局部外用马来酸噻吗洛尔治疗浅表性婴幼儿血管瘤有效性和安全性的Meta分析  

Efficacy and safety of timolol maleate in treatment of superficial infantile hemangioma:a Meta-analysis

作　　者：杨颖雯 李黎 荆丹丹 王龙 卢恩先 施燕[2] YANG Yingwen;LI Li;JING Dandan;WANG Long;LU Enxian;SHI Yan(Shanghai Auson Pharmaceuticals Co.,Ltd,Shanghai 201315,China;Institute for Clinical Trials of Drug,Shanghai East Hospital,Tongji University School of Medicine,Shanghai 200120,China)

机构地区：[1]上海奥全生物医药科技有限公司,上海201315 [2]同济大学附属东方医院药物临床试验机构,上海200120

出　　处：《中国临床药学杂志》2023年第4期285-291,共7页Chinese Journal of Clinical Pharmacy

基　　金：上海市“科技创新行动计划”(编号20S11907600)。

摘　　要：目的系统评价局部外用马来酸噻吗洛尔治疗浅表性婴幼儿血管瘤(IH)的有效性和安全性。方法构建检索策略,检索中国知网、万方资源、维普期刊、中国生物医学文献、PubMed、Cochrane、Embase和Web of Science数据库自建库到2022年2月11日发表的关于马来酸噻吗洛尔治疗浅表性IH的研究。根据纳入和排除标准筛选文献,进行文献质量评价和指标提取后,采用R4.0.3软件进行Meta统计分析。结果本研究共纳入10项随机对照试验(RCT),638例患者,其中试验组(噻吗洛尔)346例,对照组包括普萘洛尔组133例和安慰剂或无处理组159例。分析结果表明:有效性方面,局部外用马来酸噻吗洛尔治疗浅表性IH的疗效与口服普萘洛尔无显著差异(RR=1.12;95%CI:0.98~1.27;P=0.10);优于安慰剂或无处理组(RR=2.48;95%CI:1.62~3.79;P<0.01)。安全性方面,噻吗洛尔治疗浅表性IH的不良反应发生率显著低于口服普萘洛尔(RR=0.28;95%CI:0.18~0.44;P<0.01),与安慰剂或无处理组比较差异无统计学意义(RR=4.37;95%CI:0.76~25.19;P=0.10)。结论局部外用马来酸噻吗洛尔治疗浅表性婴幼儿血管瘤安全、有效。建议未来开展更多高质量的大样本、多中心研究,进一步探索噻吗洛尔的远期疗效和安全性,评估用法用量对疗效的影响。AIM To evaluate the efficacy and safety of topical timolol maleate in the treatment of superficial infantile hemangioma(IH).METHODS The databases of CNKI,Wanfang Data,Weipu Database,China Biomedical Literature Database,PubMed,Cochrane,Embase and Web of Science were searched from inception to February 11,2022 for researches on the treatment of superficial IH with timolol maleate.The literature was screened according to the inclusion and exclusion criteria,and after literature quality evaluation and data extraction,R4.0.3 software was used for statistical analysis of Meta-analysis.RESULTS Ten randomized controlled studies(RCT) including 638 patients were included in this study,including 346 patients in the trial group(timolol),133 patients in the propranolol group and 159patients in the placebo or no-treatment group.The results showed that there was no significant difference between the efficacy of topical timolol maleate in the treatment of superficial IH and oral propranolol(RR=1.12;95%CI:0.98-1.27;P=0.10).The efficacy of topical timolol maleate was better than placebo or no treatment group(RR=2.48;95% CI:1.62-3.79;P<0.01).In terms of safety,the adverse reaction rate of timolol in the treatment of superficial IH was significantly lower than that of oral propranolol(RR = 0.28;95% CI:0.18-0.44;P<0.01),and was not significantly different with placebo or no treatment group(RR=4.37;95% CI:0.76-25.19;P=0.10).CONCLUSION Topical timolol maleate is safe and effective in the treatment of superficial infantile hemangioma.It is recommended that more multi-center studies with larger sample size and higher quality be conducted in the future to further explore the long-term efficacy and safety of timolol and the effect of usage and dosage on efficacy.

关 键 词：马来酸噻吗洛尔 浅表性婴幼儿血管瘤 META分析 

分 类 号：R732.2[医药卫生—肿瘤]