CAJ | 학술논문

目的：系统评价司维拉姆(Sevelamer)和含钙的磷结合剂对血液透析患者疗效和终点事件的影响。方法在 Cochrane 图书馆的临床试验注册中心、PUBMED、EMBASE、中国期刊全文数据库(CNKI)和万方数据库中检索国内外已发表的相关文献,选择针对慢性肾病(CKD)患者、使用司维拉姆和含钙的磷结合剂两种药物进行比较的随机对照试验(RCTs)和队列研究。两位评价者分别按检索策略收集资料,根据入选标准和排除标准筛选文献,对符合标准的文献进行荟萃分析。结果共有10篇 RCTs 和3篇队列研究(共40448例)符合入选标准。在钙磷代谢方面,司维拉姆与含钙磷结合剂相比,治疗后的血磷水平(MD =-0.02,95% CI =-0.29~0.25,P >0.05)及血钙水平(MD =-0.30,95% CI =-0.37~0.25,P >0.05)差异无统计学意义。在脂代谢方面,司维拉姆与含钙磷结合剂相比,治疗后的高密度脂蛋白胆固醇水平(MD =1.42,95% CI =-0.83~3.66,P >0.05)及甘油三酯水平差异无统计学意义(MD =-0.39,95% CI =-11.84~11.06,P =0.95)；而治疗后司维拉姆组总胆固醇水平(MD =-19.21,95% CI =-28.63~-9.80,P <0.01)及低密度脂蛋白胆固醇水平比钙剂组明显降低(MD =-15.30,95% CI =-23.37~-7.23,P <0.01)。治疗后司维拉姆组甲状旁腺激素(iPTH)水平比钙剂组高(MD =78.23,95% CI =26.67~129.78,P <0.01)。治疗后司维拉姆组超敏 C 反应蛋白(CRP)水平比钙剂组低(MD =-1.42,95% CI =-2.10~-0.73,P <0.01)。司维拉姆组患者全因病死率比钙剂组低(RR =0.66,95% CI =0.51~0.85,P <0.01)；心血管事件病死率两者比较差异无统计学意义(RR =0.3,95% CI =0.07~1.22,P =0.09)。结论在血液透析患者中司维拉姆的降磷效果与含钙的磷结合剂相同,并且有着改善脂代谢紊乱、及减轻体内微炎症状态的作用。司维拉姆在降低血液透析患者全因病死率方面有优势。
목적：계통평개사유랍모(Sevelamer)화함개적린결합제대혈액투석환자료효화종점사건적영향。방법재 Cochrane 도서관적림상시험주책중심、PUBMED、EMBASE、중국기간전문수거고(CNKI)화만방수거고중검색국내외이발표적상관문헌,선택침대만성신병(CKD)환자、사용사유랍모화함개적린결합제량충약물진행비교적수궤대조시험(RCTs)화대렬연구。량위평개자분별안검색책략수집자료,근거입선표준화배제표준사선문헌,대부합표준적문헌진행회췌분석。결과공유10편 RCTs 화3편대렬연구(공40448례)부합입선표준。재개린대사방면,사유랍모여함개린결합제상비,치료후적혈린수평(MD =-0.02,95% CI =-0.29~0.25,P >0.05)급혈개수평(MD =-0.30,95% CI =-0.37~0.25,P >0.05)차이무통계학의의。재지대사방면,사유랍모여함개린결합제상비,치료후적고밀도지단백담고순수평(MD =1.42,95% CI =-0.83~3.66,P >0.05)급감유삼지수평차이무통계학의의(MD =-0.39,95% CI =-11.84~11.06,P =0.95)；이치료후사유랍모조총담고순수평(MD =-19.21,95% CI =-28.63~-9.80,P <0.01)급저밀도지단백담고순수평비개제조명현강저(MD =-15.30,95% CI =-23.37~-7.23,P <0.01)。치료후사유랍모조갑상방선격소(iPTH)수평비개제조고(MD =78.23,95% CI =26.67~129.78,P <0.01)。치료후사유랍모조초민 C 반응단백(CRP)수평비개제조저(MD =-1.42,95% CI =-2.10~-0.73,P <0.01)。사유랍모조환자전인병사솔비개제조저(RR =0.66,95% CI =0.51~0.85,P <0.01)；심혈관사건병사솔량자비교차이무통계학의의(RR =0.3,95% CI =0.07~1.22,P =0.09)。결론재혈액투석환자중사유랍모적강린효과여함개적린결합제상동,병차유착개선지대사문란、급감경체내미염증상태적작용。사유랍모재강저혈액투석환자전인병사솔방면유우세。
ABSTRACT:Objective To evaluate the effect of sevelamer and calcium-based phosphate binders on curative effect and endpoint events in hemodialysis patients.Methods Publications in English and Chinese literature were retrieved by using the key words “sevelamer or Renagel”,“calcium carbonate”,“hemodialysis”as to search the materials about the randomized controlled clinical trials and controlled clinical trials that had compared the effects of sevelamer and calcium-based phosphate binders on curative effect and endpoint events in hemodialysis patients. A meta-analysis was conducted.Results Ten documents about randomized controlled clinical trials and three documents about cohort trials, including 40 448 patients.Sevelamer had no statistically significant benefit in concentration of serum phosphate after treatment(MD =-0.02,95% CI = -0.29 to -0.25,P > 0.05 )and serum calcium (MD = -0.30,95% CI =-0.37 to 0.25,P > 0.05 ).In terms of lipid metabolism,there were no significant difference in high density lipoprotein cholesterol and triglyceride (MD =1.42,95% CI =-0.83 to 3.66,P >0.05;MD = -0.39,95% CI =-1 1.84 to 1 1.06,P =0.95 ).But,total cholesterol and low density lipoprotein cholesterol levels were significantly lower in hemodialysis patients treated with sevelamer (MD =-19.21,95% CI =-28.63 to -9.80,P <0.01;MD =-1 5.30,95% CI =-23.37 to -7.23,P <0.1).There were significant difference in iPTH and CRP of hemodialysis patients receiving sevelamer compared with calcium-based phosphate binders (MD = 78.23,95% CI = 26.67 to 129.78,P <0.01;MD =-1.42,95% CI =-2.10 to -0.73,P <0.01).And there were significant difference in all-cause mortality in hemodialysis patients receiving sevelamer compared with calcium-based phosphate binders (RR =0.66, 95% CI =0.5 1-0.85,P < 0.01 ).Four trials reported on cardiovascular events showed no significant difference in hemodialysis patients receiving sevelamer compared with calcium-based phosphate binders (RR =0.3,95% CI =0.07 to 1.22,P > 0.05 ).Conclusion Comparing to calcium-based phosphate binders,sevelamer has the same effect of reducing serum phosphate.Sevelamer can correct the lipid metabolism disorders better.And there was significantly lower incidence of all-cause mortality in sevelamer group than in calcium-based phosphate binders group.