目的:观察古方青娥丸治疗绝经后骨质疏松症临床疗效,同时初步探讨剂量与有效性、安全性的关系。方法:60例绝经后骨质疏松症患者随机分成3组:A组(大剂量组),B组(正常剂量组),C组(安慰剂组),三组患者均治疗24周,服用钙尔奇D片。对三组患者治疗前后的临床症状、腰背四肢骨痛进行VAs评分,并对骨密度的改善情况进行评估,治疗期间行常规肝肾功能等检查。结果:A组与B组的主要临床症状、腰背四肢骨痛VAS评分治疗后均改善,差异有统计学意义(P值均小于0.01);A组改善优于B组,组间差异有统计学意义(P〈0.05),C组治疗后差异无统计学意义(P〉0.05);A组和B组治疗后骨密度增加差异有统计学意义(P值均小于0.01),A组增加优于B组,组间差异有统计学意义(P〈0.05),C组治疗后差异无统计学意义(P〉0.05)。结论:古方青娥丸能改善临床症状,升高骨密度值,用药安全,其疗效与剂量相关。
Objective:To observe the clinical efficacy of ancient Qing'e pill on the treatment of postmenopausal osteoporosis,and to investigate the relationship between the dose and efficacy, the dose and safety. Methods: All 60 patients with postmenopausal osteoporosis were randomly divided into 3 groups: group A (large dose group), group B (normal dose group), and group C (placebo group). They were taking calcium and other treatment for 24 weeks. The clinical symptoms, VAS score of lower back and four limbs pain,and the improvement of the bone mineral density (BMD) were analyzed. The regular examination such as liver and kidney function during the treatment were detected. Results:The main clinical symptoms,VAS score of lower back and four limbs pain, and BMD in group A and B after treatment were significantly improved than baseline (P〈0. 01), and group A was better than group B (P〈0.05) ,there was no statistically difference in group C after treatment (P〉0.05). Conclusion:Ancient Qing'e pill can safely and effectively improve clinical symptoms, and increase BMD.