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目的评价肾移植术后从新三联免疫抑制方案中撤出激素的安全性和有效性。方法计算机检索MEDLINE(1966～2005.9)、OVID(1966～2004)、EMBASE(1984～2004)、Cochrane图书馆(2005年第4期)、中国生物医学文献数据库(1990～2005.9)。手工检索《中华器官移植杂志》(1995～2005)等7种中文杂志。纳入肾移植术后环孢A(CsA)/他克莫司(Tac)+霉酚酸酯(MMF)+激素(新三联)方案中激素撤出的随机对照试验(RCT):包括激素撤出组与持续应用激素的对照组。纳入研究的方法学质量按CochraneReviewer’sHandbook4.2.5随机对照试验的质量标准评价。统计分析采用RevMan4.2.7版软件。结果共纳入9个RCT,1681例受者(SW/SC:845/836),随访时间6～12个月。在CsA/Tac+MMF+激素治疗方案中,CsA和Tac对急性、慢性排斥的发生、病人和移植物存活率的影响均无统计学差异,Meta分析显示:①试验组急性排斥发生率比对照组约高2倍,主要为BanffⅠ级。②移植物、病人存活率和慢性排斥发生率两组均无统计学差异。③激素撤出可以降低泌尿系、单纯疱疹病毒和念珠菌机会性感染的发生频次;巨细胞病毒和败血症感染两组发生频次比较均无统计学差异。结论在肾移植术后3个月内从新三联免疫抑制剂方案中撤出激素:①会增加BanffⅠ级急性排斥发生率,但对中、重度急性排斥发生率无影响;②激素撤出不影响移植物、病人存活率和慢性排斥发生率;③可降低机会性感染和泌尿系感染发生频次,但不影响CMV感染和败血症的发生频次。为预防严重感染,在足量免疫抑制剂治疗方案中撤出激素值得考虑,临床医生可权衡利弊,个体化用药。
Objective To evaluate the safety and efficacy of hormone withdrawal from neo-triple immunosuppressive regimen after renal transplantation. Methods The data of MEDLINE (1966 ~ 2005.9), OVID (1966 ~ 2004), EMBASE (1984 ~ 2004), Cochrane Library (2005) and Chinese Biomedical Literature Database (1990 ~ 2005.9) were searched by computer. Hand-searched “Chinese Organ Transplant Magazine” (1995 ~ 2005) and other 7 kinds of Chinese magazines. Included randomized controlled trials (RCTs) of hormone withdrawal in CsA / Tac + MMF + hormone (neo-triplet) regimen after renal transplantation: including hormone withdrawal Group and continued application of hormones in the control group. The quality of the methodology included in the study was assessed according to the quality standards of the Cochrane Reviewer’s Handbook 4.2.5 randomized controlled trial. Statistical analysis using RevMan4.2.7 version of the software. Results Nine RCTs and 1681 recipients (SW / SC: 845/836) were enrolled in this study. The follow-up time ranged from 6 to 12 months. In the CsA / Tac + MMF + hormone therapy regimen, the effects of CsA and Tac on acute and chronic rejection, patient and graft survival had no statistical significance. Meta analysis showed that: ①The incidence of acute rejection in the experimental group was significantly higher than that in the control group About 2 times higher, mainly Banff Ⅰ level. ② graft, patient survival and chronic rejection rates were no significant difference between the two groups. ③ hormone withdrawal can reduce the incidence of opportunistic infections urinary tract, herpes simplex virus and Candida; cytomegalovirus and sepsis infection frequency of occurrence of the two groups were no significant difference. Conclusion The withdrawal of hormones from the new triple immunosuppressant regimen within 3 months after kidney transplantation: (1) increased the incidence of acute rejection of Banff class I, but had no effect on the incidence of moderate and severe acute rejection; (2) withdrawal of hormones did not affect the transplantation The survival rate of patients and the incidence of chronic rejection; ③ can reduce the frequency of opportunistic infections and urinary tract infections, but does not affect the frequency of CMV infection and sepsis. In order to prevent serious infection, withdrawal of hormones in adequate immunosuppressant regimens is worth considering and clinicians can weigh the pros and cons and individualize their use.