骨瓜提取物对活动期类风湿性关节炎的疗效和安全性

Efficacy and safety of cervus and cucumis polypeptide on treatment of patients with rheumatoid arthritis in active stage

目的 观察和分析骨瓜提取物对活动期类风湿性关节炎（RA）的疗效和安全性。方法 选取100例活动期RA患者作为研究对象,将其随机分为观察组和对照组,每组50例。对照组患者在常规疗法的基础上加用骨肽注射注进行治疗,观察组患者在常规疗法的基础上加用骨瓜提取物注射液进行治疗。对2组患者治疗前后的视觉模拟量表（VAS）评分、晨僵时间、疾病活动性评分-28（DAS28评分）、红细胞沉降率（ESR）水平、C反应蛋白（CRP）水平、类风湿因子（RF）水平及血液指标、肝功能指标、肾功能指标进行观察和比较;对2组患者治疗期间的不良反应发生率进行观察和比较。结果 观察组患者治疗后的VAS评分、晨僵时间、DAS28评分均显著低于对照组（t=4.216、4.786、3.658,P〈0.05）,ESR水平显著低于对照组（t=4.538,P〈0.05）;2组患者治疗前后的各项血液及肝肾功能指标、治疗期间各项不良反应的发生率及总发生率的差异均无统计学意义（t=0.037~0.728,χ2=0.122~1.010,P〉0.05）。结论 应用骨瓜提取物辅助治疗RA,可显著缓解患者受累关节的疼痛、压痛、肿胀、运动受限等症状。

Objective To observe and analyze the therapeutic effect and safety of cervus and cucumis polypeptide in treatment of patients with rheumatoid arthritis（ RA） in active stage. Methods A total of 100 patients with RA in active stage were selected as the study objects and randomly divided into observation group and control group,50 cases in each group. The patients in the control group were treated with ossotide injection on the basis of conventional therapy,while the patients in the observation group were treated with cervus and cucumis polypeptide injection on the basis of conventional therapy. The visual analogue scale（ VAS） score,the time of morning stiffness,the disease activity score 28（ DAS28 score）,the red cell sedimentation rate（ ESR）,the C- reactive protein（ CRP） level,the rheumatoid factor（ RF） level and the blood indexes,the liver function indexes,the renal function indexes of the two groups before and after the treatment were observed and compared. The incidence rates of the adverse events of the patients in the two groups during the treatment were observed and compared. Results The VAS score,the time of morning stiffness,the DAS28 score of the patients in the observation group were significantly lower than those in the control group（ t = 4. 216,4. 786,3. 658,P〈 0. 05）,and ESR level was significantly lower than that in the control group（ t = 4. 538,P〈 0. 05）. There were no significant differences of the blood indexes,the liver function indexes,the renal function indexes before and after the treatment as well as incidences of various adverse events between the t wo groups（ t = 0. 0 3 7- 0. 7 2 8,χ2= 0. 1 2 2- 1. 010,P〉0. 0 5）. Conclusion Application of cervus and cucumis polypeptide in treatment of RA can significantly relieve the symptoms of pain,tenderness,swelling,limitation of movement of the joints in the patients.