CAJ | 학술논문

目的：系统荟萃分析奥马珠单克隆抗体（单抗）治疗慢性特发性荨麻疹的疗效与安全性。方法采用PubMed数据库、Cochrane图书馆临床对照试验数据库、中国生物医学文献数据库、中国知网全文数据库及万方科技期刊全文数据库等收集文献，研究文献为奥马珠单抗治疗慢性特发性荨麻疹的随机双盲对照试验，观察对象为年龄大于12岁，经抗H1受体拮抗剂治疗未达到满意效果的慢性特发性荨麻疹患者。应用RevMan5.0.24软件对数据进行meta分析，评价奥马珠单抗的疗效及安全性。结果共纳入4项随机双盲对照试验，1128例患者。各组7 d荨麻疹活动性评分（UAS7）＜6分的病例数比较：75 mg奥马珠单抗治疗组优于安慰剂对照组，差异有统计学意义[相对危险度（RR）=1.73，95%可信区间（95%CI）：1.10~2.71，P=0.020]，300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组，差异有统计学意义（RR=0.45，95%CI：0.33~0.60，P=0.001）；各组治疗后UAS7降低值比较：75 mg奥马珠单抗治疗组优于安慰剂对照组，差异有统计学意义[均方差（MD）=5.03，95%CI：1.72~8.34，P=0.003]，300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组，差异有统计学意义（MD=-7.73，95%CI：-11.15~-4.30，P=0.001）；各组1周瘙痒严重程度评分比较：75 mg奥马珠单抗治疗组优于安慰剂对照组，差异有统计学意义（MD=1.75，95%CI：0.55~2.95，P=0.004），300 mg奥马珠单抗治疗组优于75 mg奥马珠单抗治疗组，差异有统计学意义（MD=-3.35，95%CI：-4.97~-1.73，P=0.001）。300 mg奥马珠单抗治疗组总的不良反应和严重不良反应发生情况与安慰剂对照组比较，差异均无统计学意义（RR=1.07、0.39，95%CI：0.97~1.18、0.39~1.38，P=0.200、0.340）。75 mg奥马珠单抗治疗组总的不良反应发生情况与300 mg奥马珠单抗治疗组比较，差异也无统计学意义[RR=0.91，95%CI：0.78~1.06，P=0.240]。结论慢性特发性荨麻疹患者在常规治疗未奏效时加用奥马珠单抗治疗可改善疗效，且安全性高。目的：繫統薈萃分析奧馬珠單剋隆抗體（單抗）治療慢性特髮性蕁痳疹的療效與安全性。方法採用PubMed數據庫、Cochrane圖書館臨床對照試驗數據庫、中國生物醫學文獻數據庫、中國知網全文數據庫及萬方科技期刊全文數據庫等收集文獻，研究文獻為奧馬珠單抗治療慢性特髮性蕁痳疹的隨機雙盲對照試驗，觀察對象為年齡大于12歲，經抗H1受體拮抗劑治療未達到滿意效果的慢性特髮性蕁痳疹患者。應用RevMan5.0.24軟件對數據進行meta分析，評價奧馬珠單抗的療效及安全性。結果共納入4項隨機雙盲對照試驗，1128例患者。各組7 d蕁痳疹活動性評分（UAS7）＜6分的病例數比較：75 mg奧馬珠單抗治療組優于安慰劑對照組，差異有統計學意義[相對危險度（RR）=1.73，95%可信區間（95%CI）：1.10~2.71，P=0.020]，300 mg奧馬珠單抗治療組優于75 mg奧馬珠單抗治療組，差異有統計學意義（RR=0.45，95%CI：0.33~0.60，P=0.001）；各組治療後UAS7降低值比較：75 mg奧馬珠單抗治療組優于安慰劑對照組，差異有統計學意義[均方差（MD）=5.03，95%CI：1.72~8.34，P=0.003]，300 mg奧馬珠單抗治療組優于75 mg奧馬珠單抗治療組，差異有統計學意義（MD=-7.73，95%CI：-11.15~-4.30，P=0.001）；各組1週瘙癢嚴重程度評分比較：75 mg奧馬珠單抗治療組優于安慰劑對照組，差異有統計學意義（MD=1.75，95%CI：0.55~2.95，P=0.004），300 mg奧馬珠單抗治療組優于75 mg奧馬珠單抗治療組，差異有統計學意義（MD=-3.35，95%CI：-4.97~-1.73，P=0.001）。300 mg奧馬珠單抗治療組總的不良反應和嚴重不良反應髮生情況與安慰劑對照組比較，差異均無統計學意義（RR=1.07、0.39，95%CI：0.97~1.18、0.39~1.38，P=0.200、0.340）。75 mg奧馬珠單抗治療組總的不良反應髮生情況與300 mg奧馬珠單抗治療組比較，差異也無統計學意義[RR=0.91，95%CI：0.78~1.06，P=0.240]。結論慢性特髮性蕁痳疹患者在常規治療未奏效時加用奧馬珠單抗治療可改善療效，且安全性高。
목적：계통회췌분석오마주단극륭항체（단항）치료만성특발성담마진적료효여안전성。방법채용PubMed수거고、Cochrane도서관림상대조시험수거고、중국생물의학문헌수거고、중국지망전문수거고급만방과기기간전문수거고등수집문헌，연구문헌위오마주단항치료만성특발성담마진적수궤쌍맹대조시험，관찰대상위년령대우12세，경항H1수체길항제치료미체도만의효과적만성특발성담마진환자。응용RevMan5.0.24연건대수거진행meta분석，평개오마주단항적료효급안전성。결과공납입4항수궤쌍맹대조시험，1128례환자。각조7 d담마진활동성평분（UAS7）＜6분적병례수비교：75 mg오마주단항치료조우우안위제대조조，차이유통계학의의[상대위험도（RR）=1.73，95%가신구간（95%CI）：1.10~2.71，P=0.020]，300 mg오마주단항치료조우우75 mg오마주단항치료조，차이유통계학의의（RR=0.45，95%CI：0.33~0.60，P=0.001）；각조치료후UAS7강저치비교：75 mg오마주단항치료조우우안위제대조조，차이유통계학의의[균방차（MD）=5.03，95%CI：1.72~8.34，P=0.003]，300 mg오마주단항치료조우우75 mg오마주단항치료조，차이유통계학의의（MD=-7.73，95%CI：-11.15~-4.30，P=0.001）；각조1주소양엄중정도평분비교：75 mg오마주단항치료조우우안위제대조조，차이유통계학의의（MD=1.75，95%CI：0.55~2.95，P=0.004），300 mg오마주단항치료조우우75 mg오마주단항치료조，차이유통계학의의（MD=-3.35，95%CI：-4.97~-1.73，P=0.001）。300 mg오마주단항치료조총적불량반응화엄중불량반응발생정황여안위제대조조비교，차이균무통계학의의（RR=1.07、0.39，95%CI：0.97~1.18、0.39~1.38，P=0.200、0.340）。75 mg오마주단항치료조총적불량반응발생정황여300 mg오마주단항치료조비교，차이야무통계학의의[RR=0.91，95%CI：0.78~1.06，P=0.240]。결론만성특발성담마진환자재상규치료미주효시가용오마주단항치료가개선료효，차안전성고。
Objective To perform the systematical meta analysis on the efficacy and safety of omalizumab for treating chronic idiopathic urticaria(CIU). Methods The double blind randomized controlled trials(RCT) on omalizumab for treating CIU were retrieved from the Cochrane Central Register of Controlled Trials,PubMed,CBM,CNKI and Wanfang database. The observation subjects were the CIU patients aged over 12 years old without satisfactory effect to the H1 receptor antagonist therapy. The obtained data were performed the meta analysis by using the RevMan 5.0 software. The curative effect and safety of omalizumab were evaluated. Results 4 double blind RCT were included involving 1 128 patients. In the comparison of urticaria activity score on 7 d(UAS7)<6 points among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[RR=1.73,95%CI(1.10~2.71),P=0.020] and the omalizumab 300 mg group was superior to the omalizumab 75 mg group, the differences were statistically significant[RR=0.45,95%CI(0.33~0.60),P=0.001];in the comparison of UAS7 decreased values after treatment among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[MD=5.03,95%CI(1.72~8.34),P=0.003] and the omalizumab 300 mg group was superior to the omalizumab 75 mg group,the differences were statistically significant[MD=-7.73,95%CI(-11.15~-4.30),P<0.001];in the comparison of 1-week itching degrees among various groups,the omalizumab 75 mg group was superior to the placebo group and the control group[MD=1.75,95%CI(0.55~2.95), P=0.004] the omalizumab 300 mg group was superior to the omalizumab 75 mg group ,the differences were statistically significant [MD=-3.35,95%CI(-4.97~-1.73),P<0.00]. The total adverse reactions and severe adverse reactions had no statistical difference between the omalizumab 300 mg group with the placebo group and the control group (RR=1.07,0.39,95%CI:0.97~1.18,0.39~1.38, P=0.200,0.340). Furthermore,the occurrence situation of the total adverse reactions also had no statistical difference between the omalizumab 75 mg group and omalizumab 300 mg group[RR=0.91,95%CI(0.78~1.06),P=0.240]. Conclusion Adding omalizumab in CIU patients without effect to the conventional therapy can improve the curative effect with high safety.