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High-dose dexamethasone therapy as the initial treatment for idiopathic thrombocytopenic purpura.
International Journal of Hematology ( IF 1.7 ) Pub Date : 2020-01-02 , DOI: 10.1007/s12185-019-02808-6
Ken Takase 1 , Hirokazu Nagai 2 , Moe Kadono 3 , Takanori Yoshioka 4 , Nobuyuki Yoshio 5 , Yukio Hirabayashi 6 , Takuo Ito 7 , Morio Sawamura 8 , Akihiro Yokoyama 9 , Shinichiro Yoshida 10 , Ikuyo Tsutsumi 11 , Maki Otsuka 12 , Youko Suehiro 13 , Michihiro Hidaka 14 , Isao Yoshida 15 , Hisayuki Yokoyama 16 , Hitoshi Inoue 17 , Hiroatsu Iida 2 , Maki Nakayama 18 , Terutoshi Hishita 19 , Hiromi Iwasaki 1 , Akiko Kada 20 , Akiko M Saito 20 , Yoshiaki Kuroda 3
Affiliation  

There is a controversy which short term high dose dexamethasone therapy (HDD) or standard dose prednisolone therapy as the initial treatment leads to long term efficacy in idiopathic thrombocytopenic purpura (ITP) patients. We conducted a multicenter, prospective trial to determine the efficacy and safety of short-term HDD in ITP patients aged 18-80 years with platelet counts of < 20 × 109/l, or < 50 × 109/l and bleeding symptoms. The primary endpoints are the proportion of complete response (CR) plus partial response (R) on day 180 after the completion of the 46-day HDD. Twenty-three patients were enrolled. Test for Helicobacter pylori (H. pylori) was positive for 6 patients and negative for 17 patients. In positive patients, 5 were received successful H. pylori eradication therapy. The proportion of CR + R was 60.9% (14/23) with 90% confidence interval of 41.7-77.8%. For patients with positive H. pylori and successful eradication, the proportion of CR + R was 80.0% (4/5). There was one grade 4 adverse event. Although we have enrolled relatively old, severe ITP patients with a median age of 63 years in this study, the efficacy was comparable to the reported clinical trials with HDD therapy.

中文翻译:

大剂量地塞米松治疗是特发性血小板减少性紫癜的初始治疗。

短期高剂量地塞米松治疗(HDD)或标准剂量泼尼松龙治疗存在争议,因为初始治疗可导致特发性血小板减少性紫癜(ITP)患者获得长期疗效。我们进行了一项多中心前瞻性试验,以测定18-80岁ITP患者血小板计数<20×109 / l或<50×109 / l并伴有出血症状的短期HDD的疗效和安全性。主要终点是完成46天硬盘驱动器后第180天的完全缓解(CR)加上部分缓解(R)的比例。纳入了23位患者。幽门螺杆菌(H. pylori)测试阳性6例,阴性17例。在阳性患者中,有5人成功接受了根除幽门螺杆菌的治疗。CR + R的比例为60。9%(14/23),其90%置信区间为41.7-77.8%。对于幽门螺杆菌阳性并成功根除的患者,CR + R的比例为80.0%(4/5)。有一个4级不良事件。尽管我们在这项研究中招募了年龄相对较大的重度ITP患者,中位年龄为63岁,但其疗效与报告的HDD治疗临床试验相当。
更新日期:2020-01-04
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