中国循证儿科杂志
中國循證兒科雜誌
중국순증인과잡지
CHINESE JOURNAL OF EVIDENCE-BASED PEDIATRICS
2014年
6期
429-435
,共7页
李少军%谭利平%许峰%郭鹏飞%邹庆%何富香%周璟
李少軍%譚利平%許峰%郭鵬飛%鄒慶%何富香%週璟
리소군%담리평%허봉%곽붕비%추경%하부향%주경
热性惊厥%地西泮%抗惊厥药物%儿童%Meta分析%随机对照试验
熱性驚厥%地西泮%抗驚厥藥物%兒童%Meta分析%隨機對照試驗
열성량궐%지서반%항량궐약물%인동%Meta분석%수궤대조시험
Febrile seizure%Diazepam%Anticonvulsant drug%Chlidren%Meta-analysis%Randomized controlled trial
目的:采用Meta分析方法评价间歇使用地西泮预防热性惊厥( FS)复发的疗效及安全性。方法计算机检索The Cochrane Library(2014年第7期)、PubMed、EMBASE、中国生物医学文献数据库、中国知网、维普中文期刊数据库和万方数据库,收集使用地西泮预防儿童FS复发的RCT文献,检索时限均为建库至2014年7月。由2位研究者按照纳入与排除标准筛选文献,提取数据和评价纳入文献的方法学质量。根据FS复发危险因素行亚组分析。采用RevMan 5.2软件进行Meta分析。结果9篇RCT文献( n=1578)进入Meta分析。纳入文献的随机序列产生、分配隐藏和盲法为高度偏倚,选择性报告研究结果、结果的完整性和其他偏倚来源为低度偏倚。①随访6个月地西泮组与对照组FS复发率差异无统计学意义,RR=0.62(95% CI:0.34~1.13),P=0.12;RD=_0.07(95%CI:_0.16~0.02);对FS复发危险因素行亚组分析:地西泮低危险亚组与对照组FS复发率差异无统计学意义,RR=0.69(95%CI:0.40~1.21),P=0.20,中危险亚组与高危险亚组FS复发率显著低于对照组,RR分别为0.31(95%CI:0.15~0.62)和0.24(95%CI:0.10~0.56)。②随访12和24个月地西泮组FS复发率显著低于对照组,RR分别为0.59(95%CI:0.38~0.91)和0.54(95%CI:0.37~0.78);RD分别为_0.12(95%CI:_0.22~_0.02)和_0.17(95%CI:_0.27~_0.07)。对FS复发危险因素行亚组分析:地西泮低危险亚组与对照组FS复发率差异无统计学意义,RR分别为0.81(95% CI:0.47~1.42)和0.71(95%CI:0.45~1.11),中危险亚组与高危险亚组FS复发率显著低于对照组,12个月:RR分别为0.39(95% CI:0.20~0.75)和0.27(95%CI:0.13~0.58);24个月:RR分别为0.43(95%CI:0.24~0.77)和0.35(95%CI:0.19~0.62)。③纳入文献均无地西泮严重不良事件的报告。结论地西泮间歇给药可有效降低12和24个月FS复发率,对于FS中高危人群显示出较好疗效的趋势,但仍需进一步补充研究明确。
目的:採用Meta分析方法評價間歇使用地西泮預防熱性驚厥( FS)複髮的療效及安全性。方法計算機檢索The Cochrane Library(2014年第7期)、PubMed、EMBASE、中國生物醫學文獻數據庫、中國知網、維普中文期刊數據庫和萬方數據庫,收集使用地西泮預防兒童FS複髮的RCT文獻,檢索時限均為建庫至2014年7月。由2位研究者按照納入與排除標準篩選文獻,提取數據和評價納入文獻的方法學質量。根據FS複髮危險因素行亞組分析。採用RevMan 5.2軟件進行Meta分析。結果9篇RCT文獻( n=1578)進入Meta分析。納入文獻的隨機序列產生、分配隱藏和盲法為高度偏倚,選擇性報告研究結果、結果的完整性和其他偏倚來源為低度偏倚。①隨訪6箇月地西泮組與對照組FS複髮率差異無統計學意義,RR=0.62(95% CI:0.34~1.13),P=0.12;RD=_0.07(95%CI:_0.16~0.02);對FS複髮危險因素行亞組分析:地西泮低危險亞組與對照組FS複髮率差異無統計學意義,RR=0.69(95%CI:0.40~1.21),P=0.20,中危險亞組與高危險亞組FS複髮率顯著低于對照組,RR分彆為0.31(95%CI:0.15~0.62)和0.24(95%CI:0.10~0.56)。②隨訪12和24箇月地西泮組FS複髮率顯著低于對照組,RR分彆為0.59(95%CI:0.38~0.91)和0.54(95%CI:0.37~0.78);RD分彆為_0.12(95%CI:_0.22~_0.02)和_0.17(95%CI:_0.27~_0.07)。對FS複髮危險因素行亞組分析:地西泮低危險亞組與對照組FS複髮率差異無統計學意義,RR分彆為0.81(95% CI:0.47~1.42)和0.71(95%CI:0.45~1.11),中危險亞組與高危險亞組FS複髮率顯著低于對照組,12箇月:RR分彆為0.39(95% CI:0.20~0.75)和0.27(95%CI:0.13~0.58);24箇月:RR分彆為0.43(95%CI:0.24~0.77)和0.35(95%CI:0.19~0.62)。③納入文獻均無地西泮嚴重不良事件的報告。結論地西泮間歇給藥可有效降低12和24箇月FS複髮率,對于FS中高危人群顯示齣較好療效的趨勢,但仍需進一步補充研究明確。
목적:채용Meta분석방법평개간헐사용지서반예방열성량궐( FS)복발적료효급안전성。방법계산궤검색The Cochrane Library(2014년제7기)、PubMed、EMBASE、중국생물의학문헌수거고、중국지망、유보중문기간수거고화만방수거고,수집사용지서반예방인동FS복발적RCT문헌,검색시한균위건고지2014년7월。유2위연구자안조납입여배제표준사선문헌,제취수거화평개납입문헌적방법학질량。근거FS복발위험인소행아조분석。채용RevMan 5.2연건진행Meta분석。결과9편RCT문헌( n=1578)진입Meta분석。납입문헌적수궤서렬산생、분배은장화맹법위고도편의,선택성보고연구결과、결과적완정성화기타편의래원위저도편의。①수방6개월지서반조여대조조FS복발솔차이무통계학의의,RR=0.62(95% CI:0.34~1.13),P=0.12;RD=_0.07(95%CI:_0.16~0.02);대FS복발위험인소행아조분석:지서반저위험아조여대조조FS복발솔차이무통계학의의,RR=0.69(95%CI:0.40~1.21),P=0.20,중위험아조여고위험아조FS복발솔현저저우대조조,RR분별위0.31(95%CI:0.15~0.62)화0.24(95%CI:0.10~0.56)。②수방12화24개월지서반조FS복발솔현저저우대조조,RR분별위0.59(95%CI:0.38~0.91)화0.54(95%CI:0.37~0.78);RD분별위_0.12(95%CI:_0.22~_0.02)화_0.17(95%CI:_0.27~_0.07)。대FS복발위험인소행아조분석:지서반저위험아조여대조조FS복발솔차이무통계학의의,RR분별위0.81(95% CI:0.47~1.42)화0.71(95%CI:0.45~1.11),중위험아조여고위험아조FS복발솔현저저우대조조,12개월:RR분별위0.39(95% CI:0.20~0.75)화0.27(95%CI:0.13~0.58);24개월:RR분별위0.43(95%CI:0.24~0.77)화0.35(95%CI:0.19~0.62)。③납입문헌균무지서반엄중불량사건적보고。결론지서반간헐급약가유효강저12화24개월FS복발솔,대우FS중고위인군현시출교호료효적추세,단잉수진일보보충연구명학。
Objective To systematically review the efficacy and safety of intermittent use of diazepam to prevent recurrence of febrile seizure(FS)using meta-analysis methods. Methods The Cochrane Library(Issue 7,2014),PubMed,EMBASE,CBM, CNKI,VIP and Wanfang Data were searched for the randomized controlled trails( RCTs)about prophylactic use of dizapam to control FS relapse in children up to July 2014. Two reviewers independently screened literature according to the inclusion and exclusion criteria,extracted data and evaluated the methodological quality of included studies. Then meta-analysis was performed using RevMan 5. 2 software,in subjects with low-,moderate- and high-risk of FS recurrence respectively. Results Nine studies involving 1 578 patients were included. The methodological quality evaluation defined generation of random sequences for randomization,allocation concealment,and blinding as high bias risk;selective result reporting,loss of follow up,and alternative sources of bias as low bias risk. Meta-analysis showed no significant difference in FS recurrence rate in 6-month treatment group and intermittent diazepam compared with the control group(RR=0. 62,95% CI:0. 34 to 1. 13,P=0. 12;RD= _0. 07,95%CI:_0. 16 to 0. 02). However,FS relapse rate was markedly decreased at 12 months treatment(RR=0. 59,95%CI:0. 38~0. 91, P=0. 02;RD= _0. 12,95%CI:_0. 22~ _0. 02)and 24 months treatment(RR=0. 54,95%CI:0. 37 to 0. 78,P=0. 001;RD= _0. 17,95%CI:_0. 27 to _0. 07),compared with the control group. The results of subgroup analysis by FS recurrence risk factors indicated that reduced FS recurrence rate was found in the moderate-risk group(6 months:RR=0. 31,95%CI:0. 15 to 0. 62,P=0. 000 9;12 months:RR=0. 39,95%CI:0. 20 to 0. 75 ,P=0. 005;24 months:RR=0. 43,95%CI:0. 24 to 0. 77,P=0. 005)and high-risk group(6 months:RR=0. 24,95%CI:0. 10 to 0. 15;12 months:RR=0. 27,P=0. 00 09. 95%CI:0. 13 to 0. 58,P=0. 000 7;24 months:RR=0. 35,95%CI:0. 19 to 0. 62,P=0. 000 4)but not in the low-risk group (6 months:RR=0. 69,95%CI:0. 40 to 1. 21,P=0. 20;12 months:RR=0. 81,95%CI:0. 47 to 1. 42,P=0. 46;24 months:RR=0. 71,95%CI:0. 45 to 1. 11,P=0. 14). No serious complications about diazepam was reported in the included studies. Conclusion Intermittent diazepam for 12 months or 24 months can effectively reduce FS recurrence rate,and shows good efficacy for moderate-risk and high-risk patients. Additional high quality studies are still expected to verify the above conclusion.