Rheumatology Unit, Hospital Clinico San Carlos, Madrid, Spain.
Clin Exp Rheumatol. 2012 May-Jun;30(3):380-7. Epub 2012 Jun 26.
To evaluate long-term use of antimalarial drugs and to analyse all causes of discontinuation.
This is a retrospective study of a cohort of rheumatic diseases patients on antimalarials, during a maximum period of 17.5 years. Case was defined as antimalarial treatment discontinuation due to: a) lack of efficacy, b) adverse events, and c) other causes. Survival techniques were used to estimate the incidence rate (IR) per 1,000 patient-years with the 95% Confidence Interval (95% CI) of antimalarial treatment discontinuation. Cox regression models were conducted to evaluate possible associated factors to antimalarial discontinuation.
One thousand, two hundred and ninety-one medical records were reviewed, and 778 patients were included. Patients started 869 different courses of treatment, with a total follow-up of 2,263 person-years. The IR of global discontinuation was 204 (95% CI 186-224). Fifty-two per cent of the treatments stopped were related to adverse events, 14% to lack of efficacy; and 34% to other reasons (refusal to take medication, ocular comorbidity, remission, or pregnancy). Adverse events discontinuations were related to non-ophthalmologic reasons in 54.5% (gastrointestinal, neuro-psychiatric, skin problems), and to ophthalmologic adverse events in 45.5%. Nine patients suffered definite presence of antimalarial retinopathy (IR: 3.97 [IC 95%: 2.06-7.62]) and one of them irreversible loss of vision (IR: 0.44 [IC 95%: 0.06-3.12]). Women, increasing age, and chloroquine vs. hydroxychloroquine use, increased the risk of discontinuation due to ophthalmologic adverse events.
Results suggest that antimalarials have a good balance between benefit and risk. However, we noted a number of discontinuations due to both inefficacy and adverse events. The potential for an unusual but serious ophthalmologic toxicity emphasises the importance of close ophthalmologic monitoring.
评估抗疟药物的长期使用情况，并分析所有停药原因。
这是一项对接受抗疟药物治疗的风湿性疾病患者队列进行的回顾性研究，最长随访时间为 17.5 年。病例定义为因以下原因停止抗疟治疗：a）无效，b）不良反应，和 c）其他原因。使用生存技术估计每 1000 患者年的发生率（IR）及其 95%置信区间（95%CI）。采用 Cox 回归模型评估与抗疟药停药相关的可能因素。
共回顾了 1291 份病历，纳入了 778 名患者。患者开始了 869 种不同的治疗方案，总随访时间为 2263 人年。总体停药的 IR 为 204（95%CI 186-224）。52%的治疗停止与不良反应有关，14%与无效有关；34%与其他原因（拒绝服药、眼部合并症、缓解或妊娠）有关。不良反应停药中，54.5%与非眼科原因有关（胃肠道、神经精神、皮肤问题），45.5%与眼科不良反应有关。9 名患者确诊存在抗疟药视网膜病变（IR：3.97[95%CI：2.06-7.62]），其中 1 名患者视力不可逆转丧失（IR：0.44[95%CI：0.06-3.12]）。女性、年龄增长和使用氯喹与羟氯喹，增加了因眼科不良反应而停药的风险。
结果表明，抗疟药物在获益和风险之间具有良好的平衡。然而，我们注意到由于疗效不佳和不良反应而导致的停药人数较多。罕见但严重的眼科毒性的可能性强调了密切眼科监测的重要性。
