青娥丸治疗绝经后骨质疏松症(肾虚血瘀证)的临床研究

Clinical Research of Qing'e Pill in Treatment of Postmenopausal Osteoporosis with Kidney Deficiency and Blood Stasis Syndrome

目的观察古方青娥丸治疗绝经后骨质疏松症(PMOP)肾虚血瘀证患者的临床疗效。方法选择PMOP肾虚血瘀证的患者72例,随机分为A组(钙剂对照组)、B组(青娥丸低剂量组)及C组(青娥丸高剂量组),治疗24周。分别在治疗前与治疗8、16、24周后观察患者疼痛VAS评分;在治疗前、治疗24周后观察患者中医证候积分疗效变化,并检测患者骨密度(BMD)及血清中骨代谢标志物水平。结果B组与C组能有效改善患者临床症状(P<0.01),C组能更快缓解疼痛(P<0.05);B组与C组均能增加各部位BMD(P<0.05),C组对股骨颈及Ward’s三角的效果更为显著(P<0.01);C组能显著降低患者血清中骨代谢标志物(P<0.05),B组仅对β-CTX有降低作用(P<0.05);A组则无明显作用(P>0.05)。结论青娥丸能改善PMOP肾虚血瘀证患者的临床症状,增加BMD,降低患者骨代谢标志物,并且其效果跟用药剂量呈正相关。

Objective This study aimed to evaluate the clinical efficacy of traditional Chinese medical formulae Qing’e pill in the treatment of postmenopausal osteoporosis patients with kidney deficiency and blood stasis syn-drome.Methods Seventy-two postmenopausal osteoporosis patients with kidney deficiency and blood stasis syn-drome were randomly divided into A group （calcium supplements control group ） ,B group（Qing’e pill lower dose group）and C group （Qing’e pill higher dose group ）. All the patients in three groups received treatment for 24 weeks.Patients’ pain VAS score were detected at baseline ,after 8 weeks treatment ,after 16 weeks treatment and after 24 weeks treatment ,respectively. TCM syndrome integral effect change ,bone mineral density and bone me-tabolism markers were detected at baseline and after 24 weeks treatment.Results Compared with A group ,the clinical syndrome of B group and C group improved significantly （P〈0.01） ,and the pain relieved more rapidly in C group than in B group（P〈 0.05）.The bone mineral density of B group and C group increased significantly （P〈0.05） ,however ,the bone mineral density of C group in femoral neck and Ward’s triangle increased more signifi-cantly（P〈0.01）.After 24 weeks treatment ,all the bone metabolism markers of C group reduced obviously （P〈0.05） ,whereas only the bone absorption marker β-CTX decreased in B group（P〈0.05）. The group A had no obvi-ous clinical effect（P〉0.05）.Conclusion Qing’e pill can benefit postmenopausal osteoporosis patients with kidney deficiency and blood stasis syndrome through improving the clinical syndrome ,increasing bone mineral density and inhibiting bone metabolism.