Objective To evaluate the safety of mycophenolate mofetil (MMF) versus azathioprine (AZA) for rejection after renal transplantation. Methods We searched MEDLINE (1966 to Jun. 2004), EMBASE (1984 to Jun. 2004), The Cochrane Library (Issue 2, 2004) and Chinese Biomedical Database (CBM, 1979 to Jun. 2004). Randomized controlled trials (RCTs) comparing MMF with AZA for rejection 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 4.1.1 software. Results Twenty-Four RCTs comparing MMF (2 g/day or 3 g/day) with AZA for rejection after renal transplantation were identified. The digest system morbidity of MMF group was higher than that of AZA group. The incidence of vomiting, bellyache and diarrhea of MMF 3 g/day group was statistical by higher than that of AZA group (P＜0.05). The cytom egalovirus (CMV) infection morbidity of MMF 3 g/day group during 6 months, 1 year and 2 years follow-up was higher than AZA group with statistical difference, but for MMF 2 g/day group, this difference was only seen during 1 year follow-up. Leukopenia incidence of MMF 3g/day group was higher than AZA group with statistical difference, but this difference was not seen in MMF 2 g/day group. Thrombocytopenia incidence of MMF 3 g/day group was lower than AZA group with statistical difference. For skin carcinoma morbidity, no statistical difference was found among MMF 3 g/day, MMF 2 g/day and AZA groups. Conclusions Compared with AZA, MMF represents higher digest system side-effects incidence, higher morbidity of leucopenia and CMV infection and lower incidence of thrombocytopenia. The dose-response relationship of adverse drug reaction is found.
Objective To evaluate the efficacy of mycophenolate Mofetil (MMF) and azathioprine (AZA) after renal transplantation. Method Searching: Medline, Embase, Cochrane library and Chinese Biomedicine database (CBM); identified the randomized controlled trials (RCTs) and applied Revman 4.11 for statistical analyses. Results Twenty-two RCTs were identified, involving MMF and AZA for anti-rejection after renal transplantation. The data shown that MMF (2 g/d) was more beneficial than AZA in improving the graft survival rate of short periods and the long-term patient survival rate, but there was no statistical differences between MMF (3 g/d) with AZA. Whether in 6 months or in 1 year after renal transplantation, the use of MMF (2 g/d) or MMF (3 g/d) could markedly reduce the incidence of biopsy-proven rejection. Conclusions Comparing with AZA, MMF is a more potent immunosuppressive drug, and more efficient in reducing the acute rejection after renal transplantation. MMF can improve the graft and patient survival rate. The 2 gram per day is more acceptable.
【摘要】 目的 采用循证医学的方法评价硫唑嘌呤（aiathioprine，AZA）治疗溃疡性结肠炎（ulcerative colitis，UC）的有效性和安全性。 方法 计算机检索PubMed、Cochrane library、Embase、CNKI、维普和CBM数据库收集国内外关于AZA诊疗UC的随机对照试验（ramdomized controllel trial，RCT）。按Cochrane系统评价的方法评价纳入研究质量，并进行Meta分析。 结果 共纳入5个RCT，共262例UC患者。Meta分析结果显示，AZA治疗UC在缓解率方面与安慰剂比较，差异无统计学意义[P=1.19，95%CI（0.94，1.49），P=0.14]；在复发率方面，两者比较差异有统计学意义[P=0.72，95%CI（0.54，0.95），P=0.02]；全部不良反应方面和严重不良反应方面，两者比较差异无统计学意义，Meta分析结果分别为[P=2.52，95%CI（0.82，7.74），P=0.11]和[P=4.03，95%CI（0.88，18.53），P=0.07]。 结论 系统评价结果为AZA在疗效方面优于安慰剂，在不良反应发生率方面差异无统计学意义。但由于纳入的5个研究中没有高质量的RCT，且有1个可能产生高度偏倚，使得这一结论受到影响，有必要开展更多设计严谨，大样本、多中心的RCT。【Abstract】 Objective To assess the efficacy and safety of azathio-prine in the treatment of ulcerative colitis through an evidence-based method. Methods We searched the literature from databases like PubMed, Cochrane library, CNKI, VIP, and CBM, and evaluated the quality of studies according to Cochrane systematic review. Finally, Meta-analysis was performed. Results Five randomized controlled trials (RCT) were included in this study with a total of 262 patients. Meta-analysis showed that there was no significant difference in the rate of remission between azathio-prine and placebo in treating ulcerative colitis [P=1.19, 95%CI (0.94, 1.49),P=0.14]. There was significant difference in the relapse rate between the two treating methods [P=0.72, 95%CI (0.54, 0.95),P=0.02]. In addition, there was no statistical difference in all adverse effects [P=2.52, 95%CI (0.82, 7.74),P=0.11] and serious adverse effects [P=4.03, 95%CI (0.88, 18.53),P=0.07] between the two treating methods. Conclusion In the treatment of ulcerative colitis, azathio-prine has a significant advantage in efficacy than placebo, but there is no significant difference in the rate of adverse events between the two groups. However, none of the 5 RCT included in this review has a high quality and one of them even probably has a high bias, which has a big influence on our conclusion. Consequently, multi-center large-scale randomized controlled trials of higher quality are needed to make confirmation.