东莨菪碱透皮帖剂预防膝关节置换术后恶心呕吐的有效性及安全性研究

Efficacy and Safety of Transdermal Scopolamine for Prevention of Nausea and Vomiting After Total Knee Arthroplasty

目的:通过观察东莨菪碱透皮贴剂(transdermal scopolamine,TDS)对全膝关节置换术患者术后恶心呕吐发生率、视觉模拟评分(visual analogue scale,VAS)改善情况以及术后首次下地时间的影响,评价该药的有效性及安全性。方法:选取2019年6月至2021年9月于西安市红会医院膝关节病区行初次全膝关节置换术的患者97例,采用随机数字表法分为研究组(使用TDS)49例和对照组(使用安慰剂贴)48例。两组均于术前4 h在患者耳后贴敷贴片,并保留72 h。所有患者均采用全身麻醉+股神经阻滞麻醉,术前宣教、手术操作、术后康复及多模式镇痛均由同一组医师完成。由独立的观察者记录并统计术后4~24、24~48、48~72以及72 h恶心呕吐发生情况及其VAS评分的改善情况,以及患者术后首次下地时间。结果:研究组患者术后恶心呕吐发生率为对照组的0.2619倍(95%CI=0.105~0.654,P=0.004)。研究组与对照组患者术后4~24、24~48和48~72 h的恶心呕吐VAS评分比较,差异均有统计学意义(P<0.05),且研究组患者显著低于对照组。在术后首次下地时间方面,62.50%(30例)的对照组患者术后第1日可下地锻炼,85.71%(42例)的研究组患者术后第1日可下地锻炼,研究组术后第1日下地患者所占比例明显高于对照组,差异有统计学意义(χ^(2)=6.83,P=0.009)。两组患者不良反应发生率的差异无统计学意义(P>0.05)。结论:TDS对减少全膝关节置换术后恶心呕吐的发生具有正向作用,避免了口服药物时的肝脏首过效应和对胃肠道的刺激,可延长药物作用时间,给药及中止给药均较方便,且不良反较少,安全性较高。

OBJECTIVE:To evaluate the efficacy and safety of the drug by observing the effects of transdermal scopolamine(TDS)on the incidence of nausea and vomiting,improvement of visual analogue scale(VAS)and the first time of postoperative activity out of bed after total knee arthroplasty.METHODS:A total of 97 patients with total knee arthroplasty in department of knee joint of Xi’an Honghui Hospital from Jun.2019 to Sept.2021 were extracted to be divided into the study group(TDS,n=49)and the control group(placebo,n=48)via the random number table.In both groups,patches were applied behind the patients’ear 4 h before surgery,and kept for 72 h.All patients were anesthetized with general anesthesia+femoral nerve block,and preoperative education,surgical operation,postoperative rehabilitation,and multi-mode analgesia were performed by the same group of clinicians.The occurrence of nausea and vomiting in from 4 to 24 h,from 24 to 48 h,from 48 to 72 h and 72 h after surgery,improvement of VAS score and the first time of postoperative activity out of bed was recorded and counted by independent observers.RESULTS:The incidence of PONV in the study group was 0.2619 times of that in the control group(95%CI=0.105-0.654,P=0.004).The VAS scores of nausea and vomiting were statistically different between the study group and the control group from 4 to 24 h,from 24 to 48 h and from 48 to 72 h after surgery(P<0.05),and the study group was lower than the control group.In terms of the first time of postoperative activity out of bed,62.50%(30 cases)of patients in the control group and 85.71%(42 cases)of patients in the study group could take exercise on the first day after operation,the proportion of patients in the study group was significantly higher than that in the control group,with statistically significant differences(χ^(2)=6.83,P=0.009).There was no significant difference in the incidence of adverse dru reactions between two groups(P>0.05).CONCLUSIONS:TDS has the positive effects on reducing the incidence of nausea and vomiting after total knee arthroplasty,avoiding the hepatic intestinal first pass effect and stimulation of the gastrointestinal tract during oral administration,prolonging the duration of drug action,being more convenient for administration and discontinuation of drug administration,and having less adverse drug reactions and higher safety.