中华肾脏病杂志
中華腎髒病雜誌
중화신장병잡지
2013年
6期
429-434
,共6页
陆任华%倪兆慧%钱家麒%张政%袁伟杰%戎殳%梅长林%宦红娣%张景红
陸任華%倪兆慧%錢傢麒%張政%袁偉傑%戎殳%梅長林%宦紅娣%張景紅
륙임화%예조혜%전가기%장정%원위걸%융수%매장림%환홍제%장경홍
血液透析%高磷血症%醋酸钙片%钙磷乘积%甲状旁腺激素
血液透析%高燐血癥%醋痠鈣片%鈣燐乘積%甲狀徬腺激素
혈액투석%고린혈증%작산개편%개린승적%갑상방선격소
Hemodialysis%Hyperphosphatemia%Calcium acetate%Calcium-phosphorus%Parathyroid hormone
目的 研究醋酸钙治疗血液透析患者高磷血症的疗效与安全性.方法 采用随机、对照、多中心研究的方法,171例来自全国10家三甲医院的血液透析高磷血症患者分别进入试验组(醋酸钙片,86例)和对照组(碳酸钙片,85例).经过2周药物洗脱筛选后,根据患者的血磷水平分为两层(1.94～ 2.26 mmol/L和2.27～ 2.75 mmol/L,1 mg/dl=0.323 mmol/L),每天分别给予含有元素钙1000 mg、1500 mg的醋酸钙片、碳酸钙片进行治疗,疗程8周,期间不再调整药物剂量.结果 纳入研究的171例患者全部进入安全性分析集,其中123例符合方案完成研究的患者进入疗效分析集.与治疗前相比,两组的血磷、钙磷乘积、全段甲状旁腺激素(iPTH)水平均显著下降(均P＜ 0.05),血钙水平略有上升；两组患者血磷水平[(1.73±1.85)比(0.99± 1.60) mmol/L]、药物响应比率(与基线相比血磷水平下降超过25％)(51.6％比32.8％)比较差异有统计学意义(P＜0.05).两组患者不良事件发生率(19.8％比18.8％)、不良反应发生率(8.1％比4.7％)的差异无统计学意义(均P＞ 0.05).醋酸钙的主要不良反应为轻中度胃肠道反应(包括恶心、呕吐等),转归良好.结论 醋酸钙可用于治疗慢性肾脏病血透患者高磷血症,并有效降低钙磷乘积、iPTH水平,降磷能力优于碳酸钙.不良反应以轻中度胃肠道反应最常见.
目的 研究醋痠鈣治療血液透析患者高燐血癥的療效與安全性.方法 採用隨機、對照、多中心研究的方法,171例來自全國10傢三甲醫院的血液透析高燐血癥患者分彆進入試驗組(醋痠鈣片,86例)和對照組(碳痠鈣片,85例).經過2週藥物洗脫篩選後,根據患者的血燐水平分為兩層(1.94～ 2.26 mmol/L和2.27～ 2.75 mmol/L,1 mg/dl=0.323 mmol/L),每天分彆給予含有元素鈣1000 mg、1500 mg的醋痠鈣片、碳痠鈣片進行治療,療程8週,期間不再調整藥物劑量.結果 納入研究的171例患者全部進入安全性分析集,其中123例符閤方案完成研究的患者進入療效分析集.與治療前相比,兩組的血燐、鈣燐乘積、全段甲狀徬腺激素(iPTH)水平均顯著下降(均P＜ 0.05),血鈣水平略有上升；兩組患者血燐水平[(1.73±1.85)比(0.99± 1.60) mmol/L]、藥物響應比率(與基線相比血燐水平下降超過25％)(51.6％比32.8％)比較差異有統計學意義(P＜0.05).兩組患者不良事件髮生率(19.8％比18.8％)、不良反應髮生率(8.1％比4.7％)的差異無統計學意義(均P＞ 0.05).醋痠鈣的主要不良反應為輕中度胃腸道反應(包括噁心、嘔吐等),轉歸良好.結論 醋痠鈣可用于治療慢性腎髒病血透患者高燐血癥,併有效降低鈣燐乘積、iPTH水平,降燐能力優于碳痠鈣.不良反應以輕中度胃腸道反應最常見.
목적 연구작산개치료혈액투석환자고린혈증적료효여안전성.방법 채용수궤、대조、다중심연구적방법,171례래자전국10가삼갑의원적혈액투석고린혈증환자분별진입시험조(작산개편,86례)화대조조(탄산개편,85례).경과2주약물세탈사선후,근거환자적혈린수평분위량층(1.94～ 2.26 mmol/L화2.27～ 2.75 mmol/L,1 mg/dl=0.323 mmol/L),매천분별급여함유원소개1000 mg、1500 mg적작산개편、탄산개편진행치료,료정8주,기간불재조정약물제량.결과 납입연구적171례환자전부진입안전성분석집,기중123례부합방안완성연구적환자진입료효분석집.여치료전상비,량조적혈린、개린승적、전단갑상방선격소(iPTH)수평균현저하강(균P＜ 0.05),혈개수평략유상승；량조환자혈린수평[(1.73±1.85)비(0.99± 1.60) mmol/L]、약물향응비솔(여기선상비혈린수평하강초과25％)(51.6％비32.8％)비교차이유통계학의의(P＜0.05).량조환자불량사건발생솔(19.8％비18.8％)、불량반응발생솔(8.1％비4.7％)적차이무통계학의의(균P＞ 0.05).작산개적주요불량반응위경중도위장도반응(포괄악심、구토등),전귀량호.결론 작산개가용우치료만성신장병혈투환자고린혈증,병유효강저개린승적、iPTH수평,강린능력우우탄산개.불량반응이경중도위장도반응최상견.
Objective To evaluate the efficacy and safety of calcium acetate in treating hemodialysis(HD) patients with hyperphosphatemia.Methods A randomized,controlled multicenter study was performed.Phosphate binders were discontinued during a two-week washout period.A total of 171 hemodialysis patients from 10 sites with serum phosphorus during 1.94-2.75 mmol/L after two-week washout period were randomized to calcium acetate or calcium carbonate for 8-week treatment period.Patients with serum phosphorus between 1.94-2.26 mmol/L were given elemental calcium 1000 mg/d andbetween 2.27-2.75 mmol/L were given elemental calcium 1500 mg/d.The dose was constant during the 8-week treatment period.Results All of 171 patients entered the safety analysis set,including 123 cases who completed the study into effect analysis set.In terms of efficacy:compared with the baseline,serum phosphorus,calcium-phosphorus products,parathyroid hormone (iPTH) levels were significantly decreased (all P ＜ 0.05) and serum calcium levels increased slightly in both groups; compared with the calcium carbonate group,calcium acetate group had a significant advantage in the change of serum phosphorus content [(1.73 ± 1.85) vs (0.99 ± 1.60) mmol/L,P ＜ 0.05] and drug response ratio (compared with the baseline serum phosphorus level fell more than 25％) (51.6％ vs 32.8％,P ＜ 0.05).In safety aspects,calcium acetate group and the control group had no significant differences in the incidence of adverse events (19.8％ vs 18.8％) and adverse reactions (8.1％ vs 4.7％),all P ＞0.05.The main adverse reactions of calcium acetate were mild to moderate gastrointestinal reactions,including nausea,vomiting.Conclusions In hemodialysis patients with hyperphosphatemia,calcium acetate can decrease serum phosphorus and reduce the levels of calcium-phosphorus product and iPTH.In the phosphate binding capacity,calcium acetate is superior to calcium carbonate.Mild to moderate gastrointestinal reactions are most common after administration.
