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
LIU Fucun;SHAN Letian;TONG Peijian;ZOU Jianqin;XIAO Luwei;Zhejiang Provincial Hospital of Traditional Chinese Medicine;Institute of Traumatology and Orthopedics Affiliated to Zhejiang University of Traditional Chinese Medicine;
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 Mc Master 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 7patients 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 vs5. 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 vs87. 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.
【Fund】： 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)
【CateGory Index】： R274.9
【CateGory Index】： R274.9