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西沙必利对糖尿病患者胃排空影响的双盲对照试验

Double blind controlled trial of effect of cisapride on gastric emptying in diabetics.

作者信息

Dutta U, Padhy A K, Ahuja V, Sharma M P

机构信息

All India Institute of Medical Sciences, New Delhi, India.

出版信息

Trop Gastroenterol. 1999 Jul-Sep;20(3):116-9.

Abstract

AIMS

Diabetic gastroparesis is a common complication seen in 20-50% of patients due to autonomic neuropathy involving vagal supply. Cisapride, a specific gastrointestinal cholinomimetic agent may thus be effective.

METHODS

Fifty-one diabetic patients (age 12-65 years) of disease duration > 5 years were assessed for symptomatic gastroparesis, other diabetic complications and glycemic control. Gastric emptying time (GET) was estimated using a solid meal method (99mTc labeled rice based idli) and patients randomized to receive either cisapride or placebo for a period of 2 weeks. Cisapride was administered in a dose of 10 mg TID. GET and symptom scores were reassessed on the therapy after 2 weeks.

RESULTS

Twenty nine of 51 (56.8%) patients had gastroparesis. Mean GET in the gastroparesis group was 141 +/- 66 minutes compared to 24.53 +/- 10 minutes in the non gastroparesis group (p < 0.01). GET decreased by 72% amongst the patients who received cisapride compared to 23% in the placebo group (p < 0.001). Symptom scores also improved in the cisapride group; no adverse effects were noted.

CONCLUSIONS

Cisapride improves the symptom score and the solid gastric emptying time in patients suffering from diabetic gastroparesis.

摘要

目的

糖尿病胃轻瘫是一种常见并发症,见于20%至50%的患者,由涉及迷走神经供应的自主神经病变引起。西沙必利作为一种特定的胃肠拟胆碱药可能有效。

方法

对51名病程超过5年、年龄在12至65岁的糖尿病患者进行症状性胃轻瘫、其他糖尿病并发症及血糖控制情况的评估。采用固体餐法(基于99mTc标记大米的印度蒸米糕)估算胃排空时间(GET),患者被随机分为两组,分别接受西沙必利或安慰剂治疗,为期2周。西沙必利剂量为10毫克,每日三次。2周治疗后重新评估GET及症状评分。

结果

51名患者中有29名(56.8%)患有胃轻瘫。胃轻瘫组的平均GET为141±66分钟,而非胃轻瘫组为24.53±10分钟(p<0.01)。接受西沙必利治疗的患者GET下降了72%,而安慰剂组下降了23%(p<0.001)。西沙必利组的症状评分也有所改善;未观察到不良反应。

结论

西沙必利可改善糖尿病胃轻瘫患者的症状评分及固体胃排空时间。

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