| Objective: To evaluate the short and long term effectiveness and safety ofrapamycin-based immunosuppression regimes with CsA preserving versusCsA withdrawal. Methods: MEDLINE, EMBASE, The Cochrane Libraryand CNKI were searched from Jan. 1995 to Dec. 2006. And we identifiedrandomized controlled trials of rapamycin-based immunosuppression regimeswith CsA preserving versus CsA withdrawal for renal transplantation patients.The quality of included trials was evaluated by two estimators. Andmeta-analysis was conducted on homogeneous studies. Results: Ten studies(1121 patients) undergoing renal transplantation were included. All includedstudies were graded in term of randomization, allocation concealment, andblinding. Six studies were graded B and the other four were graded C.Meta-analysis based on included studies shows CsA withdrawal insirolimus-based therapy in renal transplantation that patients survivalOR(95%CI) values were 0.77(0.17, 3.52),1.24(0.48, 3.16),1.32(0.57, 3.08),1.21(0.60, 2.41) at the end of 6, 12, 24, 36 months respectively, patientssurvival of the two group difference had no significance statistically, p value＞0.05; renal allograft survival OR (95%CI) values were 1.79, (0.63, 5.06),1.15(0.56, 2.36), 1.39(0.68, 2.85), 1.80(0.99, 3.29), 2.13(1.16, 3.89),2.01 (1.15, 3.51) at the end of 6, 12, 24, 36, 48, 54 months respectively, renalallograft survival of two group difference had no significance statistically, pvalue＞0.05 before 48 months; and acute rejection OR(95%CI) values were0.92(0.48, 1.78), 1.90(1.25, 2.89), 2.01 (0.94, 4.27), 1.93(0.93, 4.00), 1.52(0.77, 3.02) at the end of 6, 12, 24, 36, 48 months respectively, only at 12month the difference of two groups had significance statistically, p value＜0.05. The GFR of allograft WMD(95%CI) were 4.35 (-1.31, 10.01),11.11(7.21, 15.01), 10.33 (3.50, 17.17), 3.00 (-3.11, 9.11), 9.97(9.66, 10.28),12.12(11.78, 12.46) at the end of 1, 3, 6, 12, 24, 36 months respectively,difference of two groups had significance statistically, p value＜0.05 at 3, 6,24, 36 months respectively; the SCr WMD(95%CI) values of allograft were-26.52(-47.89, -5.15), -17.54(-33.77, -1.30), -21.21(-33.98, -8.43), -28.40(-29.34, -27.46) at the end of 3, 6, 12, 24 months respectively, difference oftwo group had significance statistically, p value＜0.05; the serum cholesterolWMD(95%CI) values were -0.18(-0.77, 0.41), -0.10(-0.50, 0.31), 0.70(0.41,0.98) at the end of 3, 6, 12 months respectively, difference of two groups hadsignificance statistically at 12 month, p value＜0.05; hypertension occurringOR(95%CI) values were 0.53(0.21, 1.32), 0.39(0.10, 1.47), 0.41(0.27, 0.63),0.36(0.21, 0.61) end of 6, 12, 24, 36 months respectively, difference of twogroups had significance statistically at 24 and 36 month, p value＜0.05;diabetes mellitus occurring OR(95%CI) values was 0.73 (0.33, 1.61 ) end of6months, p value＞0.05; the platelet count WMD(95%CI) values were-21.00(-55.50, 13.50), -9.00(-10.04, -7.96) at the end of 6, 12 monthsrespectively difference of two groups had significance statistically at 12month, p value＜0.05; the infection of bacterium occurring OR(95%CI)values were 1.91 (1.12, 3.25), 2.33 (1.17, 4.63) at the end of 6, 12 months respectively, difference of two groups had significance statistically, p value＜0.05; the infection of virus occurring OR(95%CI) values were 0.37 (0.01,11.26), 0.07(0.01,0.56) at the end of 6, 12 months respectively, difference oftwo groups had significance statistically at 12 month, p value＜0.05; canceroccurring OR(95%CI) values were 0.14 (0.02, 1.14), 0.47 (0.23, 0.97),0.40 (0.18, 0.90) at the end of 12, 24, 36 months respectively, difference oftwo groups had significance statistically at 24 and 36 months, p value＜0.05.Conclusions: Our study shows that CsA withdrawal in rapamycin-basedimmunosuppression regimes make no statistical difference to viability ofpatients/renal allograft in cases with stabilized renal functionpost-transplantation compared with CsA preserving. And CsA withdrawalbenefit to allografts for long term survival. And no of treatment of CsA washelpful to recovery of renal function, maintenance of lower blood pressure,and decrease of occurrence of neoplasm. Compared with CsA preserving,CsA withdrawal could lead to higher incidence rates of acute rejection at oneyear and higher level of blood fat and susceptibility to bacteria and viruswhile make no significant impact on incidence of diabetes mellitus. Owing tohigh possibility of selection bias and measurement bias in included studies,there must be a negative impact on evidence intensity of our results. Weexpect high quality evidences provided by high quality double blindrandomized control trials. Objective: To evaluate the short and long term effectiveness and safety ofdifferent dose rapamycin immunosuppression regimes. Methods: MEDLINE,EMBASE, The Cochrane Library and CNKI were searched from Jan.1995 toDec.2006. And we identified randomized controlled trials ofimmunosuppression regimes with low dose rapamycin versus high dose forrenal transplantation patients. The quality of included trials was evaluated bytwo estimators. And meta-analysis was conducted on homogeneous studies.Results: Nine studies (2869 patients) undergoing renal transplantation wereincluded. All included studies were graded in term of randomization,allocation concealment, and blinding. Seven studies were graded A and theother 2 were graded C. Meta-analysis based on included studies shows lowdose sirolimus in renal transplantation that patients survival OR(95%CI)values were 1.7(0.52, 5.6), 0.97(0.62, 1.54), 0.83(0.54, 1.26), the differencehad no significance statistically, p value＞0.05, ORcombine (95%CI) was0.95(0.72, 1.27), P value＞0.05 at the end of 6, 12, 24 months respectively;renal allografts survival OR (95%CI) values were 1.02(0.56, 1.84),1.27(0.64, 2.51),0.81(0.60, 1.10),2.57(1.33, 4.97), ORcombine (95%CI) was 1.14(0.81,1.60) at the end of 6, 12, 24, 36 months respectively, the difference had nosignificance statistically, p value＞0.05, except for the point of 36 month;and acute rejection OR(95%CI) values were 1.36(1.07, 1.72), 1.40(1.11,1.77), 1.31(1.03, 1.66), 0.97(0.61, 1.55), ORcombine (95%CI) was1.32(1.16,1.65) at the end of 6, 12, 24, 36 months respectively, the difference hadsignificance statistically, and p value＜0.05 except the point of 36 month. TheGFR of allograft WMD(95%CI) were 3.12(2.90, 3.36), 6.44(5.90,6.98),6.00(0.15, 11.85), 5.00(-1.37, 11.37), WMDcombine (95%CI) was3.93(1.70, 6.16) at the end of 1, 3, 6, 12, 24, 36 months respectively, thedifference had significance statistically, p value＜0.05, except the point of 36month; the SCr WMD(95%CI) values of allograft were -4.45(-7.70, -1.19),-11.10(-12.01, -10.19), -29.00(-52.45, -5.54), -34.00(-65.51, 2.49),WMDcombine(95%CI) was -7.10(-11.13, -3.02) at the end of 6, 12, 24 monthsrespectively, the difference had significance statistically, p value＜0.05; theserum cholesterol WMD(95%CI) values were -0.58(-0.66, -0.50), -0.30(-0.60,0.01), -0.32(-0.38, -0.26), WMDcombine (95%CI) was -0.40(-0.53, -0.26) atthe end of 6, 12, 24 months respectively, the difference had significancestatistically, p value＜0.05; the WBC count WMD(95%CI) values were0.29(0.22, 0.35), 0.29(0.04, 0.53), 0.22(-0.04, 0.49), WMDcombine (95%CI)was 0.27(0.17, 0.36) at the end of 6, 12 months respectively, the differencehad significance statistically, p value＞0.05, except the point of 24 months.Conclusions: Our study shows that low dose sirolimus immunosuppressionregimes make no statistical difference to viability of patients/renal allograft in cases with stabilized renal function post-transplantation compared with highdose. And low dose sirolimus benefit to allografts for long term survival andwas helpful to maintain of renal function and low blood fat. Compared withhigh dose rapamycin, low dose could lead to higher incidence rates of acuterejection at one year. While Owing to high possibility of selection bias andmeasurement bias in included studies, there must be a negative impact onevidence intensity of our results. We expect high quality evidences providedby high quality double blind randomized control trials.
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