附子汤治疗轻中度膝骨关节炎寒湿痹阻证的临床研究  

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] 

机构地区：[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

出　　处：《中医正骨》2016年第1期10-13,共4页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：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)

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 Mc Master 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。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） ,0.75 g 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 glu- cosamine group were given meloxicam tablets for aggravated knee pain for no more than 3 consecutive days, and the rate of emergency medi- cation was higher in glucosamine group compared to Fuzi Tang group（x2 = 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

关 键 词：骨关节炎 膝 附子汤 氨基葡萄糖 痹证 临床试验 

分 类 号：R274.9[医药卫生—中西医结合]