Grasela T H, Pasko M T, Goodwin S D, Walawander C A, Blackwelder N, Bruder-Holt R J
Center for Pharmacoepidemiology Research, State University of New York (SUNY) at Buffalo.
Ann Pharmacother. 1994 Feb;28(2):261-70. doi: 10.1177/106002809402800220.
To evaluate the prescribing patterns of antifungal agents in the hospital setting after the introduction of fluconazole, a new broad-spectrum bis-triazole antifungal agent. Also compared are the prescribing patterns of antifungal agents prior to (phase I) and following (phase II) fluconazole marketing.
A prospective cohort of hospitalized patients prescribed topical or systemic antifungal agents. Data were collected from December 1990 to April 1991.
Fifty-seven hospitals ranging in size from 100 to more than 500 beds. Sixty-three percent are affiliated with medical schools.
Participating pharmacists consecutively identified 15 patients receiving systemic antifungal therapy and 5 patients receiving topical antifungal therapy.
Observational data on patient antifungal therapy, risk factors for fungal infections, comorbidities, concurrent medications, and culture data were collected.
Differences in prescribing patterns before and after the marketing of fluconazole were assessed using t-tests and chi-square tests.
Of 818 patients studied, 615 (75.2 percent) received systemic antifungal therapy. Five hundred forty-six patients received a single antifungal agent; 348 (63.7 percent) received fluconazole, 105 (19.2 percent) received ketoconazole, 92 (16.8 percent) received amphotericin B, and 1 (0.2 percent) received flucytosine. Sixty-nine patients received two or more systemic agents either concurrently or consecutively. The use of parenteral amphotericin B, alone or in combination with flucytosine and/or an azole, declined from 56.8 percent in the phase I study to 24.2 percent in the current study. The use of parenteral therapy also declined from 56.8 to 40.2 percent. Ketoconazole was used in more than 90 percent of the oral and esophageal infections in the phase I study, but its use declined to only 33 percent in this study. Fluconazole was used most frequently across all sites of presumed or documented infections, with the exception of fungemia. Of the presumed or proven systemic or blood infections, amphotericin B was used alone or in combination in 48.4 percent of the patients and fluconazole was used exclusively in 39.0 percent of the patients. Fluconazole was used more often than amphotericin B (22 vs. 3 patients, respectively) for prophylaxis of systemic infections. The overall use of antifungal prophylaxis also increased from the phase I (9.5 percent) to phase II (13.7 percent).
The introduction of fluconazole had a major impact on the prescribing patterns of antifungal therapy. Although amphotericin B remained the preferred agent for treatment of suspected or proven systemic, central nervous system, or blood infections, use of fluconazole for these indications approached nearly 40 percent. Further studies are needed to address the role of fluconazole in the prophylaxis and treatment of systemic mycoses.
评估新型广谱双三唑类抗真菌药氟康唑引入医院后抗真菌药物的处方模式。同时比较氟康唑上市前（第一阶段）和上市后（第二阶段）抗真菌药物的处方模式。
对接受局部或全身抗真菌药物治疗的住院患者进行前瞻性队列研究。数据收集时间为1990年12月至1991年4月。
57家医院，床位从100张到500多张不等。63%的医院附属于医学院。
参与研究的药剂师连续确定15例接受全身抗真菌治疗的患者和5例接受局部抗真菌治疗的患者。
收集患者抗真菌治疗的观察数据、真菌感染的危险因素、合并症、同时使用的药物以及培养数据。
使用t检验和卡方检验评估氟康唑上市前后处方模式的差异。
在研究的818例患者中，615例（75.2%）接受了全身抗真菌治疗。546例患者接受单一抗真菌药物治疗；348例（63.7%）接受氟康唑治疗，105例（19.2%）接受酮康唑治疗，92例（16.8%）接受两性霉素B治疗，1例（0.2%）接受氟胞嘧啶治疗。69例患者同时或连续接受两种或更多种全身用药。静脉注射两性霉素B单独使用或与氟胞嘧啶和/或唑类联合使用的比例从第一阶段研究中的56.8%降至本研究中的24.2%。静脉注射治疗的比例也从56.8%降至40.2%。在第一阶段研究中，超过90%的口腔和食管感染使用酮康唑，但在本研究中其使用比例降至仅33%。除真菌血症外，在所有疑似或确诊感染部位，氟康唑使用最为频繁。在疑似或确诊的全身或血液感染中，48.4%的患者单独使用或联合使用两性霉素B，39.0%的患者仅使用氟康唑。在预防全身感染方面，氟康唑的使用频率高于两性霉素B（分别为22例和3例）。抗真菌预防的总体使用率也从第一阶段（9.5%）增加到第二阶段（13.7%）。
氟康唑的引入对抗真菌治疗的处方模式产生了重大影响。尽管两性霉素B仍然是治疗疑似或确诊的全身、中枢神经系统或血液感染的首选药物，但氟康唑在这些适应症中的使用比例接近40%。需要进一步研究以探讨氟康唑在全身真菌病预防和治疗中的作用。
