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用于治疗胃轻瘫症状的格拉司琼透皮系统:一项处方登记研究。

Granisetron Transdermal System for Treatment of Symptoms of Gastroparesis: A Prescription Registry Study.

作者信息

Midani Deena, Parkman Henry P

机构信息

Department of Medicine, Section of Gastroenterology, Temple University School of Medicine, Philadelphia, PA, USA.

出版信息

J Neurogastroenterol Motil. 2016 Oct 30;22(4):650-655. doi: 10.5056/jnm15203.

Abstract

BACKGROUND/AIMS: Serotonin receptor (eg, 5-HT₃) antagonists are used to treat nausea and vomiting from a variety of causes. Granisetron transdermal system (GTS) is an appealing delivery system for patients with gastroparesis. To assess if GTS improves nausea and vomiting and other gastroparesis symptoms in patients with gastroparesis.

METHODS

Patients with gastroparesis and symptoms of nausea and vomiting refractory to conventional treatment were treated with GTS. Symptoms of gastroparesis were assessed using a modified Gastroparesis Cardinal Symptom Index (GCSI). Following 2 weeks of treatment, patients were asked to assess their symptoms and indicate their therapeutic response using the Clinical Patient Grading Assessment Scale (CPGAS) reporting if symptoms of nausea and vomiting improved on a scale: 0 = no change to +7 = completely better.

RESULTS

Fifty-one patients received GTS by prescription: average age was 40 ± 17 years, 44 female, 11 diabetics, 23 ± 20% retention at 4 hours on gastric emptying scintigraphy. Thirty-nine of the 51 (76%) patients stated improvement with GTS. There was significant improvement in nausea and vomiting as assessed with CPGAS at 2 weeks (2.28 ± 2.53; < 0.05). Symptoms of nausea and vomiting significantly improved. Other symptoms including postprandial fullness, loss of appetite, upper abdominal pain, and early satiety improved. Side effects reported included redness at the site of the patch in 7 patients, pruritus in 5, and constipation in 5.

CONCLUSIONS

GTS was moderately effective in reducing nausea and/or vomiting in 76% of gastroparesis patients. In addition to nausea and vomiting, symptoms of postprandial fullness, loss of appetite, upper abdominal pain, and early satiety also improved.

摘要

背景/目的:血清素受体(如5-HT₃)拮抗剂用于治疗各种原因引起的恶心和呕吐。格拉司琼透皮系统(GTS)对胃轻瘫患者来说是一种有吸引力的给药系统。旨在评估GTS是否能改善胃轻瘫患者的恶心、呕吐及其他胃轻瘫症状。

方法

对胃轻瘫且常规治疗难以缓解恶心和呕吐症状的患者采用GTS治疗。使用改良的胃轻瘫主要症状指数(GCSI)评估胃轻瘫症状。治疗2周后,要求患者评估自身症状,并使用临床患者分级评估量表(CPGAS)指出其治疗反应,报告恶心和呕吐症状改善情况,范围为:0 = 无变化至 +7 = 完全好转。

结果

51例患者按处方接受了GTS治疗:平均年龄为40±17岁,女性44例,糖尿病患者11例,胃排空闪烁扫描4小时时潴留率为23±20%。51例患者中有39例(76%)表示GTS治疗后症状改善。2周时通过CPGAS评估,恶心和呕吐有显著改善(2.28±2.53;<0.05)。恶心和呕吐症状显著改善。其他症状包括餐后饱胀、食欲不振、上腹部疼痛和早饱也有所改善。报告的副作用包括7例患者贴片部位发红,5例瘙痒,5例便秘。

结论

GTS对76%的胃轻瘫患者减少恶心和/或呕吐有中度疗效。除恶心和呕吐外,餐后饱胀、食欲不振、上腹部疼痛和早饱症状也有所改善。

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