目的 探討注射用益氣復(fù)脈（凍干，YQFM）對乳腺癌術(shù)后靶向治療（注射用曲妥珠單抗＋甲苯磺酸拉帕替尼片）后心肌損傷的防治效果。方法 選取2021年3月—2024年3月貴州醫(yī)科大學(xué)附屬醫(yī)院收治的HER-2陽性乳腺癌術(shù)后患者100例，隨機(jī)分為觀察組、對照組各50例。對照組給予注射用曲妥珠單抗＋甲苯磺酸拉帕替尼片治療，21 d為1個周期；觀察組靶向治療同對照組，每個周期靶向治療前3 d使用YQFM，每次8瓶（5.2 g）靜脈滴注，每天1次，連續(xù)使用14 d，于靶向治療前和治療2、4個周期后對兩組患者中醫(yī)癥狀進(jìn)行評分，超聲檢查心臟左室射血分?jǐn)?shù)（LVEF），檢測血清肌酸激酶（CK）、肌酸激酶同工酶（CK-MB）、乳酸脫氫酶（LDH）水平，檢測心肌損傷標(biāo)志物［心肌肌鈣蛋白（cTnI）、腦利尿鈉肽（BNP）］及心電圖變化，并進(jìn)行生活質(zhì)量評分。結(jié)果 靶向治療前，兩組中醫(yī)癥狀積分、心功能、心肌酶、心肌損傷標(biāo)志物等各項指標(biāo)比較，差異均無統(tǒng)計學(xué)意義（P＞0.05）。治療4個周期后，觀察組和對照組總有效率分別為92%、72%，組間比較差異有統(tǒng)計學(xué)意義（P＜0.05）。靶向治療前兩組患者心肌損傷相應(yīng)癥狀（胸悶、胸痛、心悸、畏寒制冷、下肢水腫）的中醫(yī)癥狀積分比較，差異無統(tǒng)計學(xué)意義（P＞0.05）。對照組治療4個周期后心肌損傷中醫(yī)癥狀積分高于同組靶向治療前和治療2個周期（P＜0.05）；觀察組治療2個周期后中醫(yī)癥狀積分顯著高于本組靶向治療前（P＜0.05），治療4個周期后中醫(yī)癥狀積分較本組治療2個周期顯著降低（P＜0.05），基本恢復(fù)至靶向治療前水平；且治療2、4個周期后心肌損傷中醫(yī)癥狀積分觀察組明顯低于同時間點對照組（P＜0.05）。治療2個周期和4個周期后，兩組LVEF均明顯低于同組靶向治療前（P＜0.05），且治療4個周期后明顯低于治療2個周期后（P＜0.05）；但觀察組治療2個周期和4個周期后LVEF均明顯高于對照組（P＜0.05）。對照組治療2、4個周期后血清CK、CK-MB、LDH水平均高于靶向治療前（P＜0.05），且治療4個周期后均明顯高于治療2個周期后（P＜0.05）；觀察組治療2、4個周期后血清CK、CK-MB、LDH水平均明顯高于靶向治療前（P＜0.05），但治療4個周期后血清CK、CK-MB、LDH水平均低于2個周期治療后，且明顯低于同期對照組（P＜0.05）。對照組治療2、4個周期后血清cTnI、BNP水平均高于靶向治療前（P＜0.05），且治療4個周期后均明顯高于治療2個周期后（P＜0.05）；觀察組治療2、4個周期后血清cTnI、BNP水平均高于靶向治療前（P＜0.05），但治療4個周期后血清cTnI、BNP水平均低于治療2個周期后，且明顯低于同期對照組（P＜0.05）。兩組治療2、4個周期后生活質(zhì)量各項指標(biāo)評分均高于本組靶向治療前（P＜0.05），且觀察組明顯高于對照組（P＜0.05）。兩組治療2、4個周期后心電圖異常發(fā)生例數(shù)均較治療前顯著增加（P＜0.05），但觀察組增加例數(shù)（治療2個周期時非特異性ST-T改變例數(shù)除外）少于對照組（P＜0.05）。結(jié)論 YQFM能夠改善HER-2陽性乳腺癌術(shù)后患者靶向治療的臨床癥狀，抑制LVEF下降，保護(hù)心肌，提高患者對靶向治療所致心肌損傷的耐受力，預(yù)防心肌損傷事件發(fā)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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