膝痹消肿方联合西药治疗膝骨关节炎30例临床观察

Clinical Observation on 30 Cases of Xibixiaozhong Formula( 膝痹消肿方) Combining with Western Medicine Treating Knee Osteoarthritis

目的探讨膝痹消肿方治疗膝骨关节炎的临床疗效及安全性。方法将60例膝骨关节炎患者随机分为治疗组和对照组各30例。两组均给予盐酸氨基葡萄糖胶囊口服,每次0.48 g,每日3次。对照组加用洛索洛芬钠片口服,每次60 mg,每日3次。治疗组加用膝痹消肿方加减口服,每日1剂。两组均服药4周。治疗前后观察两组患者膝关节疼痛程度、肿胀度和屈伸活动度,并进行膝关节功能评定(HSS评分)和膝关节症状评分,并评价临床疗效。结果治疗组临床疗效控显率为63.3%,总有效率为96.7%,对照组控显率为36.7%,总有效率为90.0%,两组间临床疗效总有效率比较,差异无统计学意义(P>0.05),治疗组控显率明显高于对照组(P=0.046)。两组治疗后膝关节疼痛程度、肿胀度和活动度均较治疗前有明显改善(P<0.01);治疗后治疗组关节屈伸活动度改善优于对照组(P<0.01)。两组治疗后HSS评分均有显著上升(P<0.01);治疗后两组HSS评分比较,差异均无统计学意义(P>0.05)。在用药过程中治疗组未见明显不良反应,对照组中有2例轻度胃肠道反应。结论膝痹消肿方治疗膝骨关节炎疗效与洛索洛芬钠片相当,安全性良好。

Objective To explore therapeutic effects and safety of Xibixiaozhong Formula treating knee osteoar- thritis. Methods Randomly divided 60 cases of knee osteoarthritis patients into a treatment group and a control group, with 30 cases each. Both groups were given Glucosamine Hydrochloride Capsules orally, 0. 48 g each time, three times each day. The control group took Loxoprofen Sodium Tablets orally in addition, 60mg each time, three times each day. The treatment group took modification of Xibixiaozhong Formula orally in addition, one dose each day. Both groups were treated all took medicine for 4 weeks. Observe degree of knee joint pain, degree of swelling and range of flexion-extension of patients in two groups before and after treatment. Conducted the knee joint function evaluation （ HSS score） and knee joint syndrome score to evaluate clinical effects. Results Curative effective rate of the treatment group was 63.3%, with total effective rate of 96.7%. Curative effective rate of the control group was 36. 7%, with total effective rate of 90. 0%. The difference of total effective rate of both groups was not statistically significant （P 〉 0. 05 ）. The score of treatment group was remarkably higher than that of the control group （ P = 0. 046）. Degree of knee joint pain, degree of swelling and range of flexion-extension of two groups all remarkably im- proved after treatment, compared with that before treatment （P 〈 0. 01 ） ; The improvement of range of joint flexion- extension of treatment group after treatment was inferior to that of the control group （ P 〈 0. 01 ）. HSS score of two groups after treatment all remarkably increased （P 〈 0. 01 ） ; The difference was not statistically significant when HSS score of two groups after treatment were compared （P 〉 0. 05 ）. during taking There was no obvious adverse reaction of treatment group medicine, while there were 2 cases of slight gastrointestinal reaction in control group. therapeutic effect of Xibixiaozhong Formula treating knee osteoarthritis seems equivalent to that of Loxoprofen Sodium Tablet, with good safety.