文拉法辛和卡馬西平治療痛性糖尿病周圍神經病變的隨機雙盲雙模擬多中心臨床試驗_《中國循證醫學雜志》

作者：

賈海燕 ¹ , 李啟富 ² , 宋滇平 ³ , 安振梅 ¹ , 劉玉平 ¹ , 冉興無 ¹ , 武仁華 ¹ , 田浩明 ¹

1. 四川大學華西醫院內分泌科（成都 610041） 2. 重慶醫科大學第一附屬醫院內分泌科（重慶 400016） 3. 昆明醫學院糖尿病科（昆明650031）;

關鍵詞：

痛性糖尿病周圍神經病變文拉法辛卡馬西平疼痛生活質量

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目的　評價文拉法辛和卡馬西平治療痛性糖尿病周圍神經病變的療效和安全性。
方法　本試驗是一個隨機雙盲雙模擬多中心臨床試驗。3個臨床中心共納入132例患者。隨機分為試驗組，文拉發辛膠囊， 25 mg，每日2次，66例和陽性對照組，卡馬西平片，0.1 g，每日2次， 66例，療程為14天。主要的療效指標為數字強度分級法評價疼痛強度。次要指標為生活質量評價。
結果　共119例患者完成試驗。在試驗的第5、7、10和14天時，文拉法辛組較卡馬西平組明顯改善疼痛強度（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量評價的總分（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于卡馬西平。文拉法辛最常見的不良反應是胃腸道不適、頭昏和嗜睡。文拉法辛組的不良反應發生率為43.90%（4例患者因為不良反應退出試驗）；卡馬西平組的不良反應發生率為25.76%（2例患者因為不良反應退出試驗）。
結論　文拉發辛和卡馬西平均有減輕糖尿病神經病變性疼痛以及改善患者生活質量的作用，但文拉發辛在減輕疼痛、改善生活質量方面的作用優于卡馬西平，兩組的不良反應和不良事件均相似，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,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病變的隨機雙盲雙模擬多中心臨床試驗. 中國循證醫學雜志, 2006, 06(5): 321-328. doi: 復制

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2.	Holliday SM, Venlafax BP. A review of its pharmacology and therapeutic potential in depression. Drugs, 1995; 49(7): 280-294.
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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.
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11.	Backonja MM. Use of anticonvulsants for treatment of neuropathic pain. Nerurology, 2002; 59 (suppl 2): S14-S17.
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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. 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.

《中國循證醫學雜志》

文拉法辛和卡馬西平治療痛性糖尿病周圍神經病變的隨機雙盲雙模擬多中心臨床試驗

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《中國循證醫學雜志》

文拉法辛和卡馬西平治療痛性糖尿病周圍神經病變的隨機雙盲雙模擬多中心臨床試驗

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