Fujinami Haruka, Kajiura Shinya, Nishikawa Jun, Ando Takayuki, Sugiyama Toshiro
Department of Endoscopy, Toyama University Hospital, Toyama, Japan.
Department of Gastroenterology, Graduate School of Medicine and Pharmaceutical Science, University of Toyama, Sugitani 2630, Toyama City, Toyama 930-0194 Japan.
Chin Med. 2017 Jan 9;12:3. doi: 10.1186/s13020-016-0125-6. eCollection 2017.
Anti-cholinergic agents may be used to inhibit duodenal peristalsis, but they may have adverse effects. Shakuyakukanzoto () has an anti-spasmodic effect and has been used before for oesophagogastroduodenoscopy and colonoscopy. This randomised clinical trial aimed to evaluate the inhibitory effect of Shakuyakukanzoto on duodenal peristalsis, and its usefulness when administered into the duodenum just before endoscopic retrograde cholangiopancreatography (ERCP).
Participants were recruited between June 2008 and December 2010. All were aged ≥18 years and provided written informed consent. Exclusion criteria were: acute pancreatitis, a history of ischemic heart disease, prostatic hypertrophy or glaucoma, and altered/postsurgical upper gastrointestinal anatomy. The recruited participants were randomly assigned to the Shakuyakukanzoto group and control group. Shakuyakukanzoto 100 mg/mL solution or placebo (warm water) was administered directly as a spray into the duodenum during endoscopy. Efficacy was evaluated by observing the extent of duodenal peristalsis and assessing the difficulty of cannulating the common bile duct, the required time (RT) from administration to inhibition of duodenal peristalsis and the stop duration time (DT, the duration for which peristalsis was inhibited). Side effects were evaluated by measuring serum potassium concentration after ERCP.
Of 28 participants, 15 were assigned to the Shakuyakukanzoto group and 13 to the control group. Duodenal peristalsis was inhibited in eight of the 10 eligible participants (80.0%) in the Shakuyakukanzoto group and none (0%) of the nine eligible participants in the control group ( = 0.026). In the Shakuyakukanzoto group, mean RT (±standard deviation) was 76.0 ± 23.9 s and DT was 11.3 ± 4.2 min. No adverse effects were observed in the Shakuyakukanzoto group during or after ERCP.
Duodenal peristalsis can be inhibited by spraying Shakuyakukanzoto solution directly into the duodenum. UMIN Clinical Trials Registry (UMIN-CTR) UMIN000011469.
抗胆碱能药物可用于抑制十二指肠蠕动，但可能有不良反应。芍药甘草汤（）具有解痉作用，此前已用于食管胃十二指肠镜检查和结肠镜检查。这项随机临床试验旨在评估芍药甘草汤对十二指肠蠕动的抑制作用，以及在内镜逆行胰胆管造影术（ERCP）前注入十二指肠时的有效性。
2008年6月至2010年12月招募参与者。所有参与者年龄≥18岁并提供书面知情同意书。排除标准为：急性胰腺炎、缺血性心脏病史、前列腺肥大或青光眼，以及上消化道解剖结构改变/手术后改变。招募的参与者被随机分配到芍药甘草汤组和对照组。在内镜检查期间，将100mg/mL的芍药甘草汤溶液或安慰剂（温水）直接作为喷雾剂注入十二指肠。通过观察十二指肠蠕动程度、评估胆总管插管难度、从给药到抑制十二指肠蠕动的所需时间（RT）以及停止持续时间（DT，蠕动被抑制的持续时间）来评估疗效。通过在ERCP后测量血清钾浓度来评估副作用。
28名参与者中，15名被分配到芍药甘草汤组，13名被分配到对照组。芍药甘草汤组10名符合条件的参与者中有8名（80.0%）十二指肠蠕动受到抑制，而对照组9名符合条件的参与者中无一例（0%）受到抑制（P = 0.026）。在芍药甘草汤组中，平均RT（±标准差）为76.0±23.9秒，DT为11.3±4.2分钟。在ERCP期间或之后，芍药甘草汤组未观察到不良反应。
将芍药甘草汤溶液直接喷入十二指肠可抑制十二指肠蠕动。UMIN临床试验注册中心（UMIN-CTR）UMIN000011469。
