基因指导华法林剂量有效性和安全性的系统评价

发布时间：2019-03-28 13:24

【摘要】：目的本研究遵循PRISMA声明,评价基因指导华法林初始剂量的疗效及安全性。方法电子检索Pub Med、Web of Science、Cochrane图书馆、相关期刊论文(CNKI)、中国生物医学文献数据库(CBM)、万方数据库,纳入比较基因指导华法林剂量与常规剂量抗凝治疗的随机对照研究(RCT),由2名独立研究者用End Note X7软件根据预定的纳入及排除标准筛选文献,评价方法学质量,提取资料,用Revman 5.2软件进行Meta分析。结果最终有9篇文献符合纳入标准,共有1 390患者随机分为基因指导组和常规剂量组接受华法林抗凝治疗。随访时间为28 d至3个月。分析的主要结局指标是国际标准化比率(international normalized ratio,INR)在治疗范围的时间百分比和不良事件。次要结局指标有达稳定剂量的时间,达稳定剂量的患者比例。结果显示,基因指导华法林初始剂量与常规剂量比较可延长国际标准化比率(INR)在治疗范围的时间百分比,[SMD=0.26,95%CI(0.11,0.41),P=0.000 6]。降低不良事件发生的患者数[RR=0.74,95%CI(0.65,0.84),P0.000 01]。基因指导华法林剂量组患者达稳定剂量的时间早于常规剂量组[SMD=-3.49,95%CI(-6.15,-0.84),P=0.01],但各研究间有显著地异质性(P0.000 01,I2=99%)。基因指导组中达稳定剂量的患者比例多于常规剂量组[RR=1.25,95%CI(1.15,1.35),P0.000 01]。结论基因指导华法林初始剂量可减少不良事件发生,延长国际标准化比率(INR)在治疗范围的时间百分比,缩短患者达稳定剂量的时间,增加患者达稳定剂量的百分比。
[Abstract]:Objective this study followed the PRISMA statement to evaluate the efficacy and safety of gene-guided warfarin initial dose. Methods Pub Med,Web of Science,Cochrane Library, Chinese Journal full-text Database (CNKI), Chinese Biomedical Literature Database (CBM), Wanfang Database were searched electronically. A randomized controlled study of comparative gene-directed warfarin dose versus conventional dose anticoagulation therapy (RCT),) was selected by two independent researchers using End Note X7 software to evaluate methodological quality and extract data according to predetermined inclusion and exclusion criteria. Meta analysis was carried out with Revman 5.2software. Results A total of 1 390 patients were randomly divided into gene guidance group and routine dose group to receive warfarin anticoagulant therapy. The follow-up period ranged from 28 days to 3 months. The main outcome indicators of the analysis were the percentage of time and adverse events of the international standardized ratio (international normalized ratio,INR) in the treatment range. The secondary outcome index had a time to reach stable dose and the proportion of patients with stable dose. The results showed that the initial dose of warfarin could prolong the time percentage of (INR) in the treatment range compared with the conventional dose, [SMD=0.26,95%CI (0.11, 0.41), P < 0.0006]. The number of patients with adverse events was reduced [RR=0.74,95%CI (0.65, 0.84), P0.000 01]. The time of gene-guided warfarin dose group to reach stable dose was earlier than that of conventional dose group [SMD=-3.49,95%CI (- 6.15, P < 0.01), P < 0.01], but there was significant heterogeneity among the studies (P0.000 01, I 2 = 99%). The proportion of patients with stable dose in gene guidance group was higher than that in routine dose group [RR=1.25,95%CI (1.15, 1.35), P0.000 01]. Conclusion Gene-guided warfarin initial dose can reduce the occurrence of adverse events, prolong the percentage of time of (INR) in the treatment range, shorten the time to reach stable dose, and increase the percentage of stable dose in patients.
【作者单位】：新疆医科大学;新疆医科大学附属中医医院;
【基金】：新疆维吾尔自治区自然科学基金资金资助项目(2014211C102)
【分类号】：R969

【共引文献】