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

• Main Authors: SUN Xin, LI Ping, LIANG Hui, ZHOU Jinhua, ZHA Mingbao, LIU Zhenchang
• Format: Article
• Language: zho
• Published: Magazine House of Cancer Research on Prevention and Treatment 2019-03-01
• Series: Zhongliu Fangzhi Yanjiu
• Subjects: kang'ai injection; ofl regimen; gastric cancer; random; clinical study
• Online Access: http://html.rhhz.net/ZLFZYJ/html/8578.2019.18.1177.htm

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.