目的 观察注射用益气复脉（冻干）对老年性慢性心力衰竭（气阴两虚证）患者的中医证候及临床疗效。方法 回顾性选取2021年1月—2022年3月淮北市中医医院心内科收治的老年性慢性心力衰竭（气阴两虚证）住院患者117例为研究对象，根据治疗方案不同将患者分为对照组（n＝58）和试验组（n＝59）。对照组患者进行常规抗心衰治疗，试验组患者在对照组基础上联合注射用益气复脉（冻干），每次取5.2g注射用益气复脉（冻干）溶于0.9%氯化钠注射液250mL中，静脉滴注，每天1次。两组疗程均为2周。比较两组患者治疗前、治疗7d、治疗14d中医心衰主证候积分、证候总积分、6min步行试验距离（6MWD）、明尼苏达生活质量（MLHFQ）评分、脑钠肽（BNP）等指标。比较两组中医证候疗效和心功能疗效，同时观察两组患者不良反应发生情况。结果 与治疗前比较，两组治疗14d的中医主证候积分、证候总积分、6MWD、MLHFQ均显著改善（P＜0.05、0.01），试验组治疗7d的中医主证候积分、证候总积分、6MWD、MLHFQ均显著改善（P＜0.05），对照组治疗7d的主证候积分、证候总积分、6MWD、MLHFQ无统计学意义（P＞0.05）。与治疗7d比较，试验组治疗14d中医主证候积分、证候总积分、6MWD、MLHFQ、BNP均显著改善（P＜0.05）。与对照组同期比较，试验组治疗7d的中医主证候积分、证候总积分、6MWD、MLHFQ均显著改善（P＜0.05），试验组治疗14d的中医主证候积分、证候总积分、6MWD、MLHFQ、BNP均显著改善（P＜0.05）。试验组中医证候疗效总有效率为91.5%，显著高于对照组的75.9%（P＜0.05）；试验组心功能疗效总有效率为89.8%，显著高于对照组的74.1%（P＜0.05）。结论 注射用益气复脉（冻干）能更早、更快、更明显地改善老年性心力衰竭（气阴两虚证）患者的临床症状，提高运动耐力及生活质量，且中医证候、6MWD、MLHFQ的改善优先于BNP，在常规抗心衰治疗基础上加用注射用益气复脉（冻干）未增加不良反应的发生。

Objective To observe the TCM syndrome and clinical effect of Yiqi Fumai Lyophilized Injection on elderly patients with chronic heart failure (deficiency of Qi and Yin syndrome).Methods A total of 117 elderly patients with chronic heart failure (deficiency of Qi and Yin syndrome) admitted to the Department of Cardiology of Huaibei Hospital of Traditional Chinese Medicine from January 2021 to March 2022 were selected retrospectively as the research objects. The patients were divided into the control group (n = 58) and the experimental group (n = 59) according to different treatment schemes. The patients in the control group were treated with conventional anti heart failure therapy. The patients in the experimental group were treated with Yiqi Fumai Lyophilized Injection on the basis of the control group. 5.2 g of Yiqi Fumai Lyophilized Injection was taken each time and dissolved in 250 mL of 0.9% sodium chloride injection, intravenous drip, once a day. The course of treatment was two weeks in both groups. The main syndrome score of TCM, total TCM syndrome score, 6-minute walk test distance (6MWD), Minnesota quality of life (MLHFQ) score, brain natriuretic peptide (BNP) and other indicators of the two groups were compared before treatment, seven days of treatment and 14 days of treatment. The curative effect of TCM syndrome and cardiac function of the two groups were compared, and the adverse reactions of the two groups were observed.Results Compared with before treatment, the main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ of the two groups were significantly improved after 14 days of treatment (P <0.05, 0.01). The main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ of the experimental group were significantly improved after seven days of treatment (P <0.05). The main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ of the control group were not statistically significant after seven days of treatment (P>0.05). Compared with seven days of treatment, the main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ, BNP of the experimental group were significantly improved after 14 days of treatment (P <0.05). Compared with the control group in the same period, the main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ of the experimental group were significantly improved after seven days of treatment (P <0.05), while the main syndrome score of TCM, total TCM syndrome score, 6MWD, MLHFQ, BNP of the experimental group were significantly improved after 14 days of treatment (P <0.05). The total effective rate of TCM syndrome in the experimental group was 91.5%, which was significantly higher than that in the control group (75.9%, P <0.05). The total effective rate of cardiac function in the experimental group was 89.8%, which was significantly higher than that in the control group (74.1%, P <0.05).Conclusion Yiqi Fumai Lyophilized Injection can improve the clinical symptoms, exercise endurance and quality of life of eldly patients with heart failure (deficiency of Qi and Yin syndrome) earlier, faster and more obviously, and the improvement of TCM syndrome, 6MWD, MLHFQ is prior to BNP. The addition of Yiqi Fumai Lyophilized Injection on the basis of conventional anti heart failure treatment did not increase the occurrence of adverse reactions.

R972

淮北科技计划资助项目(2021HK034)