Clinical study on treating chronic heart failure of Qi deficiency and blood stasis type with modified Yangxin Decoction and Guan's ear needle combination therapy
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摘要:
目的 观察养心汤加减联合管式耳针对慢性心力衰竭(CHF)患者的心功能、活动耐力、中医证候、临床疗效的影响，探讨养心汤加减联合管式耳针改善CHF患者心功能、活动耐力、中医证候的作用机制。 方法 选择2021年1—12月期间就诊于黑龙江中医药大学附属第一医院心内科门诊，气虚血瘀型CHF患者100例，采用随机单盲方案将100例CHF患者分为观察组与对照组，最终完成实验的观察组48例，对照组47例。2组患者均给予基础治疗，对照组给予基础治疗+常规西医治疗方案，观察组给予基础治疗+常规西医治疗方案+养心汤加减联合管氏耳针治疗方案。观察2组患者治疗前后中医证候、心脏功能、活动耐力、N末端B型利钠肽原(NT-proBNP)水平及心脏彩超变化，比较2组患者临床疗效。 结果 治疗后观察组中医证候积分、NT-proBNP水平、Lee氏心衰计分显著低于对照组，活动耐力较对照组显著提升(P＜0.05)；观察组左室舒张末内径(LVEDD)、左室收缩末内径(LVESD)、左室心肌质量指数(LVMI)、室间隔厚度(IVST)较对照组显著下降，LVEF显著升高(P＜0.05)；观察组总有效率为93.8%(45/48)，显著优于对照组的总有效率78.7%(37/47)，P＜0.05。 结论 养心汤加减联合管式耳针能显著提升CHF患者临床疗效，可有效改善CHF患者中医症候活动耐力以及心功能，提高CHF患者LVEF，降低CHF患者LVEDD、LVESD、LVMI、IVST及NT-proBNP水平。 Abstract:Objective To observe the effects of modified Yangxin Decoction combined with Guan's ear needle on heart function, activity endurance, Chinese medicine syndrome, and clinical efficacy in patients with chronic heart failure (CHF), and to explore the mechanism by which this combination improves these parameters in CHF patients. Methods During the period from January to December 2021, 100 patients with Qi deficiency and blood stasis type CHF were treated at the Internal Medicine Clinic. They were randomly divided into an observation group and a control group using a single-blind protocol. Finally, 48 patients in the observation group and 47 patients in the control group were completed. Both groups of patients were given basic treatment. The control group received routine western medicine treatment, including cardiac strengthening, diuresis, and vasodilation. The observation group received a combination of modified Yangxin Decoction and Guan's ear needle treatment in addition to the control group. Changes in Chinese medicine syndromes, cardiac function, activity endurance, N-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels, and cardiac ultrasound were observed before and after treatment in two groups of patients. The clinical efficacy of the two groups was then compared. Results After treatment, the Chinese medicine syndrome score, NT-proBNP level, and Lee's heart failure score in the observation group were significantly lower than those in the control group, and the activity endurance was significantly improved compared to the control group (P < 0.05). The left ventricular end-diastolic diameter (LVEDD), left ventricular end-systolic diameter (LVESD), left ventricular mass index (LVMI), and interventricular septal thickness (IVST) in the observation group were significantly decreased, while left ventricular ejection fraction (LVEF) was significantly increased compared to the control group (P < 0.05). The total effective rate of the observation group was 93.8% (45/48), significantly higher than the 78.7% (37/47) in the control group (P < 0.05). Conclusion The combination of modified Yangxin Decoction and Guan's ear needle can significantly improve the clinical efficacy for CHF patients. It effectively improves their Chinese medicine syndrome, activity endurance, and heart function, increases LVEF, and reduces LVEDD, LVESD, LVMI, IVST, and NT proBNP levels. -
表 1 2组CHF患者治疗前后症候积分比较(x±s，分)
Table 1. Comparison of symptom scores before and after treatment between two groups(x±s, points)
组别 例数 治疗前 治疗后 观察组 48 16.65±2.36 7.33±0.84b 对照组 47 17.01±2.12 10.36±1.25b 统计量 0.782a 2.214c P值 0.436 ＜0.001 注：a为t值，c为F值。与同组治疗前比较，bP＜0.05。 
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表 2 2组CHF患者治疗前后Lee氏心衰计分、6MWT、血清NT-proBNP水平比较(x±s)
Table 2. Comparison of Lee's heart failure score, 6MWT, and serum NT proBNP levels before and after treatment between two groups(x±s)
组别 例数 Lee氏心衰计分(分) 6MWT(m) NT-proBNP(ng/mL) 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 观察组 48 13.32±2.11 5.41±1.36b 263.28±70.01 495.77±84.54b 652.13±97.01 128.54±25.54b 对照组 47 12.81±2.03 7.87±1.82b 274.16±77.06 355.61±68.41b 672.26±99.06 245.61±28.41b 统计量 1.200a 1.791c 0.721a 1.527c 1.001a 1.237c P值 0.233 ＜0.001 0.473 ＜0.001 0.320 ＜0.001 注：a为t值，c为F值。与同组治疗前比较，bP＜0.05。
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表 3 2组CHF患者治疗前后LVEDD、LVESD、LVMI、IVST和LVEF比较(x±s)
Table 3. Comparison of LVEDD, LVESD, LVMI, IVST, and LVEF before and after treatment between two groups of patients(x±s)
组别 例数 LVEDD(mm) LVESD(mm) LVMI(g/m2) IVST(mm) LVEF(%) 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 观察组 48 67.35±6.85 51.54±6.21b 46.62±5.32 35.95±3.84b 182.62±25.02 135.65±20.32b 11.21±1.22 9.21±0.86b 42.02±5.92 49.62±8.05b 对照组 47 67.65±6.61 61.32±6.47b 47.01±6.02 40.65±5.12b 180.91±24.62 171.21±22.32b 11.61±1.34 9.72±0.98b 41.29±5.61 45.62±6.84b 统计量 0.195a 1.085c 0.335a 1.778c 0.338a 1.207c 1.522a 1.299c 0.617a 1.385c P值 0.846 ＜0.001 0.739 ＜0.001 0.736 ＜0.001 0.131 0.008 0.539 0.011 注：a为t值，c为F值。与同组治疗前比较，bP＜0.05。
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表 4 2组CHF患者临床疗效比较[例(%)]
Table 4. Comparison of clinical efficacy between two groups[cases (%)]
组别 例数 显效 有效 无效 总有效 观察组 48 20(41.7) 25(52.1) 3(6.3) 45(93.8) 对照组 47 14(29.8) 23(48.9) 10(21.3) 37(78.7) 注：2组总有效率比较，χ2=4.540，P=0.033。
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