Objective To evaluate the effectiveness and safety of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor(TOR-I)-based immunosuppression in kidney transplant recipients. Methods We searched MEDLINE, EMbase, SCI, CBM and The Cochrane Library to screen randomized controlled trials (RCT) of calcineurin inhibitor (CNI) withdrawal from target-of-rapamycin-inhibitor-(TOR-I)-based immunosuppression in kidney transplant recipients. The search was updated in Semptember 2009. The quality of the included trials was assessed. RevMan 5.0 software was used for meta-analyses. Results A total of 14 reports from 10 RCTs were identified. Five RCTs were graded A and five graded B. The meta-analyses indicated: RR (95%CI) values of the 1, 2, 4-year acute rejection rates were 1.64 (1.19, 2.27), 1.53 (1.06, 2.22) and 1.21 (0.73, 1.98), respectively; RD (95%CI) values of 1, 2, 4-year patient survival rates were – 0.01 (– 0.02, 0.01), – 0.00 (– 0.03, 0.02) and 0.03 (– 0.01, 0.08), respectively; RD (95%CI) values of 1, 2, 4-year graft survival rates were 0.00 (– 0.02, 0.02), 0.00 (– 0.03, 0.04) and 0.07 (0.01, 0.12), respectively; and glomerular filtration rate WMD was 9.50 and 95%CI 2.96 to 16.03. Conclusion Based on the current evidence, compared to CNI, CNI withdrawal from sirolimus-based immunosuppression in kidney transplantation could be advantageous for renal function. One-year acute rejection rate and 4-year graft survival rate increase. One-year patient/graft survival and fouryear acute rejection rate remain virtually unvariable. The long-term results need further confirmation.
ObjectiveTo compare tacrolumus (FK506) with cyclosporine A (CsA) in clinical application to organ transplantation.MethodsThe literature in recent years has been reviewed and compared. ResultsFK506 was a powerful immunosuppression with a mechanism of action similar to that of CsA, but significantly superiori to CsA in terms of prophylaxis and treatment of allograft acute rejection, delay of chronic rejection, and withdrawal of steroid in early period. The cardiovascular mortality and chronic graft nephropathy (CGN),such as hypertension and hyperlipidemia were less frequently seen in FK506treated patients and FK506 also had an acceptable safety profile, including a low incidence of hypertrichosis,gingival hyperplasia and infections.However, CsA had been showed a better result in prevention of posttransplantation diabetes mellitus (PTDM ) and more economic agent than FK506. Pharmacokinetic studies showed CsA in the form of Sandimmun Neoral showed less inter an intrapatient variability than FK506.Meanwhile, the combination of MMF and FK506 or CsA has been proved effectively with excellent graft and patients survival. Conclusion FK506 and CsA are safe and effective long term maintenance immunosuppressive agents in organ transplantation with wonderful prospect.
OBJECTIVE To study the effect of combined application of external cyclosporine A (CsA) and CTLA4Ig in inhibiting rejection and inducing immune tolerance in composite tissue allograft. METHODS: The auricles with vessel pedicle were transplanted from Lewis rats to BN rats under microsurgery. CsA was spreaded on the surface of grafts in combination with administration of CTLA4Ig intraperitoneally after transplantation. The rejection response and survival time of grafts were observed, and the IL-2 level in serum was measured. RESULTS: The mean survival time was (7.8 +/- 1.7) days in control group. It was (15.2 +/- 1.9) days when recipients treated by CsA and (16.6 +/- 2.1) days by CTLA4Ig. Under the combination of CsA and CTLA4Ig, the mean survival time was significantly prolonged to (28.8 +/- 3.5) days (P lt; 0.05) with the lowest level of IL-2 in serum of recipients. CONCLUSION: The combined application of external CsA and CTLA4Ig inhibits rejection of allograft effectively, which can be a favorable therapy on composite tissue allo-transplantation.
Objective To evaluate the efficacy and safety of low-dose versus standard-dose cyclosporine immunosuppressive therapy in kidney transplant recipients. Methods We searched MEDLINE, EMbase, SCI, CBM and The Cochrane Library from the establishment to December 2009 to screen randomized controlled trials (RCTs) of low-dose versus standard-dose cyclosporine immunosuppressive therapy in kidney transplant recipients. Quality assessment and meta-analyses were performed for the included studies. Results A total of 6 RCTs involving 1551 patients were identified, among which 4 RCTs were graded A and two were graded B. The meta-analyses indicated that there were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the acute rejection rate at a RR 1.07, 95%CI 0.69 to 1.65 and a RR 1.06, 95%CI 0.71 to 1.57, respectively. There were no significant differences between the two groups at the end of 6-month and 12-month follow-up in the patients’ death rate at a RR 0.64, 95%CI 0.20 to 2.03 and a RR 0.61, 95%CI 0.30 to 1.24, respectively. There were no significant differences between the two groups in renal function and safety. Conclusion Based on the current evidence, compared with standard-dose CsA, low-dose CsA has the same effect and safety for the short-term results, but the long-term results need to be further studied.
Objective To assess the effectiveness and safety of cyclosporine A (CsA) for aplastic anemia (AA) in China. Methods Randomized controlled trails (RCTs) of CsA for AA were collected from CBMdisc (1978 to 2008), CNKI (1979 to 2008), and VIP (1989 to 2008). Other relevant journals were also hand searched. The methodological quality of included studies was evaluated, and data analyses were performed with The Cochrane Collaboration’s software RevMan 4.2.0. Results A total of 19 RCTs were included. As for the total effective rate and complete remission rate, significant differences were noted between CsA + androgen vs. androgen alone, CsA + androgen combination vs. androgen combination, as well as CsA + androgen + other drugs vs. androgen + other drugs [total effective rate: RRs and 95%CIs were 1.48 (1.28 to 1.70), 1.67 (1.17 to 2.39), and 1.51 (1.09 to 2.08); complete remission rate: RRs and 95%CIs were 2.06 (1.33 to 3.19), 3.52 (1.19 to 10.39), and 1.54 (1.00 to 2.38)]. Conclusion According to the domestic evidence, treatment with CsA for AA may improve the total effective rate and complete remission rate. However, more high quality clinical trials are expected for further study.
Objective To asses the clinical effectiveness and safety of combined treatment with antilymphocyte globulin (ATG) and cyclosporine A (CSA) versus antilymphocyte globulin alone in patients with aplastic anemia (AA). Methods Randomized controlled trials (RCTs) were identified from MEDLINE (1966 to September 2007), EMBASE (1984 to September 2007), The Cochrane Library (issue 4, 2007) and CBM-disc (1978 to September 2007). The references of eligible studies were hand searched. RCTs involving ATG and CSA in the treatment of AA were included. Data were evaluated and extracted by two reviewers independently with designed extraction form. The Cochrane Collaboration’ s RevMan 4.2.10 software was used for data analyses. Results Two RCTs involving 160 patients were included. Two studies showed that the effective rate in the ATG+CSA group was significantly higher than that in the ATG group (Plt;0.0001). Two studies indicated that the survival rate in the ATG+CSA group was improved compared with the ATG group (P=0.0002). One study reported adverse effect. The ATG group caused more fever and serum diseases compared with the ATG+CSA group, but the ATG+CSA group had a higher incidence of hepatotoxicity. Conclusion Treatment with ATG+CSA for aplastic anemia has higher effective rate and survival rate than ATG alone. More trials of high quality are required.
Objective To evaluate the short and long term effectiveness and safety of rapamycin-based immunosuppression regimes with CsA preserving versus CsA withdrawal. Methods We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from Jan. 1995 to Dec. 2005. We identified randomized controlled trials of rapamycin-hased immunosuppression regimes with CsA preserving versus CsA withdrawal for renal transplantation patients. The quality of included trials was evaluated by two reviewers. Meta-analysis was conducted on homogeneous studies. Results Ten studies （1 121 patients） undergoing renal transplantation were included. All included studies were graded in term of randomization, allocation concealment and bhnding. Six studies were graded A and the other 4 were graded B. Meta-analysis results showed CsA withdrawal in sirolimus-based therapy in renal transplantation patients survival rate OR.（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; renal allografts survival rate 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; and acute rejection OP,（95% CI） values were 0.92（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 of6, 12, 24, 36, 48 months respectively. Conclusions Available evidence shows that compared with CsA preserving, CsA withdrawal in rapamycin-based immunosuppression regimes can lead to higher incidence rates of acute rejection at the end of one year while there is no statistical difference to survival rate of patients/renal allograft in cases with stabilized renal function post-transplantation. And CsA withdrawal is of benefit to allografts for long term survival rate and is helpful to recovery of renal function. Owing to high possibility of selection bias and measurement bias in included studies, there must be a negative impact on evidence intensity of our results. We expect best evidence from with high quality double blind randomized control trials.
Objective To evaluate the effectiveness of tacrolimus and cyclosporine A on acute rejection, chronic rejection and survival rate of patient and graft after renal transplantation. Methods We searched MEDLINE (1989 to Nov.2004), EMBASE (1989 to Nov.2004), The Chinese Biomedical Database (CBM) (1998 to Nov.2004), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 4, 2004) and handsearched 8 Chinese journals. Trials comparing tacrolimus with cyclosporine A after renal transplantation were included. The quality of included studies such as randomization, blinding, allocation concealment was evaluated and meta-analysis was performed using RevMan 4.2.7 software. Results Eighteen studies involving 3 738 patients were included. Tacrolimus was more effective in decreasing the incidence of acute rejection and chronic rejection than that of cyclosporine A with RR 0.65, 95％CI 0.56 to 0.75 at the end of 6 months; with RR 0.70, 95％CI 0.54 to 0.92 at the end of 12 months for number of patients of acute rejection. The pooled RR was 0.65 (95％CI 0.47 to 0.89) for number of patients of chronic rejection. Tacrolimus could reduce the severity of acute rejection. The relative risks of pathologic grade BanffⅠand Banff (Ⅱ＋Ⅲ) were 1.64 (95％CI 1.08 to 2.49) and 0.75 (95％CI 0.63 to 0.89) respectively. But there was no significant difference on the survival rate of patient and graft within 5 years between the two groups. The relative risk of 6, 12, 24, 36 and 60 months were 1.01 (95％CI 0.99 to 1.02), 1.00 (95％CI 0.99 to 1.02), 1.01 (95％CI 0.97 to 1.05), 1.00 (95％CI 0.97 to 1.03) and 0.97 (95％CI 0.88 to 1.07) respectively for the survival rate of patient and 1.04 (95％CI 1.01 to 1.07), 1.03 (95％CI 1.00 to 1.06), 0.99 (95％CI 0.91 to 1.07), 1.04 (95％CI 0.99 to 1.09) and 1.04 (95％CI 0.90 to 1.21) respectively for the survival rate of grafts. Conclusions On acute rejection and chronic rejection, tacrolimus is more effective than cyclosporine A, but there is no difference in the graft or patient survival rate.
【摘要】 目的 探讨肾移植术后药物（环孢素A和钙离子拮抗剂）、口腔卫生与牙龈增生的关系。 方法 随访2003年1月—2010年3月间321例肾移植患者，记录患者术后药物使用和口腔卫生情况，观察牙龈增生程度。结果 〖HTSS〗口腔卫生水平与牙龈增生程度之间存在统计学相关性（rs=0.344，P=0.000），口腔卫生水平越差，牙龈增生越严重。服用环孢素A和钙离子拮抗剂患者（A组）牙龈增生发生率为62.15%，高于单纯服用环孢素A患者（B组）23.40%，二者比较，差异有统计学意义（χ2=39.220，P=0.000）。结论 〖HTSS〗肾移植术后环孢素A和钙离子拮抗剂联合应用明显增加了牙龈增生的发病率。口腔卫生水平与牙龈增生程度之间存在重要关联，口腔卫生差是牙龈增生的危险因素。【Abstract】 Objective To investigate the correlation between drugs (cyclosporine A and calcium channel blocker), oral hygiene and gingival hyperplasia in patients after renal transplantation. Methods We continuously followed up 321 patients undergoing renal transplantation from January 2003 to July 2009 in our hospital. The levels of oral hygiene, medication and gingival hyperplasia were recorded. Results There was a close relationship between the level of oral hygiene and the degree of gingival hyperplasia (rs=0.344, P=0.000). Higher grades of gingival hyperplasia (grades Ⅱ and Ⅲ) were found exclusively in patients who did not have good oral hygiene. There was a higher tendency of developing gingival hyperplasia among patients who received cyclosporine A and calcium channel blocker than those who only received cyclosporine A (62.15% vs. 23.40%; χ2=39.220, P=0.000). Conclusion The prevalence of gingival hyperplasia is higher in renal transplant recipients taking cyclosporine A and calcium channel blockers. There is a significant relationship between the level of oral hygiene and the development of gingival hyperplasia. Poor oral hygiene is a risk factor of gingival hyperplasia.