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[基于缺血性脑血管病患者风险分层实现胆固醇降低目标的他汀类药物剂量]

[The statin dosage for achieving goal of cholesterol-lowering based on risk stratification in patients with ischemic cerebrovascular diseases].

作者信息

Tan Ze-Feng, Guo Ya-Dong, Xu An-Ding, Yang Wan-Yong, Fu Yao-Gao, Wang Tong-Ge

机构信息

Department of Neurology of the First Affiliated Hospital, Brain Research Institute, Jinan University, Guangzhou 510630, China.

出版信息

Zhonghua Nei Ke Za Zhi. 2009 Apr;48(4):280-3.

Abstract

OBJECTIVE

To explore statin dosages for targeting goal of LDL-C lowering on the basis of stroke risk stratification and the dosage-effective relation of statin and LDL-C lowering in Chinese patients with ischemic stroke and transient ischemic attack (TIA).

METHODS

This is a prospective and open clinical trial patients with ischemic stroke/TIA within 6 months were enrolled and the dosages of atorvastatin were calculated based on risk stratification according to "Chinese Consensus for Prevention of Ischemic Stroke/TIA with Statin" (Chinese Consensus). A dose of 10 mg of atorvastatin daily to target LDL-C goal was taken as the standard dosage targeting goal (SDTG). Patients taking this dosage of atorvastatin constituted a SDTG group. Those who needed a daily dose of 20 mg or more of atorvastatin were randomized into an intensive dosage targeting goal (IDTG) group (atorvastatin 20 - 80 mg/d) and a standard dosage non-targeting goal (SDNTG) group (atorvastatin 10 mg/d without targeting goal). All patients took atorvastatin for 12 weeks. The primary outcome was the rate of targeting goal for LDL-C lowering at 2, 4 and 12 weeks, respectively and the secondary outcome was the occurence of recurrent stroke and other vascular events within 12 weeks. The main safety endpoint was serial adverse events including symptomatic intracranial hemorrhage.

RESULTS

Altogether 102 cases were enrolled and 99 cases were followed up for 12 weeks. According to the Chinese Consensus, the rate of high risk, very high risk-I and very high risk-II was 44%, 28% and 28%, respectively. Targeting rate for LDL-C lowering was 77% - 85% at each time point in the SDTG and IDTG groups, being significantly higher than those in the SDNTG group (12% - 16%, P < 0.01). No significant difference was found concerning the occurrence of recurrent stroke, other vascular events and safety endpoints among the three groups. The amplitude of LDL-C lowering was 32% - 35%, 46% - 49%, 51% - 52% and 60% - 65% with corresponding to daily dosage of 10 mg, 20 mg, 40 mg and 80 mg atorvastatin.

CONCLUSIONS

At least more than half of the patients after ischemic stroke/TIA need intensive statin therapy to target the LDL-C lowering goal. The dosage-effective relation of atorvastatin and LDL-C lowering in Chinese is similar to the reported data in other races.

摘要

目的

基于中国缺血性脑卒中及短暂性脑缺血发作(TIA)患者的卒中风险分层以及他汀类药物降低低密度脂蛋白胆固醇(LDL-C)的剂量-效应关系,探索针对LDL-C降低目标的他汀类药物剂量。

方法

这是一项前瞻性开放临床试验,纳入6个月内发生缺血性脑卒中/TIA的患者,并根据《中国他汀类药物预防缺血性脑卒中/TIA专家共识》(《中国共识》)进行风险分层计算阿托伐他汀剂量。以每日10 mg阿托伐他汀剂量达到LDL-C目标作为标准剂量达标(SDTG)组。需要每日20 mg及以上阿托伐他汀剂量的患者随机分为强化剂量达标(IDTG)组(阿托伐他汀20 - 80 mg/d)和标准剂量未达标(SDNTG)组(阿托伐他汀10 mg/d未设定目标)。所有患者服用阿托伐他汀12周。主要结局分别为2周、4周和12周时LDL-C降低达标率,次要结局为12周内复发性卒中及其他血管事件的发生情况。主要安全终点为包括症状性颅内出血在内的一系列不良事件。

结果

共纳入102例患者,99例随访12周。根据《中国共识》,高危、极高危-I和极高危-II的比例分别为44%、28%和28%。SDTG组和IDTG组各时间点LDL-C降低达标率为77% - 85%,显著高于SDNTG组(12% - 16%,P < 0.01)。三组间复发性卒中、其他血管事件及安全终点的发生情况无显著差异。对应阿托伐他汀每日剂量10 mg、20 mg、40 mg和80 mg时,LDL-C降低幅度分别为32% - 35%、46% - 49%、51% - 52%和60% - 65%。

结论

缺血性脑卒中/TIA后至少半数以上患者需要强化他汀治疗以达到LDL-C降低目标。中国人群中阿托伐他汀与LDL-C降低的剂量-效应关系与其他种族报道的数据相似。

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