金天格胶囊联合利塞膦酸钠治疗绝经后骨质疏松的临床研究

Clinical study on Jintiange Capsules combined with risedronate sodium in treatment of postmenopausal osteoporosis

目的探讨金天格胶囊联合利塞膦酸钠胶囊治疗绝经后骨质疏松的临床疗效。方法选取2015年12月—2016年12月焦作市第二人民医院风湿免疫科收治的绝经后骨质疏松患者151例作为研究对象,所有患者随机分为对照组(75例)和治疗组(76例)。对照组早餐前30 min直立位口服利塞膦酸钠胶囊,1粒/次,1次/d。治疗组在对照组基础上口服金天格胶囊,3粒/次,3次/d。两组患者均连续治疗6个月。观察两组的临床疗效,比较两组的骨代谢指标和骨密度。结果治疗后,对照组和治疗组的总有效率分别为80.00%、96.05%,两组比较差异有统计学意义(P<0.05)。治疗后,两组Ⅰ型前胶原氨基端前肽(PINP)、骨钙素(BGP)和β-胶原降解产物(β-CTx)水平均明显降低,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组骨密度均明显升高,同组治疗前后比较差异有统计学意义(P<0.05);且治疗组骨密度明显高于对照组,两组比较差异具有统计学意义(P<0.05)。结论金天格胶囊联合利塞膦酸钠胶囊治疗绝经后骨质疏松具有较好的临床疗效,能改善患者体内的骨代谢指标,提高骨密度,安全性较好,具有一定的临床推广应用价值。

Objective To explore the clinical effect of Jintiange Capsules combined with Risedronate Sodium Capsules in treatment of postmenopausal osteoporosis. Methods Patients（151 cases） with postmenopausal osteoporosis in Department of Rheumatology of Jiaozuo Second People＇s Hospital from December 2015 to December 2016 were randomly divided into the control group（75 cases） and the treatment group（76 cases）. Patients in the control group were po administered with Risedronate Sodium Capsules at 30 minutes before the meal, 1 grain/time, once daily. Patients in the treatment group were po administered with Jintiange Capsules on the basis of the control group, 3 grains/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and bone metabolism indexes and bone mineral density in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 80.00% and 96.05%, respectively, and there was difference between two groups（P〈0.05）. After treatment, the levels of PINP, BGP, and β-CTx in two groups were significantly decreased, and the difference was statistically significant in the same group（P〈0.05）. And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups（P〈0.05）. After treatment, the bone mineral densities in two groups were significantly increased, and the difference was statistically significant in the same group（P〈0.05）. And the bone mineral density in the treatment group was significantly higher than that in the control group, with significant difference between two groups（P〈0.05）. Conclusion Jintiange Capsules combined with Risedronate Sodium Capsules has clinical curative effect in treatment of postmenopausal osteoporosis, can improve bone metabolism indexes, and increase the bone mineral density, with good safety, which has a certain clinical application value.