目的 系統(tǒng)評價(jià)克立硼羅軟膏治療特應(yīng)性皮炎(AD)的有效性和安全性。方法 檢索Cochrane Library、Embase、PubMed、中國學(xué)術(shù)期刊全文數(shù)據(jù)庫(CNKI)、萬方數(shù)據(jù)知識服務(wù)平臺(Wanfang Data)、維普中文期刊全文數(shù)據(jù)庫(VIP)、中國生物醫(yī)學(xué)文獻(xiàn)服務(wù)系統(tǒng)(SinoMed)、中華醫(yī)學(xué)期刊全文數(shù)據(jù)庫(Yiigle),系統(tǒng)收集建庫至2024年1月30日發(fā)表的克立硼羅軟膏治療特應(yīng)性皮炎的臨床隨機(jī)對照試驗(yàn)(RCT)。由2名研究者獨(dú)立篩選、提取信息,通過Review Manager 5.3軟件進(jìn)行Meta分析,所形成的證據(jù)體使用GRADE系統(tǒng)進(jìn)行證據(jù)質(zhì)量評估。結(jié)果 共納入11項(xiàng)RCTs,包括2 789例AD患者。Meta分析顯示:與安慰劑或空白治療比較,克立硼羅軟膏可提高研究者靜態(tài)總體評分成功率[RR=1.52,95 % CI (1.28,1.80),P<0.000 01]和緩解率[RR=1.43,95 % CI (1.27,1.62),P<0.000 01],降低濕疹面積及嚴(yán)重程度指數(shù)(EASI)評分[MD=-2.44,95 % CI (-4.15,-0.73),P=0.005],緩解瘙癢,增加無復(fù)發(fā)維持時(shí)間,減少復(fù)發(fā)次數(shù);與陽性對照相比,具有更高的疾病療效愈顯率[RR=1.80,95 % CI (1.33,2.43),P=0.000 1],可提高生活質(zhì)量;與一線藥物聯(lián)合使用對比單獨(dú)使用一線治療藥物,聯(lián)合治療組具有更高的疾病療效愈顯率[RR=1.23,95 % CI (1.03,1.48),P=0.02],較高的EASI評分變化值[MD=-2.11,95 % CI (-3.13,-1.10),P<0.000 1],可緩解瘙癢,提高生活質(zhì)量。安全性方面,不良反應(yīng)主要表現(xiàn)為給藥部位的局部反應(yīng),如給藥部位刺激、疼痛、瘙癢、變色、感覺異常等,多數(shù)為輕度、中度反應(yīng),預(yù)后較好。結(jié)論 克立硼羅軟膏可緩解AD疾病嚴(yán)重程度,緩解瘙癢,提高生活質(zhì)量,病情穩(wěn)定后以小劑量長期維持治療可減少AD復(fù)發(fā);在兒童、成人群體中應(yīng)用耐受性較好,臨床使用時(shí)應(yīng)關(guān)注給藥部位的異常局部反應(yīng)。

Objective To evaluate the efficacy and safety of Crisaborole Ointment in the treatment of atopic dermatitis. Methods Randomized controlled trials (RCT) on the treatment of atopic dermatitis with Crisaborole ointment published in databases of Cochrane Library, Embase, PubMed, CNKI, Wanfang Database, VIP, SinoMed and Yiigle were electronically searched from database establishment until January 30, 2024. Two researchers independently screened and extracted information, assessed bias risk using the ROB-2 tool, conducted Meta-analysis using Review Manager 5.3, and evaluated the quality of evidence using the GRADE system. Results A total of 11 RCTs were involved with 2 789 AD patients. Meta-analysis showed that compared to placebo treatment, Crisaborole Ointment increased the ISGA success rate[RR=1.52, 95 %CI (1.28, 1.80), P < 0.000 01] and relief rate[RR=1.43, 95 %CI (1.27, 1.62), P < 0.000 01], decreased EASI scores[MD=-2.44, 95 %CI (-4.15, -0.73), P=0.005], relieved itching, prolonged flare-free time, and reduced relapse frequency. Compared to positive controls, it demonstrated a higher disease efficacy cure rate[RR=1.80, 95 %CI (1.33, 2.43), P=0.000 1], improving quality of life. When compared to the use of positive drug, combination therapy had a higher disease efficacy cure rate[RR=1.23, 95 %CI (1.03, 1.48), P=0.02], higher EASI score change value[MD=-2.11, 95 %CI (-3.13, -1.10), P < 0.000 1], relieved itching, and improved quality of life. In terms of safety, adverse reactions were mainly local reactions at the administration site, such as irritation, pain, itching, discoloration, and abnormal sensations, mostly mild to moderate, with a good prognosis. Conclusion Crisaborole Ointment can alleviate the severity of AD, relieve itching, improve the quality of life, and long-term maintenance therapy with a low dose can reduce AD recurrence after the condition stabilizes. It is well-tolerated in both children and adults, but clinicians should pay attention to abnormal local reactions at the administration site during clinical use.

R969.3;R986

國家科技重大專項(xiàng)課題:兒童中藥新藥臨床評價(jià)技術(shù)示范性平臺建設(shè)(2020ZX09201-008)