目的 评价生脉饮口服液应用于肿瘤患者围手术期快速康复的安全性及有效性,探讨生脉饮在加速康复外科中的 临床价值。 方法 纳入 2023 年 5 月至 2024 年 5 月于中国医学科学院肿瘤医院、山西省肿瘤医院、北京中医药大学东直门医院、 中国中医科学院广安门医院就诊的新辅助化疗后的肿瘤患者 400 例,采用分层区组随机设计,在术后常规治疗的基础上,试验 组围手术期应用生脉饮口服液,主要观察指标包括术后第 1 天、第 7 天和第 14 天肿瘤患者生活质量(QOL)评分,次要观察指 标包括首次排气时间、首次排便时间、引流管留置时间、住院时间等。 结果 试验组患者术后第1 天、第7 天、第14 天肿瘤患者 QOL 评 分均明显高于对照组患者(P<0. 05);试验组患者首次排气时间、首次排便时间均早于对照组,且差异有统计学意义(P<0. 05);试验组 患者引流管拔除时间、出院时间与对照组之间差异无统计学意义(P>0. 05);两组患者不良反应发生率未见明显差异(P>0. 05)。 结论 生脉饮口服液联合基础治疗可促进新辅助化疗后肿瘤患者围手术期加速康复,具有较好的安全性及疗效。

Objective To evaluate the safety and efficacy of Shengmaiyin oral solution in promoting rapid recovery during the perioperative period in cancer patients and to explore its clinical value in enhanced recovery after surgery . Method From May 2023 to May 2024 400 cancer patients who underwent neoadjuvant chemotherapy were recruited from the Cancer Hospital of the Chinese Academy of Medical Sciences Shanxi Cancer Hospital Dongzhimen Hospital of Beijing University of Chinese Medicine and Guang' anmen Hospital of the China Academy of Chinese Medical Sciences. The patients were randomly divided into two groups. The experimental group received Shengmaiyin oral solution during the perioperative period on top of routine postoperative treatment. Primary outcomes included quality of life QOL scores on postoperative days 1 7 and 14. Secondary outcomes included the time to first flatus time to first defecation drainage tube removal time and length of hospital stay. Result The QOL scores on postoperative days 1 7 and 14 were significantly higher in the experimental group than in the control group P<0. 05 . The time to first flatus and first defecation in the experimental group was earlier than in the control group with statistically significant differences P<0. 05 . There was no statistically significant difference between the two groups in terms of drainage tube removal time and length of hospital stay P> 0. 05 . The incidence of adverse events was not significantly different between the two groups P>0. 05 . Conclusion Shengmaiyin oral solution combined with standard care can promote rapid recovery during the perioperative period in cancer patients undergoing neoadjuvant chemotherapy demonstrating good safety and efficacy.