中国药物应用与监测

目的 探究多柔比星(DOX)脂质体相关新辅助化疗治疗乳腺癌的疗效。方法 前瞻性纳入2020年1月至2023年1月河南科技大学第一附属医院收治的60例乳腺癌患者，通过随机数字表法将其分为常规组和脂质体组，每组30例。常规组采用DOX、环磷酰胺(CPA)序贯多西他赛(DTX)新辅助化疗，脂质体组采用DOX脂质体、CPA序贯DTX新辅助化疗，21 d为1个周期，两组均治疗8个周期。两组均随访至手术治疗。比较两组的疗效、手术治疗情况、不良反应发生情况以及治疗前后肿瘤标志物、生活质量。结果 治疗8个周期后，脂质体组总有效率为76.67%(23/30)，高于常规组的50.00%(15/30)(χ²=4.593,P<0.05)。脂质体组手术时间和术中出血量分别为(73.23±8.68)min和(190.73±17.88)m L，常规组分别为(84.88±7.77)min和(226.31±20.79)m L，差异有统计学意义(t=5.477、7.107，均P<0.05)。治疗8个周期后，两组血清CA19-9、CEA、CA15-3水平均降低，且脂质体组[分别为(41.42±6.23)U/L、(14.71±2.44)μg/L、(88.37±9.26)U/L]低于常规组[分别为(46.81±5.16)U/L、(19.73±2.12)μg/L、(97.10±9.29)U/L](t=3.649、8.506、3.645，均P<0.05)。治疗8个周期后，两组总功能领域、总体健康状况评分均升高，脂质体组[(78.21±7.37)、(74.11±6.17)分]高于常规组[(69.06±6.26)、(63.00±6.96)分](t=5.183、6.542，均P<0.05)；两组症状领域评分降低，脂质体组[(54.05±5.39)分]低于常规组[(60.67±5.26)分](t=4.815,P<0.05)。治疗期间，脂质体组白细胞减少和脱发的发生率[33.33%(10/30)、26.67%(8/30)]低于常规组[60.00%(18/30)、53.33%(16/30)](χ²=4.286、4.444，均P<0.05)。结论 DOX脂质体相关新辅助化疗治疗乳腺癌的疗效较好，可改善后续手术治疗指标，降低血清肿瘤标志物水平，提高患者生活质量，安全性更高。

Objective To explore the efficacy of liposomal doxorubicin(DOX)-based neoadjuvant chemotherapy in the treatment of patients with breast cancer. Methods A total of 60 patients with breast cancer admitted to the First Affiliated Hospital of Henan University of Science and Technology from January 2020 to January 2023 were prospectively included and divided into the conventional group and the liposome group by random number table method, with 30 cases in each group. The conventional group received neoadjuvant chemotherapy with DOX and cyclophosphamide(CPA) followed by docetaxel(DTX), while the liposome group received liposomal DOX and CPA followed by DTX. One treatment cycle was defined as 21 days, and both groups were treated for 8 cycles. Both groups were followed up until surgery. The curative effect, surgical treatment conditions, incidence of adverse reactions, tumor markers levels, and quality of life before and after treatment were compared between the two groups. Results After 8 cycles of treatment, the total effective rate in the liposome group was 76.67%(23/30), higher than that in the conventional group(50.00%(15/30))(χ²=4.593, P<0.05). The surgical duration and intraoperative blood loss in the liposome group were(73.23±8.68) min and(190.73±17.88) mL, compared to(84.88±7.77) min and(226.31±20.79) mL in the conventional group, with statistically significant differences(t=5.477, 7.107, both P<0.05). After 8 cycles of treatment, the serum levels of carbohydrate antigen 19-9(CA19-9), carcinoembryonic antigen, and CA15-3 decreased in the two groups, and the levels in the liposome group((41.42±6.23) U/L,(14.71±2.44) μg/L,(88.37±9.26) U/L, respectively) were lower than those in the conventional group((46.81±5.16) U/L,(19.73±2.12) μg/L,(97.10±9.29) U/L, respectively)(t=3.649, 8.506, 3.645, all P<0.05). After 8 cycles of treatment, scores in the functional domains and overall health status improved in both groups, and the scores in the liposome group((78.21±7.37),(74.11±6.17) points) were higher than those in the conventional group((69.06±6.26),(63.00±6.96) points)(t=5.183, 6.542, both P<0.05). Symptom domain scores decreased in both groups, with lower scores in the liposome group((54.05±5.39) points) than in the conventional group((60.67±5.26) points)(t=4.815, P<0.05). During treatment, the incidence of leukopenia and alopecia in the liposome group(33.33%(10/30) and 26.67%(8/30)) was lower than that in the conventional group(60.00%(18/30) and 53.33%(16/30))(χ²=4.286, 4.444, both P<0.05). Conclusion Liposomal doxorubicin-based neoadjuvant chemotherapy demonstrates favorable efficacy in breast cancer treatment. It improves subsequent surgical outcomes, reduces serum tumor marker levels, enhances patient quality of life, and exhibits a better safety profile.