牛Ⅱ型胶原冻干粉剂治疗类风湿关节炎的临床研究

Efficacy of oral freeze-dried powders of bovine type Ⅱ collage for the treatment of rheumatoid arthritis

目的:评价牛Ⅱ型胶原(CⅡ)冻干粉剂和阳性对照药甲氨蝶呤(MTX)治疗类风湿关节炎(RA)的疗效和安全性。方法:采用随机、双盲、双模拟、平行对照的临床试验方法。42例患者随机分为试验组和对照组各21例。试验组口服CⅡ冻干粉剂100／μg·d-1,每日清晨空腹餐前服用;对照组口服MTX10 mg,每周1次。疗程均为12周。结果:治疗4周后CⅡ组和MTX组有效率分别为52．38％和61．90％(P>0．05);8周后分别为61．90％和90．47％,MTX疗效优于CⅡ(P<0．05);12周后分别为80．95％和90．47％。(P>0．05)。治疗前后比较,CⅡ能显著改善RA患者的休患痛、晨僵、关节压痛数和指数、关节肿胀数和指数、关节功能和患者评估(P<0．05)。除对双手平均握力的改善明显差于MTX外(P<0．05),其他指标的改善在两组间无明显差别(P>0．05)。CⅡ组不良反应发生率4．76％(1／21);MTX组19．05％(4／21)。不良反应均以轻度的胃肠道症状为主。不良反应发生率和总体耐受性比较差异无显著性(P>0．05)。结论:CⅡ能有效地改善RA患者的关节症状,不良反应少。

Objective： To assess the efficacy and safety of oral freeze-dried powders of bovine type Ⅱ collage （ C Ⅱ ） versus methotrexate （MTX） in the treatment of rheumatoid arthritis （RA）. Methods ： A double-blinded, randomized, parallel controlled and double dummy clinical trial recruited 42 patients with RA, who were randomized 1 ： 1 orally to take either freeze-dried powders of bovine C Ⅱ 100μg daily or MTX 10 mg once per week for 12 weeks. Results： The patients who received C Ⅱ or MTX experienced the efficacy rate of 52.38% versus 61.90（P 〉0. 05） at the end of 4-week therapy, 61.9% versus 90.47% （P 〈 0.05） at the end of 8-week therapy and 80.95% versus 90.47% （P 〉 0.05 ） at the end of 12-week therapy. No statistical difference of C Ⅱ from MTX was found in the tolerance and improvements of the pain at rest, morning stiffness, joint press pain index, joint swelling index and joint functions. MTX was superior to C Ⅱ in the improvement of grip strength of two hands（ P 〈 0.05）. The incidence rate of adverse events the patients receiving Cll or MTX was 4. 76% versus 19.05%. The major adverse event was mild GI disorder. Conclusion： CⅡ offered an alternative option for patients with RA.