Efficacy and Safety of Tacrolimus and Pimecrolimus Ointment on Vitiligo: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

WU Yan ¹ , LIU Yubo ¹ , ZHU Xia ¹ , DONG Guanghui ² , GU Xiaochuan ¹ , GAO Xinghua ¹ ,  CHEN HongDuo ¹

1. Department of Dermatology, No 1 Hospital of China Medical University, Key Laboratory of Immunodermatology, Ministry of Health, Shenyang 110001, China;2. Department of Biostatistics, China Medical University, Shenyang 110001, China;

Corresponding author：

CHEN HongDuo, Email: chenhd@cae.cn

Keywords：

Vitiligo; Tacrolimus; Pimecrolimus; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20090137

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Objective 　To assess the efficacy and safety of tacrolimus and pimecrolimus ointment for treating Vitiligo.
Methods 　We searched the MEDLINE (1966 to June 2008), Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2008), OVID (1978 to June 2008), EMbase (1980 to June 2008), CBM (1978 to June 2008), and CNKI (1979 to June 2008) to collect randomized controlled trials (RCTs). We also handsearched relevant journals and conference proceedings. The language was confined to English and Chinese. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses using the Cochrane Collaboration’s RevMan 4.2 software.
Results 　Fourteen trials involving 414 patients in 11 self-control trials and 182 patients in other 3 trials were included and assessed. The rate of 75% repigmentation induced by combination of topical tacrolimus with monochromatic excimer light was higher than that of control [RR= – 2.28, 95%CI (1.02, 5.10)]. The efficacy rate of combination treatment was also obviously higher than that of control [RR= 1.24, 95%CI (1.13, 1.37)]. The irradiation number of initial repigmentation induced by combination of topical pimecrolimus with monochromatic excimer light was less than that of control [WMD= – 3.00, 95%CI (– 3.22, – 2.78)], and the repigmentationrate of facial lesions in the combination group was higher than that of control. The efficacy rate of topical tacrolimus combination with Fufang Kaliziran Ding was significantly higher than that of control [RR= 1.83, 95% (1.14, 2.94)]. No significant difference was seen between topical tacrolimus combination with the NB-UVB group and the control group, or between the topical tacrolimus or pimecrolimus alone group with the control group. The side effects were limited and brief.
Conclusion 　The limited evidence indicats that the combination of topical tacrolimus with monochromatic excimer light or Fufang Kaliziran Ding could improve the efficacy rate of treating vitiligo leukoplakia. The combination of topical pimecrolimuswith monochromatic excimer light shortens the irradiation number of initial repigmentation and works better on facial lesions.

Citation： WU Yan,LIU Yubo,ZHU Xia,DONG Guanghui,GU Xiaochuan,GAO Xinghua,CHEN HongDuo. Efficacy and Safety of Tacrolimus and Pimecrolimus Ointment on Vitiligo: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2009, 09(7): 788-795. doi: 10.7507/1672-2531.20090137 Copy

1.	鲁严. 白癜风的细胞免疫研究进展. 国外医学. 皮肤性病学分册, 2001, 27(6): 355-358.
2.	汪科, 朱学骏. 局部免疫调节剂他克莫司、吡美莫司在皮肤病的应用. 药物不良反应杂志, 2005, (5): 345-348.
3.	Lan CC, Chen GS, Chiou MH, et al. FK506 promotes melanocyte and melanoblast growth and creates a favourable milieu for cell migration via keratinocytes: possible mechanisms of how tacrolimus ointment induces repigmentation in patients with vitiligo. Br J Dermatol, 2005, 153(3): 498-505.
4.	徐世正. 主译. 安德鲁斯临床皮肤病学. 第九版. 北京: 科学出版社, 2004. 1050.
5.	郭新峰, 温泽淮, 老膺荣, 等. 临床试验质量评价工具及其应用. 中国循证医学杂志, 2004, 4 (7): 484, 584, 684, 784, 205.
6.	谭少英, 麦丽霞, 麦毅忠. 中西医结合治疗白癜风38例. 江西中医药, 2007, 38 (295): 16, 26.
7.	Esfandiarpour I, Ekhlasi A, Farajzadeh S, et al. The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: A double-blind, placebo-controlled clinical trial. J Dermatolog Treat, 2008, Jun 16: 1-5. [Epub ahead of print].
8.	Kawalek AZ, Spencer JM and Phelps RG. Combined Excimer Laser and Topical Tacrolimus for the Treatment of Vitiligo: A Pilot Study. Dermatol Surg, 2004, 30(2 Pt 1): 130-135.
9.	Passeron T, Ostovari N, Zakaria W, et al. Topical tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol, 2004, 140(9): 1065-1069.
10.	薛梅, 刁庆春, 李彦希, 等. 他克莫司软膏联合 308nm准分子激光治疗白癜风临床疗效观察. 临床皮肤科杂志, 2007, 36(8): 531-532.
11.	刘仲荣, 杨慧兰, 林挺, 等. 他克莫司软膏联合308 nm准分子激光治疗白癜风临床观察. 中国美容医学, 2007, 16(12): 1713-1716.
12.	黄小晏, 杨慧兰, 樊建勇, 等. 308 nm准分子激光联合吡美莫司乳膏治疗儿童白癜风的疗效观察. 中华皮肤科杂志, 2008, 41(4): 220-222.
13.	Mehrabi D and Pandya AG. A randomized, placebo-controlled, double-blind trial comparing narrowband UV-B Plus 0.1% tacrolimus ointment with narrowband UV-B plus placebo in the treatment of generalized vitiligo. Arch Dermatol, 2006, 142(7): 927-929.
14.	解士海, 钱如发, 黄小雄, 等. 他克莫司软膏联合窄谱中波紫外线照射治疗白癜风疗效观察. 临床皮肤科杂志, 2008, 37(1): 56-57.
15.	方芳, 曾义斌, 王红枫, 等. 他克莫司软膏联合窄谱UVB治疗白癜风的临床研究. 中华皮肤科杂志, 2008, 41(1): 58-59.
16.	高淑芬, 史维平.他克莫司软膏联合窄谱中波紫外线治疗白癜风疗效观察. 山西职工医学院学报, 2008, 18(1): 43, 53.
17.	奚丹, 纪黎明, 王玉茹, 等. 0.1%他克莫司软膏联合复方卡力孜然配治疗白癜风. 中华皮肤科杂志, 2008, 41 (5): 347.
18.	Lepe V, Moncada B, Castanedo-Cazares JP, et al. A Double-blind Randomized Trial of 0.1% Tacrolimus vs 0.05% Clobetasol for the Treatment of Childhood Vitiligo. Arch Dermatol, 2003,139(5): 581-585.
19.	班武, 袁进, 刘仲荣, 等. 三种常用药物治疗稳定期白癜风的药物效价比评估. 中国美容医学, 2008, 17(2): 262-264.
20.	胡雅玉, 任小丽. 他克莫司软膏治疗面颈部白癜风疗效观察. 中国中西医结合皮肤性病学杂志, 2008, 7(2): 107-108.
21.	Dawid M, Veensalu M, Grassberger M, et al. Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized, double-blind,vehicle-controlled study. J Dtsch Dermatol Ges, 2006, 4(11): 942-926.

1. 鲁严. 白癜风的细胞免疫研究进展. 国外医学. 皮肤性病学分册, 2001, 27(6): 355-358.
2. 汪科, 朱学骏. 局部免疫调节剂他克莫司、吡美莫司在皮肤病的应用. 药物不良反应杂志, 2005, (5): 345-348.
3. Lan CC, Chen GS, Chiou MH, et al. FK506 promotes melanocyte and melanoblast growth and creates a favourable milieu for cell migration via keratinocytes: possible mechanisms of how tacrolimus ointment induces repigmentation in patients with vitiligo. Br J Dermatol, 2005, 153(3): 498-505.
4. 徐世正. 主译. 安德鲁斯临床皮肤病学. 第九版. 北京: 科学出版社, 2004. 1050.
5. 郭新峰, 温泽淮, 老膺荣, 等. 临床试验质量评价工具及其应用. 中国循证医学杂志, 2004, 4 (7): 484, 584, 684, 784, 205.
6. 谭少英, 麦丽霞, 麦毅忠. 中西医结合治疗白癜风38例. 江西中医药, 2007, 38 (295): 16, 26.
7. Esfandiarpour I, Ekhlasi A, Farajzadeh S, et al. The efficacy of pimecrolimus 1% cream plus narrow-band ultraviolet B in the treatment of vitiligo: A double-blind, placebo-controlled clinical trial. J Dermatolog Treat, 2008, Jun 16: 1-5. [Epub ahead of print].
8. Kawalek AZ, Spencer JM and Phelps RG. Combined Excimer Laser and Topical Tacrolimus for the Treatment of Vitiligo: A Pilot Study. Dermatol Surg, 2004, 30(2 Pt 1): 130-135.
9. Passeron T, Ostovari N, Zakaria W, et al. Topical tacrolimus and the 308-nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol, 2004, 140(9): 1065-1069.
10. 薛梅, 刁庆春, 李彦希, 等. 他克莫司软膏联合 308nm准分子激光治疗白癜风临床疗效观察. 临床皮肤科杂志, 2007, 36(8): 531-532.
11. 刘仲荣, 杨慧兰, 林挺, 等. 他克莫司软膏联合308 nm准分子激光治疗白癜风临床观察. 中国美容医学, 2007, 16(12): 1713-1716.
12. 黄小晏, 杨慧兰, 樊建勇, 等. 308 nm准分子激光联合吡美莫司乳膏治疗儿童白癜风的疗效观察. 中华皮肤科杂志, 2008, 41(4): 220-222.
13. Mehrabi D and Pandya AG. A randomized, placebo-controlled, double-blind trial comparing narrowband UV-B Plus 0.1% tacrolimus ointment with narrowband UV-B plus placebo in the treatment of generalized vitiligo. Arch Dermatol, 2006, 142(7): 927-929.
14. 解士海, 钱如发, 黄小雄, 等. 他克莫司软膏联合窄谱中波紫外线照射治疗白癜风疗效观察. 临床皮肤科杂志, 2008, 37(1): 56-57.
15. 方芳, 曾义斌, 王红枫, 等. 他克莫司软膏联合窄谱UVB治疗白癜风的临床研究. 中华皮肤科杂志, 2008, 41(1): 58-59.
16. 高淑芬, 史维平.他克莫司软膏联合窄谱中波紫外线治疗白癜风疗效观察. 山西职工医学院学报, 2008, 18(1): 43, 53.
17. 奚丹, 纪黎明, 王玉茹, 等. 0.1%他克莫司软膏联合复方卡力孜然配治疗白癜风. 中华皮肤科杂志, 2008, 41 (5): 347.
18. Lepe V, Moncada B, Castanedo-Cazares JP, et al. A Double-blind Randomized Trial of 0.1% Tacrolimus vs 0.05% Clobetasol for the Treatment of Childhood Vitiligo. Arch Dermatol, 2003,139(5): 581-585.
19. 班武, 袁进, 刘仲荣, 等. 三种常用药物治疗稳定期白癜风的药物效价比评估. 中国美容医学, 2008, 17(2): 262-264.
20. 胡雅玉, 任小丽. 他克莫司软膏治疗面颈部白癜风疗效观察. 中国中西医结合皮肤性病学杂志, 2008, 7(2): 107-108.
21. Dawid M, Veensalu M, Grassberger M, et al. Efficacy and safety of pimecrolimus cream 1% in adult patients with vitiligo: Results of a randomized, double-blind,vehicle-controlled study. J Dtsch Dermatol Ges, 2006, 4(11): 942-926.

Chinese Journal of Evidence-Based Medicine

Efficacy and Safety of Tacrolimus and Pimecrolimus Ointment on Vitiligo: A Systematic Review

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