六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松的临床研究

Clinical study of Liuwei Dihuang Pills combined with zoledronic acid in treatment of postmenopausal osteoporosis in women

目的探讨六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松的临床效果。方法选取2015年6月—2017年1月广东医科大学附属医院收治的86例绝经后骨质疏松患者,随机分为对照组和治疗组,每组各43例。对照组静脉滴注唑来膦酸注射液,5 mg/次,1次/年。治疗组在此基础上口服六味地黄丸,8丸/次,3次/d。所有患者均连续治疗12个月。观察两组的临床疗效,比较两组治疗前后视觉模拟(VAS)评分、简明健康状况调查量表(SF-36)评分、腰椎1~4骨质密度(BMD)、全髋关节骨BMD、左侧股骨颈BMD、Ⅰ型原胶原氨基端前肽(PINP)、β-胶原降解产物(β-CTX)、碱性磷酸酶(ALP)、骨钙素(BGP)的变化情况。结果治疗后,对照组和治疗组的总有效率分别为79.07%、95.35%,两组比较差异有统计学意义(P<0.05)。治疗后,两组VAS评分、血清PINP、β-CTX、ALP及BGP水平显著降低,SF-36评分、腰椎1~4 BMD值、全髋关节骨BMD值、左侧股骨颈BMD值显著升高,同组治疗前后比较差异有统计学意义(P<0.05);治疗后,治疗组VAS评分、血清PINP、β-CTX、ALP及BGP水平低于对照组,SF-36评分、腰椎1~4 BMD值、全髋关节骨BMD值、左侧股骨颈BMD值高于对照组,两组比较差异有统计学意义(P<0.05)。结论六味地黄丸联合唑来膦酸治疗妇女绝经后骨质疏松具有较好的临床疗效,可有效缓解患者疼痛症状,增加骨密度,提高生活质量,具有一定的临床推广应用价值。

Objective To investigate the clinical effects of Liuwei Dihuang Pills combined with zoledronic acid in treatment of postmenopausal osteoporosis in women. Methods Patients（86 cases） with postmenopausal osteoporosis in Affiliated Hospital of Guangdong Medical University from June 2015 to January 2017 were randomly divided into control（43 cases） and treatment（43 cases） groups. Patients in the control group were iv administered with Zoledronic Acid Injection, 5 mg/time, once yearly. Patients in the treatment group were po administered with Liuwei Dihuang Pills on the basis of the control group, 8 pills/time, three times daily. Patients in two groups were treated for 12 months. After treatment, the clinical efficacy was evaluated, and the VAS score, SF-36 score, lumbar vertebrae 1-4 BMD, total hip bone BMD, left femoral neck BMD, PINP, β-CTX, ALP, and BGP in two groups before and after treatment. Results After treatment, the clinical efficacy in the control and treatment groups were 79.07% and 95.35%, and there were differences between two groups（P〈0.05）. After treatment, VAS score, PINP, β-CTX, ALP, and BGP in two groups were significantly decreased, but SF-36 score, lumbar vertebrae 1-4 BMD, total hip bone BMD, left femoral neck BMD were significantly increased, and there were differences in the same group（P〈0.05）. After treatment, VAS score, PINP, β-CTX, ALP, and BGP in the treatment group were lower than those in the control group, but SF-36 score, lumbar vertebrae 1-4 BMD, total hip bone BMD, left femoral neck BMD were higher than those in the control group, and there were differences between two groups（P〈0.05）. Conclusion Liuwei Dihuang Pills combined with zoledronic acid has significant clinical effect in treatment of postmenopausal osteoporosis in women, and can effectively relieve pain symptoms, also can increase bone density and improve life quality, which has a certain clinical application value.