健脾益气方联合肠内营养乳剂与术后常规疗法治疗胃癌术后脾胃气虚证临床研究

Clinical Study on Jianpi Yiqi Prescription Combined with Enteral Nutrition Emulsion and Postoperative Conventional Therapy for Gastric Cancer with Spleen-Stomach Qi Deficiency Syndrome After Surgery

摘要:

目的：观察在术后常规疗法与肠内营养乳剂的基础上加用健脾益气方联合治疗Ⅱ～Ⅲ期胃癌术后脾胃气虚证的临床疗效。方法：选取2021年1月—2023年1月濮阳市安阳地区医院收治的130例Ⅱ～Ⅲ期胃癌术后脾胃气虚证患者，采用随机数字表法分为标准营养组和联合治疗组各65例。2组均采用胃癌术后常规疗法与肠内营养乳剂治疗，联合治疗组加用健脾益气方治疗。2组疗程均为2个月。治疗前后检测2组的营养指标［前白蛋白（PA）、白蛋白（ALB）、转铁蛋白（TRF）］，免疫指标［CD4+/CD8+比值、自然杀伤（NK） 细胞活性，免疫球蛋白A（IgA）、免疫球蛋白G（IgG）、免疫球蛋白M（IgM）］，肠道菌群指标［Shannon指数，厚壁菌门/拟杆菌门（F/B） 比值，双歧杆菌、大肠杆菌、普拉梭菌的相对丰度］，血清肿瘤标志物［跨膜蛋白160 （TMEM160） 抗体、X-射线修复交叉互补蛋白1 （XRCC1） 抗体的相对表达水平］，评估中医证候评分。统计2组的不良反应发生率，以及术后1年、2年的生存率。结果：治疗后，2组PA、ALB、TRF水平均较治疗前升高（P＜0.05）。联合治疗组PA、ALB、TRF水平均高于标准营养组（P＜0.05）。2组Shannon指数、F/B比值、普拉梭菌相对丰度、双歧杆菌相对丰度均较治疗前升高，大肠杆菌相对丰度均较治疗前降低，差异均有统计学意义（P＜0.05）。联合治疗组Shannon指数、F/B比值、普拉梭菌相对丰度、双歧杆菌相对丰度均高于标准营养组，大肠杆菌相对丰度低于标准营养组，差异均有统计学意义（P＜0.05）。2组CD4+/CD8+比值、NK细胞活性及IgG、IgA、IgM水平均较治疗前升高（P＜0.05）。联合治疗组CD4+/CD8+比值、NK细胞活性及IgG、IgA、IgM 水平均高于标准营养组（P＜0.05）。2组血清TMEM160、XRCC1抗体相对表达水平均较治疗前降低（P＜0.05）。联合治疗组血清TMEM160、XRCC1抗体相对表达水平均低于标准营养组（P＜0.05）。2组胃脘隐痛、喜暖喜按、脘腹胀满、面色少华、肢倦乏力、气短懒言、大便溏薄评分均较治疗前降低（P＜0.05）。联合治疗组7项评分均低于标准营养组（P＜0.05）。2组不良反应发生率比较，差异无统计学意义（P＞0.05）。2组术后1年、2年的生存率比较，差异均无统计学意义（P＞0.05）。结论：在胃癌术后常规疗法与肠内营养乳剂的基础上加用健脾益气方治疗可有效提高Ⅱ～Ⅲ期胃癌术后脾胃气虚证患者的营养状况和免疫功能，缓解相关中医证候，调节肠道菌群，其作用机制可能与抑制TMEM160、XRCC1抗体表达，阻断免疫逃逸，逆转化疗耐药，清除微小残留灶，降低复发转移风险有关。

Abstract:

Abstract： Objective： To observe the clinical efficacy of Jianpi Yiqi Prescription combined with postoperative conventional therapy and enteral nutrition emulsion in the treatment of stage Ⅱ-Ⅲ gastric cancer with spleen-stomach qi deficiency syndrome after surgery. Methods： A total of 130 patients with stage Ⅱ-Ⅲ gastric cancer of spleenstomach qi deficiency syndrome admitted to Anyang District Hospital of Puyang from January 2021 to January 2023 were enrolled. They were randomly divided into the combined intervention group and the standard nutrition group using the random number table method， with 65 cases in each group. Both groups received postoperative conventional therapy and enteral nutrition emulsion， while the combined intervention group additionally received Jianpi Yiqi Prescription. The treatment duration was two months for both groups. Before and after treatment， nutritional indicators [prealbumin （PA），albumin （ALB），transferrin （TRF）]，immune indicators [CD4+/CD8+ ratio，natural killer （NK） cell activity， immunoglobulin A （IgA）， immunoglobulin G （IgG）， immunoglobulin M （IgM）]， gut microbiota indicators [Shannon index，Firmicutes/Bacteroidetes （F/B） ratio，relative abundance of Bifidobacterium，Escherichia coli， and Faecalibacterium prausnitzii]， serum tumor markers [relative expression levels of transmembrane protein 160 （TMEM160） antibody and X-ray repair cross-complementing protein 1 （XRCC1） antibody] were measured，and traditional Chinese medicine syndrome scores were assessed. The incidence of adverse reactions and the one-year and two-year survival rates after surgery were also recorded. Results： After treatment， PA， ALB， and TRF levels increased in both groups compared with those before treatment （P＜0.05）. The levels of these indicators were significantly higher in the combined intervention group than in the standard nutrition group （P＜0.05）. The Shannon index，F/B ratio，and relative abundance of Faecalibacterium prausnitzii and Bifidobacterium increased in both groups， while the relative abundance of Escherichia coli decreased，all with statistically significant differences （P＜0.05）. The combined intervention group showed higher Shannon index， F/B ratio， relative abundance of Faecalibacterium prausnitzii and Bifidobacterium， and lower relative abundance of Escherichia coli compared to the standard nutrition group （P＜0.05）. The CD4+/CD8+ ratio，NK cell activity，and levels of IgG，IgA，and IgM increased in both groups after treatment （P＜0.05）， and the levels of these indicators were significantly higher in the combined intervention group than in the standard nutrition group （P＜0.05）. The relative expression levels of serum TMEM160 and XRCC1 antibodies decreased in both groups after treatment （P＜0.05）， and were significantly lower in the combined intervention group than in the standard nutrition group （P＜0.05）. The traditional Chinese medicine syndrome scores for stomach cavity dull pain， preference for pressure and warmth， abdominal distension and fullness， lusterless complexion， limb weakness and fatigue， shortness of breath and reluctance to speak， and loose stools decreased in both groups after treatment （P＜0.05），and all seven sub-item scores of traditional Chinese medicine syndrome were significantly lower in the combined intervention group than in the standard nutrition group （P＜0.05）. There was no statistically significant difference in the incidence of adverse reactions between the two groups （P＞0.05）. No significant differences were found in one-year or two-year survival rates between the two groups （P＞0.05）. Conclusion：Jianpi Yiqi Prescription combined with enteral nutrition emulsion and postoperative conventional therapy can effectively improve nutritional status and immune function， alleviate relevant manifestations of traditional Chinese medicine syndrome， and regulate gut microbiota in stage Ⅱ - Ⅲ gastric cancer patients with spleen-stomach qi deficiency syndrome after surgery. The mechanism may involve inhibition of the expression of TMEM160 and XRCC1 antibodies， blockade of immune escape， reversal of chemotherapy resistance， clearance of minimal residual tumor， and a decreased risk of recurrence and metastasis.