[1]罗成贵,姜泉△,李振彬,等.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[J].中国中医骨伤科杂志,2023,31(08):19-23+27.[doi:10.20085/j.cnki.issn1005-0205.230804 ]
　LUO Chenggui,JIANG Quan,LI Zhenbin,et al.Panlongqi Tablets on the Treatment of Knee Osteoarthritis:A Multicenter Randomized Double-Blind Placebo Parallel Controlled Study[J].Chinese Journal of Traditional Medical Traumatology & Orthopedics,2023,31(08):19-23+27.[doi:10.20085/j.cnki.issn1005-0205.230804 ]
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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()
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《中国中医骨伤科杂志》[ISSN:1005-0205/CN:42-1340/R]

卷:
第31卷
期数:
2023年08期
页码:
19-23+27
栏目:
临床研究
出版日期:
2023-08-15

文章信息/Info

Title:
Panlongqi Tablets on the Treatment of Knee Osteoarthritis:A Multicenter Randomized Double-Blind Placebo Parallel Controlled Study
文章编号:
1005-0205(2023)08-0019-05
作者:
罗成贵1; 姜泉1△; 李振彬2; 高明利3; 张国建4; 黄传兵5; 张俊莉6; 张剑勇7; 关凤媛8
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
Author(s):
LUO Chenggui1; JIANG Quan1△; LI Zhenbin2; GAO Mingli3; ZHANG Guojian4; HUANG Chuanbing5; ZHANG Junli6; ZHANG Jianyong7; GUAN Fengyuan8
1Department of Rheumatology,Guang'anmen Hospital of Chinese Academy of Chinese Medical Sciences,Beijing 100053,China; 2Bethune International Peace Hospital of PLA,Shijiazhuang 050082,China; 3The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110033,China; 4Pinggu Hospital of Beijing Hospital of Traditional Chinese Medicine,Beijing 101200,China;...
关键词:
膝骨关节炎;  盘龙七片;  治疗结局;  安全性
Keywords:
knee osteoarthritis;  Panlong qi tablets;  treatment outcome;  safety
分类号:
R684.3
DOI:
10.20085/j.cnki.issn1005-0205.230804
文献标志码:
A
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。盘龙七片治疗膝骨关节炎安全性良好,不良事件发生率与安慰剂相似。
Abstract:
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 others were mild.In the test group,there were 4 cases(2.1%)of 6 cases of adverse events,including high white blood cell count,high percentage of neutrophils,nose bleeding,abnormal liver function,agitation,and sore throat,respectively.In the control group,there was 1 case(1%)and 1 case,which was a body rash; each group had 2% or more adverse events,and the control group had 2 cases(2%)with an upset stomach.There was no incidence above 2% of adverse events in the test group.Other safety indicators showed that laboratory indicators in both the test group and the control group were normal,such as blood routine,urine routine,biochemical examination,electrocardiogram,vital signs,and physical examination.Conclusion:Panlongqi tablets as a monotherapy can significantly help patients with knee osteoarthritis reduce knee pain(VAS score)and improve joint function(WOMAC scale).The treatment outcome is even better after 4 weeks treatment.Comparing between placebo and Panlongqi tablets,the incidence rate of adverse events is similar.Therefore,Panlongqi tablets are safe for patients with knee osteoarthritis.

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备注/Memo

备注/Memo:
基金项目:中国中医科学院科技创新工程项目(CI2021A01511)
△通信作者 E-mail:doctorjq@126.com
更新日期/Last Update: 2023-08-01