BACKGROUND Postoperative nausea and vomiting (PONV) are common complications after gynecological laparoscopic surgery. Pyridoxine has been recommended as a first-line drug to prevent and treat nausea and vomiting during pregnancy; however, its efficacy in preventing PONV remains unclear. METHODS Patients of 18 to 65 years old, who received elective gynecological laparoscopic surgery under general anesthesia, were randomized into either the pyridoxine or control group. The pyridoxine group received 0.2g vitamin B6 before anesthesia induction, and the control group received normal saline intravenously. Both groups received a similar regimen of combined intravenous and inhalation general anesthesia. All patients received dexamethasone(intravenous) after anesthesia induction and ondansetron(intravenous) before surgery completion. PONV occurrence was recorded according to the patients' self-reported data. Other clinical data were collected from hospital system, and concentrations of blood interleukin-6 and substance P were measured by ELISA. RESULTS A total of 442 patients were screened and 240 patients were equally randomized to the pyridoxine or control group. The incidence of PONV was statistically significant lower in the pyridoxine group than in the control group (16.7% [20/120] vs. 35.8% [43/120]; relative risk (RR) = 0.47 [95% CI: 0.29, 0.74]; absolute risk reduction (ARR) = 0.20 [95% CI: 0.08, 0.30]; P = 0.001), and pyridoxine decreased the incidence of postoperative nausea (12.5% [15/120] vs. 35% [42/120]; RR = 0.36 [95% CI: 0.21, 0.61]; ARR = 0.23 [95% CI: 0.12, 0.33]; P < 0.001). There were no statistical differences in postoperative vomiting, time to the first PONV occurrence, pain, serum interleukin-6 and substance P, and white blood cell and neutrophil counts. CONCLUSION In this single center randomized trial, pyridoxine plus dexamethasone and ondansetron reduced the incidence of PONV in patients undergoing elective gynecological laparoscopic surgery under general anesthesia. These findings need to be validated in multicenter studies in diverse populations to ensure generalizability.

中文翻译：

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吡哆醇预防妇科腹腔镜手术术后恶心和呕吐：一项双盲随机对照试验。


背景 术后恶心呕吐 （PONV） 是妇科腹腔镜手术后的常见并发症。吡哆醇已被推荐作为预防和治疗妊娠期恶心和呕吐的一线药物;然而，其预防 PONV 的疗效仍不清楚。方法 将 18 至 65 岁在全身麻醉下接受择期妇科腹腔镜手术的患者随机分为吡哆醇组或对照组。吡哆醇组麻醉诱导前给予维生素 B6 0.2g，对照组静脉给予生理盐水。两组接受相似的静脉和吸入联合全身麻醉方案。所有患者在麻醉诱导后接受地塞米松 （静脉注射） 和手术完成前接受昂丹司琼 （静脉注射）。根据患者自我报告的数据记录 PONV 发生率。从医院系统收集其他临床资料，ELISA 测定血白细胞介素 6 和 P 物质浓度。结果 共筛选出 442 例患者，其中 240 例患者平等随机分配到吡哆醇组或对照组。吡哆醇组的 PONV 发生率低于对照组，具有统计学意义 （16.7% [20/120] vs. 35.8% [43/120];相对风险 （RR） = 0.47 [95% CI： 0.29， 0.74];绝对风险降低 （ARR） = 0.20 [95% CI： 0.08， 0.30];P = 0.001），吡哆醇降低了术后恶心的发生率 （12.5% [15/120] vs. 35% [42/120];RR = 0.36 [95% CI： 0.21， 0.61];ARR = 0.23 [95% CI： 0.12， 0.33];P < 0.001）。术后呕吐、首次 PONV 发生时间、疼痛、血清白细胞介素 6 和 P 物质以及白细胞和中性粒细胞计数无统计学差异。 结论 在这项单中心随机试验中，吡哆醇联合地塞米松和昂丹司琼降低了全身麻醉下择期妇科腹腔镜手术患者 PONV 的发生率。这些发现需要在不同人群的多中心研究中得到验证，以确保可推广性。