神经系统和微血管并发症的发生和进展:有高质量证据表明,以将血糖维持在接近正常范围为目标的强化胰岛素治疗有效延缓 1 型糖尿病患者糖尿病神经病变、肾病和视网膜病的发生和进展。[8]The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.http://www.nejm.org/doi/full/10.1056/NEJM199309303291401#t=articlehttp://www.ncbi.nlm.nih.gov/pubmed/8366922?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
神经系统和微血管并发症的发生和进展:有高质量证据表明,以将血糖维持在接近正常范围为目标的强化胰岛素治疗有效延缓 1 型糖尿病患者糖尿病神经病变、肾病和视网膜病的发生和进展。[8]The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.http://www.nejm.org/doi/full/10.1056/NEJM199309303291401#t=articlehttp://www.ncbi.nlm.nih.gov/pubmed/8366922?tool=bestpractice.com
异常自主神经检查结果的发生和进展:有高质量的证据表明,对于 1 型糖尿病患者,与强化胰岛素治疗相比,传统的胰岛素治疗会随时间显著增加 R-R 变异性及 Valsalva 比的下降速率。[173]The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia. 1998;41:416-423.http://www.ncbi.nlm.nih.gov/pubmed/9562345?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
异常自主神经检查结果的发生和进展:有高质量的证据表明,对于 1 型糖尿病患者,与强化胰岛素治疗相比,传统的胰岛素治疗会随时间显著增加 R-R 变异性及 Valsalva 比的下降速率。[173]The effect of intensive diabetes therapy on measures of autonomic nervous system function in the Diabetes Control and Complications Trial (DCCT). Diabetologia. 1998;41:416-423.http://www.ncbi.nlm.nih.gov/pubmed/9562345?tool=bestpractice.com
微血管并发症的风险:有中等质量的证据表明,对于新诊断患有 2 型糖尿病的患者,使用磺脲类或胰岛素的强化血糖控制与接受常规治疗的疗法相比,能够大幅降低患者 10 年内微血管并发症的风险。[28]UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.http://www.ncbi.nlm.nih.gov/pubmed/9742976?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
微血管并发症的风险:有中等质量的证据表明,对于新诊断患有 2 型糖尿病的患者,使用磺脲类或胰岛素的强化血糖控制与接受常规治疗的疗法相比,能够大幅降低患者 10 年内微血管并发症的风险。[28]UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998;352:837-853.http://www.ncbi.nlm.nih.gov/pubmed/9742976?tool=bestpractice.com
1 型糖尿病中振动觉阈值 (vibration perception threshold, VPT) 的敏感性和特异性:有中等质量证据表明,对接受强化或常规糖尿病治疗的 1177 名 1 型糖尿病患者的周围神经病变进行评估(VPT 与标准评估),VPT 对于确诊临床神经病变 (87%) 和明确的临床神经病变 (80%) 是一个敏感指标,对于异常神经传导是一个特异性指标 (62%)。[78]Martin CL, Waberski BH, Pop-Busui R, et al; DCCT/EDIC Research Group. Vibration perception threshold as a measure of distal symmetrical peripheral neuropathy in type 1 diabetes: results from the DCCT/EDIC study. Diabetes Care. 2010;33:2635-2641.http://care.diabetesjournals.org/content/33/12/2635.longhttp://www.ncbi.nlm.nih.gov/pubmed/20833868?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
1 型糖尿病中振动觉阈值 (vibration perception threshold, VPT) 的敏感性和特异性:有中等质量证据表明,对接受强化或常规糖尿病治疗的 1177 名 1 型糖尿病患者的周围神经病变进行评估(VPT 与标准评估),VPT 对于确诊临床神经病变 (87%) 和明确的临床神经病变 (80%) 是一个敏感指标,对于异常神经传导是一个特异性指标 (62%)。[78]Martin CL, Waberski BH, Pop-Busui R, et al; DCCT/EDIC Research Group. Vibration perception threshold as a measure of distal symmetrical peripheral neuropathy in type 1 diabetes: results from the DCCT/EDIC study. Diabetes Care. 2010;33:2635-2641.http://care.diabetesjournals.org/content/33/12/2635.longhttp://www.ncbi.nlm.nih.gov/pubmed/20833868?tool=bestpractice.com
糖尿病性神经病的发生和进展:有中等质量的证据表明,接受多次胰岛素注射治疗的 2 型糖尿病患者在 6 年期间神经传导情况明显改善,而接受常规胰岛素治疗的患者在 6 年期间正中神经传导速度和振动阈值恶化。[105]Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995;28:103-117.http://www.ncbi.nlm.nih.gov/pubmed/7587918?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病性神经病的发生和进展:有中等质量的证据表明,接受多次胰岛素注射治疗的 2 型糖尿病患者在 6 年期间神经传导情况明显改善,而接受常规胰岛素治疗的患者在 6 年期间正中神经传导速度和振动阈值恶化。[105]Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995;28:103-117.http://www.ncbi.nlm.nih.gov/pubmed/7587918?tool=bestpractice.com
糖尿病周围神经性疼痛改善:有中等质量的证据表明,与安慰剂相比,在治疗 1 周内,普瑞巴林显著改善疼痛评分(持续 6–8 周)。报告显示,40% 接受普瑞巴林治疗的患者疼痛减少 50% 或以上,而仅 14.5% 接受安慰剂治疗的患者疼痛减少。[120]Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628-638.http://www.ncbi.nlm.nih.gov/pubmed/15288403?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病周围神经性疼痛改善:有中等质量的证据表明,与安慰剂相比,在治疗 1 周内,普瑞巴林显著改善疼痛评分(持续 6–8 周)。报告显示,40% 接受普瑞巴林治疗的患者疼痛减少 50% 或以上,而仅 14.5% 接受安慰剂治疗的患者疼痛减少。[120]Rosenstock J, Tuchman M, LaMoreaux L, et al. Pregabalin for the treatment of painful diabetic peripheral neuropathy: a double-blind, placebo-controlled trial. Pain. 2004;110:628-638.http://www.ncbi.nlm.nih.gov/pubmed/15288403?tool=bestpractice.com
糖尿病周围神经性疼痛改善:有中等质量的证据表明,与安慰剂相比,每天一次或两次度洛西汀 (60 mg),12 周后疼痛性糖尿病性神经病患者(无抑郁共病)的 24 小时平均疼痛严重性平均得分显著改善。[131]Wernicke JF, Pritchett YL, D'Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006;67:1411-1420.http://www.ncbi.nlm.nih.gov/pubmed/17060567?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病周围神经性疼痛改善:有中等质量的证据表明,与安慰剂相比,每天一次或两次度洛西汀 (60 mg),12 周后疼痛性糖尿病性神经病患者(无抑郁共病)的 24 小时平均疼痛严重性平均得分显著改善。[131]Wernicke JF, Pritchett YL, D'Souza DN, et al. A randomized controlled trial of duloxetine in diabetic peripheral neuropathic pain. Neurology. 2006;67:1411-1420.http://www.ncbi.nlm.nih.gov/pubmed/17060567?tool=bestpractice.com
症状改善:有中等质量的证据来源于间接的 meta 分析,以安慰剂作为共同对照药物,比较了度洛西汀与普瑞巴林和加巴喷丁的有效性和耐受性。结果表明度洛西汀在治疗糖尿病神经病变方面的疗效和耐受性不逊于普瑞巴林和加巴喷丁。[133]Quilici S, Chancellor J, Löthgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol. 2009;9:6.http://www.biomedcentral.com/1471-2377/9/6http://www.ncbi.nlm.nih.gov/pubmed/19208243?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
症状改善:有中等质量的证据来源于间接的 meta 分析,以安慰剂作为共同对照药物,比较了度洛西汀与普瑞巴林和加巴喷丁的有效性和耐受性。结果表明度洛西汀在治疗糖尿病神经病变方面的疗效和耐受性不逊于普瑞巴林和加巴喷丁。[133]Quilici S, Chancellor J, Löthgren M, et al. Meta-analysis of duloxetine vs. pregabalin and gabapentin in the treatment of diabetic peripheral neuropathic pain. BMC Neurol. 2009;9:6.http://www.biomedcentral.com/1471-2377/9/6http://www.ncbi.nlm.nih.gov/pubmed/19208243?tool=bestpractice.com
糖尿病性周围神经性疼痛改善:有中等质量证据证明,曲马多(平均剂量:210 mg/日)对于糖尿病性神经性疼痛的治疗远比安慰剂有效。恶心、便秘、头痛和嗜睡是曲马多的不良反应。[154]Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998;50:1842-1846.http://www.ncbi.nlm.nih.gov/pubmed/9633738?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病性周围神经性疼痛改善:有中等质量证据证明,曲马多(平均剂量:210 mg/日)对于糖尿病性神经性疼痛的治疗远比安慰剂有效。恶心、便秘、头痛和嗜睡是曲马多的不良反应。[154]Harati Y, Gooch C, Swenson M, et al. Double-blind randomized trial of tramadol for the treatment of the pain of diabetic neuropathy. Neurology. 1998;50:1842-1846.http://www.ncbi.nlm.nih.gov/pubmed/9633738?tool=bestpractice.com
使用红霉素改善胃排空:从几项开放性临床试验得到的中等质量证据发现,胃排空平均改善了 40% 以上。[202]Sturm A, Holtmann G, Goebell H, et al. Prokinetics in patients with gastroparesis: a systematic analysis. Digestion. 1999;60:422-427.http://www.ncbi.nlm.nih.gov/pubmed/10473966?tool=bestpractice.com一项单盲试验也显示胃排空改善了 50%。[202]Sturm A, Holtmann G, Goebell H, et al. Prokinetics in patients with gastroparesis: a systematic analysis. Digestion. 1999;60:422-427.http://www.ncbi.nlm.nih.gov/pubmed/10473966?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
使用红霉素改善胃排空:从几项开放性临床试验得到的中等质量证据发现,胃排空平均改善了 40% 以上。[202]Sturm A, Holtmann G, Goebell H, et al. Prokinetics in patients with gastroparesis: a systematic analysis. Digestion. 1999;60:422-427.http://www.ncbi.nlm.nih.gov/pubmed/10473966?tool=bestpractice.com一项单盲试验也显示胃排空改善了 50%。[202]Sturm A, Holtmann G, Goebell H, et al. Prokinetics in patients with gastroparesis: a systematic analysis. Digestion. 1999;60:422-427.http://www.ncbi.nlm.nih.gov/pubmed/10473966?tool=bestpractice.com
糖尿病周围神经性疼痛改善:有低质量证据表明,无论是抑郁和非抑郁患者,阿米替林、丙米嗪和地昔帕明都能缓解糖尿病性神经病患者的疼痛,效果优于安慰剂。其效果看起来与任何抗抑郁效应无关。[137]Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326:1250-1256.http://www.ncbi.nlm.nih.gov/pubmed/1560801?tool=bestpractice.com[138]Kvinesdal B, Molin J, Froland A, et al. Imipramine treatment of painful diabetic neuropathy. JAMA. 1984;251:1727-1730.http://www.ncbi.nlm.nih.gov/pubmed/6366276?tool=bestpractice.com[139]Max MB, Culnane M, Schafer SC, et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987;37:589-596.http://www.ncbi.nlm.nih.gov/pubmed/2436092?tool=bestpractice.com[140]Sindrup SH, Ejlertsen B, Froland A, et al. Imipramine treatment in diabetic neuropathy: relief of subjective symptoms without changes in peripheral and autonomic nerve function. Eur J Clin Pharmacol. 1989;37:151-153.http://www.ncbi.nlm.nih.gov/pubmed/2792168?tool=bestpractice.com[141]Max MB, Kishore-Kumar R, Schafer SC, et al. Efficacy of desipramine in painful diabetic neuropathy: a placebo-controlled trial. Pain. 1991;45:3-9.http://www.ncbi.nlm.nih.gov/pubmed/1861872?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病周围神经性疼痛改善:有低质量证据表明,无论是抑郁和非抑郁患者,阿米替林、丙米嗪和地昔帕明都能缓解糖尿病性神经病患者的疼痛,效果优于安慰剂。其效果看起来与任何抗抑郁效应无关。[137]Max MB, Lynch SA, Muir J, et al. Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy. N Engl J Med. 1992;326:1250-1256.http://www.ncbi.nlm.nih.gov/pubmed/1560801?tool=bestpractice.com[138]Kvinesdal B, Molin J, Froland A, et al. Imipramine treatment of painful diabetic neuropathy. JAMA. 1984;251:1727-1730.http://www.ncbi.nlm.nih.gov/pubmed/6366276?tool=bestpractice.com[139]Max MB, Culnane M, Schafer SC, et al. Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood. Neurology. 1987;37:589-596.http://www.ncbi.nlm.nih.gov/pubmed/2436092?tool=bestpractice.com[140]Sindrup SH, Ejlertsen B, Froland A, et al. Imipramine treatment in diabetic neuropathy: relief of subjective symptoms without changes in peripheral and autonomic nerve function. Eur J Clin Pharmacol. 1989;37:151-153.http://www.ncbi.nlm.nih.gov/pubmed/2792168?tool=bestpractice.com[141]Max MB, Kishore-Kumar R, Schafer SC, et al. Efficacy of desipramine in painful diabetic neuropathy: a placebo-controlled trial. Pain. 1991;45:3-9.http://www.ncbi.nlm.nih.gov/pubmed/1861872?tool=bestpractice.com
糖尿病性周围神经性疼痛改善:有低质量证据证明,每天 40 mg 帕罗西汀显著减少神经病变的症状,但不如丙米嗪有效。[149]Sindrup SH, Gram LF, Brosen K, et al. The selective serotonin reuptake inhibitor paroxetine is effective in the treatment of diabetic neuropathy symptoms. Pain. 1990;42:135-144.http://www.ncbi.nlm.nih.gov/pubmed/2147235?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病性周围神经性疼痛改善:有低质量证据证明,每天 40 mg 帕罗西汀显著减少神经病变的症状,但不如丙米嗪有效。[149]Sindrup SH, Gram LF, Brosen K, et al. The selective serotonin reuptake inhibitor paroxetine is effective in the treatment of diabetic neuropathy symptoms. Pain. 1990;42:135-144.http://www.ncbi.nlm.nih.gov/pubmed/2147235?tool=bestpractice.com
糖尿病周围神经性疼痛改善:有质量差的证据表明,与安慰剂相比,对于治疗糖尿病性神经病疼痛,羟考酮在 4 周期间显著减少平均每日疼痛,使疼痛稳定,减少总疼痛和残疾。[153]Watson CP, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105:71-78.http://www.ncbi.nlm.nih.gov/pubmed/14499422?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
糖尿病周围神经性疼痛改善:有质量差的证据表明,与安慰剂相比,对于治疗糖尿病性神经病疼痛,羟考酮在 4 周期间显著减少平均每日疼痛,使疼痛稳定,减少总疼痛和残疾。[153]Watson CP, Moulin D, Watt-Watson J, et al. Controlled-release oxycodone relieves neuropathic pain: a randomized controlled trial in painful diabetic neuropathy. Pain. 2003;105:71-78.http://www.ncbi.nlm.nih.gov/pubmed/14499422?tool=bestpractice.com
恶心和呕吐症状改善:有低质量证据证明,胃刺激虽然不能显著改善胃排空,但是可显著减少胃轻瘫(主要是糖尿病性)患者自我报告的恶心和呕吐的频率和严重程度。[216]Forster J, Sarosiek I, Delcore R, et al. Gastric pacing is a new surgical treatment for gastroparesis. Am J Surg. 2001;182:676-681.http://www.ncbi.nlm.nih.gov/pubmed/11839337?tool=bestpractice.com
系统评价或者受试者>200名的随机对照临床试验(RCT)。
恶心和呕吐症状改善:有低质量证据证明,胃刺激虽然不能显著改善胃排空,但是可显著减少胃轻瘫(主要是糖尿病性)患者自我报告的恶心和呕吐的频率和严重程度。[216]Forster J, Sarosiek I, Delcore R, et al. Gastric pacing is a new surgical treatment for gastroparesis. Am J Surg. 2001;182:676-681.http://www.ncbi.nlm.nih.gov/pubmed/11839337?tool=bestpractice.com