Lorber M I, Fastenau J, Wilson D, DiCesare J, Hall M L
Department of Surgery, Yale University School of Medicine, New Haven, CT 06520-8062, USA.
Clin Transplant. 2000 Oct;14(5):479-85. doi: 10.1034/j.1399-0012.2000.140506.x.
Immunoprophylaxis with basiliximab (Simulect), an anti-interleukin-2-receptor (anti-IL-2R; CD25) chimeric monoclonal antibody, has been demonstrated to significantly reduce the incidence of acute cellular rejection in adult renal allograft recipients (32% vs. placebo, p < 0.01).
An economic evaluation was conducted as part of a U.S. multi-center, randomized, double-blind, placebo-controlled clinical trial comparing basiliximab plus dual immunosuppressive therapy (cyclosporine modified [Neoral] and corticosteroids) to dual therapy alone. Healthcare resources utilized by the 346 subjects in the 'intent-to-treat' population were prospectively collected over the 1-yr study period. Direct medical costs were determined for all hospitalizations, outpatient provider visits, procedures (excluding the initial transplant procedure), laboratory and diagnostic tests, and immunosuppressants, including basiliximab when administered.
Total first-year medical costs were lower for the basiliximab group than for the placebo group ($28 927 vs. $32 300, difference = $3373). although this difference was not statistically significant. First-year hospital costs for treating acute rejection were also lower for the basiliximab group ($9328 vs. $10761, difference = $1433); however, this difference did not achieve statistical significance. Importantly, the efficacy analysis demonstrated a significant reduction in the incidence of acute rejection (38 vs. 55%, p < 0.01) in the basiliximab arm, and this was accomplished without increasing the overall cost of care. Fewer basiliximab-treated patients (8 vs. 15%,, p = 0.03) were hospitalized. This observation suggested less serious illness and reduced treatment costs among basiliximab-treated patients, because the overall incidence of infection was similar between the groups. The adverse event profile of patients receiving basiliximab was clinically and economically indistinguishable from that of those treated with placebo.
Induction immunosuppression with basiliximab, combined with cyclosporine modified and corticosteroids, was therapeutically beneficial and contained medical costs during the initial post-transplant year.
巴利昔单抗（舒莱）是一种抗白细胞介素-2受体（抗IL-2R；CD25）嵌合单克隆抗体，免疫预防已被证明可显著降低成年肾移植受者急性细胞排斥反应的发生率（32%对安慰剂组，p<0.01）。
作为一项美国多中心、随机、双盲、安慰剂对照临床试验的一部分，进行了一项经济学评估，该试验比较了巴利昔单抗加双重免疫抑制治疗（环孢素改良剂[新山地明]和皮质类固醇）与单纯双重治疗。在为期1年的研究期间，前瞻性收集了“意向性治疗”人群中346名受试者使用的医疗资源。确定了所有住院、门诊就诊、手术（不包括初次移植手术）、实验室和诊断检查以及免疫抑制剂（包括使用巴利昔单抗时）的直接医疗费用。
巴利昔单抗组第一年的总医疗费用低于安慰剂组（28927美元对32300美元，差值=3373美元），尽管这一差异无统计学意义。巴利昔单抗组治疗急性排斥反应的第一年住院费用也较低（9,328美元对10,761美元，差值=1,433美元）；然而，这一差异未达到统计学意义。重要的是，疗效分析表明巴利昔单抗组急性排斥反应的发生率显著降低（38%对55%，p<0.01），并且在不增加总体护理成本的情况下实现了这一点。接受巴利昔单抗治疗的住院患者较少（8%对15%，p=0.03）。这一观察结果表明，接受巴利昔单抗治疗的患者病情较轻，治疗成本降低，因为两组之间的总体感染发生率相似。接受巴利昔单抗治疗的患者的不良事件谱在临床和经济方面与接受安慰剂治疗的患者无异。
巴利昔单抗联合环孢素改良剂和皮质类固醇进行诱导免疫抑制在移植后第一年具有治疗益处并控制了医疗费用。
