title: Synergistic effects of tetrandrine on the antifungal activity of topical ketoconazole cream in the treatment of dermatophytoses: a clinical trial.
abstract: OBJECTIVE
  To evaluate the synergistic effects of tetrandrine (TET) on the antifungal activity of topical ketoconazole (KCZ) in the treatment of dermatophytoses.
  
  
  METHODS
  The minimum inhibitory concentrations (MICs) for KCZ and combined KCZ and TET were compared in vitro. A randomized, double-blind trial was conducted among 97 patients with dermatophytoses who were assigned to 3 groups and received: treatment with combination of 2% KZC and 2% TET cream (KCZ + TET group), or only 2% KZC cream (KCZ group), or 2% TET cream (TET group). Patients with tinea corporis and/or tinea cruris were treated for 2 weeks, separately. The patients with tinea pedis and/or tinea manuum were treated for 4 weeks.
  
  
  RESULTS
  Compared with KZC alone, combined use of KZC and TET showed lower MICs against clinical isolates of dermatophytes (P<0.05 for all). In the patients with tinea corporis and/or tinea cruris, the rates of overall cure (clinical cure plus mycologic clearance) were 81.25% vs. 33.33% for combined treatment and KZC monotherapy, respectively, after 4 weeks. All clinical indices were significantly different between the combination therapy and only KCZ therapy groups (P<0.05). Among the patients with tinea pedis and/or tinea manuum after 4 weeks treatment, the overall cure rates in the KCZ + TET group and KCZ group were 75.00% vs. 40.00%, respectively. In the KCZ + TET group, all the clinical indices were significantly better than those in the KCZ group and TET group (P<0.05). The rates of overall efficacy in the TET group were all zero. No local skin redness or itching was observed during TET treatment. No clinically significant changes were found in post-treatment routine blood, urine, or stool tests, ECG, or tests for liver and kidney function; no serious adverse events occurred.
  
  
  CONCLUSIONS
  TET synergistically enhanced the clinical efficacy of topical KZC cream in the treatment of dermatophytoses.
authors: Department of Dermatology, the First Affiliated Hospital, Jinan University, Guangzhou 510632, China.
authors: Jian-Ping
authors: JP
authors: Shi
authors: Hong
authors: H
authors: Zhang
authors: Zhi-Dong
authors: ZD
authors: Zhang
authors: Ge-Hua
authors: GH
authors: Zhang
authors: Ai-Li
authors: AL
authors: Gao
authors: Shou-Bao
authors: SB
authors: Xiang
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D044182:Benzylisoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests; D014005:Tinea / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D044182:Benzylisoquinolines; C009438:tetrandrine; D007654:Ketoconazole