CAJ | 학술논문

目的：运用循证医学方法评价环磷酰胺（CTX）治疗儿童紫癜性肾炎（HSPN）的疗效和安全性。方法检索Cochrane Library、ACP Journal Club、PubMed、OVID、EBSCO、中国期刊全文数据库（CNKI）、万方数据库和维普中文期刊数据库以及手工检索会议资料和学位论文，尽可能获取所有CTX治疗儿童HSPN的文献。制定严格的纳入和排除标准，依据Cochrane手册5.1.0质量评价标准对文献进行质量评价。采用Review Manager 5.2软件进行Meta分析。结果共检索文献423篇，英文176篇，中文247篇。依据纳入及排除标准最终纳入分析的随机对照试验（RCT）文献8篇。8篇RCT文献均未对随机分组方法作详细描述，均未采用分配隐藏，未采用盲法，未提及退出和失访，亦未提及选择性报告研究结果和其他偏倚，但都采用了公认的诊断方法，基线资料具有可比性。Meta分析结果显示：（1）CTX/激素（GC）联合组临床缓解率显著高于单用GC组：RR值为1.58（95% CI：1.36，1.85），差异有统计学意义；（2）CTX/GC联合组治疗后尿蛋白定量和血清白蛋白量均优于单用GC组，MD值分别为：-2.04（95%CI：-2.92，-1.71）和7.61（95%CI：4.69，10.52），差异均有统计学意义；（3）不良反应发生率：CTX/GC联合组的激素不良反应低于单用 GC 组，但急性胃肠道反应发生率较高，差异均有统计学意义，而两组患儿的呼吸道感染、白细胞减少、出血性膀胱炎、肝功能损害和脱发发生率差异均无统计学意义。结论 GC联合CTX治疗儿童HSPN比单用GC治疗临床缓解率高，降低蛋白尿和升高血清白蛋白效果更明显，对重症HSPN患儿疗效优于单用 GC 治疗。除急性胃肠道反应发生率较激素高外，呼吸道感染、白细胞减少、出血性膀胱炎、肝功能损害和脱发等不良反应少，安全性好，但确切疗效仍需要大量前瞻性研究进一步证实。目的：運用循證醫學方法評價環燐酰胺（CTX）治療兒童紫癜性腎炎（HSPN）的療效和安全性。方法檢索Cochrane Library、ACP Journal Club、PubMed、OVID、EBSCO、中國期刊全文數據庫（CNKI）、萬方數據庫和維普中文期刊數據庫以及手工檢索會議資料和學位論文，儘可能穫取所有CTX治療兒童HSPN的文獻。製定嚴格的納入和排除標準，依據Cochrane手冊5.1.0質量評價標準對文獻進行質量評價。採用Review Manager 5.2軟件進行Meta分析。結果共檢索文獻423篇，英文176篇，中文247篇。依據納入及排除標準最終納入分析的隨機對照試驗（RCT）文獻8篇。8篇RCT文獻均未對隨機分組方法作詳細描述，均未採用分配隱藏，未採用盲法，未提及退齣和失訪，亦未提及選擇性報告研究結果和其他偏倚，但都採用瞭公認的診斷方法，基線資料具有可比性。Meta分析結果顯示：（1）CTX/激素（GC）聯閤組臨床緩解率顯著高于單用GC組：RR值為1.58（95% CI：1.36，1.85），差異有統計學意義；（2）CTX/GC聯閤組治療後尿蛋白定量和血清白蛋白量均優于單用GC組，MD值分彆為：-2.04（95%CI：-2.92，-1.71）和7.61（95%CI：4.69，10.52），差異均有統計學意義；（3）不良反應髮生率：CTX/GC聯閤組的激素不良反應低于單用 GC 組，但急性胃腸道反應髮生率較高，差異均有統計學意義，而兩組患兒的呼吸道感染、白細胞減少、齣血性膀胱炎、肝功能損害和脫髮髮生率差異均無統計學意義。結論 GC聯閤CTX治療兒童HSPN比單用GC治療臨床緩解率高，降低蛋白尿和升高血清白蛋白效果更明顯，對重癥HSPN患兒療效優于單用 GC 治療。除急性胃腸道反應髮生率較激素高外，呼吸道感染、白細胞減少、齣血性膀胱炎、肝功能損害和脫髮等不良反應少，安全性好，但確切療效仍需要大量前瞻性研究進一步證實。
목적：운용순증의학방법평개배린선알（CTX）치료인동자전성신염（HSPN）적료효화안전성。방법검색Cochrane Library、ACP Journal Club、PubMed、OVID、EBSCO、중국기간전문수거고（CNKI）、만방수거고화유보중문기간수거고이급수공검색회의자료화학위논문，진가능획취소유CTX치료인동HSPN적문헌。제정엄격적납입화배제표준，의거Cochrane수책5.1.0질량평개표준대문헌진행질량평개。채용Review Manager 5.2연건진행Meta분석。결과공검색문헌423편，영문176편，중문247편。의거납입급배제표준최종납입분석적수궤대조시험（RCT）문헌8편。8편RCT문헌균미대수궤분조방법작상세묘술，균미채용분배은장，미채용맹법，미제급퇴출화실방，역미제급선택성보고연구결과화기타편의，단도채용료공인적진단방법，기선자료구유가비성。Meta분석결과현시：（1）CTX/격소（GC）연합조림상완해솔현저고우단용GC조：RR치위1.58（95% CI：1.36，1.85），차이유통계학의의；（2）CTX/GC연합조치료후뇨단백정량화혈청백단백량균우우단용GC조，MD치분별위：-2.04（95%CI：-2.92，-1.71）화7.61（95%CI：4.69，10.52），차이균유통계학의의；（3）불량반응발생솔：CTX/GC연합조적격소불량반응저우단용 GC 조，단급성위장도반응발생솔교고，차이균유통계학의의，이량조환인적호흡도감염、백세포감소、출혈성방광염、간공능손해화탈발발생솔차이균무통계학의의。결론 GC연합CTX치료인동HSPN비단용GC치료림상완해솔고，강저단백뇨화승고혈청백단백효과경명현，대중증HSPN환인료효우우단용 GC 치료。제급성위장도반응발생솔교격소고외，호흡도감염、백세포감소、출혈성방광염、간공능손해화탈발등불량반응소，안전성호，단학절료효잉수요대량전첨성연구진일보증실。
Objective To assess the efficacy and safety of cyclophosphamide(CTX) therapy for Henoch-Sch?nlein purpura nephritis(HSPN) in children. Methods Cochrane Library, ACP Journal Club, PubMed, OVID, EBSCO, CNKI, Wanfang Data and VIP Database were searched for studies, conference materials and dissertations concerning CTX therapy for HSPN in children without language restriction as completely as possible. Formulate the including and excluding criteria as well as the efficacy judgement criteria. According to the criterias and quality evaluation standards of Cochrane Handbook 5.1.0, articles were screened and evaluated with by two researchers respectively. Review Manager 5.2 software was used for meta-analysis. Results A total of 423 papers were included, containing 176 English articles and 247 Chinese articles. According to the including and excluding criteria, eight RCTs were enrolled for meta-analysis. Eight RCTs all didn’t describe the method of random allocation and didn’t use double blind method. All of them were lack of information about allocation concealment, withdrawal and loss of subject, selectively reporting and other bias, but all used established diagnostic criteria. The results were as follows:(1)The remission rate of CTX plus GC group was higher than that of GC group(RR=1.58, 95%CI:1.36, 1.85); (2)The 24 h urine protein of CTX plus GC group was lower than that of GC group(MD=-2.04, 95%CI: -2.92, -1.71), and albumin was higher than that of GC group(MD=7.61, 95%CI:4.69, 10.52);(3)Adverse effects: Hormone side effects incidence of CTX plus GC group was lower than that of GC group, gastrointestinal reaction incidence of CTX plus GC group was higher than that of GC group, but there was no significant difference in respiratory infection, leukopenia, hemorrhagic cystitis, alopecia and hepatic dysfunction between two groups. Conclusions Compared to GC, the remission rate in CTX plus GC group was higher and this treatment was more effective in reducing proteinuria and elevating albumin. The efficacy of GC combined with CTX pulse therapy for severe HSPN was superior to that of GC alone. Respiratory infection, leukopenia, hemorrhagic cystitis, alopecia and hepatic dysfunction rarely occur apart from gastrointestinal reaction compared to GC alone and it was very safe. Nevertheless, multicentral and large-scale RCT studies are needed to confirm the conclusions.