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happykeren2008捐助贵宾 (正式写手)
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[求助]
文章段落中翻英已完成，还需虫友修改
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以下翻译修改15金币：（英文部分的修改，该部分翻译由11楼的sdau100 完成） 单次给药的耐受性试验：26名健康受试者，男女各半，根据体重和性别随机分配到6个剂量组（A组、B组、C组、D组、E组、F组）。A组2人；B组、C组每组4人，D组、E组每组6人；F组4人。参照费氏递增法（改良Fibonacci法）递增给药，各组分别涂布艾迪康唑乳膏2%×2g、2%×4g、4%×4g、4%×6g、6%×6g、6%×7g。每个受试者只接受一个相应的剂量，从小剂量开始，每个剂量应用后未见不良反应，才可用下一个剂量，观察给药后健康人体对艾迪康唑乳膏的反应和耐受性。 多次（累积）给药的耐受性试验：6名健康受试者涂布艾迪康唑乳膏2%×4g，每日1次，连续7d，观察给药后健康人体对艾迪康唑乳膏的反应和耐受性。 药代动力学试验：选择单次给药耐受性试验中第2剂量组（2%×4g）的2例受试者进行预试验，如检测不出血药浓度，则选择单次给药耐受性试验中第3剂量组（4%×4g）的2例受试者进行再次预试验，再根据预试验结果审核并修正原设计的采样点。如仍检测不出血药浓度，说明艾迪康唑基本不通过皮肤吸收入血，则停止单次给药药代动力学试验。 在多次给药耐受性试验同时进行药代动力学研究，选取多次给药耐受性试验6名受试者，连续给药4天后，在第5、6、7天给药前采集血样、第7天给药后不同时间（根据单次给药的药代动力学试验结果确定）采集血样，用LC-MS-MS测定血浆中艾迪康唑的浓度。 Single administration of the Tolerance test: 26 healthy volunteers, men and women account for half of, according to their weight and gender,were randomly assigned to six-dose group (A group, B group, C group, D group, E Group, F Group ). A Group 2; B group, C group four in each, D group, E Group 6 each; F Group 4. The light's incremental costs (modified Fibonacci) increased administration, the groups were coated Andiconazole cream 2% × 2g, 2% × 4g, 4% × 4g, 4% × 6g, 6% × 6g, 6% × 7g. Each of the volunteers only accept a corresponding dose, small doses first, after each dose of no adverse reactions, then the next dose used to observe the response and tolerance the health body may does after given of Andiconazole cream. Multiple (cumulative) administration's tolerance test: six healthy volunteers were coated Andiconazole cream 2% × 4g daily, for 7 d, observed the response and tolerance after health body administration of Andiconazole cream. Pharmacokinetics test: choose a single administration tolerance test in the No. 2-dose group (2% × 4g) of the two cases pre-trial, If not detected plasma concentration, then choose the two cases No. 3-dose group a single administration the test in (4% × 4g),to pre-test subjects, according to pre-test results to review and amend the original design of the sampling points. If still not detected plasma concentration ,that may show few Andiconazole cream was absorbed into the blood through the skin, then stop the single administration pharmacokinetics trial. During the administration tolerance tests,at the same time pharmacokinetics, select multiple administration tolerance test of six volunteers, Continuous administration four days, in section 5, 6, 7 days before delivery collecting blood samples, the 7th days after administration at different times (based on a single administration of the pharmacokinetics test results) collecting blood samples, using LC-MS-MS determinate the Andiconazole concentration in plasma. [ Last edited by happykeren2008 on 2008-6-3 at 22:05 ] |
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10楼2008-06-03 21:38:42
BigJake
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第二部分翻译，仅供参考： Finally: After single and many times of Adye-Kang-Zuo cream, the volunteers showed no significant responses to the circumference blood, breath, pulse, blood pressure, body temperature and the hepatorenal function and so on. Furthermore, the skin-reaction and the subjective sensation (pain, itches) were not observed after partial medication. As for 4 healthy volunteers given Adye-Kang-Zuo cream, the dosage of Adye-Kang-Zuo cream was lower than the lowest examination to limit and unable to calculate the medicine generation of dynamics parameter. As for other 6 healthy volunteers, individual blood medicine density showed time curve was assumed multi-dosage Adye-Kang-Zuo in vivo and showed the wave shape. Thus, it was also unable with the non-auriculo-ventricular modeling to estimate the medicine generation of dynamics parameter. Conclusion: This was good in the healthy volunteer tolerance and no obvious side effects were showed. Furthermore, the use margin for safety was wide and the clinical uses might be 2% was acceptable every day (Total less tha 20 g). |
2楼2008-06-03 03:23:25
BigJake
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第二部分接着翻译如下，仅供参考：（艾迪康唑乳膏翻译为Adye-Kang-Zuo cream可能不是很好，建议修订） After the healthy volunteer spreaded singly Adye-Kang-Zuo cream, The blood plasma concentration of Adye-Kang-Zuo cream was lower than the lowest examination of limit at most samples time. It showed that few Adye-Kang-Zuo cream was absorbed into the blood. After the healthy volunteer spreaded repetitiously Adye-Kang-Zuo cream, The blood plasma concentration of Adye-Kang-Zuo cream was also lower and it also showed that few Adye-Kang-Zuo cream was absorbed into the blood. Therefore, The Adye-Kang-Zuo cream possibly only operated partially function. |
3楼2008-06-03 03:48:52
happykeren2008
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4楼2008-06-03 10:40:32
