Background Alemtuzumab, a humanized CD52 monoclonal antibody, with its profound lymphocyte depletion property, was expected to be a promising induction therapy agent for kidney transplantation （KTx）. However, curren...Background Alemtuzumab, a humanized CD52 monoclonal antibody, with its profound lymphocyte depletion property, was expected to be a promising induction therapy agent for kidney transplantation （KTx）. However, currently no consensus is available about its efficacy and safety. The aim of this meta-analysis was to make a profound review and an objective appraisal of this issue. Methods Relevant papers were searched, essentially in the PubMed database and the Cochrane library. After a thorough review, randomized controlled trials （RCTs） comparing the outcome of KTx using alemtuzumab induction therapy （test group） with a control group were collected according to the inclusion criteria. Data of general characteristic of studies and major outcomes of Ktx were extracted and meta-analyses were performed with RevMan 4.2 software. The odds ratio （OR） with a 95% confidence intervals （Co was the principle measurement of effect. Results Five RCTs were included. The chi square test showed no significant between-study heterogeneity, thus fixed effect model was employed. Sub-group analysis with studies including alemtuzumab induction followed by a tacrolimus-based immunosuppressive regimen showed that the acute rejection rate （ARR） was lower relative to the control （OR=0.59, 95% CI 0.34-1.01, P=0.05）. However, meta-analysis with all included studies revealed that neither ARR nor patient/graff survival rates differ significantly between the test and the control group, but the cytomegalovirus （CMV） infection rate was higher in the test group （OR 2.50, 95% CI 1.22-5.12, P=0.01）. A great number of the test group recipients safely remained on a regimen that was steroid-free and with a reduced dose of conventional immunosuppressive drugs. Conclusions Alemtuzumab induction therapy for KTx was an effective and safe protocol in the tested follow-up period. Steroid avoidance and a dose reduction of conventional immunosuppressive drugs after alemtuzumab induction therapy may have clinical importance. However, high quality RCTs with larger population and longer follow-up are needed for a more accurate and objective appraisal of this novel protocol.展开更多
文摘Background Alemtuzumab, a humanized CD52 monoclonal antibody, with its profound lymphocyte depletion property, was expected to be a promising induction therapy agent for kidney transplantation （KTx）. However, currently no consensus is available about its efficacy and safety. The aim of this meta-analysis was to make a profound review and an objective appraisal of this issue. Methods Relevant papers were searched, essentially in the PubMed database and the Cochrane library. After a thorough review, randomized controlled trials （RCTs） comparing the outcome of KTx using alemtuzumab induction therapy （test group） with a control group were collected according to the inclusion criteria. Data of general characteristic of studies and major outcomes of Ktx were extracted and meta-analyses were performed with RevMan 4.2 software. The odds ratio （OR） with a 95% confidence intervals （Co was the principle measurement of effect. Results Five RCTs were included. The chi square test showed no significant between-study heterogeneity, thus fixed effect model was employed. Sub-group analysis with studies including alemtuzumab induction followed by a tacrolimus-based immunosuppressive regimen showed that the acute rejection rate （ARR） was lower relative to the control （OR=0.59, 95% CI 0.34-1.01, P=0.05）. However, meta-analysis with all included studies revealed that neither ARR nor patient/graff survival rates differ significantly between the test and the control group, but the cytomegalovirus （CMV） infection rate was higher in the test group （OR 2.50, 95% CI 1.22-5.12, P=0.01）. A great number of the test group recipients safely remained on a regimen that was steroid-free and with a reduced dose of conventional immunosuppressive drugs. Conclusions Alemtuzumab induction therapy for KTx was an effective and safe protocol in the tested follow-up period. Steroid avoidance and a dose reduction of conventional immunosuppressive drugs after alemtuzumab induction therapy may have clinical importance. However, high quality RCTs with larger population and longer follow-up are needed for a more accurate and objective appraisal of this novel protocol.
