目的 分析华蟾素注射液联合盐酸安罗替尼胶囊治疗恶性浆膜腔积液的临床效果。方法 选取2023年1月—2024年1月无锡市锡山人民医院收治的64例恶性浆膜腔积液患者，根据随机数字表法将患者分为对照组（31例）和治疗组（30例）。对照组患者餐后30 min温水送服盐酸安罗替尼胶囊，体质量≤60 kg患者，8 mg/次，体质量＞60 kg患者，12 mg/次，1次/d。治疗组在对照组基础上于浆膜腔穿刺置管术排出积液后灌注华蟾素注射液，胸腔灌注40～125 mL，腹腔灌注40～150 mL，心包灌注10～50 mL，使用生理盐水稀释，每周3次。两组患者均在2周治疗完成后，持续观察至少4周，结束时评估疗效。比较两组患者的临床疗效、健康状况、积液相关指标、不良反应、生存情况。结果 治疗组的疾病控制率为93.33%，高于对照组的疾病控制率70.97%（P＜0.05）。治疗后，两组KPS评分较治疗前显著升高（P＜0.05），治疗组KPS评分高于对照组（P＜0.05）。治疗后，两组积液中血管内皮生长因子（VEGF）、低氧诱导因子-1α（HIF-1α）水平较治疗前显著降低（P＜0.05），治疗组积液中VEGF、HIF-1α水平低于对照组（P＜0.05）。治疗组患者高血压、皮疹、腹泻3级占比低于对照组（P＜0.05），无进展生存时间长于对照组（P＜0.05）。结论 华蟾素注射液联合盐酸安罗替尼胶囊治疗恶性浆膜腔积液能增效减毒，可改善患者健康状态，降低积液中VEGF、HIF-1α水平，延长患者无进展生存时间。

Objective To analyze the clinical efficacy of Cinobufacin Injection combined with Anlotinib Hydrochloride Capsules in treatment of malignant serous cavity effusion.Methods 64 Malignant serous cavity effusion patients admitted to Wuxi Xishan People's Hospital from January 2023 to January 2024 were selected and divided into control group (31 cases) and treatment group (30 cases) using a random number table method. The control group received oral administration of Anlotinib Hydrochloride Capsules with warm water 30 min after meals, once daily, 8 mg/time for patients with a body weight of ≤ 60 kg, and 12 mg/time for patients with a body weight of >60 kg. On the basis of the control group, the treatment group was treated with Cinobufacin Injection. After the discharge of fluid through the serosal cavity puncture and catheterization, Cinobufacin Injection was infused into the chest cavity with 40 — 125 mL, the abdominal cavity with 40 — 150 mL, and the pericardium with 10 — 50 mL, diluted with physiological saline, three times weekly. Both groups of patients were observed continuously for at least 4 weeks after completing 2 weeks of treatment, and the efficacy was evaluated at the end. The clinical efficacy, health status, fluid related indicators, adverse reactions, and survival status of two groups of patients were compared.Results The disease control rate of the treatment group was 93.33%, which was higher than the disease control rate of 70.97% in the control group (P < 0.05). After treatment, the KPS scores of both groups were significantly increased compared to those before treatment (P < 0.05), and the KPS scores in the treatment group were higher than those in the control group (P < 0.05). After treatment, the fluid levels of VEGF and HIF-1α in both groups were significantly reduced compared to those before treatment (P < 0.05). The fluid levels of VEGF and HIF-1α in the treatment group were lower than those in the control group (P < 0.05). The proportion of grade 3 hypertension, rash, and diarrhea in the treatment group was lower than that in the control group (P < 0.05), and the progression free survival time was longer than that in the control group (P < 0.05).Conclusion The combination of Cinobufacin Injection and Anlotinib Hydrochloride Capsules can enhance efficacy and reduce toxicity in treatment of malignant serous cavity effusion, improve the health status of patients, reduce the fluid levels of VEGF and HIF-1α, and prolong the progression free survival time of patients.

R979.1

江苏大学临床医学科技发展基金项目（JLY2021126）