摘要
目的系统评价康柏西普治疗黄斑水肿的疗效和安全性,为临床用药提供参考。方法计算机检索Cochrane图书馆(The Cochrane Library)、PubMed、中国期刊全文数据库(CNKI)和万方医学网,收集康柏西普与对照组比较对黄斑水肿治疗的随机对照试验(RCT),提取相关资料并按照Jadad评分量表评价纳入研究质量,采用RevMan 5.3统计软件进行Meta-分析。结果共纳入21项RCTs,合计1 337例患者。Meta-分析结果显示,与对照组比较,康柏西普显著提高患者随访1个月[MD=0.08,95%CI(0.05,0.12),P<0.001],3个月[MD=0.09,95%CI(0.06,0.13),P<0.001]和6个月[MD=0.07,95%CI(-0.02,0.17),P=0.12]最佳矫正视力(BCVA)及治疗有效率[RR=2.15,95%CI(1.29,3.57),P=0.003];显著降低患者随访1个月[MD=-79.71,95%CI(-107.52,-51.91),P<0.001]、3个月[MD=-61.12,95%CI(-82.42,-39.81),P<0.001]和6个月[MD=-67.95,95%CI(-201.37,65.46),P=0.32]黄斑中心凹视网膜厚度(CMT);除随访6个月的CMT和BCVA与对照组比较没有统计学差异(P=0.12、0.32),其余指标与对照组差异具有显著的统计学意义。剔除治疗方案差异(单次玻璃体腔注药)的一项研究再做Meta-分析后,两组6个月CMT和BCVA与对照组比较具有统计学差异(P=0.01、0.001)。不良反应方面,两组不具有统计学差异。结论对于黄斑水肿患者,康柏西普短期内(3个月)比对照组更好的降低黄斑中心凹厚度、改善患者视力、提高治疗有效率,疗效可靠且耐受性好。
Objective To evaluate the effectiveness and safety of Conbercept for macular edema (ME) systematically, in order to provide evidence-based reference for clinical use. Methods The pertinent randomized controlled trials (RCTs) about Conbercept trail group and control group in the treatment of ME were retrieved from Cochrane Library, PubMed, CNKI and Wan fang Database. The quality of included studies were evaluated after extracting data and according to modified Jadad scale. Meta-analysis was performed by using RevMan 5.3 statistical software. Results A total of 21 RCTs were included,involving 1337 patients. The results of Meta-analysis showed that best corrected visual acuity (BCVA) at 1 month[MD=0.08, 95%CI (0.05, 0.12), P<0.001], 3 month[MD=0.09, 95%CI (0.06, 0.13), P<0.001] and 6 month[MD=0.07, 95%CI (-0.02, 0.17), P=0.12] and therapeutic efficiency ratio[RR=2.15, 95%CI (1.29, 3.57), P=0.003] were significantly improved; the central macular thickness (CMT) was markedly decreased at 1 month[MD=-79.71, 95%CI(-107.52, -51.91), P<0.001], 3 months[MD=-61.12, 95%CI (-82.42, -39.81), P<0.001] and 6 months[MD=-67.95, 95% CI(-201.37, 65.46), P=0.32] after treatment; and which was statistically different to control group, but BCVA and CMT at 6 months (P=0.12 and P=0.32). when a different study in treatment regimens was eliminated, then, the BCVA and CMT at 6 months was statistically different to control group (P=0.01 and P=0.001). Conclusion Conbercept has good therapeutic efficacy and safety for ME and effectively decrease CMT, improve BCVA and therapeutic efficiency ratio at the end of 3 months.
作者
李春杏
张亚同
LI Chunxing;ZHANG Yatong(Department of Pharmacy,Aerospace Center Hospital,Beijing 100049,China;Department of Pharmacy,Beijing Hospital,Beijing 100073,China)
出处
《药物评价研究》
CAS
2018年第10期1885-1893,共9页
Drug Evaluation Research
关键词
康柏西普
黄斑水肿
疗效
安全性
系统评价
META-分析
Conbercept
macular edema (ME)
effectiveness
safety
systematic evaluation
Meta-analysis
