Department of Surgery, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Center of Traditional Chinese Medicine Applications Perioperative, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, 510120, China.
Chin J Integr Med. 2024 Dec;30(12):1059-1067. doi: 10.1007/s11655-024-3813-6. Epub 2024 Sep 10.
OBJECTIVE: To evaluate the efficacy and safety of Wuda Granule (WDG) on recovery of gastrointestinal function after laparoscopic bowel resection in the setting of enhanced recovery after surgery (ERAS)-based perioperative care. METHODS: A total of 108 patients aged 18 years or older undergoing laparoscopic bowel resection with a surgical duration of 2 to 4.5 h were randomly assigned (1:1) to receive either WDG or placebo (10 g/bag) twice a day from postoperative days 1-3, combining with ERAS-based perioperative care. The primary outcome was time to first defecation. Secondary outcomes were time to first flatus, time to first tolerance of liquid or semi-liquid food, gastrointestinal-related symptoms and length of stay. Subgroup analysis of the primary outcome according to sex, age, tumor site, surgical time, histories of underlying disease or history of abdominal surgery was undertaken. Adverse events were observed and recorded. RESULTS: A total of 107 patients [53 in the WDG group and 54 in the placebo group; 61.7 ± 12.1 years; 50 males (46.7%)] were included in the intention-to-treat analysis. The patients in the WDG group had a significantly shorter time to first defecation and flatus [between-group difference -11.01 h (95% CI -20.75 to -1.28 h), P=0.012 for defecation; -5.41 h (-11.10 to 0.27 h), P=0.040 for flatus] than the placebo group. Moreover, the extent of improvement in postoperative gastrointestinal-related symptoms in the WDG group was significantly better than that in the placebo group (P<0.05). Subgroup analyses revealed that the benefits of WDG were significantly superior in patients who were male, or under 60 years old, or surgical time less than 3 h, or having no history of basic disease or no history of abdominal surgery. There were no serious adverse events. CONCLUSION: The addition of WDG to an ERAS postoperative care may be a viable strategy to enhance gastrointestinal function recovery after laparoscopic bowel resection surgery. (Registry No. ChiCTR2100046242).
目的:评价五达颗粒(WDG)在基于加速康复外科(ERAS)的围手术期护理的腹腔镜肠切除术后胃肠道功能恢复中的疗效和安全性。
方法:将 108 名年龄在 18 岁及以上、手术时间为 2 至 4.5 小时的腹腔镜肠切除患者随机(1:1)分配至 WDG 组或安慰剂组(10 g/袋),每天 2 次,从术后第 1 天至第 3 天,同时接受基于 ERAS 的围手术期护理。主要结局为首次排便时间。次要结局为首次排气时间、首次耐受液体或半液体食物时间、胃肠道相关症状和住院时间。对主要结局进行了根据性别、年龄、肿瘤部位、手术时间、既往基础疾病史或腹部手术史的亚组分析。观察并记录不良事件。
结果:共有 107 名患者(WDG 组 53 例,安慰剂组 54 例;61.7±12.1 岁;男性 50 例[46.7%])纳入意向治疗分析。WDG 组首次排便和排气时间明显短于安慰剂组[组间差异-11.01 h(95%CI-20.75 至-1.28 h),P=0.012;-5.41 h(-11.10 至 0.27 h),P=0.040]。此外,WDG 组术后胃肠道相关症状的改善程度明显优于安慰剂组(P<0.05)。亚组分析显示,WDG 在男性、年龄<60 岁、手术时间<3 小时、无基础疾病史或无腹部手术史的患者中优势更为显著。无严重不良事件。
结论:在 ERAS 术后护理中添加 WDG 可能是增强腹腔镜肠切除术后胃肠道功能恢复的可行策略。(注册号:ChiCTR2100046242)
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