复方七叶皂苷凝胶改善膝关节骨性关节炎患者功能症状及其应用安全性

Reparil-gel compound for the functional symptoms of patients with knee osteoarthritis and the application reliability of the compound

目的:观察复方七叶皂苷凝胶(商品名利百素)改善膝关节骨性关节炎患者功能症状与其应用安全性。方法:2004-05/11中山大学第一附属医院康复科收治膝关节骨性关节炎患者98例,随机分为2组。治疗组予复方七叶皂苷凝胶4g均匀外涂于膝关节处皮肤,4次/d,治疗6周,对照组予布洛芬缓释胶囊(商品名芬必得),600mg/次,2次/d,治疗6周。分别运用WesternOntarioandMcMasterUniversityOsteoarthritisindex(WOMAC)在用药0,2,6周时进行评估及观察不良反应发生率。结果:用药2周后,治疗组、对照组治疗前后在3个子量表中所获分值,除对照组晨僵外经统计学处理差异无显著性意义(P>0.05),两组间治疗效果比较差异有显著性意义(P<0.05),用药6周后,两组治疗前后差异有非常显著性意义(P<0.01),两组间治疗效果比较差异无显著性意义(P>0.05)。治疗组未出现不良反应,治疗2周后对照组出现胃痛1例、恶心2例、食欲减退4例,发生率为14.3%,而治疗6周后对照组出现胃痛2例、恶心4例、食欲减退5例,发生率为24.5%。结论:复方七叶皂苷凝胶与布洛芬缓释胶囊均有较好的治疗效果,但复方七叶皂苷凝胶起效较快,副作用发生率较布洛芬缓释胶囊低。

AIM:To observe the effect of reparil gel compound(name of product:reparil gel N) in the improvement of functional symptoms of patients with osteoarthritis(OA) and the security of reparil gel compound therapy.METHODS:Ninety eight patients with OA hospitalized in the Department of Rehabilitation Medicine,First Affiliated Hospital of Sun Yat sen University from May to November 2004 were randomized to reparil gel treatment group and ibuprofen(name of product:Fenbid) treatment group(control group).Reparil gel 4 g was embrocated on the skin of knee joint in reparil gel treatment group,four times per day for 6 weeks,and ibuprofen capsule was taken orally in the control group 600 mg twice per day for 6 weeks.Western Ontario and McMaster University Osteoarthritis index(WOMAC) was used to assess the knee indices and observe the incidence of adverse reaction at 0,2 and 6 weeks after administration.RESULTS:At 2 weeks after administration as compared before administration,the scores of three subscales were all insignificantly different between the two the groups(P >0.05),expect the score of morning stiffness with insignificant differencein the control group with statistical analysis (P >0.05).At 6 weeks after administration,the scores of all the three subscales were significantly different between the two groups(P< 0.01),however,there was no significant difference in the curative effect between the two groups(P >0.05).No adverse reaction was were found in treatment group,but in the control group,stomachache was found in 1 case,nausea in 2 cases and decreased food appetite in 4 cases at 2 weeks with the incidence of 14.3% ,and stomachache in 2 cases,nausea in 4 and decreased food appetite in 5 at 6 weeks with the incidence of 24.5% .CONCLUSION:Both reparil gel compound and ibuprofen capsule are obviously effective,but the former has better effect,and with lower ratio of side effects.