复方苦参注射液联合贝伐珠单抗治疗肺癌恶性胸腔积液的应用研究

Application study of compound Sophora flavescens injection combined with bevacizumab in the treatment of malignant pleural effusion in lung cancer

目的观察复方苦参注射液联合贝伐珠单抗治疗肺癌恶性胸腔积液(MPE)的临床效果。方法本研究为前瞻性研究,病例纳入南阳市第一人民医院2021年6月至2023年1月收治的100例肺癌患者,所有患者均确认合并MPE,应用电脑随机分组法将其分别列为单抗组(50例)和联合组(50例),单抗组予以贝伐珠单抗治疗,联合组采用复方苦参注射液联合贝伐珠单抗治疗,治疗后均随访1年,比较2组患者的肿瘤标志物,免疫功能,近期疗效及预后情况。结果在不同治疗方案下,联合组的癌胚抗原(CEA)、神经元特异性烯醇化酶(NSE)、糖类抗原125(CA125)分别为(8.4±1.2)ng/ml、(18.3±3.2)ng/ml、(32.3±5.2)U/ml,均低于单抗组[(10.3±2.4)ng/ml、(20.4±3.2)ng/ml、(35.4±5.4)U/ml];联合组的免疫球蛋白A(IgA)、免疫球蛋白G(IgG)、免疫球蛋白M(IgM)分别为(3.3±0.4)g/L、(20.3±5.2)g/L、(3.2±0.4)g/L,均高于单抗组[(2.85±0.42)g/L、(18.43±3.25)g/L、(2.46±0.77)g/L];联合组的客观缓解率(ORR)、疾病控制率(DCR)分别为84.0%(42/50)、90.0%(45/50),均高于单抗组[60.0%(30/50)、68.0%(34/50)];联合一年内生存率、中位无进展生存期(PFS)、中位总生存期(OS)分别为92.0%(46/50)、(10.3±2.1)个月、(11.4±2.3)个月,均高于单抗组[74.0%(37/50)、(9.12±2.35)个月、(10.25±2.19)个月],差异均具有统计意义(P<0.05);联合组的不良反应发生率10.0%(5/50)与单抗组6.0%(3/50)比较,差异无统计学意义(P>0.05)。结论复方苦参注射液联合贝伐珠单抗能下调MPE患者的肿瘤标志物水平并改善免疫功能,对增强患者近期疗效、改善短期预后均有积极意义。

Objective To observe the clinical efficacy of the compound Sophora flavescens injection combined with bevacizumab in treating malignant pleural effusion(MPE).Methods This study is a prospective study of 100 lung cancer patients admitted to our hospital from June 2021 to January 2023.All patients were confirmed to have MPE and were randomly assigned to the monoclonal antibody group(50 cases)and the combination group(50 cases)using computer randomization.The monoclonal antibody group was treated with bevacizumab,while the combination group was treated with compound Sophora flavescens injection combined with bevacizumab.After treatment,all patients were followed up for one year to compare their tumor markers,immune function,recent efficacy,and prognosis.Results Under different treatment regimens,the carcinoma embryonic antigen(CEA),neuron-specific enolase(NSE),and carbohydrate antigen(CA)125 of the combination group were(8.4±1.2)ng/ml,(18.3±3.2)ng/ml,and(32.3±5.2)U/ml,lower than the monoclonal antibody group[(10.3±2.4)ng/ml,(20.4±3.2)ng/ml,and(35.4±5.4)U/ml].The IgA,IgG,and IgM of the combination group were(3.3±0.4)g/L,(20.3±5.2)g/L,and(3.2±0.4)g/L,higher than the monoclonal antibody group[(2.85±0.42)g/L,(18.4±3.2)g/L,and(2.5±0.8)g/L].The objective remission rate(ORR)and disease control rate(DCR)of the combination group were 84.0%(42/50)and 90.0%(45/50),higher than the monoclonal antibody group[60.0%(30/50)and 68.0%(34/50)].The combination group′s one-year survival rate,median progression-free survival(PFS),and median overall survival(OS)were 92.0%(46/50),(10.3±2.1)months and(11.4±2.3)months,higher than the monoclonal antibody group[74.0%(37/50),(9.1±2.4)months,and(10.2±2.3)months](P<0.05).The incidence of adverse reactions in the combination group was approximately 10.0%(5/50)compared to 6.0%(3/50)in the monoclonal antibody group (P>0.05). Conclusion The combination of compound Sophora flavescens injection and bevacizumab can downregulate tumor marker levels and improve immune function in MPE patients, which has a positive significance in enhancing short-term efficacy and improving short-term prognosis.