Abstract: Background　Unstable angina pectoris（UAP）should be classified as "chest pain and heart pain" in traditional Chinese medicine.The pathogenesis of UAP is cardiopulmonary obstruction，and the nature of the disease is deficiency in origin but excess in superficiality.Tongqiao Jiuxin Oil，owning aromatic and warm ingredients，has a unique therapeutic effect on this disease via resuscitating and restoring consciousness，and regulating qi to alleviate pain.Objective　To explore the changes in clinical outcome and quality of life in response to sublingually administered Tongqiao Jiuxin Oil in UAP patients with qi stagnation and blood stasis syndrome.Methods　Totals of 240 UAP patients with qi stagnation and blood stasis syndrome were included in this study from May 2017 to April 2018.By use of a random number table，they were divided into control group（59 cases），oral group（60 cases），external use group（61 cases）and sublingual group（60 cases）．Oral Isosorbide Dinitrate Tablets were given to the control group，three times a day，for 7 consecutive days.Besides western treatment，Tongqiao Jiuxin Oil was given to the latter 3 groups via oral way，smearing on philtrum acupoint，and sublingual way，respectively，three times a day，for 7 consecutive days．Data concerning TCM symptoms score，heart fucnions evaluated by ECG，scores of SAQ，SF-12 and EQ-5D，and safety parameters before and after treatment，and adverse events during treatment were collected and analyzed statistically.Results　Post-treatment improvement in heart functions evaluated by ECG differed significantly across four groups（P<0.05）．Specifically，the improvement in sublingual group was significantly better than that of oral group and external use group（P<0.008 3），and was similar to that of the control group（P>0.008 3）．Pre- and post-treatment differences in TCM symptom score，SF-12 and EQ-5D were significantly different in four groups（P<0.05）．To be specific，post-treatment improvements in these three parameters in sublingual group were much better than those of other groups（P<0.05）．After treatment，there were significant differences in SAQ scores and their differences among the four groups in terms of physical activity limitation，stable state of angina pectoris and attack of angina pectoris（P<0.05）．Sublingual group was better than oral group and external use group（P<0.05）.Safety measurements of the all groups treated with Tongqiao Jiuxin Oil were found with no deterioration，and no adverse events occurred．Conclusion　Sublingual administration of Tongqiao Jiuxin Oil could achieve a positive efficacy with good safety，and significantly improve the overall quality of life in UAP patients with qi stagnation and blood stasis syndrome.

Key words: Angina, unstable；Qi stagnation blood stasis；Quality of life；Administration, sublingual；Tongqiao Jiuxin Oil

摘要： 背景　不稳定性心绞痛辨病当属中医的“胸痹心痛”，其病机为心脉痹阻，病性是本虚标实。通窍救心油具有芳香开窍、理气止痛之效，在治疗胸痹心痛方面独具特色。目的　观察通窍救心油舌下给药途径对不稳定性心绞痛气滞血瘀证患者疗效及生活质量的影响。方法　2017年5月—2018年4月，纳入合格受试者240例，根据随机数字表将纳入的患者随机分为对照组59例、口服组60例、外搽组61例及舌下组60例。对照组在西医基础治疗上加口服硝酸异山梨酯片，3次/d，疗程7 d；口服组、外搽组、舌下组分别在西医基础治疗上，加用通窍救心油，给药方式依次为口服给药、外搽人中穴、舌下给药，3次/d，疗程7 d。于治疗前后采集中医证候疗效积分、心电图、西雅图心绞痛量表（SAQ）评分、12条简明健康状况调查表（SF-12）联合欧洲五维健康量表（EQ-5D）评分、安全性指标和不良反应事件资料，进行统计学处理。结果　4组患者心电图疗效评价总有效率比较，差异有统计学意义（P<0.05），舌下组高于口服组、外搽组（P<0.008 3），不劣于对照组（P>0.008 3）。治疗后，4组患者中医证候、SF-12、EQ-5D评分及治疗前后评分差值比较，差异有统计学意义（P<0.05），舌下组优于对照组、口服组、外搽组（P<0.05）。治疗后，4组患者SAQ在躯体活动受限程度、心绞痛稳定状态、心绞痛发作情况3个维度的评分及其差值比较，差异有统计学意义（P<0.05），舌下组优于口服组、外搽组（P<0.05）。治疗后通窍救心油各组安全性指标均无恶化，未见不良反应。结论　通窍救心油舌下给药途径在确保疗效和安全性的同时，能明显改善不稳定性心绞痛气滞血瘀证患者的整体生活质量。

关键词: 心绞痛, 不稳定型；气滞血瘀；生活质量；投药, 舌下；通窍救心油