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首页> 美国卫生研究院文献>BMJ Open Access >Comparison of a powered bone marrow biopsy device with a manual system: results of a prospective randomised controlled trial
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Comparison of a powered bone marrow biopsy device with a manual system: results of a prospective randomised controlled trial

机译：动力骨髓活检设备与手动系统的比较：一项前瞻性随机对照试验的结果

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The diagnostic and clinical usefulness of a powered bone marrow biopsy device (OnControl()) versus a standard manual device (TRAP Hospital System) was studied. Primary endpoints were biopsy quality and patient pain during the procedure. Fifty patients underwent a total of 60 procedures by three expert operators in a randomised stratified fashion. Baseline demographic and clinical parameters were similar in both groups. The usage of conscious sedation, dosage of lidocaine/pethidin was similar between groups. Biopsy quality was rated ‘sufficient for diagnosis’ in 24/30 in the control group and 25/30 in the powered group (p=0.74). Biopsy cylinder length, procedure time (from skin contact of the biopsy needle to placement of the biopsy cylinder in the formalin container) and patient reported pain during the procedure (T1), 15 min after the procedure (T2) and 3–5 days after the procedure (T3) there were comparable between groups. In the small subgroup of patients that did not receive conscious sedation (n=15; manual 6, powered 9) significantly lower median pain scores were observed with the powered system (median pain score 3 vs 7; p=0.015). Patients were satisfied with either device whether sedation was used (sedation: median 9 for both groups, range 3–10 (manual) and 0–10 (powered)) no sedation (median 8 (manual) vs 9 (powered)). In summary bone marrow biopsies taken with the manual or powered device produce similar technical and clinical results. If no conscious sedation is used, pain during the procedure appears to be lower with the powered system. The use of a powered system seems to be justified in selected patients.
机译：研究了动力骨髓活检设备（OnControl（））与标准手动设备（TRAP Hospital System）的诊断和临床意义。主要终点是活检质量和手术过程中的患者疼痛。 50名患者由三位专家操作员以随机分层方式进行了总共60例手术。两组的基线人口统计学和临床​​参数相似。两组之间清醒镇静的用法，利多卡因/比妥丁的剂量相似。对照组的活检质量在24/30中被评为“足以诊断”，而动力治疗组的活检质量被评为25/30（p = 0.74）。活检筒长度，手术时间（从活检针的皮肤接触到将活检筒放置在福尔马林容器中）以及患者在手术期间（T1），手术后15分钟（T2）和术后3-5天报告疼痛程序（T3）在各组之间具有可比性。在没有进行镇静镇静的小亚组患者中（n = 15；手册6，功能强大的9），使用动力系统观察到的中位疼痛评分明显降低（中位疼痛评分3比7； p = 0.015）。无论使用镇静剂，患者都对这两种设备感到满意（镇静：两组的中位数为9，范围3-10（手动）和0-10（电动））不镇静（中位数8（手动）与9（电动））。总之，用手动或动力装置进行的骨髓活检产生相似的技术和临床结果。如果不使用有意识的镇静剂，则电动系统在手术过程中的疼痛感会减轻。在选定的患者中使用动力系统似乎是合理的。

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