目的 觀察注射用益氣復脈（凍干）對老年性慢性心力衰竭（氣陰兩虛證）患者的中醫(yī)證候及臨床療效。方法 回顧性選取2021年1月—2022年3月淮北市中醫(yī)醫(yī)院心內(nèi)科收治的老年性慢性心力衰竭（氣陰兩虛證）住院患者117例為研究對象，根據(jù)治療方案不同將患者分為對照組（n＝58）和試驗組（n＝59）。對照組患者進行常規(guī)抗心衰治療，試驗組患者在對照組基礎上聯(lián)合注射用益氣復脈（凍干），每次取5.2g注射用益氣復脈（凍干）溶于0.9%氯化鈉注射液250mL中，靜脈滴注，每天1次。兩組療程均為2周。比較兩組患者治療前、治療7d、治療14d中醫(yī)心衰主證候積分、證候總積分、6min步行試驗距離（6MWD）、明尼蘇達生活質(zhì)量（MLHFQ）評分、腦鈉肽（BNP）等指標。比較兩組中醫(yī)證候療效和心功能療效，同時觀察兩組患者不良反應發(fā)生情況。結(jié)果 與治療前比較，兩組治療14d的中醫(yī)主證候積分、證候總積分、6MWD、MLHFQ均顯著改善（P＜0.05、0.01），試驗組治療7d的中醫(yī)主證候積分、證候總積分、6MWD、MLHFQ均顯著改善（P＜0.05），對照組治療7d的主證候積分、證候總積分、6MWD、MLHFQ無統(tǒng)計學意義（P＞0.05）。與治療7d比較，試驗組治療14d中醫(yī)主證候積分、證候總積分、6MWD、MLHFQ、BNP均顯著改善（P＜0.05）。與對照組同期比較，試驗組治療7d的中醫(yī)主證候積分、證候總積分、6MWD、MLHFQ均顯著改善（P＜0.05），試驗組治療14d的中醫(yī)主證候積分、證候總積分、6MWD、MLHFQ、BNP均顯著改善（P＜0.05）。試驗組中醫(yī)證候療效總有效率為91.5%，顯著高于對照組的75.9%（P＜0.05）；試驗組心功能療效總有效率為89.8%，顯著高于對照組的74.1%（P＜0.05）。結(jié)論 注射用益氣復脈（凍干）能更早、更快、更明顯地改善老年性心力衰竭（氣陰兩虛證）患者的臨床癥狀，提高運動耐力及生活質(zhì)量，且中醫(yī)證候、6MWD、MLHFQ的改善優(yōu)先于BNP，在常規(guī)抗心衰治療基礎上加用注射用益氣復脈（凍干）未增加不良反應的發(fā)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

淮北科技計劃資助項目(2021HK034)