| Background: Intravesical therapy for superficial bladder cancer after TURB-t is aimed to prevent postoperative recurrence and progression. At present, there are two kinds of intravesical therapy drugs, one is the chemotherapy drug, and another is the immunotherapy drug. The fact that BCG is superior in preventing recurrence of superficial bladder cancer after TURB-t, compared to many chemotherapy drugs, is confirmed in numerous randomized trials. Unfortunately, Toxic and untoward side effects of intravesical BCG have discouraged some urologist, which resulting in its limit use in clinical practice. Therefore, randomized controlled trials of intravesical BCG and chemotherapy drug appear. However, whether this combined therapy can reduce the recurrence and progression rates of superficial bladder cancer after TURB-t still remains a question. Objective: To evaluate the efficacy and safety for intravesical BCG and chemotherapy drug, compared with intravesical BCG alone, on recurrence rate, progression rate and side effects rate.Methods: According to the Cochrane handbook for systematic reviews of interventions, we established corresponding inclusion criteria, exclusion criteria and search strategy. Trials were identified from Pubmed, Ovid, EMbase, the Cochrane library, CBM and VIP. We hand-searched correlative 12 kinds of Chinese journals, articles in the meeting collections, articles in the academic degree collections and references of all included trials. At least two reviewers independently screened the studies for eligibility, evaluated the quality and extracted the data from the eligible studies, with confirmation of cross-check. Trials were assessed for quality according to the randomization, allocation concealment, blinding, loss to follow-up and baseline, and graded their methodological quality according to the Cochrane handbook for systematic reviews of interventions. Meta-analysis was performed using Revman 4.2.9 software provided by the Cochrane collaboration. For dichotomous data, results were expressed as relative risk (RR) and 95% confidence internals (CI). For continuous data, results were expressed as weighted mean difference (WMD) and 95% CI. After heterogeneity test, data without heterogeneity could be pooled using fixed effect model, and those with heterogeneity could be solved by randomized effect model, subgroup analysis or sensitivity analysis.Results: Four trials involving 681patients were included. One trial was clinical controlled trial and three trials were randomized controlled trials. Most trials were of poor quality. According to the results of meta-analysis: (1) When it comes to phase Ta and T1 superficial bladder cancer, the RR and its 95% CI of total recurrence rate and total progression rate for intravesical BCG and chemotherapy drug were 0.69 (0.53,0.90) and 0.45 (0.25,0.82) respectively. (2) When it comes to phase Tis bladder cancer, the RR and its 95% CI of total recurrence rate and total progression rate for intravesical BCG and chemotherapy drug were 1.22 (0.97,1.54) and 1.55 (0.94,2.57) respectively. (3) The RR and its 95% CI of total side effects rate for intravesical BCG and chemotherapy drug were 0.85 (0.70,1.03).Conclusion: Intravesically administered BCG and chemotherapy drug in patients with Ta and Tl superficial bladder cancer can reduce the incidence of tumor recurrence and disease progression more effectively, compared with BCG alone. As to patients with Tis bladder cancer, the two therapeutic modalities do not differ in the incidence of tumor recurrence and disease progression. In terms of side effects rate, the two therapeutic modalities do not differ with each other, either. Owing to moderate possibility of selection bias, performance bias and publication bias in limited included studies, there must be a negative impact on evidence intensity of our results. We expect best evidence from more high quality double blind randomized controlled trials.
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