新疆地区女性绝经后原发性骨质疏松患者联合用药治疗的临床研究

Clinical study of drug combination treatment for postmenopausal primary osteoporosis in Xinjiang area

目的通过完全随机化对照研究,探讨不同药物组合对女性绝经后原发性骨质疏松症患者的治疗效果。方法选择我院2008年5月～2009年12月期间,绝经后的骨质疏松患者;共298人,年龄50～87岁,平均(67.3±10.5)岁。随机被分为3组,分别为:A组:钙(Ca)+骨化三醇组(C);B组:钙(Ca)+骨化三醇(C)+降钙素(CT)组;C组:钙(Ca)+骨化三醇(C)+双磷酸盐组(BP)。进行药物治疗观察1年以上。观察药物治疗期间骨密度、骨生化指标25-(OH)D3、BAP、TRACP-5b变化情况,从药物疗效、依从性、恶性事件,骨折发生率等多方面加以研究。结果:最终完成研究的共有220人(74.5%)。A组治疗依从性要好于B组和C组(P<0.01),B组治疗依从性要差于C组尤其前半年(P<0.05)。B组,C组联合用药前后骨密度的改善最为明显,骨生化指标变化明显,差异有显著性(P<0.05)。显示A组对治疗骨质疏松症效果有限,B组治疗半年后患者BAP水平明显上升且TRACP-5b明显下降(P<0.05),一年后患者胸椎及髋部BMD分别提高了7.08%及9.60%。C组骨生化变化趋势与B组类似,胸椎及髋部BMD分别提高了5.07%和6.92%。B组,C组再骨折发生低于A组。结论钙剂和维生素D基础用药的基础上联合抗骨吸收药物阿伦膦酸钠或降钙素早期较明显抑制骨吸收,一年后可以明显提高骨密度,且降低新发骨折的发生率。它们联合治疗达到了叠加的效果,即1+1>2。但联合治疗由于费用、不良反应的增加,降低了治疗依从性。此外新疆地区女性绝经后原发性骨质疏松患者25-(OH)D3用药剂量不足,应更多补充维生素D。

Objective To investigate the effect of different drug eombinations on the treatment of postmenopausal primary osteoporosis using completely randomized control study. Methods A total of 298 patients with postmenopausal osteoporosis, who came to our hospital from May 2008 to December 2009, were selected. Their age ranged from 50 to 87 years old, with an average age of 67.3 ± 10.5 years old. All the patients were randomly divided into 3 groups with different treatment： Group A was treated with Calcium （Ca） ＋ ealcitriol （C） , Croup B was treated with Ca ＋ C ＋ ealeitonin （CT） , and Group C was treated with Ca ＋ C ＋ bisphosphonates （BP）. The whole treatment lasted for more than 1 year. Changes of BMD and bone biochemical markers including 25-（ OH）-D3, BAP, and TRACP-Sb were observed during the whole treatment. The data was analyzed from many aspects including the effectiveness of the drugs, compliance, severe side effects, and re-fracture rate. Results Two hundred and twenty patients received the whole 1-year treatment, accounting for 74.5%. The compliance of patients in Group A was better than that in Group B and C （P 〈 0. 01 ）. The compliance of patients in Group B was worse than that in Group C,especially in the first half of the year （P 〈 0.05）. BMD in Group B and C increased more significantly than that in Group A, and biochemical markers in Group B and C increased obviously （P 〈 0.05）. The effect of the treatment in Group A on osteoporosis was limited. BAP level increased markedly, but TRACP-5b decreased obviously in Group B after a 6-month treatment （ P 〈 0. 05 ）. BMD of the lumbar vertebrae and the hip in Group B after 1-year treatment increased 7.08% and 9.60% , respectively. The changes in Group C were similar with those in Group B, and BMD of the lumbar vertebrae and the hip increased 5.07% and 6.92% , respectively. The re-fracture rate in Group B and C was lower than that in Group A. Conclusion The combined use of anti-osteoporotic drugs such as zoledronic acid or calcitonin on the basis of calcium and vitamin D at early stage can significantly inhibit bone resorption. BMD was significantly improved after 1- year treatment. The rate of new fractures decreased. The drug combination treatment is more efficient than the single use of each drug, but the compliance decreases with the increase of cost and adverse reactions. In addition, the dosage of 25-（OH）-D3 for patients with postmenopausal primary osteoporosis in Xinjiang area is insufficient. The VitD supplementation should be more.