奈达铂联合5-氟尿嘧啶治疗晚期食管癌的Meta分析

Effectiveness and Safety of Nedaplatin Combined with 5-Fluorouracil for Advanced Esophageal Cancer: A Meta-Analysis

目的系统评价奈达铂联合5-氟尿嘧啶(5-Fu)与顺铂联合5-Fu比较治疗晚期食管癌的有效性和安全性。方法计算机检索PubMed、Cochrane Library、EMbase、CBM、CNKI、VIP、WanFang Data和中国随机对照试验数据库等,收集奈达铂联合5-Fu与顺铂联合5-Fu比较治疗晚期食管癌的随机对照试验(RCT),检索时限均从建库至2012年5月4日。由2名研究者按照纳入排除标准独立筛选文献、提取资料和质量评价后,采用RevMan 5.1软件进行Meta分析。结果纳入15个RCT,共863例患者。Meta分析结果显示,与顺铂联合5-Fu相比,奈达铂联合5-Fu可以提高晚期食管癌患者的近期疗效[RR=1.31,95%CI(1.14,1.52),P=0.000 2],减少胃肠道反应和肾功能损伤,但奈达铂组骨髓抑制较严重,血小板下降明显增多,白细胞和血红蛋白下降亦有增多的趋势。两组在肝功能损伤、腹泻和周围神经毒性等方面差异无统计学意义。结论奈达铂联合5-Fu对晚期食管癌的治疗具有一定的优越性,可显著提高近期疗效,减轻胃肠道反应和肾功能损伤,但同时加重骨髓抑制,临床应用中应密切观察。奈达铂联合5-Fu方案可作为晚期食管癌的替代治疗方案,但尚缺乏长期疗效相关证据。由于纳入研究的质量和数量有限,降低了本系统评价的证据强度,故本系统评价的结论仅供临床实践与研究参考。

Objective To assess the effectiveness and safety of nedaplatin combined with 5-fluorouracil （5-Fu） for advanced esophageal cancer. Methods Such databases as PubMed, The Cochrane Library, EMbase, CBM, CNKI, VIP and WanFang Data were searched from the date of their establishment to May 4th, 2012 to collect the randomized con- trolled trials （RCTs） about nedaplatin combined with 5-Fu versus cisplatin combined with 5-Fu for advanced esophageal cancer. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data and assessed the quality of the included studies. Then meta-analysis was conducted using RevMan 5.1 software. Resuits A total of 15 RCTs invloving 863 patients were included. The results of meta-analysis suggested that, compared with cisplatin combined with 5-Fu, nedaplatin combined with 5-Fu could improve short-term effects （RR=1.31, 95%CI 1.14 to 1.52, P=0.000 2） and reduce gastrointestinal reaction and renal function impairment, but it was associated with aggravated myelosuppression, increase of thrombocytopenia and leukopenia, and decrease of hemoglobin. There were no significant differences between the two groups in liver function impairment, diarrhea and peripheral neurovirulence. Conclusion Nedaplatin combined with 5-fluorouracil can increase short-term effects and reduce gastrointestinal reaction and renal function impairment. However, nedaplatin is associated with aggravated myelosuppression, so it should be applied in clinic with cautious. Nedaplatin combined with 5-fluorouracil can be used as a replacement chemotherapy regimen for advanced esophageal cancer, but the evidence about long-term effects and safety is still required. For the quality and quantity limitation of the included studies which decreases the level of evidence, so the conclusion of this systematic review only provides some references for clinical practice and research.