目的 观察并探讨注射用益气复脉（冻干）（YQFM）联合顺铂对乳腺癌荷瘤小鼠的抗肿瘤作用。方法 接种4T1肿瘤细胞悬液0.1 mL （细胞总数约1×10⁷）于SPF级BALB/C小鼠第4对乳头下方的皮下脂肪垫制备乳腺癌模型。造模小鼠随机分为模型组、顺铂（1 mg/kg）组、YQFM（914 mg/kg，临床等效剂量）组、1/2顺铂（0.5 mg/kg）＋YQFM（914 mg/kg）组、顺铂（1 mg/kg）＋YQFM（914 mg/kg）组，各组小鼠均于接瘤后第7天开始给药，顺铂均ip给药，隔天给药1次，共7次；YQFM均尾iv给药，每天1次，共14 d。模型组同法给予9%氯化钠注射液。观察小鼠生活状态、体质量变化；检测实体瘤质量并计算抑瘤率；测量瘤体积变化；ELISA法检测各组小鼠血清白细胞介素-2 （IL-2）、白细胞介素-4 （IL-4）、γ-干扰素（IFN-γ）、乳酸脱氢酶（LDH）和肿瘤坏死因子-α （TNF-α）、腺嘌呤核苷三磷酸（ATP）水平。结果 与模型组比较，顺铂组、顺铂＋YQFM、1/2顺铂＋YQFM组小鼠从顺铂第3次给药左右开始出现毛发稀疏、掉毛严重、发呆、行动迟缓、喜抱团等现象，1/2顺铂＋YQFM组比单纯顺铂组稍好。与模型组比较，YQFM组体质量显著增加（P<0.05、0.001）；顺铂组体质量增长显著减缓（P<0.05、0.001）； 1/2顺铂＋YQFM组和顺铂＋YQFM组2组小鼠体质量无显著性差异。与模型组比较，顺铂组、1/2顺铂＋YQFM组及顺铂＋YQFM组瘤质量均显著减轻（P<0.05），YQFM＋顺铂组的抑瘤率最佳，1/2顺铂+YQFM组与顺铂组抑瘤效果相当。与模型组比较，顺铂＋YQFM组、顺铂组、1/2顺铂＋YQFM组分别是在给药后第7、9、11天时瘤体积出现显著降低（P<0.05）。与模型组比较，顺铂组、1/2顺铂＋YQFM组及YQFM＋顺铂均能够显著提高IL-2、IL-4、IFN-γ、TNF-α水平和降低ATP的含量（P<0.01、0.001）；顺铂组和1/2顺铂＋YQFM组的LDH含量显著提高（P<0.05）； YQFM也能显著性提高IL-2、IFN-γ、TNF-α含量和降低ATP的含量水平（P<0.01、0.001）。与顺铂组比较，1/2顺铂＋YQFM组的TNF-α含量显著降低（P<0.01）。结论 YQFM与顺铂联合使用对乳腺癌荷瘤小鼠具有一定的增效协同作用。

Objective To observe and investigate the anti-tumor effect of Yiqi Fumai Lyophilized Injection (YQFM) combined with cisplatin on breast cancer-bearing mice. Methods The breast cancer model was prepared by inoculated 0.1 mL of 4T1 tumor cell suspension (about 1×10⁷ cells) into the subcutaneous fat pad below the fourth pair of nipples of SPF BALB/C mice. Model mice were randomly divided into model group, cisplatin (1 mg/kg) group, YQFM (914 mg/kg, clinical equivalent dose) group, 1/2 cisplatin (0.5 mg/kg) +YQFM (914 mg/kg) group, cisplatin (1 mg/kg) +YQFM (914 mg/kg) group, Mice in each group were given cisplatin on the 7th day after tumor grafting, and cisplatin was given ip once every other day for 7 times in total. YQFM was given iv medication, once a day, for 14 days. Model group was given 9% sodium chloride injection. Life status and body weight of mice were observed. The quality of solid tumor was detected and the tumor inhibition rate was calculated. The change of tumor volume was measured. Serum interleukin-2 (IL-2), interleukin-4 (IL-4), γ -interferon (IFN-γ), lactate dehydrogenase (LDH) and tumor necrosis factor -α (TNF-α) and adenine nucleoside triphosphate (ATP) levels were detected by ELISA. Results Compared with model group, mice in cisplatin group, cisplatin + YQFM group and 1/2 cisplatin +YQFM group began to show hair thinning, severe hair loss, trance, slow movement, and agglutination from about the third administration of cisplatin, and the 1/2 cisplatin + YQFM group was slightly better than that in the single cisplatin group. Compared with model group, body weight of YQFM group was significantly increased (P<0.05, 0.001); The increase of body weight in cisplatin group was significantly decreased (P<0.05, 0.001); There was no significant difference in body weight between 1/2 cisplatin + YQFM group and cisplatin +YQFM group. Compared with the model group, the tumor weight of cisplatin group, 1/2 cisplatin + YQFM group and cisplatin +YQFM group was significantly reduced (P<0.05). The tumor inhibition rate of YQFM + cisplatin group was the best, and the tumor inhibition effect of 1/2 cisplatin +YQFM group was similar to that of cisplatin group. Compared with model group, tumor volume in cisplatin +YQFM group, cisplatin group and 1/2 cisplatin +YQFM group was significantly decreased on day 7, 9 and 11 after administration (P<0.05). Compared with model group, cisplatin group, 1/2 cisplatin +YQFM group and YQFM+ cisplatin group could significantly increase the levels of IL-2, IL-4, IFN-γ and TNF-α and decrease the content of ATP (P<0.01, 0.001). LDH content of cisplatin group and 1/2 cisplatin +YQFM group was significantly increased (P<0.05); YQFM also significantly increased the contents of IL-2, IFN-γ, TNF-α and decreased the content of ATP (P<0.01, 0.001). Compared with cisplatin group, the TNF-α content in 1/2 cisplatin +YQFM group was significantly decreased (P<0.01). Conclusion YQFM combined with cisplatin has a certain synergistic effect on breast cancer bearing mice.

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