摘要：
目的 比较放射导向定位技术, 包括导向放射隐匿性病灶定位 (ROLL) 和放射性粒子定位 (RSL) 技术与导丝定位 (WGL) 的临床效果, 评估放射导向定位技术在不可触及的乳腺病灶 (NPBL) 检测中的应用价值.方法 检索PubMed、Embase、Cochrane、万方、中国知网、维普数据库, 收集截至2017年4月关于放射导向定位与WGL对比的随机对照临床试验.由2名研究者独立完成文献筛选、数据提取, 运用Cochrane协作网系统评价手册推荐的偏倚风险评价工具进行文献质量评价.采用风险比 (RR) 和95％置信区间 (CI) 评价二分类数据的差异, 采用均数差 (MD) 和95％CI评价连续性数据的差异, 使用RevMan 5.3软件进行Meta分析.结果 共纳入14项随机对照研究, 纳入患者2 311例, 其中, ROLL组562例, RSL组614例, WGL组1 135例.ROLL组与WGL组的定位并发症发生率 (RR=0.53, 95％CI:0.24～1.18, P=0.120) 、病灶成功切除率 (RR=1.01, 95％CI:0.99～1.02, P=0.240) 、切缘阳性率 (RR=0.88, 95％CI:0.68～1.13, P=0.310) 、术中再切除率 (RR=1.07, 95％CI:0.71～1.61, P=0.750) 、再次手术率 (RR=0.54, 95％CI:0.23～1.25, P=0.150), 术后并发症发生率 (RR=0.88, 95％CI:0.56～1.40, P=0.590) 及切除标本体积 (MD=-2.11, 95％CI:-8.39～4.16, P=0.510) 比较, 差异均无统计学意义.RSL组与WGL组的定位并发症发生率 (RR=1.02, 95％CI:0.21～5.08, P=0.980) 、切缘阳性率 (RR=0.84, 95％CI:0.65～1.09, P=0.190) 、再次手术率 (RR=0.78, 95％CI:0.55～1.11, P=0.170) 及术后并发症发生率 (RR=1.34, 95％CI:0.81～2.22, P=0.260) 比较, 差异也均无统计学意义.结论 在NPBL的定位技术中, 放射导向定位技术具有与传统导丝定位技术相似的定位效果及广泛的临床应用前景.%Objective To compare the therapeutic outcome of radioguided occult lesion localization (ROLL) and radioactive seed localization (RSL) with wire-guided localization (WGL) in patients with non-palpable breast lesions (NPBL). Methods The PubMed, Embase, Cochrane, CNKI, Wanfang and VIP databases were searched for randomized control studies which compared ROLL/RSL with WGL from the earliest available date up to April 2017. Two researchers independently completed literature retrieval and data extraction, and evaluated the quality of the studies based on Cochrane handbook. Risk ratio (RR) and mean difference (MD) with 95％ confidence interval (CI) were pooled for dichotomous and continuous variables, respectively. RevMan 5.3 software was adopted for a meta-analysis. Results Fourteen randomized controlled trials (RCT) were eligible, involving a total of 2 311 patients (ROLL:n=562, RSL:n=614, WGL:n=1 135). There was no significant difference in localization-related complication rate (RR=0.53, 95％CI:0.24-1.18, P=0.120), successful excision rate (RR=1.01, 95％CI:0.99-1.02, P=0.240), positive margin rate (RR=0.88, 95％CI:0.68-1.13, P=0.310), intra-operative re-excision rate (RR=1.07, 95％CI:0.71-1.61, P=0.750), re-operation rate (RR=0.54, 95％CI:0.23-1.25, P=0.150), postoperative complication rate (RR=0.88, 95％CI:0.56-1.40, P=0.590) and specimen volume (MD=-2.11, 95％CI:-8.39-4.16, P=0.510) between ROLL group and WGL group. No significant difference was observed in localization-related complication rate (RR=1.02, 95％CI:0.21-5.08, P=0.980), positive margin rate (RR=0.84, 95％CI:0.65-1.09, P=0.190), re-operation rate (RR=0.78, 95％CI:0.55-1.11, P=0.170) and postoperative complication rate (RR=1.34, 95％CI:0.81-2.22, P=0.260) between RSL group and WGL group. Conclusion With similar effect to WGL, ROLL and RSL are feasible for the localization of non-palpable breast lesions in clinic.
