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[1]劉福存,單樂天,童培建,等.附子湯治療輕中度膝骨關節(jié)炎寒濕痹阻證的臨床研究[J].中醫(yī)正骨,2016,28(01):10-13.
　LIU Fucun,SHAN Letian,TONG Peijian,et al.Clinical study on Fuzi Tang(附子湯)for treatment of mild-to-moderate knee osteoarthritis with COLD-DAMPNESS STAGNATION(寒濕痹阻)syndrome[J].The Journal of Traditional Chinese Orthopedics and Traumatology,2016,28(01):10-13.
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附子湯治療輕中度膝骨關節(jié)炎寒濕痹阻證的臨床研究()
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《中醫(yī)正骨》[ISSN:1001-6015/CN:41-1162/R]

卷:
第28卷
期數(shù):
2016年01期
頁碼:
10-13
欄目:
臨床研究
出版日期:
2016-01-20

文章信息/Info

Title:
Clinical study on Fuzi Tang(附子湯)for treatment of mild-to-moderate knee osteoarthritis with COLD-DAMPNESS STAGNATION(寒濕痹阻)syndrome
作者:
劉福存1; 單樂天2; 童培建1; 鄒建琴1; 肖魯偉2
1.浙江省中醫(yī)院,浙江 杭州 310006;
2.浙江中醫(yī)藥大學骨傷研究所,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
關鍵詞:
骨關節(jié)炎; 膝;  附子湯;  氨基葡萄糖;  痹證;  臨床試驗
Keywords:
osteoarthritis; knee;  Fuzi Tang;  chitosamine;  arthralgia syndrome;  clinical trial
摘要:
目的:觀察附子湯治療輕中度膝骨關節(jié)炎(knee osteoarthritis,KOA)寒濕痹阻證的臨床療效和安全性。方法:納入163例輕中度KOA寒濕痹阻證患者。82例服用附子湯(附子湯組),每日1劑,分2次服用,連服4周; 81例服用鹽酸氨基葡萄糖膠囊(氨基葡萄糖組),每日2次,每次0.75 g,連服4周。2組均以美洛昔康片作為應急用藥。分別于治療前及治療后5個月評定患者的西安大略和麥克馬斯特大學(Western Ontario and McMaster Universities,WOMAC)骨關節(jié)炎指數(shù)和50 m行走后膝關節(jié)疼痛視覺模擬量表(visual analogue scale,VAS)評分,并觀察患者的不良反應發(fā)生率和應急用藥率。結果:附子湯組1例患者服藥3 d后因口部感覺麻木停藥; 2組患者的不良反應發(fā)生率比較,差異無統(tǒng)計學意義(P=0.053)。治療后5個月時,附子湯組5例失訪、氨基葡萄糖組7例失訪; 因疼痛加重,附子湯組7例服用美洛昔康片、氨基葡萄糖組23例服用美洛昔康片,2組均無連續(xù)應用美洛昔康片超過3 d者,氨基葡萄糖組的應急用藥率高于附子湯組(χ2=10.701,P=0.001)。治療前2組患者50 m行走后膝關節(jié)疼痛VAS評分和WOMAC骨關節(jié)炎指數(shù)比較,組間差異均無統(tǒng)計學意義[(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]; 治療后5個月,附子湯組50 m行走后膝關節(jié)疼痛VAS評分和WOMAC骨關節(jié)炎指數(shù)均小于氨基葡萄糖組[(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]。結論:服用附子湯可有效減輕輕中度KOA寒濕痹阻證患者的膝關節(jié)疼痛癥狀,提高患者的生活質量,療效優(yōu)于氨基葡萄糖,而且不良反應較少。
Abstract:
Objective:To observe the clinical curative effects and safety of Fuzi Tang(附子湯)in treatment of mild-to-moderate knee osteoarthritis(KOA)with COLD-DAMPNESS STAGNATION(寒濕痹阻)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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備注/Memo

備注/Memo:
基金項目:浙江省自然科學基金(LY16H060005); 中國博士后科學基金面上項目(2014M561793); 中國博士后科學基金特別資助項目(2015T80637); 國家自然科學基金青年項目(81302989); 浙江省中醫(yī)藥科技計劃項目(2013ZQ007)
通訊作者:童培建 E-mail:[email protected]
更新日期/Last Update: 2016-02-29