重组人血管内皮抑制素联合复方苦参注射液腹腔灌注治疗消化道肿瘤恶性腹腔积液的疗效观察

Efficacy of Recombinant Human Vascular Endostatin Combined with Compound Kushen Injection by Intraperitoneal Infusion in the Treatment of Malignant Peritoneal Effusion of Gastrointestinal

目的:探讨重组人血管内皮抑制素联合复方苦参注射液腹腔灌注治疗消化道肿瘤恶性腹腔积液的临床疗效和安全性。方法:采用前瞻性研究,按照随机数字表法,将2020年8月至2023年2月该院92例消化道肿瘤恶性腹腔积液患者分为对照组(46例,使用5-氟尿嘧啶治疗)和观察组(46例,使用重组人血管内皮抑制素+复方苦参注射液治疗)。治疗3周后,比较两组患者的临床疗效、肿瘤标志物[癌胚抗原(CEA)、糖类抗原199(CA199)、糖类抗原125(CA125)]水平和不良反应发生率。结果:持续腹腔灌注治疗3周后,观察组患者的客观缓解率相比对照组更高[71.74%(33/46)vs.39.13%(18/46)],差异有统计学意义(P<0.05)。经过3周的治疗,两组患者的血清肿瘤标志物(CEA、CA199、CA125)水平均降低,且观察组患者低于对照组,差异均有统计学意义(P<0.05)。治疗期间,观察组患者的血细胞毒性发生率为8.70%(4/46),明显低于对照组的32.61%(15/46);观察组的总体不良反应发生率低于对照组[36.96%(17/46)vs.71.74%(33/46)],差异均有统计学意义(P<0.05)。结论:采用重组人血管内皮抑制素联合复方苦参注射液腹腔灌注治疗晚期消化道肿瘤恶性腹腔积液患者,能够有效控制疾病进展,改善临床症状及疾病预后,安全性相对较高。

OBJECTIVE:To probe into the clinical efficacy and safety of recombinant human vascular endostatin combined with compound Kushen injection by intraperitoneal infusion in the treatment of malignant peritoneal effusion of gastrointestinal tumors.METHODS:This study was a prospective study,92 patients with malignant peritoneal effusion of gastrointestinal tumors admitted into the hospital from Aug.2020 to Feb.2023 were extracted to be divided into the control group(46 cases,5-fluorouracil)and observation group(46 cases,recombinant human vascular endostatin+compound Kushen injection)according to the random number table method.After treatment of 3 weeks,the clinical efficacy,tumor markers[carcinoembryonic antigen(CEA),carbohydrate antigen 199(CA199),and carbohydrate antigen 125(CA125)]levels and incidence of adverse drug reactions were compared between two groups.RESULTS:After 3 weeks of continuous peritoneal perfusion,the objective response rate in the observation group was higher than that in the control group[71.74%(33/46)vs.39.13%(18/46)],with statically significant difference(P<0.05).After treatment of 3 weeks,the serum tumor markers(CEA,CA199,and CA125)in two groups decreased,and the observation group was lower than the control group,with statically significant difference(P<0.05).During the treatment period,the incidence of blood cytotoxicity in the observation group was 8.70%(4/46),significantly lower than 32.61%(15/46)in the control group,and the overall incidence of adverse drug reactions in the observation group were lower than that in control group[36.96%(17/46)vs.71.74%(33/46)],with statically significant difference(P<0.05).CONCLUSIONS:Recombinant human vascular endostatin combined with compound Kushen injection in the treatment of malignant peritoneal effusion of gastrointestinal tumors can effectively control disease progression,improve the clinical symptoms and disease prognosis of patients,with higher safety.