金古乐片治疗膝骨性关节炎疗效研究  

Clinical observation of Jingule tablets for knee osteoarthritis

作　　者：严可[1] 卢敏[1] 王平[2] 万小明[3] 陈久毅 孙树新[5] YAN Ke;LU Min;WANG Ping;WAN Xiao-ming;CHEN Jiu-yi;SUN Shu-xin(The First Affiliated Hospital of Hunan University of Chinese Medicine,Changsha 410007;The First Affiliated Hospital of Tianjin University of TCM,Tianjin 300193;Affiliated Hospital of Jiangxi University of Traditional TCM,Nanchang 330006;The First Affiliated Hospital of Guiyang College of TCM,Guiyang 550025;Affiliated Hospital of Liaoning University of TCM,Shenyang 110033)

机构地区：[1]湖南中医药大学第一附属医院,长沙410007 [2]天津中医药大学第一附属医院,天津300193 [3]江西中医药大学附属医院,南昌330006 [4]贵阳中医药大学第一附属医院,贵阳550025 [5]辽宁中医药大学附属医院,沈阳110033

出　　处：《中南药学》2019年第12期2186-2189,共4页Central South Pharmacy

摘　　要：目的评价金古乐片治疗膝骨性关节炎的有效性和安全性。方法选择2009年8月-2011年4月五家医院收治的169例膝骨性关节炎患者为研究对象。随机分为安慰剂组(金古乐片模拟剂6片/次,3次·d^-1),剂量1组(金古乐片4片/次+金古乐片模拟剂2片/次,3次·d^-1).剂量2组(金古乐片6片/次,3次·d^-1),干预4周,疗效指标为膝关节疾病疗效、次疼痛积分变化情况、中医证候积分变化情况、单项症状体征疗效,安全性评价指标为肝功能,肾功能,血、尿、便常规,心电图及不良事件与不良反应。结果3组膝骨性关节炎疾病疗效比较,剂量1组、剂量2组疗效优于安慰剂组(P<0.05),剂量1组与剂量2组比较差异无统计学意义(P>0.05);3组疼痛积分,中医证候积分,单项症状如夜间疼痛、行走疼痛、下蹲活动等,治疗后均有下降,组间比较差异具有统计学意义(P<0.05);剂量1组与剂量2组比较差异无统计学意义(P>0.05),对疼痛程度改善均优于安慰剂;本次临床试验不良事件共6例,其中安慰剂组3例,剂量1组1例,剂量2组2例,试验过程中未出现肝功能异常的不良事件。结论金古乐片治疗膝骨性关节炎,具有良好的临床疗效,能有效改善患者的疼痛、日常活动等情况,且无毒副作用,值得临床推广应用。Objective To observe the clinical effects and safety of Jingule tablets on patients with knee osteoarthritis.Methods From August 2009 to April 2011,169 patients with knee osteoarthritis were selected from 5 hospitals.They were randomly divided into a placebo group(6 tablets/time,3 times/day),dose 1 group(4 tablets/time+2 tablets/time,3 times/day),and dose 2 group(6 tablets/time,3 times/day).The intervention lasted 4 weeks.The therapeutic indexes were the curative effect of knee joint disease,the change of pain scores and the change of TCM indication scores,etc.Safety evaluation indicators included liver function(ALT),renal function(BUN,Cr),blood,urine,stool routine,electrocardiogram,and adverse reactions.Results The curative effect of knee osteoarthritis in the three groups was significantly different(P<0.05).The curative effect of dose 1 group and dose 2 group was better than that of the placebo group.There was no significant difference between dose 1 group and dose 2 group.The pain score,scores of TCM indications,symptoms such as night pain,walking pain and squatting activity of the 3 groups were decreased after the treatment.Six adverse drug reactions were found,including 3 in the placebo group,1 in dose 1 group and 2 in dose 2 group.There were no adverse events of abnormal liver function during the test.Conclusion Jingule tablets show good clinical effect on knee osteoarthritis without toxic side effects.

关 键 词：金古乐 中药复方 膝骨性关节炎 

分 类 号：R96[医药卫生—药理学]