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目的:评价火针治疗痤疮的有效性,为临床决策提供客观依据.方法:检索PubMed、中国知网、中国生物医学文献数据库、万方数据库创库至今所发表RCT文献,筛选后评价其偏倚风险并提取数据,进行Meta分析及亚组分析.结果:总共纳入33项RCT研究,包含3362例病人.这些研究中多数具有高或未知的偏倚风险,特别在分配隐藏及数据不完整和选择性报道等方面较为突出.Meta分析结果提示,相较于对照组,火针疗法具有更高的总有效率,合并效应量RR=1.19,95％CI:1.16-1.22,P＜0.000 01,差异具有统计学意义.鉴于异质性较高,进行亚组分析,结果如下:①相较于西药疗法,单纯使用火针具有更高的有效率,合并效应量RR=1.20,95％CI:1.14-1.28,P＜0.000 01,差异具有统计学意义;②相较于其他干预措施,火针结合其他中医疗法具有更高的有效率,合并效应量RR=1.18,95％CI:1.12-1.24,P＜0.00001,差异具有统计学意义;③相较于单纯中药内服,火针结合中药内服疗法具有更高的有效率,合并效应量RR=1.18,95％CI:1.13-1.24,P＜0.000 01,差异具有统计学意义;④相较于单纯西药疗法,火针结合西药疗法具有更高的有效率,合并效应量RR=1.28,95％CI:1.18-1.39,P＜0.000 01,差异具有统计学意义.所纳入研究中没有报道不良事件,其安全性评价因此无法进行.结论:本研究表明火针是一种有效的痤疮治疗手段,但证据强度因为纳入文献的质量不高等原因而具有局限性.安全性评价因纳入文献未提及而无法进行.有待补充高质量文献以加强本研究结论的可靠性.“,”Objective To evaluate the efficacy of fire-needle therapy for acne to provide an objective basis for clinical decisions.Method PubMed,Chinese Biomedical Medicine disc (CBM),Chinese National knowledge infrastructure (CNKI),and Wanfang database were searched to include eligible randomized controlled trails.Bias risk was assessed and data were extracted.Meta-analysis was performed and as was subgroup analysis.Results Thirty-three RCTs involving 3362 patients were included.Most of them had a high risk or unclear risk of bias regarding allocation concealment,incomplete outcome data and selective reporting.Compared with control groups,meta-analysis revealed that fireneedle therapy had an overall higher total effectiveness rate (RR=1.19,95％ Cl:1.16-1.22,P＜0.000 01).Subgroup analysis showed fire-needle therapy was associated with an increased total effective rate (RR=1.20,95％CI:1.14-1.28,P＜0.000 01),when compared against drug therapy.Fire-Needle therapy was associated with an increased total effective rate (RR=1.18,95％CI:1.12-1.24,P＜0.000 01),when fire-needle plus other TCM therapy was compared against other therapy.fire-needle therapy was associated with an increased total effective rate (RR=1.18,95％CI:1.13-1.24,P＜0.000 01),when fire-needle plus Chinese herb therapy was compared against Chinese herb therapy alone.fireneedle therapy was associated with an increased total effective rate (RR=1.28,95％CI:1.18-1.39,P＜0.000 01),when compared fire-needle plus Western drug therapy against western drug therapy alone.Adverse events were not reported in most articles.Conclusion Our study showed that fire-needle appears to be an effective therapy for treating acne,but the evidence is currently insufficient due to the poor quality of the studies.The safety of fire-needle therapy is also uncertain due to the small sample size and the lack of reporting in included articles.Larger sample,higher quality studies are needed.