益骨汤治疗老年性骨质疏松症的临床疗效评价  

Clinical evaluation of Yigu decoction in treating senile osteoporosis

作　　者：闫坤 张瑞坤 吴雨伦 陈智能[2] 陈华 姚新苗[2] YAN Kun;ZHANG Ruikun;WU Yulun;CHEN Zhineng;CHEN Hua;YAO Xinmiao(Zhejiang Chinese Medical University, Hangzhou 310053, China;Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 311005, China;Second Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou 310005, China)

机构地区：[1]浙江中医药大学,浙江杭州310053 [2]浙江中医药大学附属第三医院,浙江杭州311005 [3]浙江中医药大学附属第二医院,浙江杭州310005

出　　处：《中国骨质疏松杂志》2022年第5期675-679,共5页Chinese Journal of Osteoporosis

基　　金：全国名老中医药专家传承工作室建设项目(国中医药人教发[2014]20号);浙江省国医名师建设项目(浙卫发[2018]70号);浙江省中医药科技重大疾病攻关计划项目(2012ZGG044);浙江省自然基金项目(LY17H270005)。

摘　　要：目的评价益骨汤治疗老年性骨质疏松症(senile osteoporosis,SOP)的临床疗效和安全性。方法采用多中心随机对照的临床设计方案,从2015年1月至2016年12月的住院患者中,选取214例患有SOP的患者,按照治疗方案随机分为治疗组和对照组。对照组105例,其中男性43例,女性62例,年龄(77.1±6.6)岁,运用基础治疗(元素钙600 mg、维生素D 125 U,每日1次,连续服用;福善美70 mg/片,每周1次,连续服用3个月;结合运动疗法)。治疗组109例,其中男性52例,女性57例,年龄(76.5±7.1)岁,在对照组的治疗方案基础上再加服益骨汤。两组患者均以3个月为一个疗程,随访期为6个月。治疗后,采用视觉模拟评分法(visual analogue scale,VAS)评分、腰椎骨密度(bone mineral density,BMD)、骨折风险评估(fracture risk assessment,FRAX)、中医证候评分以及骨代谢指标(碱性磷酸酶ALP和血浆抗酒石酸酸性磷酸酶TRAP5b)评定两组临床疗效。结果214例患者获得随访,治疗后SOP患者VAS评分、BMD、FRAX、中医证候评分和骨代谢指标(ALP、TRAP5b)较治疗前均有明显改善,差异有统计学意义(P<0.05),且经治疗后,治疗组改善程度较对照组明显,VAS评分及中医证候评分比较差异有统计学意义(P<0.01)。观察组总有效率82.6%高于对照组68.6%,对比差异具有统计学意义(P<0.05)。结论在常规抗SOP的同时口服中药益骨汤,可以提高BMD,促进骨形成,在缓解SOP患者疼痛程度及综合活动功能方面,优势更加明显,具有较好的临床疗效和安全性。Objective To evaluate the clinical efficacy and safety of Yigu decoction in the treatment of senile osteoporosis.Methods A multi-center randomized controlled clinical design was adopted.From January 2015 to December 2016,214 patients with senile osteoporosis were randomly divided into treatment group and control group.There were105 patients in the control group,including 43 males and 62 females,aged(77.10±6.64)years,were treated with basic therapy(element calcium 600 mg,vitamin D125U,once a day,continuous used;alendronate 70 mg/tablets,once a week,continuous for 3 months;combined with exercise therapy).There were 109 patients in the treatment group,including 52 males and 57 females,aged(76.51±7.13)years old,were treated with Yigu decoction on the basis of the treatment plan of the control group.Patients in both groups took 3 months as a course of treatment,and the follow-up period was 6 months.After treatment,the clinical effects of the two groups were evaluated by visual analog score(VAS),lumbar bone mineral density(BMD),fracture risk assessment(FRAX),TCM syndrome score and bone metabolism index(alkaline phosphatase,ALP and plasma tartrate resistant acid phosphatase,TRAP5b).Results A total of 214 patients were followed up.After treatment,the VAS score,BMD,FRAX,TCM syndrome score and bone metabolism index(ALP,TRAP5b)of elderly patients with fracture and osteoporosis were significantly improved compared with those before treatment,and the difference was statistically significant(P<0.05).After treatment,the improvement in the treatment group was more obvious than that in the control group,and the differences in VAS score and TCM syndrome score were statistically significant(P<0.01).The total effective rate in the observation group was 82.6%higher than that in the control group 68.6%(P<0.05).Conclusion Oral administration of Yigu decoction can improve BMD and promote bone formation.It has more obvious advantages in relieving pain and comprehensive activity function of patients with senile osteoporosis,and has bett

关 键 词：益骨汤 老年性骨质疏松症 临床疗效 安全性 

分 类 号：R274.9[医药卫生—中西医结合]