Gombert M E, duBouchet L, Aulicino T M, Butt K M
Department of Medicine, State University of New York, Health Science Center, Brooklyn 11203.
JAMA. 1987 Nov 13;258(18):2553-5.
An open study designed to compare the effectiveness and safety of clotrimazole troches with nystatin oral suspension in the prevention of oropharyngeal candidiasis was conducted. This study was performed as the troche form of clotrimazole was easier to administer and less costly than nystatin oral suspension. Sixty assessable patients were randomized to receive either clotrimazole troches (n = 32) or nystatin oral suspension (n = 28) for a 60-day period after receiving a renal allograft. The two groups were comparable in age, sex, type of transplant, and amount of immunosuppression. Both regimens were 100% effective in preventing the development of thrush in the patients studied. Adverse effects were infrequently seen in either group (one case of mild nausea in the clotrimazole group and three cases in the nystatin group). One patient chose to withdraw from the clotrimazole group, and eight patients withdrew from the nystatin group before completing 60 days of therapy (P = .002). Reasons given for withdrawal were the unpleasant taste of the drugs, or an inability to comply with the protocol. The cost of clotrimazole troches in the prophylactic doses given in this study was approximately one tenth that of nystatin oral suspension. Clotrimazole troches are effective, less expensive, and easier to self-administer than nystatin oral suspension.
开展了一项开放性研究,旨在比较克霉唑含片与制霉菌素口服混悬液在预防口咽念珠菌病方面的有效性和安全性。进行这项研究是因为克霉唑含片剂型比制霉菌素口服混悬液更易于给药且成本更低。60例可评估患者在接受肾移植后被随机分为两组,一组接受克霉唑含片(n = 32),另一组接受制霉菌素口服混悬液(n = 28),为期60天。两组在年龄、性别、移植类型和免疫抑制程度方面具有可比性。在本研究的患者中,两种治疗方案预防鹅口疮发生的有效率均为100%。两组均很少出现不良反应(克霉唑组1例轻度恶心,制霉菌素组3例)。1例患者选择退出克霉唑组,8例患者在完成60天治疗前退出制霉菌素组(P = .002)。退出原因是药物味道不佳或无法遵守方案。本研究中给予预防性剂量的克霉唑含片成本约为制霉菌素口服混悬液的十分之一。与制霉菌素口服混悬液相比,克霉唑含片有效、成本更低且更易于自行给药。