基于不均匀沉降理论的揉膝推髌点穴法联合口服盐酸氨基葡萄糖治疗早期膝骨关节炎

A clinical study of rubbing-knee,pushing-patella and pressing-points under the guidance of uneven sagging theory combined with oral application of glucosamine hydrochloride for treatment of early knee osteoarthritis

目的:观察基于不均匀沉降理论的揉膝推髌点穴法联合口服盐酸氨基葡萄糖治疗早期膝骨关节炎(knee osteoarthritis,KOA)的临床疗效和安全性。方法:将符合要求的KOA患者(均为Kellgren-LawrenceⅠ级或Ⅱ级)随机分为2组,分别采用揉膝推髌点穴法联合口服盐酸氨基葡萄糖治疗(推拿组)和口服盐酸氨基葡萄糖联合外用双氯芬酸二乙胺乳胶剂治疗(药物组)。揉膝推髌点穴法隔天治疗1次,共治疗2周;盐酸氨基葡萄糖胶囊口服,每次750 mg,每日2次,服用2周;双氯芬酸二乙胺乳胶剂,在痛处涂抹,每日3次,共治疗2周。分别于治疗前和治疗结束后采用Lysholm膝关节评分标准和西安大略和麦克马斯特大学(Western Ontario and McMaster Universities,WOMAC)骨关节炎指数量表评价疗效,观察记录不良反应发生情况。结果:纳入患者共160例(221膝),推拿组80例(111膝)、药物组80例(110膝)。至试验结束时,因未按规定完成治疗,推拿组脱落12例(16膝),药物组脱落15例(21膝)。治疗前2组Kellgren-LawrenceⅠ、Ⅱ级患者的Lysholm评分比较,组间差异均无统计学意义(t=0. 364,P=0. 548; t=0. 169,P=0. 682);治疗结束后2组Kellgren-LawrenceⅠ、Ⅱ级患者的Lysholm评分均较治疗前增高[(59. 71±6. 41)分,(81. 24±6. 28)分,t=25. 432,P=0. 000;(60. 54±6. 27)分,(77. 66±7. 04)分,t=25. 112,P=0. 000;(51. 64±6. 85)分,(71. 07±5. 92)分,t=23. 778,P=0. 000;(52. 27±7. 21)分,(66. 93±7. 31)分,t=16. 610,P=0. 000],推拿组Kellgren-LawrenceⅠ、Ⅱ级患者的评分均高于药物组(t=6. 227,P=0. 015; t=7. 916,P=0. 006)。治疗前2组Kellgren-LawrenceⅠ、Ⅱ级患者的WOMAC骨关节炎指数比较,组间差异均无统计学意义(t=0. 270,P=0. 604; t=0. 244,P=0. 622);治疗结束后2组Kellgren-LawrenceⅠ、Ⅱ级患者的WOMAC骨关节炎指数均较治疗前降低[(10. 07±4. 46)分,(2. 67±2. 35)分,t=14. 714,P=0. 000;(9. 56±4. 56)分,(3. 71±3. 53)分,t=11. 003,P=0. 000;(14. 07±4. 62)分,(7. 44±2. 87)分,t=12. 141,P=0. 000;(13. 56±4. 86)分,(8. 76±3. 82)分,t=9. 937,P=0. 000],推拿组Kellgren-LawrenceⅠ级患者的WOMAC骨关节炎指数低于药物组(t=10. 134,P=0. 002),推拿组Kellgren-LawrenceⅡ级患者的WOMAC骨关节炎指数与药物组比较,差异无统计学意义(t=3. 275,P=0. 074)。2组患者治疗期间均未出现不良反应。结论:基于不均匀沉降理论的揉膝推髌点穴法联合口服盐酸氨基葡萄糖,可有效缓解早期KOA患者的临床症状、改善关节功能,安全性较高,且疗效优于口服盐酸氨基葡萄糖联合外用双氯芬酸二乙胺乳胶剂治疗。

Objective ：To observe the clinical curative effects and safety of rubbing - knee, pushing - patella and pressing - points（ RK- PPPP） under the guidance of uneven sagging theory combined with oral application of glueosamine hydroehloride for treatment of early knee osteoarthritis（KOA）. Methods：The patients with KOA （Kellgren -Lawrence grade I and II ）enrolled in the study were randomly divided into 2 groups and were treated with combination therapy of RKPPPP method and oral application of glueosamine hydroehloride（ manipulation group） and combination therapy of oral application of glueosamine hydroehloride and external application of dielofenae diethylamine enmlgel （drug group）respectively. The RKPPPP method was performed on patients on alternate days for 2 weeks. The glueosamine hydroehloride capsules were taken twice a day for consecutive 2 weeks ,750 mg at a time. The ddiclofenae diethylamine emulgel was applied on pain spots three times a day for consecutive 2 weeks. The curative effects were evaluated by using Lysholm knee scoring standard and Western Ontario and MeMaster Universities（WOMAC） osteoarthritis index scale before and after the treatment respectively, and the adverse reactions were observed and recorded. Results ：One hundred and sixty patients（221 knees）were enrolled in the study,80 cases（ 111 knees）in manipula- tion group and 80 cases （ 110 knees） in drug group. By the end of the trial, 12 patients （ 16 knees） in manipulation group and 15 patients （21 knees） in drug group dropped out because the treatment were mffinished according to plan. There were no statistical difference in Lysholm scores between the 2 groups before the treatment （ t = 0. 364,P = 0. 548 ; t = 0. 169, P = 0.682 ）. The Lysholm scores increased after the end of the treatment compared to pretreatment in the 2 groups（59.71 ＋/- 6.41 vs 81.24 ＋/- 6.28 points, t = 25. 432,P = 0. 000 ;60.54 ＋/- 6.27 vs 77.66 ＋/- 7.04 points,t =25. 112 ,P =0.000;51.64 ＋/-6.85 vs 71.07 ＋/-5.92 points,t =23. 778 ,P =0.000;52.27 ＋/- 7.21 vs 66.93 ＋/-7.31 points,t = 16. 610,P = 0.000） , and were higher in manipulation group compared to drug group （t = 6. 227, P = 0. 015; t = 7. 916,P = 0. 006）. There were no statistical difference in WOMAC osteoarthritis index between the 2 groups before the treatment（ t = 0. 270,P = 0. 604;t = 0. 244,P = 0.622）. The WOMAC osteoarthritis index decreased after the end of the treatment compared to pretreat- ment in the 2 groups（ 10.07 ＋/- 4.46 vs 2.67 ＋/- 2.35 points, t = 14. 714, P = 0. 000; 9.56 ＋/- 4.56 vs 3.71 ＋/- 3.53 points, t = 11. 003,P =0.000;14.07 ＋/-4.62 vs 7.44 ＋/-2.87 points,t =12. 141,P =0.000;13.56 ＋/-4.86 vs 8.76 ＋/-3.82 points,t =9. 937, P = 0.000） , and the WOMAC osteoarthritis index of patients with Kellgren - Lawrence grade I KOA was lower in manipulation group com- pared to drug group（ t = 10. 134,P = 0.002） ,and there was no statistical difference in WOMAC osteoarthritis index of patients with Kell- gren - Lawrence grade II KOA between the 2 groups （ t = 3. 275,P = 0. 074）. No adverse reactions were found in the 2 groups during the treatment. Conclusion：The combination therapy of RKPPPP under the guidance of uneven sagging theory and oral application of glu- eosamine hydroehloride can effectively relieve the clinical symptoms and improve the knee function of patients with early KOA, meanwhile, it has high safty, moreover, its curative effect is better than that of oral application of glueosamine hydroehloride combined with external ap- plication of dielofenae diethylamine emulgel.