四烯甲萘醌联合PKP术治疗骨质疏松性椎体压缩骨折患者的临床研究  

Clinical trial of menatetrenone combined with PKP in the treatment of patients with osteoporotic vertebral compression fracture

作　　者：朱衍 邱雷雨 周筱 ZHU Yan;QIU Lei-yu;ZHOU Xiao(Department tof Spine Surgery,Zhuji People's Hospital,Zhuji 311800,Zhejiang Province,China;Department of Intervention,Zhuji People's Hospital,Zhuji 311800,Zhejiang Province,China;Department of Endocrinology,Zhuji People's Hospital,Zhuji 311800,Zhejiang Province,China)

机构地区：[1]诸暨市人民医院脊柱外科,浙江诸暨311800 [2]诸暨市人民医院介入科,浙江诸暨311800 [3]诸暨市人民医院内分泌科,浙江诸暨311800

出　　处：《中国临床药理学杂志》2024年第10期1409-1413,共5页The Chinese Journal of Clinical Pharmacology

基　　金：浙江省卫生健康科技计划基金资助项目(2022KY1320)。

摘　　要：目的观察四烯甲萘醌联合经皮球囊扩张椎体后凸成形术(PKP)治疗骨质疏松性椎体压缩骨折(OVCF)患者的临床疗效及安全性。方法将OVCF患者用随机数字表法分为试验组和对照组。对照组予以PKP术及常规抗骨质疏松治疗,试验组在对照组基础上加用四烯甲萘醌15 mg,tid,连续治疗6个月,比较2组骨密度T值、Oswestry功能障碍指数(ODI)、视觉模拟评分(VAS)、骨代谢指标[骨钙素(OC)、碱性磷酸酶(ALP)、Ⅰ型胶原交联C-末端肽(CTX-Ⅰ)、25羟维生素D(25(OH)D)]变化,记录2组再骨折和药物不良反应发生情况。结果试验组和对照组各40例。治疗后,试验组和对照组的腰椎L2-4骨密度T值分别为-1.79±0.24和-2.16±0.28,股骨颈骨密度T值分别为-1.44±0.16和-2.01±0.22,股骨大转子骨密度T值分别为-1.76±0.18和-1.97±0.23,在统计学上差异均有统计学意义(均P<0.05)。术后3个月试验组和对照组ODI评分分别为(34.12±3.56)和(37.67±3.89)分,术后6个月ODI评分分别为(17.85±1.84)和(26.75±2.78)分,术后3个月VAS分别为(2.61±0.28)和(2.84±0.31)分,术后6个月VAS分别为(0.85±0.11)和(1.23±0.16)分,在统计学上差异均有统计学意义(均P<0.05);治疗后,试验组和对照组的OC分别为(9.08±0.95)和(7.64±0.79)μg·L^(-1),ALP分别为(86.27±8.79)和(91.33±9.25)U·L^(-1),CTX-Ⅰ分别为(0.21±0.04)和(0.25±0.03)ng·mL^(-1),25(OH)D分别为(30.14±3.28)和(26.55±2.73)ng·mL^(-1),在统计学上差异均有统计学意义(均P<0.05)。6个月内试验组和对照组的再骨折发生率分别为10.00%和2.50%,总药物不良反应发生率分别为10.00%和17.50%,在统计学上差异均无统计学意义(均P>0.05)。结论四烯甲萘醌联合PKP可明显提高OVCF患者骨密度,改善骨代谢指标,减少腰椎功能障碍及疼痛,不增加再骨折风险和药物不良反应发生率。Objective To observe the effect and safety of menatetrenone combined with percutaneous kyphoplasty(PKP)in the treatment of osteoporotic vertebral compression fracture(OVCF).Methods Patients with OVCF were divided into treatment group and control group by random number table method.The control group was treated with PKP and conventional anti-osteoporosis treatment,and the treatment group was treated with menatetrenone 15 mg,tid,on the basis of control group.The two groups were compared on the changes in T value of bone mineral density,Oswestry disability index(ODI)scores,visual analogue scale(VAS)and bone metabolism indicators[osteocalcin(OC),alkaline phosphatase(ALP),C-telopeptide of typeⅠcollagen(CTX-Ⅰ)and 25-hydroxyvitamin D(25(OH)D)].The incidence rates of refracture and adverse reactions were recorded.Results There were 40 cases in treatment group and 40 cases in control group.After treatment,T values of bone mineral density of lumbar spine(L2-4)in treatment group and control group were-1.79±0.24 and-2.16±0.28;T values of bone mineral density of femoral neck were-1.44±0.16 and-2.01±0.22;T values of bone mineral density of femoral great trochanter were-1.76±0.18 and-1.97±0.23,all with significant difference(all P<0.05).Three months after operation,ODI scores in treatment group and control group were 34.12±3.56 and 37.67±3.89;six months after operation,ODI scores were 17.85±1.84 and 26.75±2.78;three months after operation,VAS were 2.61±0.28 and 2.84±0.31;six months after operation,VAS were 0.85±0.11 and 1.23±0.16,all with significant difference(all P<0.05).After treatment,OC levels in treatment group and control group were(9.08±0.95)and(7.64±0.79)μg·L^(-1);ALP levels were(86.27±8.79)and(91.33±9.25)U·L^(-1);CTX-Ⅰlevels were(0.21±0.04)and(0.25±0.03)ng·mL^(-1);the above indexes were significantly different between control group and treatment group(all P<0.05).The incidence of refracture in treatment group and control group were 10.00%and 2.50%,and the incidence of adverse drug reactio

关 键 词：四烯甲萘醌胶囊 骨质疏松性椎体压缩骨折 经皮球囊扩张椎体后凸成形术 骨代谢 

分 类 号：R97[医药卫生—药品]