药物不良反应杂志
藥物不良反應雜誌
약물불량반응잡지
Adverse Drug Reactions Journal
2015年
4期
268-274
,共7页
黄金柱%罗晓%李咏%李欣%王子绮%佟春香%赵振满%卢来春
黃金柱%囉曉%李詠%李訢%王子綺%佟春香%趙振滿%盧來春
황금주%라효%리영%리흔%왕자기%동춘향%조진만%로래춘
泊沙康唑%预防和防护用药%安全%Meta 分析
泊沙康唑%預防和防護用藥%安全%Meta 分析
박사강서%예방화방호용약%안전%Meta 분석
Posaconazole%Protective agents%Safety%Mata-analysis
目的：评价泊沙康唑预防性抗真菌的疗效与安全性。方法检索中国知网中国期刊全文数据库、维普数据库、中国生物医学文献数据库、万方医学数据库、PubMed、Cochrane Library、Embase、OVID、Web of Science（建库至2014年3月），收集泊沙康唑与安慰剂或其他抗真菌药物比较预防真菌感染并以侵袭性真菌感染发生率、病死率和不良反应发生率中任何一项作为研究终点的随机对照试验（RCT），提取相关数据并应用 RevMan 5.1软件进行 Meta 分析，结果以比值比（OR）以及95%置信区间（CI）表示。结果共纳入6项 RCT，其中4项为泊沙康唑与1种其他抗真菌药比较，2项 RCT 为泊沙康唑与2种其他抗真菌药比较，试验组患者共1410例，对照组929例。Meta 分析结果显示，试验组侵袭性真菌感染发生率低于对照组，差异有统计学意义（ OR =0.37，95% CI：0.27~0.50，P ﹤0.00001）。与不同对照药物比较的结果显示，试验组侵袭性真菌感染发生率低于氟康唑对照组（OR =0.42，95% CI：0.28~0.64，P ﹤0.0001）和伊曲康唑对照组（OR =0.33，95% CI：0.21~0.53，P ﹤0.00001）；与伏立康唑对照组和两性霉素 B 脂质体对照组差异均无统计学意义（ OR =0.13，95% CI：0.01~2.67，P =0.19；OR =0.11，95% CI：0.01~2.34，P =0.16）。试验组侵袭性霉菌感染发生率低于氟康唑对照组（OR =0.25，95% CI：0.12~0.51，P ﹤0.00001），与伊曲康唑对照组差异无统计学意义（OR =0.10，95% CI：0.01~1.59，P =0.10）。试验组侵袭性念珠菌感染发生率与氟康唑、伊曲康唑对照组比较差异均无统计学意义（P =0.91；P =0.33）。试验组全因病死率低于对照组，差异有统计学意义（OR =0.64，95% CI：0.49~0.82，P =0.0005）。试验组不良反应发生率低于对照组，差异有统计学意义（OR =0.81，95% CI：0.66~0.99，P =0.04），但亚组分析结果显示试验组与氟康唑、伊曲康唑、伏立康唑和两性霉素 B 脂质体对照组比较，差异均无统计学意义（均 P >0.05），考虑可能存在发表偏倚。结论泊沙康唑预防侵袭性真菌感染的疗效优于非泊沙康唑类药物，安全性与非泊沙康唑类药物相似。
目的：評價泊沙康唑預防性抗真菌的療效與安全性。方法檢索中國知網中國期刊全文數據庫、維普數據庫、中國生物醫學文獻數據庫、萬方醫學數據庫、PubMed、Cochrane Library、Embase、OVID、Web of Science（建庫至2014年3月），收集泊沙康唑與安慰劑或其他抗真菌藥物比較預防真菌感染併以侵襲性真菌感染髮生率、病死率和不良反應髮生率中任何一項作為研究終點的隨機對照試驗（RCT），提取相關數據併應用 RevMan 5.1軟件進行 Meta 分析，結果以比值比（OR）以及95%置信區間（CI）錶示。結果共納入6項 RCT，其中4項為泊沙康唑與1種其他抗真菌藥比較，2項 RCT 為泊沙康唑與2種其他抗真菌藥比較，試驗組患者共1410例，對照組929例。Meta 分析結果顯示，試驗組侵襲性真菌感染髮生率低于對照組，差異有統計學意義（ OR =0.37，95% CI：0.27~0.50，P ﹤0.00001）。與不同對照藥物比較的結果顯示，試驗組侵襲性真菌感染髮生率低于氟康唑對照組（OR =0.42，95% CI：0.28~0.64，P ﹤0.0001）和伊麯康唑對照組（OR =0.33，95% CI：0.21~0.53，P ﹤0.00001）；與伏立康唑對照組和兩性黴素 B 脂質體對照組差異均無統計學意義（ OR =0.13，95% CI：0.01~2.67，P =0.19；OR =0.11，95% CI：0.01~2.34，P =0.16）。試驗組侵襲性黴菌感染髮生率低于氟康唑對照組（OR =0.25，95% CI：0.12~0.51，P ﹤0.00001），與伊麯康唑對照組差異無統計學意義（OR =0.10，95% CI：0.01~1.59，P =0.10）。試驗組侵襲性唸珠菌感染髮生率與氟康唑、伊麯康唑對照組比較差異均無統計學意義（P =0.91；P =0.33）。試驗組全因病死率低于對照組，差異有統計學意義（OR =0.64，95% CI：0.49~0.82，P =0.0005）。試驗組不良反應髮生率低于對照組，差異有統計學意義（OR =0.81，95% CI：0.66~0.99，P =0.04），但亞組分析結果顯示試驗組與氟康唑、伊麯康唑、伏立康唑和兩性黴素 B 脂質體對照組比較，差異均無統計學意義（均 P >0.05），攷慮可能存在髮錶偏倚。結論泊沙康唑預防侵襲性真菌感染的療效優于非泊沙康唑類藥物，安全性與非泊沙康唑類藥物相似。
목적：평개박사강서예방성항진균적료효여안전성。방법검색중국지망중국기간전문수거고、유보수거고、중국생물의학문헌수거고、만방의학수거고、PubMed、Cochrane Library、Embase、OVID、Web of Science（건고지2014년3월），수집박사강서여안위제혹기타항진균약물비교예방진균감염병이침습성진균감염발생솔、병사솔화불량반응발생솔중임하일항작위연구종점적수궤대조시험（RCT），제취상관수거병응용 RevMan 5.1연건진행 Meta 분석，결과이비치비（OR）이급95%치신구간（CI）표시。결과공납입6항 RCT，기중4항위박사강서여1충기타항진균약비교，2항 RCT 위박사강서여2충기타항진균약비교，시험조환자공1410례，대조조929례。Meta 분석결과현시，시험조침습성진균감염발생솔저우대조조，차이유통계학의의（ OR =0.37，95% CI：0.27~0.50，P ﹤0.00001）。여불동대조약물비교적결과현시，시험조침습성진균감염발생솔저우불강서대조조（OR =0.42，95% CI：0.28~0.64，P ﹤0.0001）화이곡강서대조조（OR =0.33，95% CI：0.21~0.53，P ﹤0.00001）；여복립강서대조조화량성매소 B 지질체대조조차이균무통계학의의（ OR =0.13，95% CI：0.01~2.67，P =0.19；OR =0.11，95% CI：0.01~2.34，P =0.16）。시험조침습성매균감염발생솔저우불강서대조조（OR =0.25，95% CI：0.12~0.51，P ﹤0.00001），여이곡강서대조조차이무통계학의의（OR =0.10，95% CI：0.01~1.59，P =0.10）。시험조침습성념주균감염발생솔여불강서、이곡강서대조조비교차이균무통계학의의（P =0.91；P =0.33）。시험조전인병사솔저우대조조，차이유통계학의의（OR =0.64，95% CI：0.49~0.82，P =0.0005）。시험조불량반응발생솔저우대조조，차이유통계학의의（OR =0.81，95% CI：0.66~0.99，P =0.04），단아조분석결과현시시험조여불강서、이곡강서、복립강서화량성매소 B 지질체대조조비교，차이균무통계학의의（균 P >0.05），고필가능존재발표편의。결론박사강서예방침습성진균감염적료효우우비박사강서류약물，안전성여비박사강서류약물상사。
Objective To evaluate the effectiveness and safety of posaconazole in antifungal prophylaxis. Methods CNKI,VIP,CBM,Wangfang Database,PubMed,Cochrane Library,Embase, OVID,and Web of Science from the inception to March 2014 were searched. The randomized controlled trials(RCT)which compared posaconazole with placebo or other antifungal drugs in antifungal prophylaxis and the endpoint was the incidences of invasive fungal infection( IFI),all-cause mortality,or adverse reactions were collected. The related information was selected and RevMan 5. 1 software of Cochrane Collaboration was used for statistical analysis. The results were expressed as odds ratios( OR)and its corresponding 95% confidence intervals(CI). Results A total of 6 RCTs were enrolled into the study. Of them,4 RCTs were comparison of posaconazole with one other antifungal drug,and 2 RCTs were <br> comparison of posaconazole with two kinds of other antifungal drugs. There were 1 410 cases in the experimental group and 929 cases in the control group. The results of Meta-analysis showed that the incidence of IFI in the experimental group was lower than that in the control group(OR = 0. 37,95% CI:0. 27-0. 50,P ﹤ 0. 000 01). The results of comparison of posaconazole with other antifungal drugs showed that the incidence of invasive fungal infections in the experimental group were lower than those in the fluconazol group(OR = 0. 42,95% CI:0. 28-0. 64,P ﹤ 0. 000 1)and the itraconazole group(OR = 0. 33, 95% CI:0. 21-0. 53,P ﹤ 0. 000 01). There were no statistical significant differences in incidence of invasive fungal infections between the experimental group and the control groups of voriconazole and amphotericin B(OR =0. 13,95% CI:0. 01-2. 67,P =0. 19;OR =0. 11,95% CI:0. 01-2. 34,P =0. 16). The incidence of invasive mold infection in the experimental group was lower than that in the fluconazole group(OR = 0. 25,95% CI:0. 12-0. 51,P = 0. 000 1). There was no statistical significant difference in incidence of invasive mold infection between the experimental group and the itraconazole group(OR = 0. 10, 95% CI:0. 01-1. 59,P = 0. 10). There were no statistical significant differences in incidence of invasive candida infection between the experimental group and the control groups of fluconazol and itraconazole(P =0. 91,P = 0. 33). The all-cause mortality in the experimental group was lower than that in the control group (OR = 0. 64,95% CI:0. 49-0. 82,P = 0. 000 5). The incidence of adverse reactions in the experimental group was lower than that in the control group(OR =0. 81,95% CI:0. 66-0. 99,P =0. 04);but the result of subgroup analysis showed that there were no statistical significant difference in the incidence of adverse reactions between the experimental group and the control groups such as fluconazol,itraconazole,voriconazole, and amphotericin B liposomes( all P > 0. 05). It was considered that publication bias existed in above-mentioned 6 RCTs. Conclusion The effectiveness of posaconazole in antifungal prophylaxis is better than those in the non-posaconazole drugs and the safety of posaconazole is similar to the non-posaconazole drugs.
