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[1]郑昱新,詹红生,莫文,等.滑膜炎颗粒治疗膝关节滑膜炎湿热阻络证的随机、双盲、安慰剂对照、多中心临床研究[J].中医正骨,2015,27(12):29-36.
　ZHENG Yuxin,ZHAN Hongsheng,MO Wen,et al.A randomized,double-blind,placebo-controlled,multicenter,clinical trial of Huamoyan Keli(滑膜炎颗粒)for treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2015,27(12):29-36.
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滑膜炎颗粒治疗膝关节滑膜炎湿热阻络证的随机、双盲、安慰剂对照、多中心临床研究()

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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:: 第27卷
期数:: 2015年12期

页码:: 29-36

栏目:: 临床研究

出版日期:: 2015-12-30

文章信息/Info

Title:: A randomized,double-blind,placebo-controlled,multicenter,clinical trial of Huamoyan Keli(滑膜炎颗粒)for treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome

作者:: 郑昱新¹; 詹红生¹; 莫文²; 闻辉³; 董忠⁴; 郭艳幸⁵; 林定坤⁶; 李慧英⁷; 汤敏予⁸; 赵建⁹; 1.上海中医药大学附属曙光医院,上海 201203;
2.上海中医药大学附属龙华医院,上海 200032;
3.长春中医药大学附属医院,吉林长春 130021;
4.福建省中医药研究院, 福建福州 350003;
5.河南省洛阳正骨医院/河南省骨科医院,河南洛阳 471002;
6.广东省中医院,广东广州 510120;
7.河南中医学院第一附属医院,河南郑州 450000;
8.江西中医药大学附属医院,江西南昌 330006;
9.河北省中医院,河北石家庄 050011

Author(s):: ZHENG Yuxin¹; ZHAN Hongsheng¹; MO Wen²; WEN Hui³; DONG Zhong⁴; GUO Yanxing⁵; LIN Dingkun⁶; LI Huiying⁷; TANG Minyu⁸; ZHAO Jian⁹; 1.Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China
2.Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200032,China
3.The Affiliated Hospital to Changchun University of Chinese Medicine,Changchun 130021,Jilin,China
4.Fujian Academy of Chinese Medicine,Fuzhou 350003,Fujian,China
5.Luoyang Orthopedic-Traumatological Hospital,Luoyang 471002,Henan,China
6.Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 510120,Guangdong,China
7.The First Affiliated Hospital of Henan University of Traditional Chinese Medicine,Zhengzhou 450000,Henan,China
8.The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine,Nanchang 330006,Jiangxi,China
9.Hebei Provincial Hospital of Traditional Chinese Medicine,Shijiazhuang 050011,Hebei,China

关键词:: 滑膜炎; 膝关节; 滑膜炎颗粒; 临床试验

Keywords:: synovitis; knee joint; Huamoyan Keli; clinical trial

摘要:: 目的:评价滑膜炎颗粒治疗膝关节滑膜炎湿热阻络证的疗效和安全性。方法:采用随机、双盲、安慰剂对照、多中心的临床试验方法,共纳入480例膝关节滑膜炎湿热阻络证患者,滑膜炎颗粒组360例(急性120例,慢性240例),安慰剂组120例(急性40例,慢性80例)。滑膜炎颗粒组口服滑膜炎颗粒,安慰剂组口服安慰剂,2组患者均戴护膝作为基础治疗,同时将对乙酰氨基酚片作为疼痛应急用药。滑膜炎颗粒和安慰剂均为每次12 g,每日3次,急性膝关节滑膜炎患者治疗4周,慢性膝关节滑膜炎患者治疗8周。评价患者的膝关节肿胀改善情况、西安大略和麦克马斯特大学(Western Ontario and McMaster Universities,WOMAC)骨关节炎指数、中医证候疗效、对乙酰氨基酚片应用率、依从性及不良反应发生情况。结果:2组患者依从性均较好,滑膜炎颗粒组脱落14例,安慰剂组脱落2例,其余患者均按照医嘱完成治疗。滑膜炎颗粒组2例慢性滑膜炎患者发生不良反应,其中1例出现轻度上腹部不适,未采取措施继续试验; 1例出现轻度腹泻,停用药物并退出试验。急性膝关节滑膜炎患者治疗2、4周后,滑膜炎颗粒组的膝关节肿胀改善情况均优于安慰剂组(2周:R^-_{滑膜炎颗粒组}=73.85,R^-_安慰剂组=100.46,Z=-3.549,P=0.000; 4周:R^-_{滑膜炎颗粒组}=73.68,R^-_安慰剂组=109.95,Z=-5.000,P=0.000); 中医证候疗效也均优于安慰剂组(2周:R^-_{滑膜炎颗粒组}=75.93,R^-_安慰剂组=92.11,Z=-2.291,P=0.022; 4周:R^-_{滑膜炎颗粒组}=69.21,R^-_安慰剂组=107.64,Z=-4.859,P=0.000)。治疗前2组急性膝关节滑膜炎患者的WOMAC评分比较,差异无统计学意义(Z=0.272,P=0.790); 治疗2、4周后滑膜炎颗粒组患者的WOMAC评分均低于安慰剂组(Z=4.089,P=0.000; Z=4.722,P=0.000)。急性膝关节滑膜炎患者在治疗的4周内,滑膜炎颗粒组8例服用对乙酰氨基酚片,安慰剂组7例服用对乙酰氨基酚片。2组患者对乙酰氨基酚片应用率比较,差异无统计学意义(P=0.058)。慢性膝关节滑膜炎患者治疗2、4、8周后,滑膜炎颗粒组的膝关节肿胀改善情况均优于安慰剂组(2周:R^-_{滑膜炎颗粒组}=156.65,R^-_安慰剂组=172.04,Z=-2.382,P=0.017; 4周:R^-_{滑膜炎颗粒组}=149.54,R^-_安慰剂组=193.38,Z=-4.244,P=0.000; 8周:R^-_{滑膜炎颗粒组}=143.30,R^-_安慰剂组=212.09,Z=-6.166,P=0.000); 中医证候疗效也均优于安慰剂组(2周:R^-_{滑膜炎颗粒组}=150.69,R^-_安慰剂组=165.55,Z=-2.656,P=0.008; 4周:R^-_{滑膜炎颗粒组}=141.55,R^-_安慰剂组=192.03,Z=-4.964,P=0.000; 8周:R^-_{滑膜炎颗粒组}=133.90,R^-_安慰剂组=213.02,Z=-7.197,P=0.000)。治疗前2组慢性膝关节滑膜炎患者的WOMAC评分比较,差异无统计学意义(Z=0.377,P=0.702); 治疗2、4、8周后滑膜炎颗粒组患者的WOMAC评分均低于安慰剂组(Z=2.886,P=0.004; Z=5.182,P=0.000; Z=6.613,P=0.000)。慢性膝关节滑膜炎患者在治疗的8周内,滑膜炎颗粒组1例服用对乙酰氨基酚片,安慰剂组2例服用对乙酰氨基酚片。2组患者的对乙酰氨基酚片的应用率比较,差异无统计学意义(P=0.155)。结论:滑膜炎颗粒能够减轻急性和慢性膝关节滑膜炎湿热阻络证患者的膝关节肿胀和疼痛,改善关节功能,而且具有较高的安全性。

Abstract:: Objective:To evaluate the clinical curative effects and safety of Huamoyan Keli(滑膜炎颗粒,HMYKL)in the treatment of gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome.Methods:Four hundred and eighty patients with type DAMPNESS-HEAT BLOCK COLLATERALS gonarthromeningitis were recruited in a randomized,double-blind,placebo-controlled,multicenter,clinical trial.The patients were divided into HMYKL group(360 cases:120 acute cases and 240 chronic cases)and placebo group(120 cases:40 acute cases and 80 chronic cases)and were treated with oral application of HMYKL and placebo respectively(12 g at a time,three times a day).Meanwhile,all the patients were administered with kneepad and the acetaminophen tablets were used for emergency treatment of knee pain.The course of treatment was 4 weeks for acute cases and 8 weeks for chronic cases.Improvements in knee swelling,Western Ontario and McMaster Universities(WOMAC)osteoarthritis index,curative effect on TCM SYMPTOM COMPLEX,utility rate of acetaminophen tablets,compliance rates and incidence rate of adverse reactions were evaluated and compared between the 2 groups.Results:The compliance of patients was good in the 2 groups.Fourteen patients dropped out in HMYKL group and 2 patients dropped out in placebo group and the treatment were finished in other patients on the advice of doctor.Adverse reactions including mild epigastric discomfort and mild diarrhoea were found in 2 chronic cases in HMYKL group and one of them dropped out.The HMYKL group surpassed the placebo group in the improvements in knee swelling of patients with acute gonarthromeningitis after 2- and 4-week treatment(2 weeks:R^-_{HMYKL group}=73.85,R^-_{placebo group}=100.46,Z=-3.549,P=0.000; 4 weeks:R^-_{HMYKL group}=73.68,R^-_{placebo group}=109.95,Z=-5.000,P=0.000),and also the same to the curative effect on TCM SYMPTOM COMPLEX(2 weeks:R^-_{HMYKL group}=75.93,R^-_{placebo group}=92.11,Z=-2.291,P=0.022; 4 weeks:R^-_{HMYKL group}=69.21,R^-_{placebo group}=107.64,Z=-4.859,P=0.000).There was no statistical difference in the WOMAC scores between the 2 groups of acute cases before the treatment(Z=0.272,P=0.790).The WOMAC scores were lower in HMYKL group compared to placebo group after 2- and 4-week treatment(Z=4.089,P=0.000; Z=4.722,P=0.000).The acetaminophen tablets were used in 8 acute cases in HMYKL group and 7 acute cases in placebo group during the 4 -week treatment.There was no statistical difference in the utility rate of acetaminophen tablets between the 2 groups(P=0.058).The HMYKL group surpassed the placebo group in the improvements in knee swelling of patients with chronic gonarthromeningitis after 2-,4- and 8-week treatment(2 weeks:R^-_{HMYKL group}=156.65,R^-_{placebo group}=172.04,Z=-2.382,P=0.017; 4 weeks:R^-_{HMYKL group}=149.54,R^-_{placebo group}=193.38,Z=-4.244,P=0.000; 8 weeks:R^-_{HMYKL group}=143.30,R^-_{placebo group}=212.09,Z=-6.166,P=0.000),and also the same to the curative effect on TCM SYMPTOM COMPLEX(2 weeks:R^-_{HMYKL group}=150.69,R^-_{placebo group}=165.55,Z=-2.656,P=0.008; 4 weeks:R^-_{HMYKL group}=141.55,R^-_{placebo group}=192.03,Z=-4.964,P=0.000; 8 weeks:R^-_{HMYKL group}=133.90,R^-_{placebo group}=213.02,Z=-7.197,P=0.000).There was no statistical difference in the WOMAC scores between the 2 groups of chronic cases before the treatment(Z=0.377,P=0.702).The WOMAC scores were lower in HMYKL group compared to placebo group after 2-,4- and 8-week treatment(Z=2.886,P=0.004; Z=5.182,P=0.000; Z=6.613,P=0.000).The acetaminophen tablets were used in 1 chronic case in HMYKL group and 2 chronic cases in placebo group during the 8-week treatment.There was no statistical difference in the utility rate of acetaminophen tablets between the 2 groups(P=0.155).Conclusion:For patients with acute and chronic gonarthromeningitis with DAMPNESS-HEAT BLOCK COLLATERALS syndrome,HMYKL can relieve swelling and pain of the knee and improve the knee function,meanwhile it has high safety.

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备注/Memo:: 2015-04-08收稿 2015-11-04修回
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