Dong Yi, Li Huiqin, Dong Qiang
Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China.
Depart of Medical Affair, Chengdu Baiyu Pharmaceutical Co., Ltd, Chengdu, China.
Neurol Res. 2020 Mar;42(3):260-266. doi: 10.1080/01616412.2020.1724462. Epub 2020 Feb 12.
: To compare the efficacy of ginkgolide in the treatment of Chinese patients with ischemic stroke between pre-marketing and post-marketing studies.: This is a re-analysis of a pre-marketing (phase II/III, multicenter, double-blind, parallel-controlled; February 2005 to September 2005) and post-marketing (phase IV, multicenter, open, single-arm registration; April 2013 to June 2014) studies. The intervention groups received intravenous ginkgolide (10 mL daily, 14 days). Primary outcome was an improvement of National Institute of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores after 14 days.: In pre- and post-marketing studies, NIHSS and mRS scores all improved, compared to that of baseline ( < 0.001) in acute phase. Those factors significantly associated with △NIHSS after 14 days of therapy with ginkgolide were grouping (pre-marketing vs. post-marketing; OR 2.169, 95%CI = 1.462-3.216, < 0.001), male (OR = 1.532, 95%CI = 1.152-2.037, = 0.003), enrollment within 30 days after onset (OR = 1.915, 95%CI = 1.452-2.526, < 0.001) and NIHSS score more than 8 points at baseline (OR = 15.140, 95%CI = 11.436-20.045, < 0.001) after adjustment. Ginkgolide had a greater effect on patients in a relatively acute phase (time of onset to enrollment ≤30 days) and moderate-severe stroke (baseline NIHSS>8 points). Incidences of adverse reactions in the pre-marketing and post-marketing studies were 0.46% and 5.28%, respectively ( < 0.001).: Intravenous ginkgolide may improve the outcome of acute ischemic stroke. Differences in effect between pre-marketing and post-marketing studies may be associated with gender, time of onset to enrollment and severity of stroke.
比较银杏内酯在上市前和上市后研究中治疗中国缺血性中风患者的疗效。这是一项对上市前（II/III期，多中心，双盲，平行对照；2005年2月至2005年9月）和上市后（IV期，多中心，开放，单臂登记；2013年4月至2014年6月）研究的重新分析。干预组接受静脉注射银杏内酯（每日10 mL，共14天）。主要结局是14天后美国国立卫生研究院卒中量表（NIHSS）和改良Rankin量表（mRS）评分的改善。在上市前和上市后研究中，急性期与基线相比，NIHSS和mRS评分均有所改善（<0.001）。银杏内酯治疗14天后与△NIHSS显著相关的因素为分组（上市前与上市后；OR 2.169，95%CI = 1.462 - 3.216，<0.001）、男性（OR = 1.532，95%CI = 1.152 - 2.037，P = 0.003）、发病后30天内入组（OR = 1.915，95%CI = 1.452 - 2.526，<0.001）以及基线时NIHSS评分超过8分（OR = 15.140，95%CI = 11.436 - 20.045，<0.001），经调整后。银杏内酯对相对急性期（发病至入组时间≤30天）和中重度中风（基线NIHSS>8分）患者的疗效更佳。上市前和上市后研究中不良反应的发生率分别为0.46%和5.28%（<0.001）。静脉注射银杏内酯可能改善急性缺血性中风的结局。上市前和上市后研究中疗效的差异可能与性别、发病至入组时间和中风严重程度有关。
