冰黄肤乐软膏治疗湿疹有效性和安全性的系统评价与Meta分析Systematic review and Meta-analysis of efficacy and safety of Binghuang Fule Ointment in treatment of eczema
杨硕;吕健;王连心;谢雁鸣;
YANG Shuo;LYU Jian;WANG Lian-xin;XIE Yan-ming;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;
摘要(Abstract):
为系统评价冰黄肤乐软膏治疗湿疹的有效性和安全性,该研究通过检索中国知网(CNKI)、维普(VIP)、万方(Wanfang)、中国生物医学文献服务系统(SinoMed)、PubMed、Web of Science、Cochrane Library、EMbase数据库,有效筛选冰黄肤乐软膏治疗湿疹的随机对照试验(RCTs),采用RevMan 5.4软件对最终纳入文献进行Meta分析。共纳入19项RCTs,总样本量1 919例,其中试验组973例,对照组946例。Meta分析结果显示:(1)冰黄肤乐软膏+西医常规的疗效积分指数≥60%(临床有效率)(RR=1.32,95%CI[1.13,1.55],P=0.000 4)优于西医常规,复发率(RR=0.37,95%CI[0.20,0.65],P=0.000 7)低于西医常规,不良反应(RR=1.05,95%CI[0.52,2.15],P=0.88)与西医常规差异无统计学意义;(2)单用冰黄肤乐软膏的疗效积分指数≥60%(临床有效率)(RR=1.20,95%CI[1.09,1.33],P=0.000 3)优于西医常规,不良反应(RR=0.92,95%CI[0.45,1.89],P=0.82)与西医常规差异无统计学意义;(3)冰黄肤乐软膏+西医常规或单用冰黄肤乐软膏的症状体征有效缓解(临床有效率)(RR=1.41,95%CI[1.07,1.85],P=0.01)优于西医常规。结果表明,冰黄肤乐软膏+西医常规或单用冰黄肤乐软膏治疗湿疹相较于西医常规治疗效果好,复发率低,安全性与西医常规治疗相当,临床用药可以借鉴。但由于纳入文献质量较低,故今后仍需更多大样本、多中心、方法学质量高的RCT进一步验证冰黄肤乐软膏治疗湿疹的疗效和安全性。
To expeditiously assess the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema, we screened out the papers with randomized controlled trials(RCTs) for studying the efficacy of Binghuang Fule Ointment in the treatment of eczema from CNKI, VIP, Wanfang, SinoMed, PubMed, Web of Science, Cochrane Library, and EMbase and then performed Meta-analysis of the included studies via RevMan 5.4. A total of 19 studies were included, involving 1 919 cases(973 cases in the experimental group and 946 cases in the control group). Meta-analysis results showed that Binghuang Fule Ointment combined with conventional western medicine had better efficacy score index(clinical effectiveness ≥60%)(RR=1.32, 95%CI[1.13, 1.55], P=0.000 4) and lower recurrence rate(RR=0.37, 95%CI[0.20, 0.65], P=0.000 7) than conventional western medicine alone. The adverse reactions(RR=1.05, 95%CI[0.52, 2.15], P=0.88) did not show significant difference between the two groups. The application of Binghuang Fule Ointment alone had better efficacy score index(clinical effectiveness≥60%)(RR=1.20, 95%CI[1.09, 1.33], P=0.000 3) than conventional western medicine alone and the adverse reactions(RR=0.92, 95%CI[0.45, 1.89], P=0.82) insignificantly different from conventional western medicine alone. Binghuang Fule Ointment alone or combined with conventional western medicine demonstrated better effective in remission of symptoms and signs(clinical effectiveness)(RR=1.41, 95%CI[1.07, 1.85], P=0.01) than conventional western medicine alone. Compared with the single application of western medicine, Binghuang Fule Ointment alone or combined with conventional western medicine has better curative effect, low recurrence rate, and equivalent safety in the treatment of eczema. Nevertheless, owing to the low quality of the included papers, randomized controlled trials with large sample size, multiple centers, high methodological quality are needed to further verify the efficacy and safety of Binghuang Fule Ointment in the treatment of eczema.
关键词(KeyWords):
冰黄肤乐软膏;湿疹;系统评价;Meta分析
Binghuang Fule Ointment;eczema;systematic review;Meta-analysis
基金项目(Foundation): 国家重点研发计划项目(2018YFC1707400);; 国家自然科学基金面上项目(81973982)
作者(Authors):
杨硕;吕健;王连心;谢雁鸣;
YANG Shuo;LYU Jian;WANG Lian-xin;XIE Yan-ming;Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences;Xiyuan Hospital, China Academy of Chinese Medical Sciences;
DOI: 10.19540/j.cnki.cjcmm.20220215.501
参考文献(References):
- [1] 赵辨.中国临床皮肤病学[M].苏州:江苏凤凰科学技术出版社,2017.
- [2] 吴实,邓列华,胡云峰,等.氯雷他定联合冰黄肤乐软膏治疗亚急性及慢性手部湿疹的临床观察[J].暨南大学学报(自然科学与医学版),2012,33(6):608.
- [3] 朱晓云.亚急性及慢性手部湿疹采用氯雷他定联合冰黄肤乐软膏治疗的临床体会[J].大家健康(中旬版),2014,8(6):523.
- [4] 张俊.氯雷他定联合冰黄肤乐软膏治疗亚急性及慢性手部湿疹的临床观察[J].东方食疗与保健,2016,14(10):103.
- [5] 雷玲.冰黄肤乐软膏联合氯雷他定治疗亚急性及慢性手部湿疹的临床效果[J].深圳中西医结合杂志,2017,27(3):26.
- [6] 宋洁.氯雷他定联合冰黄肤乐软膏治疗亚急性及慢性手部湿疹的临床效果研究[J].临床医药文献电子杂志,2017,4(51):10041.
- [7] 刘姝萍.冰黄肤乐软膏联合曲咪新霜治疗手足慢性湿疹100例[J].中医杂志,2009,50(5):392.
- [8] 胡基盛.冰黄肤乐软膏联合派瑞松软膏治疗肛周、外生殖器慢性湿疹疗效观察[J].中外医学研究,2009,7(7):81.
- [9] 邹树仁.冰黄肤乐软膏联合卡介菌多糖核酸治疗慢性湿疹[J].宜春学院学报,2012,34(4):81.
- [10] 徐凤菊.慢性湿疹采用左西替利嗪胶囊联合冰黄肤乐软膏治疗的临床疗效分析[J].中国继续医学教育,2015,7(32):195.
- [11] 张培霞,董红建,张芳.地氯雷他定联合冰黄肤乐软膏治疗亚急性及慢性手部湿疹的临床观察[J].临床医学,2014,34(11):76.
- [12] 李占国,郭金梅,付丹丹,等.冰黄肤乐软膏治疗婴儿湿疹临床研究[J].中国妇幼保健,2010,25(31):4644.
- [13] 蓝仕.西药配合冰黄肤乐软膏治疗婴儿湿疹疗效分析[J].实用中医药杂志,2013,29 (5):373.
- [14] 佟盼琢,孙修蓉.冰黄肤乐软膏封包治疗慢性湿疹的疗效观察[J].现代中西医结合杂志,2004,13(14):1872.
- [15] 杨晓晶.冰黄肤乐软膏治疗神经性皮炎和慢性湿疹疗效观察[J].中国麻风皮肤病杂志,2006,22(11):906.
- [16] 刘向梅.两种药物治疗慢性湿疹的效果观察[J].中国医疗美容,2014,4(5):121.
- [17] 吴军,阎国富,林自华,等.冰黄肤乐软膏治疗阴囊慢性湿疹疗效观察[J].中国医师杂志,2003,9(5):702.
- [18] 魏文国,曾三武.冰黄肤乐软膏治疗湿疹疗效观察[J].国际中医中药杂志,2007,29 (2):120.
- [19] 隋国庆,张士良,纪强.冰黄肤乐软膏与三九皮炎平软膏治疗肛周湿疹疗效比较[J].中国肛肠病杂志,2008,28(9):32.
- [20] 钟润,李海.冰黄肤乐软膏治疗婴幼儿湿疹临床观察[J].中国医学文摘(皮肤科学),2008,25(6):355.
- [21] 杨志波.中医皮肤性病学[M].上海:上海科学技术出版社,2020.
- [22] 周一彤,赵艳霞.挖掘中医古籍文献再次探讨湿疹的病因病机[J].中国中西医结合皮肤性病学杂志,2021,20(5):514.
- [23] 宋飞妮,余土根.湿疹的中医辨证治疗[J].浙江中西医结合杂志,2011,21(8):58.
- [24] 李晓睿,李咏梅.冰黄肤乐软膏治疗亚急性湿疹103例临床疗效观察[J].中国中西医结合皮肤性病学杂志,2007,6(4):242.
- [25] 王成玉.冰黄肤乐软膏的体外抗菌活性观察[J].山东医药,2010,50(33):18.
- [26] 孟祥慧,薛凡,谢忠艳.冰黄肤乐治疗湿疹与皮炎临床分析[J].黑龙江医学,2010,34(6):454.
- [27] 李邻峰,李元文.中成药治疗湿疹临床应用指南(2020年)[J].中国中西医结合杂志,2021,41(2):133.
- [28] 王晓宇,胡海殷,季昭臣,等.养心定悸胶囊治疗心律失常的疗效及安全性系统评价及Meta分析[J].中国中药杂志,2021,46(20):5418.
- [29] 贾君迪,李玉峰,肖珉,等.宁心宝胶囊治疗心律失常的疗效及安全性系统评价及Meta分析[J].中国中药杂志,2021,46(5):1260.
- [30] HIGGINS J,GREEN S E.Cochrane handbook for systematic reviews of interventions version 5.1.0 the cochrane collaboration (Eds)[J].N-S Arch Pharmacol,2011,5(2):S38.
- 杨硕
- 吕健
- 王连心
- 谢雁鸣
YANG Shuo- LYU Jian
- WANG Lian-xin
- XIE Yan-ming
- Institute of Basic Research in Clinical Medicine
- China Academy of Chinese Medical Sciences
- Xiyuan Hospital
- China Academy of Chinese Medical Sciences
- 杨硕
- 吕健
- 王连心
- 谢雁鸣
YANG Shuo- LYU Jian
- WANG Lian-xin
- XIE Yan-ming
- Institute of Basic Research in Clinical Medicine
- China Academy of Chinese Medical Sciences
- Xiyuan Hospital
- China Academy of Chinese Medical Sciences