Capell H A, Maiden N, Madhok R, Hampson R, Thomson E A
Centre for Rheumatic Diseases, Royal Infirmary, Glasgow, UK.
J Rheumatol. 1998 Oct;25(10):1880-6.
To assess existing disease modifying antirheumatic drugs (DMARD) using a strategy aiming for sustained suppression of inflammation.
We conducted intention-to-treat analysis of open randomized study [sulfasalazine (SASP) or penicillamine (PEN)], followup 12 years, conducted at specialist rheumatology clinics in Glasgow, Scotland. Subjects were 200 patients with rheumatoid arthritis (RA) with established disease. In this "true to life" approach, comorbidity was not an exclusion criterion unless it prejudiced assessment of drug toxicity. The main outcome measure was the Health Assessment Questionnaire (HAQ) functional score.
Over 12 year followup 95 (47.5%) patients died; this was the commonest reason for study groups being unfulfilled. There was one drug related death (methotrexate). Patients who were socially disadvantaged were more likely to die prematurely. HAQ did not deteriorate significantly in those who continued taking their original DMARD, or in the SASP intention-to-treat group over 12 years. Sustained suppression of disease activity was possible in the entire group available for followup at 12 years. Most toxicity occurred early and no unexpected side effects were observed.
High premature mortality in RA was confirmed and an association between mortality and deprivation was demonstrated. Sustained reduction in acute phase response was possible using sequential single DMARD. This study provides useful baseline and longterm information against which to evaluate combination therapy or new agents.
采用旨在持续抑制炎症的策略评估现有的改善病情抗风湿药物（DMARD）。
我们对在苏格兰格拉斯哥的专科风湿病诊所进行的一项为期12年的开放随机研究（柳氮磺胺吡啶[SASP]或青霉胺[PEN]）进行了意向性分析。研究对象为200例确诊为类风湿关节炎（RA）的患者。在这种“贴近现实生活”的研究方法中，合并症并非排除标准，除非其影响对药物毒性的评估。主要结局指标为健康评估问卷（HAQ）功能评分。
在12年的随访中，95例（47.5%）患者死亡；这是研究组未达预期的最常见原因。有1例药物相关死亡（甲氨蝶呤）。社会经济地位不利的患者更易过早死亡。在持续服用原DMARD的患者或SASP意向性分析组中，HAQ在12年期间未出现显著恶化。在12年可进行随访的整个研究组中，疾病活动得到持续抑制是可能的。大多数毒性反应出现在早期，未观察到意外的副作用。
证实了RA患者过早死亡率较高，并证明了死亡率与贫困之间的关联。使用序贯单一DMARD可使急性期反应持续降低。本研究提供了有用的基线和长期信息，可据此评估联合治疗或新药物。
