吡美莫司治疗口腔扁平苔藓的系统评价_《中国循证医学杂志》

作者：

龚忠诚 ¹ ,  林兆全 ¹ , 阿地力莫明 ¹ , 王玲 ¹ , 熊卉 ² , 廖锋 ³ , 龙星 ³

1. 新疆医科大学第一附属医院口腔颌面外科（乌鲁木齐 830054）2. 武汉大学附属中南医院口腔科（武汉 430079）3. 武汉大学口腔医学院（武汉 430079）;

关键词：

吡美莫司口腔扁平苔藓系统评价随机对照试验

DOI：

10.7507/1672-2531.20080056

视频：

导出 下载 收藏 扫码 引用

摘要 全文 图表 视频 参考文献 施引文献 补充材料

目的　系统评价吡美莫司治疗口腔扁平苔藓的疗效及安全性。
方法　运用Cochrane系统评价方法，检索Cochrane图书馆临床对照试验资料库（2007年第3期）、MEDLINE（1990～2007）、EMbase（1990～2007）和中国生物医学文献数据库（1990～2007），筛选吡美莫司治疗口腔扁平苔藓的随机对照试验（RCT）和交叉设计试验，并用RevMan4.2软件进行统计分析。
结果　共检索到10篇相关文献，评价后纳入3个RCT，未检索到交叉设计试验。Meta分析结果显示，与曲安耐德比较，吡美莫司治疗口腔扁平苔藓并没有明显减轻患者的口腔疼痛［WMD=–0.5，95%CI（–9.77，8.77）］和明显改善患者生活质量［WMD=0.9，95%CI（–0.6，2.4）］，病损面积也没有明显缩小［WMD=0.00mm2，95%CI（–0.40，0.40）］;与安慰剂比较，吡美莫司治疗口腔扁平苔藓并不能明显改善患者口腔疼痛［WMD=–3.30，95%CI（–20.20，13.92）］和明显缩小病损面积［WMD=–56.57，95%CI（–134.02，20.88)］，也没有明显减少用药后口腔灼痛感的发生［OR=4.98，95%CI（0.49，50.22）］。
结论　吡美莫司治疗口腔扁平苔藓，在减轻患者口腔疼痛、改善生活质量、缩小病损面积和减轻口腔灼痛感方面并不优于曲安耐德和安慰剂。由于本系统评价纳入的病例数仅有72例，且纳入临床试验中疗效评价指标不尽相同，因此有必要继续开展高质量、大样本、统一疗效评价指标的随机对照试验，以获得更可靠的证据。

引用本文： 龚忠诚,林兆全,阿地力莫明,王玲,熊卉,廖锋,龙星. 吡美莫司治疗口腔扁平苔藓的系统评价. 中国循证医学杂志, 2008, 08(4): 261-266. doi: 10.7507/1672-2531.20080056 复制

1.	Axell T. Occurrence of leukoplakia and some other oral white lesions among 20,333 adult Swedish people. Community Dent Oral Epidemiol, 1987, 15: 46-51.
2.	Altman J, Perry HO. The variations and course of lichen planus. Arch Dermatol, 1961, 84: 179-191.
3.	Eisen D. The clinical features, malignant potential, and systemic associations of oral lichen planus: a study of 723 patients. J Am Acad Dermatol, 2002, 46: 207-214.
4.	Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting, part 2; clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2005, 100: 164-178.
5.	Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM981) -preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg, 2001, 20(4): 233.
6.	Gorouhi F, Solhpour A, Beitollahi JM, et al. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus. J Am Acad Dermatol, 2007, 57(5): 806-813.
7.	Passeron T, Lacour JP, Fontas E, et al. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol, 2007, 143(4): 472-476.
8.	Scheer M, Kawari-Mahmoodi N, Neugebauer J, et al. Pimecrolimus (Elidel) for therapy of lichen ruber mucosae. Mund Kiefer Gesichtschir, 2006, 10(6): 403-407.
9.	Cedro M, Chaudhry S, Porter S. OC10 Topical pimecrolimus for the treatment of erosive oral lichen planus. Oral Dis, 2006, 12(s1): 11.
10.	Swift JC, Rees TD, Plemons JM. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. J Periodontol, 2005, 76(4): 627-635.
11.	Thongprasom K, Luangjarmekorn L, Sererat T, et al. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med, 1992, 21: 456-458.
12.	Scott J, Huskisson EC. Graphic representation of pain. Pain, 1976, 2: 175-184.
13.	Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol, 1997, 25: 284-290.
14.	Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
15.	Moher D, Pham B, Jones A, et al. Does quality of reports of randomized trials affect estimates of intervention eficacy reported in Meta-analyses. Lancet, 1998, 352(9128): 609-613.
16.	Anon. News: Cream for atopic enzema launched. Pharm J, 2002, 269(7220): 560-563.
17.	Meingassner JG, Kowalsky E, Schwendinger H, et al. Pimecrolimus does not affect Langerhans cells in murine epidermis. Br J Dermatol, 2003, 149: 853-857.
18.	Billich A, Aschauer H, Aszodi A, et al. Percutaneous absorption of drugs used in atopic eczema: pimecrolimus permeates less through skin than corticosteroids and tacrolimus. Int J Pharm, 2004, 269: 29-35.
19.	Gupta AK, Chow M. Pimecrolimus: a review. J Eur Acad Dermatol Venereol, 2003, 17: 493-503.
20.	Dissemond J, Schroter S, Franckson T, et al. Pimecrolimus in an adhesive ointment as a new treatment option for oral lichen planus. Br J Dermatol, 2004, 150: 782-784.
21.	Esquivel-Pedraza L, Fernandez-Cuevas L, Ortiz-Pedroza G, et al. Treatment of oral lichen planus with topical pimecrolimus 1% cream. Br J Dermatol, 2004, 150: 771-773.
22.	Allen BR, Lakhanpaul M, Morris A, et al. Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child, 2003, 88: 969-973.
23.	Rappersberger K, Komar M, Ebelin ME, et al. Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol, 2002, 119: 876-887.
24.	Lo Muzio L, della Valle A, Mignogna MD, et al. The treatment of oral aphthous ulceration or erosive lichen planus with topical clobetasol propionate in three preparations: a clinical and pilot study on 54 patients. J Oral Pathol Med, 2001, 30: 611-617.
25.	Carbone M, Goss E, Carrozzo M, et al. Systemic and topical corticosteroid treatment of oral lichen planus: a comparative study with long-term follow-up. J Oral Pathol Med, 2003, 32: 323-329.
26.	Berger TG, Duvic M, Van Voorhees AS, et al. The use of topical calcineurin inhibitors in dermatology: safety concerns. Report of the American Academy of Dermatology Association task force. J Am Acad Dermatol, 2006, 54: 818-823.
27.	Spergel JM, Leung DY. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence. Curr Allergy Asthma Rep, 2006, 6: 270-274.

1. Axell T. Occurrence of leukoplakia and some other oral white lesions among 20,333 adult Swedish people. Community Dent Oral Epidemiol, 1987, 15: 46-51.
2. Altman J, Perry HO. The variations and course of lichen planus. Arch Dermatol, 1961, 84: 179-191.
3. Eisen D. The clinical features, malignant potential, and systemic associations of oral lichen planus: a study of 723 patients. J Am Acad Dermatol, 2002, 46: 207-214.
4. Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting, part 2; clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2005, 100: 164-178.
5. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM981) -preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg, 2001, 20(4): 233.
6. Gorouhi F, Solhpour A, Beitollahi JM, et al. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus. J Am Acad Dermatol, 2007, 57(5): 806-813.
7. Passeron T, Lacour JP, Fontas E, et al. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol, 2007, 143(4): 472-476.
8. Scheer M, Kawari-Mahmoodi N, Neugebauer J, et al. Pimecrolimus (Elidel) for therapy of lichen ruber mucosae. Mund Kiefer Gesichtschir, 2006, 10(6): 403-407.
9. Cedro M, Chaudhry S, Porter S. OC10 Topical pimecrolimus for the treatment of erosive oral lichen planus. Oral Dis, 2006, 12(s1): 11.
10. Swift JC, Rees TD, Plemons JM. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. J Periodontol, 2005, 76(4): 627-635.
11. Thongprasom K, Luangjarmekorn L, Sererat T, et al. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med, 1992, 21: 456-458.
12. Scott J, Huskisson EC. Graphic representation of pain. Pain, 1976, 2: 175-184.
13. Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol, 1997, 25: 284-290.
14. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
15. Moher D, Pham B, Jones A, et al. Does quality of reports of randomized trials affect estimates of intervention eficacy reported in Meta-analyses. Lancet, 1998, 352(9128): 609-613.
16. Anon. News: Cream for atopic enzema launched. Pharm J, 2002, 269(7220): 560-563.
17. Meingassner JG, Kowalsky E, Schwendinger H, et al. Pimecrolimus does not affect Langerhans cells in murine epidermis. Br J Dermatol, 2003, 149: 853-857.
18. Billich A, Aschauer H, Aszodi A, et al. Percutaneous absorption of drugs used in atopic eczema: pimecrolimus permeates less through skin than corticosteroids and tacrolimus. Int J Pharm, 2004, 269: 29-35.
19. Gupta AK, Chow M. Pimecrolimus: a review. J Eur Acad Dermatol Venereol, 2003, 17: 493-503.
20. Dissemond J, Schroter S, Franckson T, et al. Pimecrolimus in an adhesive ointment as a new treatment option for oral lichen planus. Br J Dermatol, 2004, 150: 782-784.
21. Esquivel-Pedraza L, Fernandez-Cuevas L, Ortiz-Pedroza G, et al. Treatment of oral lichen planus with topical pimecrolimus 1% cream. Br J Dermatol, 2004, 150: 771-773.
22. Allen BR, Lakhanpaul M, Morris A, et al. Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child, 2003, 88: 969-973.
23. Rappersberger K, Komar M, Ebelin ME, et al. Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol, 2002, 119: 876-887.
24. Lo Muzio L, della Valle A, Mignogna MD, et al. The treatment of oral aphthous ulceration or erosive lichen planus with topical clobetasol propionate in three preparations: a clinical and pilot study on 54 patients. J Oral Pathol Med, 2001, 30: 611-617.
25. Carbone M, Goss E, Carrozzo M, et al. Systemic and topical corticosteroid treatment of oral lichen planus: a comparative study with long-term follow-up. J Oral Pathol Med, 2003, 32: 323-329.
26. Berger TG, Duvic M, Van Voorhees AS, et al. The use of topical calcineurin inhibitors in dermatology: safety concerns. Report of the American Academy of Dermatology Association task force. J Am Acad Dermatol, 2006, 54: 818-823.
27. Spergel JM, Leung DY. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence. Curr Allergy Asthma Rep, 2006, 6: 270-274.

《中国循证医学杂志》

吡美莫司治疗口腔扁平苔藓的系统评价

摘要 全文 图表 视频 参考文献 施引文献 补充材料

上一篇

下一篇

Format

Content

《中国循证医学杂志》

吡美莫司治疗口腔扁平苔藓的系统评价

摘要 全文 图表 视频 参考文献 施引文献 补充材料

上一篇

下一篇

Format

Content

摘要全文图表视频参考文献施引文献补充材料