摘要
目的 观察通脉安神方加减治疗稳定型心绞痛(SAP)合并睡眠障碍的临床疗效。方法 纳入148例SAP合并睡眠障碍患者,随机分为对照组和治疗组,每组74例。对照组给予西药常规治疗,治疗组在对照组的基础上加用通脉安神方加减治疗(每日1剂),两组均治疗4周。比较两组患者治疗前后心绞痛症状、中医证候、睡眠质量、生活质量以及血清学指标[包括血清细胞间黏附分子-1 (ICAM-1)、血管细胞黏附分子-1 (VCAM-1)、脑源性神经生长因子(BDNF)和酪氨酸激酶受体B (TrkB)]的变化情况,并进行安全性评价。结果 治疗组与对照组中医证候总有效率(82.43%vs 52.70%)、心绞痛总有效率(79.73%vs64.86%)、睡眠总有效率(89.19%vs 68.92%),差异均有统计学意义(P<0.01)。治疗后两组中医证候总积分、主症积分、次症积分(及次症中不寐、心烦、乏力与神疲积分)、心绞痛积分、匹兹堡睡眠质量指数(PSQI)总分及各单项积分均较本组治疗前降低,SF-36各单项积分均较本组治疗前升高,差异有统计学意义(P<0.05)。治疗组治疗后中医证候总积分和主症积分、次症中单项(不寐、心烦、乏力和神疲)积分、心绞痛积分、入睡时间、睡眠质量、催眠药物、睡眠障碍、日间功能障碍积分和PSQI总分均明显低于对照组(P<0.05),而躯体疼痛、一般健康状况、社会功能、情感职能、精神健康和健康变化积分均明显高于对照组(P<0.05)。治疗后治疗组ICAM-1和VCAM-1水平均较治疗前明显降低(P<0.05),BDNF和TrkB水平升高(P<0.05);而对照组BDNF水平减低(P<0.05)。治疗组治疗后,TrkB较对照组明显升高(P<0.05)。治疗期间共发生不良事件4例,均判断为与本研究无关。结论 通脉安神方加减对SAP合并睡眠障碍患者心绞痛症状、中医证候、睡眠质量和生活质量均有显著改善,其机制可能与保护血管内皮功能和中枢神经元有关。
Objective To observe the clinical efficacy of the Modified Tongmai Anshen Formula(通脉安神方加减,MTAF)in the treatment of stable angina pectoris(SAP)with sleep disorders.Methods A total of 148 patients suffering from SAP with sleep disorder were included and randomly divided into control group and treatment group,with 74 patients in each group.The control group received conventional western medicine,and the treatment group additionally received MTAF(1 dose per day),both for 4 weeks.The changes in angina pectoris symptoms,tradition⁃al Chinese medicine(TCM)syndromes,sleep quality,quality of life,serological indicators including serum intercel⁃lular adhesion molecule-1(ICAM-1)and vascular cell adhesion molecule-1(VCAM-1),brain-derived nerve growth factor(BDNF)and tyrosine kinase receptor B(TrkB)were compared between groups before and after treatment,and the safety was evaluated.Results In the treatment group and the control group,the total effective rates of TCM syn⁃dromes(82.43%vs 52.70%),angina pectoris(79.73%vs 64.86%)and sleep(89.19%vs 68.92%)showing sig⁃nificant difference(P<0.001).After treatment,the total TCM syndrome score,primary symptom score,secondary symptom score,and secondary symptoms sleeplessness,restlessness,tiredness and fatigue individual score,angina pectoris score,PSQI total score and each item score were all significantly reduced in both groups,while the SF-36 single item score significantly increased(P<0.05).The total TCM syndromes and primary symptom scores,secondary symptoms sleeplessness,restlessness,tiredness and fatigue individual score,angina pectoris score,time to fall asleep,sleep quality,hypnotic medication,sleep disturbance,daytime dysfunction score and PSQI total score were significantly lower in the treatment group than those in the control group after treatment(P<0.05),while the somatic pain,general health status,social functioning,emotional functioning,mental health,and health change were signifi⁃cantly higher in the treatment group(P<0.05).After treatment,ICAM-1 and VCAM-1 level significantly decreased(P<0.05),and BDNF and TrkB levels increased(P<0.05)in the treatment group,while BDNF level significantly decreased in the control group(P<0.05).The TrkB level was significantly higher in the treatment group compared to the control group after treatment(P<0.05).A total of four adverse events occurred during the treatment,none of which were considered to be related to this study.Conclusion MTAF can significantly improve angina pectoris symptoms,TCM syndromes,sleep quality and quality of life in patients suffering from SAP with sleep disorders,the mechanism of which may be related to the protection of vascular endothelial function and central neurons.
作者
范新彪
耿小飞
严志鹏
李婷婷
范雅洁
李澳琳
尚文钰
张弛
张军平
FAN Xinbiao;GENG Xiaofei;YAN Zhipeng;LI Tingting;FAN Yajie;LI Aolin;SHANG Wenyu;ZHANG Chi;ZHANG Junping(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine/National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin,300380)
出处
《中医杂志》
CSCD
北大核心
2023年第17期1777-1785,共9页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(81774232)
国家中医药管理局岐黄学者支持项目(国中医药人教函[2022]6号)
天津市卫生健康委员会名中医项目(津卫中[2020]732号)。
关键词
稳定型心绞痛
通脉安神方
睡眠障碍
血管内皮
神经元损伤
stable angina pectoris
Tongmai Anshen Formula(通脉安神方)
sleep disorders
vascular endothelium
neurons injury
