Clinical trial of istretinoin combined with azithromycin on moderate to severe acne occurred after puberty
10.13699/j.cnki.1001-6821.2017.16.001
- VernacularTitle:异维A酸联合阿奇霉素治疗青春期后中重度痤疮的临床研究
- Author:
Zi-Jin QIU
1
;
De-Qing CHEN
Author Information
1. 重庆医药高等专科学校医学美容教研室
- Keywords:
acne;
puberty;
isotretinoin;
azithromycin;
sex hormone
- From:
The Chinese Journal of Clinical Pharmacology
2017;33(16):1519-1522
- CountryChina
- Language:Chinese
-
Abstract:
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 were 0.86 ±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.
