目的观察阿伦膦酸钠治疗绝经后骨质疏松症(PMO)患者,其骨密度(BMD)、IL-6、TNFα、胰岛素样生长因子-Ⅰ(IGF-Ⅰ)及骨代谢指标的变化。方法选择年龄55—60岁的PMO患者共185例,随机分为:阿伦膦酸钠组69例,替勃龙组66例,钙剂组50例和年龄相匹配的正常妇女20例作为对照组。各组均于用药前和用药后24、48周测定BMD(采用DEXA骨密度仪)、雌二醇(E2)、碱性磷酸酶(ALP,放免法)、骨钙素(BGP)、Ⅰ型胶原N末端肽(NTX)、IL-6、TNFα、IGF-Ⅰ(ELISA)。结果阿伦膦酸钠组和替勃龙组BMD较治疗前均有不同程度的提高,腰椎BMD增幅分别为2.53%、3.65%(P〈0.05),非优势侧股骨近端增幅分别为7.17%、3.01%(P〈0.001)。替勃龙组E2水平明显上升(P〈0.01),IL-6、TNFα、NTX下降(P〈0.01);阿伦膦酸钠组E2水平无变化(P〉0.05),ALP、BGP水平上升(P〈0.05),NTX水平下降(P〈0.05),IGF-Ⅰ、IL-6、TNFα水平无明显变化(P〉0.05);钙剂组和对照组各部位BMD、E2、IGF-Ⅰ、ALP、BGP继续下降(P〈0.05),而IL-6、TNFα、NTX升高(P〈0.05)。结论阿伦膦酸钠组治疗PMO疗效显著,与替勃龙相仿。单纯服用钙剂不能治疗PMO.且继续骨量丢失。
Objective To observe the effects of alendronate on bone mineral density (BMD), cytokines and indices of bone metabolism in postmenopausal osteoporotic (PMO) patients. Methods 185 PMO patients, aged from 55 to 60 years, were randomized into three groups. All of them received a kind of calcium preparation, 1.0 g/d. Group A, 69 patients, received alendronate,10 mg/d; group B, 66 patients, received tibolone 1.25 mg/d . The remaining patients, group C, received calcium preparation only. 20 women of 55-60(57.4 ± 3. 5) years old were taken as normal controls. Dual-energy X-ray absorptiometry and measurement of a series of biochemical indices were carried out before and after medication at 24th and 48th week. Results After medication, BMD increased in alendronate and tibolone group. The increment in spine BMD was 2. 53% and 3.65% (P 〈0. 05) and that in nondominant proximal femur BMD was 7. 17% and 3.01% ( P 〈 0. 001 ). In the tibolone group, the levels of estradiol( E2 ) increased rapidly( P 〈 0. 01 ) , but those of IL-6, TNFα and type Ⅰ collagen cross-linked N-telopeptides (NTX) decreased ( P 〈 0. 01 ). In the alendronate group, no change of levels of E2 happened, while levels of alkaline phosphatase(ALP) and osteocalcin (BGP) increased (P 〈 0. 05 )and levels of NTX decreased( P 〈 0. 05 ). There was no change of the levels of other parameters. In the calcium preparation group and control group, the levels of BMD, E2, ALP,BGP and insulin-like growth factor Ⅰdecreased ( P 〈 0. 05 ), while those of IL-6, TNFα and NTX increased ( P 〈 0. 05 ). Condusion Alendronate can significantly improve BMD as tibolone do. Thus it plays an important role in the treatment of osteoporosis. However calcium tablet can not prevent the loss of bone.