摘要：目的观察新加良附颗粒联合化疗治疗晚期胃癌对患者生活质量及免疫功能的影响。方法采用前瞻性随机对照的临床试验方法，通过中央随机法将符合胃癌IV期的患者50例随机分对照与治疗两组，治疗组采用新加良附颗粒配合化疗方案治疗，对照组采用单纯化疗，两组治疗中均给予最佳对症支持治疗，分别观察两个化疗周期，观察疾病控制率、患者生活质量以及免疫指标的变化。结果新加良附颗粒配合化疗组25例，单纯化疗组25例，脱落1例，研究结果显示：(1) 治疗组较对照组虽有更高的疾病控制率，但无统计学意义，P>0.05。(2) 单纯化疗组患者治疗后生活质量评分下降，治疗前后比较有显著差异，具有统计学意义（P＜0.01）；新加良附颗粒配合化疗组治疗前后KPS差异无统计学意义（P＞0.05）； (3) CD4＋/CD8＋治疗后与治疗前比较，单纯化疗组治疗前后差异无统计学意义（P＞0.05），联合治疗组治疗后较治疗前升高（P＜0.05）；单纯化疗组治疗前后Foxp3值差异无统计学意义，联合治疗组治疗后Foxp3值较前降低，但差异无统计学意义（P＞0.05）。组间Foxp3值比较，联合治疗组低于单纯化疗组（P＜0.05）。结论两组疾病控制率比较无统计学差异；新加良附颗粒配合化疗能提高患者生活质量；新加良附颗粒配合化疗具有调整免疫抑制状态的作用。?????
Impact of Modified Liang-Fu Granules combined with chemotherapy on advanced gastric cancer in quality of life and immune function
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine,Beijing,100700
Abstract： Objective Modified Liang-Fu Granule (MLFG) is a Chinese medicine formula with claims for the treatment of severe gastric distress. The purpose of this clinical study was to observe the effect of MLFG combined with chemotherapy on quality of life and immune function in patients with advanced gastric cancer. Methods In this prospective randomized controlled clinical trial, all patients were randomly assigned to the treatment arm in which MLFG was provided in addition to chemotherapy, or the control arm in which chemotherapy was provided alone. Both arms were provided with best supportive care. Evaluation points were observed and recorded throughout four cycles of chemotherapy including the control rate of disease, Karnofsky performance status, and immune indicators. Results There were 50 patients included in this trial, with 25 in the treatment arm and 25 in the control arm, 1 patient failed to finish the study in the control arm. We found out that (1)Compared with the control group, the treatment group tended to have a higher control rate of disease but there was no statistical significance, P>0.05. (2) The KPS of patients in the chemotherapy alone group decreased after treatment, and there was significant difference between before and after treatment (P <0.01). There was no significant difference in the KPS before and after the treatment with MLFG combined with the chemotherapy group (P> 0.05).(3) There was no significant difference in CD4 + / CD8 + before and after treatment in the chemotherapy alone group (P> 0.05). The CD4 + / CD8 + ratio of the combined treatment group was significantly higher than that before treatment (P <0.05). There was no significant difference in Foxp3 between the two groups before and after treatment. Foxp3 decreased in the combined treatment group after treatment, but the difference was not statistically significant (P> 0.05). Foxp3 in the combined treatment group was lower than that in the chemotherapy alone group (P <0.05). Conclusion This study indicates that there was no significant difference in disease control rate between the two groups; MLFG with chemotherapy can improve patient quality of life and adjust the immunosuppressive status of advanced gastric cancer patients.