大株红景天注射液不良反应系统评价及Meta分析

Systematic evaluation and Meta-analysis of adverse drug reactions of Sofren injection

目的系统评价大株红景天注射液临床应用的安全性。方法计算机检索中国知网、万方、维普及PubMed等数据库中2008-2019年发表的关于大株红景天注射液的临床随机对照研究、描述性研究,提取符合要求文献的相关数据。随机对照研究采用Cochrane系统评价员手册5.1.0进行文献质量评价,采用Rev Man 5.3.3统计软件对大株红景天注射液的不良反应进行Meta分析,同时将纳入研究按照不同疗程和溶媒分为2个亚组分析。对描述性研究进行定性的系统评价。结果最终共纳入25篇文献。随机对照21篇,共计2 317例患者,其中试验组1 161例,对照组1 156例,试验组不良反应发生率(4.05%)略低于对照组(4.41%),差异无统计学意义[RR=0.91,95%CI(0.63,1.32),P=0.62];亚组分析显示,不同溶媒的亚组分析(5%葡萄糖注射液250 ml组和0.9%氯化钠注射液250 ml组)和不同疗程的亚组分析(≤10 d组、>10 d且≤20 d组、>20 d组)的试验组与对照组不良反应发生率差异均无统计学意义(P>0.05)。描述性研究4篇,其中主动监测1篇,共4 476例患者,不良反应发生率为2.38%,主要表现为过敏性反应;被动监测2篇,共1 748例,65岁及以上者所占比例最高,不良反应主要为全身性损害、皮肤及其附件损害,大多数患者经停药或对症治疗后好转或治愈;案例报道1篇,为静脉输注大株红景天注射液致过敏性休克的报道。结论大株红景天注射液是一种较安全的药物,但仍需规范其临床合理使用,减少不良反应的发生,对于糖代谢异常患者可以参考使用0.9%氯化钠注射液做溶媒。

Objective To systematically evaluate the safety of clinical application of Sofren injection.Methods Perform researches through computers about the clinical randomized controlled trials,descriptive studies and case reports on Sofren injection published from 2008 to 2019 in the database of CNKI,Wanfang,VIP and PubMed,etc.,and extract relevant data of the required documents.For the randomized controlled study,the Cochrane System Evaluator′s Handbook 5.1.0 was used for literature quality evaluation,and Rev Man 5.3.3 statistical software was used for meta-analysis of the adverse reactions of Sofren injection;the included studies were divided into 2 subgroups according to different course of treatment and menstruum.A qualitative systematic review was made for descriptive studies and case reports.Results A total of 25 literatures were eventually included.There were 21 randomized controlled articles,including a total of 2 317 patients:1 161 in the experimental group and 1 156 in the control group.The incidence of adverse reactions in the experimental group(4.05%) was slightly lower than that in the control group(4.41%) and the differences were not statistically significant [RR=0.91,95%CI(0.63,1.32),P=0.62];subgroup analysis showed that by subgroup analysis of different menstruum(5% glucose injection 250 ml group and 0.9% sodium chloride injection 250 ml group) or by subgroup analysis of different courses(≤10 days group,>10 days and ≤20 days group,>20 days group),there was no significant difference in the incidence of adverse reactions between the experimental group and the control group(P>0.05).There were 4 descriptive studies,including 1 active monitoring and a total of 4 476 patients,and the incidence of adverse reactions was 2.38%,mainly allergic reactions;there were 2 articles of passive monitoring and a total of 1 748 cases,and the proportion of patients aged 65 and above was the highest,and the main adverse reactions were systemic damage and skin and its attachment damage;most patients got improved or cured after stopping the drug or symptomatic treatment;one case report reported that anaphylactic shock was caused by intravenous infusion of Sofren injection.Conclusion Sofren injection is a relatively safe drug,but it still needs to be standardized in its clinical rational use to minimize the occurrence of adverse reactions;for patients with abnormal glucose metabolism,0.9% sodium chloride injection can be used as the solvent.