目的 系統(tǒng)評(píng)價(jià)碳酸鑭治療維持性血液透析患者高磷血癥的療效和安全性。
方法 計(jì)算機(jī)檢索MEDLINE(1996~2006.4) 、EMbase(1996~2006.4)、Cochrane圖書館臨床對(duì)照試驗(yàn)資料庫(kù)(2006年第1期)和中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫(kù)(1996~2006.4)、中文科技期刊全文數(shù)據(jù)庫(kù)(1996~2006.4)、中文學(xué)術(shù)期刊全文數(shù)據(jù)庫(kù)(1996~2006.4)。手工檢索已發(fā)表或未發(fā)表的相關(guān)文獻(xiàn),包括會(huì)議摘要等。檢索無(wú)語(yǔ)種限制。納入碳酸鑭與安慰劑或傳統(tǒng)磷結(jié)合劑比較治療維持性血液透析患者高磷血癥的隨機(jī)對(duì)照試驗(yàn)。由兩名評(píng)價(jià)員獨(dú)立評(píng)價(jià)納入研究的質(zhì)量和提取資料,并用RevMan 4.2.8軟件進(jìn)行Meta分析。
結(jié)果 共納入6個(gè)試驗(yàn)。Meta分析結(jié)果顯示,碳酸鑭與安慰劑相比,在治療維持性血液透析患者高磷血癥療效方面兩組間差異有統(tǒng)計(jì)學(xué)意義[OR=4.74,95%CI(2.66,8.45),P lt;0.000 1],兩組間總的不良反應(yīng)發(fā)生情況差異無(wú)統(tǒng)計(jì)學(xué)意義 [OR=1.23,95%CI(0.74,2.04),P=0.42];碳酸鑭與傳統(tǒng)磷結(jié)合劑相比,降低血磷水平的療效差異無(wú)統(tǒng)計(jì)學(xué)意義[OR=0.97,95%CI(0.74,1.27),P=0.81],但碳酸鑭治療組血鈣水平低于傳統(tǒng)磷結(jié)合劑,兩組間總的不良反應(yīng)發(fā)生情況無(wú)明顯差異。
結(jié)論 碳酸鑭治療可能對(duì)終末期腎臟疾病維持性血液透析患者高磷血癥有效,且其高鈣血癥發(fā)生率低于傳統(tǒng)磷結(jié)合劑,但證據(jù)強(qiáng)度不高。尚需要大樣本、長(zhǎng)療程的研究為碳酸鑭治療終末期腎臟疾病患者的高磷血癥有效性和安全性提供進(jìn)一步的證據(jù)。
引用本文: 高玉春,李 孜,唐曉紅. 碳酸鑭治療維持性血液透析患者高磷血癥有效性和安全性的系統(tǒng)評(píng)價(jià). 中國(guó)循證醫(yī)學(xué)雜志, 2006, 06(10): 727-732. doi: 復(fù)制
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2. | Malluche HH, Monier-Faugere MC. Understanding and managing hyperphosphatemia in patients with chronic renal disease. Clin Nephrol, 1999; 52 (15): 267–277. |
3. | Block GA, Hulbert-Shearon TE, Levin NW, et al. Association of serum phosphorus and calcium_phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis, 1998; 31 (66): 607–617. |
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5. | Indridason OS, Quarles LD. Hyperphosphatemia in end-stage renal disease. Adv Ren Replace Ther, 2002; 9 (3): 184–192. |
6. | Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis, 2000; 35 (723): 1226–1237. |
7. | Kates DM, Andress DL: Control of hyperphosphatemia in renal failure: role of aluminum. Semin Dial, 9:301–315, 1996. |
8. | Sperschneider H, Gunther K, Marzoll I, et al. Calcium carbonate (CaCO3): an efficient and safe phosphate binder in haemodialysis patients? A 3-year study, Nephrol Dial Transplant, 1993; 8:530–534. |
9. | Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med, 2000; 342(485): 1478–1483. |
10. | Schaefer K. Alternative phosphate binders: an update. Nephrol Dial Transplant, 1993; 1(2): 35–39. |
11. | Locatelli F, D’Amico M. Lanthanum carbonate AnorMED. Curr Opin Cardiovasc Pulmon Renal Invest Drugs, 2000; 2 (4): 372–377. |
12. | D’Haese PC. Spasovski GB. Sikole A, et al. A multicenter study on the effects of lanthanum carbonate (Fosrenol) and calcium carbonate on renal bone disease in dialysis patients. Kidney International- Supplement, 2003; 1(85): S73–78. |
13. | Finn WF, Joy MS, Hladik G. Lanthanum Study Group; Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis. Clinical Nephrology, 2004; 62(3): 193–201. |
14. | Chiang SS, Chen JB, Yang WC. Lanthanum carbonate (Fosrenol) efficacy and tolerability in the treatment of hyperphosphatemic patients with end-stage renal disease. Clinical Nephrology, 2005; 63(6): 461–470. |
15. | Al-Baaj F, Speake M, Hutchison AJ. Control of serum phosphate by oral lanthanum carbonate in patients undergoing haemodialysis and continuous ambulatory peritoneal dialysis in a short-term, placebo-controlled study, 2005; 20(4): 775–782. |
16. | Hutchison AJ, Maes B, Vanwalleghem J, et al. Efficacy, tolerability, and safety of lanthanum carbonate in hyperphosphatemia: a 6-month, randomized, comparative trial versus calcium carbonate. Nephron Clinical Practice, 2005; 100(1): C8–C19. |
17. | Finn WF. SPD 405-307 Lanthanum Study Group; Lanthanum carbonate versus standard therapy for the treatment of hyperphosphatemia: safety and efficacy in chronic maintenance hemodialysis patients. Clinical Nephrology, 2006; 65(3): 191–202. |
- 1. .12 Joy MS, Finn WF. LAM-302 Study Group; Randomized, double-blind, placebo-controlled, dose-titration, phase III study assessing the efficacy and tolerability of lanthanum carbonate: a new phosphate binder for the treatment of hyperphosphatemia. American Journal of Kidney Diseases, 2003; 42(1): 96–107.
- 2. Malluche HH, Monier-Faugere MC. Understanding and managing hyperphosphatemia in patients with chronic renal disease. Clin Nephrol, 1999; 52 (15): 267–277.
- 3. Block GA, Hulbert-Shearon TE, Levin NW, et al. Association of serum phosphorus and calcium_phosphate product with mortality risk in chronic hemodialysis patients: a national study. Am J Kidney Dis, 1998; 31 (66): 607–617.
- 4. Albaaj F, Hutchison A. Hyperphosphataemia in renal failure: causes, consequences and current management. Drugs, 2003; 63 (6): 577–596.
- 5. Indridason OS, Quarles LD. Hyperphosphatemia in end-stage renal disease. Adv Ren Replace Ther, 2002; 9 (3): 184–192.
- 6. Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis, 2000; 35 (723): 1226–1237.
- 7. Kates DM, Andress DL: Control of hyperphosphatemia in renal failure: role of aluminum. Semin Dial, 9:301–315, 1996.
- 8. Sperschneider H, Gunther K, Marzoll I, et al. Calcium carbonate (CaCO3): an efficient and safe phosphate binder in haemodialysis patients? A 3-year study, Nephrol Dial Transplant, 1993; 8:530–534.
- 9. Goodman WG, Goldin J, Kuizon BD, et al. Coronary-artery calcification in young adults with end-stage renal disease who are undergoing dialysis. N Engl J Med, 2000; 342(485): 1478–1483.
- 10. Schaefer K. Alternative phosphate binders: an update. Nephrol Dial Transplant, 1993; 1(2): 35–39.
- 11. Locatelli F, D’Amico M. Lanthanum carbonate AnorMED. Curr Opin Cardiovasc Pulmon Renal Invest Drugs, 2000; 2 (4): 372–377.
- 12. D’Haese PC. Spasovski GB. Sikole A, et al. A multicenter study on the effects of lanthanum carbonate (Fosrenol) and calcium carbonate on renal bone disease in dialysis patients. Kidney International- Supplement, 2003; 1(85): S73–78.
- 13. Finn WF, Joy MS, Hladik G. Lanthanum Study Group; Efficacy and safety of lanthanum carbonate for reduction of serum phosphorus in patients with chronic renal failure receiving hemodialysis. Clinical Nephrology, 2004; 62(3): 193–201.
- 14. Chiang SS, Chen JB, Yang WC. Lanthanum carbonate (Fosrenol) efficacy and tolerability in the treatment of hyperphosphatemic patients with end-stage renal disease. Clinical Nephrology, 2005; 63(6): 461–470.
- 15. Al-Baaj F, Speake M, Hutchison AJ. Control of serum phosphate by oral lanthanum carbonate in patients undergoing haemodialysis and continuous ambulatory peritoneal dialysis in a short-term, placebo-controlled study, 2005; 20(4): 775–782.
- 16. Hutchison AJ, Maes B, Vanwalleghem J, et al. Efficacy, tolerability, and safety of lanthanum carbonate in hyperphosphatemia: a 6-month, randomized, comparative trial versus calcium carbonate. Nephron Clinical Practice, 2005; 100(1): C8–C19.
- 17. Finn WF. SPD 405-307 Lanthanum Study Group; Lanthanum carbonate versus standard therapy for the treatment of hyperphosphatemia: safety and efficacy in chronic maintenance hemodialysis patients. Clinical Nephrology, 2006; 65(3): 191–202.