【目的】观察参七颗粒 （由红参、三七两味中药组成） 对气虚血瘀型射血分数保留心衰 （heart failure with preserved ejection fraction，HFpEF） 患者预后的影响。 【方法】将130例气虚血瘀型HFpEF患者随机分为观察组和对照组，每组各65例。对照组给予常规西药治疗，观察组在对照组的基础上加用参七颗粒治疗，疗程为6个月。观察2 组患者治疗前后心肺运动试验（CPET） 指标、左室射血分数 （LVEF） 、中医证候积分及血清氨基末端脑利钠肽前体 （NT-proBNP） 水平的变化情况，并评价2 组患者的中医证候疗效和安全性。 【结果】（1） 中医证候疗效方面，治疗6个月后，观察组的总有效率为89.23% （58/65） ，对照组为71.31% （47/65） ，组间比较 （χ2检验） ，观察组的中医证候疗效明显优于对照组，差异有统计学意义 （P＜0.05） 。（2） CPET指标改善情况方面，治疗后，2组患者的最大摄氧量 （VO2max） 、无氧代谢阈值 （AT） 、代谢当量值 （METs） 、斜率值（VE /VCO2 ） 均较治疗前升高 （P＜0.05） ，且观察组对VO2max、AT、METs、VE/VCO2的升高幅度均明显优于对照组，组间治疗后及治疗前后差值比较，差异均有统计学意义 （P＜0.01） 。 （3） 心功能指标改善情况方面，治疗后，2组患者的LVEF值均较治疗前升高（P＜0.05），血清NT-proBNP水平均较治疗前降低（P＜0.05），且观察组对LVEF值的升高幅度及对血清NT-proBNP水平的降低幅度均明显优于对照组，组间治疗后及治疗前后差值比较，差异均有统计学意义 （P＜0.01） 。 （4） 中医证候积分改善情况方面，治疗后，2组患者的中医证候积分均较治疗前降低 （P＜0.05） ，且观察组对中医证候积分的降低幅度明显优于对照组，组间治疗后及治疗前后差值比较，差异均有统计学意义 （P＜0.01） 。 （5） 安全性方面，治疗过程中，2组患者均无明显不良反应发生，患者的血常规、小便常规、大便常规、肝肾功能均无明显异常变化。 【结论】参七颗粒能显著改善气虚血瘀型HFpEF患者的预后，有效降低血清NT-proBNP水平。

Objective To observe the effect of Shenqi Granules （composed of Ginseng Radix et Rhizoma Rubra and Notoginseng Radix et Rhizoma） on the prognosis of patients suffering from heart failure with preserved ejection fraction （HFpEF） of qi deficiency and blood stasis type. Methods A total of 130 patients with HFpEF of qi deficiency and blood stasis type were randomly divided into the observation group and the control group，with 65 patients in each group. The control group was treated with conventional western medicine，and the observation group was treated with Shenqi Granules on the basis of treatment for the control group. The course of treatment for the two groups covered six months. Before and after treatment，the changes of cardiopulmonary exercise testing （CPET） indicators，left ventricular ejection fraction （LVEF），traditional Chinese medicine （TCM） syndrome scores and serum N-terminal pro-brain natriuretic peptide （NT-proBNP） level in the two groups were observed. After treatment，the efficacy for TCM syndrome and clinical safety in the two groups were evaluated. Results （1） After six months of treatment，the total effective rate of the observation group was 89.23% （58/65） ，and that of the control group was 71.31% （47/65） . The intergroup comparison （by chi-square test） showed that the efficacy for TCM syndrome in the observation group was significantly superior to that in the control group， and the difference was statistically significant （P＜0.05） . （2） After treatment，CPET indicators such as the maximal oxygen uptake （VO2max），anaerobic threshold （AT），metabolic equivalents of task （METs），and slope value （the ratio of ventilation to carbon dioxide production，VE/VCO2） were increased in the two groups when compared with those before treatment （P＜0.05）， and the increase of VO2max， AT， METs， and VE/VCO2 in the observation group was significantly superior to that in the control group. There were statistically significant differences in the post-treatment levels of CPET indicators and in the pre- and post-treatment difference value of CPET indicators between the two groups （P＜0.01） . （3） After treatment，the LVEF values of the two groups were increased （P＜0.05） and the serum NT-proBNP levels were decreased when compared with those before treatment （P＜0.05） ，and the increase of the LVEF value and the decrease of the serum NT-proBNP level in the observation group were significantly superior to those in the control group. And statistically significant differences were shown in the post-treatment levels of cardiac function indicators and in the pre- and post-treatment difference value of cardiac function indicators between the two groups （P＜0.01） . （4） After treatment，the TCM syndrome scores of the two groups of patients were decreased when compared with those before treatment （P＜0.05） ，and the decrease of TCM syndrome scores of the observation group was significantly superior to that of the control group. There were statistically significant differences in the post-treatment scores and in the pre- and post-treatment difference value of scores between the two groups（P＜0.01） . （5） During the treatment，there were no obvious adverse reactions occurring in both groups，or no abnormal changes were shown in the safety indexes such as blood routine test，urine routine test，stool routine test，liver and kidney function examination of the patients. Conclusion Shenqi Granules can significantly improve the prognosis of HFpEF patients with qi deficiency and blood stasis type，and effectively decrease the serum NT-proBNP level.

R259.416

广东省中医药局科研项目 （编号：20203009）