Zhou Peiyang, Lu Zuneng, Gao Ping, Wang Puqing, Cao Zhihua, Zhang Guibin, Wang Shouan, Feng Yuhua, Wang Pu
Department of Neurology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei Province, People's Republic of China; Xiangyang No. 1 People's Hospital, Hubei University of Medicine, Xiangyang 441000, Hubei Province, People's Republic of China.
Department of Neurology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei Province, People's Republic of China.
Clin Neurol Neurosurg. 2014 May;120:6-13. doi: 10.1016/j.clineuro.2014.02.001. Epub 2014 Feb 10.
The purpose of this study is to validate the efficacy of intensive statin therapy for patients with atherosclerotic intracranial arterial stenosis (AICAS).
In this study, we performed a single-center, randomized, single-blind, parallel-group clinical trial. A total of 120 Chinese patients with AICAS were enrolled and randomly divided into three groups [low-dose atorvastatin therapy (LAT, 10mg/day), standard-dose atorvastatin therapy (SAT, 20mg/day), and intensive-dose atorvastatin therapy (IAT, 40mg/day) groups] in a 1:1:1 ratio. Evaluation variables, including changes in serum lipid profiles, degree of stenosis, and perfusion-related parameters derived from computed tomography perfusion (CTP) imaging from baseline to weeks 26 and 52, as well as the occurrence of cerebrovascular events during the study period, were used to compare the benefits of these three statin therapies.
After 52 weeks of treatment, improvement of serum lipid profiles, degree of stenosis, and perfusion-related parameters were all significantly better in the IAT group. In addition, the cumulative probability of cerebrovascular events at 52 weeks was significantly lower in the IAT group than in the LAT group, although there was no statistical difference between the IAT group and the SAT group. The proportion of patients experiencing any adverse event was similar among the three treatment groups. Adverse events caused by IAT were generally mild; no serious adverse events occurred throughout the entire period of study.
In conclusion, long-term use of IAT appears to be a safe and effective treatment at least for Chinese patients with AICAS.
本研究旨在验证强化他汀类药物治疗对动脉粥样硬化性颅内动脉狭窄（AICAS）患者的疗效。
在本研究中，我们进行了一项单中心、随机、单盲、平行组临床试验。共纳入120例中国AICAS患者，并按1:1:1的比例随机分为三组[低剂量阿托伐他汀治疗组（LAT，10mg/天）、标准剂量阿托伐他汀治疗组（SAT，20mg/天）和强化剂量阿托伐他汀治疗组（IAT，40mg/天）]。评估变量包括血清脂质谱的变化、狭窄程度以及从基线到第26周和第52周计算机断层扫描灌注（CTP）成像得出的灌注相关参数，以及研究期间脑血管事件的发生情况，用于比较这三种他汀类药物治疗的益处。
治疗52周后，IAT组在血清脂质谱改善、狭窄程度改善和灌注相关参数方面均明显更好。此外，IAT组52周时脑血管事件的累积概率显著低于LAT组，尽管IAT组与SAT组之间无统计学差异。三个治疗组中发生任何不良事件的患者比例相似。IAT引起的不良事件一般较轻；在整个研究期间未发生严重不良事件。
总之，至少对于中国AICAS患者而言，长期使用IAT似乎是一种安全有效的治疗方法。
