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[摘要]
目的 研究平消胶囊联合注射用奥沙利铂治疗食管癌的临床疗效。方法 选取2017年2月-2018年2月西安医学院第二附属医院收治的110例食管癌患者为研究对象,将所有患者随机分为对照组和治疗组,每组各55例。对照组患者静脉注射注射用奥沙利铂,130 mg/m2,1次/3周;治疗组患者在对照组治疗的基础上口服平消胶囊,3粒/次,3次/d。一个治疗疗程为21 d,两组持续治疗2个疗程。观察两组的临床疗效,比较两组的免疫功能指标、肿瘤标志物水平、Karnofsky(KPS)评分、不良反应、总生存期(OS)和无进展生存期(PFS)。结果 治疗后,对照组和治疗组的客观缓解率(ORR)分别为47.27%、54.55%,疾病控制率(DCR)分别为74.55%、81.82%,两组比较差异有统计学意义(P<0.05)。治疗后,治疗组患者CD3+、CD4+、CD4+/CD8+水平均显著高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,两组患者糖链抗原199(CA199)、癌胚抗原(CEA)、糖链抗原724(CA724)水平均显著降低,同组治疗前后比较差异具有统计学意义(P<0.05);并且治疗组患者肿瘤标志物水平均明显低于对照组,两组比较差异有统计学意义(P<0.05)。治疗后,两组患者KPS评分显著升高,同组治疗前后比较差异有统计学意义(P<0.05);并且治疗组患者KPS评分明显高于对照组,两组比较差异有统计学意义(P<0.05)。治疗过程中,治疗组白细胞降低、恶心呕吐、腹泻发生率显著低于对照组,两组不良反应发生率比较差异有统计学意义(P<0.05)。治疗后,治疗组患者OS和PFS显著高于对照组,两组比较差异有统计学意义(P<0.05)。结论 平消胶囊联合注射用奥沙利铂治疗食管癌具有较好的临床疗效,能改善免疫功能,降低肿瘤标志物水平,延长OS和PFS,安全性较好,具有一定的临床推广应用价值。
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[Abstract]
Objective To study the efficacy of Pingxiao Capsules combined with Oxaliplatin for injection in treatment of esophageal cancer. Methods Patients (110 cases) with esophageal cancer in the Second Affiliated Hospital of Xi'an Medical University from February 2017 to February 2018 were randomly divided into control and treatment groups, and each group had 55 cases. Patients in the control group were iv administered with Oxaliplatin for injection, 130 mg/m2, once every 3 weeks. Patients in the treatment group were po administered with Pingxiao Capsules on the basis of the control group, 3 grains/time, three times daily. One course had 21 d, and patients in two groups were treated for 2 courses. After treatment, the clinical efficacies were evaluated, and immune function indexes, tumor marker levels, KPS scores, adverse reactions, OS and PFS in two groups were compared. Results After treatment, the ORR in the control and treatment groups were 47.27% and 54.55%, respectively, and the DCR in the control and treatment groups were 74.55% and 81.82%, respectively, and there was difference between two groups (P<0.05). After treatment, the levels of CD3+, CD4+, and CD4+/CD8+ in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P<0.05). After treatment, the levels of CA199, CEA, and CA724 in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the tumor marker levels in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the KPS score in two groups were significantly increased, and the difference was statistically significant in the same group (P<0.05). And the KPS score in the treatment group were significantly higher than that in the control group, with significant difference between two groups (P<0.05). After treatment, the incidences of leucopenia, nausea and vomiting, diarrhea in the treatment group were significantly lower than those in the control group, and there was difference between two groups (P<0.05). After treatment, the OS and the PFS in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P<0.05). Conclusion Pingxiao Capsules combined with Oxaliplatin for injection has clinical curative effect in treatment of esophageal cancer, can improve the immune function, reduce the level of tumor markers, and prolong OS and PFS, with good safety, which has a certain clinical application value.
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