Observation on curative effect of Bushen Qiangxin Prescription combined with Dapagliflozin in treating heart failure with preserved ejection fraction
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摘要:
目的 观察补肾强心方联合达格列净治疗射血分数保留型心衰(HFpEF)的疗效，探索中西医结合治疗HFpEF的方法。 方法 将2022年1月—2024年11月就诊于宁国市中医院的70例HFpEF患者按随机数字表法分为观察组与对照组，各35例，2组均接受达格列净为主的基础治疗，观察组另给予中药补肾强心方汤剂。4周后比较2组的中医证候积分与总有效率、6分钟步行距离(6MWD)、N末端B型脑钠肽前体(NT-proBNP)及心脏超声参数[左室射血分数(LVEF)、左心房内径(LAD)、左室后壁厚度(LVPW)、E/e’、三尖瓣反流速度峰值(TRV)]。 结果 观察组中医证候总有效率高于对照组(97.1% vs. 68.6%，χ2=10.057，P＜0.01)；治疗后中医证候积分均下降，6MWD增加, 且观察组优于对照组(P＜0.01)；NT-proBNP水平下降，组间治疗后比较及差值比较差异均有统计学意义，观察组更优(P＜0.01)；2组治疗后LVEF增加，E/e'、TRV减少(P＜0.01)，且观察组的改善幅度均优于对照组(P＜0.01)；治疗后2组比较LVPW、LAD差异均无统计学意义(P＞0.05)；2组均无不良反应。 结论 在以达格列净为主的基础上加用补肾强心方治疗HFpEF，能进一步降低NT-proBNP，提高6MWD，更显著地改善中医证候，有助于改善左室舒张功能，且安全性好。 Abstract:Objective To observe the efficacy of Bushen Qiangxin Prescription combined with Dapagliflozin in the treatment of heart failure with preserved ejection fraction (HFpEF), and to explore the treatment of HFpEF with integrated traditional Chinese and Western medicine. Methods Seventy patients with HFpEF who were admitted to the Ningguo Hospital of Traditional Chinese Medicine from January 2022 to November 2024 were divided into observation group and control group according to the random number table method, with 35 patients in each group. Both groups received basic treatment primarily consisting of Dapagliflozin, and the observation group was additionally given Bushen Qiangxin Prescription. After 4 weeks, the traditional Chinese medicine (TCM) syndrome score, total effective rate, 6-minute walking distance (6MWD), N-terminal B-type natriuretic peptide precursor (NT-proBNP), and cardiac ultrasound parameters [left ventricular ejection fraction (LVEF), left atrial diameter (LAD), left ventricular posterior wall (LVPW), E/e', tricuspid regurgitation velocity(TRV)] were compared between the two groups. Results The total effective rate of TCM syndrome in the observation group was higher than that in the control group (97.1% vs. 68.6%, χ2=10.057, P < 0.01), the TCM pattern score decreased after treatment, and the 6MWD increased, and the observation group was better than the control group (P < 0.01); the level of NT-proBNP decreased, and the value and difference between the two groups were statistically significant after treatment, and the observation group was better (P < 0.01); the two groups had an increase in LVEF and a decrease in E/e' and TRV (P < 0.01), and the magnitude of improvement in the observation group was greater than that in the control group (P < 0.01), and there was no significant difference in LVPW and LAD between the two groups after treatment (P>0.05). No adverse reactions were observed in either group. Conclusion The addition of Bushen Qiangxin Prescription in the treatment of HFpEF based on Dapagliflozin can further reduce NT-proBNP, increase 6MWD, significantly improve TCM syndrome, and help improve left ventricular diastolic function, with good safety. -
表 1 2组HFpEF患者中医证候总有效率比较[例(%)]
Table 1. Comparison of TCM syndrome response rates between the two groups of HfpEF patients [cases (%)]
组别 例数 显效 有效 无效 总有效 观察组 35 4(11.4) 30(85.7) 1(2.9) 34(97.1) 对照组 35 2(5.7) 22(62.9) 11(31.4) 24(68.6) 注：2组总有效率比较，χ2=10.057，P < 0.001。 
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表 2 2组HFpEF患者治疗前后中医证候积分比较(x±s，分)
Table 2. Comparison of TCM pattern scores before and after treatment between the two groups of HfpEF patients (x±s)
组别 例数 治疗前 治疗后 t值 P值 观察组 35 23.20±4.04 10.80±3.33 17.037 ＜0.001 对照组 35 22.29±3.85 14.69±3.53 12.229 ＜0.001 统计量 0.969a 31.245b P值 0.336 ＜0.001 注：a为t值，b为F值。
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表 3 2组HFpEF患者治疗前后6MWD比较(x±s，m)
Table 3. Comparison of 6-minute walking distance before and after treatment between the two groups of HfpEF patients (x±s, m)
组别 例数 治疗前 治疗后 t值 P值 观察组 35 272.20±54.66 360.09±60.39 16.598 ＜0.001 对照组 35 271.80±61.29 323.37±58.96 11.195 ＜0.001 统计量 0.029a 27.508b P值 0.977 ＜0.001 注：a为t值，b为F值。
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表 4 2组HFpEF患者治疗前后NT-proBNP比较[M(P25, P75)，pg/mL]
Table 4. Comparison of NT-proBNP before and after treatment between the two groups of HfpEF patients [M(P25, P75), pg/mL]
组别 例数 治疗前 治疗后 差值 观察组 35 1 670(1 192，2 119) 778(510，1 100) 523(350，928) 对照组 35 1 760(1 157，3 084) 1 200(813，2 156) 862(667，1 132) Z值 -0.258 -3.213 2.737 P值 0.796 0.001 0.006
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表 5 2组HFpEF患者治疗前后心脏超声参数比较(x±s)
Table 5. Comparison of cardiac ultrasound parameters before and after treatment between the two groups of HfpEF patients (x±s)
组别 例数 LVEF(%) t值 P值 LAD(mm) t值 P值 治疗前 治疗后 治疗前 治疗后 观察组 35 59.91±6.59 65.00±5.03 8.507 ＜0.001 45.17±5.90 40.71±4.36 6.970 ＜0.001 对照组 35 60.33±6.72 61.84±5.93 5.215 ＜0.001 44.86±7.59 39.94±8.77 5.569 ＜0.001 统计量 0.260a 41.138b 0.847a 0.249b P值 0.795 ＜0.001 0.931 0.619 组别 例数 E/e’ t值 P值 TRV(m/s) t值 P值 治疗前 治疗后 治疗前 治疗后 观察组 35 13.66±0.92 9.84±0.94 36.058 ＜0.001 3.23±0.31 3.23±0.31 19.556 ＜0.001 对照组 35 13.47±1.54 11.24±1.18 16.187 ＜0.001 3.21±0.26 2.19±0.34 15.412 ＜0.001 统计量 0.648a 109.672b 0.335a 39.626b P值 0.519 ＜0.001 0.739 ＜0.001 注：a为t值，b为F值。
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表 6 2组HFpEF患者治疗前后LVPW比较[M(P25, P75)，mm]
Table 6. Comparison of LVPW before and after treatment between the two groups of HfpEF patients [M(P25, P75), mm]
组别 治疗前 治疗后 差值 观察组 10(9, 12) 10(9, 11) 1(0, 1) 对照组 11(9, 12) 10(9, 11) 1(0, 1) Z值 -0.214 -1.075 -1.387 P值 0.830 0.282 0.166
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