塞来昔布联合双氯芬酸钠治疗膝关节骨关节炎患者的临床研究

Clinical trial of celecoxib combined with diclofenac sodium in the treatment of patients with knee osteoarthritis

目的观察塞来昔布胶囊联合双氯芬酸钠乳膏治疗膝关节骨关节炎患者的临床疗效及安全性。方法将患有膝关节骨关节炎患者随机分为对照组和试验组。对照组给予口服塞来昔布胶囊100 mg,bid;试验组在对照组治疗的基础上,给予双氯芬酸钠乳膏治疗,外用,一次取适量涂于患侧膝关节疼痛部位,tid。2组患者均连续治疗2周。比较2组患者的临床疗效、膝关节功能情况、疼痛情况、骨关节炎指数、血清炎症因子,以及药物不良反应的发生情况。结果试验过程中未出现脱落病例,最终试验组和对照组分别纳入64例。治疗后,试验组和对照组的总有效率分别为95.31%(61例/64例)和84.38%(54例/64例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的膝关节评定量表(Lysholm)评分分别为(86.22±4.44)和(64.47±3.51)分,视觉模拟评分法(VAS)评分分别为(3.21±0.97)和(4.18±1.19)分,安大略省西部和麦克马斯特大学骨关节炎指数(WOMAC)评分中僵硬分别为(2.84±1.36)和(4.42±1.61)分,疼痛分别为(8.32±2.12)和(11.15±3.32)分,日常活动的难度分别为(31.32±3.52)和(53.48±3.45)分,白细胞介素-1β(IL^(-1)β)表达量分别为(30.18±4.16)和(45.41±5.23)ng·mL^(-1),基质金属蛋白酶-3(MMP-3)表达量分别为(45.01±8.55)和(66.45±8.95)mg·L^(-1),试验组的上述指标与对照组比较,差异均有统计学意义(均P<0.05)。2组患者均未出现药物不良反应。结论塞来昔布胶囊联合双氯芬酸钠乳膏治疗膝关节骨关节炎的临床效果比塞来昔布胶囊单独更佳,具有极高的临床应用价值。

Objective To observe the clinical efficacy and safety of celecoxib capsules combined with diclofenac sodium cream in the treatment of osteoarthritis of the knee joint.Methods Patients with knee osteoarthritis will be randomly divided into control group and treatment group.The control group was given celecoxib capsules 100 mg,bid,orally;the treatment group on the basis of the control group was given diclofenac sodium cream treatment,external use,take an amount on the affected side of the knee pain site,tid.Two groups were treated for 2 weeks.Compared the clinical efficacy,knee function,pain,osteoarthritis index,serum inflammatory factors,and the occurrence of adverse drug reactions in 2 group.Results No shedding cases occurred during the trial.Finally,64 cases were included in the treatment group and the control group.After treatment,the total effective rates in the treatment and control groups were 95.31%(61 cases/64 cases)and 84.38%(54 cases/64 cases),respectively,and the difference was statistically significant(P<0.05).After treatment,the Lysholm score of the treatment group and the control group were(86.22±4.44)and(64.47±3.51)points;the visual analogue scale(VAS)score were(3.21±0.97)and(4.18±1.19)points;the Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)score were(2.84±1.36)and(4.42±1.61)points,and the pain were(8.32±2.12)and(11.15±3.32)points;the difficulty of daily activities were 31.32±3.52 and 53.48±3.45;the expression levels of interleukin-1β(IL-1β)were(30.18±4.16)and(45.41±5.23)ng·mL^(-1);the expression levels of matrix metalloproteinase-3(MMP-3)were(45.01±8.55)and(66.45±8.95)mg·L^(-1),respectively.The above indexes in the treatment group were significantly different from those in the control group(all P<0.05).There were no adverse drug reactions in the two groups.Conclusion The combination of celecoxib and diclofenac sodium has a better clinical effect than celecoxib alone in the treatment of knee osteoarthritis,and has a very high clinical application value.