慈丹胶囊联合奥沙利铂和替吉奥治疗老年晚期胆囊癌的临床研究

目的探讨慈丹胶囊联合注射用奥沙利铂和替吉奥胶囊治疗老年晚期胆囊癌的临床疗效。方法选取2013年5月—2016年5月宝鸡市人民医院肿瘤科收治的老年晚期胆囊癌患者96例,采用随机数字表法将所有患者分为对照组和治疗组,每组各48例。对照组静脉滴注注射用奥沙利铂,130 mg/m~2加入到5%葡萄糖溶液300 m L中,输注4 h,1次/3周;治疗第1~14天口服替吉奥胶囊,2片/次,2次/d,每3周重复1次。治疗组在对照组基础上口服慈丹胶囊,5粒/次,4次/d。两组患者均治疗6周。观察两组的临床疗效,比较两组的生活质量、免疫球蛋白(IgG、IgA和IgM)、T细胞亚群(CD~(3+)、CD~(4+)和CD~(8+))和毒副作用。结果治疗后,对照组和治疗组的总有效率分别为70.8%、85.4%,两组比较差异有统计学意义(P0.05)。治疗3~6周后,两组KPS评分明显升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗4~6周后,治疗组KPS评分升高程度明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组IgG、IgA、IgM、CD~(3+)、CD~(4+)和CD~(8+)水平均明显升高,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标的升高程度明显优于对照组,两组比较差异具有统计学意义(P0.05)。对照组和治疗组粒细胞减少发生率分别为58.3%、45.8%;血小板减少发生率分别为45.8%、33.3%;恶心呕吐发生率分别为58.3%、43.7%;腹泻腹痛发生率分别为27.0%、16.7%;肝功能损伤发生率分别为29.1%、16.7%;肾功能损伤发生率分别为12.5%、6.3%;皮疹发生率分别为27.0%、18.7%;口腔黏膜炎发生率分别为20.8%、14.5%,两组毒副反应发生率比较差异有统计学意义(P0.05)。结论慈丹胶囊联合注射用奥沙利铂和替吉奥胶囊治疗老年晚期胆囊癌具有较好的临床疗效,可改善生活质量,升高免疫球蛋白和T淋巴细胞亚群水平,毒副作用轻,具有一定的临床推广应用价值。

Clinical study on Cidan Capsules combined with oxaliplatin and Tegafur Gimeracil and Oteracil Potassium Capsules in treatment of advanced gallbladder cancer in the elderly

Objective To investigate the clinical effects of Cidan Capsules combined with oxaliplatin and Tegafur Gimeracil and Oteracil Potassium Capsules in treatment of advanced gallbladder cancer in the elderly. Methods Elderly patients (96 cases) with advanced gallbladder cancer in Baoji People''s Hospital from May 2013 to May 2016 were randomly divided into control and treatment groups, and each group had 48 cases. Patients in the control group were iv administered with Oxaliplatin for injection, 130 mg/m² added into 5% glucose solution (300 mL), infusion time of 4 h, once every 3 weeks. Patients in the control group were po administered with Tegafur Gimeracil and Oteracil Potassium Capsules on day 1 - 14, 2 tablets/time, twice daily, repeat every 3 weeks. Patients in the treatment group were po administered with Cidan Capsules on the basis of the control group, 5 grains/time, four times daily. Patients in two groups were treated for 6 weeks. After treatment, the clinical efficacies were evaluated, and quality of life, immunoglobulin (IgG, IgA, and IgM), T cell subsets (CD³⁺, CD⁴⁺, and CD⁸⁺), and toxic side effects in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 70.8% and 85.4%, respectively, and there was difference between two groups (P < 0.05). After treatment for 3 - 6 weeks, the KPS scores in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). And after treatment for 4 - 6 weeks, the KPS score in the treatment group was significantly higher than that in the control group, with significant difference between two groups (P < 0.05). After treatment, the levels of IgG, IgA, IgM, CD³⁺, CD⁴⁺ and CD⁸⁺ in two groups were significantly increased, and the difference was statistically significant in the same group (P < 0.05). The observational indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P < 0.05). The incidence rate of granulocyte depletion in the control and treatment groups were 58.3% and 45.8%, respectively, the incidence rate of thrombocytopenia, nausea and vomiting, diarrhea abdominal pain, liver function injury, renal function injury, rash, and oral mucositis in the control and treatment groups were 45.8% and 33.3%, 58.3% and 43.7%, 27.0% and 16.7%, 29.1% and 16.7%, 12.5% and 6.3%, 27.0% and 18.7%, and 20.8% and 14.5%, respectively, and there was difference between two groups (P < 0.05). Conclusion Cidan Capsules combined with Oxaliplatin for injection and Tegafur Gimeracil and Oteracil Potassium Capsules has clinical curative effect in treatment of advanced gallbladder cancer in the elderly, can improve quality of life, increase the levels of immunoglobulin and T cell subsets, and mild toxic side effects, which has a certain clinical application value.