Department of Dermatology, the First Affiliated Hospital, Jinan University, Guangzhou 510632, China.
Chin J Integr Med. 2011 Jul;17(7):499-504. doi: 10.1007/s11655-010-0782-3. Epub 2011 Jul 3.
To evaluate the synergistic effects of tetrandrine (TET) on the antifungal activity of topical ketoconazole (KCZ) in the treatment of dermatophytoses.
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.
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.
TET synergistically enhanced the clinical efficacy of topical KZC cream in the treatment of dermatophytoses.
评估汉防己甲素（TET）对治疗皮肤癣病时局部酮康唑（KCZ）抗真菌活性的协同作用。
体外比较 KCZ 及联合 KCZ 和 TET 的最低抑菌浓度（MIC）。对 97 例皮肤癣病患者进行随机、双盲试验，分为三组，分别接受：联合 2% KCZ 和 2% TET 乳膏（KCZ+TET 组）、仅 2% KCZ 乳膏（KCZ 组）或 2% TET 乳膏（TET 组）治疗。分别治疗体股癣患者 2 周，手足癣患者 4 周。
与单独使用 KCZ 相比，联合使用 KCZ 和 TET 可降低皮肤癣菌临床分离株的 MIC（均 P<0.05）。在体股癣患者中，治疗 4 周后，联合治疗和 KCZ 单药治疗的总治愈率（临床治愈加真菌学清除）分别为 81.25%和 33.33%。联合治疗组与 KCZ 单药治疗组之间所有临床指标均有显著差异（P<0.05）。在治疗 4 周的手足癣患者中，KCZ+TET 组和 KCZ 组的总治愈率分别为 75.00%和 40.00%。在 KCZ+TET 组中，所有临床指标均明显优于 KCZ 组和 TET 组（P<0.05）。TET 组的总有效率均为零。在 TET 治疗过程中未观察到局部皮肤发红或瘙痒。治疗后常规血液、尿液或粪便检查、心电图、肝肾功能检查均无临床显著变化；未发生严重不良事件。
TET 可协同增强局部 KCZ 乳膏治疗皮肤癣病的临床疗效。
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