首页> 外文期刊>The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation >Induction therapy in lung transplantation: a prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab.
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Induction therapy in lung transplantation: a prospective, controlled clinical trial comparing OKT3, anti-thymocyte globulin, and daclizumab.

机译:肺移植中的诱导治疗:一项比较OKT3,抗胸腺细胞球蛋白和daclizumab的前瞻性对照临床试验。

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BACKGROUND: Because acute rejection is associated with inferior outcomes in lung transplantation, we have routinely employed OKT3, anti-thymocyte globulin (ATG), or daclizumab as adjuncts to reduce rejection. METHOD: We performed a 4-year prospective, controlled clinical trial of these 3 therapies to determine differences in post-operative infection, rejection, survival, and bronchiolitis obliterans syndrome (BOS). Eighty-seven consecutive lung transplant patients received OKT3 (n = 30), ATG (n = 34), and daclizumab (n = 23) as induction agents. The groups had similar demographics and immunosuppression protocols differing only in induction agents used. RESULTS: No differences were observed in immediate post-operative outcomes such as length of hospitalization, ICU stay, or time on ventilators. Twelve months post-transplant, OKT3 had more infections per patient than the other agents, a difference that only became significant 2 months post-operatively (p = 0.009). The most common infection was bacterial and OKT3 had more bacterial infections than any other agent. Daclizumab had more patients remain infection free in the first year (p = 0.02), having no fungal infections and a low rate of viral infections. No patient receiving daclizumab developed drug specific side-effects. Only those patients with episodes of acute rejection developed BOS. There were no significant differences in the freedom from acute rejection or BOS between the groups. The 2-year survival for the entire cohort was 68%, with no differences observed in patient survival. CONCLUSIONS: This study again reveals the importance of acute rejection in the subsequent development of BOS. Although daclizumab offers a low risk of post-transplant infection and drug specific side-effects, no drug is superior in delaying rejection or BOS or in prolonging long-term survival.
机译:背景:由于急性排斥反应与肺移植效果差有关,因此我们常规使用OKT3,抗胸腺细胞球蛋白(ATG)或达克珠单抗作为辅助药物以减少排斥反应。方法:我们对这3种疗法进行了为期4年的前瞻性对照临床试验,以确定术后感染,排斥反应,生存率和闭塞性细支气管炎综合征(BOS)的差异。连续八十七例肺移植患者接受了OKT3(n = 30),ATG(n = 34)和daclizumab(n = 23)作为诱导剂。这些组的人口统计学和免疫抑制方案相似,只是所用的诱导剂不同。结果:术后即刻住院时间,ICU停留时间或呼吸机时间等未观察到差异。移植后12个月,OKT3每位患者的感染率高于其他药物,这种差异仅在术后2个月才变得很明显(p = 0.009)。最常见的感染是细菌,OKT3的细菌感染比任何其他病原体都多。达克珠单抗在第一年中有更多的患者保持无感染(p = 0.02),无真菌感染且病毒感染率低。没有接受达珠单抗治疗的患者出现药物特异性副作用。只有那些发生急性排斥反应的患者才会出现BOS。两组之间急性排斥或BOS的自由度无显着差异。整个队列的2年生存率为68%,患者生存率无差异。结论:本研究再次揭示了急性排斥反应在随后的BOS发生中的重要性。尽管达克珠单抗的移植后感染和药物特异性副作用的风险较低,但在延迟排斥反应或BOS或延长长期生存方面,没有哪种药物具有优势。

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