受试者英文

临床试验（ClinicalTrial），指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。 临床试验一般分为I、II、III、IV期临床试验和EAP临床试验。

什么是临床试验？临床试验是最受欢迎的显示因果关系的研究类型。它们的重要性排在各种研究的前列，只被综合性临床试验超越过。临床试验可以评估药物对疾病或身体状况的影响。研究人员通常会测试一种特定的治疗方法，并将其结果与另一种治疗方法或无治疗组进行比较(如果这样做合乎伦理的话)。理想的设计是研究人员和参与者并不知道谁被分配到哪种治疗方案。这被称为盲测。有时盲测是无法进行的。以食品测试为例，很难不知会参与测试的志愿者他们需要试吃的是什么。尽管，测试过程会尽量最小化受试者知情对结果的影响。“OSTRICH”临床试验“OSTRICH”临床试验的目的是测试一种真实的类固醇药物，而比较的对象是一种看起来很类似但是不含活性成分的安慰剂。研究人员对389名两到八岁的儿童进行了研究，这些儿童有耳部感染症状，耳部积液至少三个月，并证实双耳听力下降。200名儿童接受口服类固醇治疗，189名接受安慰剂治疗7天。通过这种方法，他们记录了治疗对耳道和中耳的影响，并进行了听力的临床试验。患儿的父母记录了孩子的症状，并填写了调查问卷。这些孩子在治疗结束后5周、6个月和12个月接受随访。试验的主要指标是在五周内通过听力测试确认，恢复可接受的听力。在研究结束之前，患者家属和研究人员都不知道谁服用了真正的药物，这被称为双盲。这段时间意味着研究人员必须小心对待他们收集的信息，以避免潜在的错误。孩子的行动是难以预测的即使有最完善的计划，孩子们的行为也很难预测。除了观察药物对疾病的影响外，遵循所有指示并按照计划完成研究的受试者数量也是一个重要的数据。由于各种各样的原因，并非所有的389个孩子都完成了为期12个月的“OSTRICH”试验。一开始，有些家庭不同意参加，有些孩子不符合听力损失标准；随着时间的推移，有些家庭联系不到了，有些孩子并不连续服药。如果你曾经试着让孩子吃药，就知道这并不新鲜。在完成试验的孩子里，结果显示接受类固醇治疗的孩子的症状与接受安慰剂治疗的孩子之间没有统计学上的显著差异。在五周的评估中，与服用安慰剂的孩子相比，服用真实药物的孩子的听力只有轻微的改善。研究人员写道：短期口服强的松龙治疗大多数2-8岁顽固性中耳炎伴积液患儿疗效不佳，但耐受性良好。14个孩子中只有一个提高了听力，但并没有提高生活质量。

The fourth part of reduced tooth fungus spot and reduces the gum inflammation the examination standard applicable scope: This standard is suitable to the appraisal and the confirmation includes the reduced tooth fungus spot and reduces the gum inflammation ingredient the product, including the toothpaste, rinses the saliva as well as other products. Formulates literature and standard which this standard refers: The reduced tooth fungus spot and reduces the gum inflammation the clinical test one, the principle of equality 1. Includes the new active constituent either the system product includes the new active constituent or the system reduced tooth fungus spot and reduces the gum inflammation the product merit effect by two independent clinical laboratories confirmations. 2. includes clinical has confirmed the active constituent product was included already clinical has confirmed the reduced tooth fungus spot and reduces the gum inflammation active constituent or the system oral cavity nurses the thing the effect, may choose the suitable gum inflammation patient, the confirmation includes the same density active constituent to examine the product and the masculine comparison product , also should set up the negative comparison or the placebo comparison group. 3. products (for example toothpaste) includes differently, is possible when affects the reduced tooth fungus spot and reduces the gum inflammation active excipient (non- active constituent), its merit effect through clinical test confirmation. In 4. formulas the active constituent biology and the stability needs to provide the effective proof by the applicant. Second, the research design (is stochastic and comparison) generally should use method, the lamination, two units parallel observations clinical research technique blindly. Third, the experimental deadline reduction tooth fungus spot and reduces the gum inflammation the clinical laboratory to need the viewing time to be longer. Generally should be 6 months, at least carries on three times of clinical examinations (baseline, 3 months, 6 months). Fourth, research object: For tallies trying brings into line with and removes the standard to contract the gum inflammation the adult male and the female. The common each group completes experimental the crowd quantity to be supposed to be bigger than 30 people. Fifth, the inspection target or uses index 1. to be supposed to include the recognition the tooth fungus spot index and the reflection gum inflammation degree target. Former including the tooth fungus spot cover area (for example by Turesky improvement Quigley & Hein PLI) or fungus spot thickness (Silness & L e PLI), should observe nearby the reason and the neighbouring surface fungus spot with emphasis. When selects the above target, should give the reason. The use gum hemorrhage index recording inflammation serious degree, may use BI (Mazza) or MBI, after also may use BOP% (namely to search examines has hemorrhage position spot to occupy the entire mouth total position spot %). Also may use by the edge and the nipple the shape color changes for the foundation index, like gum index (GI). If has used the alternative means, these methods should have at least the same sensitivity. 2. in principle should inspect and record entire mouth all toeet, each tooth inspects 6 units places (cheek center, cheek side central committee, cheek side far center, tongue center, tongue side central committee, tongue side is far) or 4 units places (cheek side three units places and tongue side central). Not suitably uses represents the tooth (for example the Ramfjord tooth, the CPI tooth and so on). Sixth, the product provides and uses 1. to receive examines the product and the masculine comparison product should include the same active principle and the density, other supplementary materials and so on become the duty same or are similar. The outside wrapping and the outward appearance should be same, if cannot meet this requirements, then only can implement the list blind experiment, provides the product by the non- inspector. 2. to receives the trying explanation operation requirements and the matters needing attention. Achieves as far as possible quantitative, the toothpaste each time amount of use (for example paste body length is 1 centimeter, contains rinses fluid each time 10ml or a bottle cap and so on), the unification uses the number of times every day, the duration and so on. 3. should maintain as far as possible besides the confirmation product the condition is consistent, if possesses the trying use same toothbrush, but may maintain the trying original custom is cleaned the teeth the method. Because (1) even if teaches to unify the method, the uncertain each person all can very good grasp and observe; (2) Causes the experiment comparatively to conform to in the real life the different crowd's situation. Seventh, the effect appraises 1. to press the medicine statistical method, to experiments the group and around the comparison component other statistics experiment each target entire mouth average value change situation; And carries on two groups of between each o'clock compartment, various targets change statistics analysis. 2. The effect evaluates should based on each clinical target average value change and the group quite definite, reported should list each value and statistics result, not the suitable pure use from draws up four levels of evaluation criterias (show results, effectively, progressive, are invalid). In each clinical research, the comparison group and the experimental group compare, each target reduction should satisfy the following condition: [ (Comparison - experiment)/comparison ] >= 15%. 3. controls the gum inflammation through the reduced fungus spot quantity either the change fungus spot pathogenicity the product to be supposed to determine the fungus spot quantity the reduction or pathogenic decreasing, and has statistics difference.

Part IV reduce inflammation of the gums behind and mitigation standards Application : The standards applicable to the assessment and certification contain enough to reduce inflammation and alleviate inner components of products including toothpaste, wash water and other products. The enactment of this standard reference literature and standards : Ability to reduce inflammation and alleviate Most clinical trials First, the general principles 1. Containing new active ingredients or product system Containing new active ingredients or systematic enough to reduce inflammation and alleviate back the efficacy of products should be two independent clinical testing certification. 2. Has been tested to contain the active ingredient clinical products Clinical containing has been tested to reduce plaque and periodontal inflammation active ingredients or reduce the system's effectiveness oral care supplies, choose appropriate Yakenyan patients, the certification contain the same concentration of active ingredients imported products and products with the equivalent of positive, but also negative in the establishment of a control group or placebo. 3. Products (such as toothpaste) containing different, may affect ability to reduce inflammation and alleviate Most of the 237,448 active (non-reactive components), its effectiveness through clinical testing certification. 4. Biological active ingredients, recipes and stability needed for use by the applicant to provide effective proof. Second, the research design (random and compare) General law should be applied blind, stratified, two units parallel observation clinical research methods. Third, the duration of the pilot Ability to reduce inflammation and alleviate Most clinical trials required to observe longer. Normally be for six months, at least three clinical examination (baseline, three months, six months). 4, the study : Applying the exclusion criteria and to meet with Yakenyan into adult male and female. General group completed pilot groups should be greater than the number 30. 5, inspection or use indicators index 1. Should include recognized easily index and the indicators reflect the degree of periodontal inflammation. The former includes enough coverage (such as from the Turesky improved Quigley & Hein PLI) or Junban thickness (Silness & L ö e PLI), the focus should be observed near the gums and neighbors face the fate Junban. In selecting the above-mentioned indicators, should be explained and justified. Use the index recorded Kenyan bleeding gums extent of available BI (controls) or MBI, also available BOP% (mine up the place after a bleeding point total population% of the total spaces points). May also be used to bite and bite at the nipple changes colour patterns based index, such as the ability index (GI). If the use of other methods, these methods should have at least the same sensitivity. 2. In principle, there should be checks and records all around the mouth of teeth, dental check every six spaces points (adjacent to the mouth, cheek side of the central and lateral entry far, nearly broke side, adjacent to the tongue, tongue side far), or four spaces points (adjacent to three entry points and places adjacent to the tongue). Inappropriate use of teeth (as Ramfjord teeth, CPI teeth, etc.). 6, the issuance and use of products 1. Quick comparison of products and positive effective products should contain the same concentration of ingredients and other textiles, and other elements should be identical or similar. Overpack and appearance should be similar, if not achieved this requirement, then only a single blind testing by the inspection of non-payment products. 2. To the degree that use requirements and attention matters. As far as possible quantitative, toothpaste every usage (such as the length of one Gaoti centimeters, or one 10ml bottle each Hanshu fluid, etc.), daily use of uniform frequency, duration, etc. 3. In addition to the certification of products should be maintained outside the terms agreed, as all use the same toothbrush degree, but can maintain the original degree Brushing habits. First, because even with the uniform methodology, not necessarily good person can grasp and compliance; Second, to test a more realistic life different groups. 7, the evaluation results 1. According to the medical statistical methods to test and control groups, respectively, the indicators of statistical tests and the entire population mean changes; And the time between the two groups, and changes in the statistical analysis of the indicators. 2. Results of the assessment should be based on the clinical indicators and distance changes between the comparative group identified, the report should include the value of statistics and the results should not simply be used from the 4 evaluation criteria (soil, effective, progress, invalid). In each clinical research, testing group compared with a control group, the target should be reduced to meet the following conditions : [(contrast-test) / contrast ]=15%. 3. By reducing the volume or change Junban Junban pathogenic inflammation of the gums and control products should be reduced or volume measurement Junban reduce pathogenic nature, and have statistical differences. 不晓得准不?

临床试验的协助研究者进行受试者筛选,入...英文翻译_Help clinical trials of screening subjects into groups and follow-up work