Department of Hematology, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, 510000, China.
Support Care Cancer. 2018 Sep;26(9):2995-3002. doi: 10.1007/s00520-018-4142-0. Epub 2018 Mar 15.
This randomized, open-label trial was conducted to investigate the optimal duration of bed rest after intrathecal chemotherapy to reduce the incidence of complications without increasing patients' tolerance to long-term bed rest.
A total of 390 patients receiving intrathecal chemotherapy were randomly assigned 1:1:1 to undergo bed rest for 6, 8, or 10 h after intrathecal chemotherapy. The primary outcome was the rate of complications after intrathecal chemotherapy. The analysis was per protocol.
A total of 359 patients among the 390 patients in our study completed follow-up with 120 patients in the 6-h group, 120 in the 8-h group, and 119 in the 10-h group. The complications among the three groups differed significantly (P = 0.005). The 6-h group had significantly more complications than the 8- (50, 41.7% vs 29, 24.2%, P = 0.004) and 10-h groups (50, 41.7% vs 31, 26.1%, P = 0.011), whereas the difference between the 8- and 10-h groups was not significant (29, 24.2% vs 31, 26.1%, P = 0.737).
The overall results support that the optimal time interval for bed rest in the supine position after intrathecal chemotherapy is 8 h. This trial is registered with the Chinese Clinical Trial Registry (number ChiCTR-IOR-17011671).
本随机、开放标签试验旨在研究鞘内化疗后卧床休息的最佳时间,以降低并发症发生率,同时不增加患者对长期卧床休息的耐受度。
共 390 例接受鞘内化疗的患者按 1:1:1 随机分为三组,分别在鞘内化疗后卧床休息 6、8 或 10 小时。主要结局为鞘内化疗后并发症发生率。分析采用意向性治疗原则。
本研究共 390 例患者中的 359 例完成了随访,其中 6 小时组 120 例,8 小时组 120 例,10 小时组 119 例。三组的并发症发生率差异有统计学意义(P=0.005)。6 小时组的并发症发生率显著高于 8 小时组(50,41.7% vs. 29,24.2%,P=0.004)和 10 小时组(50,41.7% vs. 31,26.1%,P=0.011),而 8 小时组和 10 小时组之间的差异无统计学意义(29,24.2% vs. 31,26.1%,P=0.737)。
总体结果支持鞘内化疗后仰卧位卧床休息的最佳时间间隔为 8 小时。本试验在中国临床试验注册中心注册(注册号 ChiCTR-IOR-17011671)。