^(125)I粒子近距离放射治疗恶性梗阻性黄疸有效性及安全性的Meta分析

The efficacy and safety of ^(125)I seed brachytherapy for malignant obstructive jaundice: A Meta-analysis

目的通过Meta分析评估^(125)I粒子近距离放射治疗恶性梗阻性黄疸的疗效及安全性。方法检索中国生物医学数据库(CBM)、万方数据库、中国学术期刊全文数据库(CNKI)、维普数据库(VIP)、Pubmed、Cochrane library、Embase、Ovid建库以来到2018年3月已公开发表的^(125)I粒子治疗恶性梗阻性黄疸的随机对照试验文献。由2名研究者独立筛选文献、评价文献质量、提取数据,通过Rev Man5.3软件进行Meta分析。结果符合纳入标准的文献共15篇,共1 015例病人。Meta分析结果显示,^(125)I放射组病人1年生存率高于对照组(RR=2.06,95%CI:1.62～2.62,P<0.000 1),生存风险低于对照组(HR=0.38,95%CI:0.26～0.57,P<0.000 1);^(125)I放射组术后1个月总胆红素低于对照组(WMD=-6.08,95%CI:-9.05～-3.10,P<0.000 1),术后3个月总胆红素也低于对照组(WMD=-37.72,95%CI:-44.99～-30.45,P<0.000 1);胆道通畅情况优于对照组;术后1个月^(125)I近距离放射组肿瘤缩小,而对照组肿瘤增大(SMD=-2.77,95%CI:-5.10～0.44,P=0.02);术后1个月2组谷丙转氨酶差异无统计学意义(WMD=-3.06,95%CI:-7.97～1.85,P=0.22);术后常见并发症发生率差异无统计学意义(RR=0.96,95%CI:0.68～1.35,P=0.80);^(125)I近距离放射组的病人疼痛缓解率明显优于对照组(RR=21.08,95%CI:4.43～100.16,P=0.000 1)。结论与单纯放置支架、胆道引流术相比,^(125)I近距离放射能有效地延长恶性梗阻性黄疸病人的生存时间和胆道通畅时间,并能抑制肿瘤生长和缓解疼痛等,同时并不增加肝功能损害和手术并发症。

Objective To evaluate the efficacy and safety of ^（125）I seed brachytherapy in the treatment of malignant obstructive jaundice（MOJ） with Meta-analysis. Methods We searched published randomized controlled trials（RCTs） of ^（125）I seed brachytherapy in the treatment of MOJ in the databases： CBM, Wan Fang Data, CNKI, VIP, Pub Med, the Cochrane library, Embase, Ovid from inception to March 2018. Two researchers independently screened literature, assessed the quality of the included studies and extracted data, statistical analysis was performed with Rev Man5.3 software. Results A total of15 RCTs including 1 015 patients were involved. Meta-analysis showed that： 1 year survival rate in the ^（125）I brachytherapy group was higher than in the control group（RR=2.06, 95%CI： 1.62～2.62, P〈0.000 1）, and survival risk was lower than in the control group（HR=0.38, 95%CI： 0.26～0.57, P〈0.000 1）. The total bilirubin（TBIL） at 1 month after operation（WMD=-6.08,95%CI：-9.05～-3.10, P〈0.000 1）, the TBIL at 3 months after operation（WMD=-37.72, 95%CI：-44.99～-30.45, P〈0.000 1）in the ^（125）I radiation group were lower than in the control group, biliary patency in ^（125）I brachytherapy group was better than in the control group. At one month after operation, the tumor size decreased in the ^（125）I brachytherapy group, but increased in the control group（SMD=-2.77, 95%CI：-5.10～0.44, P=0.02）. There were no significant differences in alanine aminotransferase（ALT） at one month after operation（WMD=-3.06, 95%CI：-7.97～1.85, P=0.22） and the common postoperative complication rate（RR=0.96, 95%CI： 0.68～1.35, P=0.80）. The rate of pain relief in the ^（125）I brachytherapy group was significantly higher than in the control group（RR=21.08, 95%CI： 4.43～100.16, P=0.000 1）. Conclusion Compared with single stent and biliary drainage, ^（125）I brachytherapy can effectively prolong survival, improve the biliary patency, inhibit tumor growth, while not damage to the liver function or increase complications.