Patel Nishal, Roe Adrian, Stanton Donna, Roberts Jay, Kothari Akshay
Department of Urology, The Prince Charles Hospital, Brisbane, Queensland, Australia.
Faculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia.
Adv Urol. 2024 Mar 26;2024:7870425. doi: 10.1155/2024/7870425. eCollection 2024.
We conducted a prospective randomised control trial. Included patients were males and females greater than 18 years of age with single or multiple ipsilateral renal calculi of total ≤10 mm on plain X-ray and noncontrast CT KUB. ESWL was performed at a single centre, at supine position under general anaesthesia with maximum 3000 shocks at a rate of 100 shocks per minute. Patients were discharged and randomised to either the control arm or MPI therapy. MPI therapy was self-directed in a home setting for 10 minutes a day, three times per week. Both arms had standard follow-up at 12 weeks with a plain X-ray KUB. Patients in the control group were offered cross over to the MPI arm after 12 weeks if residual stone fragments were detected. Statistical analysis was performed using SPSS software via Chi squared and Fisher's exact tests. Ethical approval was obtained via the Prince Charles Hospital HREC Committee, HREC/2022/QPCH/84961.
70 patients met inclusion criteria and underwent ESWL, and 5 were withdrawn. 33 patients were randomised to the MPI group and 32 to the control group. MPI significantly increased the stone clearance rate anywhere in the kidney (87.9% in the MPI group versus 59.4% in the control group, =0.089), as well as the clearance rate in the lower pole (91.7% in the MPI group versus 63.2% in the control group, =0.022). Delayed percussion did not improve the clearance rate over primary percussion (=0.835).
This study has shown that MPI can be effectively performed in a home setting without the need for medical supervision and results in improved stone clearance rates post ESWL. The main limitations to the study were the use of X-ray over CT during the follow-up and variability in MPI compliance and administration. Further research is warranted into standardising home MPI protocols. This trial is registered with ANZCTR387061.
我们进行了一项前瞻性随机对照试验。纳入的患者为年龄大于18岁的男性和女性，其在X线平片和非增强CT KUB上显示同侧单个或多个肾结石，总直径≤10毫米。体外冲击波碎石术（ESWL）在单一中心进行，患者在全身麻醉下仰卧位接受治疗，最大冲击次数为3000次，每分钟冲击速率为100次。患者出院后被随机分为对照组或多脉冲干预（MPI）治疗组。MPI治疗在家庭环境中自行进行，每天10分钟，每周三次。两组均在12周时进行标准的X线KUB随访。如果在对照组患者中检测到残留结石碎片，12周后可转至MPI治疗组。使用SPSS软件通过卡方检验和Fisher精确检验进行统计分析。本研究通过查尔斯王子医院人类研究伦理委员会（HREC/2022/QPCH/84961）获得伦理批准。
70例患者符合纳入标准并接受了ESWL治疗，5例退出研究。33例患者被随机分配至MPI组，32例被分配至对照组。MPI显著提高了肾脏任何部位的结石清除率（MPI组为87.9%，对照组为59.4%，P = 0.089），以及下极的结石清除率（MPI组为91.7%，对照组为63.2%，P = 0.022）。延迟冲击与初次冲击相比，并未提高结石清除率（P = 0.835）。
本研究表明，MPI可在无需医疗监督的家庭环境中有效进行，并能提高ESWL后的结石清除率。本研究的主要局限性在于随访期间使用X线而非CT，以及MPI依从性和实施的变异性。有必要进一步研究以规范家庭MPI方案。本试验已在澳大利亚和新西兰临床试验注册中心（ANZCTR387061）注册。
