Prostatitis

一、肿瘤标志物是什么？肿瘤标志物（TM），学术上通常是指在恶性肿瘤的发生和增殖过程中，由肿瘤细胞本身所产生的或是由机体对肿瘤细胞反应异常产生/升高的，反映肿瘤存在和生长的一类物质。包括蛋白质、激素、酶等等。通俗一点来说，就像是肿瘤细胞在你的身体里和你打仗，无论是打赢了还是打输了总要留下点“战争的痕迹”，以此来彰显它的存在。正是它的“虚荣心”出卖了它的行踪，留下了“肿瘤标记物”。二、肿瘤标志物升高就代表得了癌症？没有肿瘤的人，肿瘤标志物也可能会升高。特别当肿瘤标志物轻度升高时，可能是体内存在一些非肿瘤性的其他疾病。比如：月经期、妊娠早期血清 CA125 可增高；妊娠期 CEA 可轻度升高，AFP 明显升高；肝肾功能异常、胆道梗阻和炎症感染等均可造成肿瘤标志物，如 CEA、CYFRA 21-1、SCC、ProGRP 等浓度增高；肝硬化、慢性活动性肝炎、结核、子宫内膜异位症患者 CA125 可升高；胆汁淤积能导致血清 CA19-9 浓度增高。肿瘤标志物升得越高，恶性可能就越大么？肿瘤标志物升高几倍、十多倍、几十倍，当然比只升高一点点、升高一倍更有意义，但也并非绝对。比如，有些慢性肝炎AFP可高达1000ug/L以上（正常<30ug/L），但增强磁共振没有发现肝脏肿块，而且AFP随着肝功能好转而下降，就可以排除肝癌。因此，肿瘤标志物升高还需结合临床综合判断。（主要通过临床影像检查，要找到肿瘤存在的客观依据才能确诊！）三、肿瘤标志物正常能排除癌吗？既然肿瘤标志物升高不能代表得了癌症，那反过来，肿瘤标志物正常能不能说明没有癌症呢？实际上即便得了肿瘤，也并不能保证肿瘤标志物检测结果100%是高的。也就是说，肿瘤标志物阴性，也不能完全排除相关肿瘤。比如在肝癌病人中，肝癌标志物甲胎蛋白（AFP）的阳性率仅为79%~90%，10%～30%的原发性肝癌患者指标正常或只有轻度升高。肿瘤细胞在体内发展初期，很难被检测到，只有当肿瘤细胞分泌出来蛋白分子，我们才能在血液里检测到，这个“时间差”可能有三四个月。此外，有些癌型不分泌蛋白分子，就更难被“捕捉”了。实际上动态观察肿瘤标志物更重要。特别是肿瘤标志物升高幅度不大的情况下，动态观察它的变化趋势更有价值，一般1～2个月复查一次该肿瘤标志物，并有必要做其它关联的肿瘤标志物检测。如果肿瘤标志物逐步增高或持续增高，或出现其它肿瘤标志物也增高，有必要在3个月后，再行影像学或胃肠镜检查，或更精密检查。因为在初期不一定发现小的肿瘤，经过3个月长大后，就有可能被发现了。如果多次复查，结果大致保持稳定，没有一次比一次升高（允许小幅度上下波动），或肿瘤标志物逐步下降，那通常表示它不是癌症引起的，也就是说这个指标跟癌症没有直接关系。四、不同细胞来源的肿瘤标志物种类大有不同由于不同脏器的细胞来源和属性不同，所形成的的肿瘤标志物也是不尽相同的。因此，当健康人群出现某一肿瘤标志物的异常升高时，我们可以寻找到相应的“患病脏器”；在肿瘤患者治疗过程中，出现某一异常指标升高时，也能提示有“转移”或“新发癌症”类型的存在。而即使同一脏器，肿瘤起源细胞也可大不相同。比如肺癌，可以包含起源于腺泡细胞肺腺癌，伴随CEA指标的升高；也可以起源于支气管鳞状上皮细胞的肺鳞癌，伴随SCC指标的升高；也可以起源于支气管粘膜上或腺上皮的嗜银细胞的小细胞肺癌，伴随NSE指标的升高。不同肿瘤标志物的升高还有助于我们“病理类型”的诊断。当一位肺腺癌的患者在长期靶向治疗后，出现了NSE和Cyfry21指标的升高，提示可能出现“小细胞肺癌”的类型转化。而混合型肿瘤患者，往往同时兼具不同肿标的同时升高。因此，学会解读肿瘤标志物，对我们的肿瘤治疗非常有实用价值。不同脏器的代表肿标1、甲胎蛋白（AFP）【参考值】AFP＜20μg/L【临床意义】① AFP是诊断原发性肝癌的最佳标志物，诊断阳性率为60%~70%。② 血清AFP>400μg/L 持续4周，或 200~400μg/L持续8周者，结合影像检查，可做出原发性肝癌的诊断。③AFP可早于影像学6~12月出现异常，为肝癌的早期诊断提供重要依据，建议肝硬化患者定期复查AFP。④ 病毒性肝炎、肝硬化患者血清中AFP浓度可有不同程度升高，其水平常＜300μg/L。⑤ 内胚层癌、畸胎瘤、睾丸癌、卵巢癌、胃癌等伴肝转移者AFP可升高。⑥妇女妊娠3个月后，AFP开始升高，7~8个月时达高峰，一般在400ng/ml以下，分娩后3 周恢复正常。若在妊娠期AFP异常升高，要排除胎儿神经管缺损、畸形可能。2、α-L-岩藻糖苷酶（AFU）【参考值】ELISA法和分光光度连续监测法为234~414μmol/L【临床意义】① AFU是对原发性肝细胞性肝癌检测的又一敏感、特异的标志物。② 原发性肝癌患者血清AFU活力显著高于其他各类疾患（包括良、恶性肿瘤）。③ 血清AFU活性动态曲线对判断肝癌治疗效果、估计预后和预示复发有着极其重要的意义，在某些方面比AFP更具有价值。但是，血清AFU活力测定在某些转移性肝癌、肺癌、乳腺癌、卵巢或子宫癌，甚至在某些非肿瘤性疾患如肝硬化、慢性肝炎和消化道出血等也有轻度升高。④ 在使用AFU时应与AFP同时测定，可提高原发性肝癌的诊断率，有较好的互补作用。3、癌胚抗原（CEA）【参考值】≦5.9μg/L【临床意义】①CEA升高主要见于结/直肠癌、胃癌、肝癌、肺癌、胰腺癌、乳腺癌、卵巢癌、子宫及子宫颈癌、泌尿系肿瘤等，其他恶性肿瘤也有不同程度的阳性率。②肝硬化、肝炎、肺气肿、肠道憩室、直肠息肉、结肠炎等良性病CEA也可升高。③癌症病人的胸水、腹水、消化液、分泌物中的CEA常升高。④正常人吸烟者CEA 可升高。4、糖类抗原125（CA125）【参考值】＜2.5万u/L（男性及50岁以上女性）；＜4.0万u/L（20~40岁女性）【临床意义】① CA125对卵巢上皮癌的敏感性可达约70%。②其他非卵巢恶性肿瘤（宫颈癌、宫体癌、子宫内膜癌、胰腺癌、肺癌、胃癌、结/直肠癌、乳腺癌）也有一定的阳性率。③良性妇科病（盆腔炎、卵巢囊肿、子宫内膜异位症、盆腔炎、胰腺炎、肝炎、肝硬化等）和早期妊娠可出现不同程度的血清CA125含量升高。④在许多良性和恶性胸、腹水中也可发现CA125升高。5、糖类抗原15-3（CA15-3）【参考值】＜2.5万u/L【临床意义】① CA15—3可作为乳腺癌辅助诊断，术后随访和转移复发的指标。②其他恶性肿瘤也有一定的阳性率，如∶肺癌、结肠癌、胰腺癌、卵巢癌、子宫颈癌、原发性肝癌等。③肝脏、胃肠道、肺、乳腺、卵巢等非恶性肿瘤性疾病，阳性率一般＜10%。6、糖类抗原19-9（CA19-9）【参考值】0~40kU/L【临床意义】① 血清CA19—9可作为胰腺癌、胆囊癌等恶性肿瘤的辅助诊断指标，对监测病情变化和复发有很大意义。② 胃癌、结/直肠癌、肝癌、乳腺癌、卵巢癌、肺癌等患者的血清CA19—9水平也有不同程度的升高。③ 某些消化道炎症CA19—9也会升高，如∶急性胰腺炎、胆囊炎、胆汁淤积性胆管炎、肝炎、肝硬化等。7、糖类抗原50（CA50）【参考值】0~2.0万u/L【临床意义】CA50在多种恶性肿瘤中可检出不同的阳性率，对胰腺癌和胆囊癌的阳性检出率居首位，其他依次为肝癌、胃癌、结直肠癌、卵巢与子宫癌、恶性胸水等。8、糖类抗原242（CA24-2）【参考值】＜20IU/ml【临床意义】① CA24-2用于胰腺癌，大肠癌的辅助诊断，有较好的敏感性（80%）和特异性（90%）。② 肺癌、肝癌、卵巢癌患者的血清CA24-2含量也可见升高。9、糖类抗原72-4（CA72-4）【参考值】＜6.7μg/L【临床意义】① CA72-4是目前诊断胃癌的最佳肿瘤标志物之一，若与CA19—9及CEA联合检测可以监测70%以上的胃癌。② CA72-4水平与胃癌的分期有明显的相关性，有转移者更高。③结/直肠癌、胰腺癌、肝癌、肺癌、乳腺癌、卵巢癌也有一定的阳性率。④ 良性胃病患者中，其检出率仅0.7%。10、神经元特异性烯醇化酶（NSE）【参考值】＜16.3ng/ml【临床意义】① NSE是小细胞肺癌（SCLC）的肿瘤标志物，诊断阳性率为91%。②有助于小细胞肺癌和非小细胞肺癌（NSCLC）的鉴别诊断。对小细胞肺癌的疗效观察和复发监测也有重要价值。③ 神经母细胞瘤、神经内分泌细胞瘤的血清NSE浓度可明显升高。11、鳞状上皮细胞糖类抗原（ SCCA）【参考值】≦1.5μg/L【临床意义】SCCA是鳞癌的肿瘤标志物，适用于宫颈癌、肺鳞癌、食管癌、头颈部癌、膀胱癌的辅助诊断，治疗观察和复发监测。12、前列腺特异抗原（PSA）【参考值】＜4.0μg/L【临床意义】① PSA是目前广泛应用于前列腺癌的肿瘤标志物。②前列腺癌血清PSA升高，阳性率在50%～80%，前列腺增生、前列腺炎、肾脏和泌尿生殖系统的疾病也可见血清PSA升高。③ 良性前列腺增生血清中游离PSA的比例是显著增高的。④ 有关前列腺损伤的各种检查均可引起PSA的明显升高。⑤PSA水平随年龄的增加而增加，一般以每年0.04ug/L的速度递增。PSA水平与前列腺的体积有关。13、前列腺酸性磷酸酶（PAP）【参考值】≦4.0μg/L【临床意义】①前列腺癌时，血清PAP浓度明显升高，其升高程度与肿瘤发展基本呈正相关。②病情好转时，PAP水平降低，若再次升高时，常提示癌症有复发、转移及预后不良。14、胃泌素释放肽前体（ProGRP）【参考值】≦65pg/mL【临床意义】①ProGRP＞150pg/mL时，提示小细胞肺癌（SCLC）的可能性＞93%，是小细胞肺癌的首选标志物之一。②血清ProGRP持续升高，提示预后不良。15、核基质蛋白-22（NMP-22）【参考值】≦10kU/mL【临床意义】①以10kU/mL为临界值，对膀胱癌诊断的敏感度为70%，特异度78.5%。②对浸润性膀胱癌诊断的敏感度为100%。识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

转自：中华中医药学会 编辑：水晶近日，中华中医药学会发布了《中药新药研发用临床需求清单（第一批）》（征求意见稿），公开征求意见。《清单(第一批) 》，共涉及恶性肿瘤、干燥综合征、类风湿关节炎、慢性非细菌性前列腺炎、慢性心力衰竭、特应性皮炎胃食管反流病、腺样体肥大、原发性肾病综合征、子宫内膜异位症等10 个病种。《中药注册管理专门规定》提出，中药新药研制应当坚持以临床价值为导向，重视临床获益与风险评估，发挥中医药防病治病的独特优势和作用，注重满足尚未满足的临床需求。为了明确各专科的具体临床需求，引导药品研发机构或制药企业主动开展中药研发立项评估，我会试点组织肿瘤分会、风湿病分会、男科分会、心血管病分会、皮肤科分会、脾胃病分会、儿科分会、妇科分会、肾病分会和肺系病分会等10个分支机构，以及北京中医药大学东方医院转化医学中心和中日友好医院的相关专家，基于流行病学资料充分分析临床需求、结合中药治疗的特点，起草了《中药新药研发用临床需求清单（第一批）》（征求意见稿），现公开征求意见。  本次公开征求意见的时间为2023年11月1日至2023年11月15日。有关单位和个人可以将意见反馈至cacmfzyj@163.com，主题请注明“中药新药研发用临床需求意见反馈”。  中华中医药学会  2023年11月1日

Most of Chris Turner’s career is steeped in healthcare, having worked for companies such as Healthgrades, Evariant, and Medici. His latest challenge as CEO of HealthBook+ is twofold: Provide a way for individuals to aggregate and leverage their personal health information safely and securely for health guidance and give employers predictive insights to help their staff get to their best health. Turner said he came up with the idea for HealthBook+ with Co-founders Stathis Topouzoglou, who owns a shipping company, and Dr. Panos Sechopoulos, who became the company’s Chief Medical Officer. In the shipping world, if a crew member gets sick, it can be very costly for the company to return the ship to shore to attend to them. Adding to the medical challenge is that commonly there is a language barrier between a captain and their crew. What Stathis needed was a way to ensure crew members received personalized and appropriate healthcare while at the same time avoiding unnecessary shipping delays. The solution, Turner soon realized, was to tap into a personalized medicine approach developed by Dr. Sechopoulos. It ensured each member of the crew had a portable medical history on their mobile phone as well as AI that could detect the triage level and give a list of possible conditions that could be easily shared if the crew member became ill at sea. Not only would they be provided with prompt treatment directed by a physician, but the company would mitigate additional costs resulting from delays and disruption. Turner explained how the core of HealthBook+ technology is set up. It uses a very secure and private database which connects with companies managing about 85% of the electronic health records in the U.S. That data ports over into its data warehouse and is augmented with other sources of data, which includes claims data obtained through relationships with 40% of the commercial payers. It also obtains data through wearables from Apple Health, Google Health, Fitbit, Garmin and glucose monitors, with potential to add an additional 500 remote patient monitoring devices. Turner added that the company also purchases socio-economic data and is working on adding genetic information. Chris Turner “If we take this as the core, and then add a bunch of different data sets so that we have the most data on an individual, layer some AI-driven predictive analytics and inference engines on top of that data, then we would have something that is really cool,” Turner said. “We can help people take ownership of their health by leveraging all the data that is available, as well as AI tools, so that people could understand what the next step in their healthcare journey needs to be.” But the benefits go beyond just the individual. Employers are also helped by HealthBook+’s technology, particularly those who face substantial insurance claims due to employees’ cancer diagnosis or treatment for other costly health conditions, which, cause their plan rates to increase. “What we’re able to do is work with the de-identified and aggregated employee population data and then help employers negotiate with their plan for a better premium,” said Turner. “For all employers we can leverage these population sets of data to identify the best benefits specific to an employer’s staff.” HealthBook+ has two sets of AI engines — one focused on preventive care and another on reactive care. The preventive engine deploys models around the most expensive and debilitating conditions for employers, spanning mental health, diabetes, heart disease, and high-risk pregnancy. The idea is to provide a way for users to receive earlier intervention and then help direct them to an in-network primary care physician or a specialist, if needed. The reactive AI-driven engine is for acute care situations with the goal of directing people to the appropriate level of care. The app’s interface provides a way for users to enter their symptoms for an instant health check. The AI engine will ask a set of questions based on the symptom information provided and then provide a shortlist of possible conditions and where they can get in-network help. Turner offered an example of a success story with the instant health check. A young male in his mid-thirties and 6 ‘6″-6’ 7″ tall experienced pelvic pain and went to the emergency room nine different times, including three by ambulance. Clinicians kept telling him he had prostatitis — an infection of the prostate — and he was not getting better. He started losing his hair and in four months lost about 20% of his body weight. Using the instant health check, he entered his symptoms, and because the app already had his health history, he was able to get a personalized list of possible conditions to share with his team of clinicians. “In bringing these two sets of data together, the AI engine concluded that it was likely a kidney-related issue,” Turner said. “That led physicians to perform a pelvic MRI, and he was diagnosed with a blocked urethra, which was causing his kidneys to swell to 50% larger than they should be. That’s what was causing all the pain and discomfort, so he ended up having a couple surgeries and he’s now on the mend.” Turner added: “With the differential diagnosis alone, we’ve identified about a 40% reduction in people who said they were set to go to the emergency room and the AI determined their care level should be telehealth or primary care, so they made the conversion to the more appropriate care level. The instant health check combined with telemedicine is a perfect way to reduce costs for patients, employers and payers while improving access to care. It is about a $1,800 savings per occurrence for employers and payers just even in that one component alone.” Turner has an ambitious outlook for the company. Asked what’s on his to do list for the next 12 months, Turner highlighted some of the goals. One is to further leverage the company’s Medical Advisory Board to improve the service’s accuracy and personalization. In January, HealthBook+ will be launching its Care Club+ which helps people manage care of their children and parents. HealthBook+ is also expanding its partnerships and adding an API gateway to realize its goal of providing a health hub that streamlines an individual’s access to digital health tools and clinicians. “If people go to multiple hospitals, they’ve got maybe two or three different patient portals they need to log into. When they go to clinics, each one of those typically has a different patient portal,” Turner said. “Their health plan has a different patient portal, and if they have a wearable that data lives somewhere else. If the employer sponsors any digital health applications, all that data is also somewhere else. We want to be that hub for access to all this healthcare data.”