中药联合化疗对晚期胰腺癌的临床疗效及安全性研究

Efficacy and safety of traditional Chinese medicine combined with chemotherapy for patients with advanced pancreatic cancer

目的观察中药联合含吉西他滨的化疗方案治疗晚期胰腺癌的临床疗效和安全性。方法将88例晚期胰腺癌患者分为治疗组和对照组(各44例)。对照组患者只接受吉西他滨联合替吉奥(或卡培他滨)化疗。治疗组患者在接受化疗的同时联合中药治疗。观察两组患者的临床疗效、卡氏功能状态(KPS)评分和不良反应发生的情况。结果两组患者的临床疗效比较差异无统计学意义(P>0.05),两组客观缓解率(ORR)和疾病控制率(DCR)比较,差异亦均无统计学意义(均P>0.05)。治疗组和对照组的中位无进展生存期(PFS)分别为6.7个月(95%CI:5.5~7.9)和5.6个月(95%CI:3.3~7.9),差异有统计学意义(P<0.05)。治疗组和对照组的中位总生存期(OS)分别为10.9个月(95%CI:9.2~12.6)和10.2个月(95%CI:9.6~10.8),差异无统计学意义(P>0.05)。治疗组KPS评分好转例数明显多于对照组(P<0.05)。治疗组Ⅲ/Ⅳ级不良反应包括粒细胞减少、胃肠道反应、皮疹发生率均显著低于对照组,均有统计学差异(均P<0.05)。结论以吉西他滨为主的化疗联合中药治疗晚期胰腺癌,能显著改善患者KPS评分,同时能减轻化疗不良反应,延长PFS。

Objective To evaluate the clinical efficacy and safety of traditional Chinese medicine combined with gemcitabine-based chemotherapy for patients with advanced pancreatic cancer. Methods Eighty eight patients with advanced pancreatic cancer were randomly divided into two groups. All patients were treated with gemcitabine plus S-1 or capecitabine chemotherapy regimens, while patients in study group received additional Chinese medicine. The efficacy,Karnofsly performance status(KPS) score and adverse events were compared between the two groups. Results There were no significant difference in ORR and DCR between two groups. The median PFS was 6.7 months(95%CI: 5.5 to 7.9) in the study group and 5.6 months(95%CI: 3.3 to 7.9) in the control group(P<0.05). The median OS was 10.9 months(95%CI: 9.2 to 12.6) in the study group and 10.2 months(95%CI:9.6 to 10.8) in the control group(P >0.05). In addition, The KPS score in study group was better than that in control group. The incidence of grade 3 or grade 4 adverse reactions, including granulocytopenia, gastrointestinal reactions and skin rash was lower in the control group(P<0.05). Conclusion Gemcitabine-based chemotherapy regimens combined with traditional Chinese medicine can significantly improve the KPS score in advanced pancreatic cancer patients compared to chemotherapy alone. Meanwhile, it can reduce the adverse reaction of chemotherapy and prolong the PFS of patients.