闪修侠换屏靠谱吗:请帮忙翻译成英文（有关医学的）

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第四部分减少牙菌斑和减轻牙龈炎症的检测标准
适用范围：
本标准适用于评价和验证含有减少牙菌斑和减轻牙龈炎症成分的产品，包括牙膏、漱口水以及其它产品。
制定本标准所参考的文献和标准：
减少牙菌斑和减轻牙龈炎症的临床试验
一、一般原则
1。含有新型活性成分或系统的产品
含有新型活性成分或系统的减少牙菌斑和减轻牙龈炎症的产品的功效应被两个独立的临床试验所验证。
2．含有已被临床验证过的活性成分的产品
含有已经被临床验证过的减少牙菌斑和减轻牙龈炎症活性成分或系统的口腔护理用品的功效，可选择适当的牙龈炎患者，验证含有相同浓度活性成分的受检产品与阳性对照产品的等效性，也应设立阴性对照或安慰剂对照组。
3．产品（如牙膏）含有不同的、可能影响减少牙菌斑和减轻牙龈炎症活性的赋形剂（非活性成分）时，其功效应通过临床试验验证。
4．配方中活性成分的生物利用度和稳定性需要由申请者提供有效证明。
二、研究设计（随机和对照）
一般应采用盲法、分层、二单位平行观察的临床研究方法。
三、试验期限
减少牙菌斑和减轻牙龈炎症的临床试验所需要观察时间较长。一般应为6个月，至少进行三次临床检查（基线、3个月、6个月）。
四、研究对象：
受试者为符合纳入及排除标准的患有牙龈炎的成年男性和女性。
一般每组完成试验的人群数量应大于30人。
五、检查指标或采用指数
1．应包括公认的牙菌斑指数和反映牙龈炎症程度的指标。前者包括牙菌斑覆盖面积（如由Turesky改良的Quigley & Hein的PLI）或菌斑厚度（Silness & Löe的PLI）, 重点应观察龈缘附近和邻面的菌斑。在选用上述指标时，应说明理由。使用牙龈出血指数记录龈炎的严重程度，可用BI（Mazza）或MBI，也可用BOP%（即探诊后有出血的位点占全口总位点的%）。还可使用以龈边缘和龈乳头的的形态颜色改变为基础的指数，如牙龈指数（GI）。如果使用了其他方法，这些方法应具有至少相同的灵敏度。
2．原则上应检查和记录全口所有牙齿，每个牙检查6个位点（颊侧近中、颊侧中央、颊侧远中、舌侧近中、舌侧中央、舌侧远中）或4个位点（颊侧三个位点和舌侧中央）。不宜使用代表牙（如Ramfjord牙、CPI牙等）。
六、产品的发放和使用
1．受检产品和阳性对照产品应含有相同的有效成份及浓度，其他辅料等成份应相同或相似。外包装及外观应相同，若不能达到此要求，则只能实施单盲试验，由非检查者发放产品。
2．向受试者说明使用要求及注意事项。尽量做到定量化，牙膏每次使用量（如膏体长度为1公分，含漱液每次10ml或一瓶盖等），统一每天使用次数、持续时间等。
3．应尽量保持除验证产品以外的条件一致，如所有受试者使用同样的牙刷，但可以保持受试者原有习惯的刷牙方法。因为①即便教以统一方法，不一定每人都能很好掌握和遵守；②使试验较符合现实生活中不同人群的情况。
七、效果评价
1．按医学统计方法，对试验组和对照组分别统计试验前后各项指标的全口均值变化情况；并进行两组之间各时间段、各指标变化的统计学分析。
2。效果评定应基于各项临床指标的均值变化及组间比较确定，报告中应列出各项数值及统计学结果，不宜单纯使用自拟的四级评价标准（显效、有效、进步、无效）。
在每个临床研究中，对照组与试验组比较，各项指标的减少应满足下列条件：[（对照－试验）/对照]≥15％。
3．通过减少菌斑量或改变菌斑致病性而控制牙龈炎症的产品应测定菌斑量的减少或致病性的减低，并具有统计学差异。

http://www.moh.gov.cn/uploadfile/200662153858558.doc
牙菌斑:plaque (疾病及健康词汇: http://www.geocities.jp/ps_dictionary/medical2/102.htm)
牙龈炎症gingivitis
牙龈指数gingivitis index
牙龈出血指数（bleeding index，BI）：
检测标准testing standard
适用范围Application scope
牙膏toothpaste
漱口水Mouthwash(Gargle, Dental water也可以的)
制定本标准所参考的文献和标准Reference and criteria
临床试验clinical trial
活性成分Active Ingredients
一般原则”（general principles）
患者 suffers
control对照
随机randomization
盲法(Blind Method)
Stratified method分层
功效应Effect
口腔护理用品Oral & dental care Products
阴性对照negative control
阳性对照positive control
赋形剂(excipitens).
稳定性 stability
生物利用度Biological Utilization
药剂等效性, pharmaceutical equivalence
安慰剂, placebo
位点 site
受试者subject
成年男性和女性 male and female adults
为符合纳入及排除标准的: 不能理解，抱歉，自己再改改吧！
BOP Bleeding on probing
颊侧buccal ridge
舌侧lingual

The fourth part: Testing criteria of plaque reduction and gingivitis abating.
Application scope: This criteria is applicable for the products for plaque reduction and gingivitis abating, including toothpaste, mouthwash and other products.
Reference and criteria：
Clinical trials of plaque reduction and gingivitis abating

First: General principles

1. The products containing new active ingredients or systems
The effects of the products containing new active ingredients or systems for plaque reduction and gingivitis abating should be determined by two separate clinical trails.

2．The products containing the active ingredients determined by clinical trails
The effects of oral & dental care products containing the active ingredients and systems determined by clinical trails for plaque reduction and gingivitis abating should be tested the equivalence between the products to be checked and the positive control products which contained the same concentration of active ingredients after choosing proper gingivitis suffers, and also should set up negative control or placebo control group.

3．The effects of the products (such as toothpaste) containing various excipitens（inactive ingredients）which may affect the activity of plaque reduction and gingivitis abating should be tested by clinical trails.

4．The biological utilization and stability of the active ingredients in the blend should be provided with available testimony by the applicant.

Second: Research designs (randomization and control)
Generally the blind method、the stratified method, and the dual-unit parallel observation are used as clinical research methods.

Third: Testing period
The period need for the clinical trails of plaque reduction and gingivitis abating is fairly long. Generally it should be six months, and three clinical check at least (baseline, three months, and six months).

Fourth: Research objectives:
The subjects should be male and female adults suffered from gingivitis
Generally the subject number should be more than 30 in a complete trail.

Fifth: Checking index
1．The checking index should include acknowledged plaque index and the index which may reflect the gingivitis degree. The former includes plaque coverage (such as Quigley & Hein’s PLI modified by Turesky) or bacterium spot thickness (Silness & Löe’s PLI), stress on the observation of bacterium spots near and adjacent to the edge of the gum. If the above index is used, the reasons should be given. Record the degree of gingivitis expressed as bleeding index (BI) (Mazza), MBI, and BOP % (the percent of bleeding on probing sites to the total sites in the whole mouth after examination). The shape and color changing of gum edge and gum nipple could also be used as basic index, such as gingivitis index (GI). If other methods are used, they should have at least the same sensitivity as the above methods.

2．In principle, all the teeth in the mouth should be checked and recorded and six sites (Near-central of the buccal ridge, central of the buccal ridge, far-central of the buccal ridge, near-central of the lingual, central of the lingual, far-central of the lingual) or four sites (three sites of the buccal ridge and central of the lingual) of each tooth should be checked. The representative teeth shouldn’t be used(such as Ramfjord teeth, CPI teeth, etc).

Sixth: Issue and application of products

1．The effective ingredients and concentration of the products to be checked
should be the same as that of thepositive control products, other accessory ingredients should be the same or similar. Their appearance should be similar, if this requirement can not be achieve, then we can only fulfill the single-blind trail and issued the products by non-checkers.

2. Tell the subjects about the using requirement and the attention. We should do quantification as possible, the dosage of toothpaste (such as 1 cm long, 10ml mouthwash or one cover of the bottle/time), applied times daily, duration etc.

3．The conditions should be kept identical as possible except for the testing products. If the subjects use the same toothbrush, their original brushing habits might be kept. For the following reasons: ① Even though they are taught the uniform methods, not always every person can grasp and abide them; ② we should make the experiment similar to various people in their natural lives.

Seventh: Evaluation of effect

1．According to medical stat. Method, we analyze the variation of the whole-mouth mean values of every index of the treatment group and the control group respectively before and after the tests, then analyzes the index variations during every period between the two groups.

2. The evaluation of the effect should be determined according to the mean value variation and block comparison of each clinical index. And all the values and stat. Results should be listed in the report, The subjective evaluated criterion should not be used alone（high effective, effective, little effective, non-effective）. In every clinical trail by comparison of the control group and the treatment group, every index reduction should meet the following conditions:[(Control-Treatment)/Control]≥15％。
3．The products for gingivitis controlling by reducing the amount of bacteric spots or change the disease caused by the bacteric spots should have significant difference.

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.

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