Nakazaki Kumi, Hosoi Masataka, Hangaishi Akira, Ichikawa Motoshi, Nannya Yasuhito, Kurokawa Mineo
Department of Hematology and Oncology, Graduate School of Medicine, The University of Tokyo, Japan.
Intern Med. 2012;51(8):859-63. doi: 10.2169/internalmedicine.51.7005. Epub 2012 Apr 15.
Recently, pulsed high-dose dexamethasone (HD-Dexa) therapy was proposed as a possible alteration for the classical prednisolone (PSL) therapy for primary immune thrombocytopenia (ITP) patients, however it remains to be confirmed which of these remedies is superior. So the objective of this study is to compare the efficacy and the sustainability of these options.
The first-line therapy at our institute for untreated adult ITP cases was accordingly changed as follows, and we retrospectively evaluated the outcomes: 1) daily administration of 0.5-1 mg/kg PSL for 2-4 weeks and subsequently stepwise reduction, 2) one course of HD-Dexa (40 mg/day for four consecutive days, 1xHD-Dexa), 3) three courses of the same dose of HD-Dexa (3xHD-Dexa) repeated biweekly. This study was approved by the ethical committee of the University of Tokyo.
Twenty-five patients were enrolled consecutively. A good initial response was attained through all the regimens. Meanwhile, time to next treatment for lack of response or relapse was significantly longer in the PSL group than in the other groups (log-rank test, PSL vs. 1xHD-Dexa p<0.001, PSL vs. 3xHD-Dexa p=0.0053, respectively). Additionally, PSL regimen conferred a significantly longer duration time of response (PSL vs. 1xHD-Dexa p=0.0024, PSL vs. 3xHD-Dexa p=0.028, respectively) and CR (PSL vs. 1xHD-Dexa p=0.012, PSL vs. 3xHD-Dexa p=0.0090, respectively). No patient discontinued the treatment due to side effects in this study.
PSL regimen was considered to be superior to pulsed HD-Dexa regimens in the sustainability of response.
最近，脉冲式高剂量地塞米松（HD-Dexa）疗法被提议作为原发性免疫性血小板减少症（ITP）患者经典泼尼松龙（PSL）疗法的一种可能替代方案，然而这两种疗法哪种更优仍有待证实。因此，本研究的目的是比较这两种方案的疗效和可持续性。
我们研究所对未经治疗的成人ITP病例的一线治疗方案做了如下相应改变，并对结果进行回顾性评估：1）每日给予0.5 - 1mg/kg PSL，持续2 - 4周，随后逐步减量；2）一个疗程的HD-Dexa（连续4天每日40mg，1xHD-Dexa）；3）相同剂量的HD-Dexa三个疗程（3xHD-Dexa），每两周重复一次。本研究经东京大学伦理委员会批准。
连续纳入25例患者。所有治疗方案均取得了良好的初始反应。同时，PSL组因无反应或复发而进行下一次治疗的时间显著长于其他组（对数秩检验，PSL与1xHD-Dexa相比p<0.001，PSL与3xHD-Dexa相比p = 0.0053）。此外，PSL方案的反应持续时间显著更长（PSL与1xHD-Dexa相比p = 0.0024，PSL与3xHD-Dexa相比p = 0.028），完全缓解（CR）情况也是如此（PSL与1xHD-Dexa相比p = 0.012，PSL与3xHD-Dexa相比p = 0.0090）。本研究中无患者因副作用而停止治疗。
在反应的可持续性方面，PSL方案被认为优于脉冲式HD-Dexa方案。
