摘要
目的 观察复方苦参注射液联合化疗治疗乳腺癌伴破溃患者的临床疗效及安全性。方法 采用前瞻性随机对照临床研究设计,纳入2022年4月—2024年4月首都医科大学附属北京中医医院肿瘤科住院的乳腺癌伴有胸壁肿物破溃的患者共70例,随机分为对照组35例,治疗组35例。对照组采用TP(白蛋白紫杉醇联合顺铂)方案化疗,治疗组采用TP方案化疗联合复方苦参注射液,观察两组患者肿瘤破溃缓解率、肿瘤客观缓解率(objective response rate, ORR)、疾病控制率(disease control rate, DCR)、乳腺癌患者生存质量测定量表(functional assessment of cancer therapy-breast, FACT-B)测定生活质量评分、不良反应发生率等指标评价中西结合治疗乳腺癌肿瘤破溃临床疗效及安全性。结果 两组患者治疗后,治疗组患者肿瘤的客观缓解率及疾病控制率分别为65.7%(23/35)、82.8%(29/35),对照组患者的肿瘤客观缓解率及疾病控制率分别为40%(14/35)、60%(21/35),治疗组近期疗效明显优于对照组(P<0.05);治疗组患者的肿瘤破溃缓解率为80.0%(28/35),高于对照组57.1%(P<0.05),两组患者治疗前后FACT量表多维度生活质量评分均较治疗前提高,且治疗组患者优于对照组,差异具有统计学意义(P<0.05),在骨髓抑制、消化道反应等不良反应方面两组患者发生率相似(P>0.05)。结论 复方苦参注射液联合化疗治疗乳腺癌伴肿瘤破溃患者具有较好的疗效,可提高化疗客观缓解率及疾病控制率,提高肿物破溃好转率,改善乳腺癌患者生活质量,并且安全性良好,未显著增加不良反应。
Objective To evaluate the clinical efficacy of Compound Kushen Injection(复方苦参注射液)combined with chemotherapy in the treatment of breast cancer patients with ulceration.Methods A prospective randomized controlled clinical research design was adopted.Totally 70 patients with breast cancer accompanied by chest wall tumor collapse were enrolled in the oncology department of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University from April 2022 to April 2024.They were randomly divided into 35 patients in the control group and 35 patients in the treatment group.The control group was treated with TP(albumin paclitaxel combined with cisplatin)regimen chemotherapy,and the treatment group was treated with TP regimen chemotherapy combined with Compound Kushen Injection.Tumor collapse response rate,objective response rate(ORR),disease control rate(DCR),FACT-B quality and adverse reaction rate of the two groups were observed to evaluate the clinical efficacy and safety of integrated Chinese and western medicine in the treatment of breast cancer tumor collapse.Results After treatment,the ORR and DCR of the treatment group were 65.7%(23/35)and 82.8%(29/35),respectively,while the objective remission rate and disease control rate of the control group were 40%(14/35)and 60%(27/35),respectively.The short-term efficacy of the treatment group was significantly better than that of the control group(P<0.05).The tumor rupture relief rate of the treatment group was 80.0%(28/35),which was higher than that(57.1%,20/35)of the control group(P<0.05).The multidimensional quality of life scores of FACT scale were improved in both groupsafter treatment,and the quality of of treatment group was better than that of the control group,with statistical significance(P<0.05).The incidence of adverse reactions such as bone marrow suppression and gastrointestinal reactions was similar between the two groups(P>0.05).Conclusion Compound Kushen Injection combined with chemotherapy has good efficacy in the treatment of breast cancer patients with tumor ulceration.It can improve the ORR and DCR of chemotherapy,the improvement rate of tumor ulceration and the quality of life of breast cancer patients,and has good safety without significantly increasing adverse reactions.
作者
薛娜
李欣
许炜茹
张怡
于明薇
张青
富琦
刘声
杨霖
XUE Na;LI Xin;XU Weiru;ZHANG Yi;YU Ming wei;ZHANG Qing;FU Qi;LIU Sheng;YANG Lin(Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China;Graduate School of Beijing University of Chinese Medicine,Beijing 100010,China)
出处
《辽宁中医杂志》
北大核心
2025年第7期60-63,共4页
Liaoning Journal of Traditional Chinese Medicine
基金
北京市科技计划项目(Z221100007422108)。
关键词
乳腺癌
破溃
化疗
复方苦参注射液
breast cancer
ulceration
chemotherapy
Compound Kushen Injection(复方苦参注射液)
