续断壮骨胶囊治疗原发性骨质疏松症的Ⅲ期临床试验研究

Phase Ⅲ clinical investigation of XuDuanZhuangGu capsules to the primary osteoporotic patient

目的确证续断壮骨胶囊治疗原发性骨质疏松症的临床有效性和安全性。方法采用多中心、随机、双盲、安慰剂和阳性药物平性对照的试验设计，将合格受试者以3：1：1的比例分配至治疗组、两个对照组。进行为期6个月的治疗和观察。结果续断壮骨胶囊对腰椎、股骨颈、Ward三角、大粗隆等部位的骨矿密度有明显改善，与安慰组比较差异均具有统计学意义（P〈0．05）。在中医证候的改善方面，续断壮骨胶囊明显优于阳性对照组、安慰剂组，均有统计学意义。治疗期间肝肾功能、血常规、尿常规均无明显异常。结论续断壮骨胶囊能有效提高骨密度，缓解腰背疼痛等症状，疗效好，副作用小，可用于治疗骨质疏松症。

Objective Further comments XuDuanZhuangGu capsule treatment of osteoporosis clinical efficacy and safety. Methods A multicenter, randomized, double-blind, placebo and positive control of the drug-test design, the subjects will be allocated to the ratio of 3 ： 1 ： 1 to the treatment group, two control group. For a six-month treatment and observation. Results XuDuanZhuanggGu capsule on the L2-4, Neck, Wards, Troch of BMD has improved significantly, as compared with the comfort have statistically significant differences（ P 〈 0.05）. TCM Syndrome in the improvements, XuDuanZhuangGu capsule is superior to the positive control group, two placebo group, have statistical significance. During the treatment of liver and kidney function, blood, urine routine presented no significant abnormalities. Conclusion XuDuanZhuangGu capsule can improve BMD, ease back pain etc., good effects, mild after-effect, can be used for treatment of osteoporosis.