吡美莫司治療口腔扁平苔蘚的系統評價_《中國循證醫學雜志》

作者：

龔忠誠 ¹ ,  林兆全 ¹ , 阿地力莫明 ¹ , 王玲 ¹ , 熊卉 ² , 廖鋒 ³ , 龍星 ³

1. 新疆醫科大學第一附屬醫院口腔頜面外科（烏魯木齊 830054）2. 武漢大學附屬中南醫院口腔科（武漢 430079）3. 武漢大學口腔醫學院（武漢 430079）;

關鍵詞：

吡美莫司口腔扁平苔蘚系統評價隨機對照試驗

DOI：

10.7507/1672-2531.20080056

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目的　系統評價吡美莫司治療口腔扁平苔蘚的療效及安全性。
方法　運用Cochrane系統評價方法，檢索Cochrane圖書館臨床對照試驗資料庫（2007年第3期）、MEDLINE（1990～2007）、EMbase（1990～2007）和中國生物醫學文獻數據庫（1990～2007），篩選吡美莫司治療口腔扁平苔蘚的隨機對照試驗（RCT）和交叉設計試驗，并用RevMan4.2軟件進行統計分析。
結果　共檢索到10篇相關文獻，評價后納入3個RCT，未檢索到交叉設計試驗。Meta分析結果顯示，與曲安耐德比較，吡美莫司治療口腔扁平苔蘚并沒有明顯減輕患者的口腔疼痛［WMD=–0.5，95%CI（–9.77，8.77）］和明顯改善患者生活質量［WMD=0.9，95%CI（–0.6，2.4）］，病損面積也沒有明顯縮小［WMD=0.00mm2，95%CI（–0.40，0.40）］;與安慰劑比較，吡美莫司治療口腔扁平苔蘚并不能明顯改善患者口腔疼痛［WMD=–3.30，95%CI（–20.20，13.92）］和明顯縮小病損面積［WMD=–56.57，95%CI（–134.02，20.88)］，也沒有明顯減少用藥后口腔灼痛感的發生［OR=4.98，95%CI（0.49，50.22）］。
結論　吡美莫司治療口腔扁平苔蘚，在減輕患者口腔疼痛、改善生活質量、縮小病損面積和減輕口腔灼痛感方面并不優于曲安耐德和安慰劑。由于本系統評價納入的病例數僅有72例，且納入臨床試驗中療效評價指標不盡相同，因此有必要繼續開展高質量、大樣本、統一療效評價指標的隨機對照試驗，以獲得更可靠的證據。

引用本文： 龔忠誠,林兆全,阿地力莫明,王玲,熊卉,廖鋒,龍星. 吡美莫司治療口腔扁平苔蘚的系統評價. 中國循證醫學雜志, 2008, 08(4): 261-266. doi: 10.7507/1672-2531.20080056 復制

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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.
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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.

《中國循證醫學雜志》

吡美莫司治療口腔扁平苔蘚的系統評價

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《中國循證醫學雜志》

吡美莫司治療口腔扁平苔蘚的系統評價

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