克霉唑500mg单剂量疗法治疗霉菌性阴道炎的药物经济学研究

Single-Dose Therapy of Vaginal Mycosis with Clotrimazol (500 mg) Vaginal Tablet:A Pharmacoeconomic Study

通过随机对照的多中心临床研究比较充霉唑500mg阴道片单剂量疗法与硝酸咪康唑阴道栓剂7日疗法治疗霉菌性阴道炎的疗效与费用。共收治201例霉菌检查确诊的霉菌性阴道炎患者。治疗开始后48h及结束后4d各随访一次，观察阴道霉菌、临床症状与体征。治疗结束时进行问卷调查以了解患者的支付意愿及对不同疗法在用药方便性、用药后主观感受等方面的综合接受程度。结果：克霉唑500mg阴道片能显著缩短疗程，治疗后48h阴道霉菌阳性率降至13％，对照组此时仍为30％（P＜0．01）。克霉唑组患者症状消失时间平均较对照组提前2d。但治疗结束4d后评价两级治愈率无显著性差异。问卷调查结果显示，克霉唑组在用药方便性、主观感受性上更为患者所接受，患者用药的依从性明显高于对照组。每一无症状日的费用在克霉唑组为33元，对照组为60元。克霉唑组每一无症状日的增量费用为6元，而患者对每增加一个无症状日的支付意愿为18元。本研究结果提示治疗霉菌性阴道炎用克霉唑500mg单剂量疗这较常规的多剂量疗法具有更好的费用-有效性。

A random, controlled multi-center (10 centers) clinical trial was catried out tocompare the effectiveness and cost of single-dose therapy with clotrimazole (500 mg) vaginaltablets and that of seven-day therapy with miconazole nitrate vaginal tablets (control).Two hundred and one outpatients with mycologically confirmed vaginal mycosis wereincluded in the study. Two follow-up visits, scheduled 48 hours after first dose and 4 daysafter final dose respectively, were made to collect the clinical data, including microscopicexamination, time course of signs and symptoms. The patients were also asked to keep adiary about the daily change of their symptom scores. On completion of the treatment, aquestionnaire survey was performed to evaluate the willingness to pay (WTP), overallacceptability and preference for the different therapies. Results' compared with miconazolenitrate, clotrimazole (500 mg) significantly shortened the duration of treatment. The positiverate of vaginal fungus decreased to 13% 48 hours after first dose in clotrimazole group,while it remained 30% in control group (P<0.01). on the average clotrimazole (500 mg)completely relieved patients of symptoms 2 days earlier than miconazole nitrate, thoughthere was no significant difference in their cure rate when evaluated 4 days after final dose.The result of questionnaire survey revealed a general preference for clotrimazole (500 mg)on account of its quick onset of symptom alleviation, convenience in application andfavorable subjective feelings during drug administration which resulted in good patientcompliance. The cost per symptom-free day was estimated at 33 RMB Yuan in clotrimazolegroup and 60 RMB Yuan in control group. The incremental cost per symptom-free day ofclotrimazole (500 mg) was 6 RMB Yuan whereas the patients were willing to pay anadditional 18 RMA for every added symptom-free day. The results suggest that single-dose therapy with clotrimazole (500mg)is morecost-effective than customary multiple-dose therapy in the treatment of Vaginal mycosis.