[1]刘福存,单乐天,童培建,等.附子汤治疗轻中度膝骨关节炎寒湿痹阻证的临床研究[J].中医正骨,2016,28(01):10-13.
　LIU Fucun,SHAN Letian,TONG Peijian,et al.Clinical study on Fuzi Tang(附子汤)for treatment of mild-to-moderate knee osteoarthritis with COLD-DAMPNESS STAGNATION(寒湿痹阻)syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(01):10-13.
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附子汤治疗轻中度膝骨关节炎寒湿痹阻证的临床研究()
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《中医正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期数:
2016年01期
页码:
10-13
栏目:
临床研究
出版日期:
2016-01-20

文章信息/Info

Title:
Clinical study on Fuzi Tang(附子汤)for treatment of mild-to-moderate knee osteoarthritis with COLD-DAMPNESS STAGNATION(寒湿痹阻)syndrome
作者:
刘福存1; 单乐天2; 童培建1; 邹建琴1; 肖鲁伟2
1.浙江省中医院,浙江 杭州 310006;
2.浙江中医药大学骨伤研究所,浙江 杭州 310053
Author(s):
LIU Fucun1; SHAN Letian2; TONG Peijian1; ZOU Jianqin1; XIAO Luwei2
1.Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,Zhejiang,China 2.Institute of Traumatology and Orthopedics Affiliated to Zhejiang University of Traditional Chinese Medicine,Hangzhou 310053,Zhejiang,China
关键词:
骨关节炎; 膝;  附子汤;  氨基葡萄糖;  痹证;  临床试验
Keywords:
osteoarthritis; knee;  Fuzi Tang;  chitosamine;  arthralgia syndrome;  clinical trial
摘要:
目的:观察附子汤治疗轻中度膝骨关节炎(knee osteoarthritis,KOA)寒湿痹阻证的临床疗效和安全性。方法:纳入163例轻中度KOA寒湿痹阻证患者。82例服用附子汤(附子汤组),每日1剂,分2次服用,连服4周; 81例服用盐酸氨基葡萄糖胶囊(氨基葡萄糖组),每日2次,每次0.75 g,连服4周。2组均以美洛昔康片作为应急用药。分别于治疗前及治疗后5个月评定患者的西安大略和麦克马斯特大学(Western Ontario and McMaster Universities,WOMAC)骨关节炎指数和50 m行走后膝关节疼痛视觉模拟量表(visual analogue scale,VAS)评分,并观察患者的不良反应发生率和应急用药率。结果:附子汤组1例患者服药3 d后因口部感觉麻木停药; 2组患者的不良反应发生率比较,差异无统计学意义(P=0.053)。治疗后5个月时,附子汤组5例失访、氨基葡萄糖组7例失访; 因疼痛加重,附子汤组7例服用美洛昔康片、氨基葡萄糖组23例服用美洛昔康片,2组均无连续应用美洛昔康片超过3 d者,氨基葡萄糖组的应急用药率高于附子汤组(χ2=10.701,P=0.001)。治疗前2组患者50 m行走后膝关节疼痛VAS评分和WOMAC骨关节炎指数比较,组间差异均无统计学意义[(5.6±2.9)分,(5.8±3.1)分,t=0.425,P=0.671;(89.1±24.6),(88.4±26.3),t=0.176,P=0.861]; 治疗后5个月,附子汤组50 m行走后膝关节疼痛VAS评分和WOMAC骨关节炎指数均小于氨基葡萄糖组[(2.1±3.8)分,(5.7±3.3)分,t=6.188,P=0.000;(29.7±19.8),(87.9±27.3),t=1.933,P=0.000]。结论:服用附子汤可有效减轻轻中度KOA寒湿痹阻证患者的膝关节疼痛症状,提高患者的生活质量,疗效优于氨基葡萄糖,而且不良反应较少。
Abstract:
Objective:To observe the clinical curative effects and safety of Fuzi Tang(附子汤)in treatment of mild-to-moderate knee osteoarthritis(KOA)with COLD-DAMPNESS STAGNATION(寒湿痹阻)syndrome.Methods:One hundred and sixty-three patients with mild-to-moderate KOA with COLD-DAMPNESS STAGNATION syndrome were enrolled in the study.Eighty-two patients were treated with oral application of Fuzi Tang(Fuzi Tang group),one dose at a time,twice a day for 4 consecutive weeks; while the others were treated with oral application of glucosamine hydrochloride capsules(glucosamine group),0.75g at a time,twice a day for 4 consecutive weeks.Meloxicam tablets were used to meet the emergency in the 2 groups.The Western Ontario and McMaster Universities(WOMAC)osteoarthritis index and knee pain visual analogue scale(VAS)scores after 50-m walk were evaluated and compared between the 2 groups before the treatment and at 5 months after the treatment respectively,and the incidence rate of adverse reactions and the rate of emergency medication were also observed.Results:Drug withdrawal were found in 1 patient for oral anesthesia after 3-day medication in Fuzi Tang group.There was no statistical difference in the incidence rate of adverse reactions between the 2 groups(P=0.053).Five patients in Fuzi Tang group and 7 patients in glucosamine group lost to follow-up at 5 months after the treatment.Seven patients in Fuzi Tang group and 23 patients in glucosamine group were given meloxicam tablets for aggravated knee pain for no more than 3 consecutive days,and the rate of emergency medication was higher in glucosamine group compared to Fuzi Tang group(χ2=10.701,P=0.001).There was no statistical difference between the 2 groups before the treatment in the knee pain VAS scores after 50-m walk and WOMAC osteoarthritis index(5.6+/-2.9 vs 5.8+/-3.1 points,t=0.425,P=0.671; 89.1+/-24.6 vs 88.4+/-26.3,t=0.176,P=0.861),which were less in Fuzi Tang group compared to glucosamine group at 5 months after the treatment(2.1+/-3.8 vs 5.7+/-3.3 points,t=6.188,P=0.000; 29.7+/-19.8 vs 87.9+/-27.3,t=1.933,P=0.000).Conclusion:Oral application of Fuzi Tang can effectively alleviate the knee pain and improve the quality of live of patients with mild-to-moderate KOA with COLD-DAMPNESS STAGNATION syndrome,moreover,it surpasses the glucosamine in the curative effects with less adverse reactions.

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备注/Memo

备注/Memo:
基金项目:浙江省自然科学基金(LY16H060005); 中国博士后科学基金面上项目(2014M561793); 中国博士后科学基金特别资助项目(2015T80637); 国家自然科学基金青年项目(81302989); 浙江省中医药科技计划项目(2013ZQ007)
通讯作者:童培建 E-mail:tongpeijian@163.com
更新日期/Last Update: 2016-02-29