通阳宽胸颗粒配合西医常规疗法治疗气滞痰瘀证稳定型心绞痛临床研究

The clinical study on the effect of Tongyang-Kuanxiong guanule （TKG） for the stable angina pectoris patients with the type of Qi and phlegm stasis

目的 评价通阳宽胸颗粒配合西医常规疗法治疗气滞痰瘀证稳定型心绞痛（stable angina pectoris, SAP）疗效。方法 将符合入选标准的86例SAP患者按随机按数字表法分为2组，每组43例。对照组采用常规西医疗法治疗，观察组在对照组基础上加服通阳宽胸颗粒，2组均治疗28 d。分别于治疗前后进行中医证候及心绞痛症状积分评估，采用运动平板试验观察患者运动持续时间、代谢当量、最大ST段下降值、达到最大负荷量时心率、ST段下移持续时间，记录不良反应，评价临床疗效。结果 观察组总有效率为88.4%（38/43）、对照组为67.4%（29/43），2组比较差异有统计学意义（χ2＝5.549，P＝0.018）。治疗后，观察组运动持续时间[（9.5±1.2）min比（8.6±1.2）min，t＝3.371]、代谢当量[（10.8±2.5）METs比（9.2±2.4）METs，t＝3.084]大于对照组（P＜0.01或P＜0.05），最大ST段下降值[（1.2±0.6）mV比（1.9±0.6）mV，t＝5.484]、ST段下降持续时间[（125.0±94.5）s比（162.4±96.9）s，t＝1.795]短于对照组（P＜0.01或P＜0.05）；观察组心绞痛发作次数[（9.7±1.6）次/周比（17.3±2.1）次/周，t＝18.778]、持续时间[（3.2±1.4）min比（6.4±1.5）min，t＝10.146]及硝酸甘油消耗量[（1.3±0.8）mg比（2.5±0.8）mg，t＝7.624]、心绞痛症状积分[（8.3±2.8）分比（12.5±3.1）分，t＝6.593]均小于对照组（P＜0.01）。结论 通阳宽胸颗粒可明显提高气滞痰瘀证SAP患者的运动耐量，降低心肌耗氧，改善心绞痛症状，减少心绞痛发作次数。

Objective To observe the effect of Tongyang-Kuanxiong guanule combined with conventional western medicine for the stable angina pectoris （SAP） with qi and phlegm and blood stasis syndrome. Methods Eighty-six SAP patients who met the inclusion criteria were randomly divided into two groups according to the digital table method, with 43 cases in each group. The control group was treated with routine Western medical therapy. The observation group was given Tongyang-Kuanxiong guanule on the basis of the control group. Both groups were treated for 28 days. The TCM syndromes and angina pectoris scores were evaluated before and after treatment. The treadmill exercise test was used to observe the duration of exercise, the metabolic equivalent, the maximum value of ST segment depression, the heart rate at maximum load, the duration of ST segment depression. And the adverse reactions were recorded. Results The total effective rate was 88.4% （38/43） in the observation group and 67.4% （29/43） in the control group. The difference between the two groups was statistically significant （χ2=5.549, P=0.018）. After treatment, the duration of exercise （9.5 ± 1.2 min vs. 8.6 ± 1.2 min, t=3.371）, metabolic equivalent （10.8 ± 2.5 METs vs. 9.2 ± 2.4 METs, t=3.084） in the observation group were significantly higher than those in the control group （P〈0.01 or P〈0.05）. The largest degree of ST segment changes （1.2 ± 0.6 mV vs. 1.9 ± 0.6 mV, t=5.484）, and the duration of ST segment descent （125.0 ± 94.5 s vs. 162.4 ± 96.9 s, t=1.795） in the observation group were significantly lower than those in the control group （P〈0.01 or P〈0.05）. Thefrequency of angina attacks （9.7 ± 1.6 times per week vs. 17.3 ± 2.1 times per week, t=18.778）, duration of attacks （3.2 ± 1.4 min vs. 6.4 ± 1.5 min, t=10.146） consumption of nitroglycerin （1.3 ± 0.8 mg vs. 2.5 ± 0.8 mg, t=7.624） and Symptom score （8.3 ± 2.8 vs. 12.5 ± 3.1, t=6.593） in the observation group were significantly lower than the control group （P〈0.01）. Conclusions The Tongyang-Kuanxiong guanule can significantly improve the exercise tolerance of SAP patients with qi and phlegm and blood stasis, reduce myocardial oxygen consumption, improve angina pectoris and reduce the number of angina attacks.