普羅加比治療難治性癲癇有效性及安全性的Meta分析_《中國循證醫學雜志》

作者：

袁婷婷 , 吳波 ,  鄒曉毅

四川大學華西醫院神經內科（成都 610041）;

關鍵詞：

普羅加比難治性癲癇 Meta分析系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20120124

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目的　系統評價普羅加比（progabide，PGB）治療難治性癲癇的有效性及安全性。
方法　計算機檢索PubMed、EMbase、The Cochrane Central Register of Controlled Trials（CENTRAL）、CNKI、VIP和CBM等電子數據庫，查找PGB治療難治性癲癇的隨機對照試驗（RCT），檢索時間均從建庫至2011年7月。對符合納入標準的RCT，由兩位評價員按Cochrane 系統評價的方法，獨立進行資料提取、質量評價并交叉核對后，采用RevMan 5.1軟件進行Meta分析。
結果　共納入7個研究，合計231例患者。Meta分析結果顯示，在常規治療基礎上，與安慰劑相比，PGB對單純難治性部分性癲癇無效［OR=1.76，95%CI（0.40，7.65），P=0.45］；對難治性部分性+全面性癲癇的有效率高于安慰劑組［OR=4.46，95%CI（2.06，9.65），P=0.000 1］。PGB的主要不良反應為嗜睡、頭暈、頭痛等，但表現多輕微、短暫，減少劑量多可恢復正常，僅少數患者需停藥。
結論　現有研究證據顯示，PGB可能對難治性部分性+全面性癲癇具有較好的療效，但對單純性難治性癲癇的療效尚不確定。PGB不良反應多輕微。但由于納入研究的方法學質量存在中度選擇性偏倚的可能性，可能影響結果的真實性，因此上述結論還有待開展更多高質量大樣本的隨機雙盲臨床對照試驗來驗證。

引用本文： 袁婷婷,吳波,鄒曉毅. 普羅加比治療難治性癲癇有效性及安全性的Meta分析. 中國循證醫學雜志, 2012, 12(7): 810-816. doi: 10.7507/1672-2531.20120124 復制

1.	Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(10): 919-926.
2.	Granata T, Marchi N, Carlton E, et al. Management of the patient with medically refractory epilepsy. Expert Rev Neurother, 2009, 9(12): 1791-1802.
3.	Kwan P, Arzimanoglou A, Berg A, et al. De?nition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
4.	Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol, 2010, 9(1): 27-29.
5.	Lloyd KG, Munari C, Worms P, et al. The role of GABA mediated neurotransmission in convulsive states. Adv Biochem Psychopharmacol, 1981, 26: 199-206.
6.	Lloyd KG, Arbilla S, Beaumont K, et al. gamma-Aminobutyric acid (GABA) receptor stimulation. II. Specificity of progabide (SL 76002) and SL 75102 for the GABA receptor. J Pharmacol Exp Ther, 1982, 220(3): 672-677.
7.	De Pasquet EG, Scaramelli A, de Cáceres MP, et al. Double-blind, placebo-controlled, cross-over trial of progabide as add-on therapy inepileptic patients. Epilepsia, 1991, 32(1): 133-139.
8.	Martinez-Lage JM, Bossi L, Morales G, et al. Progabide treatment in severe epilepsy: a double-blind cross-over trial versus placebo. Epilepsia, 1984, 25(5): 586-593.
9.	Schmidt D, Utech K. Progabide for refractory partial epilepsy:a controlled add-on trial. Neurology, 1986, 36(2): 217-221.
10.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
11.	Crawford P, Chadwick D. A comparative study of progabide, valproate, and placebo as add-on therapy in patients with refractory epilepsy. J Neurol Neurosurg Psychiatry, 1986, 49(11): 1251-1257.
12.	Musch B, Cambier J, Loiseau P, et al. Long-term treatment of epilepsy: open multicenter trial with progabide in epileptic patients. Eur Neurol, 1987, 26(2): 113-119.
13.	Leppik IE, Dreifuss FE, Bowman T, et al. A double-blind crossover evaluation of progabide in partial seizures. Neurology, 35 Suppl 1(4): 285, 1985.
14.	Leppik IE, Dreifuss FE, Porter R, et al. A controlled study of progabide in partial seizures: methodology and results. Neurology, 1987, 37(6): 963-968.
15.	Dam M, Gram L, Philbert A, et al. Progabide: a controlled trial in partial epilepsy. Epilepsia,1983, 24(2): 127-134.
16.	Schmidt D. Progabide as an add-on drug for epilepsy refractory to high dose antiepileptic drugtherap. Neurosci Lett, 1984, 47(3): 357-360.
17.	Loiseau P, Bossi L, Guyot M, et al. Double-blind crossover trial of progabide versus placebo in severe epilepsies. Epilepsia, 1983, 24(6): 703-715.
18.	Brundage RC, Cloyd JC, Leppik IE, et al. Effect of progabide on serum phenytoin and carbamazepine concentrations. Clin Neuropharmacol, 1987, 10(6): 545-554.

1. Kwan P, Schachter SC, Brodie MJ. Drug-resistant epilepsy. N Engl J Med, 2011, 365(10): 919-926.
2. Granata T, Marchi N, Carlton E, et al. Management of the patient with medically refractory epilepsy. Expert Rev Neurother, 2009, 9(12): 1791-1802.
3. Kwan P, Arzimanoglou A, Berg A, et al. De?nition of drug resistant epilepsy: Consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia, 2010, 51(6): 1069-1077.
4. Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol, 2010, 9(1): 27-29.
5. Lloyd KG, Munari C, Worms P, et al. The role of GABA mediated neurotransmission in convulsive states. Adv Biochem Psychopharmacol, 1981, 26: 199-206.
6. Lloyd KG, Arbilla S, Beaumont K, et al. gamma-Aminobutyric acid (GABA) receptor stimulation. II. Specificity of progabide (SL 76002) and SL 75102 for the GABA receptor. J Pharmacol Exp Ther, 1982, 220(3): 672-677.
7. De Pasquet EG, Scaramelli A, de Cáceres MP, et al. Double-blind, placebo-controlled, cross-over trial of progabide as add-on therapy inepileptic patients. Epilepsia, 1991, 32(1): 133-139.
8. Martinez-Lage JM, Bossi L, Morales G, et al. Progabide treatment in severe epilepsy: a double-blind cross-over trial versus placebo. Epilepsia, 1984, 25(5): 586-593.
9. Schmidt D, Utech K. Progabide for refractory partial epilepsy:a controlled add-on trial. Neurology, 1986, 36(2): 217-221.
10. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials, 1996, 17(1): 1-12.
11. Crawford P, Chadwick D. A comparative study of progabide, valproate, and placebo as add-on therapy in patients with refractory epilepsy. J Neurol Neurosurg Psychiatry, 1986, 49(11): 1251-1257.
12. Musch B, Cambier J, Loiseau P, et al. Long-term treatment of epilepsy: open multicenter trial with progabide in epileptic patients. Eur Neurol, 1987, 26(2): 113-119.
13. Leppik IE, Dreifuss FE, Bowman T, et al. A double-blind crossover evaluation of progabide in partial seizures. Neurology, 35 Suppl 1(4): 285, 1985.
14. Leppik IE, Dreifuss FE, Porter R, et al. A controlled study of progabide in partial seizures: methodology and results. Neurology, 1987, 37(6): 963-968.
15. Dam M, Gram L, Philbert A, et al. Progabide: a controlled trial in partial epilepsy. Epilepsia,1983, 24(2): 127-134.
16. Schmidt D. Progabide as an add-on drug for epilepsy refractory to high dose antiepileptic drugtherap. Neurosci Lett, 1984, 47(3): 357-360.
17. Loiseau P, Bossi L, Guyot M, et al. Double-blind crossover trial of progabide versus placebo in severe epilepsies. Epilepsia, 1983, 24(6): 703-715.
18. Brundage RC, Cloyd JC, Leppik IE, et al. Effect of progabide on serum phenytoin and carbamazepine concentrations. Clin Neuropharmacol, 1987, 10(6): 545-554.

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普羅加比治療難治性癲癇有效性及安全性的Meta分析

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《中國循證醫學雜志》

普羅加比治療難治性癲癇有效性及安全性的Meta分析

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