头孢拉定不良反应的meta分析

Meta-analysis of Adverse Reactions of Cephradine

关键词:  头孢拉定  不良反应  meta分析  试验序贯分析

Key words:  cephradine  adverse reactions  meta-analysis  trial sequential analysis

摘要:

目的 系统评价拉氧头孢及其对照药物在治疗感染时不良反应的发生率。方法 由2位研究者分别独立检索中国知网、万方数据库、维普期刊数据库、中国生物医学文献数据库、PubMed、Embase、Cochrane Library等数据库自建库至2018年3月有关头孢拉定及其不良反应的临床随机对照试验文献，严格按照纳入与排除标准筛选文献，评价文献质量并提取相关数据，采用RevMan 5.3软件进行meta分析，试验序贯分析（trial sequential analysis，TSA）软件进行TSA。结果 共纳入符合条件文献50篇，总计7 477例患者。Meta分析以及TSA结果显示：①头孢拉定组与对照组在不良反应发生率上差异具有统计学意义[RR=0.62，95%CI（0.54，0.72），P<0.000 01]。②适应证亚组分析中呼吸道感染亚组中，头孢拉定组与对照组在不良反应发生率上差异具有统计学意义[RR=0.66，95%CI（0.53，0.80），P<0.000 1]，其他适应证因样本量过少未予分析。③对照药物亚组分析结果显示，头孢拉定组不良反应发生率高于阿奇霉素、头孢克肟、头孢克洛3组，而低于阿莫西林/克拉维酸组，仅阿奇霉素组差异具有统计学意义[RR=0.44，95%CI（0.28，0.70），P=0.000 5]，同时，TSA结果表明证据确切。④剂量亚组分析结果显示超剂量组[RR=0.70，95%CI（0.54，0.91），P=0.008]与常规剂量组[RR=0.61，95%CI（0.52，0.71），P≤0.000 01]不良反应发生率差异均具有统计学意义。结论 头孢拉定不良反应的发生率明显高于对照药物组，故临床用药时应严格按照说明规定用量进行用药，警惕其不良反应的发生。

Abstract:

OBJECTIVE To systematically evaluate the adverse reactions of cephradine and its control drugs in the treatment of infection. METHODS CNKI, Wangfang, VIP, Sinomed, PubMed, Embase and Cochrane Library database were searched by two researchers and randomized controlled trials(RCTs) about the safety of cephradine in clinical application for infection were retrieved according to inclusion and exclusion criteria. The eligible RCTs were given meta analysis by using the statistical software RevMan 5.3 and the trial sequential analysis(TSA) software performs test sequence analysis. RESULTS Totally 50 RCTs with 7 477 cases were included in this study. The results of meta-analysis and TSA were as follows:①there were statistical differences in the incidence of adverse reaction between cephradine groups and control group[RR=0.62, 95%CI(0.54, 0.72), P<0.000 01]. ②Respiratory infection subgroup analysis showed that there were statistical differences in the incidence of adverse reaction between two groups[RR=0.66, 95%CI(0.53, 0.80), P<0.000 1], sample size of other indications was too small to be analyzed. ③The subgroup analysis of control drugs indicated that the incidence of adverse reaction in cefradine group was higher than azithromycin, cefixime and cefaclor group, but lower than amoxicillin/clavulanic acid group, only azithromycin group showed statistical differences[RR=0.44, 95%CI(0.28, 0.70), P=0.000 5], and the TSA result showed that the evidence was definite. ④The subgroup analysis of drug does showed that there were statistical difference in over dosage group[RR=0.70, 95%CI(0.54, 0.91), P=0.008] and routine dosage group[RR=0.61, 95%CI(0.52, 0.71), P ≤ 0.000 01]. CONCLUSION The incidence of cephradine adverse reaction is significantly higher than other group. It is necessary to be cautious in the occurrence of adverse reactions and strictly follow the instructions.