Chinese quality control indices for standardized diagnosis and treatment of renal cancer(2022 edition)

Renal cancer is one of the most common malignancies of the urinary system,and the number of deaths continues to increase.The standardized management of the diagnosis and treatment of renal cancer is challenging due to the great differences in the diagnosis and treatment of renal cancer in different regions.The Renal Cancer Expert Committee of the National Cancer Quality Control Center(NCQCC)identified a lack of authoritative quality control standards as an opportunity to utilize its multidisciplinary membership to improve the standardized diagnosis and treatment of renal cancer.The Renal Cancer Expert Committee of the NCQCC aims to promote quality control and national standardization,uniformity,and normalization of renal cancer diagnosis and treatment,which ultimately improved the survival rate and quality of life of renal cancer patients.A panel of experts with renal cancer surgery,renal cancer medicine,medical imaging,pathology and radiotherapy were drawn together and determined the quality control standards for the standardized diagnosis and treatment of renal cancer.The Indices includes 20 items that cover all key areas in the diagnosis and treatment of renal cancer,such as standard diagnosis,surgery treatment,systemic treatment,and prognostic evaluation.

Quality control indices for standardized diagnosis and treatment of esophageal cancer in China (2022 edition)

Esophageal cancer(EC)is particularly common in China.With the continuing progress of multi-disciplinary therapy including early screening,minimally invasive techniques,radiotherapy and chemotherapy,the 5-year survival of EC has been improved in China.However,there are considerable disparities in the diagnosis and treatment quality among different regions.The Esophageal Cancer Expert Committee of the National Cancer Quality Control Center(NCQCC)considers a set of authoritative quality control standards as an opportunity to eliminate the disparities and improve the overall survival and quality of life of EC.To further promote the quality control for standardized diagnosis and treatment of EC,the National Cancer Center commissioned the Esophageal Cancer Quality Control Expert Committee to draft and formulate the Chinese Quality Control Indices for Standardized Diagnosis and Treatment of Esophageal Cancer(2022 edition).The Indices includes 21 items that cover all key areas in the diagnosis and treatment of esophageal cancer,such as medical oncology,radiation oncology,endoscopy,and pathology.

A holistic strategy for quality and safety control of traditional Chinese medicines by the “iVarious” standard system

An effective quality control system is the key to ensuring the quality, safety and efficacy of traditional Chinese medicines(TCMs). However, the current quality standard research lacks top-level design and systematic design,mostly based on specific technologies or evaluation methods. To resolve the challenges and questions of quality control of TCMs, a brand-new quality standard system, named "iVarious", was proposed. The system comprises eight elements in a modular format. Meaning of every element was specifically illustrated via corresponding research instances. Furthermore, frankincense study was taken as an example for demonstrating standards and research process, based on the "i Various" system. This system highlighted a holistic strategy for effectiveness,security, integrity and systematization of quality and safety control standards of TCMs. The establishment of"i Various" integrates multi-disciplinary technologies and progressive methods, basis elements and key points of standard construction. The system provides a novel idea and technological demonstration for regulation establishment of TCMs quality standards.

Chinese quality control indices for standardized diagnosis and treatment of gastric cancer(2022 edition)

Gastric cancer is one of the most common malignancies of the digestive system,and the number of deaths continues to increase.The standardized management of the diagnosis and treatment of gastric cancer is challenging due to the great differences in the diagnosis and treatment of gastric cancer in different regions.The Gastric Cancer Expert Committee of the National Cancer Quality Control Center(NCQCC)identified a lack of authoritative quality control standards as an opportunity to utilize its multidisciplinary membership to improve the standardized diagnosis and treatment of gastric cancer.The Gastric Cancer Expert Committee of the NCQCC aims to promote quality control and national standardization,uniformity,and normalization of gastric cancer diagnosis and treatment,which ultimately improved the survival rate and quality of life of gastric cancer patients.A panel of experts with gastrointestinal cancer surgery,gastrointestinal cancer medicine,medical imaging,pathology and radiotherapy were drawn together and determined the quality control standards for the standardized diagnosis and treatment of gastric cancer.The authors then utilized a modified Delphi approach to generate consensus recommendations.

Establishment of Characteristic Chromatogram of Honeysuckle Stem Formula Granules Based on the Concept of Whole Process Quality Control

[Objectives]To establish a HPLC characteristic spectrum of honeysuckle stem formula granules,and to evaluate the quality consistency based on the standard decoction.[Methods]Using Agilent ZORBAX SB-C_(18)(5μm,250 mm×4.6 mm)chromatographic column;gradient elution with acetonitrile-0.4%phosphoric acid solution(0.2:99.8,V/V),column temperature at 25℃;detection wavelength at 236 nm;flow rate 1.0 mL/min;using"Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine",to evaluate the similarity of the characteristic chromatogram of crude drug,standard decoction and formula granules of honeysuckle stem.[Results]The similarity of characteristic chromatogram was higher than 0.94,and 6 components were identified from 10 characteristic peaks.[Conclusions]The established method can more comprehensively reflect the overall appearance of the chemical substances in the honeysuckle stem and the transmission law,and can provide an experimental basis for the consistency of the quality of the honeysuckle stem formula granules.

Quality Standard Research of Shenqi Qiangjing Granules

[Objectives]The paper was to establish the quality standard of Shenqi Qiangjing granules and to conduct routine inspection of granular dosage forms.[Methods]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were detected.Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis were qualitatively identified by thin layer chromatography(TLC).[Results]The particle size,moisture,loss on drying,dissolubility,content uniformity and microbial limit of Shenqi Qiangjing granules were all in line with the relevant regulations of Pharmacopoeia of the People's Republic of China(2020 edition).Radix Astragali,Herba Epimedii,Radix Dipsaci and Fructus Schisandrae Chinensis had clear fluorescent spots in TLC assay,and no such spots were found in negative control.[Conclusions]The method has the advantages of simple operation,accurate and reliable results,strong specificity and good repeatability,and can effectively control the quality of Shenqi Qiangjing granules.

Standardization and Quality control parameters of Kayam Churna

Kayam Churna is proprietary ayurvedic formulation which is blend of seven ingredients which are Senna leaves(Cassia angustifolia),Black Salt,Mulethi(Glycyrrhiza glabra),Nishoth(Operculina turpethum),Ajwain(Trachyspermum ammi),Haritaki(Terminalia chebula)and Svarjikshara(Sodium bicarbonate)with Senna as a major ingredient.Standardization and stability studies play a vital role for each herbal formulation,so the research was carried out to prepare the formulation in the laboratory and to standardize the Churna,by means of its physicochemical properties,phytochemical analysis and microbiology study.The organoleptic and powdered characteristics were studied and compared with monographs.Various physicochemical analysis was carried out like bulk density,tapped density,percent compressibility,loss on drying,ash value and heavy metal determination.Phytochemical analysis was carried out to find the presence of tannins,alkaloids,glycosides,flavonoids and steroids.Microbiological analysis was evaluated using the Total Viable Count method.HPTLC Chromatographic technique was used for fingerprinting.Microscopic analysis of Formulation showed the presence of Vessels,Fibre,Calcium oxalate crystals,etc.Tannins,Alkaloids,flavonoids were found to be present in the formulation.Microbial count and all physicochemical parameters were found to be within the limits as per the WHO guidelines.Further studies can be carried out for finding out its efficacy and potency.

Improving tuberculosis infection control practice and microbial air quality in a general hospital after intervention

Objective:Hospital personnel,especially nurses are at risk for tuberculosis(TB) infection and the intervention for reducing the risk should be established.Methods:To compare the TB infection control practices and standard precaution in 154 registered nurses and auxiliary nurses working in risk wards.Additionally,microbial air quality in the studied wards was investigated before and after implementation of an intervention including twoday training program on TB infection control and standard precaution practices and managing the ward environments. Results:Post-intervention,the percentage of studied nurses who always practiced increased in every item of TB infection control practice(6 items) and standard precaution(9 items) when compared with the preintervention period.Both mean scores were significantly higher than those before intervention(5.0±1.0 vs 4. 4±1.1,and 7.6±1.3 vs 6.7±1.5,P【0.001,respectively).As well as,bacterial and fungal counts in air samples collected from every studied ward decreased after implementing the intervention,for example, mean of bacterial counts in OPD decreased from 387.8±249.5 cfu/m^3 to 194.4±134.3 cfu/m^3.Additionally, there was no air sample with high level of bacterial and fungal counts,whereas,3.7 -22.2%of air samples collected before intervention had high level of bacterial counts(】500 cfu/m^3).Conclusion:Two-day training program and management of the ward environment could improve the scores of TB infection control practices and the standard precaution among studied nurses and reduce the microbial counts in air samples collected from the studied wards.

The development of Fructus corni quality standard considering the effects of processing

The quality standards for Fructus Comi have been established based on the effects of the manufacturing processes.Three critical process parameters(CPPs)of extraction,filtration,and concentration to prepare Fructus Comi concentrate were identified by Plackett-Burman design with a single batch of Fructus Corni,which were heating medium temperature,extraction time,and water addition.Morroniside yield,loganin yield,and dry matter yield were process critical quality attributes(CQAs).CPPs arranged with a Box-Behnken design were applied to treat different batches of Fructus Comi After constructing a model that included CPPs,material propertie s,and process CQAs,loganin content was found to be the critical material attribute(CMA).The design space was calculated with a probability method.According to the limits of process CQAs,the minimum content of loganin in Fructus Corni was calculated with an error propagation method,which was 6.92 mg·g^(-1).When the content of loganin in Fructus Corni reaches up to 6.92 mg·g^(-1),the material is considered high-quality and is most suitable for the process.High-quality material can be used for production of Fructus Comi concentrate.This method can also be used to set material quality standards for other Chinese medicines.

Quality control methods for KOOS operational sea surface temperature products

Sea surface temperature SST obtained from the initial version of the Korea Operational Oceanographic System（KOOS） SST satellite have low accuracy during summer and daytime. This is attributed to the diurnal warming effect. Error estimation of SST data must be carried out to use the real-time forecasting numerical model of the KOOS. This study suggests two quality control methods for the KOOS SST system. To minimize the diurnal warming effect, SSTs of areas where wind speed is higher than 5 m/s were used. Depending on the wind threshold value, KOOS SST data for August 2014 were reduced by 0.15°C. Errors in SST data are considered to be a combination of random, sampling, and bias errors. To estimate bias error, the standard deviation of bias between KOOS SSTs and climatology SSTs were used. KOOS SST data yielded an analysis error standard deviation value similar to OSTIA and NOAA NCDC（OISST） data. The KOOS SST shows lower random and sampling errors with increasing number of observations using six satellite datasets. In further studies, the proposed quality control methods for the KOOS SST system will be applied through more long-term case studies and comparisons with other SST systems.

System Control Research of Multi-link Fructus Trichosanthis Quality

It could not guarantee the quality of medicinal materials and decoction pieces to purely make quality standard of traditional Chinese medicine and carry out quality control. For the problems existed in each process and link of traditional Chinese medicine production,control techniques and measures of guaranteeing and improving quality should be proposed,thereby forming process control system for quality of each traditional Chinese medicine. Based on systemic research on Fructus Trichosanthis which is common traditional Chinese medicine more than30 years,the concept of establishing process control system of Fructus Trichosanthis quality is proposed firstly in this paper. The research aims to find quality problems from 10 processes and links( plant variety,cultivation and propagation,field pest control,fruiting and maturity degree of fruit,storage,regulator,chemical ingredient,quality standard,limited index and circulation),and form feasible techniques and measures solving problems in each process and link,thereby systemically guaranteeing the quality of Fructus Trichosanthis medicinal material and decoction pieces. It guarantees and improves clinical efficacy of Fructus Trichosanthis in Chinese medicine,and could provide reference for establishing process control system of quality of other traditional Chinese medicines.

Importance of quality control in lipidomics profiling based on mass spectrometry

As a current analytical instrument for lipidomics profiling with high sensitivity, selectivity, and throughput, mass spectrometry (MS) has been widely used in the field of clinical medicine, nutrition, bromatology, botany and etc. During the routine use of shotgun- MS and high performance liquid chromatography-MS (HPLC-MS) in lipid analysis, an important problem to be solved is the defective repeatability and stability resulting from signal attenuation or drifts in LC-peak shape and retention time of MS platform. To remove or minimize the influence, extensively accepted and applied QC (quality control) samples must be performed. In this review, we emphasize the importance of the application of QC samples, which could 1) provide the ability to equilibrate the analytical platform at the beginning; 2) act as a quality assurance (QA) procedure during the analytical process; 3) perform signal correction in the data handling with the purpose of reducing analytical variation and improving the precision of quantitative analysis; 4) the data between different laboratories can be compared through the incorporation of particular QC samples-Standard Reference Material (SRM) 1950. In addition, we display 4 types and requirements of QC samples during quality control in lipidomics profiling. Lipidomics profiling based on MS strongly requires commonly accepted guidelines for quality control to perform routine, large-scale researches, so as to integrate data from different scientists for more information.

Considerations on the Quality Standards Reflecting the Characteristics of Compound Preparations of Traditional Chinese Medicine

Objective To study the current quality standard of traditional Chinese medicine(TCM)and its limitations in China,and encourage enterprises to take more responsibility to promote the development of this industry.Methods Based on the analysis of the status quo and problems of the quality standard system of TCM,the quality control mode,as well as the problems found in the reevaluation after marketing,some suggestions were put forward for adjusting the current quality standard of TCM.Results and Conclusion Through strengthening the quality control of the source,and under the premise of ensuring the safety,effectiveness and stability of TCM,the quality standards of TCM can be improved greatly.

影像检查规范化及管理体系建设与实施

基于“健康中国”战略的正式实施,为响应我国“十四五”时期党中央以及国务院对于人民群众医疗高质量发展的要求,通过优化医疗资源的利用效率,降低就医负担,并保障医疗质量以及安全;其内容包括影像检查规范化。本研究基于文献查阅以及江苏省影像规范化执行现状提出建设性意见和建议;影像检查规范化需要行政部门和医疗机构的体系支撑,同时还要有行业以及设备厂家的技术保障;行政主管部门制定和定期更新符合我国国情的影像指南以及具体实施细则,加强影像平台数据库建设,建立影像检查管理与评估体系,加大影像质控覆盖范围。医疗机构基于影像检查指南以及相关制度,强化培训并严格落实考核制度,执行影像检查和报告的智能质控和评价系统;开设独立的影像门诊或多科室联合门诊,提高临床诊疗的科学性和精准性。医务人员加强学习和执行相关检查指南以及实施细则,基于多学科诊疗平台提高规范化影像检查水平,积极开展影像新技术的研发和应用,提高影像检查的高效性和诊断的精准性。通过制定统一的符合我国国情和时代的影像指南以及影像工作实施细则,执行具体规范措施和方案,大力推进影像检查规范化。

油田开发中精细油藏描述成果平台建设研究

精细油藏描述是油田开发最基础的工作之一,历来受到研究者的高度重视。目前精细油藏描述中存在的突出问题主要包括研究成果继承性差、基础资料存储不规范、专业软件需求缺口大、成果应用需加强和成果存储管理不规范等5方面。文章通过精细油藏描述成果平台建设,可以从基础数据的整理准备、专业软件共享和协同研究、成果标准规范化存储管理等方面解决上述问题。精细油藏描述数据管理主要包括项目整体数据信息的统计和分析、项目研究数据的整理和统计、成果平台与其他数据平台的对接和数据调用等。精细油藏描述协同研究过程主要包括专业软件的平台实现和使用、不同专业软件之间中间成果的转换和调用、研究工作的自动化实现和完成。精细油藏描述成果存储和管理主要包括成果上传管理中格式的统一规范、成果存储上传中的质量控制、成果生产应用中的跟踪和更新。

中国与美国环境空气监测用标气管理比较与经验启示

中国生态环境监测事权上收改革后,生态环境监测工作实施的主体呈现多元化发展趋势,作为生态环境监测关键“量具”的气体标准物质/标准样品涉及的制造商日趋多元化,其量值准确性和一致性直接影响中国大气环境监测数据的准确性和可比性。为掌握并提升中国生态环境监测在用气体标准物质/标准样品质量,总结了美国环境监测气体标准管理经验,提出中国气体监测用标准物质/标准样品管理建议,助力实现中国大气环境监测数据真、准、全、快、新。

新收入准则会影响审计费用吗?——来自A+H股上市公司的经验证据

收入是企业利益相关者评价企业财务状况和经营业绩的关键指标。新收入准则的实施成效也成为理论界与实务界共同关注的焦点议题。从审计费用的视角,以2018年修订后的新收入准则在A+H股上市公司的实施为研究契机,选取2017—2019年中国A股上市公司数据,实证检验新收入准则对审计费用的影响。研究发现,新收入准则的施行提高了企业的审计费用。机制检验发现,新收入准则通过增加重大错报风险和提高审计投入两条路径提高了审计费用。异质性检验发现,新收入准则对审计费用的正向影响主要存在于受新收入准则影响较大、存在内部控制缺陷、由大规模事务所审计的企业中。进一步研究发现,新收入准则在提高审计费用的同时,还会使审计质量得到一定程度的改善。研究结论丰富了新收入准则经济效应领域的研究文献,同时为审计师在新收入准则背景下提高专业胜任能力、完善审计工作及控制审计风险提供新思路。

控制图在车用催化器中贵金属测定中的应用

研究建立一种应用于催化器中贵金属测定过程监控的均值-标准差质控图,以确保实验室日常分析结果的准确、可靠。采用标准HJ 509-2009中电感耦合等离子体质谱法测定催化转化器中的铑、钯、铂等3种贵金属元素的含量,收集近两年的质控样的60组数据,进行了正态分布检验,计算了各元素含量结果的平均值、标准偏差,绘制了均值控制图和标准差控制图。结果表明,质控样中铑、钯、铂贵金属元素的数据结果均在均值控制图、标准差控制图的上下限范围内,表明实验室在该段期间内利用电感耦合等离子体质谱法对催化转化器样品中的铑、钯、铂的测定结果的准确可靠。均值-标准差控制图可以有效地观察整个贵金属元素测定过程中的数据变化趋势,有助于判断检测过程是否受控,以保证日常的报告检测结果符合实验室报出的要求,确保结果的准确可靠。

腹腔镜结肠直肠癌手术的标准化操作、质量控制与疗效评价

腹腔镜结肠直肠癌手术的安全性和有效性已得到多项大型临床研究的证实,腹腔镜已成为我国结肠直肠癌外科治疗的主要方式。基于循证医学证据与临床实践积累的经验,腹腔镜结肠直肠癌手术技术仍在持续优化和改进,其关键技术主要围绕以下3方面:(1)完整的手术切除范围;(2)合适的淋巴结清扫范围;(3)安全的消化道重建。重视腹腔镜结肠直肠癌手术的标准化操作,推动手术的规范化开展,形成科学的手术评价体系,做好手术疗效评估,并开展高质量的临床研究,是提高我国腹腔镜结肠直肠癌手术规范化水平的关键。