康艾注射液联合OFL方案治疗胃癌随机对照多中心临床试验

孙鑫; 李平; 梁惠; 周晋华; 查名宝; 刘振昌

doi:10.3971/j.issn.1000-8578.2019.18.1177

康艾注射液联合OFL方案治疗胃癌随机对照多中心临床试验

A Multi-center Randomized Controlled Clinical Study of Kang'ai Injection Combined with OFL Regimen on Gastric Cancer Patients

摘要

摘要:
目的探讨康艾注射液联合奥沙利铂（OXA）+氟尿嘧啶（5-Fu）+亚叶酸钙（LV）（OFL方案）治疗胃癌的临床疗效及安全性。
方法采用多中心、随机、对照的研究方式对全国五所医院在2012年3月至2015年6月期间收治的300例胃癌患者进行研究。随机将患者分成对照组和试验组，对照组予以OFL方案进行治疗，试验组在对照组基础上加用康艾注射液，治疗结束后比较两组患者近远期疗效以及治疗过程中不良反应发生情况。
结果（1）试验组的近期临床疗效（35.62%）明显高于对照组（22.86%）（P < 0.05）；（2）治疗后试验组患者生活质量明显优于对照组（P < 0.05）；（3）对照组和试验组PFS比较差异无统计学意义（25.89月vs. 26.35月）（P > 0.05），两组患者3年生存率比较差异无统计学意义（P > 0.05）；（4）试验组患者神经毒性和消化道不良反应发生率、血小板下降发生率均明显低于对照组（P < 0.05）。
结论康艾注射液联合OFL方案可明显提高胃癌患者的近期临床疗效，减轻化疗不良反应。

Abstract:
Objective To investigate the clinical efficacy and safety of Kang'ai injection combined with Oxaliplatin, Fluorouracil and Leucovorin (OFL regimen) in the treatment of patient with gastric cancer.
Methods A multi-center randomized controlled study was conducted on 300 patients with gastric cancer treated in five hospitals from March 2012 to June 2015. The patients were randomly divided into control group and experimental group. The control group were treated with OFL regimen. The experimental group were treated with Kang'ai injection on the basis of the treatment of control group. The short- and long-term clinical efficacy after treatment and adverse reactions during the treatment were observed and compared between the two groups.
Results (1) The short-term clinical efficacy of the experimental group was significantly higher than that in the control group (35.62% vs. 22.86%, P < 0.05); (2) The quality of life of patients in the experimental group after the treatment was significantly better than that in the control group(P < 0.05); (3) The PFS was not significantly different between the control group and the experimental group (25.89 vs. 26.35 months, P > 0.05), there was no significant difference in the 3-year survival rate between the two groups (P > 0.05); (4) The incidence of neurotoxicity and gastrointestinal adverse reaction and thrombocytopenia in the experimental group were significantly lower than those in the control group (P < 0.05).
Conclusion Kang'ai injection combined with OFL regimen could significantly improve the short-term clinical curative effect and reduce toxic and side effects of chemotherapy in patients with gastric cancer.

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