联合注入法结合PKP术后联用金天格胶囊和伊班膦酸钠治疗老年骨质疏松性椎体压缩骨折的临床研究  

Clinical Study of Jintiange Capsule Combined with Ibandronate Sodium and Combined Injection Method with PKP in the Treatment of Senile Osteoporotic Vertebral Compression Fractures

作　　者：朱红叶 孙阗 李继凯 武飞 李志梅 李通宪 ZHU Hongye;SUN Tian;LI Jikai;WU Fei;LI Zhimei;LI Tongxian(Medical Examination Section,Xingtai General Hospital of North China Medical and Healthcare Group,Xingtai,Hebei 054000,China;Department of Pharmacy,Xingtai General Hospital of North China Medical and Healthcare Group,Xingtai,Hebei 054000,China;Department of Orthopaedic Spine,Xingtai General Hospital of North China Medical and Healthcare Group,Xingtai,Hebei 054000,China;Department of Radiology,Xingtai General Hospital of North China Medical and Healthcare Group,Xingtai,Hebei 054000,China;Department of Orthopaedics,The Second Affiliated Hospital of Xingtai Medical College of Higher Education,Xingtai,Hebei 054000,China)

机构地区：[1]华北医疗健康集团邢台总医院体检科,河北邢台054000 [2]华北医疗健康集团邢台总医院药学部,河北邢台054000 [3]华北医疗健康集团邢台总医院脊柱骨科,河北邢台054000 [4]华北医疗健康集团邢台总医院放射科,河北邢台054000 [5]邢台医学高等专科学校第二附属医院骨科,河北邢台054000

出　　处：《转化医学杂志》2024年第9期1517-1523,共7页Translational Medicine Journal

基　　金：河北省邢台市重点研发计划自筹项目(2021ZC070)。

摘　　要：目的探讨金天格胶囊联合伊班膦酸钠及联合注入法结合经皮椎体后凸成形术(PKP)治疗老年骨质疏松性椎体压缩骨折(OVCF)的临床疗效。方法选择2022年9月至2023年12月华北医疗健康集团邢台总医院收治的108例老年OVCF患者为研究对象,将其随机分为对照组和观察组,各54例。对照组于联合注入法结合PKP术后给予伊班膦酸钠治疗,观察组在对照组的基础上联合金天格胶囊治疗,2组连续治疗6个月后观察疗效。比较2组术前和术后6个月的伤椎前缘高度比、后凸角度(Cobb角)、骨密度以及血清骨转换标志物[Ⅰ型胶原交联C端肽(β-CTX)、抗酒石酸酸性磷酸酶5b(TRACP-5b)、骨特异性碱性磷酸酶(BALP)、骨钙素(BGP)]水平。分别于术前和术后6个月评估2组患者的腰背痛视觉模拟量表(VAS)、改良Oswestry功能障碍指数(MODI)、改良Barthel指数(MBI)评定。记录2组患者术后6个月内责任椎体再骨折、邻近椎体骨折以及药物不良反应的发生情况。结果治疗6个月后,观察组总有效率为98.15%(53/54),对照组为88.89%(48/54),组间比较差异无统计学意义(P>0.05)。术后6个月,2组伤椎前缘高度比均显著增大(P均<0.05),伤椎Cobb角均显著减小(P均<0.05),腰背痛VAS评分、MODI均显著降低(P均<0.05),MBI评分均显著升高(P均<0.05),腰椎L_(1~4)骨密度均显著增加(P均<0.05),以观察组更为显著(P均<0.05)。术后6个月,2组血清β-CTX、TRACP-5b水平均显著低于术前(P均<0.05),血清BALP、BGP水平均显著高于术前(P均<0.05),以观察组更为显著(P<0.05)。术后6个月内,2组责任椎体再骨折、邻近椎体骨折及不良反应的发生率比较差异均无统计学意义(P均>0.05)。结论联合注入法结合PKP术后联用金天格胶囊和伊班膦酸钠治疗老年OVCF,可有效缓解患者腰背部疼痛,改善骨代谢,增加骨密度,促进骨愈合。Objective To investigate Jintiange capsule combined with ibandronate sodium and the combined injection method with percutaneous kyphoplasty(PKP)for the treatment of osteoporotic vertebral compression fractures(OVCF)and to evaluate its clinical efficacy.Methods Elderly OVCF patients admitted to Xingtai General Hospital of North China Medical and Health Group between September 2022 and December 2023 were randomly divided into a control group and an observation group.The control group received ibandronate sodium after PKP with the combined injection method,while the observation group was additionally treated with Jintiange capsule.Treatment lasted for six months.The anterior vertebral height ratio,kyphotic angle(Cobb's angle),bone mineral density,and serum bone turnover markers[type I collagen carboxy-terminal peptideβspecial sequence(β-CTX),tartrate-resistant acid phosphatase 5b(TRACP-5b),bone-specific alkaline phosphatase(BALP),and bone gla-protein(BGP)]were compared before and six months after treatment.Low back pain was evaluated using the visual analogue scale(VAS),and functional outcomes were assessed using the modified Oswestry disability index(MODI)and modified Barthel index(MBI).The incidence of recurrent vertebral fractures,adjacent vertebral fractures,and adverse drug reactions within six months postoperatively was recorded.Results After six months,the total effective rate in the observation group was 98.15%(53/54)compared to 88.89%(48/54)in the control group,with no statistically significant difference(P>0.05).Six months postoperatively,both groups showed significant increases in the anterior vertebral height ratio(P<0.05)and reductions in Cobb's angle(P<0.05).VAS and MODI scores were significantly decreased(P<0.05),and MBI scores and lumbar bone mineral density(L1–L4)were significantly increased(P<0.05),with more significant improvements in the observation group(P<0.05).Serumβ-CTX and TRACP-5b levels significantly decreased(P<0.05),while BALP and BGP levels significantly increased(P<0.05)in both gr

关 键 词：金天格胶囊 伊班膦酸钠 联合注入法 经皮椎体后凸成形术 骨质疏松性椎体压缩骨折 骨代谢 

分 类 号：R683.2[医药卫生—骨科学]