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目的:对围绝经期及绝经后低骨密度女性实施性激素联合阿伦膦酸钠和钙剂干预,观察临床疗效及安全性。方法:采用随机、双盲、平行临床研究。311例围绝经期及绝经后低骨密度患者随机分为4组:联合组(HT+ALN):78例,雌孕激素+阿伦膦酸钠;性激素补充治疗(HT)组:78例,口服雌孕激素;阿伦膦酸钠(ALN)组:78例,口服阿伦膦酸钠10 mg/天,各组均加服碳酸钙600 mg和维生素D125 IU;对照组:77例,单服碳酸钙600 mg和维生素D125IU。疗程半年。观察各组治疗后患者右前臂远端骨密度变化及疼痛症状改善情况。结果:通过半年治疗,骨密度变化情况:联合组患者骨密度的上升最明显(P<0.01),骨密度提高3.7%,高于其他两组。HT组和ALN组患者的骨密度较治疗前均有明显上升(P<0.05),HT组骨密度提高2.21%,ALN组骨密度提高2.23%,两组相比较,无统计学意义(P>0.05)。对照组骨密度略有提高,但无统计学意义(P>0.05)。骨痛症状改善情况:联合组治疗后骨痛症状较治疗前显著缓解,差异明显(P<0.01),总有效率为98.7%,显效率高于其他两组。HT组和ALN组骨痛症状也较治疗前明显缓解(P<0.05),HT组总有效率为83.3%,ALN组总有效率85.9%,ALN组略高于HT组,但无统计学意义(P>0.05)。对照组骨痛缓解缓慢,总有效率27.2%。结论:HT联合阿伦膦酸钠和钙剂治疗,既可安全有效地预防与低雌激素相关的骨量丢失,降低骨质疏松性骨折的发生率,又可同时改善此阶段雌激素缺乏相关症状。
OBJECTIVE: To observe the clinical efficacy and safety of sexual hormones combined with alendronate and calcium in perimenopausal and postmenopausal women with low BMD. Methods: A randomized, double-blind, parallel clinical study. 311 cases of perimenopausal and postmenopausal low BMD were randomly divided into 4 groups: HT + ALN: 78 cases, estrogen and progesterone + alendronate sodium; sex hormone replacement therapy (HT) group: 78 cases, Oral administration of estrogen and progesterone; alendronate (ALN) group: 78 cases, oral alendronate 10 mg / day, each group were served with calcium carbonate 600 mg and vitamin D125 IU; control group: 77 Take 600 mg of calcium carbonate and vitamin D125IU. Half a course of treatment. Observe the changes of the distal right forearm bone mineral density and the improvement of the pain symptom in each group after treatment. Results: The changes of bone mineral density after six months’ treatment showed that the bone mineral density increased most significantly in the combined group (P <0.01), and the bone mineral density increased by 3.7%, higher than the other two groups. The BMD of HT group and ALN group were significantly higher than those before treatment (P <0.05). The BMD of HT group increased by 2.21% and the bone mineral density of ALN group increased by 2.23% (P <0.05). There was no significant difference between the two groups (P> 0.05). The control group had a slight increase in bone mineral density, but no significant difference (P> 0.05). The improvement of the bone pain symptom: After the treatment, the pain symptom of the joint group was significantly relieved compared with that before treatment (P <0.01). The total effective rate was 98.7%. The effective rate was higher than the other two groups. The symptoms of bone pain in HT group and ALN group were also significantly relieved (P <0.05). The total effective rate was 83.3% in HT group and 85.9% in ALN group, but slightly higher in ALN group than that in HT group (P> 0.05). The pain relief in the control group was slow, with a total effective rate of 27.2%. CONCLUSION: HT combined with alendronate and calcium can not only prevent the bone loss associated with low estrogen safely and effectively, but also reduce the incidence of osteoporotic fractures, and at the same time improve the estrogen deficiency-related symptom.