脑瘤新型植入片Gliadel Wafer（卡莫司汀植入膜晶片）是获美国FDA批准Guilford公司研发，以BCNU为活性成分，聚苯丙生20为释放基质，制成植入药物芯片Gliadel，治疗复发性恶性脑瘤，可在手术后，将药物直接放置于复发性恶性胶质细胞瘤之脑组织中，让药物缓慢释放，进行持续性化学治疗。 该治疗方法的独特之处在于其给药方式及释放系统。在外科手术过程中，先将肿瘤组织切除，留下一个小空腔，然后植入这种定期释放的芯片。这些芯片会在2~3周之内慢慢地分解、融化，释放出的药物可直接进入肿瘤区，杀死那些在外科手术中没有切除干净的肿瘤细胞，并且能在不损害其它组织的情况下使病变局部能达到有效的血药浓度，延缓了疾病的进展。 最新批准日期：2014年  公司：Arbor Pharmaceuticals, LLC GLIADEL WAFER（卡莫司汀carmustine implant）植入物,用于颅内使用 初始美国批准：1996 作用机制 GLIADEL晶片的活性是由于细胞毒性浓度的卡莫司汀（一种DNA和RNA烷化剂）释放到肿瘤切除腔中。 在暴露于切除腔的水环境时，共聚物中的酸酐键被水解，将卡莫司汀，羧基苯氧基丙烷和癸二酸释放到周围的脑组织中。 适应症和用法 GLIADEL Wafer是一种烷基化药物，用于治疗： 新诊断的高级恶性胶质瘤作为手术和放射的辅助和 复发性多形性胶质母细胞瘤作为手术的辅助 剂量和给药 推荐剂量：8颗7.7mg晶片（61.6mg总剂量）颅内植入 按照准备和处理建议。 剂量形式和强度 每个GLIADEL片包含7.7mg的卡莫司汀。 禁忌症 无 警告和注意事项 癫痫：监测植入后癫痫发作的患者。 颅内高压：监测患者颅内压增加的迹象。 受损的神经外科伤口愈合：监测患者的开颅术并发症。 脑膜炎：监测患者细菌或化学脑膜炎的迹象。 晶片迁移：监测患者的阻塞性脑积水的迹象。 胚胎 - 胎儿毒性：可导致胎儿伤害 不良反应 新诊断的高级恶性胶质瘤：最常见的不良反应（发生率>10％，手臂差异≥4％）是脑水肿，虚弱，恶心，呕吐，便秘，伤口愈合异常和抑郁。 复发性高级恶性胶质瘤：最常见的不良反应（发生率>10％，手臂差异≥4％）是尿路感染，伤口愈合异常和发烧。 在特定人群中使用 儿童使用：没有建立安全和有效性 供应/存储和处理 GLIADEL晶圆在单剂量处理盒中供应，包含八个单独包装的晶片。 每片含有7.7mg卡莫司汀，并包装在两个铝箔层压袋中。 内袋是无菌的，并被设计成保持产品的无菌性并保护产品不受潮。 外袋是可剥离的外包装。 外袋的外表面不是无菌的。 单剂量治疗盒的NDC：24338-050-08 将GLIADEL晶片存放在-20ºC（-4ºF）或以下。 不要将未打开的铝箔袋在环境室温下一次放置超过六个小时，在30天的时间内最多三个循环。 GLIADEL晶片是一种细胞毒性药物，应考虑特殊的处理和处置程序. Eisai Inc. Divests U.S. Rights for GLIADEL® Wafer (polifeprosan 20 with carmustine implant) to Arbor Pharmaceuticals U.S. rights for Gliadel® Wafer (polifeprosan 20 with carmustine implant) to specialty pharmaceutical company Arbor Pharmaceuticals, Inc.  As part of the transaction, which takes effect immediately, Eisai has transferred the New Drug Application (NDA) for Gliadel to Arbor. About GLIADEL® Wafer (polifeprosan 20 with carmustine implant) GLIADEL® Wafer is indicated in patients with newly diagnosed high-grade malignant glioma as an adjunct to surgery and radiation. GLIADEL Wafer is also indicated in patients with recurrent glioblastoma multiforme as an adjunct to surgery. Important Safety Information for GLIADEL® Wafer (polifeprosan 20 with carmustine implant) GLIADEL® Wafer (polifeprosan 20 with carmustine implant) should not be given to patients who have demonstrated a previous hypersensitivity to carmustine or any of the components of GLIADEL Wafer. Patients undergoing craniotomy for malignant glioma and implantation of GLIADEL Wafer should be monitored closely for known complications of craniotomy, including seizures, intracranial infections, abnormal wound healing, and brain edema.  Cases of intracerebral mass effect unresponsive to corticosteroids have been described in patients treated with GLIADEL Wafer, including one case leading to brain herniation. Carmustine, the active component of GLIADEL Wafer, can cause fetal harm when administered to a pregnant woman.  It is recommended that patients receiving GLIADEL Wafer discontinue nursing. Communication between the surgical resection cavity and the ventricular system should be avoided to prevent the wafers from migrating into the ventricular system and causing obstructive hydrocephalus.  If a communication larger than the diameter of a wafer exists, it should be closed prior to wafer implantation. CT and MRI of the head may demonstrate enhancement in the brain tissue surrounding the resection cavity after implantation of GLIADEL Wafer.  This enhancement may represent edema and inflammation caused by GLIADEL Wafer or tumor progression. The short-term and long-term toxicity profiles of GLIADEL Wafer when given in conjunction with chemotherapy have not been fully explored. The following four categories of adverse events are possibly related to treatment with GLIADEL® Wafer (polifeprosan 20 with carmustine implant): •Seizures: In the initial surgery trial, the incidence of seizures was 33.3% in patients receiving GLIADEL Wafer and 37.5% in patients receiving placebo.  Grand mal seizures occurred in 5% of GLIADEL Wafer–treated patients and 4.2% of placebo-treated patients. The incidence of seizures within the first 5 days after wafer implantation was 2.5% in the GLIADEL Wafer group and 4.2% in the placebo group. In the surgery for recurrent disease trial, the incidence of post-operative seizures was 19% in both patients receiving GLIADEL Wafer and placebo.  In this study, 12/22 (54%) of patients treated with GLIADEL Wafer and 2/22 (9%) of placebo patients experienced the first new or worsened seizure within the first 5 post-operative days.  The median time to onset of the first new or worsened post-operative seizure was 3.5 days in patients treated with GLIADEL Wafer and 61 days in placebo patients.  •Brain Edema: In the initial surgery trial, brain edema was noted in 22.5% of patients treated with GLIADEL Wafer and in 19.2% of patients treated with placebo.  Development of brain edema with mass effect (due to tumor recurrences, intracranial infection, or necrosis) may necessitate re-operation and, in some cases, removal of GLIADEL Wafer or its remnants. •Healing Abnormalities: The following healing abnormalities have been reported in GLIADEL Wafer clinical trials: wound dehiscence, delayed wound healing, subdural, subgaleal or wound effusions, and cerebrospinal fluid leak. In the initial surgery trial, healing abnormalities occurred in 15.8% of GLIADEL Wafer-treated patients and in 11.7% of placebo recipients. Cerebrospinal fluid leaks occurred in 5% of GLIADEL Wafer recipients and 0.8% of those given placebo. During surgery, a water-tight dural closure should be obtained to minimize the risk of cerebrospinal fluid leak. In the surgery for recurrent disease trial, the incidence of healing abnormalities was 14% in GLIADEL Wafer-treated patients and 5% in patients receiving placebo wafers.  •Intracranial Infection: In the initial surgery trial, the incidence of brain abscess or meningitis was 5% in patients treated with GLIADEL Wafer and 6% in patients receiving placebo.  In the recurrent setting, the incidence of brain abscess or meningitis was 4% in GLIADEL Wafer patients and 1% in patients receiving placebo. 完整处方资料附件： https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38962a55-a514-4c48-bea5-f99a8da4beec 胶质瘤患者的新药－Gliadel Wafer（卡莫司汀植入膜晶片） ​成人原发恶性脑肿瘤患者中，约70％为恶性胶质瘤，其致残率和致死率很高。即便接受了最佳治疗，胶质母细胞瘤患者（WHO世界卫生组织分级4级）的平均生存期也只有12-15个月，间变型胶质瘤患者（WHO分级3级）平均生存期2－5年。胶质瘤的治疗是手术，放疗和化疗为主的综合治疗。手术主张最大安全切除肿瘤，术后两周开始放疗和同步化疗。肿瘤细胞15天即可完成1个分裂周期，因此术后2周放疗，残留肿瘤可能倍增，影响后续放疗和化疗效果。如果提前放疗，会影响伤口愈合。而化疗药物不易通过血脑屏障，效果差。大多数胶质瘤在原发部位的2－3cm范围内复发，因此局部化疗药物引起重视。美国霍普金斯大学的Brem研究组用卡莫司汀（BCNU）缓释剂植入手术残腔治疗胶质瘤，填补了术后至放疗开始的2周空档期，可提高治疗胶质瘤的疗效。经美国FDA和加拿大等发达国家批准上市，为胶质瘤患者治疗带来了福音。治疗过的唯一生存期超过5年的胶质母细胞瘤患者术中就使用了Gliadel Wafer目前仍生存。