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《The Chinese Journal of Clinical Pharmacology》 2017-16
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Clinical trial of istretinoin combined with azithromycin on moderate to severe acne occurred after puberty

QIU Zi-jin;CHEN De-qing;Medical Cosmetology Department,Chongqing Medical College;Department of Endocrinology, Chongqing Hospital of Traditional Chinese Medicine;  
Objective To explore the clinical efficacy and safety profile of isotretinoin combined with azithromycin in patients with moderate to severe acne occurred after puberty,and the effect of the therapy on sex hormone levels. Methods A total of 120 patients were randomly divided into a control group and combined groups. The control group was given local application of 0. 1% adapdene gel,qd. The treatment group was given oral administration of isotretinoin capsules( 0. 2 mg,qd,at 2 h after meal) and azithromycin granule( 0. 2 g,qd,continuous treatment for 3 d and then stop for 4 d) on the basis of the control group. Both groups were treated for 4 weeks. The clinical efficacy,efficacy index,and serum sex hormone levels in testosterone,estradiol,progesteron,prolactin( PRL),follicle-stimulating hormone( FSH),luteinizing hormone( LH),sex hormone binding protein( SHBG),dehydroepiandrosterone sulfate( DHEAS)were compared in the two groups. Results After treatment,the total effective rates in treatment group and control group were 96. 67%( 58/60 cases) and 73. 33%( 44/60 cases),respectively,and the difference was statistically significant( P 0. 01). The efficacy index was 79. 68 ± 11. 34 in the treatment group and 53. 46 ± 14. 17 in the control group,with statistically significant difference( P 0. 01). In the treatment group and the control group,the level of serum estradiol were( 43. 15 ± 14. 91),( 35. 87 ± 18. 43) pg · mL~(-1); the FSH content were( 9. 23 ± 1. 29),( 8. 95 ± 2. 21) mU·mL~(-1); the LH content were( 7. 81 ± 0. 32),( 5. 63 ± 0. 73) mU·mL~(-1); the LH/FSH ratio were0. 86 ± 0. 28 and 0. 73 ± 0. 31; the testosterone content were( 1. 27 ± 0. 06),( 2. 58 ± 0. 11) nmol·L~(-1); the progesterone content were( 0. 95 ± 0. 12),( 1. 19 ± 0. 23) ng · mL~(-1); the PRL content were( 10. 31 ± 1. 17),( 14. 53 ± 1. 09) ng·mL~(-1); the SHBG content were( 51. 32 ± 18. 71),( 69. 93 ± 13. 65) nmol·L~(-1); the DHEAS content were( 169. 85 ± 28. 41),( 183. 24 ± 29. 18) μg·dL~(-1),respectively,and these differences were statistically significant( all P 0. 05). The adverse reactions of the treatment group and control group were erythema,scaling,burning,itching and dryness. The incidence of local adverse reactions was 23. 33%( 14/60 cases) in the treatment group and 18. 33%( 11/60 cases) in the control group,without statistically significant difference( P 0. 05).Conclusion Isotretinoin combined with azithromycin exerts considerable efficacy by reducing the level of sex hormone and shortening treatment time.
【Key Words】: acne puberty isotretinoin azithromycin sex hormone
【Fund】: 重庆市卫生和计生委中医药科技基金资助项目(zy20150230)
【CateGory Index】: R758.733
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