维生素E联合雷洛昔芬对绝经后女性骨质疏松症影响的临床观察

Clinical observation of the effect of vitamin E combined with raloxifene on postmenopausal osteoporosis

目的初步探索维生素E联合雷洛昔芬治疗绝经后女性骨质疏松症的安全性及有效性。方法将120名绝经后妇女随机分为治疗组和对照组,治疗组使用维生素E联合雷洛昔芬干预,对照组单纯予以雷洛昔芬干预。在试验前及试验干预12个月后分别检测两组受试者的腰椎及髋部骨密度、血清骨代谢指标、细胞因子水平及研究期间的药物不良反应和骨折发生率。结果干预12个月后两组患者腰椎(L1~4)及左侧股骨颈的骨密度明显增加,而治疗组的骨密度水平显著高于对照组(P<0.05);干预12个月后治疗组血清BGP、ALP、IL-6、TNF-α、IL-10及TGF-β1的水平均明显改变,而治疗组上述指标的改变均较对照组更为明显,差异有统计学意义(P<0.05);治疗组骨折发生率明显下降,和对照组比较,差异有明显统计学意义(P<0.05),而药物不良反应的差异无统计学意义(P>0.05)。结论维生素E联合雷洛昔芬能有效保护绝经后妇女髋部及腰椎骨密度,改善骨代谢及炎症因子水平,降低骨折发病率,具有较好的安全性。

Objective To explore the safety and efficacy of vitamin E combined with raloxifene on the treatment of postmenopausal osteoporosis.Methods A total of 120 postmenopausal women were randomly divided into the treatment group and the control group.Postmenopausal women in the treatment group received vitamin E combined with raloxifene and those in the control group received raloxifene only.Bone mineral density(BMD),serum bone metabolic index,cytokine level,the incidence of adverse reactions,and the incidence of fracture were measured in the two groups before and after 12 months of the treatment.Results BMD of the lumbar vertebrae(L1-4)and the left femoral neck increased significantly after 12 months of the intervention,while BMD of the treatment group was significantly higher than that of the control group(P<0.05).After 12 months of the intervention,the levels of BGP,ALP,IL-6,TNF-α,IL-10,and TGF-β1 of both groups changed significantly.The levels of BGP,ALP,IL-6,TNF-α,IL-10,and TGF-β1 changed more obviously in the treatment group compared with the control group(P<0.05).The incidence of fracture decreased significantly in the treatment group compared with the control group(P<0.05).The adverse drug reactions were not significantly different between the two groups(P>0.05).Conclusion Vitamin E combined with raloxifene can effectively protect the hip and lumbar vertebra BMD,change the level of bone metabolism and inflammatory factors,reduce the incidence of fracture,and the safety is better.