新加良附颗粒配合化疗治疗晚期胃癌临床研究

Objective: Modified Liang-Fu Granule (MLFG) is a Chinese medicine formula with claims for the treatment of severe gastric distress. This study is to observe the clinical efficacy of MLFG combined with chemotherapy in treating advanced gastric cancer. Methods: In this prospective randomized controlled clinical trial, all patients were randomly assigned to treatment group which received MLFG in addition to chemotherapy, or control group which got chemotherapy alone. Evaluation points were observed and recorded throughout four cycles of chemotherapy including signs and symptoms score, Karnofsky performance status, pain numerical rating scale, tumor size, blood and urine routine, liver and renal function, and electrocardiogram. Results: ①Compared with control group, there were significant improvements of clinical signs and symptoms in the treatment group, P<0.005. Symptoms such as stomach pain, abdominal distension, aversion to cold and loss of appetite were improved significantly, P<0.05. ②The overall health status in the treatment group was significantly better than that in the control group, P<0.05. ③Compared with the control group, the treatment group tended to have a higher clinical remission rate without statistical significance, P>0.05. ④MLFG were safe for clinical application. Conclusions: This study indicates that the MLFG can reduce the clinical symptoms and signs during chemotherapy, improve the quality of life, and may have some attenuated chemotherapy synergism. These critical findings in our study support further investigation of MLFG in a larger gastric cancer population.