黄精制剂联合塞来昔布胶囊口服治疗膝骨关节炎的临床疗效及其作用机制  

Clinical curative effect of oral application of polygonatum kingianum preparations and celecoxib capsules on knee osteoarthritis and its mechanism of action

作　　者：王金杰 俞倩丽 朱磊[1] 庄汝杰[2] WANG Jinjie;YU Qianli;ZHU Lei;ZHUANG Rujie(Zhejiang University of Traditional Chinese Medicine, Hangzhou 310053 ,Zhejiang, China;Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou 310006 ,Zhejiang, China)

机构地区：[1]浙江中医药大学,浙江杭州310053 [2]浙江省中医院,浙江杭州310006

出　　处：《中医正骨》2018年第4期32-38,42,共8页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：2014年浙江省重大科技专项计划(2014C03038);2016年浙江省中医药科技计划项目(2016ZA085)

摘　　要：目的:观察黄精制剂联合塞来昔布胶囊口服治疗膝骨关节炎的临床疗效及其作用机制。方法:将100例膝骨关节炎患者随机分为2组,每组50例,分别采用单纯塞来昔布胶囊口服、黄精制剂联合塞来昔布胶囊口服治疗。塞来昔布胶囊口服,每日1片,饭后服用;黄精制剂口服,每日3次,每次2袋,温水冲服;每隔3周停药1周,1个月为1个疗程,共3个疗程。分别于治疗前及治疗开始后3个月、6个月记录并比较2组患者膝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分、美国膝关节协会评分(American knee society score,KSS)以及白细胞介素1(interleukin,IL)-1、IL-33、基质金属蛋白酶(matrix metalloproteinase,MMP)-13血清含量。结果:黄精制剂联合塞来昔布胶囊组退出5例,单纯塞来昔布胶囊组退出8例。(1)膝关节疼痛VAS评分。时间因素与分组因素存在交互效应(F=0.451,P=0.038);2组患者膝关节疼痛VAS评分比较,组间差异有统计学意义,即存在分组效应(t=2.535,P=0.012);治疗前后不同时间点之间膝关节疼痛VAS评分的差异有统计学意义,即存在时间效应(F=2.193,P=0.025);2组膝关节疼痛VAS评分随时间均呈降低趋势,但2组的降低趋势不完全一致[(6.36±1.18)分,(6.01±1.16)分,(5.82±1.01)分,F=2.749,P=0.030;(6.43±1.32)分,(6.31±0.96)分,(6.18±1.46)分,F=0.246,P=0.043];治疗前和治疗开始后3个月,2组患者膝关节疼痛VAS评分比较,组间差异均无统计学意义(t=1.042,P=0.304;t=1.325,P=0.189);治疗开始后6个月,黄精制剂联合塞来昔布胶囊组膝关节疼痛VAS评分低于单纯塞来昔布胶囊组(t=2.089,P=0.041)。(2)KSS膝关节临床评分。时间因素与分组因素存在交互效应(F=7.161,P=0.001);2组患者KSS膝关节临床评分比较,组间差异有统计学意义,即存在分组效应(t=8.166,P=0.000);治疗前后不同时间点之间KSS膝关节临床评分的差异有统计学意义,即存在时间效应(F=39.069,P=0.000);2组患者KSS膝关节临�Objective： To observe the clinical curative effect of oral application of polygonatum kingianum preparations and celecoxib capsules on knee osteoarthritis（ KOA） and to study its mechanism of action. Methods ： One hundred patients with KOA were randomly divid-ed into 2 groups,50 cases in each group,and were treated with monotherapy of oral application of celecoxib capsules（ monotherapy group） and combination therapy of oral application of polygonatum kingianum preparations and celecoxib capsules（ combination therapy group） re-spectively. The celecoxib capsules were taken after meal,one tablet a day. The polygonatum kingianum preparations were taken after mixing with warm water,three times a day,2 bags at a time. Both celecoxib capsules and polygonatum kingianum preparations were taken for con-secutive 3 courses of treatment, 1 month for each course with a 1 - week rest - insertion between courses. The knee pain visual analogue scale（ VAS） score,the American knee society score（ KSS）and the serum contents of interleukin（IL） - 1 ,IL -33 and matrix metalloprotein-ase （ MMP） -13 were recorded and compared between the 2 groups before treatment and at 3 and 6 months after the beginning of the treat-ment respectively. Results： Five patients in combination therapy group and 8 patients in monotherapy group dropped out of the study. There was interaction between time factor and group factor in knee pain VAS scores（F =0.451 ,P =0. 038） . There was statistical difference in the knee pain VAS scores between the 2 groups, in other words, there was group effect（ t - 2. 535 ,P = 0. 012 ） . There was statistical difference in knee pain VAS scores between different timepoints before and after the treatment,in other words,there was time effect（F -2 . 193,P = 0. 025 ） . The knee pain VAS scores presented a time - dependent decreasing trend in both of the 2 groups, while the 2 groups were inconsis-tent with each other in the decreasing trend of knee pain VAS scores（ 6. 36

关 键 词：骨关节炎 膝 黄精 塞来昔布 白细胞介素1 白细胞介素33 基质金属蛋白酶13 临床试验 

分 类 号：R684.3[医药卫生—骨科学]