Liu Meifang, Sheng Hongqin, Huang Jiahui, Xuan Meiling, Ouyang Wenwei, Zhang Yanmei, Zhou Shuzhen, Zeng Lu, Fu Lizhe, Chen Yin, Huang Xinyi, Huang Kaiqi, Wu Yifan, Liu Xusheng, Zhang Lei
State Key Laboratory of Dampness Syndrome of Chinese Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Nephrology Department, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Ann Transl Med. 2022 Jun;10(12):688. doi: 10.21037/atm-22-2376.
Respiratory tract infection (RTI) is associated with a higher risk of kidney failure in patients with chronic kidney disease (CKD), without effective precautions. Self-administered acupressure (SAA) has been shown to potentially prevent RTI, but still lack of clinical evidence in CKD. The present randomized controlled trial assessed the efficacy and safety of SAA in preventing RTI recurrence in patients with CKD.
Participants with CKD who had been diagnosed with RTI on more than 2 occasions in the preceding 12 months were enrolled between November 6, 2017, and August, 6, 2018. They were randomly assigned (1:1) to receive daily SAA combined with usual care (intervention) or usual care alone (control) for 24 months. The primary outcome was time to first RTI. Secondary outcomes were RTI rate, kidney function, proteinuria and serum immune indicators, detected by the clinical laboratory in the hospital. The study would be discontinued if the participant met the criteria of stopping the study. Kaplan-Meier method and multivariable Cox proportional hazards regression were used to compare the primary outcome between the two groups.
Among the 540 patients screened, 114 participants were randomly assigned to the intervention group (n=57) or the control group (n=57). The median follow-up duration was 24.4 months. Compared with controls, participants in the intervention group did not have a significantly lower risk of RTI according to Kaplan-Meier analysis, but did have a significantly lower risk of RTI according to competing risk analysis (HR 0.65, 95% CI: 0.42-1.00; P=0.05), when considering endpoint (dialysis or death) and loss to follow-up as competing risks, and had a significantly lower rate of RTI [1.65 2.19 episodes per patient-year, respectively; incidence rate ratio (IRR) 0.75, 95% CI: 0.62-0.92; P=0.006]. Apart from lower study serum IgG levels in the intervention group at 24 months (mean difference 0.68 g/L; 95% CI: 0.07-1.29; P=0.029), all other secondary outcomes and overall adverse events were comparable between the 2 groups.
SAA is a promising effective and safe therapy for preventing RTI in patients with CKD. However, the efficacy of SAA in children and adolescents still needs further study.
Chinese Clinical Trials Registry identifier: ChiCTR-IOR-17012654.
呼吸道感染（RTI）与慢性肾脏病（CKD）患者发生肾衰竭的较高风险相关，且尚无有效的预防措施。自我实施穴位按压（SAA）已被证明可能预防RTI，但在CKD患者中仍缺乏临床证据。本随机对照试验评估了SAA预防CKD患者RTI复发的疗效和安全性。
纳入在2017年11月6日至2018年8月6日期间，既往12个月内有2次以上RTI诊断的CKD患者。他们被随机分配（1:1）接受每日SAA联合常规护理（干预组）或仅接受常规护理（对照组），为期24个月。主要结局是首次发生RTI的时间。次要结局包括RTI发生率、肾功能、蛋白尿和血清免疫指标，由医院临床实验室检测。如果参与者符合停止研究的标准，研究将终止。采用Kaplan-Meier法和多变量Cox比例风险回归比较两组的主要结局。
在540例筛查患者中，114例参与者被随机分配至干预组（n = 57）或对照组（n = 57）。中位随访时间为24.4个月。根据Kaplan-Meier分析，干预组参与者的RTI风险与对照组相比无显著降低，但在将终点事件（透析或死亡）和失访视为竞争风险进行竞争风险分析时，干预组参与者的RTI风险显著降低（风险比0.65，95%置信区间：0.42 - 1.00；P = 0.05），且RTI发生率显著更低[分别为每人年1.65次对2.19次；发病率比（IRR）0.75，95%置信区间：0.62 - 0.92；P = 0.006]。除干预组在24个月时血清IgG水平较低（平均差异0.68 g/L；95%置信区间：0.07 - 1.29；P = 0.029）外，两组间所有其他次要结局和总体不良事件具有可比性。
SAA是预防CKD患者RTI的一种有前景的有效且安全的治疗方法。然而，SAA在儿童和青少年中的疗效仍需进一步研究。
中国临床试验注册中心标识符：ChiCTR-IOR-17012654。
