中国医药导报
中國醫藥導報
중국의약도보
China Medical Herald
2015年
31期
70-76
,共7页
Secukinumab%斑块型银屑病%Meta分析%随机对照试验%疗效%安全性
Secukinumab%斑塊型銀屑病%Meta分析%隨機對照試驗%療效%安全性
Secukinumab%반괴형은설병%Meta분석%수궤대조시험%료효%안전성
Secukinumab%Plaque psoriasis%Meta analysis%Randomized controlled trials%Efficacy%Safety
目的：系统评价Secukinumab治疗中重度斑块型银屑病的临床效果及安全性。方法计算机检索Medline、EMbase、Cochrane图书馆、中国生物医学文献数据库(CBM)、中文科技期刊全文数据库(VIP)、中国期刊全文数据库(CNKI)和万方数据库建库至2015年5月所有关于Secukinumab治疗中重度斑块型银屑病的随机对照试验，中文检索词为银屑病、Secukinumab和随机对照试验，英文检索词为psoriasis、Secukinumab和randomized clinical trial。由2名评价员按照纳入和排除标准独立筛选文献、提取资料及评价纳入研究质量。采用RevMan 5.3软件进行Meta分析。结果共纳入4个随机对照试验，包括2490例中重度斑块型银屑病例患者。在治疗12周时，Meta分析结果显示：①与安慰剂组比较，Secukinumab 150 mg治疗组中银屑病患者皮损面积和严重性指数(PASI)积分下降75%、90%和100%的患者例数(以PASI 75、PASI 90、PASI 100表示)明显增多，差异均有统计学意义(PASI 75：P <0.00001，95%CI：10.47~20.89；PASI 90：P <0.00001，95%CI：16.73~59.86；PASI 100：P <0.00001，95%CI：9.08~66.62)；Secukinumab 300 mg治疗组中银屑病患者PASI 75、PASI 90、PASI 100的例数与安慰剂组比较也显著增多(PASI 75：P <0.00001，95%CI：12.80~25.43；PASI 90：P <0.00001，95%CI：22.85~81.34；PASI 100：P <0.00001，95%CI：18.71~133.95)；与Secukinumab 150 mg治疗组比较，Secukinumab 300 mg治疗组中PASI 75、PASI 90、PASI 100患者例数均明显增多，差异有统计学意义(PASI 75：P=0.001，95%CI：1.07~1.33；PASI 90：P<0.00001，95%CI：1.22~1.52；PASI 100：P<0.00001，95%CI：1.67~2.60)。②Secukinumab 150 mg治疗组和Secuk-inumab 300 mg治疗组中不良反应发生率明显高于安慰剂组(Secukinumab 150 mg：P=0.004，95%CI：1.05~1.33；Secukinumab 300 mg：P=0.02，95%CI：1.05~1.76)，但Secukinumab 150 mg治疗组和Secukinumab 300 mg治疗组间不良反应发生率比较差异无统计学意义(P=0.44，95%CI：0.86~1.07)。结论现有证据显示，在治疗12周时，Secukinumab能明显改善银屑病患者疾病严重程度，具有良好的临床疗效，但使用Secukinumab存在发生不良反应的风险；300 mg剂量临床疗效明显优于150 mg，且不良反应发生率无明显差异。由于纳入研究个数尚少，上述结论有待更多高质量的研究予以验证。
目的：繫統評價Secukinumab治療中重度斑塊型銀屑病的臨床效果及安全性。方法計算機檢索Medline、EMbase、Cochrane圖書館、中國生物醫學文獻數據庫(CBM)、中文科技期刊全文數據庫(VIP)、中國期刊全文數據庫(CNKI)和萬方數據庫建庫至2015年5月所有關于Secukinumab治療中重度斑塊型銀屑病的隨機對照試驗，中文檢索詞為銀屑病、Secukinumab和隨機對照試驗，英文檢索詞為psoriasis、Secukinumab和randomized clinical trial。由2名評價員按照納入和排除標準獨立篩選文獻、提取資料及評價納入研究質量。採用RevMan 5.3軟件進行Meta分析。結果共納入4箇隨機對照試驗，包括2490例中重度斑塊型銀屑病例患者。在治療12週時，Meta分析結果顯示：①與安慰劑組比較，Secukinumab 150 mg治療組中銀屑病患者皮損麵積和嚴重性指數(PASI)積分下降75%、90%和100%的患者例數(以PASI 75、PASI 90、PASI 100錶示)明顯增多，差異均有統計學意義(PASI 75：P <0.00001，95%CI：10.47~20.89；PASI 90：P <0.00001，95%CI：16.73~59.86；PASI 100：P <0.00001，95%CI：9.08~66.62)；Secukinumab 300 mg治療組中銀屑病患者PASI 75、PASI 90、PASI 100的例數與安慰劑組比較也顯著增多(PASI 75：P <0.00001，95%CI：12.80~25.43；PASI 90：P <0.00001，95%CI：22.85~81.34；PASI 100：P <0.00001，95%CI：18.71~133.95)；與Secukinumab 150 mg治療組比較，Secukinumab 300 mg治療組中PASI 75、PASI 90、PASI 100患者例數均明顯增多，差異有統計學意義(PASI 75：P=0.001，95%CI：1.07~1.33；PASI 90：P<0.00001，95%CI：1.22~1.52；PASI 100：P<0.00001，95%CI：1.67~2.60)。②Secukinumab 150 mg治療組和Secuk-inumab 300 mg治療組中不良反應髮生率明顯高于安慰劑組(Secukinumab 150 mg：P=0.004，95%CI：1.05~1.33；Secukinumab 300 mg：P=0.02，95%CI：1.05~1.76)，但Secukinumab 150 mg治療組和Secukinumab 300 mg治療組間不良反應髮生率比較差異無統計學意義(P=0.44，95%CI：0.86~1.07)。結論現有證據顯示，在治療12週時，Secukinumab能明顯改善銀屑病患者疾病嚴重程度，具有良好的臨床療效，但使用Secukinumab存在髮生不良反應的風險；300 mg劑量臨床療效明顯優于150 mg，且不良反應髮生率無明顯差異。由于納入研究箇數尚少，上述結論有待更多高質量的研究予以驗證。
목적：계통평개Secukinumab치료중중도반괴형은설병적림상효과급안전성。방법계산궤검색Medline、EMbase、Cochrane도서관、중국생물의학문헌수거고(CBM)、중문과기기간전문수거고(VIP)、중국기간전문수거고(CNKI)화만방수거고건고지2015년5월소유관우Secukinumab치료중중도반괴형은설병적수궤대조시험，중문검색사위은설병、Secukinumab화수궤대조시험，영문검색사위psoriasis、Secukinumab화randomized clinical trial。유2명평개원안조납입화배제표준독립사선문헌、제취자료급평개납입연구질량。채용RevMan 5.3연건진행Meta분석。결과공납입4개수궤대조시험，포괄2490례중중도반괴형은설병례환자。재치료12주시，Meta분석결과현시：①여안위제조비교，Secukinumab 150 mg치료조중은설병환자피손면적화엄중성지수(PASI)적분하강75%、90%화100%적환자례수(이PASI 75、PASI 90、PASI 100표시)명현증다，차이균유통계학의의(PASI 75：P <0.00001，95%CI：10.47~20.89；PASI 90：P <0.00001，95%CI：16.73~59.86；PASI 100：P <0.00001，95%CI：9.08~66.62)；Secukinumab 300 mg치료조중은설병환자PASI 75、PASI 90、PASI 100적례수여안위제조비교야현저증다(PASI 75：P <0.00001，95%CI：12.80~25.43；PASI 90：P <0.00001，95%CI：22.85~81.34；PASI 100：P <0.00001，95%CI：18.71~133.95)；여Secukinumab 150 mg치료조비교，Secukinumab 300 mg치료조중PASI 75、PASI 90、PASI 100환자례수균명현증다，차이유통계학의의(PASI 75：P=0.001，95%CI：1.07~1.33；PASI 90：P<0.00001，95%CI：1.22~1.52；PASI 100：P<0.00001，95%CI：1.67~2.60)。②Secukinumab 150 mg치료조화Secuk-inumab 300 mg치료조중불량반응발생솔명현고우안위제조(Secukinumab 150 mg：P=0.004，95%CI：1.05~1.33；Secukinumab 300 mg：P=0.02，95%CI：1.05~1.76)，단Secukinumab 150 mg치료조화Secukinumab 300 mg치료조간불량반응발생솔비교차이무통계학의의(P=0.44，95%CI：0.86~1.07)。결론현유증거현시，재치료12주시，Secukinumab능명현개선은설병환자질병엄중정도，구유량호적림상료효，단사용Secukinumab존재발생불량반응적풍험；300 mg제량림상료효명현우우150 mg，차불량반응발생솔무명현차이。유우납입연구개수상소，상술결론유대경다고질량적연구여이험증。
Objective To assess the efficacy and safety of Secukinumab on plaque psoriasis. Methods Randomized controlled trials (RCTs) of Secukinumab for plaque psoriasis were retrieved in Medline, EMbase, Cochrane Library, CBM, VIP, CNKI and Wanfang databases from their established date to May 2015. The searching words were psoriasis, Secukinumab and randomized clinical trial both in Chinese and in English. The retrieved studies were screened and e-valuated by two people according to the predefined inclusion and exclusion criteria. The extracted data was analyzed by RevMan 5.3 software. Results Four RCTs involving 2490 patients with chronic moderate to severe plaque psoriasis were included and assessed. After treatment for 12 weeks, the Meta analysis showed that the cases whose psoriasis area and severity index (PASI) scores decreased 75%, 90%and 100% (in form of PASI 75, PASI 90 and PASI 100) in patients receiving Secukinumab 150 mg were signifi-cantly higher than those in patients receiving placebo (PASI 75: P< 0.000 01, 95%CI: 10.47-20.89; PASI 90:P < 0.000 01, 95%CI: 16.73-59.86; PASI 100: P <0.000 01, 95%CI: 9.08-66.62). In comparison to placebo group, these indicators in Secukinumab 300 mg group in-creased significantly (PASI 75:P<0.000 01, 95%CI:12.80-25.43;PASI 90:P<0.000 01, 95%CI:22.85-81.34;PASI 100:P<0.000 01, 95%CI: 18.71-133.95). Compared with the patients receiving Secukinumab 150 mg, PASI 75, PASI 90 and PASI 100 in the patients receiving Secukinumab 300 mg increased significantly (PASI 75: P= 0.001, 95%CI:1.07-1.33; PASI 90: P< 0.000 01, 95%CI: 1.22-1.52; PASI 100: P< 0.000 01, 95%CI: 1.67-2.60). The incidence of adverse events was higher in Secukinumab 150 mg group and Secukinumab 300 mg group than that in placebo group (Secukinumab 150 mg: P= 0.004, 95%CI: 1.05-1.33; Secukinumab 300 mg: P= 0.02, 95%CI: 1.05-1.76). However, the incidence of adverse events showed no significant difference between Secukinumab 150 mg group and Secukinumab 300 mg group (P=0.44, 95%CI:0.86-1.07). Conclusion Clinical trial data indicates that injection of Secukinumab is efficient for patients with moderate to severe plaque psoriasis at week 12, but it can cause some adverse events. The clinical effect of 300 mg dose is significantly better than that of 150 mg dose, and the incidence of adverse events for patients in the two groups has no significant difference. But the number of enrolled studies is less, the conclusions above should be verified by more high quality studies.
