Lum C T, Umen A J, Kasiske B, Goerdt P, Heim-Duthoy K L, Andersen R C, Odland M D, Ney A L, Jacobs D M, Rao K V
Department of Surgery, Hennepin County Medical Center, Minneapolis, Minnesota 55415-1829.
Transplantation. 1995 Feb 15;59(3):371-6.
In August 1992, we replaced Minnesota antilymphocyte globulin (MALG) with lymphocyte immune globulin, antithymocyte globulin (equine) (ATGAM) in our immunosuppression protocols. The clinical impression of increased graft rejection prompted our assessment of the effect of this change on patient and graft outcome. The initial study group consisted of 426 renal transplant recipients transplanted between October 1, 1987, and September 21, 1993. After exclusions, 388 transplant events, with a minimum 8-month follow-up, made up the final study cohort: 323 patients received MALG and 65 received ATGAM. Immunosuppression included intravenous methylprednisolone, oral prednisone, oral AZA, CsA in some cases, and intravenous MALG or ATGAM, 15 mg/kg/day, for 7 to 14 days. Acute rejection was treated with high dose intravenous steroids and steroid-resistant episodes were treated additionally with either MALG or OKT3. Statistical comparisons were stratified for multiple patient characteristics and treatment variations. There was a greater incidence of rejection in general, and a higher incidence of steroid-resistant episodes requiring subsequent antilymphocyte globulin therapy (P = 0.0073) in patients receiving ATGAM versus MALG. No difference was seen in the incidence of CMV infection or blood-borne sepsis. Lymphoma occurred in 3 MALG and 2 ATGAM recipients. MALG recipients were significantly less likely to experience rejection within the first 60 days after transplant (P = 0.0127 using unstratified data; P < 0.0001 when data were stratified for patient characteristics). The relative risk of acute rejection for posttransplant days 5, 7, 10, and 14 was consistently higher for ATGAM-treated patients. We conclude that MALG and ATGAM are not equivalent drugs, and that MALG is a more effective immunosuppressant, and is just as safe as ATGAM in our protocol environment.
1992年8月,我们在免疫抑制方案中用淋巴细胞免疫球蛋白、抗胸腺细胞球蛋白(马)(即复宁)取代了明尼苏达抗淋巴细胞球蛋白。移植排斥反应增加的临床印象促使我们评估这一变化对患者和移植结果的影响。初始研究组由1987年10月1日至1993年9月21日期间接受肾移植的426例患者组成。排除相关病例后,最终研究队列包括388例移植事件,随访时间至少8个月:323例患者接受了明尼苏达抗淋巴细胞球蛋白治疗,65例患者接受了抗胸腺细胞球蛋白(马)治疗。免疫抑制治疗包括静脉注射甲泼尼龙、口服泼尼松、口服硫唑嘌呤,部分病例使用环孢素,以及静脉注射明尼苏达抗淋巴细胞球蛋白或抗胸腺细胞球蛋白(马),剂量为15mg/kg/天,持续7至14天。急性排斥反应采用大剂量静脉注射类固醇治疗,对类固醇抵抗的病例则加用明尼苏达抗淋巴细胞球蛋白或OKT3进行治疗。统计比较根据多种患者特征和治疗差异进行分层。总体而言,接受抗胸腺细胞球蛋白(马)治疗的患者与接受明尼苏达抗淋巴细胞球蛋白治疗的患者相比,排斥反应发生率更高,需要后续抗淋巴细胞球蛋白治疗的类固醇抵抗性发作的发生率也更高(P = 0.0073)。巨细胞病毒感染或血行性败血症的发生率没有差异。淋巴瘤发生在3例接受明尼苏达抗淋巴细胞球蛋白治疗的患者和2例接受抗胸腺细胞球蛋白(马)治疗的患者中。接受明尼苏达抗淋巴细胞球蛋白治疗的患者在移植后前60天内发生排斥反应的可能性显著较低(未分层数据时P = 0.0127;根据患者特征分层数据时P < 0.0001)。在移植后第5、7、10和14天,接受抗胸腺细胞球蛋白(马)治疗的患者急性排斥反应的相对风险始终较高。我们得出结论,明尼苏达抗淋巴细胞球蛋白和抗胸腺细胞球蛋白(马)并非等效药物,在我们的方案环境中,明尼苏达抗淋巴细胞球蛋白是一种更有效的免疫抑制剂,并且与抗胸腺细胞球蛋白(马)一样安全。