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目的为研究DNA条形码技术在中成药鉴定中的应用,以三七片为研究对象,对方法的适用性、专属性与精密度进行考察。方法收集15批次市售三七片样品,考察三七片DNA提取条件,并对"中药材DNA条形码分子鉴定法指导原则"中PCR扩增、序列获得、结果判定等方法适用性进行确认;收集三七、人参、西洋参,制作三七片及其掺伪品,考察方法的专属性和重现性。结果三七片取样量100 mg,56℃水浴8 h所获得DNA的质量浓度平均值为60.7 ng/μL,PCR扩增、序列获得和结果判定均可获成功;三七、人参和西洋参的ITS2序列长度均为230bp,三七与人参、三七与西洋参的序列间均存在7个稳定的SNP位点,自制三七片和掺伪三七片均可成功获得ITS2序列,不同比例三七与人参、三七与西洋参的测序峰图在SNP位点处呈现相应峰高比的SNP套峰具备专属性;重复性、中间精密度和重现性考察符合《中国药典》2015年版(通则9101)相关要求。结论 ITS2序列作为DNA条形码能够稳定、准确鉴定三七片的原料药材,具备良好的专属性和精密度,三七片DNA条形码分子鉴定法将为保障三七片临床用药安全提供新的技术手段,并对《中国药典》其他收载单方制剂的鉴定提供参考。  相似文献   
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Purpose

A hydrogel rectal spacer (HRS) is a medical device that is approved by the U.S. Food and Drug Administration to increase the separation between the prostate and rectum. We conducted a cost-effectiveness analysis of HRS use for reduction in radiation therapy (RT) toxicities in patients with prostate cancer (PC) undergoing external beam RT (EBRT).

Methods and Materials

A multistate Markov model was constructed from the U.S. payer perspective to examine the cost-effectiveness of HRS in men with localized PC receiving EBRT (EBRT alone vs EBRT + HRS). The subgroups analyzed included site of HRS placement (hospital outpatient, physician office, ambulatory surgery center) and proportion of patients with good baseline erectile function (EF). Data on EF, gastrointestinal and genitourinary toxicities incidence, and potential risks associated with HRS implantation were obtained from a recently published randomized clinical trial. Health utilities and costs were derived from the literature and the 2018 Physician Fee Schedule and were discounted 3% annually. Quality-adjusted life years (QALYs) and costs were modeled for a 5-year period from receipt of RT. Probabilistic sensitivity analysis and value-based threshold analyses were conducted.

Results

The per-patient 5-year incremental cost for spacers administered in a hospital outpatient setting was $3578, and the incremental effectiveness was 0.0371 QALYs. The incremental cost-effectiveness ratio was $96,440/QALY for patients with PC undergoing HRS insertion in a hospital and $39,286/QALY for patients undergoing HRS insertion in an ambulatory facility. For men with good baseline EF, the incremental cost-effectiveness ratio was $35,548/QALY and $9627/QALY in hospital outpatient and ambulatory facility settings, respectively.

Conclusions

Based on the current Medicare Physician Fee Schedule, HRS is cost-effective at a willingness to pay threshold of $100,000. These results contain substantial uncertainty, suggesting more evidence is needed to refine future decision-making.  相似文献   
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IntroductionPrenatal exposure to di(2-ethylhexyl) phthalate (DEHP) has been reported to be associated with adverse effects on neurodevelopment that yield behavior syndromes in young children with an estimated median exposure lower than the currently recommended tolerable daily intake (TDI) and reference dose (RfD).ObjectivesOur aim was to derive the benchmark dose for prenatal exposure to DEHP for the neurodevelopmental health in children.MethodsA total of 122 mother-child pairs from the Taiwan Maternal and Infant Cohort Study were analyzed for the dose-response relationship between maternal exposure to DEHP and children's behavioral syndromes evaluated at 8 years (n = 122, 2009), 11 years (n = 96, 2012), and 14 years (n = 78, 2015) of age. We employed a multivariate regression model to assess the statistical associations between the estimated maternal average daily intake of DEHP and child's individual CBCL scores for boys and girls at each separate age, followed by a mixed model for all the children across three ages accounting for individual variations. We then employed structural equation models by combining the children's specific behavioral problem scores at different ages and obtained a simulated overall latent score in relation to maternal exposure. Based on the established dose-response relationship, we derived the benchmark dose (BMD) and the lower limit (BMDL).ResultsAssociations of maternal DEHP exposure (median 4.54μg/kg_bw/day) with the Child Behavior Checklist (CBCL) scores were all significant, except for somatic complaints, adjusting for child's age, gender, IQ, and family income. The BMDL, given a benchmark response of 0.10 (0.05) and a background response of 0.05, was 6.01 (2.16) μg/kg_bw/dayfor an integrated CBCL score.ConclusionsThe current TDI (RfD) of 50 (20) μg/kg_bw/day for DEHP might not protect pregnant women for their children from behavioral problems. There remains the lack of comparable toxicological data. Further investigations are needed.  相似文献   
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Salivary glands tumours are uncommon tumours showing a large diversity of histological types. This article presents a synthesis of patterns and paths of invasion of parotid glands tumours in order to propose an approach of the delineation of primary tumour clinical target volumes and of the selection of lymph nodes target volumes. This article does not discuss treatment indications but defines clinical target volumes to treat if radiotherapy is indicated. Postoperative situation being the most frequent, the delineation of primary tumour clinical target volume is based on an anatomical approach.  相似文献   
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目的:为了验证丹参类黄酮-3′,5′-羟基化酶(Flavonoid 3′,5′-hydroxylase,F3′5′H)基因与丹参花色表型的相关性,本研究克隆并分析了紫花丹参99-3株系和一些白花丹参中的F3′5′H基因。方法:本研究通过提取紫花丹参和白花丹参中的总RNA,再将其反转录得到cDNA,以此cDNA为模板,利用PCR方法扩增获得F3′5′H基因全长序列。再利用生物信息学分析方法,分析了该基因编码蛋白质的理化性状、结构域、系统进化等特点,并预测了该蛋白质的亚细胞定位、跨膜区等;利用实时定量PCR方法检测了该基因的表达特异性;利用毛状根遗传转化方法获得了该基因的过表达阳性毛状根株系。结果:F3′5′H基因全长1551 bp,编码516个氨基酸,相对分子质量为57.4 kDa。该基因在丹参花中高丰度表达。在42份(紫花25份;白花17份)丹参样品中发现一个单核苷酸多态性(Single Nucleotide Polymorphisms,SNP)位点在紫花和白花丹参中呈现与花色相关的稳定变化。系统发育分析表明丹参F3′5′H与美女樱的F3′5′H具有较高序列同源性。获得了过表达F3′5′H的毛状根株系。结论:本研究在丹参中克隆到F3′5′H基因,对其序列进行了分析,为进一步研究丹参F3′5′H基因的功能奠定基础。  相似文献   
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