Department of Ultrasound in Medicine, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Institute of Ultrasound in Medicine, Yishan Road 600, Shanghai, 200233, China.
Department of Cardiovascular Surgery, The Affiliated Hospital of Qingdao University, Wutaishan Road 1677, Qingdao, 266555, China.
Trials. 2023 Jun 9;24(1):389. doi: 10.1186/s13063-023-07382-1.
Viral pneumonia has always been a problem faced by clinicians because of its insidious onset, strong infectivity, and lack of effective drugs. Patients with advanced age or underlying diseases may experience more severe symptoms and are prone to severe ventilation dysfunction. Reducing pulmonary inflammation and improving clinical symptoms is the focus of current treatment. Low-intensity pulsed ultrasound (LIPUS) can mitigate inflammation and inhibit edema formation. We aimed to investigate the efficacy of therapeutic LIPUS in improving lung inflammation in hospitalized patients with viral pneumonia.
Sixty eligible participants with clinically confirmed viral pneumonia will be assigned to either (1) intervention group (LIPUS stimulus), (2) control group (null stimulus), or (3) self-control group (LIPUS stimulated areas versus non-stimulated areas). The primary outcome will be the difference in the extent of absorption and dissipation of lung inflammation on computed tomography. Secondary outcomes include changes in lung inflammation on ultrasonography images, pulmonary function, blood gas analysis, fingertip arterial oxygen saturation, serum inflammatory factor levels, the sputum excretion volume, time to the disappearance of pulmonary rales, pneumonia status score, and course of pneumonia. Adverse events will be recorded.
This study is the first clinical study of the efficacy of therapeutic LIPUS in the treatment of viral pneumonia. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, LIPUS, as a new therapy method, might be a major advance in the treatment of viral pneumonia.
ChiCTR2200059550 Chinese Clinical Trial Registry, May 3, 2022.
病毒性肺炎一直是临床医生面临的问题，因为其发病隐匿、传染性强、缺乏有效药物。高龄或合并基础疾病患者可能症状较重，易发生严重通气功能障碍。减轻肺部炎症、改善临床症状是目前治疗的重点。低强度脉冲超声（LIPUS）可减轻炎症、抑制水肿形成。我们旨在研究治疗性 LIPUS 改善住院病毒性肺炎患者肺部炎症的疗效。
将 60 例符合临床标准的病毒性肺炎患者纳入研究，按 1∶1∶1 随机分为干预组（LIPUS 刺激）、对照组（空白刺激）和自身对照组（LIPUS 刺激区与非刺激区）。主要结局为肺部炎症 CT 吸收消散程度的差异。次要结局包括肺部炎症超声图像、肺功能、血气分析、指脉搏氧饱和度、血清炎症因子水平、痰液排出量、肺部啰音消失时间、肺炎状态评分和肺炎病程的变化。记录不良事件。
这是首个关于治疗性 LIPUS 治疗病毒性肺炎疗效的临床研究。鉴于目前临床康复主要依赖于机体的自限性和常规对症治疗，LIPUS 作为一种新的治疗方法，可能是病毒性肺炎治疗的一大进展。
中国临床试验注册中心，ChiCTR2200059550，2022 年 5 月 3 日。
