光动力疗法治疗尖锐湿疣的Meta分析及GRADE证据质量评价

Meta-analysis of Photodynamic Therapy for Genital Warts and Quality Evaluation of GRADE Evidence

目的对光动力治疗尖锐湿疣的主要指标进行国际权威的证据质量等级评估,以获得客观确切的临床疗效。方法计算机检索PubMed、中国知识资源总库、万方数据库、中国生物医学文献数据库和维普数据库中关于光动力疗法治疗尖锐湿疣的随机对照研究,按照纳入研究标准筛选文献,提取资料并按照Cochrane偏倚风险评估工具评价文献质量后,应用Rev Man5.4.1统计软件对数据进行Meta分析,并采用GRADE证据质量评价系统对结局指标的证据质量进行分级。结果共纳入25篇随机对照研究,共2571例患者。Meta分析结果显示,ALA-PDT治疗尖锐湿疣的治愈率高于单纯物理治疗(RR=1.27,95%CI:1.12~1.44,P<0.01),治疗后1个月复发率(RR=0.18,95%CI:0.09~0.36,P<0.01)、2个月复发率(RR=0.24,95%CI:0.13~0.43,P<0.01)、3个月复发率(RR=0.29,95%CI:0.23~0.37,P<0.01)、6个月复发率(RR=0.34,95%CI:0.17~0.66,P<0.01)均低于单纯物理治疗,不良反应发生率低于单纯物理治疗(RR=0.31,95%CI:0.23~0.48,P<0.01)。GRADE证据质量评价结果显示,治愈率和不良反应发生率这2个结局指标为极低等级证据质量,治疗后6个月复发率为中等级证据质量,治疗后1、2、3个月复发率为高等级证据质量。结论5-氨基酮戊酸光动力疗法可以降低尖锐湿疣的复发率,其治疗尖锐湿疣的证据质量等级为高等级(证据等级A)。

Objective To determine whether photodynamic therapy with 5-aminolaevulinic acid(ALA-PDT)was an effective strategy in the treatment of patients with genital warts,and evaluate evidence quality.Methods We retrieved from PubMed,CNKI,Wanfang,CBM and VIP database,randomized controlled trials(RCTs)reported efficacy of ALA-PDT in patients with genital warts were collected and analyzed by Rev Man5.4.1 software,and used GRADE evidence quality grading system to evaluate the evidence quality of outcome indexes.Results Totally,25 RCTs were included,involving 2571 patients in this study.Results of Meta-analysis showed that the cure rate in the ALA-PDT group were superior to the physical therapy group(RR=1.27,95%CI:1.12~1.44,P<0.01),ALA-PDT group was fewer than the physical therapy group in the 1 month recurrence rate(RR=0.18,95%CI:0.09~0.36,P<0.01),2 months recurrence rate(RR=0.24,95%CI:0.13~0.43,P<0.01),3 months recurrence rate(RR=0.29,95%CI:0.23~0.37,P<0.01),6 months recurrence rate(RR=0.34,95%CI:0.17~0.66,P<0.01),and the incidence of adverse reactions of ALA-PDT group was lower than that of physical group(RR=0.31,95%CI:0.23~0.48,P<0.01).Results of GRADE evidence quality evaluation showed that the cure rate and the incidence of adverse reactions were recommended by very low level evidence,the 6 months recurrence rate was recommended by moderate level evidence,the 1 month recurrence rate,the 2 months recurrence rate and the 3 months recurrence rate were recommended by high level evidence.Conclusion ALA-PDT can decrease the recurrence rate of genital warts,and the grade evidence quality is high level.