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首页> 美国卫生研究院文献>Annals of the Rheumatic Diseases >Long term efficacy and safety of cyclosporin versus parenteral gold in early rheumatoid arthritis: a three year study of radiographic progression renal function and arterial hypertension
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Long term efficacy and safety of cyclosporin versus parenteral gold in early rheumatoid arthritis: a three year study of radiographic progression renal function and arterial hypertension

机译：类风湿关节炎早期环孢素与肠胃外金的长期疗效和安全性：三年的影像学进展肾功能和动脉高血压研究

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Objective: To compare the three year safety and efficacy of cyclosporin and parenteral gold in the treatment of early, active, severe rheumatoid arthritis (RA), and to study the reversibility of cyclosporin associated renal dysfunction in patients who discontinued cyclosporin treatment. Methods: The patients continued to receive cyclosporin or parenteral gold in an 18 month open extension to an 18 month randomised, parallel group study. The main efficacy variable was blinded evaluation of radiographic progression of joint damage. Safety variables included serum creatinine, calculated creatinine clearance, and blood pressure. Results: Radiographic progression during follow up was similar in both groups. About 60% of the patients in the intention to treat groups (n=272) and about half of the patients in the completer groups (n=114) had definite radiographic progression in joint damage (increases >6 in the Larsen-Dale score), and about one in three also had substantial progression (>18 increase in Larsen-Dale score). Both systolic and diastolic blood pressure were significantly increased in the cyclosporin group compared with the gold group, and 12/139 (9%) versus 3/139 (2%) (p=0.03) had notably raised blood pressure. The mean serum creatinine increased by 28% at the treatment end point in the cyclosporin group as compared with 7% in the gold group. The mean calculated creatinine clearance was reduced by 16% and increased by 1% in the cyclosporin and gold groups, respectively, at the end of the study. At the final follow up visit after discontinuation of cyclosporin (at least three months after treatment was stopped) the mean serum creatinine was increased by 15% and creatinine clearance reduced by 16%. Sustained increases in serum creatinine at this post-treatment end point were mostly seen in patients with a raised serum creatinine during treatment of at least 50%. Conclusion: Three year changes in radiographic damage during cyclosporin and parenteral gold were similar in patients with early, active RA. Abnormal renal function and raised blood pressure were often seen in the cyclosporin treated patients.
机译：目的：比较环孢菌素和肠胃外金治疗早期，活跃，严重的类风湿性关节炎（RA）的三年安全性和有效性，并研究环孢菌素相关的肾功能不全患者停用环孢菌素治疗的可逆性。方法：在18个月随机，平行分组研究的18个月开放期中，患者继续接受环孢菌素或肠胃外金。主要功效变量是关节损伤影像学进展的盲法评估。安全变量包括血清肌酐，计算得出的肌酐清除率和血压。结果：两组的随访影像学进展相似。意向治疗组中的患者中约60％（n = 272），完全治疗组中的患者中约一半（n = 114）有明确的关节损伤影像学进展（Larsen-Dale评分增加> 6） ，并且大约三分之一的人也有实质性进展（Larsen-Dale得分增加了> 18）。与黄金组相比，环孢菌素组的收缩压和舒张压均显着升高，并且12/139（9％）与3/139（2％）（p = 0.03）的血压显着升高。环孢菌素组在治疗终点的平均血清肌酐增加了28％，而黄金组为7％。在研究结束时，环孢菌素和金组的平均计算的肌酐清除率分别降低了16％和增加了1％。在停用环孢菌素后（在治疗停止后至少三个月）进行最后一次随访时，平均血清肌酐增加了15％，肌酐清除率降低了16％。在治疗后的这一终点，血清肌酐的持续增加主要发生在治疗期间血清肌酐升高至少50％的患者中。结论：早期活动性RA患者的环孢素和肠胃外金在放射学损伤方面的三年变化相似。在环孢素治疗的患者中经常出现肾功能异常和血压升高。

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