| 摘要: |
| 目的：观察自拟健脾抗癌方联合化疗对胃癌术后Ⅲ期脾虚证患者的临床干预作用。方法：将60 例胃癌术后Ⅲ期脾虚证患者随机分为2组，每组各30 例。治疗组予自拟健脾抗癌方联合术后辅助化疗，对照组仅予术后辅助化疗，比较2组中医证候总有效率、中医证候积分、肿瘤指标［癌胚抗原（CEA）、糖类抗原199（CA199）］、卡氏功能评分（KPS）、入组后6个月及12个月的复发转移率、生存率，并观察不良反应发生情况。结果：将至少完成4个周期术后辅助化疗的患者纳入化疗4个周期后节点分析，其中治疗组27 例，对照组28 例。对于随机分组后6个月仍存活的患者，进一步行化疗结束后6个月节点分析，治疗组29 例，对照组27 例。同样，随机分组后12个月仍存活的患者，则纳入化疗结束后12个月节点分析，治疗组27例，对照组25例。化疗4个周期后，中医证候总有效率治疗组为66.67%（18/27），对照组为60.71%（17/28），2组比较，差异有统计学意义（P＜0.05）；化疗结束后6个月，中医证候总有效率治疗组为86.21%（25/29），对照组为70.37%（19/27），2组比较，差异有统计学意义（P＜0.05）；化疗结束后12个月，中医证候总有效率治疗组为88.89%（24/27），对照组为64.00%（16/25），2组比较，差异有统计学意义（P＜0.05）。化疗结束后6个月、12个月，治疗组CEA、CA199均低于对照组（P＜0.05）。化疗结束后12个月，治疗组KPS评分高于对照组（P＜0.05）。治疗组入组后12个月的复发转移率为17.24%（5/29），低于对照组的22.22%（6/27），2组比较，差异有统计学意义（P＜0.05）；治疗组入组后12个月的生存率为96.55%（28/29），高于对照组的85.19%（23/27），2组比较，差异有统计学意义（P＜0.05）。结论：自拟健脾抗癌方联合化疗治疗胃癌术后Ⅲ期脾虚证患者能明显减少患者的不适症状，改善患者生活质量，降低复发转移率，提高生存率，且无明显毒副作用，值得临床推广和进一步研究。 |
| 关键词: 胃癌术后 脾虚证 健脾抗癌方 干预作用 临床研究 |
| DOI： |
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| Clinical effect of self-made spleen-invigorating antitumor prescription combined with chemotherapy in treatment of stage Ⅲ gastric cancer with spleen deficiency after surgery：An analysis of 30 cases |
| XIA Ningjun,GU Genwang,CHEN Yan |
| (Danyang Hospital of Traditional Chinese Medicine，Danyang 212300，Jiangsu，China) |
| Abstract: |
| Objective：To investigate the clinical therapeutic effect of self-made spleen-invigorating antitumor prescription combined with chemotherapy on patients with stage III gastric cancer with spleen deficiency after surgery.Methods：A total of 60 patients with stage III gastric cancer with spleen deficiency after surgery were randomly divided into treatment group and control group，with 30 patients in each group.The patients in the treatment group were given self-made spleen-invigorating antitumor prescription combined with postoperative adjuvant chemotherapy，and those in the control group were given postoperative adjuvant chemotherapy alone.The two groups were compared in terms of overall response rate of TCM syndrome，TCM syndrome score，tumor markers ［carcinoembryonic antigen （CEA） and carbohydrate antigen 199 （CA199）］，Karnofsky Performance Scale (KPS) score，and recurrence and metastasis rate and survival rate within 6 and 12 months after enrollment，and the incidence rate of adverse reactions was also recorded.Results：The patients who completed at least 4 cycles of postoperative adjuvant chemotherapy were included in the analysis of 4 cycles of chemotherapy，with 27 patients in the treatment group and 28 in the control group.The patients who were still alive at 6 months after randomization were further included in the analysis of 6 cycles of chemotherapy，with 29 patients in the treatment group and 27 in the control group.Similarly，the patients who were still alive at 12 months after randomization were included in the analysis of 12 cycles of chemotherapy，with 27 patients in the treatment group and 25 in the control group.After 4 cycles of chemotherapy，there was a significant difference in the overall response rate of TCM syndrome between the treatment group and the control group ［66.67% (18/27) vs 60.71% (17/28)，P<0.05］；at 6 months after chemotherapy，there was a significant difference in the overall response rate of TCM syndrome between the treatment group and the control group ［86.21% (25/29) vs 70.37% (19/27)，P<0.05］；at 12 months after chemotherapy，there was a significant difference in the overall response rate of TCM syndrome between the treatment group and the control group ［88.89% (24/27) vs 64.00% (16/25)，P<0.05］.At 6 and 12 months after chemotherapy，the treatment group had significantly lower levels of CEA and CA199 than the control group (P<0.05).At 12 months after chemotherapy，the treatment group had a significantly higher KPS score than the control group (P<0.05).Compared with the control group at 12 months after enrollment，the treatment group had a significantly lower recurrence and metastasis rate ［17.24% (5/29) vs 22.22% (6/27)，P<0.05］ and a significantly higher survival rate ［96.55% (28/29) vs 85.19% (23/27)，P<0.05］.Conclusion：For patients with stage III gastric cancer with spleen deficiency after surgery，the self-made spleen-invigorating antitumor prescription combined with chemotherapy can significantly alleviate discomfort symptoms，improve quality of life，reduce recurrence and metastasis rate，and increase survival rate，with no obvious toxic and side effects，and therefore，it holds promise for clinical application. |
| Key words: gastric cancer after surgery spleen deficiency spleen-invigorating antitumor prescription therapeutic effect clinical research |
