舒心口服液治疗稳定性冠心病合并焦虑的疗效及对睡眠影响

Effect of Shuxin Oral Liquid on the Clinical Efficacy and Sleep in Patients with Stable Coronary Heart Disease and Anxiety

目的基于中医学"双心疾病"理论,探讨舒心口服液联合常规西药治疗对稳定性冠心病并发焦虑患者睡眠、运动能力及临床症状的影响。方法采用随机对照设计,将稳定性冠心病合并焦虑患者分为治疗组和对照组,每组43例。两组患者均给予常规西药治疗,同时治疗组加用舒心口服液,每次20 mL,bid,共持续治疗12周。所有患者在治疗前、治疗第4周及治疗第12周时进行面对面随访,记录患者一般生命体征、临床相关不良事件、心绞痛发作次数及硝酸甘油消耗量;同时采用中医证候积分量表、汉密尔顿焦虑量表(HAMA)、匹兹堡睡眠质量指数(PSQI)、多导睡眠图(PSG)、6 min步行试验(6MWT)评价两组患者临床症状、情绪及睡眠状态和运动能力。结果治疗前,两组患者中医证候评分、HAMA评分、PSQI评分、PSG监测指标和6MWT距离组间差异无统计学意义(P>0.05);在随访期间,治疗组中医证候评分、HAMA评分、PSQI评分、PSG监测指标和6MWT与治疗前比较有改善,差异有统计学意义(P<0.05);在随访同期时间点,治疗组中医证候评分、HAMA评分、PSQI评分、PSG监测治疗和6MWT距离与对照组比较均显著改善,差异有统计学意义(P<0.05)。结论舒心口服液辅助治疗可改善稳定性冠心病合并焦虑患者的临床症状和睡眠效率,提升患者的运动能力,降低心脏相关临床事件发生的频率,为中医药的身心同治提供临床依据。

Objective To explore the effect of Shuxin oral liquid combined with conventional western medicine on sleep, exercise ability and clinical symptoms in patients with stable coronary heart disease(CHD) and anxiety based on the theory of "psycho-cardiology disease" in Traditional Chinese Medicine(TCM). Methods Patients with stable coronary heart disease and anxiety were randomly divided into the treatment group and the control group, with 43 cases in each group.The patients in both groups were equally treated with conventional western medicine, while the treatment group was additionally treated with Shuxin oral liquid(20 mL,bid) for 12 weeks.All patients were conducted face-to-face communication before treatment, and were followed up at the 4 th week and the 12 th week during the treatment. The general vital signs, clinical-related adverse events, frequency of angina pectoris and nitroglycerin consumption were recorded. At the same time using the TCM syndrome score scale, HAMA,PSQI,PSG and 6 MWT were measured to evaluate the clinical symptoms, emotional and sleep state, and exercise ability of the two groups. Results Before treatment, total scores of TCM syndromes, HAMA scores, PSQI scores, PSG monitoring indicators, and 6 MWT distances were not significantly different between the groups(P>0.05);During the follow-up period, total scores of TCM syndromes, HAMA scores, PSQI scores, PSG monitoring indicators, and 6 MWT distances in the treatment group were significantly different from those at the last follow-up time(P<0.05);At the same time points of the follow-up, total scores of TCM syndromes, HAMA scores, PSQI scores, PSG monitoring indicators, and 6 MWT distances in the treatment group were significantly different from those in the control group(P<0.05). Conclusion Shuxin oral liquid in the combination therapy for stable coronary heart diseaseand anxiety patients can improve the clinical symptoms, sleep efficiency and exercise ability, and reduce the frequency of cardiac-related clinical events, which provide a theoretical basis for treating "psycho-cardiology disease" using traditional Chinese medicine.