盘龙七片治疗膝骨关节炎的多中心随机双盲安慰剂平行对照研究  

Panlongqi Tablets on the Treatment of Knee Osteoarthritis:A Multicenter Randomized Double-Blind Placebo Parallel Controlled Study

作　　者：罗成贵[1] 姜泉[1] 李振彬[2] 高明利 张国建 黄传兵 张俊莉 张剑勇[7] 关凤媛 LUO Chenggui;JIANG Quan;LI Zhenbin;GAO Mingli;ZHANG Guojian;HUANG Chuanbing;ZHANG Junli;ZHANG Jianyong;GUAN Fengyuan(Department of Rheumatology,Guang'anmen Hospital of Chinese Academy of Chinese Medical Sciences,Beijing 100053,China;Bethune International Peace Hospital of PLA,Shijiazhuang 050082,China;The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110033,China;Pinggu Hospital of Beijing Hospital of Traditional Chinese Medicine,Beijing 101200,China;The First Affiliated Hospital of Anhui University of Chinese Medicine,Hefei 230012,China;Xi'an Fifth Hospital,Xi'an 710082,China;Shenzhen Traditional Chinese Medicine Hospital,Shenzhen 518033,Guangdong China;Yingkou Traditional Chinese Medicine Hospital,Yingkou 115002,Liaoning China)

机构地区：[1]中国中医科学院广安门医院风湿病科,北京100053 [2]解放军白求恩国际和平医院 [3]辽宁中医药大学附属医院 [4]北京中医医院平谷医院 [5]安徽中医药大学第一附属医院 [6]西安市第五医院 [7]深圳市中医院 [8]营口市中医院

出　　处：《中国中医骨伤科杂志》2023年第8期19-23,27,共6页Chinese Journal of Traditional Medical Traumatology & Orthopedics

基　　金：中国中医科学院科技创新工程项目(CI2021A01511)。

摘　　要：目的:探讨盘龙七片治疗膝骨关节炎的疗效及安全性。方法:采用多中心、随机、双盲、安慰剂平行对照试验设计,于2018年5月19日至2019年9月3日纳入确诊的300例受试者,参照美国风湿病学会1995年膝骨关节炎分类标准,以2:1的比例随机分配到盘龙七片治疗组(盘龙七片,4片/次,3次/d)和安慰剂组(盘龙七片模拟片,4片/次,3次/d),两组受试者均连续给药4周。主要疗效指标为膝关节疼痛视觉模拟量表(VAS)评分,次要疗效指标为西安大略和麦克马斯特骨关节炎指数(WOMAC)评分及健康调查简表(SF-36)积分。采用符合方案数据集进行统计分析。结果:治疗4周后VAS评分较基线改变值试验组、安慰剂组组间差异有统计学意义(P<0.05)。2周后VAS评分较基线改变值试验组、安慰剂组组间差异有统计学意义(P<0.05);治疗4周后WOMAC评分较基线改善值试验组、安慰剂组组间差异有统计学意义(P<0.05);治疗2周后WOMAC评分较基线改善值组间差异无统计学意义(P>0.05);治疗4周后健康调查简表(SF-36)积分较基线变化值组间差异无统计学意义(P>0.05)。试验期间试验组8例(4.1%)受试者发生10例次不良事件,严重程度均为轻度;安慰剂组4例(4%)受试者发生5例次不良事件,其中1例中度不良事件为身上皮疹,其他为轻度;试验组不良反应为4例(2.1%)6例次,分别为白细胞升高、中性粒细胞升高、鼻出血、肝功能异常、激动、嗓子疼各1例;对照组不良反应为1例(1%)1例次,为身上皮疹;各组≥2%不良事件,安慰剂组为胃部不适2例(2%),试验组没有发生率>2%不良事件。其他安全性指标:试验组与安慰剂组中实验室指标(血常规、尿常规、生化检查)、心电图、生命体征、体格检查均未见明显异常。结论:膝骨关节炎患者接受盘龙七片单药治疗可降低患者膝关节疼痛程度(VAS评分)并改善关节功能(WOMAC评分),服药4周治疗后改善更为明显。盘�Objective:To evaluate the efficacy and safety of Panlongqi tablets on the treatment of knee osteoarthritis.Methods:A multicenter,randomized,double-blind,placebo parallel controlled study was performed on 300 outpatients with knee osteoarthritis,who were diagnosed from May 19,2018 to September 3,2019.The participants were randomly assigned 2:1 to the test group or the control group according to the American College of Rheumatology clinical classification criteria for knee osteoarthritis released in 1995(ACR 1995).The test group was given 4 Panlongqi tablets three times per day,while the control group was given 4 placebo tablets three times per day.The intervention lasted 4 weeks.The primary outcome was the knee joint pain visual analogue scale(PVAS),and the secondary outcome was the Western Ontario and McMaster Osteoarthritis Index(WOMAC)score as well as the short Form-36 health survey summary(SF-36)score.Statistical analysis was performed on the dataset which was consistent with the study.Results:After 4 weeks of treatment,the change from baseline to week 4 in the visual analogue scale(VAS)score was significantly different between the test group and the control group(P<0.05).The change from baseline to week 2 in the VAS score was also significantly different between the test group and the control group(P<0.05).Additionally,the change from baseline to week 4 in WOMAC score was significantly different between the test group and the control group(P<0.05).However,there was no significant difference in WOMAC score compared with the baseline improvement value after 2 weeks of treatment(P>0.05).Meanwhile,the change from baseline to week 4 in the SF-36 scores did not show significant difference between the test group and the control group(P>0.05).During the trial period,8 participants(4.1%)in the test group had 10 adverse events,all of which were mild in severity;4 participants(4%)in the control group had 5 adverse events,of which one case was moderate adverse events,as the participant had skin rashes on the body,while o

关 键 词：膝骨关节炎 盘龙七片 治疗结局 安全性 

分 类 号：R684.3[医药卫生—骨科学]