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Anagrelide for the treatment of thrombocythaemia in daily clinical practice: a post-marketing observational survey on efficacy and safety performed in Germany.

机译:Anagrelide在日常临床实践中用于治疗血小板增多症:在德国进行的关于疗效和安全性的上市后观察性调查。

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摘要

BACKGROUND: Myeloproliferative diseases - in particular essential thrombocythaemia (ET) - may be associated with increases in platelet count which put patients at risk of life-threatening complications such as thromboses and severe bleedings. PATIENTS AND METHODS: This multicentre post-marketing observational survey was conducted to assess the efficacy and safety of anagrelide under daily practice conditions in at-risk patients with ET who received anagrelide for the first time. RESULTS: 198 patients (median age of 64 years, range 19-88 years) were included, 61.1% of the patients were women. The mean observation time was 6.2 +/- 1.7 months. Treatment with anagrelide lowered the platelet counts by a median of 316 x 10(9)/l from a median of 797 x 10(9)/l at the beginning of the observation to 470 x 10(9)/l at the last observation (log rank test, p < 0.001). Disease-related complications were reduced during treatment compared to 6 months prior to treatment (transient ischaemic attacks from 1.5 to 0.5%; thromboses from 7.6 to 0%). The number of bleedings remained the same at 1.5%. Adverse events were documented in 46 patients (23.2%). All observed adverse events were similar to those previously reported in clinical studies. CONCLUSION: Anagrelide was effective in lowering the platelet count and was also well tolerated when used in daily clinical practice.
机译:背景:骨髓增生性疾病-特别是原发性血小板增多症(ET)-可能与血小板计数增加有关,这使患者处于危及生命的并发症如血栓形成和严重出血的危险中。病人和方法:进行这项多中心的售后观察调查,以评估在日常使用条件下,对初次接受阿那格雷德的高危ET患者,阿那格雷利的疗效和安全性。结果:包括198例患者(中位年龄为64岁,范围为19-88岁),其中61.1%的患者为女性。平均观察时间为6.2 +/- 1.7个月。用阿那格雷治疗可将血小板计数中位数降低316 x 10(9)/ l,从观察开始时的797 x 10(9)/ l降低到最后观察时的470 x 10(9)/ l (对数秩检验,p <0.001)。与治疗前的6个月相比,治疗期间与疾病相关的并发症减少了(短暂性脑缺血发作从1.5%降至0.5%;血栓形成从7.6%降至0%)。出血数量保持在1.5%不变。不良事件记录在46例患者中(23.2%)。所有观察到的不良事件均与先前在临床研究中报道的不良事件相似。结论:阿那格雷可有效降低血小板数量,并且在日常临床实践中具有良好的耐受性。

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