目的 探讨注射用益气复脉（冻干，YQFM）对乳腺癌术后靶向治疗（注射用曲妥珠单抗＋甲苯磺酸拉帕替尼片）后心肌损伤的防治效果。方法 选取2021年3月—2024年3月贵州医科大学附属医院收治的HER-2阳性乳腺癌术后患者100例，随机分为观察组、对照组各50例。对照组给予注射用曲妥珠单抗＋甲苯磺酸拉帕替尼片治疗，21 d为1个周期；观察组靶向治疗同对照组，每个周期靶向治疗前3 d使用YQFM，每次8瓶（5.2 g）静脉滴注，每天1次，连续使用14 d，于靶向治疗前和治疗2、4个周期后对两组患者中医症状进行评分，超声检查心脏左室射血分数（LVEF），检测血清肌酸激酶（CK）、肌酸激酶同工酶（CK-MB）、乳酸脱氢酶（LDH）水平，检测心肌损伤标志物［心肌肌钙蛋白（cTnI）、脑利尿钠肽（BNP）］及心电图变化，并进行生活质量评分。结果 靶向治疗前，两组中医症状积分、心功能、心肌酶、心肌损伤标志物等各项指标比较，差异均无统计学意义（P＞0.05）。治疗4个周期后，观察组和对照组总有效率分别为92%、72%，组间比较差异有统计学意义（P＜0.05）。靶向治疗前两组患者心肌损伤相应症状（胸闷、胸痛、心悸、畏寒制冷、下肢水肿）的中医症状积分比较，差异无统计学意义（P＞0.05）。对照组治疗4个周期后心肌损伤中医症状积分高于同组靶向治疗前和治疗2个周期（P＜0.05）；观察组治疗2个周期后中医症状积分显著高于本组靶向治疗前（P＜0.05），治疗4个周期后中医症状积分较本组治疗2个周期显著降低（P＜0.05），基本恢复至靶向治疗前水平；且治疗2、4个周期后心肌损伤中医症状积分观察组明显低于同时间点对照组（P＜0.05）。治疗2个周期和4个周期后，两组LVEF均明显低于同组靶向治疗前（P＜0.05），且治疗4个周期后明显低于治疗2个周期后（P＜0.05）；但观察组治疗2个周期和4个周期后LVEF均明显高于对照组（P＜0.05）。对照组治疗2、4个周期后血清CK、CK-MB、LDH水平均高于靶向治疗前（P＜0.05），且治疗4个周期后均明显高于治疗2个周期后（P＜0.05）；观察组治疗2、4个周期后血清CK、CK-MB、LDH水平均明显高于靶向治疗前（P＜0.05），但治疗4个周期后血清CK、CK-MB、LDH水平均低于2个周期治疗后，且明显低于同期对照组（P＜0.05）。对照组治疗2、4个周期后血清cTnI、BNP水平均高于靶向治疗前（P＜0.05），且治疗4个周期后均明显高于治疗2个周期后（P＜0.05）；观察组治疗2、4个周期后血清cTnI、BNP水平均高于靶向治疗前（P＜0.05），但治疗4个周期后血清cTnI、BNP水平均低于治疗2个周期后，且明显低于同期对照组（P＜0.05）。两组治疗2、4个周期后生活质量各项指标评分均高于本组靶向治疗前（P＜0.05），且观察组明显高于对照组（P＜0.05）。两组治疗2、4个周期后心电图异常发生例数均较治疗前显著增加（P＜0.05），但观察组增加例数（治疗2个周期时非特异性ST-T改变例数除外）少于对照组（P＜0.05）。结论 YQFM能够改善HER-2阳性乳腺癌术后患者靶向治疗的临床症状，抑制LVEF下降，保护心肌，提高患者对靶向治疗所致心肌损伤的耐受力，预防心肌损伤事件发生。

Objective To investigate the preventive and therapeutic effect of Yiqi Fumai Lyophilized Injection (YQFM) on myocardial injury after targeted therapy (trastuzumab for injection + lapatinib toluenesulfonate tablets) for breast cancer surgery. Methods A total of 100 patients with HER-2 positive breast cancer admitted to the Affiliated Hospital of Guizhou Medical University from 2021 March to 2024 March were randomly divided into an observation group and a control group with 50 patients in each group. The control group was treated with injection of trastuzumab and lapatinib tosylate tablets for 21 d per cycle. The observation group received targeted therapy similar to the control group. Three days before each targeted therapy cycle, YQFM was used, with eight bottles (5.2 g) intravenously administered once a day for 14 consecutive days. The traditional Chinese medicine symptoms of the two groups of patients were scored before targeted therapy and after two and four cycles of treatment. The left ventricular ejection fraction (LVEF) was examined by ultrasound, serum creatine kinase (CK), creatine kinase isoenzyme (CK-MB), lactate dehydrogenase (LDH) levels were detected, myocardial injury markers [cardiac troponin I), brain natriuretic peptide (BNP)] and electrocardiogram changes were detected, and the quality of life was evaluated. Results Before targeted therapy, there was no statistically significant difference in various indicators such as traditional Chinese medicine symptom scores, heart function, myocardial enzymes, and myocardial injury markers between the two groups (P > 0.05). After four cycles of treatment, the total effective rates of the observation group and the control group were 92% and 72%, respectively, and the difference between the groups was statistically significant (P < 0.05). There was no statistically significant difference (P > 0.05) in the TCM symptom scores of myocardial injury symptoms (chest tightness, chest pain, palpitations, chills, and lower limb edema) between the two groups of patients before targeted therapy. After two and four cycles of treatment, LVEF in both groups was significantly lower than before targeted therapy in the same group (P < 0.05), and after four cycles of treatment, LVEF was significantly lower than after two cycles of treatment (P < 0.05); However, the LVEF of the observation group was significantly higher than that of the control group after two and four cycles of treatment (P < 0.05). The levels of serum CK, CK-MB, and LDH in the control group were higher than before targeted therapy after two and four cycles of treatment (P < 0.05), and were significantly higher after four cycles of treatment than after two cycles of treatment (P < 0.05). The serum CK-MB and LDH levels in the observation group were significantly higher than before targeted therapy after two and four cycles of treatment (P < 0.05), but the serum CK-MB and LDH levels were lower than those after two cycles of treatment and significantly lower than those in the control group at the same time (P < 0.05). The serum levels of cTnI and BNP in the control group were higher than before targeted therapy after two and four cycles of treatment (P < 0.05), and were significantly higher after four cycles of treatment than after two cycles of treatment (P < 0.05). After two and four cycles of treatment, the serum levels of cTnI and BNP in the observation group were higher than before targeted therapy (P < 0.05), but after four cycles of treatment, the serum levels of cTnI and BNP were lower than after two cycles of treatment and significantly lower than those in the control group at the same time (P < 0.05). After two and four cycles of treatment, the scores of various indicators of quality of life in both groups were higher than before targeted treatment in this group (P < 0.05), and the observation group was significantly higher than the control group (P < 0.05). After two and four cycles of treatment, the number of abnormal electrocardiograms in both groups increased significantly compared to before treatment (P < 0.05), but the increase in the observation group was less than that in the control group (P < 0.05). Conclusion YQFM can improve the clinical symptoms of HER-2 positive breast cancer patients after targeted therapy, inhibit the decline of LVEF, protect myocardium, improve patients' tolerance to myocardial injury caused by targeted therapy, and prevent myocardial injury events.

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