中华肾病研究电子杂志
中華腎病研究電子雜誌
중화신병연구전자잡지
2014年
2期
91-98
,共8页
陈意志%李平%胡婕%曹雪莹%汤力%魏日胞%蔡广研%陈香美
陳意誌%李平%鬍婕%曹雪瑩%湯力%魏日胞%蔡廣研%陳香美
진의지%리평%호첩%조설형%탕력%위일포%채엄연%진향미
免疫抑制%特发性膜性肾病%Meta分析
免疫抑製%特髮性膜性腎病%Meta分析
면역억제%특발성막성신병%Meta분석
Immunosuppression%Idiopathicmembranousnephropathy%Meta-analysis
目的:评价新型免疫抑制剂治疗表现为肾病综合征的成人特发性膜性肾病( IMN)的有效性和安全性。方法检索Cochrane图书馆、PubMed、Embase从建馆(库)至2013年12月收录的期刊文献及资料。纳入随机对照试验( RCT)的试验组为新型免疫抑制剂,对照组为糖皮质激素联合烷化剂(苯丁酸氮芥或环磷酰胺)。采用Cochrane偏倚风险方法评价研究质量。使用倒方差法随机效应模型评估全因死亡率或进展至终末期肾脏病( ESRD)风险、肾功能下降率、完全或部分缓解率、蛋白尿以及导致停药或住院的不良事件发生率等指标。数据合并采用RevMan 5.2软件。有效性及安全性用风险比( rr)及其95﹪可信区间(95﹪ CI)表示,文献发表偏倚用漏斗图分析。结果共入选9项RCT(383例患者),涉及环孢素、他克莫司、吗替麦考酚酯、促肾上腺皮质激素( ACTH)等新型免疫抑制剂。与经典的糖皮质激素联合烷化剂相比,新型免疫抑制剂不能降低全因死亡率或进展至ESRD风险[3项RCT,104例患者,rr=1.37(0.52,3.61),P=0.53];不能降低肾功能下降率[3项RCT,104例患者,rr=1.19(0.78,1.81),P=0.42];不能提高完全或部分缓解率[8项RCT,349例患者,rr=1.01(0.79,1.30),P =0.93];不能降低蛋白尿[5项 RCT,175例患者,MD =-0.45(-1.56,0.66)g/d,P=0.43]。新型免疫抑制剂组与经典的糖皮质激素联合烷化剂组比较导致停药或住院的不良事件发生率的差异无统计学意义[5项RCT,80例患者,rr=0.80(0.49,1.32),P=0.39]。但亚组分析表明新型免疫制剂可显著增加完全或部分缓解率[6项RCT,240例患者,rr=1.21(1.03,1.42),P=0.02],并能显著降低蛋白尿[3项RCT,147例患者,MD=-1.35(-1.94,-0.76)g/d,P<0.0001]。结论本项Meta分析未表明新型免疫抑制剂对表现为肾病综合征的成人IMN的疗效明显优于糖皮质激素联合烷化剂。尚需开展更多的RCT进一步验证亚组分析的结果。
目的:評價新型免疫抑製劑治療錶現為腎病綜閤徵的成人特髮性膜性腎病( IMN)的有效性和安全性。方法檢索Cochrane圖書館、PubMed、Embase從建館(庫)至2013年12月收錄的期刊文獻及資料。納入隨機對照試驗( RCT)的試驗組為新型免疫抑製劑,對照組為糖皮質激素聯閤烷化劑(苯丁痠氮芥或環燐酰胺)。採用Cochrane偏倚風險方法評價研究質量。使用倒方差法隨機效應模型評估全因死亡率或進展至終末期腎髒病( ESRD)風險、腎功能下降率、完全或部分緩解率、蛋白尿以及導緻停藥或住院的不良事件髮生率等指標。數據閤併採用RevMan 5.2軟件。有效性及安全性用風險比( rr)及其95﹪可信區間(95﹪ CI)錶示,文獻髮錶偏倚用漏鬥圖分析。結果共入選9項RCT(383例患者),涉及環孢素、他剋莫司、嗎替麥攷酚酯、促腎上腺皮質激素( ACTH)等新型免疫抑製劑。與經典的糖皮質激素聯閤烷化劑相比,新型免疫抑製劑不能降低全因死亡率或進展至ESRD風險[3項RCT,104例患者,rr=1.37(0.52,3.61),P=0.53];不能降低腎功能下降率[3項RCT,104例患者,rr=1.19(0.78,1.81),P=0.42];不能提高完全或部分緩解率[8項RCT,349例患者,rr=1.01(0.79,1.30),P =0.93];不能降低蛋白尿[5項 RCT,175例患者,MD =-0.45(-1.56,0.66)g/d,P=0.43]。新型免疫抑製劑組與經典的糖皮質激素聯閤烷化劑組比較導緻停藥或住院的不良事件髮生率的差異無統計學意義[5項RCT,80例患者,rr=0.80(0.49,1.32),P=0.39]。但亞組分析錶明新型免疫製劑可顯著增加完全或部分緩解率[6項RCT,240例患者,rr=1.21(1.03,1.42),P=0.02],併能顯著降低蛋白尿[3項RCT,147例患者,MD=-1.35(-1.94,-0.76)g/d,P<0.0001]。結論本項Meta分析未錶明新型免疫抑製劑對錶現為腎病綜閤徵的成人IMN的療效明顯優于糖皮質激素聯閤烷化劑。尚需開展更多的RCT進一步驗證亞組分析的結果。
목적:평개신형면역억제제치료표현위신병종합정적성인특발성막성신병( IMN)적유효성화안전성。방법검색Cochrane도서관、PubMed、Embase종건관(고)지2013년12월수록적기간문헌급자료。납입수궤대조시험( RCT)적시험조위신형면역억제제,대조조위당피질격소연합완화제(분정산담개혹배린선알)。채용Cochrane편의풍험방법평개연구질량。사용도방차법수궤효응모형평고전인사망솔혹진전지종말기신장병( ESRD)풍험、신공능하강솔、완전혹부분완해솔、단백뇨이급도치정약혹주원적불량사건발생솔등지표。수거합병채용RevMan 5.2연건。유효성급안전성용풍험비( rr)급기95﹪가신구간(95﹪ CI)표시,문헌발표편의용루두도분석。결과공입선9항RCT(383례환자),섭급배포소、타극막사、마체맥고분지、촉신상선피질격소( ACTH)등신형면역억제제。여경전적당피질격소연합완화제상비,신형면역억제제불능강저전인사망솔혹진전지ESRD풍험[3항RCT,104례환자,rr=1.37(0.52,3.61),P=0.53];불능강저신공능하강솔[3항RCT,104례환자,rr=1.19(0.78,1.81),P=0.42];불능제고완전혹부분완해솔[8항RCT,349례환자,rr=1.01(0.79,1.30),P =0.93];불능강저단백뇨[5항 RCT,175례환자,MD =-0.45(-1.56,0.66)g/d,P=0.43]。신형면역억제제조여경전적당피질격소연합완화제조비교도치정약혹주원적불량사건발생솔적차이무통계학의의[5항RCT,80례환자,rr=0.80(0.49,1.32),P=0.39]。단아조분석표명신형면역제제가현저증가완전혹부분완해솔[6항RCT,240례환자,rr=1.21(1.03,1.42),P=0.02],병능현저강저단백뇨[3항RCT,147례환자,MD=-1.35(-1.94,-0.76)g/d,P<0.0001]。결론본항Meta분석미표명신형면역억제제대표현위신병종합정적성인IMN적료효명현우우당피질격소연합완화제。상수개전경다적RCT진일보험증아조분석적결과。
Objective Toassesstheefficacyandsafetyofnovelimmunosuppressantsinthe treatmentofadultidiopathicmembranousnephropathy(IMN)withnephroticsyndrome.Methods The Cochrane library,PubMed,and Embase were searched( December 2013)to identify randomized controlled trials ( RCTs ) that compared novel immunosuppressants with corticosteroid plus alkylating agents ( chlorambucil or cyclophosphamide ). The Cochrane-recommended bias risk tool was used to assess the quality of studies. The inverse-variance random-effects method was used to assess all-cause mortality or the risk of progression to end-stage renal disease( ESRD),the rate of decline in renal function,complete or partial remission,proteinuria,and adverse events leading to discontinuation or hospitalization. Data were synthesized with the RevMan software version 5. 2. The effect of treatment was presented with risk ratio (rr)and 95﹪ confidence interval(95﹪ CI),and the publication bias was analyzed with funnel plot. Results NineRCTswith383patientswereincluded.Thenovelimmunosuppressantsincludedwere
<br> cyclosporine,tacrolimus,mycophenolate mofetil,and adrenocorticotropic hormone( ACTH). Compared to classical therapy of corticosteroid plus alkylating agents,novel immunosuppressants did not significantly reduce the all-cause mortality or the risk of progression to ESRD[3 RCTs,104 patients,rr=1. 37(0. 52,3. 61),P=0. 53],did not decrease the rate of decline in renal function[3 RCTs,104 patients,rr=1. 19(0. 78,1. 81), P=0. 42],did not improve complete or partial remission[8 RCTs,349 patients,rr=1. 01(0. 79,1. 30),P=0. 93],or did not reduce proteinuria[5 RCTs,175 patients,MD= -0. 45(-1. 56,0. 66)g/day,P=0. 43]. There was no difference between the two groups in the risk of adverse events leading to discontinuation or hospitalization[5 RCTs,80 patients,rr =0. 80(0. 49,1. 32),P =0. 39]. However,subgroup analyses indicated that the novel immunosuppressants significantly increased complete or partial remission[ 6 RCTs, 240 patients,rr=1. 21(1. 03,1. 42),P=0. 02]and decreased proteinuria[3 RCTs,147 patients,MD=-1.35(-1.94,-0.76)g/day,P<0.00001].Conclusions Thismeta-analysisdidnotindicatethatthe efficacy of novel immunosuppressants was superior to that of corticosteroid plus alkylating agents in treating adult IMN with nephrotic syndrome. More RCTs are needed to confirm the results from subgroup analyses.