ObjectiveTo conduct a Meta-analysis to determine the clinical effect of protocol biopsy (PB)-monitored therapy after renal transplantation.MethodsPubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Standards Database and VIP Database for Chinese Technical Periodicals were searched for trials comparing the efficacy of timely intervention under PB surveillance with the conventional treatment. The quality of included studies was assessed and Meta-analysis was conducted by RevMan 5.3 software.ResultsSix randomized controlled trials met our inclusion criteria, including 698 cases. No significant difference was found between the PB group and the control group in 1-year [relative risk (RR)=0.99, 95% confidence interval (CI) (0.97, 1.01), P=0.39] and 2-year recipient survival rate [RR=1.00, 95%CI (0.97, 1.02), P=0.72]. Graft survival rate after 1 year [RR=1.01, 95%CI (0.99, 1.04), P=0.29] and 2 years [RR=1.02, 95%CI (0.99, 1.06), P=0.19] were also statistically similar. No statistical difference was found in glomerular filtration rate between the two groups [mean difference (MD)=0.45 mL/(min·1.73 m2), 95%CI (–3.77, 4.67) mL/(min·1.73 m2), P=0.83]. Renal function of PB group, monitored by serum creatinine, was superior to the control group [MD=–0.46 mg/dL, 95%CI (–0.63, –0.29) mg/dL, P<0.000 01]. No statistical difference was found in infection between the two groups [RR=1.23, 95%CI (0.69, 2.19), P=0.48].ConclusionsOur study did not suggest PB for every kidney transplantation recipient. However, long-term randomized controlled trials with larger sample size would be necessary to determine whether PB was effective for specific populations.