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More Less | | Questions answered: 2 | Sample translations submitted: 1 | : A RANDOMISED, DOUBLE-BLIND, DOUBLE DUMMY, COMPARATIVE MULTICENTRE TRIAL OF UK-109, 496 AND FLUCONAZOLE IN THE TREATMENT OF OESOPHAGEAL CANDIDIASIS IN IMMUNE COMPROMISED PATIENTS | Source text -
Pfizer has developed a new antifungal drug (UK-109, 496) which has been used successfully to treat oropharyngeal candidiasis (oral thrush) in man. This study aims to determine how effective it is against oesophageal candidiasis in man and to compare its effectiveness with that of fluconazole, which is a standard treatment for this infection. Your doctor has diagnosed that you have oesophageal candidiasis and considers that either drug would be a suitable treatment for it.
The best way of establishing the activity of a new, experimental medicine is to compare it with an accepted, standard medicine. Thus, in this study, whether you receive UK-109,496 plus placebo (dummy medication that contains no drug) or fluconazole plus placebo will be determined by chance and neither you nor your doctor will know which drug you are taking. This is to permit a fair and unbiased comparison between the two drugs.
If you consent to enter the study you will be given full medical examination. You must tell your doctor about all the other medicines you are currently taking or have taken within the last 28 days. Before you are asked to take any study drug your oesophgeal infection will be confirmed by oesophagoscopy. This means that you will be sedated and a tube will be inserted briefly into your oesophagus to look for signs of the infection. You may experience some discomfort during this procedure. Although rare, complications such as bleeding and breathing difficulties could arise. A very little material will be taken from the oesophagus to confirm the infection. But this will only be carried out when your doctor determines that it is safe to do so and there is risk of bleeding. You may experience some discomfort like soreness of the throat. In addition, you will have any eye test and you will be expected to give some blood and urine samples.
You will be expected to visit the hospital again on the eight day of treatment when you will be examined clinically and arrange your next visit. In addition, at each visit to the hospital, a blood and urine sample will be taken to check your general health status. This will include a pregnancy test for female patients of child bearing potential. If you are female and of child bearing potential or less than 2 years post menopause, you must take the necessary precautions (a barrier method of contraception) to avoid becoming pregnant whilst receiving therapy as UK-109,496 may be harmful to the unborn baby. If you use oral contraceptive pills their effectiveness may be reduced, so this means using a suitable barrier contraception method as well.
| Translation -
辉瑞开发出一种新的抗真菌药物（UK-109,496）且已成功应用于男性口咽念珠菌病（鹅口疮）的治疗。本研究的目的：确定其对食管念珠菌病的疗效并与作为此感染标准治疗药物的氟康唑比较。您的医生已诊断您患有食管念珠菌病，并认为此两药中的任何一种均将是此病适宜的治疗药物。
测定一个处于实验阶段新药的效力的最好方式就是将其与一已被接受的标准治疗药物作对比。因此，本研究中，为在两药物间进行一个公正且无偏倚的比较，不论您是接受UK-109,496联用安慰剂（不含药物成份的虚设药物）治疗还是接接受氟康唑联用安慰剂治疗都将是随机的，而您和您的医生都将不知您在服用哪一种药物。
如果您同意加入本研究，您将接受全面的医学检查。您必须告知您的医生所有您正在或最近28天内摄入的其它药物。在您被要求服用任何一种研究药物前将通过食管镜检查对您的食管念珠菌病进行确诊。这意味着为找到感染的体征您将被镇静且一个导管将被暂时插入您的食管。此过程中您可能会有些不舒适的感受。诸如出血和呼吸困难的并发症尽管少见但仍可能出现。为确诊感染，将从您的食管取下一个非常小的组织块。这有出血的风险但只会在您的医生确认其安全的情况下施行。您可能会经历一些诸如咽喉疼痛的不适。另外，您将接受全面的眼部检查，并留取一些血样和尿样。
在治疗的第8天您需再次来医院就诊，届时将对您进行临床检查并安排您的下一次就诊。另外，每次来诊都将留取一份血样和尿样以确定您的一般健康状况。这包括有生育能力女性病人的妊娠试验。如果您是有生育能力或是绝经不足两年的女性患者，您必须采取必要的预防措施（一种避孕方式）以避免在同时接受可能对胎儿有害的UK109,496治疗期间怀孕。如果您是用口服避孕药避孕，其效用可能被减弱，所以您还需选用一种适当r的避孕方式。
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More Less | | Years of translation experience: 3. Registered at ProZ.com: Mar 2009. | | N/A | | N/A | | N/A | | SDL TRADOS | | Keywords: medicine, medical, drug, plant, test,
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