盐酸依托必利联合α-硫辛酸对糖尿病胃轻瘫患者的疗效研究

Efficacy of itopride combined with alpha-lipoic acid for patients with diabetic gastroparesis

目的观察盐酸依托必利联合α-硫辛酸治疗糖尿病胃轻瘫患者（DGP）的疗效以及对患者胃功能的影响。方法纳入有上消化道症状的DGP患者110例，患者均知情同意。掷骰子法将患者随机分为联合用药组和对照组。联合用药组60例患者，给予盐酸依托必利50mg饭前口服，3次／d，α-硫辛酸0．6g溶于250ml 0．9％NaCl溶液中，避光静脉滴注；对照组50例患者，给予盐酸依托必利50mg饭前口服，3次／d，均治疗2周。统计患者餐后上腹饱胀、嗳气、反酸、厌食、恶心呕吐等临床症状的积分，计算胃排空率，并检测血浆胃动素和血清胃泌素水平的变化。结果两组DGP患者治疗后，联合用药组临床症状评分[（4．62±3．46）分比（12．26±3．43）分]、对照组临床症状评分[（5．43±3．65）分比（12．31±3．37）分]均降低，联合用药组患者临床症状改善的总有效率高于对照组（91．6％比78．0％，x2=4．098，P〈0．05）。两组DGP患者治疗后，联合用药组胃排空率[（76．9±9．7）％比（37．3±10．2）％]、对照组胃排空率[（57．2±10．4）％比（36．8±11．2）％]均高于治疗前，联合用药组较对照组胃排空改善程度更明显（t=10．221，P〈0．01）。治疗后，联合用药组血浆胃动素水平[（554．0±67．6）ng／L比（640．2±64．4）ng／L]、血清胃泌素水平[（96．8±22．2）ng／L比（152．6±20．3）ng／L]、对照组血浆胃动素水平[（589．4±48．3）ng／L比（636．3±66．4）ng／L]、血清胃泌素水平[（120．9±19．7）ng／L比（153．5±19．4）ng／L]均低于治疗前，联合用药组血浆胃动素、血清胃泌素水平下降较对照组更为显著（t值分别为3．100、5．959，均P〈0．05）。结论盐酸依托必利和α-硫辛酸联合用药能改善DGP患者的临床症状，提高胃排空率，降低血浆胃动素和血清胃泌素水平，疗效优于依托必利单药治疗。

Objective To evaluate the efficacy of itopride hydrochloride combined with alpha-lipoic acid in treatment of diabetic gastroparesis. Methods One hundred and ten patients with diabetic gastroparesis were randomly assigned to two groups. Sixty patients received α-lipoic acid plus itopride （α-lipoic acid 0. 6 g intravenously for 14 d plus itopride 50 mg orally t. i. d） , and 50 cases received oral itopride only. The clinical symptoms including postprandial abdominal fullness, belching, acid reflux, anorexia,nausea and vomiting were observed; the gastric emptying rate was tested, and plasma motilin and serum ganstrin levels were measured groups, before and after two weeks of treatment. Results The clinical symptom scores of combination therapy group （ 4. 62 ± 3.46 vs. 12. 26 ± 3.43 ） and control groups （5.43 ± 3.65 vs. 12. 31 ± 3.37 ） were improved after treatment. The overall effective rate of combination group was 91.6% and that of itopride therapy group was 78.0% （ X^2 = 4. 098, P 〈 0. 05 ）. Gastric emptying rate of combination group [ （76. 9 ±9. 7 ） % vs. （37.3 ± 10.2） % ] was increased more markedly than that ofitopridegroup[（57.2± 10.4）% vs. （36.8 ± 11.2）%] （t = 10.221, P 〈0.05）. Plasma motilin and serum ganstrin levels in combination group [ （ 640. 2 ± 64. 4 ） ng/L vs. （ 554.0 ± 67. 6 ） ng/L, （152. 6 ±20. 3）ng/L vs. （96. 8 ± 22. 2）ng/L] were reduced more markedly than those in itopride group [ （636. 3 ± 66. 4） ng/L vs. （589. 4 ± 48. 3 ） ng/L, （ 153.5 ± 19. 4 ） ng/L vs. （ 120. 9 ± 19. 7 ） ng/L ] respectively （t = 3. 100, 5. 959, all P 〈 0. 05）. Conclusion For patients with diabetic gastroparesis, α-lipoic acid and itopride combination therapy can significantly improve symptoms and gastric emptying rate, decrease motlin and gastrin levels; and the efficacy of combination therapy is better than that of itopride monotherapy.