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背景与目的:膀胱癌是泌尿系最常见的恶性肿瘤。对于非肌层浸润性膀胱癌,术后腔内灌注是预防其复发的重要措施。卡介苗被认为是最有效的免疫治疗制剂,而表柔比星是已报道肿瘤完全缓解率较高的灌注化疗药物。但两种制剂在膀胱癌的疗效比较尚无定论。本文收集相关资料,以期比较表柔比星、卡介苗膀胱灌注预防非肌层浸润性膀胱癌术后复发、疾病进展的疗效和副作用。方法:按文中所述纳入标准,检索国内外已公开发表的关于表柔比星、卡介苗膀胱灌注治疗非肌层浸润性膀胱癌的比较性研究文献,并应用Revman4.2软件进行数据处理和分析。结果:共有6个研究符合标准被纳入,涉及总病例数1288例,其中表柔比星灌注治疗657例,复发253例;卡介苗治疗631例,复发184例。Meta分析结果提示卡介苗预防复发的疗效优于表柔比星,且统计学差异有显著性(PetoOR=1.60,95%CI=[1.26,2.03],P=0.0001);在预防疾病进展方面,卡介苗同样优于表柔比星(PetoOR=1.70,95%CI=[1.16,2.49],P=0.006);5个研究报道了药物主要局部副作用的比较,Meta分析显示表柔比星组在血尿(PetoOR=0.47,95%CI=[0.35,0.62],P<0.00001)、膀胱炎/膀胱刺激症(PetoOR=0.23,95%CI=[0.11,0.48],P<0.0001)发生率上显著低于卡介苗组。结论:卡介苗膀胱灌注预防非肌层浸润性膀胱癌术后复发及疾病进展作用优于表柔比星,但副作用发生率明显升高,选择病例需谨慎。
Background and Objective: Bladder cancer is the most common malignancy of the urinary tract. For non-muscle invasive bladder cancer, postoperative intraluminal infusion is an important measure to prevent its recurrence. Bacillus Calmette-Guérin (BCG) is considered to be the most effective immunotherapeutic agent, while epirubicin is a well-established infusion chemotherapeutic drug that has reported a high complete remission rate. However, the efficacy of the two preparations in bladder cancer is inconclusive. This article collected relevant information, in order to compare the epirubicin, BCG bladder irrigation prevent non-muscle invasive bladder cancer recurrence, disease progression and side effects. Methods: According to the inclusion criteria mentioned in this article, the domestic and foreign published research reports on the comparative study of epirubicin and BCG for non-muscle invasive bladder cancer were retrieved and analyzed by Revman4.2 software . Results: A total of 6 studies were included in the standard, involving a total of 1288 cases, of which epirubicin perfusion 657 cases, 253 cases of relapse; 631 cases of BCG treatment, 184 cases of recurrence. Meta-analysis showed that the efficacy of BCG in preventing recurrence was better than that of epirubicin, and the difference was statistically significant (PetoOR = 1.60,95% CI = [1.26,2.03], P = 0.0001); in the prevention of disease progression, (PetoOR = 1.70, 95% CI = [1.16, 2.49], P = 0.006). Five studies reported the major side effects of the drugs. Meta-analysis showed that the epirubicin group had significantly higher hematuria PetoOR = 0.47, 95% CI = [0.35,0.62], P <0.00001), cystitis / bladder irritation (PetoOR = 0.23, 95% CI = [0.11,0.48], P <0.0001) BCG group. CONCLUSION: Intravesical instillation of BCG prevents postoperative recurrence and disease progression of non-muscle invasive bladder cancer is superior to epirubicin, but the incidence of side effects was significantly increased, and the choice of cases should be cautious.