养正合剂改善恶性肿瘤患者睡眠质量的影响因素研究

Factors influencing the improvement of sleep quality in malignant tumor patients treated with Yangzheng mixture

摘要:

目的 评估养正合剂对恶性肿瘤患者睡眠质量的改善效果，并分析睡眠改善的相关影响因素。方法 回顾性分析2019年1月—2020年10月在上海中医药大学附属曙光医院等10家医疗机构接受养正合剂辅助治疗的990例恶性肿瘤患者的临床资料。记录治疗前及治疗6周后的睡眠质量［匹兹堡睡眠质量指数（PSQI）］、睡眠指标（睡眠时间、睡眠效率、入睡时间）及催眠药物使用频率。以治疗后PSQI评分为睡眠质量评估依据，将990例患者分为睡眠质量相对较好组（8～14分）与睡眠质量相对较差组（15～21分）。分析两组患者基线人口学资料、生命体征［体温、脉搏、呼吸频率、收缩压（SBP）、舒张压（DBP）］、肿瘤标志物［癌胚抗原（CEA）、神经元特异性烯醇化酶（NSE）、鳞状细胞癌抗原（SCCA）、细胞角蛋白19片段（CYFRA21-1）、糖类抗原15-3（CA15-3）］、癌症相关评分［癌症食欲和症状问卷（CASQ）、欧洲癌症研究与治疗组织生命质量量表（EORTC QLQ-C30）、汉密尔顿焦虑量表（HAMA）、中医证候积分］。采用多因素一般Logistic回归模型分析睡眠质量改善的影响因素。结果 两组临床资料比较，差异均无统计学意义（P >0.05）。两组的体温、脉搏、呼吸频率、SBP、DBP、CEA、NSE、SCCA、CYFRA21-1、CA15-3水平比较，差异均无统计学意义（P >0.05）。治疗6周后，睡眠质量相对较好组PSQI评分低于睡眠质量相对较差组（P <0.05）。治疗6周后，睡眠质量相对较好组睡眠时间、睡眠效率均高于睡眠质量相对较差组，而入睡时间评分低于睡眠质量相对较差组（P <0.05）。治疗前后，两组患者催眠药物使用频率比较，差异无统计学意义（P >0.05）。治疗6周后，睡眠质量相对较好组CASQ、HAMA评分及中医证候积分均低于睡眠质量相对较差组（P <0.05），EORTC QLQ-C30评分高于睡眠质量相对较差组（P <0.05）。多因素一般Logistic回归分析结果显示，治疗6周后，睡眠时间长［O^R =0.797（95% CI：0.710，0.895）］、睡眠效率评分高［O^R =0.799（95% CI：0.770，0.828）］、EORTC QLQ-C30评分高［O^R =0.920（95% CI：0.900，0.940）］均为影响恶性肿瘤患者睡眠质量的保护因素（P <0.05）；入睡时间长［O^R =1.101（95% CI：1.046，1.159）］、CASQ评分高［O^R =1.059（95% CI：1.016，1.103）］、HAMA评分高［O^R =1.091（95% CI：1.038，1.148）］均为影响恶性肿瘤患者睡眠质量的危险因素（P <0.05）。结论 养正合剂可有效改善恶性肿瘤患者的睡眠质量，其机制可能与延长睡眠时间、提高睡眠效率、缓解疲乏与焦虑及改善整体生活质量有关。临床应重视对入睡困难、疲乏及焦虑状态的评估与干预。

Abstract:

Objective To evaluate the effect of Yangzheng Mixture on sleep quality in patients with malignant tumors and to analyze factors associated with improved sleep.Methods The clinical data of 990 patients with malignant tumors who received adjunctive treatment with Yangzheng Mixture at 10 medical institutions, including Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, from January 2019 to October 2020 were retrospectively analyzed. Sleep quality [Pittsburgh Sleep Quality Index (PSQI) ], sleep indicators (sleep duration, sleep efficiency, and sleep-onset latency), and frequency of hypnotic drug use were recorded before treatment and after 6 weeks of treatment. Based on the post-treatment PSQI score, the 990 patients were divided into a relatively good sleep quality group (8-14 points) and a poor sleep quality group (15-21 points). Baseline demographic data, vital signs [body temperature, pulse, respiratory rate, systolic blood pressure (SBP), and diastolic blood pressure (DBP) ], tumor markers [carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), squamous cell carcinoma antigen (SCCA), cytokeratin 19 fragment (CYFRA21-1), and carbohydrate antigen 15-3 (CA15-3) ], and cancer-related scores [Cancer Appetite and Symptom Questionnaire (CASQ), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Hamilton Anxiety Rating Scale (HAMA), and traditional Chinese medicine syndrome score] were analyzed in the two groups. Multivariate logistic regression was used to analyze independent factors associated with sleep quality.Results There were no significant differences in clinical data between the relatively good and poor sleep quality groups (P > 0.05). Body temperature, pulse, respiratory rate, SBP, DBP, and serum CEA, NSE, SCCA, CYFRA21-1, and CA15-3 levels did not differ significantly between the two groups (P > 0.05). After 6 weeks of treatment, the PSQI score was lower in the relatively good sleep quality group than in the poor sleep quality group (P < 0.05). The relatively good sleep quality group had longer sleep duration, higher sleep efficiency, and a lower sleep-onset latency score than the poor sleep quality group (P < 0.05). The frequency of hypnotic drug use did not differ significantly between the two groups before or after treatment (P > 0.05). After 6 weeks of treatment, CASQ and HAMA scores and the traditional Chinese medicine syndrome score were lower, whereas the EORTC QLQ-C30 score was higher, in the relatively good sleep quality group than in the poor sleep quality group (P < 0.05). Multivariate logistic regression analysis showed that longer sleep duration [O^R = 0.797 (95% CI: 0.710, 0.895)], higher sleep efficiency [O^R = 0.799 (95% CI: 0.770, 0.828) ], and a higher EORTC QLQ-C30 score [O^R = 0.920 (95% CI: 0.900, 0.940) ] were protective factors for sleep quality in patients with malignant tumors (P < 0.05), whereas longer sleep-onset latency [O^R = 1.101 (95% CI: 1.046, 1.159) ], a higher CASQ score [O^R = 1.059 (95% CI: 1.016, 1.103) ], and a higher HAMA score [O^R = 1.091 (95% CI: 1.038, 1.148) ] were risk factors (P < 0.05).Conclusion Yangzheng Mixture can effectively improve sleep quality in patients with malignant tumors. This effect may be associated with longer sleep duration, higher sleep efficiency, reduced fatigue and anxiety, and better overall quality of life. In clinical practice, sleep-onset difficulty, fatigue, and anxiety should be assessed and managed.