中华儿科杂志
中華兒科雜誌
중화인과잡지
Chinese Journal of Pediatrics
2009年
12期
898-903
,共6页
陈丽植%蒋小云%陆慧瑜%张巧玲%莫樱
陳麗植%蔣小雲%陸慧瑜%張巧玲%莫櫻
진려식%장소운%륙혜유%장교령%막앵
亲环素类%肾病综合征%儿童%随机对照试验%系统评价
親環素類%腎病綜閤徵%兒童%隨機對照試驗%繫統評價
친배소류%신병종합정%인동%수궤대조시험%계통평개
Cyclophilins%Nephrofic syndrome%Child%Randomized controlled trials%Systematic review
目的 评价环孢素A(CsA)治疗儿童难治性肾病综合征(RNS)的疗效和安全性.方法 按系统评价的要求全面检索了 Cochrane图书馆、PubMed、EMBASE、中国生物医学文献光盘数据库(CBMdisk)、中国期刊全文数据库(CNKI)和中国维普数据库(VIP),对符合纳入标准的文献按临床类型及干预措施分亚组进行Meta分析.结果 共纳入9篇文献(n=293),6篇4～7分,3篇1-3分.(1)在激素(GC)效应组中,CsA联合GC的近期疗效优于单用GC[OR值0.14,95%CI(0.03,0.71)],但与环磷酰胺、麦考酚酸酯的差异无统计学意义,比苯丁酸氮芥疗效差且易复发[OR值和95%CI分别为6.93(1.53,31.38)、0.06(0.01,0.58)],维持治疗期间保持CsA血药浓度在60～80 μg/L能降低远期复发率[OR值6.43,95%CI(1.21,34.19)],两组终末期肾病(ESRD)的发生率和病死率均为0.(2)在激素耐药组中,CsA的近期疗效优于安慰剂或支持治疗及环磷酰胺[OR值和95%CI分别为0.15(0.02,0.96)、0.41(0.03,5.00)],但复发率、ESRD的发生率和病死率的差异均无统计学意义.(3)CsA的安全性:CsA组的肾毒性、多毛和牙龈增生的发生率均高于对照组[OR值和95%CI分别为0.19(0.05,0.79)、0.06(0.02,0.19)、0.05(0.02,0.18)],但两组间高血压和肝毒性发生率的差异无统计学意义.结论 已有证据提示CsA能提高儿童RNS的近期疗效,但不能提高其远期和终点疗效,是治疗儿童RNS较理想的二线药物,其安全性较好,从总体趋势上看,CsA对儿童激素效应Ns的疗效优于激素耐药NS.此外,在维持治疗期间,保持CsA的血药浓度在60～80 ug/L能减少远期的复发率.
目的 評價環孢素A(CsA)治療兒童難治性腎病綜閤徵(RNS)的療效和安全性.方法 按繫統評價的要求全麵檢索瞭 Cochrane圖書館、PubMed、EMBASE、中國生物醫學文獻光盤數據庫(CBMdisk)、中國期刊全文數據庫(CNKI)和中國維普數據庫(VIP),對符閤納入標準的文獻按臨床類型及榦預措施分亞組進行Meta分析.結果 共納入9篇文獻(n=293),6篇4～7分,3篇1-3分.(1)在激素(GC)效應組中,CsA聯閤GC的近期療效優于單用GC[OR值0.14,95%CI(0.03,0.71)],但與環燐酰胺、麥攷酚痠酯的差異無統計學意義,比苯丁痠氮芥療效差且易複髮[OR值和95%CI分彆為6.93(1.53,31.38)、0.06(0.01,0.58)],維持治療期間保持CsA血藥濃度在60～80 μg/L能降低遠期複髮率[OR值6.43,95%CI(1.21,34.19)],兩組終末期腎病(ESRD)的髮生率和病死率均為0.(2)在激素耐藥組中,CsA的近期療效優于安慰劑或支持治療及環燐酰胺[OR值和95%CI分彆為0.15(0.02,0.96)、0.41(0.03,5.00)],但複髮率、ESRD的髮生率和病死率的差異均無統計學意義.(3)CsA的安全性:CsA組的腎毒性、多毛和牙齦增生的髮生率均高于對照組[OR值和95%CI分彆為0.19(0.05,0.79)、0.06(0.02,0.19)、0.05(0.02,0.18)],但兩組間高血壓和肝毒性髮生率的差異無統計學意義.結論 已有證據提示CsA能提高兒童RNS的近期療效,但不能提高其遠期和終點療效,是治療兒童RNS較理想的二線藥物,其安全性較好,從總體趨勢上看,CsA對兒童激素效應Ns的療效優于激素耐藥NS.此外,在維持治療期間,保持CsA的血藥濃度在60～80 ug/L能減少遠期的複髮率.
목적 평개배포소A(CsA)치료인동난치성신병종합정(RNS)적료효화안전성.방법 안계통평개적요구전면검색료 Cochrane도서관、PubMed、EMBASE、중국생물의학문헌광반수거고(CBMdisk)、중국기간전문수거고(CNKI)화중국유보수거고(VIP),대부합납입표준적문헌안림상류형급간예조시분아조진행Meta분석.결과 공납입9편문헌(n=293),6편4～7분,3편1-3분.(1)재격소(GC)효응조중,CsA연합GC적근기료효우우단용GC[OR치0.14,95%CI(0.03,0.71)],단여배린선알、맥고분산지적차이무통계학의의,비분정산담개료효차차역복발[OR치화95%CI분별위6.93(1.53,31.38)、0.06(0.01,0.58)],유지치료기간보지CsA혈약농도재60～80 μg/L능강저원기복발솔[OR치6.43,95%CI(1.21,34.19)],량조종말기신병(ESRD)적발생솔화병사솔균위0.(2)재격소내약조중,CsA적근기료효우우안위제혹지지치료급배린선알[OR치화95%CI분별위0.15(0.02,0.96)、0.41(0.03,5.00)],단복발솔、ESRD적발생솔화병사솔적차이균무통계학의의.(3)CsA적안전성:CsA조적신독성、다모화아간증생적발생솔균고우대조조[OR치화95%CI분별위0.19(0.05,0.79)、0.06(0.02,0.19)、0.05(0.02,0.18)],단량조간고혈압화간독성발생솔적차이무통계학의의.결론 이유증거제시CsA능제고인동RNS적근기료효,단불능제고기원기화종점료효,시치료인동RNS교이상적이선약물,기안전성교호,종총체추세상간,CsA대인동격소효응Ns적료효우우격소내약NS.차외,재유지치료기간,보지CsA적혈약농도재60～80 ug/L능감소원기적복발솔.
Objective To evaluate the efficacy and safety of cyclosporine A(CsA)in the treatment of refractory nephmtic syndrome(RNS)in children.Methotis The Cochrane library,PubMed,EMBASE,CBMdisk.CNKI and VIP were searched from the time when the databases were established to December 31,2008.Reports on RCTs on treating RNS in children with CsA were collected.Data were extracted and assessed independently by three reviewers.The methodological quality of included RCTs was assessed by the revised Jadad-seale(including randomization,allocation concealment,blinding method and withdrawal).Meta-analysis of homogenous RCTs was managed by using RevMan4.2.3.Result Nine RCTs involving 293 participants were included. Six RCTs were assessed as high-quality studies with scores from 4 to 7 and 3 RCTs were assessed as low-quality studies with scores from 1 to 3.Sub-category meta-analysis was based on different clinical types and interventions of RNS in children.Meta-analysis based on included RCTs showed the following results.(1)In children with steroid-dependent or frequent relapse nephrotic syndrome:the short-term efficacv of CsA plus prednisone was better than that of prednisone alone[OR 0.14,95%CI(0.03,0.71)];the short-term efficacy of CsA,cyclophosphamide(CTX)and mycophenolate mofetil had no significant differences.but compared with chlorambucil,CsA had a worse short-term efficacy[OR 6.93,95%CI(1.53,31.38)]and a higber relapse rate[OR 0.06,95%CI(0.01,0.58)];maintaining a blood level of CsA between 60 and 80 μg/L during remission period could reduce the long term relapse rate [ OR 6.43, 95% CI(1. 21,34. 19) ] ; the incidence of end-stage renal disease (ESRD) or mortality was zero in both groups. (2) In children with steroid-resistant nephrotic syndrome, the short-term efficacy of CsA was better than that of placebo or supportive treatment and CTX, OR and 95% CI were 0. 15 (0. 02,0. 96) and 0.41 (0. 03, 5.00), respectively, but no significant differences were found in the relapse rate and the incidence of ESRD or mortality. ( 3 ) Side effects of CsA: the incidence of nephrotoxicity, hypertrichosis and gum hypertrophy was higher in the CsA group than in that of control group, OR and 95% CI were 0. 19 (0. 05,0. 79), 0. 06 (0. 02,0. 19), 0. 05 (0. 02,0. 18), respectively, but no significant differences were found in the incidence of hypertension and liver toxicity. Conclusions Available evidence showed that CsA could improve short term efficacy in RNS in children, but could not improve long term and endpoint efficacy,therefore CsA could be one of the ideal second-line drugs for RNS in children. There was a trend that the effect of CsA on steroid-dependent or frequent relapse nephrotic syndrome was superior to that on steroid-resistant nephrotic syndrome.
