Salmanroghani Hassan, Mirvakili Massoud, Mirjalili Mahtabalsadat, Baghbanian Mahmud, Salmanroghani Roham
Department of Internal Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Department of Clinical Pharmacy, School of Pharmacy, Shiraz University of Medical Sciences, Shiraz, Iran.
Clin Pharmacol. 2020 Aug 20;12:123-130. doi: 10.2147/CPAA.S263531. eCollection 2020.
To evaluate the efficacy and safety of low dose versus usual dose of Hyoscine during endoscopic retrograde cholangiopancreatography (ERCP).
This randomized, open-label clinical trial included 282 patients undergoing ERCP who had duodenal peristalsis interfering with cannulation. Patients were randomly divided into two groups: Group one and two received low (5 mg) and usual (10 mg) dose of Hyoscine, respectively. Cardiovascular service consultation was performed for all patients before entering the study and performing ERCP. Hyoscine was injected intravenously, and the spasmolytic effect of the drug was assessed while the papilla was in a completely enface view. The time interval between cessation of peristalsis and its further onset was recorded by the chronometer. Also, patient's heart rate and blood pressure were monitored during ERCP by digital monitoring.
The results showed no statistically significant differences in the mean duration of peristalsis, the duration of the antispasmodic activity and the time required to increase the heart rate between two groups (P=0.38, P=0.48, P=0.32, respectively). No significant differences were observed regarding the average of heart rate and mean arterial blood pressure (MAP) before drug administration between the two groups (P=0.182 and P=0.29, respectively), but after the drug administration, tachycardia and hypotension were significantly higher in the second group (P=0.007 and P=0.001, respectively). There was no statistically significant difference in the frequency of arrhythmia between two groups (P=0.08). The results also showed that tachycardia and hypotension occurred more frequently in men and elderly patients (P <0.05).
A low dose of Hyoscine is as effective as the usual dose and its side effects such as alteration in blood pressure and heart rate are much fewer, especially in men and elderly patients.
评估在内镜逆行胰胆管造影术（ERCP）期间，低剂量与常规剂量的东莨菪碱的疗效和安全性。
这项随机、开放标签的临床试验纳入了282例行ERCP且十二指肠蠕动干扰插管的患者。患者被随机分为两组：第一组和第二组分别接受低剂量（5毫克）和常规剂量（10毫克）的东莨菪碱。所有患者在进入研究并进行ERCP之前均接受心血管服务咨询。东莨菪碱通过静脉注射，在乳头完全正面观时评估药物的解痉效果。蠕动停止与其再次出现之间的时间间隔由计时器记录。此外，在ERCP期间通过数字监测仪监测患者的心率和血压。
结果显示，两组之间蠕动的平均持续时间、解痉活性的持续时间以及心率增加所需时间无统计学显著差异（分别为P = 0.38、P = 0.48、P = 0.32）。两组给药前的平均心率和平均动脉血压（MAP）无显著差异（分别为P = 0.182和P = 0.29），但给药后，第二组的心动过速和低血压显著更高（分别为P = 0.007和P = 0.001）。两组之间心律失常的发生率无统计学显著差异（P = 0.08）。结果还显示，心动过速和低血压在男性和老年患者中更频繁发生（P <0.05）。
低剂量的东莨菪碱与常规剂量一样有效，其血压和心率改变等副作用要少得多，尤其是在男性和老年患者中。
