结合雌激素片联合用药治疗绝经后骨质疏松症的临床观察

Clinical Observation of Combined Use of Estrogens Tablets in the Treatment of Osteoporosis in Postmenopausal

目的:探讨结合雌激素片联合鲑降钙素注射液和阿仑膦酸钠片治疗绝经后骨质疏松症的临床疗效及安全性。方法:148例绝经后骨质疏松症患者按照随机数字表法分为观察组(78例)和对照组(70例)。对照组患者皮下或肌内注射鲑降钙素注射液,每次100 IU,用药第1周时每天1次,第2周为隔天1次,第3周开始每3天1次,连续注射21次为1个疗程;并口服阿仑膦酸钠片,每次70 mg,每周1次,3个月为1个疗程。观察组患者在对照组治疗基础上加服结合雌激素片,每次0.625 mg,qd,连续服用3周后停药1周,然后继续服用,3个月为1个疗程。观察两组患者的临床疗效,治疗前后的血清骨钙素(BGP)、人Ⅰ型胶原N末端肽(NTX)、血清碱性磷酸酶(ALP)等骨代谢指标和骨密度变化情况,以及不良反应发生情况。结果:治疗后,观察组患者的总有效率为94.87%,显著高于对照组的78.57%,差异有统计学意义(P<0.05);两组患者的血清BGP、腰椎及股骨的骨密度均较治疗前显著提高,且观察组提高的幅度显著大于对照组,差异均有统计学意义(P<0.05);两组患者的NTX和ALP均较治疗前显著降低,且观察组降低的幅度显著大于对照组,差异均有统计学意义(P<0.05)。观察组患者的不良反应总发生率为12.82%,对照组为8.57%,组间比较差异无统计学意义(P>0.05),且停药后各不良反应症状均消失。结论:结合雌激素片联合鲑降钙素注射液和阿仑膦酸钠片治疗绝经后骨质疏松症可有效缓解患者骨痛症状、调节骨代谢水平、增加骨密度,且不良反应轻微。

OBJECTIVE： To investigate clinical efficacy and safety of conjugeted estrogen tablets combined with Salmon calci- tonin acetate injection and Alendronate sodium tablets in the treatment of osteoporosis in postmenopausal. METHODS： 148 postmenopausal women with osteoporosis were randomly divided into observation group （78 cases） and control group （70 cases）. Con- trol group was given Salmon calcitonin acetate injection hypodermically or intramuscularly, 100 IU each time, once a day in first week, every two days in second week, every three days in third week, 21 times of consecutive injection as a treatment course; Alendronate sodium tablet, 70 mg each time, once a week, 3 months as a treatment course. Based on control group, observation group was additionally given conjugeted estrogen tablets, 0.625 mg each time, qd, for consecutive 3 weeks, drug withdrawal for one week, and then continued to taking drug, for 3 months in total. Clinical efficacy of 2 groups were observed as well as BGP, bone metabolism index as human collagen type I N-terminal peptide （NTX） and ALP, bone density and ADR before and after treatment. RESULTS： After treatment, total effective rate of observation group was 94.87%, which was significantly higher than 78.57% in control group, with statistical significance （P〈0.05） ; BGP, lumbar spine and thigh-bone density of 2 groups were all improved significantly, and the improvement of observation group was more significant than that of control group, with statistical significance （P〈0.05）. NTX and ALP of 2 groups were decreased significantly, and the decrease of observation group was more significant than that of control group, with statistical significance （P〈0,05）. The incidence of ADR was 12,82% in observation group and 8.57% in control group, without statistical significance （P〉0.05） ; various ADR disappeared after drug withdrawal. CONCLUSIONS： Conjugeted estrogen tablets combined with Salmon calcitonin acetate injection and Alendronate sodium tablets can effectively relieve bone pain, regulate bone metabolism, increase bone density and induce slight ADR in postmenopausal with osteoporosis.