Weiner R S, Kramer B S, Clamon G H, Feld R, Evans W, Moran E M, Blum R, Weisenthal L M, Pee D, Hoffman F A
J Clin Oncol. 1985 Jul;3(7):949-57. doi: 10.1200/JCO.1985.3.7.949.
One hundred nineteen patients were entered onto a randomized trial of the role of intravenous hyperalimentation (IVH) in patients with small-cell lung cancer. IVH was given during the first 30 days of induction chemotherapy to 54 patients. IVH did not effect any improvement in response or survival from therapy. In view of the lack of benefits from IVH, an analysis was made of the toxicities suffered by the 54 patients receiving IVH as well as any effects IVH might have made on chemotherapy-induced toxicity. Toxicities observed included mechanical difficulties with the catheter leading to temporary or permanent discontinuation of the IVH (11 patients), subclavian vein thrombosis (one patient), sepsis in nine patients v none of the 62 control patients, fluid overload (27 patients), hyponatremia (25 patients), and hyperglycemia requiring insulin (13 patients). Patients receiving IVH had higher granulocyte counts on days 14 and 21 of the first cycle of chemotherapy. Analysis shows that this difference is likely caused by fever and infection associated with IVH rather than any nutritional effect on granulopoiesis. In this population of patients, IVH had significant complications but did not ameliorate chemotherapy-induced toxicity and it did not effect any clinical benefit. Future studies of adjunctive nutritional therapy must consider the significant risk in this older population and must limit IVH volume or exclude patients with even mild compromise in cardiovascular functions. Further, any new trial must have a significant rationale for adjunctive use to justify the potential risks.
119例患者参与了一项关于静脉高营养(IVH)在小细胞肺癌患者中作用的随机试验。在诱导化疗的前30天,对54例患者给予IVH。IVH并未使治疗反应或生存率得到任何改善。鉴于IVH缺乏益处,对接受IVH的54例患者所遭受的毒性以及IVH可能对化疗诱导的毒性产生的任何影响进行了分析。观察到的毒性包括导管相关的机械问题导致IVH暂时或永久中断(11例患者)、锁骨下静脉血栓形成(1例患者)、9例患者发生败血症而62例对照患者均未发生、液体超负荷(27例患者)、低钠血症(25例患者)以及需要胰岛素治疗的高血糖(13例患者)。接受IVH的患者在化疗第一周期的第14天和第21天粒细胞计数较高。分析表明,这种差异可能是由与IVH相关的发热和感染引起的,而不是对粒细胞生成的任何营养作用。在这群患者中,IVH有显著的并发症,但并未改善化疗诱导的毒性,也未产生任何临床益处。未来辅助营养治疗的研究必须考虑到这群老年患者的重大风险,必须限制IVH的量或排除心血管功能即使有轻微损害的患者。此外,任何新的试验必须有辅助使用的重要理论依据,以证明潜在风险是合理的。