目的 探讨复方斑蝥胶囊联合TP方案（紫杉醇＋顺铂）治疗晚期卵巢癌的临床疗效。方法 选取2022年9月—2024年9月中国人民解放军北部战区总医院收治的114例晚期卵巢癌患者为研究对象，将患者以信封抽签法分为对照组和治疗组，每组各57例。对照组使用TP化疗方案治疗。在第1～3天静脉滴注注射用顺铂60 mg/m²，加入0.9%氯化钠注射液500 mL中稀释，滴注时间持续2 h。在第1天静脉滴注紫杉醇注射液135 mg/m²，加入到0.9%氯化钠注射液500 mL中，持续时间为2～3 h。治疗组在对照组基础上口服复方斑蝥胶囊，0.75 g/次，2次/d。以21 d为1个周期，两组连续治疗3个周期。对比两组间临床疗效、生活质量、肿瘤标志物、血管生成因子和细胞免疫功能指标。结果 治疗组的客观缓解率（ORR）、疾病控制率（DCR）均高于对照组（P＜0.05）。治疗后，两组的KPS评分、QOL评分显著升高（P＜0.05），且治疗组的KPS评分、QOL评分高于对照组（P＜0.05）。治疗后，两组血清甲胎蛋白（AFP）、人附睾蛋白4（HE4）、糖类抗原125（CA125）水平均显著降低（P＜0.05），治疗组血清AFP、HE4、CA125水平低于对照组（P＜0.05）。治疗后，两组血清血管内皮生长因子（VEGF）、成纤维细胞生长因子（FGF）、基质细胞衍生因子-1α（SDF-1α）水平均降低（P＜0.05），治疗组血清VEGF、FGF、SDF-1α水平均低于对照组（P＜0.05）。治疗后，两组CD8⁺显著升高，CD3⁺、CD4⁺、CD4⁺/CD8⁺显著降低（P＜0.05），且治疗组CD8⁺高于对照组，CD3⁺、CD4⁺、CD4⁺/CD8⁺低于对照组（P＜0.05）。结论 复方斑蝥胶囊与TP方案联合治疗可提升晚期卵巢癌患者的临床疗效，可降低肿瘤标志物和血管生成因子，提高机体免疫力。

Objective To investigate the clinical efficacy of Compound Banmao Capsules combined with TP regimen (paclitaxel + cisplatin) in treatment of advanced ovarian cancer. Methods A total of 114 patients with advanced ovarian cancer admitted to General Hospital of Northern Theater Command of PLA from September 2022 to September 2024 were selected as the study subjects. The patients were divided into control group and treatment group by sealed envelope drawing, with 57 cases in each group. Patients in the control group received the TP chemotherapy regimen. Patients in the control group were iv administered with Cisplatin for injection 60 mg/m² on day 1 to 3, diluted in 500 mL of 0.9% sodium chloride injection, with an infusion duration of 2 h. In the same time, patients in the control group were iv administered with Paclitaxel Injection 135 mg/m² on day 1, diluted in 500 mL of 0.9% sodium chloride injection, with an infusion duration of 2 to 3 h. Patients in the treatment group were po administered with Compound Banmao Capsules on the base of control group at a dose of 0.75 g/time, twice daily. A course had 21 d, and two groups were treated continuously for three courses. The clinical efficacy, quality of life, tumor markers, angiogenic factors, and cellular immune function indicators were compared between two groups. Results The objective response rate (ORR) and disease control rate (DCR) in the treatment group were higher than those in the control group (P < 0.05). After treatment, the Karnofsky Performance Status (KPS) score and Quality of Life (QOL) score significantly increased in two groups (P< 0.05), and the KPS scores and QOL scores in the treatment group were higher than those of the control group (P < 0.05). After treatment, the serum levels of alpha-fetoprotein (AFP), human epididymis protein 4 (HE4), and carbohydrate antigen 125 (CA125) significantly decreased in two groups (P< 0.05), and the serum levels of AFP, HE4, and CA125 in the treatment group were lower than those of the control group (P < 0.05). After treatment, the serum levels of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and stromal cell-derived factor-1α (SDF-1α) decreased in two groups (P < 0.05), and the serum levels of VEGF, FGF, and SDF-1α in the treatment group were lower than those in the control group (P < 0.05). After treatment, the level of CD8⁺ significantly increased, while CD3⁺, CD4⁺, and CD4⁺/CD8⁺ significantly decreased in two groups (P < 0.05). The level of CD8⁺ in the treatment group were higher than those in the control group, but CD3⁺, CD4⁺, and CD4⁺/CD8⁺ ratios were lower than those in the control group (P < 0.05). Conclusion The combination therapy of Compound Banmao Capsules and TP regimen can improve the clinical efficacy of advanced ovarian cancer patients, reduce tumor markers and angiogenic factors, and enhance the body's immunity.

R979.1

辽宁省科学技术计划项目（2023JH2/101700089）