不可切除胆管癌近距离腔内放射治疗加内置支架与单用内置支架比较的系统评价

System Evaluation of Intraluminal Brachytherapy(ILBT)Combined with Endoprostheses Comparied with Endoprostheses alone for Nonresectable Bile Duct Cancer

目的评价近距离腔内放射治疗(intraluminal brachytherapy,ILBT)对延长胆管癌患者生存时间的有效性和安全性。方法计算机检索MEDLINE(1977～2007.5)、CNKI和CBMdisk(1979～2007.5),收集所有近距离腔内放射加内置支架与单用内置支架比较治疗不可切除胆管癌的随机对照试验(RCT),采用Cochrane系统评价方法评价纳入研究质量,并提取数据进行分析。结果仅纳入1个RCT,包括42例患者;该研究结果显示,ILBT组加支架组中位生存时间387.9天[95%CI(125,613)],远长于单用内置支架组298天[95%CI(72,546)],两组差异有统计学意义(P<0.05);此外,ILBT加支架组支架未闭时间378.4天[95%CI(60,613)],也远长于单用内置支架组245.4762天[95%C(I50,434)],两组差异有统计学意义(P<0.01)。全部纳入对象均使用8F导管做经皮引流,平均放置时间为10天。ILBT加支架组治疗前胆红素值为219.3±40.5,治疗后为23.1±37.1,而单用支架组治疗前胆红素值为227.3±39.8,治疗后为22.5±44.2,治疗后两组胆红素值均未降至正常范围(<20.0mol/L)。ILBT加支架组治疗前碱性磷酸酶值为10.33±5.1,治疗后为3.57±2.93;单用支架组治疗前碱性磷酸酶值为11.69±5.8,治疗后为3.73±2.87,治疗后两组碱性磷酸酶值均降至正常范围(<1.80kat/L)。治疗期间,两组患者均未发生严重副反应。结论现有证据表明,近距离腔内放射治疗不可切除的胆管癌可明显延长患者生存时间,增加患者无症状生存时间,改善患者生存质量和生存期望,降低治疗负担;但可能增加对局部正常组织的毒性。对于后者,可通过调整放射剂量来控制,余无其它严重毒副作用。只要熟练掌控内镜技术即可实施此疗法。鉴于本次评价仅基于1个小样本量RCT,因此尚需开展更多的大样本RCT以获得更加可靠的证据。

Objective To evaluate the effectiveness and safety of intraluminal brachytherapy （ILBT） in prolonging survival and the period free of symptoms for patients with unresectable bile duct cancer. Methods We searched MEDLINE （1977 to May 2007）, CNKI （1979 to May 2007） and CBM Disk （1979 to May 2007）. The quality of included studies was assessed according to the guidance in the Cochrane Handbook for SystematicReviews of Interventions. Results One randomized controlled trial involving 42 patients with unresectable bile duct cancer fulfilled the inclusion criteria. This found that the median survival time was longer for patients treated with endoprostheses and ILBT compared to those treated with endoprostheses alone （387.9 days versus 298.0 days, P〈0.05）. The stent patency time in patients who were treated with endoprostheses and ILBT was longer than for those treated with endoprostheses alone （378.4 days versus 245.5 days, P〈0.01）. The reductions in bilirubin （mol/l） and alkaline phosphatase （kat/l） before and after drainage in patients who were treated with endoprostheses and ILBT were similar to those treated with endoprostheses alone （Mean ±SD of bilirubin： before： 219.3 ±40.5, after： 23.1 ± 37.1 versus before： 227.3 ± 39.8,after： 22.5 ± 44.2; Mean ± SD of alkaline phosphatase： before： 10.3 ± 5.1. after： 3.6 ± 2.9 versus before： 11.7 ± 5.8, after： 3.7 ± 2.9）. No severe adverse effects were observed in the trial, Conclusion Current evidence suggests that ILBT for unresectable bile duct cancer may improve the survival time of patients,prolong the time they spend symptom free,improve their quality of life and reduce the burden of treatment. However,it may increase toxicity in normal tissues,which can be managed by adjusting radiation dosage. No serious adverse effects were observed in the 42 patients in the trial in this review. More randomized controlled trials withlarge sample size are needed to provide reliable results.