[关键词]
[摘要]
【目的】 观察芳香温通散(由丹参、川芎、高良姜、荜茇、延胡索组成)穴位敷贴联合宽胸气雾剂治疗女性冠状动脉慢 血流(CSF)心绞痛的临床疗效。【方法】 经样本量估算后,选取 2023年 11月~2024年 3月在福建中医药大学附属第三人民医 院、广州中医药大学第二附属医院(广东省中医院)、广东省湛江市第一中医医院和上海中医药大学附属龙华医院心血管科 住院,西医诊断为 CSF心绞痛,中医诊断为胸痹阳虚寒凝证的女性患者,共 119例。使用随机数字表法,按 5∶2分配比例, 将119例患者随机分为治疗组84例和对照组35例。对照组使用单硝酸异山梨酯缓释胶囊治疗,治疗组使用芳香温通散穴位 敷贴(选穴:膻中、膏肓、心俞)联合宽胸气雾剂舌下给药治疗,疗程均为7 d。观察2组患者治疗前后简版西雅图心绞痛量 表(SAQ-7)评分、中国心血管病患者生活质量问卷(CQQC)评分、6 min步行距离(6MWD)及血清C反应蛋白(CRP)水平和白 细胞/血小板平均体积比值(WMR)的变化情况,比较 2 组患者的中医证候疗效,并监测 2 组的不良反应发生情况。【结果】 (1)脱落退出情况方面,治疗组中8例患者因不能配合填写量表提前退出,对照组中2例患者因服硝酸酯类药后头痛提前退 出,最终共109例患者完成研究,其中治疗组76例、对照组33例。(2)中医证候疗效方面,治疗7 d后,治疗组的总有效率为 86.84%(66/76),对照组为 72.73%(24/33),组间比较(χ2检验),治疗组的中医证候疗效明显优于对照组(P<0.05)。(3)心绞 痛病情评估方面,治疗后,2组患者 SAQ-7的活动限制、心绞痛频率评分和治疗组的主观满意度评分均较治疗前改善(P< 0.05),且治疗组对活动限制、心绞痛频率和主观满意度评分的改善程度均明显优于对照组(P<0.05)。(4)生活质量评估方 面,治疗后,治疗组的 CQQC 评分较治疗前明显改善(P<0.05),而对照组无明显改善(P>0.05);组间比较,治疗组对 CQQC 评分的改善程度明显优于对照组(P<0.05)。(5)运动耐量评估方面,治疗后,2组患者的 6MWD 均较治疗前改善(P< 0.05),且治疗组的改善程度明显优于对照组(P<0.05)。(6)炎症指标方面,治疗后,治疗组的血清CRP水平和WMR值均较 治疗前改善(P<0.05),而对照组均无明显改善(P>0.05);组间比较,治疗组对血清CRP水平和WMR值的改善程度均明显 优于对照组(P<0.05)。(7)安全性方面,治疗过程中,治疗组患者未发生相关不良反应,具有较高的安全性。【结论】 芳香温 通散穴位敷贴联合宽胸气雾剂治疗女性 CSF患者较使用单硝酸异山梨酯缓释胶囊能够更加有效地控制心绞痛,改善运动耐 量,减轻炎症反应,并在一定程度上改善患者的生活质量。
[Key word]
[Abstract]
Objective To observe the clinical efficacy of Fangxiang Wentong Powder(composed of Salviae Miltiorrhizae Radix et Rhizoma, Chuanxiong Rhizoma, Alpiniae Officinarum Rhizoma, Piper Longum, and Corydalis Rhizoma) acupoint application combined with Kuanxiong Aerosol in treating female patients with coronary slow flow(CSF) associated angina. Methods After sample size estimation, 119 female inpatients diagnosed as CSF associated angina and differentiated as chest-qi obstruction with yang deficiency and cold accumulation syndrome of traditional Chinese medicine (TCM) were collected from the cardiovascular departments of the Third People’s Hospital of Fujian University of Traditional Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Zhanjiang First Traditional Chinese Medicine Hospital,and Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from November 2023 to March 2024. Using a table of random numbers,the patients were divided into a treatment group (84 cases) and a control group (35 cases) in a ratio of 5∶2. The control group was treated with Isosorbide Monomitrate Sustained-Release Capsules,while the treatment group was treated with application of Fangxiang Wentong Powder on acupoints of Danzhong (CV17),Gaohuang(BL43),and Xinshu (BL15), together with sublingual administration of Kuanxiong Aerosol. The treatment course for both groups covered 7 days. Before and after treatment,the changes in the simplified Seattle Angina Questionnaire (SAQ-7) scores, Chinese Quality of Life Questionnaire for Cardiovascular Patients (CQQC) scores, 6-minute walking distance (6MWD),serum C-reactive protein (CRP) level,and white blood cell-to-mean platelet volume ratio (WMR) were observed. The TCM symptom efficacy was compared between the two groups,and adverse reactions were monitored. Results (1) There were 8 patients withdrew in the treatment group for failing in completing the questionnaires, and 2 patients withdrew in the control group for suffering headaches after taking nitrates. Eventually,109 patients completed the trial,including 76 in the treatment group and 33 in the control group. (2)After 7 days of treatment,the total effective rate for TCM symptom efficacy in the treatment group was 86.84% (66/76), and that in the control group was 72.73%(24/33). The intergroup comparison (tested by the chisquare test) showed that the TCM symptom efficacy in the treatment group was significantly superior to that in the control group.(3)After treatment,both groups showed improvements in the scores of activity limitation and angina frequency items of SAQ-7, and the treatment group also showed improvements in the scores of subjective satisfaction item of SAQ-7(P<0.05). The treatment group’s improvements in the scores of activity limitation, angina frequency,and subjective satisfaction items of SAQ-7 were significantly superior to those of the control group (P<0.05).(4)After treatment,the CQQC scores in the treatment group was significantly improved(P< 0.05),while no significant improvement was observed in the control group (P>0.05). The improvement of CQQC scores in the treatment group was significantly superior to that in the control group (P<0.05).(5) After treatment, both groups showed improvements in 6MWD(P<0.05), and the improvement in the treatment group was significantly superior to that in the control group (P<0.05).(6) After treatment,the serum levels of inflammatory indicators of CRP and WMR in the treatment group were significantly improved (P<0.05),while no significant improvements were presented in the control group (P>0.05). The improvements in serum CRP level and WMR value in the treatment group were significantly superior to those in the control group (P<0.05).(7) No adverse reactions were found in the treatment group, indicating high safety. Conclusion Fangxiang Wentong Powder acupoint application combined with Kuanxiong Aerosol is more effective than Isosorbide Monomitrate SustainedRelease Capsules, improving exercise tolerance, decreasing inflammatory factor levels, and improving the quality of life to some extent during the treatment of female patients with CSF.
[中图分类号]
R259.414
[基金项目]
国家自然科学基金青年科学基金项目(编号:82204662);福建省自然科学基金面上项目(编号:2023J01886);福建省中医药科 研项目(编号:X2022001,X2023026);上海中医药大学“访名校·拜名师”人才培养计划(编号:074)