Långström Satu, Huurre Anu, Kari Juho, Lohi Olli, Sievänen Harri, Palmu Sauli
Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, Helsinki University Hospital, New Children's Hospital, Helsinki, Finland.
Department of Pediatric Hematology and Oncology, Turku University Hospital, Turku, Finland.
Sci Rep. 2022 Apr 26;12(1):6799. doi: 10.1038/s41598-022-10915-4.
In this prospective single-arm study of 50 pediatric patients with acute lymphoblastic leukemia (ALL), we evaluated the clinical performance of a novel bioimpedance spinal needle system in 152 intrathecal treatment lumbar punctures (LP) of these patients. The system detects in real-time when the needle tip reaches the cerebrospinal fluid (CSF) in the spinal canal. The success was defined as getting a CSF sample and/or administering the intrathecal treatment with one needle insertion. Incidence of traumatic LP (TLP) was defined as ≥ 10 erythrocytes/µL of CSF. Post-procedural complications were monitored with a one-week diary and one-month register follow-up. The success of the first attempt was 79.5%, with the CSF detection sensitivity of 86.1%. The incidence of TLP was 17.3%. A successful first attempt was associated with a significantly lower incidence of TLP (10% vs 40%, p = 0.0015). During the week after the procedure, the incidence of post-dural puncture headache was 6%. During the follow-up, no major complications were observed. In conclusion, the novel bioimpedance spinal needle system achieved a high success rate and low incidence of TLP and other complications in pediatric patients with ALL in a real-world clinical setting, indicating clinical utility for this system in pediatric hemato-oncology.
在这项针对50例急性淋巴细胞白血病(ALL)患儿的前瞻性单臂研究中,我们评估了一种新型生物阻抗脊髓穿刺针系统在这些患者152次鞘内治疗腰椎穿刺(LP)中的临床性能。该系统可实时检测针尖何时到达椎管内的脑脊液(CSF)。成功定义为一次进针获取脑脊液样本和/或进行鞘内治疗。创伤性腰椎穿刺(TLP)的发生率定义为脑脊液中红细胞≥10个/微升。术后并发症通过为期一周的日记和为期一个月的登记随访进行监测。首次尝试的成功率为79.5%,脑脊液检测灵敏度为86.1%。TLP的发生率为17.3%。首次尝试成功与TLP的发生率显著降低相关(10%对40%,p = 0.0015)。在术后一周内,硬膜穿刺后头痛的发生率为6%。在随访期间,未观察到重大并发症。总之,在真实临床环境中,新型生物阻抗脊髓穿刺针系统在ALL患儿中取得了高成功率以及低TLP和其他并发症发生率,表明该系统在儿科血液肿瘤学中具有临床应用价值。