消瘀散贴膏治疗膝骨关节炎的临床疗效研究

Clinical Efficacy of Xiaoyusan Plaster in Treatment of Knee Osteoarthritis

目的观察消瘀散贴膏治疗膝骨关节炎的临床疗效及安全性。方法将符合纳入标准的膝骨关节炎患者40例,按就诊顺序随机分为两组,治疗组26例,给予消瘀散贴膏外敷治疗;对照组14例,给予扶他林胶剂治疗,疗程为6周。疼痛评分和关节功能用视觉模拟量表(VAS)量表和WOMAC指数;通过ELISA试验测血清中软骨代谢指标人软骨寡聚基质蛋白(COMP)和Ⅱ型胶原C端肽(CTX-Ⅱ)的浓度。结果治疗组治疗前后VAS(t=11.7,P<0.001)、WOMAC(t=6.1,P<0.001)、COMP(t=7.2,P<0.001)、CTX-Ⅱ(t=1.2,P=0.24);对照组治疗前后VAS(t=7.3,P<0.001)、WOMAC(t=5.1,P<0.001)、COMP(t=8.8,P<0.001)、CTX-Ⅱ(t=0.82,P=0.43)。两组治疗前后疼痛和关节功能均明显改善,VAS、WOMAC、CTX-Ⅱ两组间比较差异无统计学意义,COMP两组间比较差异有统计学意义(t=2.3,P=0.03)。治疗过程中两例出现皮疹,未见其他不良反应。结论消瘀散贴膏能够明显改善膝骨关节炎患者的临床症状和关节功能,且无严重的不良反应,有一定的临床应用价值。

Objective To observe the clinical efficacy and safety of Xiaoyusan Plaster in the treatment of knee osteoarthritis （KOA）. Methods Forty patients with KOA were randomly divided into treatment group （n=26） and control group（n=14）. The treatment group was treated with Xiaoyusan Plaster and the control group was treated with Voltaren Gel. The course of treatment was 6 weeks. Pain and function were measured using a visual analogue scale （VAS） and a Western Ontario and McMaster Universities （WOMAC） total score scale. The concentrations of cartilage oligomeric matrix protein（COMP ）and collagen type Ⅱ degradation C-terminal peptide（CTX-Ⅱ）measured using ELISA were served as cartilage metabolism indicators. Results Scores of VAS （t=1 1.7, P〈0.001）, WOMAC （t=6.1, P〈0.001） and concentrations of COMP（t=7.2, P〈0.001）, CTX-Ⅱ （t=1.2, P=0.24） were significantly reduced in the treatment group after 6 weeks. Scores of VAS（t=7.3, P〈0.001）, WOMAC（t=5.1, P〈0.001） and concentrations of COMP （t=-8.8, P〈0.001）, CTX-Ⅱ （t=0.82, P=-0.43） were also reduced in the control group. Pain and function of joint were significantly improved in the two groups. The differences of VAS, WOMAC, CTX-Ⅱ were not significant between the two groups, but the difference of COMP was significant between the two groups （t=2.3, P=0.03）. Adverse events were not found in both groups, excepting local rash in two cases. Conclusion Xiaoyusan Plaster can significantly improve the clinical symptoms and the joint function of KOA patients without serious adverse reaction, and it has a certain application value in the treatment of KOA.