与治疗前比较 ,差异有显著性 (P <0 .0 5 ) ;股骨颈 (Neck)、股骨粗隆 (Troch)的BMD值分别增加0 .794 %和 2 .4 34% ,与治疗前比较 ,差异无显著性 (P >0 .0 5 )。对照组L2～ 4和Troch的BMD值分别增加2 .6 97%和 3.2 14 % ,与治疗前比较 ,差异均有显著性 (P <0 .0 5 ) ;Neck的BMD值增加 1.30 0 % ,与治疗前比较 ,差异无显著性 (P >0 .0 5 )。但两组间各部位BMD平均变化百分率 ,差异均无显著性 (P >0 .0 5 )。处理组治疗后6个月血清全分子骨钙素 (BGP)较治疗前显著降低 (P <0 .0 5 ) ,与对照组相比 ,差异无显著性。处理组与对照组对骨痛缓解率分别为 88.9%、89.5 % ,两组间差异无显著?更多还原

【Abstract】 Objective To evaluate the effects and safety of home-made salmon calcitonin in the treatment of primary osteoporosis by a randomized and open study. Methods 27 women more than 50 year old with natural menopause for over 2 years and all were the victims of primary osteoporosis with bony pain. The patients were randomly divided into 2 groups. 13 women were given home-made salmon calcitonin (treated group), the mean age was (70.69±6.32) years (58～81 years) ; and 14 women were given miacalcic (matched control group) , the mean age was (72.29±6.12) years (64～84 years). The dosage of salmon calcitonin or miacalcic was 50 IU each injected intramuscularly twice a week, and both groups received one calci-chew D tablet everyday for 6 months. The BMD values were evaluated both before therapy and 6 months after therapy. The sera and urine markersof bone turnover were measured before therapy and 3, 6 months after therapy respectively. Alleviation of pain and the adverse effects of each group were evaluated as well.Results After 6 months’ therapy, both the treated group and the control group showed improvement on the average percent of BMD. In the treated group, BMD of L 2～4 increased 2.012%, the difference was significant comparing to that before therapy (P<0.05), BMD of Neck and Troch increased 0.794% and 2.434% respectively, but with no statistical difference as compared with those to before therapy (P>0.05). In the control group, BMD of L 2-4 and Troch increased 2.697% and 3.214% respectively, the difference was significant comparing to those before therapy (P<0.05), but BMD of neck increased 1.3% only, the difference of which was not significant comparing to that before therapy (P>0.05). There was no significant difference between the two groups on the average percent of BMD in all parts. The sera BGP levels of the treated group decreased with significant difference (P<0.05) after 6 months’ therapy. The rate of pain relief of the treated group and the controlled group was 88.9% and 89.5% respectively. There was no significant difference between the two groups. Both groups had slight adverse effects, as hectic fever、headache and nausea etc. Neither group had abnormalities in the liver and renal function.Conclusion Home-made calcitonin has good analgesic effect and increases the BMD effect of the osteoporotic patients with bony pain, the same is with Miacalcic, few adverse effects are seen in both drugs. Home-made calcitionin is safe and efficient for osteoporosis.更多还原