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秋水仙碱不同药物制剂治疗家族性地中海热:它们一样吗?

Different pharmaceutical preparations of colchicine for Familial Mediterranean Fever: are they the same?

机构信息

Department of Rheumatology, Trakya University Medical School, 22100, Edirne, Turkey.

Department of Internal Medicine, Yıldırım Beyazıt University Atatürk Training and Research Hospital, Ankara, Turkey.

出版信息

Rheumatol Int. 2020 Jan;40(1):129-135. doi: 10.1007/s00296-019-04432-3. Epub 2019 Aug 28.

Abstract

This study aimed to investigate the benefit of changing the pharmaceutical preparation of colchicine in Turkish Familial Mediterranean Fever (FMF) patients resistant to one preparation in terms of frequency of the attacks. Turkish adult FMF patients under treatment with an imported colchicine preparation-in the form of compressed tablet form-due to resistance to domestic colchicine preparations, which are film- or sugar-coated tablets, and not using anti-interleukin-1 or other biologic agents were included in the study. Baseline disease characteristics along with MEFV mutations were identified. Daily colchicine doses and attack frequencies before and after the pharmaceutical change were compared. Fifty patients resistant to coated tablet preparations of colchicine and under treatment with the compressed tablets were identified. The median duration of disease was 6 (interquartile range 2.7-14) years and duration under treatment with the imported colchicine was 21 (range 8-60) months. Eight (16%), ten (20%), and 32 (64%) patients had 0-3, 4-6, and more than 7 attacks per year, respectively, before the compressed tablets. After treatment with the compressed tablet form of colchicine, 44 (88%), 5 (10%), and 1 (2%) patients had 0-3, 4-6, and more than 7 attacks, respectively (p < 0.0001). Daily colchicine doses were similar before and after the pharmaceutical change (1.85 ± 0.47 vs 1.84 ± 0.37 mg, p = 0.9). Turkish FMF patients with ongoing attacks under domestic coated tablet preparations of colchicine may benefit from the compressed colchicine tablets. This may be explained by the difference in pharmacokinetic properties of different colchicine preparations.

摘要

本研究旨在探讨改变土耳其家族性地中海热(FMF)患者药物制剂对发作频率的影响。因对国产秋水仙碱制剂(薄膜或糖衣片)耐药,正在接受进口秋水仙碱制剂(压缩片剂)治疗的土耳其成年 FMF 患者,且未使用白介素-1 拮抗剂或其他生物制剂,被纳入本研究。确定了基线疾病特征和 MEFV 突变。比较了药物更换前后的每日秋水仙碱剂量和发作频率。确定了 50 名对秋水仙碱包衣片耐药且正在服用压缩片剂的患者。疾病中位病程为 6 年(四分位距 2.7-14 年),接受进口秋水仙碱治疗的中位病程为 21 个月(8-60 个月)。在服用压缩片剂之前,分别有 8 名(16%)、10 名(20%)和 32 名(64%)患者每年发作 0-3、4-6 和>7 次。服用压缩片剂后,分别有 44 名(88%)、5 名(10%)和 1 名(2%)患者每年发作 0-3、4-6 和>7 次(p<0.0001)。药物更换前后的秋水仙碱日剂量相似(1.85±0.47 vs 1.84±0.37 mg,p=0.9)。正在接受国产秋水仙碱包衣片治疗且仍有发作的土耳其 FMF 患者可能受益于服用压缩秋水仙碱片。这可能是由于不同秋水仙碱制剂的药代动力学特性不同所致。

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