CAJ | 학술논문

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。
목적：관찰고방청아환치료절경후골질소송증（PMOP）신허혈어증환자적림상료효。방법선택PMOP신허혈어증적환자72례，수궤분위A조（개제대조조）、B조（청아환저제량조）급C조（청아환고제량조），치료24주。분별재치료전여치료8、16、24주후관찰환자동통VAS평분；재치료전、치료24주후관찰환자중의증후적분료효변화，병검측환자골밀도（BMD）급혈청중골대사표지물수평。결과B조여C조능유효개선환자림상증상（P＜0.01），C조능경쾌완해동통（P＜0.05）；B조여C조균능증가각부위BMD（P＜0.05），C조대고골경급Ward’s삼각적효과경위현저（P＜0.01）；C조능현저강저환자혈청중골대사표지물（P＜0.05），B조부대β-CTX유강저작용（P＜0.05）；A조칙무명현작용（P＞0.05）。결론청아환능개선PMOP신허혈어증환자적림상증상，증가BMD，강저환자골대사표지물，병차기효과근용약제량정정상관。
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.