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北京医院药学部国家老年医学中心中国医学科学院老年医学(研究院北京市药物临床风险与个体化应用评价重点实验室(北京医院)
纸质出版日期:2021,
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张田, 李婷, 李超, 等. 法罗培南治疗细菌性感染的系统评价[J]. 中国医院用药评价与分析, 2021,21(12):1498-1503.
Systematic Review of Faropenem in the Treatment of Bacterial Infection[J]. 2021,21(12):1498-1503.
张田, 李婷, 李超, 等. 法罗培南治疗细菌性感染的系统评价[J]. 中国医院用药评价与分析, 2021,21(12):1498-1503. DOI: 10.14009/j.issn.1672-2124.2021.12.018.
Systematic Review of Faropenem in the Treatment of Bacterial Infection[J]. 2021,21(12):1498-1503. DOI: 10.14009/j.issn.1672-2124.2021.12.018.
目的:系统评价法罗培南治疗细菌性感染的疗效和安全性。方法:采用计算机检索Pub Med、the Cochrane Library、Embase、中国知网、万方数据库和中国生物医学文献数据库
对建库至2021年2月发表的法罗培南治疗细菌性感染的随机对照试验进行检索(研究组的治疗方案为法罗培南
对照组的治疗方案为常规疗法或根据患者病情选用抗感染药)。按照纳入与排除标准
由2名研究者独立筛选文献、提取相关数据
并评价纳入研究的偏倚风险
运用Rev Man 5.3软件进行荟萃分析(Meta分析)。结果:共纳入19篇文献(19项随机对照试验)
包含3 371例患者。Meta分析结果显示
有效性方面
注射用法罗培南钠与注射用亚胺培南西司他丁钠治疗泌尿系统细菌性感染的临床痊愈率(RR=1.08
95%CI=0.88~1.32
P=0.49)、细菌清除率(RR=1.03
95%CI=0.94~1.13
P=0.50)比较
差异均无统计学意义;法罗培南钠片与头孢克洛片(胶囊)治疗泌尿系统细菌性感染的临床痊愈率的差异无统计学意义(RR=1.00
95%CI=0.84~1.20
P=0.97)
但两者治疗泌尿系统细菌性感染的临床有效率(RR=1.09
95%CI=1.01~1.17
P=0.03)
治疗呼吸系统细菌性感染的临床痊愈率(RR=1.39
95%CI=1.12~1.73
P=0.003)、临床有效率(RR=1.09
95%CI=1.01~1.17
P=0.02)
以及细菌清除率(RR=1.05
95%CI=1.00~1.09
P=0.03)比较
差异均有统计学意义
法罗培南钠片的治疗效果有一定优势;法罗培南钠片与头孢呋辛酯片治疗呼吸系统细菌性感染的临床痊愈率(RR=0.96
95%CI=0.86~1.07
P=0.45)、临床有效率(RR=1.03
95%CI=1.00~1.07
P=0.07)和细菌清除率(RR=1.00
95%CI=0.96~1.03
P=0.83)比较
差异均无统计学意义。安全性方面
注射用法罗培南钠与注射用亚胺培南西司他丁钠的不良反应发生率比较(RR=1.20
95%CI=0.56~2.57
P=0.65)
法罗培南钠片与头孢克洛片(胶囊)的不良反应发生率比较(RR=1.24
95%CI=0.72~2.16
P=0.44)
法罗培南钠片与头孢呋辛酯片(RR=1.09
95%CI=0.88~1.35
P=0.43)的不良反应发生率比较
差异均无统计学意义。结论:当前证据提示
法罗培南治疗临床细菌性感染安全、有效
但受所纳入研究数量和质量的限制
上述结论尚需要更多大样本、多中心临床研究予以验证。
OBJECTIVE: To systematically review the efficacy and safety of faropenem in the treatment of bacterial infection. METHODS: Pub Med
the Cochrane Library
Embase
CNKI
Wanfang Data and CBM were retrieved to collect the randomized controlled trials( RCT) of faropenem in the treatment of bacterial infection( the study group was treated with faropenem
while the control group received conventional therapy or anti-infective drugs according to the patients’ conditions). The retrieval time was from the establishment of the database to Feb. 2021. According to the inclusion and exclusion criteria
two researchers independently screened the literature
extracted relevant data
and evaluated the risk of bias in the included literature
and Rev Man 5. 3 software was used to performed the Meta-analysis.RESULTS: A total of 19 articles( 19 RCT) were enrolled
including 3 371 patients. Meta-analysis indicated that there was no statistical significance in the clinical cure rate( RR = 1. 08
95% CI = 0. 88-1. 32
P = 0. 49) and bacterial clearance rate( RR = 1. 03
95% CI = 0. 94-1. 13
P = 0. 50) between faropenem sodium for injection and imipenem and cilastatin sodium for injection in the treatment of urinary system infection. The clinical cure rate( RR = 1. 00
95% CI =0. 84-1. 20
P = 0. 97) of faropenem sodium tablets and cefaclor tablets( capsules) in the treatment of urinary system infection was not statistically different. However
the clinical effective rate( RR = 1. 09
95% CI = 1. 01-1. 17
P = 0. 03)of faropenem sodium tablets and cefaclor tablets( capsules) in the treatment of urinary system infection
the clinical cure rate( RR = 1. 39
95% CI = 1. 12-1. 73
P = 0. 003)
clinical effective rate( RR = 1. 09
95% CI = 1. 01-1. 17
P = 0. 02)and bacterial clearance rate( RR = 1. 05
95% CI = 1. 00-1. 09
P = 0. 03) of faropenem sodium tablets and cefaclor tablets( capsules) in the treatment of respiratory system infection were statistically significant
indicating that faropenem sodium tablets had certain advantages in the treatment effects. There was no statistically significant difference in the clinical cure rate( RR = 0. 96
95% CI = 0. 86-1. 07
P = 0. 45)
clinical effective rate( RR = 1. 03
95% CI = 1. 00-1. 07
P = 0. 07) and bacterial clearance rate( RR = 1. 00
95% CI = 0. 96-1. 03
P = 0. 83) of faropenem sodium tablets and cefuroxime axetil tablets in the treatment of respiratory system infection. There was no significant difference in the incidence of adverse drug reactions between faropenem sodium for injection and imipenem and cilastatin sodium for injection( RR = 1. 20
95% CI = 0. 56-2. 57
P = 0. 65)
faropenem sodium tablets and cefaclor tablets( capsules)( RR = 1. 24
95% CI = 0. 72-2. 16
P = 0. 44)
faropenem sodium tablets and cefuroxime axetil tablets( RR = 1. 09
95% CI = 0. 88-1. 35
P = 0. 43).CONCLUSIONS: Existing evidence suggests that faropenem is safe and effective in the treatment of clinical bacterial infection
yet due to the limitations of quantity and quality of the included literature
the above conclusions need to be verified by more large-sample
multi-center clinical trials.
法罗培南细菌性感染随机对照试验Meta分析系统评价
FaropenemBacterial infectionRandomized controlled trialsMeta-analysisSystematic review
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