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1.上海中医药大学 附属龙华医院,上海 200032
2.上海市徐汇区中心医院,上海 200031
杜敏,在读博士,从事中西医结合防治心脑血管疾病的临床研究,E-mail:m18364167767@163.com
刘萍,主任医师,教授,博士生导师,从事中西医结合防治心脑血管疾病的临床研究,E-mail:liuping0207@126.com
收稿日期:2022-03-13,
网络出版日期:2022-07-21,
纸质出版日期:2023-03-05
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杜敏,沈虹,冯骁腾等.调心方治疗冠心病伴焦虑/抑郁患者临床疗效及对血清5-HT、 β-TG、 MPO水平的影响[J].中国实验方剂学杂志,2023,29(05):150-157.
DU Min,SHEN Hong,FENG Xiaoteng,et al.Clinical Effect of Tiaoxin Formula in Treatment of Patients with Coronary Heart Disease and Anxiety/Depression and Its Impact on Serum 5-HT, β-TG and MPO Levels[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(05):150-157.
杜敏,沈虹,冯骁腾等.调心方治疗冠心病伴焦虑/抑郁患者临床疗效及对血清5-HT、 β-TG、 MPO水平的影响[J].中国实验方剂学杂志,2023,29(05):150-157. DOI: 10.13422/j.cnki.syfjx.202201724.
DU Min,SHEN Hong,FENG Xiaoteng,et al.Clinical Effect of Tiaoxin Formula in Treatment of Patients with Coronary Heart Disease and Anxiety/Depression and Its Impact on Serum 5-HT, β-TG and MPO Levels[J].Chinese Journal of Experimental Traditional Medical Formulae,2023,29(05):150-157. DOI: 10.13422/j.cnki.syfjx.202201724.
目的
2
研究调心方治疗冠心病伴焦虑/抑郁患者临床疗效及对血清5-羟色胺(5-HT)、
β
-血小板球蛋白(
β
-TG)及髓过氧化物酶(MPO)水平的影响。
方法
2
将66例诊断为冠心病伴焦虑/抑郁状态患者,随机分为调心方组和黛力新组,每组33例。在冠心病常规西药治疗的基础上,黛力新组同时予西药黛力新治疗,调心方组予中药调心方治疗。连续服药治疗8周,观察治疗前后各组患者临床疗效、患者健康问卷(PHQ-9)量表、广泛性焦虑(GAD-7)量表、西雅图心痛(SAQ)量表、心率变异性分析、血清5-HT、
β
-TG及MPO水平变化两组患者不良反应发生率。
结果
2
两组患者基线各项指标差异均无统计学意义,两组具有可比性。治疗8周后,调心方组的中医证候疗效总有效率87.88%(29/33),优于黛力新组的63.64%(21/33)(
Z
=-2.653,
P
<
0.05)。与本组治疗前比较,治疗4、8周时,两组患者PHQ-9量表、GAD-7量表积分均明显下降(
P
<
0.05),治疗后两组间差异无统计学意义。与本组治疗前比较,治疗4、8周时,两组患者SAQ量表各维度积分均明显升高(
P
<
0.05);与黛力新组比较,治疗后调心方组患者的躯体活动受限程度及心绞痛稳定状态两个维度积分明显升高(
P
<
0.05)。与本组治疗前比较,治疗后两组患者血清5-HT水平均明显升高,血清
β
-TG、MPO水平明显降低(
P
<
0.05);与黛力新组比较,两组间差异无统计学意义。与本组治疗前比较,调心方组心率变异性时域指标R-R间期的总体标准差(SDNN)及R-R间期平均值标准差(SDANN)明显升高(
P
<
0.05);与黛力新组比较,治疗后调心方组时域指标SDNN、SDANN明显升高(
P
<
0.05)。试验期间药物不良反应发生率调心方组明显低于黛力新组(
P
<
0.05)。所有患者研究过程中无临床不良事件发生。
结论
2
中药调心方能改善冠心病伴焦虑/抑郁患者临床症状,升高血清5-HT水平,降低血清
β
-TG、MPO水平,药物不良反应少且安全性高,具有较高临床价值,值得推广。
Objective
2
To explore the clinical effect of Tiaoxin formula in the treatment of patients with coronary heart disease and anxiety/depression and its impact on serum levels of 5-hydroxytryptamine (5-HT),
β-
thromboglobulin (
β
-TG) and myeloperoxidase (MPO).
Method
2
A total of 66 patients with coronary heart disease and anxiety/depression were randomly divided into the Tiaoxin formula group and Deanxit group, 33 cases in each group. Both groups were given fundamental western treatment for coronary heart disease. Additionally, the Deanxit group was treated with flupentixol and melitracen tablets and the Tiaoxin formula group was treated with Tiaoxin Formula. The treatment lasted 8 weeks. Before and after treatment, the changes of clinical efficacy, Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder (GAD-7) scale, Seattle Angina Questionnaire (SAQ), heart rate variability, and serum 5-HT,
β
-TG and MPO levels, and incidence of adverse reactions in the two groups were observed.
Result
2
There was no significant difference in the baseline indexes of patients in the two groups, and thus the two groups were comparable. After treatment for 8 weeks, the total effective rate for traditional Chinese medicine (TCM) syndromes in the Tiaoxin Formula group was 87.88% (29/33) higher than 63.64% (21/33) in the Deanxit group (
Z
=-2.653,
P
<
0.05). Compared with those before treatment, the PHQ-9 and GAD-7 scores of the two groups were decreased at week 4 and 8 of treatment (
P
<
0.05), and there was no statistical difference between two groups. And the SAQ dimension scores of the two groups were increased at week 4 and 8 of treatment (
P
<
0.05). Compared with the Deanxit group, the Tiaoxin Formula group had elevation in two dimension scores: Physical limitation and angina stability (
P
<
0.05). Compared with the conditions before treatment, the serum 5-HT level in the two groups were increased, while the
β
-TG and MPO levels were lowered (
P
<
0.05), and there was no distinct difference between two groups. In addition, the standard deviation of normal-to-normal intervals (SDNN) and standard deviation of average normal-to-normal intervals (SDANN) of the heart rate variability in the Tiaoxin formula group were elevated after treatment (
P
<
0.05), which were more significant than those of the Deanxit group (
P
<
0.05). During the treatment period, the incidence of adverse drug reactions in the Tiaoxin formula group was lower than that in the Deanxit group (
P
<
0.05), and no adverse events were observed in the two groups.
Conclusion
2
Tiaoxin formula was effective for the treatment of patients with coronary heart disease accompanied by anxiety and depression, which improved the clinical symptoms, increased serum 5-HT levels, and decreased serum
β
-TG and MPO levels, and had few adverse reactions and high safety for patients, showing a high clinical value.
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