【摘要】 目的:系统评价大剂量应用维生素C治疗相关疾病的安全性,以为临床用药提供循证参考。方法:计算机检索Cochrane图书馆、EMBase、Pub Med、中国期刊全文数据库、万方数据库、中文科技期刊数据库,收集大剂量应用维生素C治疗相关疾病的临床研究,提取资料并评价质量后,采用R语言3.1.1版统计软件对数据进行Meta分析。结果:共纳入23项研究,合计2 069例患者,共发生不良反应540例。Meta分析结果显示,针对有对照组的研究,维生素C治疗组患者总体不良反应发生率与对照组比较差异无统计学意义[RR=1.42,95%CI(0.92,2.20),P=0.382];针对所有纳入研究,维生素C治疗组患者的腹痛发生率为9%[95%CI(0.05,0.14)]、口干发生率为30%[95%CI(0.14,0.54)]、头痛发生率为12%[95%CI(0.06,0.25)]、恶心发生率为25%[95%CI(0.13,0.44)]、腹泻发生率为14%[95%CI(0.07,0.26)]。结论:大剂量应用维生素C治疗相关疾病的安全性较好,但应注意消化系统的不良反应。由于缺乏大样本随机对照试验(RCT)资料,且随访时间较短,该结论尚需要更多大样本、多中心的RCT予以证实。更多还原

【Abstract】 OBJECTIVE:To systematically evaluate the safety of large dose of vitamin C(VC)treatment for related diseases and provide reference for the rational use of drug in clinic. METHODS:Cochrone Library,EMbase,Pub Med,CJFD,Wan Fang database and VIP were retrieved for collecting clinical trials with large dose of VC. A Meta-analysis was conducted by using R 3.1.1software after quality extraction and data evaluation. RESULTS:There were 23 clinical trials including 2 069 patients,540 patients with adverse reactions. Meta-analysis showed there were significant differences in the total incidence of adverse reactions between VC group and control group [RR=1.42,95%CI(0.92,2.20),P=0.382];for all included studies,the incidence of stomachache in VC group was 9% [95% CI(0.05,0.14)],incidence of thirst was 30% [95% CI(0.14,0.54)],the incidence of headache was 12%[95%CI(0.06,0.25)],the incidence of nausea was 25%[95%CI(0.13,0.44)],the incidence of diarrhea was 14%[95%CI(0.07,0.26)]. CONCLUSIONS:Large dose of VC treatment has good safety,but the adverse reactions related to the digestive system should be noted. Due to the lack of large-scale randomized controlled trials(RCT)data and the short follow-up time,the conclusion needs to be verified with more large-sample and multiple-center RCT.更多还原