托烷司琼治疗腹部手术后恶心、呕吐的多中心随机对照研究

The Randomized Controlled Multicenter Clinical Study of Tropisetron to The Patients with Nausea and Vomiting after Abdominal Operation

目的:评价iv单剂量(2 mg)托烷司琼对全身麻醉下的腹部手术后病人出现的恶心和(或)呕吐症状的疗效。方法:采用前瞻、随机、对照、平行和多中心的实验设计,患者共64例,全麻术后神智清醒、出现中度以上的恶心症状和(或)呕吐,立即通过iv托烷司琼2 mg(试验组)或昂但司琼4 mg(对照组)观察用药后24 h内,呕吐和恶心程度的变化,比较两组之间的差别。结果:完成研究61例,淘汰3例,淘汰率为4.7％;托烷司琼和昂但司琼均能显著缓解全麻术后发生的呕吐和恶心症状,其呕吐和恶心平均停止时间、用药后24 h发生呕吐病例数和呕吐病人平均呕吐次数,两组比较结果相似,研究者和病人自身评价,两种药物的疗效相似(P>0.05)。结论:托烷司琼单剂量(2 mg)对全身麻醉外科腹部手术后病人发生的呕吐和(或)恶心症状有较好的疗效。

OBSJECTIVE: To evaluate the efficacy of intravenous injection single dose (2 mg) tropisetron on patients with nausea and vomiting after abdominal operation under general anesthesia. METHODS: Applied prospective, randomised, active drug controlled, parallelled,multicenter study design, 64 writen consented patients who met with inclusion/exclusion criteria were enrolled to the study .The enrolled conscious patients after general anesthesia, turned up the medium level of nausea and/or vomiting symptom, immediately randomized into 2 study groups, the intravenous injection tropisetron 2 mg (trail group) or ondansetron 4 mg (control group). Observed the condition of nausea and vomiting within 24 hours after treatment, compared the difference between 2 groups. RESULTS: The discontinued rate is 4.7%; the symptoms of nausea and vomiting were recovered significantly in both groups after treatment,the average cure time of nausea and vomiting, the vomiting cases within 24 hours after the treatment, the number of vomiting patients were similar in both groups; the assessment of investigators and patients were similar, the efficacy of both treatments had not significant difference (P>0.05). CONCLUSION: Tropisetron had good clinical effects on patient with nausea and vomiting after abdomical operation under general anesthesia.