• 1. 四川大學(xué)華西醫(yī)院內(nèi)分泌科（成都 610041） 2. 重慶醫(yī)科大學(xué)第一附屬醫(yī)院內(nèi)分泌科（重慶 400016） 3. 昆明醫(yī)學(xué)院糖尿病科（昆明650031）;

目的　 評(píng)價(jià)文拉法辛和卡馬西平治療痛性糖尿病周圍神經(jīng)病變的療效和安全性。
方法　 本試驗(yàn)是一個(gè)隨機(jī)雙盲雙模擬多中心臨床試驗(yàn)。3個(gè)臨床中心共納入132例患者。隨機(jī)分為試驗(yàn)組，文拉發(fā)辛膠囊， 25 mg，每日2次，66例和陽(yáng)性對(duì)照組，卡馬西平片，0.1 g，每日2次， 66例，療程為14天。主要的療效指標(biāo)為數(shù)字強(qiáng)度分級(jí)法評(píng)價(jià)疼痛強(qiáng)度。次要指標(biāo)為生活質(zhì)量評(píng)價(jià)。
結(jié)果　 共119例患者完成試驗(yàn)。在試驗(yàn)的第5、7、10和14天時(shí)，文拉法辛組較卡馬西平組明顯改善疼痛強(qiáng)度（各組的P值分別為：P=0.02，P=0.03，P=0.003，P=0.001）。在治療的第10天和第14 天文拉法辛較卡馬西平明顯改善生活質(zhì)量評(píng)價(jià)的總分（P=0.02；P=0.01）。文拉法辛和卡馬西平都能明顯改善患者的睡眠和情緒，但文拉法辛的效果優(yōu)于卡馬西平。文拉法辛最常見的不良反應(yīng)是胃腸道不適、頭昏和嗜睡。文拉法辛組的不良反應(yīng)發(fā)生率為43.90%（4例患者因?yàn)椴涣挤磻?yīng)退出試驗(yàn)）；卡馬西平組的不良反應(yīng)發(fā)生率為25.76%（2例患者因?yàn)椴涣挤磻?yīng)退出試驗(yàn)）。
結(jié)論 　文拉發(fā)辛和卡馬西平均有減輕糖尿病神經(jīng)病變性疼痛以及改善患者生活質(zhì)量的作用，但文拉發(fā)辛在減輕疼痛、改善生活質(zhì)量方面的作用優(yōu)于卡馬西平，兩組的不良反應(yīng)和不良事件均相似，主要的不良事件是胃腸道不適，頭昏和嗜睡。

引用本文： 賈海燕,李啟富,宋滇平,安振梅,劉玉平,冉興無(wú),武仁華,田浩明. 文拉法辛和卡馬西平治療痛性糖尿病周圍神經(jīng)病變的隨機(jī)雙盲雙模擬多中心臨床試驗(yàn). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(5): 321-328. doi: 復(fù)制

1. Diabetes Control and Complication Trial Research Group: The effect of intensive treatment of diabetes on development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl Med, 1993; 329 (14): 977-986.
2. Holliday SM, Venlafax BP. A review of its pharmacology and therapeutic potential in depression. Drugs, 1995; 49(7): 280-294.
3. Khawaja IS, Feinstein RE. Cardiovascular effects of selective serotonin reuptake inhibitors and other novel antidepressants. Heart Dis, 2003; 5(2): 153-160.
4. Marchand F, Alloui A, Chapuy E, et al. The antihyperalgesic effect of venlafaxine in diabetic rats does not involve the opioid system. Neuroscience letters, 2003; 342(1-2): 105-108.
5. Lang E, Hord AH, Denson D. Venlafaxine HCL (Effexor) relieves thermal hyperalgesia in rats with an experimental mononeuropathy. Pain, 1996; 68: 151-155.
6. Kiayias JA, Vlachou ED, Lakka-Papadodima E. Venlafaxine HCL in the treatment of painful peripheral diabetic neuropathy. Diabetes Care, 2000; 23(5): 699.
7. Lithner F. Venlafaxine in treatment of severe painful peripheral diabetic neuropathy. Diabetes Care, 2000; 23(11): 1710-1711.
8. Davis JL, Smith RL. Painful peripheral diabetic neuropathy treated with venlafaxine HCl extended release capsules. Diabetes Care, 1999; 22 (11): 1909.
9. Sindrup, SH, Bach FW, Gram MC, et al. Venlafaxine versus imipramine in painful polyneuropathy: A randomized, controlled trialv. Neurology, 2003; 60(128): 1284-1289.
10. Rowbotham MC, Goli V, Kunz NR, et al. Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. Pain, 2004; 110(3): 697-706.
11. Backonja MM. Use of anticonvulsants for treatment of neuropathic pain. Nerurology, 2002; 59 (suppl 2): S14-S17.
12. Chakrabarti AK, Samantaray SK. Diabetic peripheral neuropathy: nerve conduction studies before, during and after carbamazepine therapy. Aust N Z J Med, 1976; 6(6): 565-568.
13. Gomez-Perez FJ, Choza R, Rios JM, et al. Nortriptyline-fluphenazine vs. carbamazepine in the symptomatic treatment of diabetic neuropathy. Arch Med Res, 1996; 27(4): 525–529.
14. Eisenberg E, Lurie Y, Braker C, et al. Lamotrigine reduces painful diabetic neuropathy: a randomized, controlled study. Neurology, 2001; 57(3): 505-509.
15. Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. Journal of Clinical Neutomuscular Disease, 2001; 3(2): 53-62.
16. Kapwz S, MannJJ MT. Antidepressant medication and the relative risk of suicide attempt and suicide. J Am Med Assoe, 1992; 268: 344-345.
17. Grothe DR, Scheckner B, Albano D. Treatment of pain syndromes with venlafaxine. Pharmacotherapy, 2004; 24(5): 621-629.
18. Muth EA, Haskins JT, Moyer JA, et al. Antidepressant biochemical profile of the novel bicyclic compound Wy-45030, an ethyl cyclohexanol derivative. Biochem Pharmacol, 1986; 35(24): 4493-4497.
19. Shen ZZ, Wu SH, Shao FY, Guohui Chen. Chronic et al. Chief editor.Complications of diabetes mellitus. Shanghai:Publishing Company of Shanghai Medical University; 1999. 261.
20. Ereshefsky L.Drug-drug interactions involving antidepressants: focus on venlafaxine.J Clin Psychopharmacol,1996;16(3Suppl2 ):37-50.
21. Rudolph RL, Derivan AT. The safety and tolerability of venlafaxine HCL: analysis of the clinical trials database. J Clin Psychopharmacol, 1996; 16(suppl 12): 54-59.
  1. 1. Diabetes Control and Complication Trial Research Group: The effect of intensive treatment of diabetes on development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl Med, 1993; 329 (14): 977-986.
  2. 2. Holliday SM, Venlafax BP. A review of its pharmacology and therapeutic potential in depression. Drugs, 1995; 49(7): 280-294.
  3. 3. Khawaja IS, Feinstein RE. Cardiovascular effects of selective serotonin reuptake inhibitors and other novel antidepressants. Heart Dis, 2003; 5(2): 153-160.
  4. 4. Marchand F, Alloui A, Chapuy E, et al. The antihyperalgesic effect of venlafaxine in diabetic rats does not involve the opioid system. Neuroscience letters, 2003; 342(1-2): 105-108.
  5. 5. Lang E, Hord AH, Denson D. Venlafaxine HCL (Effexor) relieves thermal hyperalgesia in rats with an experimental mononeuropathy. Pain, 1996; 68: 151-155.
  6. 6. Kiayias JA, Vlachou ED, Lakka-Papadodima E. Venlafaxine HCL in the treatment of painful peripheral diabetic neuropathy. Diabetes Care, 2000; 23(5): 699.
  7. 7. Lithner F. Venlafaxine in treatment of severe painful peripheral diabetic neuropathy. Diabetes Care, 2000; 23(11): 1710-1711.
  8. 8. Davis JL, Smith RL. Painful peripheral diabetic neuropathy treated with venlafaxine HCl extended release capsules. Diabetes Care, 1999; 22 (11): 1909.
  9. 9. Sindrup, SH, Bach FW, Gram MC, et al. Venlafaxine versus imipramine in painful polyneuropathy: A randomized, controlled trialv. Neurology, 2003; 60(128): 1284-1289.
  10. 10. Rowbotham MC, Goli V, Kunz NR, et al. Venlafaxine extended release in the treatment of painful diabetic neuropathy: a double-blind, placebo-controlled study. Pain, 2004; 110(3): 697-706.
  11. 11. Backonja MM. Use of anticonvulsants for treatment of neuropathic pain. Nerurology, 2002; 59 (suppl 2): S14-S17.
  12. 12. Chakrabarti AK, Samantaray SK. Diabetic peripheral neuropathy: nerve conduction studies before, during and after carbamazepine therapy. Aust N Z J Med, 1976; 6(6): 565-568.
  13. 13. Gomez-Perez FJ, Choza R, Rios JM, et al. Nortriptyline-fluphenazine vs. carbamazepine in the symptomatic treatment of diabetic neuropathy. Arch Med Res, 1996; 27(4): 525–529.
  14. 14. Eisenberg E, Lurie Y, Braker C, et al. Lamotrigine reduces painful diabetic neuropathy: a randomized, controlled study. Neurology, 2001; 57(3): 505-509.
  15. 15. Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. Journal of Clinical Neutomuscular Disease, 2001; 3(2): 53-62.
  16. 16. Kapwz S, MannJJ MT. Antidepressant medication and the relative risk of suicide attempt and suicide. J Am Med Assoe, 1992; 268: 344-345.
  17. 17. Grothe DR, Scheckner B, Albano D. Treatment of pain syndromes with venlafaxine. Pharmacotherapy, 2004; 24(5): 621-629.
  18. 18. Muth EA, Haskins JT, Moyer JA, et al. Antidepressant biochemical profile of the novel bicyclic compound Wy-45030, an ethyl cyclohexanol derivative. Biochem Pharmacol, 1986; 35(24): 4493-4497.
  19. 19. Shen ZZ, Wu SH, Shao FY, Guohui Chen. Chronic et al. Chief editor.Complications of diabetes mellitus. Shanghai:Publishing Company of Shanghai Medical University; 1999. 261.
  20. 20. Ereshefsky L.Drug-drug interactions involving antidepressants: focus on venlafaxine.J Clin Psychopharmacol,1996;16(3Suppl2 ):37-50.
  21. 21. Rudolph RL, Derivan AT. The safety and tolerability of venlafaxine HCL: analysis of the clinical trials database. J Clin Psychopharmacol, 1996; 16(suppl 12): 54-59.