关键词: 膀胱肿瘤, 非肌层浸润性膀胱癌, 吉西他滨, 丝裂霉素, 膀胱灌注化疗, 安全性, 有效性, Meta分析

Abstract: Background　Gemcitabine and mitomycin are both chemotherapy drugs for non-muscular invasive bladder cancer（NMIBC）after transurethral resection of bladder tumor（TURBT）. However，no final conclusion has been reached on these two drugs in terms of differences in clinical efficacy and safety. Objective　To evaluate the effectiveness and safety of gemcitabine versus mitomycin in the treatment of NMIBC after TURBT. Methods　Published randomized controlled studies（RCT）comparing gemcitabine and mitomycin for NMIBC after TURBT were searched in databases of PubMed，EMBase，Web of Science，The Cochrane Library，CNKI，Wanfang Data，SinoMed，and CQVIP from inception to 2020-10-01，and enrolled according to the inclusion and exclusion criteria.Data of included RCT were extracted，including the first author，publication year，design，level of evidence，sample age，sample size，tumor growth，WHO classification，TNM staging，drug infusion dosage，cancer recurrence（recurrence within one and two years after surgery），and chemotherapy perfusion-related adverse events（bladder irritation，hematuria，liver and kidney damage，rash，nausea and vomiting，suprapubic pain）. The patients were divided into GEM group and MMC group according to the drug use after TURBT. Meta-analysis of recurrence within one and two years after surgery and incidence of chemotherapy perfusion-related adverse events was performed in two groups. Results　A total of seven RCT were included，involving 484 patients，with high quality rated by the Jadad Scale. Meta-analysis showed no statistically significant difference in one-year recurrence rate between the two groups of patients〔OR=0.86，95%CI（0.29，2.56），P=0.17〕. But gemcitabine group gained more benefits in reducing the two-year recurrence rate〔OR=0.37，95%CI（0.23，0.59），P=0.01〕. Furthermore，gemcitabine group demonstrated lower overall incidence of chemotherapy perfusion-related adverse events〔OR=0.28，95%CI（0.18，0.43），P=0.01〕，lower incidence of bladder irritation〔OR=0.30，95%CI（0.17，0.54），P=0.04〕as well as lower incidence of other complications（rash，nausea and vomiting，suprapubic pain）〔OR=0.46，95%CI（0.24，0.88），P=0.01〕. There were no statistically significant intergroup differences in the incidence of postoperative hematuria〔OR=0.52，95%CI（0.21，1.26），P=0.22〕and liver and kidney damage〔OR=0.51，95%CI（0.29，0.85），P=0.16〕. Conclusion　Gemcitabine may be more effective and safe for NMIBC after TURBT，owing to its better effects on lowering the recurrence rate and incidence of adverse events.

Key words: Urinary bladder neoplasms, Non-muscular invasive bladder cancer, Gemcitabine, Mitomycin, Bladder infusion chemotherapy, Security, Effectiveness, Meta-analysis