【摘要】 目的 本研究前瞻性探索“疏肝调神”针刺法治疗乳腺癌术后睡眠障碍的临床疗效及安全性。方法 纳入2024年9月至2024年12月于东莞市人民医院中医科、肿瘤科门诊就诊并符合入组标准的乳腺癌睡眠障碍患者共70人，随机分配到2个组，治疗组和对照组各35例。治疗组采用“疏肝调神”针刺法进行治疗，每周2次，连续治疗8周。对照组口服佐匹克隆片，每次服用7.5 mg，连续治疗8周。观察患者治疗前、治疗最后1天（第8周）匹兹堡睡眠质量评分量表（pittsburgh sleep quality index,PSQI）、失眠严重程度指数量表（insomnia sererity index,ISI）、汉密尔顿焦虑量表（hamilton anxiety scale,HAMA）、汉密尔顿抑郁量表（hamiltondepressionscale, HAMD-24）评分及血清褪黑素（melatonin, MT）、 5-羟色胺（5-hydroxytryptamine,5-HT）、神经肽Y(neuropeptide Y,NPY)、癌胚抗原（carcinoembryonic antigen,CEA）、糖类抗原15-3(carbohydrate antigen 15-3,CA15-3)和糖类抗原125(carbohydrate antigen 125,CA125)水平的变化并评定疗效及安全性。结果 治疗后PSQI、ISI、HAMA、HAMD-24评分及5-HT、NPY、MT水平与治疗前比较，差异有统计学意义（P<0.05）。治疗后治疗组的PSQI、ISI、HAMA、HAMD-24评分低于对照组（P<0.001）。两组患者MT比较差异无统计学意义（P=0.204），治疗组的5-HT、NPY高于对照组（P<0.001）。治疗组的有效率高于对照组，差异有统计学意义（P=0.003）。肿瘤标志物方面，治疗组的CEA、CA15-3、CA125较对照组下降（P<0.05）。治疗组的不良事件发生率低于对照组，差异有统计学意义（P<0.001）。结论 “疏肝调神”针法可有效改善乳腺癌术后睡眠障碍患者的睡眠质量，并可通过调控MT、5-HT、NPY，调节抑郁等负向情绪，同时降低CA15-3、CEA、CA125，减少肿瘤复发率，提高乳腺癌术后患者的生存质量，疗效显著，安全性良好。更多还原

【Abstract】 Objective: This study prospectively explored the clinical efficacy and safety of “liver-soothing and spirit-regulating” acupuncture in the treatment of sleep disorders after breast cancer surgery. Methods A total of 70 breast cancer patients with sleep disorders who visited outpatient clinics of Department of Traditional Chinese Medicine and Department of Oncology of Dongguan People’s Hospital and met the inclusion criteria from September 2024 to December 2024 were involved and randomly assigned to two groups,with 35 patients in the treatment group and 35 patients in the control group. The treatment group was treated with “liver-soothing and spirit-regulating” acupuncture twice a week for 8 consecutive weeks. The control group received oral zopiclone tablets,7.5 mg each time,for 8 consecutive weeks of treatment. To evaluate efficacy and safety,the patient’s scores on the pittsburgh sleep quality index(PSQI), insomnia severity index(ISI), hamilton anxiety scale(HAMA),hamilton depression scale(HAMD-24),and levels of melatonin(MT),5-hydroxytryptamine(5-HT),neuropeptide Y(NPY), carcinoembryonic antigen(CEA), carbohydrate antigen 15-3(CA15-3), and carbohydrate antigen 125(CA125) were observed before treatment and on the last day of treatment(week 8).Results After treatment,there were statistically significant differences in the scores of the PSQI,ISI,HAMA,HAMD-24 and levels of 5-HT, NPY, and MT compared to before treatment(P<0.05). After treatment, the scores of the PSQI,ISI,HAMA,and HAMD-24 of the treatment group were lower than those of the control group(P<0.001). There was no statistically significant difference in MT between the two groups of patients(P=0.204),and the levels of 5-HT and NPY in the treatment group were higher than those in the control group(P<0.001).The effective rate of the treatment group was higher than that of the control group, and the difference was statistically significant(P=0.003). In terms of tumor markers, the treatment group showed a decrease in CEA,CA15-3,and CA125 compared to the control group(P<0.05). The incidence of adverse events in the treatment group was lower than that in the control group,and the difference was statistically significant(P<0.001).Conclusion “Liver-soothing and spirit-regulating” acupuncture can effectively improve the sleep quality of breast cancer patients with postoperative sleep disorders. It regulates negative emotions such as depression by regulating MT,5-HT,and NPY,and reduces CA15-3,CEA,and CA125,so as to reduce tumor recurrence rate and improve the quality of life of postoperative breast cancer patients with significant efficacy and good safety.更多还原