ABSTRACT
Objective To investigate the safety and feasibility of viaminate capsule in the treatment of sebor-rheic dermatitis.Methods According to the digital table, 84 patients with seborrheic dermatitis were randomly divided into the observation group(n=42) and the control group(n=42).The control group were treated with 1%pimecrolimus cream coated, 2 times/d.The observation group were treated with capsule viaminate, 50mg/times, 2 times/d,2 weeks for a course of treatment.The clinical efficacy of the two groups were observed.Results The ery thema,scaling,seborrhea,itching and other symptoms score and total score after treatment to 4 weeks,8 weeks of the two groups were compared(Erythema t=5.865,5.786;scaly t=6.112,5.886;seborrhea t=5.963,5.629;itching t=6.123,6.072.all P0.05).Conclusion Viaminate cap-sule can improve in a short period of time in patients with clinical symptoms of seborrheic dermatitis,the effect is sig-nificant,the recurrence rate is low,safe and effective.
ABSTRACT
Objective To evaluate the efficacy and safety of isotretinoin and viaminate for the treatment of moderate to severe acne vulgaris.Methods A multiple-centre,double-blind,double-analog comparative clinical trial was conducted.Patients diagnosed with moderate to severe acne by GAGS (global acne grading system) were randomly divided into isotretinoin group (10 mg,bid) and viaminate group (50 mg,tid);treatment was done for a total of 6 weeks.All subjects were evaluated before treatment,and at 2,4,6 weeks after the initiation of treatment,for evaluation of lesion count,and for observation of thera- peutic effects and side effects.Results A total of 217 patients were enrolled this trial,of which,213 could be evaluated in a FAS (Full Analysis Set) analysis and 200 in a PPS (per protocol) analysis.There was no significant difference in the efficacy at 2,4,6 weeks after the initiation of treatment between the isotretinoin group and viaminate group (6.0% vs 5.0%,29.0% vs 20.0%,57.0 % vs 51.0 %,respectively). However,the inflammatory papules and pustules decreased more rapidly in the isotretinoin group than in the viaminate group at each of the follow up evaluations (all P＜0.05).There was no obvious difference in the rate of clearance of comedones and nodules between the two groups.Both the occurrence rate (68.81% vs 36.53%,P＜0.001) and severity (P＜0.05) of side effects were higher in the isotretinoin group than in the viaminate group.The main adverse events included mouth dryness,dizziness,etc,occurred more fre- quently in the isotretinoin group than in the viaminate group.Conclusion For the treatment of moderate to severe acne,the efficacy of isotretinoin is similar to that of viaminate;however,isotretinoin has more imme- diate effect with more side effects than viaminate.
ABSTRACT
Aim To investigate the effect of oral itraconazole on pharmacokinetics of viaminate and under-stand the metabolism pathway of viaminate in healthy humans,as well as guide the reasonable medication for viaminate and itraconazole coadministration.Methods The study was conducted in a double-blind randomized and crossover manner with two phases of treatment with placebo-viaminate or itraconazole-viaminate.Eight healthy male subjects received an oral dose of 200 mg itraconazole(QD) or matched placebo for five consecutive days,and took an oral 100 mg dose of viaminate on day 4 after each treatment phase.The liquid chromatography-mass spectrometry(LC-MS) was established to measure the blood drug concentration of viaminate.Results Our results showed that the mean peak concentration of viaminate was increased with itraconazole [(21.21?11.65) ?g?L~(-1) vs(27.12?13.83) ?g?L~(-1),P0.05].Additionally,the mean elimination half life was prolonged [(2.71?0.38) h vs(4.43?0.93) h,P