Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment.
Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment.
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DOI：
10.1186/1465-9921-12-143
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发表时间：
2011-10-28
影响因子：
5.8
通讯作者：
Pirfenidone Clinical Study Group in Japan
中科院分区：
文献类型：
--
作者：
Azuma A;Taguchi Y;Ogura T;Ebina M;Taniguchi H;Kondoh Y;Suga M;Takahashi H;Nakata K;Sato A;Kudoh S;Nukiwa T;Pirfenidone Clinical Study Group in Japan
日本的一项 III 期试验表明吡非尼酮对特发性肺纤维化 (IPF) 有效。为了找出哪些患者特别受益于吡非尼酮，我们以探索性的方式分析了 III 期试验的数据。 III 期试验中的患者根据预测肺活量 (%VC) 的基线百分比、动脉氧分压 (PaO2) 以及 6 分钟稳态运动测试 (6MET) 期间脉搏血氧饱和度测定的最低氧饱和度 (SpO2) 进行分层。在亚人群中，第 52 周时，对接受高剂量（1800 mg/天）吡非尼酮、低剂量（1200 mg/天）吡非尼酮和安慰剂治疗的患者的 VC 和主观症状（Fletcher、Hugh-Jones [F, H-J] 分类量表中的咳嗽和呼吸困难）进行了评估。可以看出吡非尼酮在减少 VC 下降方面具有显着功效。基线时 %VC ≥ 70% 且 SpO2 < 90% 的亚人群。这种有利的效果伴随着 VC 和无进展生存时间的明显变化。在该亚群中，吡非尼酮显着抑制咳嗽和呼吸困难。当使用 VC（和 %VC）变化以及咳嗽和呼吸困难症状进行评估时，基线时 %VC ≥ 70% 且 SpO2 < 90% 的 IPF 患者最有可能受益于吡非尼酮。该亚群有望从吡非尼酮治疗中获益最多。该临床试验于2005年9月13日在日本药品信息中心（JAPIC）注册（注册号：JAPICCTI-050121）。
A phase III trial in Japan showed that pirfenidone is effective for idiopathic pulmonary fibrosis (IPF). To find out which patients specifically benefit from pirfenidone, we analyzed in an exploratory manner the data from the phase III trial. The patients in the phase III trial were stratified by baseline percentage predicted vital capacity (%VC), arterial oxygen partial pressure (PaO2), and the lowest oxygen saturation by pulse oximetry (SpO2) during the 6-minute steady-state exercise test (6MET). In the subpopulations, changes in VC and subjective symptoms (cough and dyspnea on the Fletcher, Hugh-Jones [F, H-J] Classification scale) were evaluated in patients treated with high-dose (1800 mg/day) pirfenidone, low-dose (1200 mg/day) pirfenidone, and placebo at week 52. Significant efficacy of pirfenidone in reducing the decline in VC could be seen in a subpopulation having %VC ≥ 70% and SpO2 < 90% at baseline. This favorable effect was accompanied by categorical change in VC and progression-free survival time. In the subpopulation, pirfenidone significantly suppressed cough and dyspnea. IPF patients having %VC ≥ 70% and SpO2 < 90% at baseline will most likely benefit from pirfenidone when evaluated using changes in VC (and %VC), and cough and dyspnea symptoms. This subpopulation could expect to benefit most from pirfenidone treatment. This clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (Registration Number: JAPICCTI-050121).
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DOI：
10.1164/ajrccm.159.4.9805017
发表时间：
1999-04-01
影响因子：
24.7
作者：
Raghu, G;Johnson, WC;Mageto, Y
通讯作者：
Mageto, Y
影响因子：
168.9
作者：
Noble, Paul W.;Albera, Carlo;du Bois, Roland M.
通讯作者：
du Bois, Roland M.
影响因子：
5
作者：
Oku, Hisashi;Shimizu, Toshikatsu;Arimura, Akinori
通讯作者：
Arimura, Akinori
DOI：
10.1152/ajplung.1999.276.2.l311
发表时间：
1999-02-01
影响因子：
4.9
作者：
Gurujeyalakshmi, G;Hollinger, MA;Giri, SN
通讯作者：
Giri, SN
DOI：
10.1164/rccm.200404-571oc
发表时间：
2005-05-01
影响因子：
24.7
作者：
Azuma, A;Nukiwa, T;Raghu, G
通讯作者：
Raghu, G