乳腺术后三阴方干预三阴性乳腺癌化疗脑症状临床研究

Clinical Study of Sanyin Formula in Treating Cognitive Impairment Related to Chemotherapy for Triple Negative Breast Cancer

目的:观察评价乳腺术后三阴方对三阴性乳腺癌化疗相关认知障碍临床症状的影响。方法:采用前瞻性队列研究设计,选取2020年12月至2021年6月上海龙华医院、上海肿瘤医院化疗患者130例作为研究对象,按照是否服用乳腺术后三阴方分为对照组(n=64)和观察组(n=66),对照组给予常规治疗,观察组给予中药乳腺术后三阴方,餐后温服,疗程3个月。治疗结束后,观察癌症患者功能评估-认知功能量表(FACT-cog)评分,神经心理学测验,中医症状及安全性指标。结果:随访结束后对照组认知异常为49例,占79.03%,观察组认知异常为47例,占75.81%,暴露因素相对危险度(RR)为0.93。观察组患者生命质量的提升与对照组比较,差异均有统计学意义(均P<0.05),对照组生命质量与治疗前比较有所提高,其余相关症状均逐渐加重。FACT-cog各维度症状与乳腺术后中医症状存在相关性。随访3个月后,观察组患者中医症状积分显著低于对照组(P<0.05)。结论:乳腺术后三阴方对认知能力的提升作用尚未明确,但其通过缓解化疗不适症状改善三阴性乳腺癌患者自我感知到的认知障碍相关症状,且对三阴性乳腺癌化疗相关认知能力的减退可能具有预防作用。

Objective:To observe and evaluate the effects of Sanyin Formula on cognitive impairment related to chemotherapy for triple negative breast cancer(TNBC).Methods:A prospective cohort study was carried out for 130 TNBC patients receiving chemotherapy at Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine and Fudan University Shanghai Cancer Center from December 2020 to June 2021.According to receiving Sanyin Formula or not after chemotherapy,the patients were assigned into a control group(n=64)and an observation group(n=66).The control group received conventional treatment,and the observation group received Sanyin Formula after chemotherapy.The drug was taken warm after meals for 3 months.After treatment,the FACT-cog score,neuropsychological test results,TCM symptoms,and safety indicators of the patients were recorded.Results:After follow-up,there were 49(79.03%)and 47(75.81%)patients with cognitive abnormalities in the control and observation groups,respectively.The relative risk of exposure factors was 0.93.The improvement of quality of life in the observation group was different from that in the control group(all P<0.05).In the control group,only the quality of life was improved,while the other symptoms were gradually aggravated.The symptoms of FACT-cog were correlated with TCM symptoms after chemotherapy.After 3 months of follow-up,TCM symptom scores in the observation group were lower than those in the control group(P<0.05).Conclusion:Although the effect of Sanyin Formula on the improvement of cognitive ability after chemotherapy remains unclear,this formula can alleviate the self-perceived symptoms of cognitive impairment in TNBC patients by relieving discomfort symptoms related to chemotherapy and may exert a preventive effect on the cognitive decline related to chemotherapy.