营养治疗对胃癌根治术后营养不良患者短期疗效影响的前瞻性随机对照研究

Influence of nutritional therapy on short‑term efficacy of gastric cancer patients with mal-nutrition after radical gastrectomy: a prospective randomised clinical trial

  • 摘要:
    目的 探讨营养治疗对胃癌根治术后营养不良患者短期疗效的影响。
    方法 采用前瞻性随机对照研究方法。选取2020年12月至2022年12月复旦大学附属中山医院收治的胃癌根治术后营养不良患者的临床病理资料,以随机数字表法分为营养治疗组和对照组。营养治疗组患者出院后给予膳食指导和每天口服营养补充剂,持续90 d。对照组患者出院后只给予与营养治疗组相同的膳食指导。观察指标:(1)入组患者分组情况。(2)随访情况。(3)出院90 d营养指标比较。(4)出院90 d炎症和机体功能指标比较。(5)出院90 d临床结局指标比较。正态分布的计量资料以x±s表示,组间比较采用独立样本t检验。偏态分布的计量资料以M(IQR)表示,组间比较采用非参数秩和检验。计数资料以绝对数或百分比表示,组间比较采用χ²检验。等级资料比较采用χ²检验。
    结果 (1)入组患者分组情况。筛选出符合条件的患者187例;男131例,女56例;年龄为(65±12)岁。187例患者中,营养治疗组95例,对照组92例。营养治疗组患者性别(男、女),年龄,心血管合并症,呼吸系统合并症,糖尿病,手术方式(部分胃切除术、全胃切除术),肿瘤分期(Ⅰ期、Ⅱ期、Ⅲ期),体质量,体质量指数(BMI),骨骼肌指数,白蛋白(Alb),血红蛋白(Hb),中性粒细胞和淋巴细胞比值(NLR),6 min步行距离,握力分别为68、27例,(64±12)岁,21例,4例,7例,59、36例,17、27、51例,(59±11)kg、(21.5±3.1)kg/m2、(42±7)cm2/m2、(39±5)g/L、(112±25)g/L、2.3(8.0)、(456±97)m、(29±8)kg;对照组患者上述指标分别为63、29例,(66±13)岁,22例,3例,9例,56、36例,14、24、54例,(58±11)kg、(21.1±2.9)kg/m2、(42±7)cm2/m2、(39±4)g/L、(111±26)g/L、2.2(8.4)、(459±98)m、(29±8)kg;两组患者上述指标比较,差异均无统计学意义(χ²=0.21,t=-1.29,χ²=0.09、0、0.35、0.03、0.51,t=0.80、0.85、0.19、0.14、0.16,Z=-0.28, t=-0.17、0.43,P>0.05)。(2)随访情况。187例患者均完成术后90 d随访。随访期间,患者依从性较好,能够遵守膳食指导。营养治疗组5例患者发生腹泻和恶心不良反应,经对症治疗后均获得缓解。对照组无不良反应患者。(3)出院90 d营养指标比较。出院90 d营养治疗组患者体质量、体质量丢失、BMI、骨骼肌指数、Alb、Hb分别为(58±10)kg、2(6)kg、(21.0±2.9)kg/m2、(41±7)cm2/m2、(41±4)g/L、(125±18)g/L;对照组患者上述指标分别为(56±10)kg、3(6)kg、(20.4±2.7)kg/m2、(39±7)cm2/m2、(41±4)g/L、(121±21)g/L;两组患者体质量丢失、骨骼肌指数比较,差异有统计学意义(Z=-4.70,t=2.39,P<0.05),体质量、BMI、Alb、Hb比较,差异均无统计学意义(t=1.30,1.51,0.80,1.32,P>0.05)。(4)出院90 d炎症和机体功能指标比较。出院90 d营养治疗组患者NLR、6 min步行距离、握力分别为2.1(5.1)、(478±99)m、(33±9)kg;对照组患者上述指标分别为2.2(5.7)、(465±96)m、(30±8)kg;两组患者握力比较,差异有统计学意义(t=2.08,P<0.05),NLR、6 min步行距离比较,差异均无统计学意义(Z=-1.28, t=0.91,P>0.05)。(5)出院90 d临床结局指标比较。出院90 d营养治疗组和对照组患者生命质量评分、再入院率分别为(79±14)分、4.2%(4/95)和(78±16)分、6.5%(6/92),两组患者上述指标比较,差异均无统计学意义(t=0.58,χ²=0.14,P>0.05)。
    结论 胃癌根治术后营养不良患者每天口服营养补充剂,能够改善其短期营养状态和机体功能。

     

    Abstract:
    Objective To investigate the influence of nutritional therapy on short-term efficacy of gastric cancer patients with malnutrition after radical gastrectomy.
    Methods The prospec-tive randomized control study was conducted. The clinicopathological data of patients with malnutri-tion after radical resection of gastric cancer who were admitted to the Zhongshan Hospital of Fudan University from December 2020 to December 2022 were selected. Based on random number table, all patients were allocated into the nutritional therapy group and the control group. Patients in the nutritional therapy group were given dietary guidance and daily oral nutrition supplements for 90 days after discharge, while patients in the control group were only given the same dietary guidance. Observation indicators: (1) grouping situations of the enrolled patients; (2) follow‑up; (3) comparison of nutritional indicators at 90 days after discharge; (4) comparison of inflammation and physical function indicators at 90 days after discharge; (5) comparison of clinical outcome indicators at 90 days after discharge. Measurement data with normal distribution were expressed as Mean±SD, and independent sample t test was used for comparison between groups. Measurement data with skewed distribution were expressed as M(IQR), and non‑parameter rank sum test was used for comparison between groups. Count data were expressed as absolute numbers or percentages, and chi-square test was used for comparison between groups. Comparison of ordinal data was conducted using the chi-square test.
    Results (1) Grouping situations of the enrolled patients. A total of 187 patients were selected for eligibility. There were 131 males and 56 females, aged (65±12)years. Of the 187 patients, there were 95 patients in the nutritional therapy group and 92 patients in the control group, respectively. The gender (male, female), age, cases with cardiovascular complications, cases with respiratory complications, cases with diabetes, surgical methods (partial gastrectomy, total gastrectomy), tumor staging (Ⅰ stage, Ⅱ stage, Ⅲ stage), body mass, body mass index (BMI), skeletal muscle index, albumin (Alb), hemoglobin (Hb), neutrophil-to-lymphocyte ratio (NLR), 6‑minutes walking distance, grip strength were 68, 27, (64±12)years, 21, 4, 7, 59, 36, 17, 27, 51, (59±11)kg, (21.5±3.1)kg/m2, (42±7)cm2/m2, (39±5)g/L, (112±25)g/L, 2.3(8.0), (456±97)m, (29±8)kg in patients of the nutritional therapy group, versus 63, 29, (66±13)years, 22, 3, 9, 56, 36, 14, 24, 54, (58±11)kg, (21.1±2.9)kg/m2, (42±7)cm2/m2, (39±4)g/L, (111±26)g/L, 2.2(8.4), (459±98)m, (29±8)kg in patients of the control group, showing no significant difference in the above indicators between the two groups (χ²=0.21, t=-1.29, χ²=0.09, 0, 0.35, 0.03, 0.51, t=0.80, 0.85, 0.19, 0.14, 0.16, Z=-0.28, t=-0.17, 0.43, P>0.05). (2) Follow‑up. All 187 patients were followed up for 90 days after surgery. During the follow‑up period, all patients had good compliance and were able to follow the dietary guidance. Five patients in the nutrition therapy group experienced diarrhea and nausea adverse reactions, which were relieved after symptomatic treatment. No adverse reactions were found in the control group. (3) Comparison of nutritional indicators at 90 days after discharge. The body mass, body mass loss, BMI, skeletal muscle index, Alb, Hb were (58±10)kg, 2(6)kg, (21.0±2.9)kg/m2, (41±7)cm2/m2, (41±4)g/L, (125±18)g/L in patients of the nutritional therapy group, versus (56±10)kg, 3(6)kg, (20.4±2.7)kg/m2, (39±7)cm2/m2, (41±4)g/L, (121±21)g/L in patients of the control group. There were significant differences in body mass loss and skeletal muscle index between the two groups (Z=-4.70, t=2.39, P<0.05), and there was no significant difference in body mass, BMI, Alb, and Hb (t=1.30, 1.51, 0.80, 1.32, P>0.05). (4) Comparison of inflammation and body function indicators at 90 days after discharge. The NLR, 6‑minutes walking distance, grip strength were 2.1(5.1), (478±99)m, and (33±9)kg in patients of the nutritional therapy group, versus 2.2(5.7), (465±96)m, (30±8)kg in patients of the control group. There was a significant difference in grip strength between the two groups (t=2.08, P<0.05), and there were no significant difference in NLR and 6‑minutes walking distance (Z=-1.28, t=0.91, P>0.05). (5) Comparison of clinical outcome indicators at 90 days after discharge. The quality of life score and readmission rate were (79±14)points, 4.2%(4/95) in patients of the nutritional therapy group, versus (78±16)points, 6.5%(6/92) in patients of the control group, showing no significant difference in the above indicators between the two groups (t=0.58, χ²=0.14, P>0.05).
    Conclusion Nutritional therapy with daily oral nutrition supplements can improve the short-term nutritional status and body function of patients with malnutrition after radical gastrectomy for gastric cancer.

     

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