目的:系统评价舒他西林治疗呼吸道感染的有效性和安全性。方法:系统检索PubMed、Embase、Cochranelibrary,CBM,VIP,CNKI和万方数据库,同时追溯纳入文献的参考文献,查找舒他西林治疗呼吸道感染的随机对照试验(RCT),检索时限为建库至2016年1月,采用RevMan5.2.0软件进行Meta分析。结果:最终纳入9项RCT研究,886例患者,其中儿童132例。舒他西林与阳性药物(包括头孢拉定、氨苄西林、青霉素)相比,有效率差异无统计学意义[RR=1.04,95%CI(0.89,1.21)],细菌清除率差异无统计学意义[RR=1.07,95%CI(0.88,1.31)];亚组分析显示,舒他西林有效性均优于氨苄西林,和头孢类、阿奇霉素、阿莫西林克拉维酸钾、左氧氟沙星、环丙沙星相比,差异无统计学意义。针对儿童的2项RCT的Meta分析结果显示,舒他西林的有效率和细菌清除率优于氨苄西林,与青霉素组无差异。舒他西林主要不良反应为轻度反应,大多数可耐受,未见严重不良反应。结论:舒他西林能有效治疗成人和儿童呼吸道感染,由于纳入研究质量的限制,尚需开展高质量的RCT研究来进一步验证其有效性和安全性。
Objective:To systematically review the efficacy and safety of sultamicillin in the treatment of respiratorytract infections.Methods:By retrieving the databases from PubMed,Embase,Cochrane library,CBM,VIP,CNKI,Wanfangand other databases,randomized controlled trials(RCTs)of sultamicillin for respiratory tract infection were collectedwith time limit from establishment to January2016.Meta-analysis was performed by RevMan5.2.0software.Results:Totally,9RCTs were enrolled,involving886patients,of which132were children.Compared to positive drugs(includingcefradine,ampicillin and penicillin),there were no statistically significant differences about effective rate[RR=1.04,95%CI(0.89,1.21)]and bacterial clearance rate[RR=1.07,95%CI(0.88,1.31)]between sultamicillin and positive drugs.Thesubgroup analysis showed that the efficacy of sultamicillin was better than that of ampicillin.However,compared with thecephalosporins,azithromycin,amoxicillin and clavulanate potassium,levofloxacin and ciprofloxacin,the difference was notstatistically significant.There were two RCTs for children,the results showed that efficacy rate and bacterial clearance rate ofsultamicillin were better than that of ampicillin,and were no difference compared with penicillin.The main adverse reactionsof sultamicillin were gastrointestinal reactions,most of them were mild,can be tolerated,and no serious adverse reaction wasfound.Conclusion:Sultamicillin was effective for the respiratory tract infection in adult and children.Due to the limitationsof the quality of literature,the dif ference of efficacy and safety between sultamicillin and other a ntibiotics need to be verified.