霉酚酸类药物用于肾移植受者免疫抑制治疗的快速卫生技术评估

摘要/Abstract

摘要： 目的：评价霉酚酸（MPA）类药物在肾移植（KT）受者术后免疫抑制治疗中的有效性、安全性和经济性，为MPA合理用药提供参考。方法：系统检索PubMed、Cochrane Library、Embase及相关HTA网站，CNKI、万方和维普等数据库，由2名评价者根据纳入和排除标准独立筛选文献、提取资料和评价质量后，对结果进行定性分析。结果：纳入4篇系统评价/Meta分析和1篇经济学研究。在有效性和安全性方面：（1）基于钙调磷酸酶抑制剂（CNIs）治疗6或12个月后，与CNIs相比，吗替麦考酚酯(MMF)不增加排斥风险，可改善肾小球滤过率，但增加了贫血和腹泻的发生率。（2）与标准剂量相比，MPA类药物强化剂量可降低经活检证实的急性排斥反应和巨细胞病毒感染的发生率，其余指标间差异无统计学意义；基于MPA暴露调整剂量的MMF浓度控制（CC）组与固定剂量（FD）组相比疗效相当，但MMF CC组总体感染发生率较高。经济学研究显示，在法国KT受者术后第1年MMF CC组与FD组相比平均总费用无差异。结论：MMF对基于至少6个月CNIs免疫抑制治疗后的KT受者而言是一种有效的治疗方案。MPA类药物强化剂量应用于KT受者时有效性、安全性与标准剂量总体相当，但应结合敏感性分析结果与临床实际谨慎解读。基于调整剂量的MMF CC组与FD组有效性总体相当，但CC组的总体感染发生率较高，而两组间移植后第一年的平均总费用无显著差异。

关键词: font-size:medium, ">霉酚酸类药物；肾移植；有效性；安全性；经济性；快速卫生技术评估

Abstract: Objective：To evaluate the efficacy， safety and economy of mycophenolic acids（MPA） in immunosuppressive therapy for renal transplant recipients， and to provide evidence for rational clinical use of MPA. Methods：PubMed， Cochrane Library， Embase and related HTA websites，CNKI， Wanfang， VIP were systematically searched. Two evaluators independently screened the literature， extracted the data and evaluated the quality according to the inclusion and exclusion criteria， and then qualitatively analyzed the results. Results： 4 systematic reviews/Meta-analyses and 1 pharmacoeconomics study were included.For efficacy and safety， when compared with calcineurin inhibitors(CNIs) after 6 or 12 months of treatment with CNIs， mycophenolate mofetil(MMF) do not increase the risk of rejection and can improve glomerular filtration rate， but increase the incidence of anemia and diarrhea.Compared with the standard dose， the intensified dose of MPA reduce the risk of biopsy-proven acute rejection and CMV infection，with no significant differences in the rates of other adverse events. The concentration-controlled group based on MPA mofetil exposure has the same therapeutic effect as the fixed dose group， but the overall incidence of infection is higher in the concentration-controlled group.Pharmacoeconomics study has shown that there is no difference in the mean total cost between the concentration-controlled group and the fixed dose group at the first year for kidney transplant recipients in France. Conclusion：MMF is an effective immunosuppressive regimen for kidney transplant recipients based on the immunosuppressive therapy of CNIs for at least 6 months. The efficacy and safety MPA intensified dose in renal transplant recipients are generally comparable to standard dose， but it should be interpreted cautiously in combination with the results of sensitivity analysis and clinical practice. As for Efficacy， it is generally comparable between the concentration-controlled group and the fixed dose group， but the concentration-controlled group has a higher overall incidence of infection， and the mean total costs are not significantly different between the two groups in the first year.

Key words: font-size:medium, ">Mycophenolic acids；Kidney transplantation； Effectiveness； Safety； Economy； Rapid health technology assessment

中图分类号:

吕建琼, 宋沧桑, 李兴德, 毛盼盼, 张函舒, 王国徽. 霉酚酸类药物用于肾移植受者免疫抑制治疗的快速卫生技术评估[J]. 中国药物评价, 2022, 39(6): 515-519.

LV Jian-qiong, SONG Cang-sang , LI Xing-de, MAO Pan-pan , ZHANG Han-shu, WANG Guo-hui. Rapid Health Technology Assessment of Mycophenolic Acids for Immunosuppressive Therapy in Kidney Transplant Recipients[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2022, 39(6): 515-519.

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