中华肾脏病杂志
中華腎髒病雜誌
중화신장병잡지
2012年
3期
183-188
,共6页
方艺%丁小强%邹建洲%方燕%钱家麒%戎殳%梅长林%邱强%陈香美%郑智华%余学清
方藝%丁小彊%鄒建洲%方燕%錢傢麒%戎殳%梅長林%邱彊%陳香美%鄭智華%餘學清
방예%정소강%추건주%방연%전가기%융수%매장림%구강%진향미%정지화%여학청
血液透析%盐酸司维拉姆%高磷血症%钙磷乘积
血液透析%鹽痠司維拉姆%高燐血癥%鈣燐乘積
혈액투석%염산사유랍모%고린혈증%개린승적
Hemodialysis%Sevelamer hydrochloride%Hyperphosphatemia%Calciumphosphorus product
目的 评价盐酸司维拉姆治疗终末期肾病维持性血液透析(MHD)患者高磷血症的短期疗效和安全性.方法 来自国内5所综合性医院共138例并发高磷血症(透析前血磷＞1.78 mmol/L)的MHD患者纳入本研究.经过2周磷结合剂洗脱后,根据患者血磷水平予以相应口服剂量的盐酸司维拉姆片剂治疗,疗程为10周,随后为2周的停药观察期,总观察期为14周.给药期间每2周根据患者血清钙磷水平调整药物剂量.结果 共有111例患者完成全部试验.经盐酸司维拉姆治疗2周后,患者血磷和血清钙磷乘积水平明显下降.10周疗程结束时,与用药前比较,患者血磷[(1.85±0.50)比(2.57±0.54) mmol/L,P＜0.01]、钙磷乘积[(4.16±1.72)比( 5.79-1.50) mmol2/L2,P＜ 0.01]和血清低密度脂蛋白水平[(1.64±0.76)比(2.31±0.87) mmol/L,P＜0.01]显著下降,而血浆全段甲状旁腺激素(iPTH)水平和血清校正血钙水平无显著变化.停药后2周,血磷和钙磷乘积水平高于10周治疗结束时,但仍显著低于基线水平[(2.26±0.7)比(2.57±0.54) mmol/L; (5.12±1.63)比(5.79±1.50)mmol2/L2,P＜0.01].纳入研究的138例患者中,106例(76.8％)发生了214件不良事件,其中89例(64.5％)的121件为不良反应.胃肠道不良事件总发生率为68.11％(94/138),以轻至中度的便秘最为常见,经对症处理后可缓解或消失.结论 盐酸司维拉姆可有效纠正终末期肾病MHD患者的高磷血症,并能降低血清钙磷乘积和血清低密度脂蛋白水平.用药后便秘等胃肠道症状较常见.
目的 評價鹽痠司維拉姆治療終末期腎病維持性血液透析(MHD)患者高燐血癥的短期療效和安全性.方法 來自國內5所綜閤性醫院共138例併髮高燐血癥(透析前血燐＞1.78 mmol/L)的MHD患者納入本研究.經過2週燐結閤劑洗脫後,根據患者血燐水平予以相應口服劑量的鹽痠司維拉姆片劑治療,療程為10週,隨後為2週的停藥觀察期,總觀察期為14週.給藥期間每2週根據患者血清鈣燐水平調整藥物劑量.結果 共有111例患者完成全部試驗.經鹽痠司維拉姆治療2週後,患者血燐和血清鈣燐乘積水平明顯下降.10週療程結束時,與用藥前比較,患者血燐[(1.85±0.50)比(2.57±0.54) mmol/L,P＜0.01]、鈣燐乘積[(4.16±1.72)比( 5.79-1.50) mmol2/L2,P＜ 0.01]和血清低密度脂蛋白水平[(1.64±0.76)比(2.31±0.87) mmol/L,P＜0.01]顯著下降,而血漿全段甲狀徬腺激素(iPTH)水平和血清校正血鈣水平無顯著變化.停藥後2週,血燐和鈣燐乘積水平高于10週治療結束時,但仍顯著低于基線水平[(2.26±0.7)比(2.57±0.54) mmol/L; (5.12±1.63)比(5.79±1.50)mmol2/L2,P＜0.01].納入研究的138例患者中,106例(76.8％)髮生瞭214件不良事件,其中89例(64.5％)的121件為不良反應.胃腸道不良事件總髮生率為68.11％(94/138),以輕至中度的便祕最為常見,經對癥處理後可緩解或消失.結論 鹽痠司維拉姆可有效糾正終末期腎病MHD患者的高燐血癥,併能降低血清鈣燐乘積和血清低密度脂蛋白水平.用藥後便祕等胃腸道癥狀較常見.
목적 평개염산사유랍모치료종말기신병유지성혈액투석(MHD)환자고린혈증적단기료효화안전성.방법 래자국내5소종합성의원공138례병발고린혈증(투석전혈린＞1.78 mmol/L)적MHD환자납입본연구.경과2주린결합제세탈후,근거환자혈린수평여이상응구복제량적염산사유랍모편제치료,료정위10주,수후위2주적정약관찰기,총관찰기위14주.급약기간매2주근거환자혈청개린수평조정약물제량.결과 공유111례환자완성전부시험.경염산사유랍모치료2주후,환자혈린화혈청개린승적수평명현하강.10주료정결속시,여용약전비교,환자혈린[(1.85±0.50)비(2.57±0.54) mmol/L,P＜0.01]、개린승적[(4.16±1.72)비( 5.79-1.50) mmol2/L2,P＜ 0.01]화혈청저밀도지단백수평[(1.64±0.76)비(2.31±0.87) mmol/L,P＜0.01]현저하강,이혈장전단갑상방선격소(iPTH)수평화혈청교정혈개수평무현저변화.정약후2주,혈린화개린승적수평고우10주치료결속시,단잉현저저우기선수평[(2.26±0.7)비(2.57±0.54) mmol/L; (5.12±1.63)비(5.79±1.50)mmol2/L2,P＜0.01].납입연구적138례환자중,106례(76.8％)발생료214건불량사건,기중89례(64.5％)적121건위불량반응.위장도불량사건총발생솔위68.11％(94/138),이경지중도적편비최위상견,경대증처리후가완해혹소실.결론 염산사유랍모가유효규정종말기신병MHD환자적고린혈증,병능강저혈청개린승적화혈청저밀도지단백수평.용약후편비등위장도증상교상견.
Objective To evaluate the short-term efficacy and safety of sevelamer hydrochloride in treating maintenance hemodialysis (MHD) patients with hyperphosphemia.Methods A multicenter,open-labeled,self-control study was performed.Phosphate binders were discontinued during a two-week washout period.Patients with more than 1.78 mmol/L serum phosphorus after two-week washout period were eligible for the trial.The dose was adjusted every two weeks as necessary to achieve serum phosphorus control. Sevelamer hydrochloride was administered to 138 MHD patients for 10 weeks and a second two-week washout period followed.Results A total of 111 from 138 patients fulfilled the whole 14-week study. Mean serum phosphorus and calcium-phosphate products starte to decline after two-week sevelamer hydrochloride treatment. By the end of 10-week sevelamer hydrochloride treatment, mean serum level of phosphorus [(1.85±0.50) vs (2.57±0.54) mmol/L,P＜0.01],calcium-phosphate product [(4.16± 1.72) vs (5.79 ± 1.50) mmol2/L2,P＜0.01 ] and low density lipoprotein [(1.64±0.76) vs (2.31 ±0.87) mmol/L,P＜0.01] were significantly decreased,while the adjusted serum level of calcium and serum intact parathyroid hormone kept steady.Both serum phosphorus and calcium-phosphrus product increased after the second washout period, but the levels were still lower as compared to pre-treatment [(2.26±0.71) vs (2.57±0.54) mmol/L; (5.12±1.63) vs (5.79±1.50) mmol2/L2,P＜0.01].Of the 138 patients involved,214 episodes in 106 patients and 121 episodes in 89 patients were reported as adverse events and adverse drug reaction respectively. Gastrointestinal symptoms,of which most were mild or moderate,happened to 68.1％ (94/138) patients. Conclusions Sevelamer hydrochloride can control serum phosphorus and reduce the levels of calcium-phosphorus product and cholesterol.Slight gastrointestinal symptoms like constipation are common during the treatment.
