益肾健骨胶囊联合阿法骨化醇治疗肝肾不足型骨质疏松症的临床研究  

Clinical study of Yishen Jiangu Capsules combined with alfacalcidol in treatment of osteoporosis of liver and kidney deficiency type

作　　者：王柯[1] 叶寒露[2] 张劲[3] WANG Ke;YE Hanlu;ZHANG Jin(Department of Orthopedics and Traumatology,Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430014,China;Department of Endocrinology,Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430014,China;Department of Orthopaedics,Second Bridge Hospital,Wuhan Hospital of Traditional Chinese Medicine,Wuhan 430000,China)

机构地区：[1]武汉市中医医院骨伤科,湖北武汉430014 [2]武汉市中医医院内分泌科,湖北武汉430014 [3]武汉市中医医院二桥院区骨科,湖北武汉430000

出　　处：《现代药物与临床》2024年第8期2077-2082,共6页Drugs & Clinic

基　　金：湖北省卫生计生委中医药科研项目资助项目(ZY2019Z009)。

摘　　要：目的探讨益肾健骨胶囊联合阿法骨化醇治疗肝肾不足型骨质疏松症的临床疗效。方法选取2021年9月—2023年10月武汉市中医医院骨科收治的200例肝肾不足型骨质疏松症患者,依据用药情况将所有患者分为对照组和治疗组,每组各100例。对照组口服阿法骨化醇片,0.25μg/次,1次/d。治疗组在对照组的治疗基础上口服益肾健骨胶囊,4粒/次,3次/d。两组用药12周。观察两组患者的临床疗效和症状缓解时间,比较两组治疗前后疼痛数字评价量表(NRS)评分、腰椎Oswetry功能障碍指数(ODI)评分、骨钙素(BGP)、骨保护素(OPG)、β-胶原降解产物(β-CTX)、Ⅰ型前胶原氨基端前肽(s-PINP)、Ⅰ型胶原羧基端交联肽(s-CTX)、肿瘤坏死因子-α(TNF-α)、促生长因子-1(IGF-1)、白细胞介素-6(IL-6)的变化情况。结果治疗后,治疗组总有效率是96.00%,显著高于对照组的88.00%(P<0.05)。治疗后,治疗组腰痛、乏力、肌肉痉挛、脊柱变形缓解时间均短于对照组(P<0.05)。治疗后,两组NRS评分、ODI评分均显著降低(P<0.05);治疗后,治疗组NRS评分、ODI评分低于对照组(P<0.05)。治疗后,两组患者BGP、OPG显著升高,而β-CTX、s-PINP显著降低(P<0.05);治疗后,治疗组骨代谢指标改善优于对照组(P<0.05)。治疗后,两组血清s-CTX、TNF-α、IL-6均显著降低,而IGF-1水平显著升高(P<0.05);治疗后,治疗组血清学指标改善优于对照组(P<0.05)。结论益肾健骨胶囊联合阿法骨化醇治疗骨质疏松症具有较好的临床疗效,患者临床症状好转显著,较好纠正骨代谢,降低机体炎性因子水平,值得借鉴与应用。Objective To explore the therapeutic effect of Yishen Jiangu Capsules combined with alfacalcidol in treatment of osteoporosis of liver and kidney deficiency type.Methods A total of 200 patients with hepatorenal deficiency osteoporosis admitted to the Orthopedics Department of Wuhan Hospital of Traditional Chinese Medicine from September 2021 to October 2023 were selected and divided into control group and treatment group according to drug use,with 100 patients in each group.Patients in the control group were po administered with Alfacalcidol Tablets,0.25µg/time,once daily.Patients in the treatment group were po administered with Yishen Jiangu Capsules on the basis of the control group,4 grains/time,three times daily.Both groups were treated for 12 weeks.The clinical efficacy and symptom remission time of the two groups were observed.The changes of NRS score,Lumbar Oswetry Dysfunction Index(ODI)score,BGP,OPG,β-CTX,s-PINP,s-CTX,TNF-α,IGF-1,and IL-6 were compared between the two groups before and after treatment.Results After treatment,the total effective rate of the treatment group was 96.00%,which was significantly higher than that of the control group(88.00%,P<0.05).After treatment,the relief time of low back pain,fatigue,muscle spasm and spinal deformation in the treatment group was shorter than that in the control group(P<0.05).After treatment,NRS score and ODI score were significantly decreased in both groups(P<0.05).After treatment,NRS scores and ODI scores in the treatment group were lower than those in the control group(P<0.05).After treatment,BGP and OPG were significantly increased,whileβ-CTX and s-PINP were significantly decreased(P<0.05).After treatment,the improvement of bone metabolism indexes in treatment group was better than that in control group(P<0.05).After treatment,serum s-CTX,TNF-αand IL-6 were significantly decreased in both groups,while the level of IGF-1 was significantly increased(P<0.05).After treatment,the improvement of serological indexes in treatment group was better than that i

关 键 词：益肾健骨胶囊 阿法骨化醇片 骨质疏松症 疼痛数字评价量表评分 腰椎Oswetry功能障碍指数评分 骨钙素 骨保护素 β-胶原降解产物 Ⅰ型前胶原氨基端前肽 

分 类 号：R977[医药卫生—药品]