摘要
目的 观察福美加联合消渴壮骨方治疗糖尿病合并骨质疏松的临床疗效及不良反应.方法 将200例糖尿病合并骨质疏松患者按随机数字表随机分为研究组和对照组.研究组100例应用福美加联合消渴壮骨方治疗,对照组100例应用福美加治疗,观察两组疗效.参照中药新药临床研究指导原则,观察L1~4骨密度平均值（BMD）、糖化血红蛋白（HbA1c）、空腹血糖（FBG）、餐后2 h血糖（2 hPG）血清学等指标变化情况,临床症状改善及不良反应等情况.结果治疗后两组临床症状较治疗前均有改善,差异具有统计学意义（P 〈 0.05）,治疗后研究组有效率高于对照组,差异具有统计学意义（P 〈 0.05）.两组均未发生严重不良反应.结论 福美加联合消渴壮骨方治疗糖尿病合并骨质疏松有较好的临床效果,疗效优于单一疗法,不良反应少,值得临床推广.
Objective To observe the clinical therapeutic effect and adverse effect of fosamax combining with xiaokezhunggu formula on patients with diabetic osteoporosis. Methods This prospective randomized trial included 200 diabetic osteoporosis patients. The 100 patients were selected as study group,who were treated by fosamax and Xiaokezhunggu formula while the other 100 patients as control group were treated by fosamax only. Consult Chinese medicine new drug clinical research guiding principle, observe the bone mineral density, bone mineral content, sero- logical index changes ,the clinical symptoms improved and adverse reactions. Results All patients showed significant improvements of clinical symptom before and after treatment （P 〈 0.05）, and the study group was better than the con- trol group （P 〈 0.05）. Conclusion Combining with fosamax and xiaokezhunggu formula on patients with diabetic os- teoporosis have more clinical effects.
出处
《中国现代医生》
2013年第16期69-71,共3页
China Modern Doctor
基金
浙江省继续医学教育项目(2011-04-07-010)
