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1. 四川省中江县人民医院皮肤科
2. 四川省中江县人民医院药剂科
3. 南充市中心医院药学部
4. 四川大学华西临床医学院
纸质出版日期:2023,
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何涯含, 冷衍恩, 周玺, 等. 度普利尤单抗治疗成人中重度特应性皮炎有效性和安全性的系统评价[J]. 中国医院用药评价与分析, 2023,(1):88-95.
HE Yahan, LENG Yanen, ZHOU Xi, et al. Systematic Review of Efficacy and Safety of Dupilumab in the Treatment of Adults with Moderate to Severe Atopic Dermatitis[J]. 2023,(1):88-95.
何涯含, 冷衍恩, 周玺, 等. 度普利尤单抗治疗成人中重度特应性皮炎有效性和安全性的系统评价[J]. 中国医院用药评价与分析, 2023,(1):88-95. DOI: 10.14009/j.issn.1672-2124.2023.01.018.
HE Yahan, LENG Yanen, ZHOU Xi, et al. Systematic Review of Efficacy and Safety of Dupilumab in the Treatment of Adults with Moderate to Severe Atopic Dermatitis[J]. 2023,(1):88-95. DOI: 10.14009/j.issn.1672-2124.2023.01.018.
目的:系统评价度普利尤单抗治疗成人中重度特应性皮炎的有效性和安全性,为其临床应用提供循证证据。方法:检索PubMed、Embase、the Cochrane Library和中国知网等数据库,检索时限均为建库至2022年6月,纳入符合标准的度普利尤单抗治疗成人中重度特应性皮炎的随机对照试验(研究组患者使用度普利尤单抗,对照组患者使用安慰剂)
使用RevMan 5.3软件进行Meta分析。结果:共纳入10项随机对照试验,合计3 383例患者。结果显示,研究组湿疹面积及严重程度指数较基线缓解≥75%的患者比例(EASI75)均显著高于对照组(总体:RR=3.01
95%CI=2.62~3.46
P<0.000 01;300 mg
1周1次:RR=2.91
95%CI=2.38~3.55
P<0.000 01;300 mg
2周1次:RR=3.16
95%CI=2.56~3.89
P<0.000 01)
湿疹面积及严重程度指数较基线缓解≥50%的患者比例(EASI50)均显著高于对照组(总体:RR=2.43
95%CI=2.24~2.64
P<0.000 01;300 mg
1周1次:RR=2.32
95%CI=2.09~2.59
P<0.000 01;300 mg
2周1次:RR=2.58
95%CI=2.27~2.93
P<0.000 01)
差异均有统计学意义;此外,在研究者整体评估评分为0或1分(清除或几乎清除)的患者比例、瘙痒指数评分降低≥3分的患者比例等6项有效性指标中,研究组患者也显著优于对照组,差异均有统计学意义(P<0.05)。对度普利尤单抗300 mg、1周1次与300 mg、2周1次进行对比分析发现,两种给药方式在各有效性指标方面的差异均无统计学意义(P>0.05)。安全性方面,研究组患者的严重不良反应发生率和皮肤过敏发生率显著低于对照组,头痛发生率、注射部位反应发生率和口腔疱疹发生率显著高于对照组,差异均有统计学意义(P<0.05);在总不良反应发生率、上呼吸道反应发生率等其余安全性指标方面,研究组与对照组患者的差异均无统计学意义(P>0.05)。度普利尤单抗300 mg、1周1次与300 mg、2周1次比较,两种给药方式在各安全性指标方面的差异均无统计学意义(P>0.05)。结论:度普利尤单抗治疗成人中重度特应性皮炎有较好的疗效,且不良反应轻微,患者可耐受。
OBJECTIVE: To systematically evaluate the efficacy and safety of dupilumab in the treatment of adults with moderate to severe atopic dermatitis
so as to provide evidence-based reference for clinical treatment. METHODS: PubMed
Embase
the Cochrane Library and CNKI were retrieved to collect the randomized controlled trial of dupilumab in the treatment of adults with moderate to severe atopic dermatitis(the study group received dupilumab
while the control group was given placebo). The retrieval time was from the establishment of the database to Jun. 2022. RevMan 5.3 software was used for Meta-analysis. RESULTS: Totally 10 randomized controlled trials were enrolled
including 3 383 patients. Proportion of patients in the study group with eczema area and severity index ≥75% of baseline remission(EASI75) were significantly higher than control group(total: RR=3.01
95%CI=2.62-3.46
P<0.000 01; 300 mg
qw: RR=2.91
95%CI=2.38-3.55
P<0.000 01; 300 mg
q2w: RR=3.16
95%CI=2.56-3.89
P<0.000 01)
proportion of patients in the study group with eczema area and severity index ≥50% of baseline remission(EASI50) were significantly higher than control group(total: RR=2.43
95%CI=2.24-2.64
P<0.000 01; 300 mg
qw: RR=2.32
95%CI=2.09-2.59
P<0.000 01; 300 mg
q2w: RR=2.58
95%CI=2.27-2.93
P<0.000 01)
with statistically significant differences. Meanwhile
compared with the proportion of patients in the study group with IGA score of 0 or 1 points(clear or almost clear)
the proportion of patients in the study group whose score of pruritus index(NRS) decreased by more than 3 points and other six effectiveness indicators
the study group was significantly better than that of control group
with statistically significant differences(P<0.05). Through the comparative analysis of 300 mg qw and 300 mg q2w
there was no significant difference in each effectiveness index between two administration methods(P>0.05). In terms of safety
the incidence of serious adverse reactions and skin allergy in the study group was significantly lower than that in the control group
and the incidence of injection site reaction
headache and oral herpes in the study group was significantly higher than that in the control group
with statistically significant differences(P<0.05). There was no significant difference in the incidence of total adverse drug reactions
upper respiratory tract reaction and other safety indicators between the study group and the control group(P>0.05). There was no significant difference between 300 mg qw and 300 mg q2w in various safety indicators(P>0.05). CONCLUSIONS: The efficacy of dupilumab in the treatment of adults with moderate to severe atopic dermatitis is significant
and the adverse drug reactions are mild and tolerable.
度普利尤单抗特应性皮炎系统评价Meta分析
DupilumabAtopic dermatitisSystematic reviewMeta-analysis
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