[英夫利昔单抗治疗活动性强直性脊柱炎患者的生活质量测量——SF - 36与SF - 12的比较]

[Measurement of quality of life in patients with active ankylosing spondylitis being treated with infliximab-a comparison of SF-36 and SF-12].

作者信息

Haibel H, Niewerth M, Brandt J, Rudwaleit M, Listing J, Sieper J, Braun J

机构信息

Deutsches Rheuma-Forschungszentrum, Berlin.

出版信息

Z Rheumatol. 2004 Oct;63(5):393-401. doi: 10.1007/s00393-004-0604-5.

DOI:10.1007/s00393-004-0604-5

PMID:15517300

Abstract

BACKGROUND

Quality of life as a part of the WHO definition of health is an important assessment tool for measuring the success in the treatment of chronic diseases. The short form 36 questionnaire (SF-36), which is measuring health related quality of life, was used in a multicentre placebo controlled study in patients with ankylosing spondylitis (AS) treated with the anti-TNF-alpha antibody infliximab. As previously reported, substantial changes of almost all outcome parameters were observed in this study because of the substantial clinical improvement that is known to occur in most patients treated with anti-TNF agents. The short form 12 questionnaire (SF-12) is shorter and quicker to complete as the SF-36. The summary scales of both questionnaires were compared in this study to answer the question whether the SF-12 can also be used in AS patient populations without too much loss of information. Using the shorter from could be an advantage for further studies in patients with AS, for example, the inception cohort for spondyloarthritides within the German Network of competence in rheumatology. Furthermore the data can be compared to the German standard population.

METHODS

In this multicentre placebo controlled study 70 patients with active disease were enrolled: 35 AS patients received placebo, 35 were treated with infliximab, 5 mg/kg at week 0/2/6. Thereafter all patients were treated in an open study with infliximab at 5 mg/kg every 6 weeks. The disease activity (BASDAI), function (BASFI), mobility (BASMI), pain (NRS) and CRP as well as SF-36 were assessed. Data to calculate the SF-12 were extracted from the SF-36 questions and compared concerning agreement of individual levels, correlation with each other and with the BASFI, sensitivity to change and missing values.

RESULTS

All outcome parameters for disease activity as well as all subscales of health related quality of life improved in patients with active AS treated with infliximab. The comparability of the sum components for SF-12 and SF-36 were high (physical health r=0.912 and mental health r=0.957).

CONCLUSION

These data suggest that the shorter version of the SF-36, the SF-12, is capable to measure quality of life in clinical studies with AS patients.

摘要

背景

生活质量作为世界卫生组织对健康定义的一部分，是衡量慢性病治疗成功与否的重要评估工具。简短健康调查问卷36项（SF - 36）用于测量与健康相关的生活质量，在一项多中心安慰剂对照研究中，该问卷被用于接受抗肿瘤坏死因子α抗体英夫利昔单抗治疗的强直性脊柱炎（AS）患者。如先前报道，由于已知大多数接受抗TNF药物治疗的患者会出现显著的临床改善，本研究中几乎所有结局参数都有显著变化。简短健康调查问卷12项（SF - 12）比SF - 36更简短且完成速度更快。本研究对这两种问卷的汇总量表进行了比较，以回答SF - 12是否也可用于AS患者群体且不会损失太多信息的问题。使用更简短的问卷对于AS患者的进一步研究可能具有优势，例如德国风湿病能力网络内脊柱关节炎的起始队列研究。此外，这些数据可与德国标准人群的数据进行比较。

方法

在这项多中心安慰剂对照研究中，纳入了70例活动期疾病患者：35例AS患者接受安慰剂治疗，35例接受英夫利昔单抗治疗，在第0/2/6周给予5mg/kg。此后，所有患者在开放研究中每6周接受5mg/kg英夫利昔单抗治疗。评估疾病活动度（BASDAI）、功能（BASFI）、活动能力（BASMI）、疼痛（NRS）和CRP以及SF - 36。从SF - 36问题中提取计算SF - 12的数据，并就个体水平的一致性、相互之间的相关性以及与BASFI的相关性、对变化的敏感性和缺失值进行比较。