MEDICAL DEVICE DISINFECTION
European Patent EP1257301
Inventors:
Daintree, Andrew (The Withies, Rectory Lane, Lymphsam, BS24 0EN, GB)
Curtis, Beverley (27 Church Close, Stoke St. Gregory, Taunton, TA3 6HA, GB)
Application Number:
Publication Date:
05/06/2004
Filing Date:
02/12/2001
Export Citation:
Bioquell Medical Limited (30-31 Lynx Crescent, Weston-Super-Mare, Somerset, BS24 9BP, GB)
International Classes:
A61L2/18; A61L2/20; (IPC1-7): A61L2/20; A61L2/18
European Classes:
A61L2/18L; A61L2/20C
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Domestic Patent References:
Foreign References:
WO/ACLEANING METHOD UTILIZING OZONATED WATER AND APPARATUS FOR PRODUCING OZONATED WATER5443801Endoscope cleaner/sterilizer5520893Apparatus with safety means for sterilizing articles with ozone5853014PC apparatus for cleaning
Attorney, Agent or Firm:
Bayliss, Geoffrey Cyril (BOULT WADE TENNANT, Verulam Gardens 70 Gray's Inn Road, London, WC1X 8BT, GB)
1. A method of disinfecting medical equipment comprising the steps of causing ozonated water to flow over the surfaces of the equipment at a predetermined concentration and flow rate for a certain time, characterised in that the concentration of ozone in the water leaving the equipment is monitored and the flow of ozonated water is terminated when the concentration of ozone leaving the equipment is substantially the same as that being delivered to the equipment.
2. A method as claimed in claim 1, characterised in that the equipment is subjected to a manual washing process prior to disinfection by ozonated water.
3. A method as claimed in claim 1 or claim 2, characterised in that the ozonated water has a concentration of at least 5 ppm and not more than 15 ppm.
4. A method as claimed in claim 3, characterised in that the ozonated water has a concentration of 15 ppm.
5. A method as claimed in claim 3 or claim 4, characterised in that the flow rate of ozonated water over the surfaces of the equipment is approximately 2.2 litres per minute.
6. A method as claimed in any of the preceding claims, characterised in that the equipment has an internal channel or channels, wherein ozonated water is'delivered over the outer surfaces of the equipment and through the internal channels of the equipment.
7. A method as claimed in any of the preceding claims, characterised in that the equipment is an endoscope having one or more internal channels through which said ozonated water is caused to flow.
8. A method as claimed in any of the preceding claims, characterised in that the equipment is subjected to a final rinse in water following said disinfecting process.
Description:
This invention relates to the disinfection of medical equipment such as endoscopes, bed pans and other health care equipment.Medical devices and in particular endoscopes have historically been disinfected by either heat or chemicals. Current disinfection of endoscopes is carrie one a cold process, and the other a heated process.
i) Cold ProcessThis is normally used when the endoscopes cannot be disinfected by using heat, i.e. most flexible endoscopes. The endoscopes are manually cleaned and then put into a washer disinfector for an automatic process. This process gives the scopes a pre-wash, a wash with a disinfectant, and a final rinse with water. The disinfectant wash allows a contact time dependent on the manufacturer of the disinfectant, e.g. Cidex (Johnson and Johnson), Nu-Cidex (Johnson and Johnson), Gigasept (Schule and Mayer).Cold processing allows a batch of disinfectant to be re-used, the number of cycles dependent on the washer disinfector and the level of dilution taking place. Once this number of cycles is completed, the batch of disinfectant is dumped to waste and the machine re-charged with a fresh bash. ii) Hot ProcessSome endoscopes (mainly rigid ones) can be
processed in a normal sterilising autoclave at 120-130°C. For endoscopes such as flexible ones that cannot withstand this temperature, there are a range of washer disinfectors that disinfect by heating to a lower temperature of 50-55°C.This process gives the scopes a pre-wash, a heated wash with a small amount of disinfectant, and then a final rinse with water. The heated wash takes a small amount of concentrated disinfectant, and by heating to 50-55°C causes the chemical to vaporise and thus provide the efficiency required. This process normally uses gluteraldehyde as the disinfectant, and the small amount used each time is a single use. This process tends to have longer cycle times than cold processing.The heated process is more prevalent in Europe, while cold processing is utilised in the UK and US. The method of the invention also provides an alternative to the use of steam.Ozonated water is widely used to kill microbiological organisms. However, when generating and dissolving ozone in water it is usual to expect levels of under 1 ppm. We have found that we are not able to disinfect medical devices to the required standard or within an acceptable time period using such levels of ozone concentration. Effective disinfection can only be achieved with a precise combination of flow over and through the device, ozone levels, and time.The criteria for disinfection of the endoscopes have been developed by Dr. J Babb of the Hospital Infection Research Laboratory (HIRL) at City Hospital NHS Trust, Birmingham, as described later and is key to the validation of the process. The process fulfils the HIRL test criteria for endoscope washer disinfectors, i.e. mean log10 reduction &6 (99.9999%) with no individual reduction &5 (see Appendix 3). Although external validation of the process can be undertaken, it is impractical to undertake on a daily basis. Within the process we have been able to measure the ozone levels at the inlet and outlet of the process. This has allowed us to calculate how long the process needs to run to give the required disinfection. As ozone concentration is depleted on contact with microbiological organisms, if the inlet and outlet levels are identical there is minimal microbiological organisms remaining. As microbiological organisms levels have to be very low to validate the unit for a predetermined time after equilibrium is reached.Thus this invention relates to ozonated water as a substitute for the traditional chemical method of disinfection. Although the development and validation has been undertaken on endoscopes, the process and technology is relevant to many medical devices.US-A 5520893 discloses an apparatus for sterilising articles with ozone. Medical instruments, including stainless steel, plastic tubing and the like are sterilised in a portable apparatus that provides a low volume, high pressure fluid of continuously circulating water containing about 2 to 6 ppm of ozone.US-A-5443801 discloses an endoscope cleaner-steriliser apparatus comprising a capsule for holding
the endoscope, the capsule having a re-sealable entry port for depositing the endoscope into the capsule and a flexible peristaltic zone which is deformable under pressure. The diaphragm encircles the endoscope within the capsule and provides a partial seal within the capsule. A liquid is contained within the capsule and an agitator-has a tray for accepting the capsule. Pressure means are provided for applying pressure to the flexible peristaltic zone of the capsule and a motor is provided for oscillating the pressure means over the section of the flexible peristaltic zone. The agitator includes a means for generating a ozone gas and means for selectively communicating the ozone gas into the capsule via the inlet port.EP-A-773031 discloses a rapid purifying method using ozonised water of high concentration. Verifying organisms such as protozoa and plankton, or bacteria or virus are subjected to the action of ozonised water for killing, or oils, fat, resins or other contaminants adhered to objects which are subjected to the action of ozonised water for exfoliation from the objects.The invention provides a method of disinfecting medical equipment comprising the steps of causing ozonated water to flow over the surfaces of the equipment at a predetermined concentration and flow rate for a certain time and monitoring the concentration of ozone in the water leaving the equipment and terminating the flow when the concentration of ozone leaving the equipment is substantially the same as that being delivered to the equipment. Thus the rinse water produced does not contain active sanitants.The following is a description of some specific embodiments of the invention, reference being made to the accompanying drawings, in which:
Figure 1 is a schematic diagram showing the apparatus used for carrying the disinfection of medical equipmen and Figure 2 shows a number of different scopes to which the cleaning process is applicable. Figure 1 shows a unit based around an electrochemical generator stack 10, where Hydrogen (H) and Ozone (O3) are generated. The stack is fed by a dedicated de-ionised water supply 11 at a pressure of one bar, to maintain the integrity and efficiency of the cells and the long-term quality of the feed water. Power for the stack is supplied from a variable DC supply (not shown). There is also a battery back-up system (not shown) to support the cell in the event of a power failure.Hydrogen gas is re-absorbed and/or catalytically converted. Ozone is supplied under pressure to a contactor 12 containing 25-50 litres of filtered water via a diffuser block. This allows the ozone gas to bubble into the water to produce a high concentration solution (typically at least 4 ppm, for example 6+ppm). The level of water in the contactor is controlled and filled through solenoid valves, the operations being initiated by a micro-processor operated control unit 13 through software instructions. Ozone concentration levels are constantly monitored to ensure correct values.Any excess ozone off-gas is collected at the top of the contactor and passed to a destruct column,
where it is processed through an absorber. When operating at full capacity the cell produces perceptible heat, and so water used in the cell for electrolysing is cooled with a heat exchanger and refrigeration plant.To disinfect effectively an endoscope, ozonated water needs to be pumped through all the internal channels of the scope at a flow rate and concentration level sufficient to kill organisms that may remain after a manual clean has taken place. The water is supplied at ambient temperature.In our testing we have found these to be concentration level of at least 4ppm, preferably about 6ppm and not more than 15ppm, and a flow rate that equates to 2.2 L/min. These parameters need to be applied for a minimum period of 10 minutes and a maximum of 15 minutes to ensure all internal channels of a normal endoscope have been disinfected.Ozonated water is supplied from the contactor to a supply pump 14 having connectors 15 for coupling to the individual endoscope channels 16. Spent ozonated water is directed to waste via the distal end of the endoscope 19.During testing and development a method was devised that determined whether ozone has achieved the intended uses. With a known concentration of ozonated water entering a test sample contaminated with "Pseudomonas aeruginosa NCTC 6749" of a known value, a second sensor was used to monitor the water output from the test equipment. When the exit concentration level rose to match the known input, it was assumed that by then ozone had killed any remaining organisms. Unlike called for in present claim 1, the flow of ozonated water was continued for a further
5 minutes after that equilibrium was reached. Sterile water samples were taken and cultured to established protocols and showed that the method had achieved the necessary kill rates, to be declared a process disinfectant.Previous tests were conducted that used ozone concentrations that varied from 0.1-18ppm, and flow rates as low as 400ml/min. Contact times also varied from 5 minutes to as much as 25 minutes, but in all cases the kill rates achieved were inferior to those reached when the optimised settings previously stated were used. KEY POINTS Safe operating media - chemical disinfectants are sensitising agents and are possibly tetragenic. Cold Process. One Shot Process. Process validated. Closed loop system - ozone levels monitored at discharge. Critical parameters of ozone concentration, flow discharge rates, and time established. Residue free disinfectant.
TEST METHODThe biopsy and suction channels of an Olympus gastroscope 20 (Type GIF Q10) shown in Figure 2 were contaminated having removed the air/water and suction valves 21,22 with an overnight broth culture of Ps. aeruginosa NCTC 6749 enriched with 10% horse serum. The-instrument was left to drain / dry for 10 minutes
at room temperature before sampling, i.e. pre-disinfection count or processing and sampling, ie. post-disinfection count. The endoscope was recontaminated prior to each test cycle. After processing in an endoscope washer disinfector by coupling supply and return conduits to the air/water and section valve parts, the endoscope channels were sampled to detect surviving test bacteria. This was done by flushing 10 ml of sterile water through the channel lumens and collecting the washings in a sterile container at the distal tip. These were diluted and plated onto typtone soya agar plates, which were incubated at 37°C for 18 hours. The number of colony forming units of the test organism were enumerated and counts transposed to the log10 system. The log reduction (RF) were calculated for each cycle, i.e.: Log10 pre-disinfection count - log10 post-disinfection count = log10 reduction (RF) It is normal to use a pre-disinfection count of 8 log10 contamination and aim for a post-disinfection count of less than 2 log10, giving a log10 reduction of 6.Similar methods are used for colonoscopes (see Figure 3) and duadenoscopes (see Figure 4). Definition of Disinfection PHLS - Chemical Disinfection in Hospitals DefinitionsDisinfection: A process used to reduce the number of micro-organisms but not usually the process does not necessarily kill or remove all micro-organisms, but reduces their number of a level which is not harmful to health.' The term is applicable to the treatment of inanimate objects and materials and may also be applied to the treatment of the skin, mucous membranes and other body tissues and cavities.
ENDOSCOPE TESTSLog10 reductions in test bacteria from the biopsy and suction channels of two endoscopes using ozonated water for 10 minutes Contact time Water (control) Ozonated water
Biopsy channel Suction channel Biopsy channel Suction channel Olympus GIF Q10 Pre-treatment8.588.418.438.54 Post-treatment
Cycle 14.743.635.956.33
Cycle 23.704.466.046.39
Cycle 34.174.456.176.39 Mean log10 RF4.204.096.056.33 Fujinon Colonoscope Pre-treatment8.598.698.598.69 Post-treatment
Cycle 15.485.285.755.99
Cycle 25.555.466.446.61 Mean log10 RF5.525.376.106.30
& 2004-. All rights reserved.为了让胎宝宝和准妈咪更安全、，到了孕12周，就要开始第一次产前检查啦。准妈咪在孕期一共需要做13次产检，每次检查涉及的项目都很多，今天小编就为大家整理了所有需要检查的项目和指标，让你清楚了解自己的孕期情况，不做迷糊的“产检小白”。
重点项目：
一、B超（包括NT检查）
4次B超检查的目的：
怀孕5-6周：胚囊在内的位置，评估宫内孕还是，判断是单胎还是多胎。
怀孕11-14周：评估胎儿染色体异常的风险。
怀孕18-24周：主要用于筛查胎儿畸形。
怀孕30-34周：用于评估胎儿的生长发育，了解胎盘的位置及羊水量的多少。
关于NT检查：
NT检查是一种B超检查项目，被认为是筛查唐氏综合征有效指标之一，不需要抽血检验，进食和饮水不会影响检查结果，因此在检查前不需要空腹。NT检查又称为颈后透明带扫描，是评估胎儿是否患有唐氏综合征的一种方法，准确率颇高。
做NT最好提前预约，一般在孕11周前就可以开始和医院预约时间以便排期。不要在孕13周后再去预约，以免排队时间过长，超过孕周做NT会影响检测结果的准确率。
NT检查数据解读：项目正常范围异常风险NT测值≤3mm有胎儿异常的危险，需进一步进行羊水穿刺或绒毛活检明确情况。B超检查数据解读：
B超单检查结果怎么看项目正常异常胎囊只在怀孕早期见到。大小：孕1.5个月直径约2cm；2.5个月约5cm。位置：子宫宫底、前壁、后壁、上部、中部都属正常。位置：下部，且伴有腹痛或阴道流血，可能有的风险。形态：圆形、椭圆形、清晰。形态：不规则形、模糊。胎头形态：轮廓完整，脑中线无移位和无。形态：缺损、变形。双顶径：孕5个月以后，基本与怀孕月份相符，例如孕7个月时双顶径约为7.0cm。孕8个月以后，平均每周增长约为0.2cm为正常。胎心跳动：有、强。跳动：无、弱。频率：120-160次/分钟。频率：过快、过慢、不规则。胎动有、强。无、弱可能胎儿在，也可能为异常情况，要结合其它项目综合分析。胎盘厚度：2.5-5cm。太厚或太薄，都表示胎儿在宫内的生长情况有些异常，建议对胎儿进行进一步的检查，密切关注胎儿的生长状况。化一项报告单：Ⅰ级为胎盘成熟的早期阶段，回声均匀，在怀30-32周可见到此种变化；Ⅱ级表示胎盘接近成熟；Ⅲ级提示胎盘已经成熟。越接近足月，胎盘越成熟，回声的不均匀。股骨长度与相应的怀孕月份的双顶径值差2-3cm左右，如双顶径为9.3cm，股骨长度应为7.3cm。羊水深度：3-7cm。深度：超过7cm为羊水增多，少于3cm为羊水减少。脊椎脊柱连续为正常。缺损为异常，可能脊柱有畸形。脐带正常情况下，脐带应漂浮在羊水中。若在胎儿颈部见到脐带影像，可能为脐带绕颈。孕期胎儿大小正常参考值孕周双顶径（平均值）cm腹围（平均值）cm股骨长（平均值）cm13周2.52±0.256.90±1.651.17±0.±0.577.77±1.821.38±0.±0.519.13±1.561.74±0.±0..922.10±0.±0..622.52±0.±0.5312.41±l.892.71±0.±0..303.03±0.±0.5814.80±l.893.35±0.±0.4215.62±l.843.64±0.±0..233.82±0.±0..854.21±0.±0..234.36±0.±0..204.65±0.±0..304.87±0.±0..125.10±0.±0..415.35±0.±0..505.61±0.±0..035.77±0.±0..326.03±0.±0..336.43±0.±0..306.52±0.±0..556.62±0.±0..836.95±0.±0..836.95±0.±0..177.10±0.±0..837.20±0.±0..127.34±0.±0..797.40±0.53注意事项：
做Ｂ超不需要空腹。怀孕３个月前做腹部Ｂ超需憋尿，怀孕3个月后（包括怀孕３个月）不需憋尿，因此，若第一次产检做B超，则不需憋尿和空腹。
唐氏综合征筛查指的是通过抽取孕妇的血液，检查血液中的甲胎蛋白（AFP）、人绒毛膜促性腺激素（HCG）、雌三醇（E3）。根据孕妇血清中这三种物质的异常升高或降低，结合孕妇年龄、体重与孕周等情况，分析出胎儿患唐氏综合征的风险度。（唐氏儿，又称先天愚型、伸样痴呆等。唐氏综合征是人类最常见的一种染色体病，由于配子形成期和合子期，细胞内多了一条21号染色体所致。）
唐氏筛查的手段目前有三种：
一是孕早期（11-13+6周）进行筛查，需要B超检查NT数据结合血液PAPPA检查；
二是孕中期（15-20+6周）的抽血进行三联激素筛查唐氏儿；
三是目前很流行的胎儿DNA检查，即检查母血中胎儿细胞中的DNA成分，推测是否为唐氏儿，可以检查的孕周为12-24周，个别医院还可以在稍大孕周进行该项检查。
就敏感度而言，胎儿DNA检查最敏感，可信度最高，其次为早唐筛查，再次为孕中期筛查。孕妇可以根据产检医院开设的检查方法选择一种手段进行化验。无论选择何种筛查方法，如出现高危结果都需要进一步羊水穿刺进行产前诊断。
唐氏筛查数据解读：
MOM：MOM值是一个比值，即孕妇体内标志物检测值除以相同孕周正常孕妇的中位数值。
AFP：是胎儿的一种特异性球蛋白。怀有先天愚型胎儿的孕妇，其血清AFP水平为正常孕妇的70%，即平均MOM值为0.7-0.8MOM。
FREE-HCG-β：游离-亚基-促绒毛膜性腺激素。怀有先天愚型胎儿的孕妇，其血清FREE-HCG-β水平呈强直性升高，平均MOM值为2.3-2.4MOM。
UE3：UE3（游离雌三醇）是胎儿胎盘单位产生的主要雌激素。怀有先天愚型胎儿的母亲血中UE3表现为降低，一般平均值为0.7MOM。
Inhibin A：抑制素-A（IhnA）是一种蛋白激素，怀有先天愚型胎儿的母亲血中InhA表现为升高，一般正常平均MOM值为2.0以上。
筛查结果是高危的孕妇需要进行产前诊断，通过羊水穿刺进行准确的判断，才能确定是否真正存在缺陷。
注意事项：
检查唐筛不一定要空腹。随着医学的进步，不少医院已经没有空腹的要求了。不过具体还是以医生的要求为准。
另外，要带好以往的检查结果，尤其是最近一次的B超单。（唐筛需要确定孕周）
三、血糖和糖耐量筛查（75g OGTT）
检测血糖的浓度，主要用于诊断，将血糖控制在正常范围内，减少母儿并发症，降低围生儿死亡率。主要方法通过糖筛查及糖耐量进行检测。每一位孕妇都要进行检查。
糖耐的检查结果会有三份，包括空腹抽血、1h后抽血和2h后抽血结果，在报告单的右上角会有标识时间，内容里会有糖耐量的正常范围值以及抽取血液检查的糖耐量实际值，如果实际值在参考值以内，则属于正常；如果实际值在血糖值以外，则可能是妊娠期糖尿病。
糖筛和糖耐的参考指标：对比项目糖筛糖耐定义是妊娠期糖尿病筛查的简称，是检查血糖和血液的一种方法。是糖筛不过关时需要进一步进行检查时做的血糖测试。糖量50g75g抽血次数4次3次正常值空腹血糖≤7.8mmol/L空腹血糖≤5.1mmol1小时血糖≤10mmol/L2小时血糖≤8.5mmol/L检查结果大于7.8mmol/L要做糖耐三项中任何一项达到或者超过临界值即可诊断为妊娠糖尿病。注意事项：
检查血糖时，要求空腹，禁食至少10小时，一般在测定前一天晚上10点以后不能吃任何食物。
四、胎心监护
胎心监护是通过绑在孕妇身上的两个探头进行的，一个绑在子宫顶端，是压力感受器，其主要作用是为了了解有无宫缩及宫缩的强度；另一个放置在胎儿的胸部或背部，进行胎心的测量。仪器的屏幕上有胎心和宫缩的相应图形显示，孕妇可以清楚地看到胎儿的心跳。
胎心监护仪上的两条线，一条是胎心率，正常情况下波动在120~160，一般表现为基础心率线，多为一条波形曲线，出现胎动时心率会上升，出现一个向上突起的曲线，胎动结束后会慢慢下降。胎动＞30次/12小时为正常，胎动计数＜10次/12小时提示胎儿缺。下一条线表示宫内压力，在宫缩时会增高，随后会保持20mmHg左右。
胎心过快或过慢不一定都有问题，异常情况出现时，医生会进行下一步的处理，或复查胎监，或做B超，或入院。
常规项目：
体重是判断孕妇体质状况的重要指标。如果孕妇身体消瘦多病，那么胎儿的生长发育自然也受影响。如果过度摄入营养导致孕妇过胖，不仅行动不便，还会引起疾病、巨大儿、、产力不足、产程过长等。
怀孕后体重多少算合适
将初次产检测得的体重值作为估计未来孕期体重增加的基准值，怀孕后孕妇体重要明显增加，整个孕期要增加10-13kg。如果不增加或者增加体重小于正常，可能是胎儿宫内发育迟缓或孕妇营养不良。如果每周增加超过0.5千克，则要注意有无异常情况发生，建议到医院检查以明确原因，最常见的情况是孕妇营养过剩引起肥胖、、妊娠水肿或多胎妊娠。
孕妇正常血压范围为：不超过（140/90mmHg），或与基础血压相比不超过（30/15mmHg）。如果大于或等于140/90mmHg就是异常，孕妇可能患有妊娠高血压疾病。
七、血常规
血常规是临床上最基础的化验检查之一，检验的项目包括红细胞、白细胞、血红蛋血小板数量等，用针刺法采集指血或垂末梢血，经稀释后滴入特制的计算盘上，再置于显微镜下计算血细胞数目，通过观察这些细胞的数量和形态分布来判断疾病。血常规检查是医生诊断病情的常用辅助手段之一。
血常规检查数据解读：项目正常范围白细胞计数(WBC)（5~12）×109 个/升中性粒细胞绝对值（NEUT）（2~7.5）×109 个/升中性粒细胞百分率（NEUT％）50％~70％单核细胞绝对值（MONO)（0~0.8）×109 个/升单核细胞百分率（MONO％）3％~8％嗜酸粒细胞绝对值（EO）（0~0.7）×109 个/升嗜酸粒细胞百分率（EO％）1％~5％嗜碱粒细胞绝对值（BASO)（0~0.1）×109 个/升嗜碱粒细胞百分率（BASO％）0~2％细胞绝对值（LYMPH)（1~3.5)×109 个/升淋巴细胞百分率（LYMPH％）20％~40％红细胞计数（RBC)3.6×1012 个/升血红蛋白（HGB)110克/升血细胞比容（HCT）0.31~0.34血小板计数（PLT）（100~300）×109 个/升网织红细胞计数（RET）（24~84）×109 个/升 （0.5％~1.5％）注意事项：
一般情况下单独检查血常规无需空腹，但因为第一次产检时做血常规是和血糖、肝功能、检查等项目一起进行，则在空腹状态下抽血即可。
当抗A（B）lgG效价&1:128时，则胎儿可能发生病。
Rh血型不合且抗体效价&1:32，提示病情严重。
注意事项：
抽血检查需空腹。
九、尿常规
尿常规通过对孕妇尿液表象及成分的分析，检测孕妇是否可能患有某些泌尿系统疾病或糖尿病。尿常规检查主要是通过尿液分析仪和显微镜人工镜检来进行分析检测的。尿常规对于泌尿系统以及糖尿病的筛查具有重大意义，更是供应病理过程本质的重要依据。
尿常规检查数据解读：项目正常值范围异常风险酸碱度（pH）4.6-8.0（平均值6.0）增高常见于频繁、等；降低常见于酸中毒、慢性肾小球、糖尿病等。尿比重（SG）1.015-1.025增高多见于高热、心功能不全、糖尿病等；降低多见于和等。尿胆原（URO）＜16超过此数值，说明有。隐血（BLO）阴性（-）阳性（+）同时有蛋白者，考虑病和出血。白细胞（WBC）阴性（-），&5个/HP超过五个，说明尿路感染。尿蛋白（PRO）阴性或仅有微量阳性提示可能有、糖尿病肾变。尿糖（GLU）阴性（-）阳性提示可能有糖尿病、、等。胆红素（BIL）阴性（-）阳性提示可能肝细胞性或阻塞性黄疸。酮体（KET）阴性（-）阳性提示可能酸中毒、糖尿病、呕吐、腹泻。尿红细胞（RBC）阴性（-）阳性提示可能、肾炎尿路感染等。尿亚硝酸盐（NIT）阴性（-）阳性提示可能膀肮炎、肾盂肾炎等。尿液颜色（GOL）浅黄色至深黄色黄绿色、尿混浊、血红色等就说明异常。十、肝功检查
通常所说的肝功五项指的是谷丙转氨酶、谷草转氨酶、总胆红素、直接胆红素和间接胆红素。肝功五项中任何一项出现异常都说明肝功能异常，此时准妈妈应医生指导下做进一步检查，查出肝功能异常的原因，并对症治疗。
肝功能检查数据解读：
1、肝细胞损伤：检查肝功能是否受损，常见的检查项目有谷丙转氨酶、谷草转氨酶等。
1）谷丙转氨酶（ALT）：谷丙转氨酶主要存在于肝细胞细胞质中。正常值是0-40U/L，偏高时说明损伤。
2）谷草转氨酶（AST）：主要存在于肝细胞线粒体中。正常值是0-40U/L，偏高时说明肝脏受损，可能是由肝脏疾病引起，也有可能是由服药、过度劳累等原因引起。
2、肝脏分泌和排泄功能：常见的检查肝功能排泄和分泌的功能的项目有直接胆红素，总胆红素等。
1）总胆红素（TBIL）：包括直接胆红素和间接胆红素。正常值是1.7-17.1μmol/l，偏高时易发生黄疸症状。
2）间接胆红素（IBIL）：在肝脏中由间接胆红素转变，从胆管排出。正常值是1.7-13.7μmol/l，偏高时说明肝脏病变或胆道受阻。
3）直接胆红素（D-BIL）：直接胆红素是红细胞死亡或破坏时，有血红蛋白释放到血液中。正常值是 0-3.4μmol/L，偏高时说明肝脏病变或红细胞遭破坏。
注意事项：
抽血检查需空腹。
十一、空腹血糖、血钙、血脂
空腹血糖正常值3.9-5.1mmol/L。如果血糖超过正常范围一点点，是没关系的。平时要注意控制。
血钙浓度比较稳定，正常值为2.25-2.75mmol/L。维持血钙正常浓度中起重要作用的激素主要有甲状旁腺素、降钙素和胆钙化醇。
血脂名称正常范围总胆固醇2.8~6.0 mmol/L甘油三酯0.56~1.7 mmol/L胆固醇脂2.8~5.17mmol/L (110~200mg/dl)占总胆固醇的70％至75％高密度脂蛋白0.9~1.55 mmol/L低密度脂蛋白0-4.2 mmol/L十二、抗体
丙肝是病毒性的一种，与具有着很多相同点有着很多不同点。丙肝抗体其正常值是1000，即为阴性。如果丙肝抗体的值大于1000，预示着丙肝抗体已呈阳性，从而丙肝抗体阳性也说明了丙肝病毒的出现。
十三、反应素
正常参考值：阴性。
孕妇应该常规在孕早期和孕晚期各进行一次毒血清学检查，梅毒孕妇在治疗后及分娩前应该每月进行一次梅毒血清学检查，梅毒孕妇的孩子出生后应该立即留脐血做梅毒血清学检查，无论结果是阴性还是阳性，均需定期复查，以便了解治疗效果和及时发现、处理无症状的梅毒感染。
十四、HIV抗体
正常参考值：阴性。
孕妇如何感染了HIV病毒，其HIV抗测结果可为阳性，由于这类方法存在一定假阳性，HIV抗体筛查呈阳性反应的标本，必须做进一步的确认试验。
十五、优生四项（巨细胞病毒、病毒、风疹病毒、弓形虫）
包括巨细胞病毒、单纯疱疹病毒、风疹病毒和弓形虫。
巨细胞病毒正常参考值：阴性。
单纯疱疹病毒正常参考值：阴性。
风疹病毒正常参考值：阴性。
弓形虫正常参考值：阴性。
十六、微量元素
孕妇微量元素正常值
卵脂——1000MG
牛磺酸——20MG
叶酸——200UG
1——0.8MG
B2——0.8MG
十七、骨密度检测
一般情况下，专业医生会建议孕妇在怀孕期间最好进行3次骨密度检查。第一次一般在怀孕初期~16周之间均可，检查的目的是看孕妇自身的钙储备情况；第二次一般在怀孕20~24周，检查孕妇的钙吸收情况，以确保孕妇能够在胎儿骨骼发育初期，为胎儿提供充足的钙；第三次一般在怀孕28周以后，这个阶段胎儿生长迅速，通过检查，可以了解孕妇是否可以为胎儿提供足量的钙。因此，在孕20周左右进行一次骨密度的检查还是很有必要的。
骨密度检查结果参考：
世界卫生组织(WHO)根据骨密度水平的测量结果(BMD)与健康年轻人数据两者之间的标准差(SD)，定出以下4项指标。
正常：骨密度在年轻人平均值的1SD内(+1～-1SD)
低骨密度：骨密度低于年轻人平均值1～2.5SD(-1～-2.5SD)
症：骨密度低于年轻人平均值2.5SD(低于-2.5SD)
严重骨质疏松症：骨密度低于年轻人平均值2.5SD，伴有一处或多处骨质疏松性。
十八、宫高、腹围
妊娠期子宫的增大是有规律性的，表现为宫底升高，腹围增加。一般从怀孕20周开始，每4周测量1次，怀孕28-35周每2周测量一次，怀孕36周后每周测量一次。
宫高标准时间参考值（cm)时间参考值(cm)孕20周16.0-20.5孕31周25.0-31.5孕21周17.0-21.5孕32周26.0-32.5孕22周18.0-22.5孕33周27.0-33.5孕23周19.0-23.5孕34周27.5-34.5孕24周20.0-24.5孕35周28.5-35.5孕25周21.0-25.5孕36周29.0-36.5孕26周21.5-26.5孕37周29.5-37.5孕27周22.5-27.5孕38周30.5-38.5孕28周23.0-28.5孕39周31.0-38.5孕29周23.5-29.5孕40周32.0-38.5孕30周24.0-30.5腹围标准时间腹围下限(cm)腹围上限(cm)标准腹围(cm)孕5月月月月月月8910094十九、胎心率
胎心就是胎儿的心跳。正常胎心率为120-160次/分钟，心音强而有规律。
如果胎心率在无宫缩时加快，超过160次/分钟，说明胎儿处于缺氧早期。
如果胎心率减慢，低于120次/分钟，则说明缺氧严重。
如果B超监测发现胎心不规律，则提示有的可能性。
二十、胎位
胎位是指胎位先露的指定部位与母体前、后、左、右的关系，正常胎位多为枕前位。妊娠32周后经产前检查，发现臀位、横位等称为胎位不正，其中以臀位较为常见。胎位不正如果得不到纠正，分娩时可造成难产或无法顺产。
二十一、胎动
胎儿在妈妈子宫内的活动叫做胎动，是胎儿在宫内安危的重要指标。胎动可分为转动、翻动、滚动及高频率活动。通常在怀孕4个月左右，孕妇即可以感受到胎动。胎动有一定的规律，往往早晨最少，上午8-12时胎动较均匀，以后逐渐减少，下午2-3时减至最少，晚上6-10时左右最活跃。此外，胎动还与孕妇的血糖水平有一定的关系，往往孕妇在后一个小时左右胎动较为活跃。
数胎动是保障胎儿安全的自我监测的最好方法。孕妇自28周开始，每天早、中、晚各数一次胎动，数胎动时取侧卧位（最好左侧位）或坐位，保持安静和注意力集中，双手置于腹部计数1小时，一下胎动算为一次，连续胎动算为一次，将三次胎动数相加乘以4，即为12小时胎动数。
二十二、骨盆测量
骨盆能够支持并保护生殖器官和骨盆内的其他器官，同时它也是产道最重要的组成部分，是生产时胎儿生出的重要通道，其形态和大小都关系着是否能顺利分娩，因此，孕妇在初次产前检查时都必须要进行骨盆测量及检查。
骨盆测量数据解读：
骨盆的大小是以各骨之间的距离，即骨盆径线大小来表示。每个人的骨盆大小和形态受到个人的身体发育、营养状况、遗传和种族差异的影响而有所不同，所以，在正常范围内骨盆各径线，其长短也有一定的差别。目前在各种资料中描述的骨盆径线值，是许多正常骨盆的平均数值。
1、骨盆形态正常，但各条径线均小于正常径线最低值2厘米以上，诊断为均小骨盆，可发生难产。
2、若骨盆形态轻微异常，但各径线均大于正常低值径线，则可能经阴道顺利分娩。
3、骶耻外径（EC）小于18cm、对角径（DC）小于11.5cm时，诊断为扁平骨盆。
4、耻骨弓角度小于90°，坐骨结节间径小于8cm，坐骨结节间径与出口矢状径之和小于15cm，骨切迹宽度小于2横指时，诊断为漏斗性骨盆。
5、坐骨切迹宽度间接反映中骨盆后矢状径大小、中骨盆狭窄往往伴有骨盆出口狭窄，通过测量坐骨结节间径、坐骨棘内突程度以及坐骨切迹宽度，间接判断中骨盆狭窄程度。
（以上内容由快乐孕期hy280t撰稿发布）
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