石氏三色敷药外敷治疗早中期膝骨关节炎瘀血阻滞证的临床研究  

A clinical study of external application of Shi's Sanse Fuyao for treatment of blood-stasis-stagnation-type early-middle knee osteoarthritis

作　　者：郭天旻[1] 李浩钢 吴军豪 石琤[1] 屠安琪 余益群 吴海洋 桂璟 GUO Tianmin;LI Haogang;WU Junhao;SHI Cheng;TU Anqi;YU Yiqun;WU Haiyang;GUI Jing(Huangpu District Central Hospital,Shanghai 200002,China)

机构地区：[1]上海市黄浦区中心医院,上海200002

出　　处：《中医正骨》2018年第11期21-27,共7页The Journal of Traditional Chinese Orthopedics and Traumatology

基　　金：上海市卫生和计划生育委员会中医药科研基金项目(2014LP042A)

摘　　要：目的:观察石氏三色敷药外敷治疗早中期膝骨关节炎瘀血阻滞证的临床疗效和安全性。方法:将符合要求的90例早中期膝骨关节炎瘀血阻滞证患者随机分为2组,每组45例,分别采用石氏三色敷药外敷和双氯芬酸二乙胺乳胶剂外涂治疗。石氏三色敷药外敷患膝疼痛处,每2 d更换1次,连续贴敷28 d;双氯芬酸二乙胺乳胶剂外涂患膝疼痛处,每天3～4次,连续外涂28 d。分别于治疗前、治疗开始后7 d、14 d、28 d,比较2组患者西安大略和麦克马斯特大学(Western Ontario and McMaster universities,WOMAC)骨关节炎指数量表疼痛评分、僵硬评分、躯体功能评分;于治疗前及治疗开始后28 d,比较2组患者膝关节活动度;于治疗开始后28 d,比较2组患者的膝关节肿胀消退率和综合疗效,并比较2组患者并发症发生情况。结果:①WOMAC疼痛评分。时间因素和分组因素存在交互效应(F=14. 266,P=0. 000); 2组患者WOMAC疼痛评分比较,组间差异有统计学意义,即存在分组效应(F=10. 648,P=0. 001);治疗前后不同时间点间WOMAC疼痛评分的差异有统计学意义,即存在时间效应(F=222. 342,P=0. 000); 2组患者WOMAC疼痛评分随时间均呈下降趋势,但2组的下降趋势不完全一致[(38. 77±16. 60)分,(26. 05±12. 92)分,(17. 48±10. 84)分,(7. 85±10. 19)分,F=9. 192,P=0. 000;(37. 40±13. 08)分,(30. 72±12. 78)分,(25. 23±14. 02)分,(19. 11±15. 15)分,F=23. 720,P=0. 000];治疗前和治疗开始后7 d,2组患者的WOMAC疼痛评分比较,组间差异均无统计学意义(t=0. 189,P=0. 665; t=2. 976,P=0. 088);治疗开始后14 d、28 d,石氏三色敷药外敷组WOMAC疼痛评分均低于双氯芬酸二乙胺乳胶剂外涂组(t=8. 617,P=0. 004; t=17. 089,P=0. 000)。②WOMAC僵硬评分。时间因素和分组因素不存在交互效应(F=1. 918,P=0. 248); 2组患者WOMAC僵硬评分比较,组间差异无统计学意义,即不存在分组效应(F=0. 630,P=0. 428); 2组患者治疗前后不同时间点WOMAC僵硬�Objective：To observe the clinical curative effects and safety- of external application of Shi＇ s Sanse Fuyao （三色敷药, SS- FY） for treatment of blood-stasis-stagnation-type early-middle knee osteoarthritis（KOA）. Methods ： Ninety- patients with blood-stasis-stagna- tion-type early-middle KOA enrolled in the study were randomly divided into 2 groups ,45 cases in each group, and were treated with exter- nal application of Shi＇ s SSFY（ group A） and external application of diclofenac diethylamine emulgel（ group B） respectively. The Shi＇ s SSFY was applied to the pain spots of affected knee every- other day- for consecutive 28 day-s ; while the diclofenac diethylamine emulgel was applied to the pain spots of affected knee,3 -4 times a day- for consecutive 28 day-s. The Western Ontario and McMaster universities （WOMAC）os- teoarthritis index pain scores, stiffness scores and physical function scores were compared between the 2 groups before treatment and at 7,14 and 28 days after the beginning of the treatment respectively. The range of motion（ROM） of knee was compared between the 2 groups before treatment and at 28 day-s after the beginning of the treatment respectively. The knee swelling subsidence rate, total clinical curative effects and complication incidences were compared between the 2 groups at 28 clays after the beginning of the treatment. Results ：There was inter- action between time factor and group factor in WOMAC pain scores（ F = 14. 266 ,P = 0. 000）. There was statistical difference in WOMAC pain scores between the 2 groups,in other words, there was group effect（ F = 10.648,P = 0.001 ）. There was statistical difference in WOM- AC pain scores between different timepoints before and after the treatment, in other words, there was time effect（ F = 222. 342, P = 0. 000）. The WOMAC pain scores presented a time-dependent decreasing trend in the 2 groups ,while the 2 groups were inconsistent with each other in the decreasing trend of WOMAC pain scores（ 38.77 �

关 键 词：骨关节炎 膝 瘀血阻滞 中药外敷 石氏三色敷药 双氯芬酸二乙胺乳胶剂 

分 类 号：R274.9[医药卫生—中西医结合]