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双重滤过血浆置换治疗活动性类风湿关节炎的对照研究。

A controlled study of double filtration plasmapheresis in the treatment of active rheumatoid arthritis.

作者信息

Yu Xiaoxia, Ma Jinrong, Tian Junge, Jiang Shunua, Xu Ping, Han Heping, Wang Lixin

机构信息

Department of Rheumatology, Blood Purification Center of Cangzhou, Traditional Chinese Medicine-Western Medicine Hospital of Cangzhou of Hebei, Cangzhou, Hebei, People's Republic of China.

出版信息

J Clin Rheumatol. 2007 Aug;13(4):193-8. doi: 10.1097/RHU.0b013e318124a483.

DOI:10.1097/RHU.0b013e318124a483
PMID:17762452
Abstract

BACKGROUND

Double-filtration plasmapheresis with a plasma fractionator pore size of 20 nm should selectively remove large molecular weight substances like rheumatoid factor and IgM. This was proposed to be more likely to be helpful for rheumatoid arthritis than standard plasma exchange.

OBJECTIVE

To evaluate the efficacy of double-filtration plasmapheresis (DFPP) in the treatment of patients with active rheumatoid arthritis.

METHODS

Eighty-two patients were randomly assigned, 42 to the DFPP group and 40 to the no-DFPP group. All patients received sulfasalazine (0.75 g 3 times daily) plus methotrexate (10 mg orally once weekly). All patients had been on stable doses for more than 3 months. DFPP was performed once a week for 2 to 3 sessions. A total of 121 plasmapheresis procedures were performed in 42 patients. Control patients did not receive sham DFPP. The efficacy measures recorded 1 day after the final treatment and every month in follow-up for 4 to 22 months included the American College of Rheumatology (ACR) 20%, 50%, and 70% improvement criteria (ACR20, ACR50, and ACR70), the Health Assessment Questionnaire estimate of disability and the disease activity index.

RESULTS

Patients in the DFPP group had ACR20, ACR 50, and ACR70 improvements immediately after the last treatment of 100%, 92.9%, and 81.0%, when compared with the patients in no-DFPP group 17.5%, 0%, and 0% (P < 0.001). Significant change from baseline was observed in Health Assessment Questionnaire scores in the DFPP group, but not in the no-DFPP group (P < 0.001). The changes from baseline in the disease activity scores were significantly greater than in the no-DFPP group (P < 0.001). Improvements were maintained during follow-up of 7 to 22 months.

CONCLUSION

This open trial showed that DFPP therapy significantly altered the signs and symptoms of active rheumatoid arthritis. There were increases in physical function and improvement in quality of life. This is proposed as an approach that merits further investigation.

摘要

背景

采用孔径为20纳米的血浆成分分离器进行双重滤过血浆置换术应能选择性清除类风湿因子和IgM等大分子物质。有人认为,相较于标准血浆置换,双重滤过血浆置换术可能对类风湿关节炎更有帮助。

目的

评估双重滤过血浆置换术(DFPP)治疗活动期类风湿关节炎患者的疗效。

方法

82例患者被随机分组,42例进入DFPP组,40例进入非DFPP组。所有患者均接受柳氮磺胺吡啶(每日3次,每次0.75克)加甲氨蝶呤(每周口服1次,每次10毫克)治疗。所有患者均已服用稳定剂量药物超过3个月。DFPP每周进行1次,共进行2至3个疗程。42例患者共进行了121次血浆置换操作。对照组患者未接受假DFPP治疗。疗效评估指标包括在最后一次治疗后1天以及随访4至22个月期间每月记录的美国风湿病学会(ACR)20%、50%和70%改善标准(ACR20、ACR50和ACR70)、健康评估问卷残疾评估以及疾病活动指数。

结果

DFPP组患者在最后一次治疗后即刻的ACR20、ACR50和ACR70改善率分别为100%、92.9%和81.0%,而非DFPP组患者分别为17.5%、0%和0%(P<0.001)。DFPP组的健康评估问卷评分较基线有显著变化,而非DFPP组则无(P<0.001)。疾病活动评分较基线的变化显著大于非DFPP组(P<0.001)。在7至22个月的随访期间,改善情况得以维持。

结论

这项开放性试验表明,DFPP疗法显著改变了活动期类风湿关节炎的体征和症状。身体功能得到改善,生活质量有所提高。这被认为是一种值得进一步研究的方法。

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