目的 观察慈丹胶囊联合mFOLFOX6方案治疗Bismuth-Corlette Ⅱ型肝门部胆管癌的临床疗效。方法 选取2010年1月-2014年1月陕西省核工业二一五医院收治的Bismuth-Corlette Ⅱ型肝门部胆管癌患者82例，随机分为对照组和治疗组，每组各41例。对照组患者第1天静脉泵入5-氟尿嘧啶注射液2 800 mg/m²，持续4~6 h，同时泵入亚叶酸钙注射液400 mg/m²，及静脉滴注奥沙利铂注射液，85 mg/m²加入5%葡萄糖溶液500 mL，持续3 h。治疗组在对照组基础上口服慈丹胶囊，5粒/次，4次/d。2周为1个疗程，两组患者共治疗6个疗程。观察两组患者近期和远期疗效，同时比较治疗前后两组患者免疫功能、KPS评分和不良反应。结果 治疗后，对照组客观缓解率和临床获益率分别为73.1%和50.9%，均分别显著低于治疗组的81.7%和62.5%，两组比较差异具有统计学意义（P<0.05）。治疗后，治疗组1年生存率、2年生存率、3年生存率及总生存时间均明显高于对照组（P<0.05）。治疗后，两组患者CD3⁺、CD4⁺、IgG、IgA及IgM指标水平均明显升高（P<0.05），且治疗组患者免疫功能指标明显优于对照组患者（P<0.05）。治疗第5、6个疗程后，对照组KPS均明显高于本组治疗前（P<0.05）；治疗第3、4、5、6个疗程后，治疗组KPS均明显高于本组治疗前（P<0.05），且明显高于同期对照组患者（P<0.05）。治疗期间，治疗组不良反应发生率均明显低于对照组患者，两组比较差异具有统计学意义（P<0.05）。结论 慈丹胶囊联合mFOLFOX6方案治疗Bismuth-Corlette Ⅱ型肝门部胆管癌可有效提高患者免疫功能，延长患者生存时间，降低毒副作用。

Objective To study the clinical effects of Cidan Capsules combined with mFOLFOX6 regimen in treatment of Bismuth-Corlette Ⅱ hilar cholangiocarcinoma. Methods Patients (82 cases) with Bismuth-Corlette Ⅱ hilar cholangiocarcinoma in NO.215 Hospital of Shaanxi Nuclear Industry from January 2010 to January 2014 were randomly divided into control and treatment groups, and each group had 41 cases. Patients in the control group were iv administered with 5-Fluorouracil Injection on the first day, 2 800 mg/m² for 4-6 h, as well as iv administered with Calcium Folinate Injection 400 mg/m², and with Oxaliplatin Injection 85 mg/m² added into 5% glucose solution 500 mL for 3 h. Patients in the treatment group were po administered with Cidan Capsules on the basis of the control group, 5 grains/time, four times daily. Two weeks was a course of treatment, and patients in two groups were treated for 6 courses. After treatment, the short-term and long-term efficacy was evaluated, and the immune function, life quality and adverse actions in two groups before and after treatment were compared. Results After treatment, the objective reaction rate and clinical benefit rate in the control group were 73.1% and 50.9%, which were significantly lower than 81.7% and 62.5% in the treatment group, respectively, and there were differences between two groups (P < 0.05). After treatment, the survival rate of 1 year, 2 years, and 3 years, and OS in the treatment group were significantly higher than those in the control group (P < 0.05). After treatment, the CD3⁺, CD4⁺, IgG, IgA and IgM levels in two groups were significantly increased (P < 0.05), and the immune function in the treatment group was significantly better than that in the control group (P < 0.05). After treatment for 5 and 6 courses of treatment, the KPS scores in control group were significantly higher than pretherapy (P < 0.05). After treatment for 3, 4, 5, and 6 courses of treatment, the KPS scores in treatment group were significantly higher than pretherapy (P < 0.05), and were significantly higher than that in the control group (P < 0.05). During the treatment, the adverse reactions rate in the treatment group was significantly lower than that in the control group, with significant difference between two groups (P < 0.05). Conclusions Cidan Capsules combined with mFOLFOX6 regimen in treatment of Bismuth-Corlette Ⅱ hilar cholangiocarcinoma can improve the immune function, lengthen the survival time and decrease the toxic and side effects.

陕西省自然科学基础研究计划项目（2012JQ4016）