Yin Gang, Li Na, Xu Dan, Meng Zhen, Zheng Shuyun, Chen Ying
Department of Blood Transfusion, Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Hospital), Qingdao 266000, China.
Intensive Care Medicine Department, Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Hospital), Qingdao 266000, China.
Noise Health. 2024;26(123):577-583. doi: 10.4103/nah.nah_111_24. Epub 2024 Dec 30.
Evaluate the effect of white noise intervention on sleep quality and immunological indicators of patients with breast cancer undergoing neoadjuvant chemotherapy (NAC).
From January 2020 to December 2022, 104 newly diagnosed female patients (the number of people who met the inclusion criteria) with breast cancer who were confirmed to be preoperative NAC by puncture pathology were selected for a randomised single-blind trial. The patients were randomly divided into an observation group and a control group, with 52 cases in each group. The control group of patients received routine NAC treatment. The observation group played white noise at regular intervals every night on the basis of routine NAC, covering the entire treatment cycle. We evaluated the clinical efficacy, safety, sleep quality and immunological indicators of the two groups.
We found no statistically significant difference in the objective response rate between the two groups (P > 0.05). There was no statistically significant difference in the incidence of safety events between the two groups (P > 0.05). The total incidence of adverse reactions in the observation group was significantly lower than that in the control group (P < 0.05). After intervention, the sleep latency, subjective sleep quality, sleep duration, daytime function and sleep disorder scores of both groups decreased, and the observation group had significantly lower scores than the control group (P < 0.05). After intervention, both groups showed changes in immunoglobulin A (IgA), immunoglobulin G (IgG), immunoglobulin M (IgM), C-reactive protein and serum interleukin-6, but the differences between the groups were not statistically significant (P > 0.05).
White noise intervention can improve the sleep quality of the NAC population with breast cancer and reduce the incidence of adverse reactions. In addition, it has no effect on the treatment efficacy, safety and immune indicators of patients.
评估白噪音干预对接受新辅助化疗（NAC）的乳腺癌患者睡眠质量和免疫指标的影响。
选取2020年1月至2022年12月期间，经穿刺病理确诊为术前NAC的104例新诊断乳腺癌女性患者（符合纳入标准人数），进行随机单盲试验。患者随机分为观察组和对照组，每组52例。对照组患者接受常规NAC治疗。观察组患者在常规NAC基础上，每晚定时播放白噪音，覆盖整个治疗周期。评估两组的临床疗效、安全性、睡眠质量和免疫指标。
两组客观缓解率差异无统计学意义（P>0.05）。两组安全事件发生率差异无统计学意义（P>0.05）。观察组不良反应总发生率显著低于对照组（P<0.05）。干预后，两组的睡眠潜伏期、主观睡眠质量、睡眠时间、日间功能及睡眠障碍评分均下降，且观察组评分显著低于对照组（P<0.05）。干预后，两组免疫球蛋白A（IgA）、免疫球蛋白G（IgG）、免疫球蛋白M（IgM）、C反应蛋白及血清白细胞介素-6均有变化，但组间差异无统计学意义（P>0.05）。
白噪音干预可改善NAC乳腺癌患者的睡眠质量，降低不良反应发生率。此外，对患者的治疗疗效、安全性及免疫指标无影响。
