Herbal Textual Research on Olibanum in Famous Classical Formulas / 中国实验方剂学杂志

By consulting the ancient and moderm literature， this paper makes a textual research on the name， origin， quality evaluation， harvesting and processing of Olibanum， so as to provide a basis for the development of the famous classical formulas containing this medicinal material. According to the herbal textual research， the results showed that Olibanum was first described as a medicinal material by the name of Xunluxiang in Mingyi Bielu（《名医别录》）， until Ruxiang had been used as the correct name since Bencao Shiyi（《本草拾遗》） in Tang dynasty. The main origin was Boswellia carterii from Burseraceae family. The mainly producing areas in ancient description were ancient India and Arabia， while the modern producing areas are Somalia， Ethiopia and the southern Arabian Peninsula. The medicinal part of Olibanum in ancient and modern times is the resin exuded from the bark， which has been mainly harvested in spring and summer. It is concluded that the better Olibanum has light yellow， granular， translucent， no impurities such as sand and bark， sticky powder and aromatic smell. There were many processing methods in ancient times， including cleansing（water flying， removing impurities）， grinding（wine grinding， rush grinding）， frying（stir-frying， rush frying， wine frying）， degreasing， vinegar processing， decoction. In modern times， the main processing methods are simplified to cleansing， stir-frying and vinegar processing. Nowadays， the commonly used specifications include raw， fried and vinegar-processed products. Among the three specifications， raw products is the Olibanum after cleansing， fried products is a kind of Olibanum processed by frying method， vinegar-processed products is the processed products of pure frankincense mixed with vinegar. Based on the research results， it is recommended to select the resin exuded from the bark of B. carterii for the famous classical formulas such as Juanbitang containing Olibanum， processing method should be carried out in accordance with the processing requirements of the formulas， otherwise used the raw products if the formulas without clear processing requirements.

Establishment of a multifunctional impact system and a study of a pancreatic trauma model in rats based on controlling the injury area.

Background: At present, basic scientific research on pancreatic trauma is rare due to the lack of ideal animal models and modeling equipment for pancreatic trauma. Therefore, we intend to develop a multifunctional impact system with simple operation, diverse impact and accurate measurement and to establish a rat pancreatic trauma model based on injury area control by using the system. Methods: The impactor was designed based on the convenience of the impact energy acquisition, the diversity of the impact operation, and the precision of the impact strength parameter measurement by the team. The efficacy and stability/repeatability of the impactor were preliminarily evaluated. An impact head with different impact areas (3 cm2 and 6 cm2) of the impactor was used to squeeze the rat pancreas in the abdomen to form different injury areas under a pressure of 400 kPa. The efficacy features of this trauma model were evaluated by detecting the outcomes of pathology and biochemistry at 24 h after injury in the two groups. Furthermore, these changes were also evaluated at 6 h, 24 h, 48 h and 72 h after injury in the 3 cm2 trauma group. Result: Multifunctional impactors were successfully explored. The impact force was continuously adjustable with a range of 0-200 kg. The compression and extrusion stress ranges were continuously adjustable from 0 to 100 kg. System adjustment verified that the impactor had fine efficacy (P < 0.05) and stability/repeatability (P > 0.05). Compared with the control group, rats in the pancreatic trauma group with different injury areas exhibited obvious injuries (P < 0.05), and compared with the 3 cm2 trauma group, the 6 cm2 trauma group exhibited the more severe injury (P < 0.05). After modeling, the injury characteristics at different time points showed stable differences(P < 0.05). Conclusions: A rat pancreatic trauma model based on injury area control was successfully established using the impactor developed in this study. This model is simple, effective, controllable, and suitable for animal experimental research on pancreatic trauma.

Demand and supply of community-based care services for the elderly in China and its influencing factors / 中华老年医学杂志

Objective:To explore the demand and actual supply of community-based care services for the elderly residents and the factors that affecting care mode for them in the context of rapid urbanization and population aging in China.Methods:Based on the cross-sectional data of the seventh China Longitudinal Survey on Health and Longevity(CLHLS)(2018), 15 854 elderly residents aged 60 and above were selected as the research population.Logistic regression method was used to analyze the patterns of community-based care services and their influencing factors.Results:Among 15 854 elderly residents, 6 912(43.60%)were male and 8 942(56.40%)were female.The results of activities of daily living(ADL)evaluation showed that 11 109 elderly residents could take care of themselves completely, and 3 889 elderly residents were disabled.The disability rate was 25.93%.The proportion of social services that elderly town dwellers expect the community to provide is higher than those living in cities and rural areas in terms of daily care, spiritual care, providing health care knowledge, and dealing with neighborhood disputes.From the perspective of social services actually provided by the community, in addition to providing home-based care, the proportion of community services available to the elderly living in towns and rural areas are similar, but significantly lower than the proportion of social services provided for elderly city dwellers.Age, marital status, residence, cultural differences, health status, source of life and living preference had significant impacts on the choice of care demand patterns.Those of older age( OR=2.29, 95% CI: 1.04-5.03 for 70-79 years old; OR=2.94, 95% CI: 1.38-6.25 for elderly 80 years old or above), having no spouse( OR=3.50, 95% CI: 2.49-4.92), and with higher levels of disability( OR=4.24, 95% CI: 3.12-5.77 for mild disability; OR=7.54, 95% CI: 5.19-10.95 for moderate disability; OR=10.50, 95% CI: 7.59-14.53 for severe disability)are more inclined to choose socialized care. Conclusions:In the process of rapid urbanization in China, the demands for care services of elderly living in towns has increased, but the actual care services provided for them by the communities are yet to be improved.Moreover, elderly town dwellers are still inclined to family care, the same as those of elderly rural dwellers.

Ginkgo biloba extract protects against depression-like behavior in mice through regulating gut microbial bile acid metabolism / 中国天然药物

Depression is a mental disorder with high morbidity, disability and relapse rates. Ginkgo biloba extract (GBE), a traditional Chinese medicine, has a long history of clinical application in the treatment of cerebral and mental disorders, but the key mechanism remains incompletely understood. Here we showed that GEB exerted anti-depressant effect in mice through regulating gut microbial metabolism. GBE protected against unpredictable mild stress (UMS)-induced despair, anxiety-like and social avoidance behavior in mice without sufficient brain distribution. Fecal microbiome transplantation transmitted, while antibiotic cocktail abrogated the protective effect of GBE. Spatiotemporal bacterial profiling and metabolomics assay revealed a potential involvement of Parasutterella excrementihominis and the bile acid metabolite ursodeoxycholic acid (UDCA) in the effect of GBE. UDCA administration induced depression-like behavior in mice. Together, these findings suggest that GBE acts on gut microbiome-modulated bile acid metabolism to alleviate stress-induced depression.

Experimental study on the therapeutic effect of different bleaching methods on white-spot lesions of the enamel using optical coherence tomography / 口腔医学

Objective@#To investigate the efficacy of different bleaching methods on white-spot lesions of the enamel using optical coherence tomography and to evaluate its feasibility for monitoring the therapeutic effects on white-spot lesions. @*Methods@#Forty-eight sound premolars extracted for orthodontic reasons were selected and cut for 4 mm×4 mm×2 mm enamel blocks in buccal surfaces of the crowns. The samples were covered with acid-resistant varnish (except for the buccal surfaces) and immersed in demineralization solution for 18 days to establish the white-spot lesion models of the enamels. Samples were randomly divided into four groups (n=12). Group A was given demineralization only. Specimens in Group B, C and D were treated with 40% hydrogen peroxide, resin infiltration and 40% hydrogen peroxide combined with resin infiltration, respectively. Eight samples in each group were randomly selected. OCT was applied to observe the optical changes of the enamel surface and according to the OCT scanning results, the demineralization depth of enamel samples in each group was calculated. Then, the enamel blocks were embedded in epoxy resins, except the buccal surfaces, and measured for the microhardness values of the enamel surface by a microindentation hardness tester. Four samples in each group were cut longitudinally, and the ultrastructural changes of enamel samples in each group were observed by scanning electron microscope. @* Results@#OCT showed that the light scattering characteristics of enamel surface changed in all groups, and the bright layer was formed, but the thickness of bright layer in Group C and D was significantly lower than that in Group A and B (P<0.05). The microhardness values (kg/mm2) of the samples in Group A-D were (214.99±31.70), (250.66±33.64), (312.42±18.01) and(286.53±26.65), respectively. The microhardness of enamel surfaces in Group C and D was significantly higher than that in Group A and B (P<0.05), and the ultrastructure of enamel surfaces in Group C and D were more flat and dense in SEM observation (P<0.05). @*Conclusion@#The methods of resin infiltration therapy or 40% hydrogen peroxide combined with resin infiltration could effectively improve white-spot lesions of the enamel and the non-invasive OCT can be used as a better evaluation method for the diagnosis and treatment of white-spot lesions of the enamel.

Role of new serological markers in evaluating the progression of liver disease in patients with chronic HBV infection and normal aminotransferases / 临床肝胆病杂志

Antiviral therapy is the basic treatment method for improving prognosis recommended in the management guidelines of chronic hepatitis B in China and globally. For patients with chronic HBV infection and normal transaminases, it is difficult in clinical practice to accurately evaluate the progression of hepatitis and identify suitable patients who need antiviral therapy. In order to objectively and accurately evaluate the degree of liver inflammatory activity in such patients, more and more noninvasive evaluation indicators have been used in addition to conventional liver biopsy. This article reviews the new serological indicators that can reflect the degree of liver inflammation and/or fibrosis in patients with chronic HBV infection and normal aminotransferase levels, hoping to provide a reference for antiviral decision-making in these patients.

Herbal Textual Research on Eucommiae Cortex in Famous Classical Formulas / 中国实验方剂学杂志

In order to provide the basis for the development of famous classical formulas， the name， origin， quality evaluation， harvesting and processing of Eucommiae Cortex were systematically researched by consulting the ancient herbal and medical books， combining with the modern literature. According to the textual research， materia medica in the past dynasties used Eucommiae Cortex as the correct name. Combined with characteristics， origin and efficacy， Eucommiae Cortex in ancient times to the present is the dry bark of Eucommia ulmoides from family Eucommiaceae. The earliest producing areas of Eucommiae Cortex are Henan， Shanxi， Shaanxi and Sichuan. Since the Ming dynasty， the producing areas have expanded to most of the regions in the country， and Sichuan， Shaanxi， Chongqing， Guizhou and Hubei are regarded as the authentic producing areas. It has been concluded that the quality of Eucommiae Cortex is best if the bark has thick body， large block， scraped rough skin， multi silk section and dark purple internal surface. In ancient times， the processing methods of Eucommiae Cortex were mainly included removing rough bark and cutting for raw use， processing with auxiliary materials such as honey， ginger juice， salt water， wine， and so on. While in modern times， the processing methods have become increasingly simplified which are mainly cutting raw materials after cleansing and salt processing. It is need to excavate the connotation of different processed products and restore the traditional main processing methods through standards. Based on the requirement of Eucommiae Cortex in Sanbitang， it is suggested to use ginger-processed products according to the research results， which is used ginger juice as auxiliary material and processed with stir frying method according to the 2020 edition of Chinese Pharmacopoeia.

Determination of biological exposure limit of damage in red blood cells caused by exposure to polycyclic aromatic hydrocarbons using benchmark dose method in general population / 公共卫生与预防医学

Objective To explore the biological exposure limit of blood system damage caused by long-term exposure to polycyclic aromatic hydrocarbons (PAHs) in non-occupational population by using the benchmark dose method, and to provide relevant reference for further improving the assessment of PAHs-induced health damage effects. Methods Adult residents living in downwind direction of a coke-oven plant in Shanxi Province were selected as the research subjects, and the information collected from baseline was used as the control. The metabolites of PAHs in urine were used as exposure biomarker, and the abnormal rate of red blood cell index was used as response biomarker. The relationship between urinary OH-PAHs and the erythrocyte damage rate was analyzed, and the benchmark dose (BMD) and the lower confidence limitation for the benchmark dose (BMDL) were calculated using Bayesian dose-optimizing software. Results The urinary PAH metabolites were mainly naphthalene and fluorene. The detection concentrations of 2-OHFlu and 1-OHPhe in the final year were higher than those in the baseline (P<0.05). With the increase of exposure years, the abnormal rate of red blood cells in the final year was higher than that in the baseline (P<0.05). In addition, the abnormal rate of red blood cells increased with the increase of the concentrations of five metabolites of PAHs in urine, and the chi-square trend test was significant (P<0.05). The benchmark dose (BMD) of OH-PAHs was 0.67 μmol/mol Cr, 0.82 μmol/mol Cr, 1.40 μmol/mol Cr and 0.78 μmol/mol Cr, respectively. The BMD of 2-OHNap in people with barbecue diet habits was 0.23 μmol/mol Cr. The BMD of 2-OHNap in people without barbecue diet habits was 1.44 μmol/mol Cr. Conclusion There is a dose-response relationship between the concentration of PAHs metabolites in urine and the damage of red blood cells. Long-term exposure to PAHs can lead to hematological damage. It is suggested that targeted public health interventions should be formulated to reduce the exposure of the general population to PAHs.

Silencing of SMAD family member 3 promotes M2 polarization of macrophages and the expression of SMAD7 in rheumatoid arthritis / 细胞与分子免疫学杂志

Objective To investigate the effect of SMAD family member 3(SMAD3) silenced by small interfering RNA (siRNA) on macrophage polarization and transforming growth factor β1 (TGF-β1)/ SMAD family signaling pathway in rheumatoid arthritis (RA). Methods RA macrophages co-cultured with rheumatoid arthritis fibroblast-like synoviocytes (RA-FLS) were used as a cell model. TGF-β1 was used to stimulate macrophages, and SMAD3-specific siRNA (si-SMAD3) and negative control siRNA (si-NC) were transfected into human RA macrophages co-cultured in TranswellTM chamber. The expression of SMAD3 mRNA was detected by real-time fluorescence quantitative PCR, and the expression of TGF-β1, SMAD3 and SMAD7 protein was detected by Western blot analysis. The contents of TGF-β1 and IL-23 in cell culture supernatant were determined by ELISA. Cell proliferation was detected by CCK-8 assay. TranswellTM chamber was used to measure cell migration. Results Compared with the model group and the si-NC group, the expression of TGF-β1, SMAD3 mRNA and protein in RA macrophages decreased significantly after silencing SMAD3. In addition, the secretion of IL-23 decreased significantly, and the cell proliferation activity and cell migration were inhibited, with high expression of SMAD7. Conclusion Knockdown of SMAD3 can promote M2 polarization and SMAD7 expression in RA macrophages.

High-fat intake alleviates lung injury induced by Paragonimus proliferus infection in rats through up-regulating CYP 4A1 expression in lung tissues / 中国血吸虫病防治杂志

Objective To explore the improvements of high-fat intake on lung injury induced by Paragonimus proliferus infection in rats, and to preliminarily explore the mechanisms underlying the role of cytochrome P450 4A1 (CYP 4A1) in the improve ments. Methods SD rats were randomly assigned into three groups, including the normal control group (n = 10), the infection and normal diet group (n = 12) and the infection and high-fat diet group (n = 12). Rats in the normal control group were fed with normal diet and without any other treatments, and animals in the infection and normal diet group were subcutaneously injected with 8 excysted metacercariae of P. proliferus via the abdominal wall, followed by feeding with normal diet, while rats in the infection and high-fat diet group were subcutaneously injected with 8 excysted metacercariae of P. proliferus via the abdominal wall, followed by feeding with high-fat diet. All rats were sacrificed 28 weeks post-infection, and serum samples and lung specimens were collected. Following hematoxylin-eosin (HE) staining of rat lung specimens, the rat lung injury was observed under an optical microscope, and alveolitis was evaluated using semi-quantitative scoring. Serum interleukin-1β (IL-1β) and tumor necrosis factor alpha (TNF-α) levels were measured using enzyme-linked immunosorbent assay (ELISA), and the cytochrome P450 4A1 (CYP 4A1) expression was quantified in rat lung specimens at transcriptional and translational levels using quantitative real-time PCR (qPCR) and Western blotting assays. Results Alveolar wall thickening, edema and inflammatory cell infiltration were alleviated 28 weeks post-infection with P. proliferus in rats in the infection and high-fat diet group relative to the infection and normal diet group, and no alveolar consolidation was seen in the infection and high-fat diet group. The semi-quantitative score of alveolitis was significantly higher in the infection and normal diet group [(2.200 ± 0.289) points] than in the normal control group [(0.300 ± 0.083) points] and the infection and high-fat diet group [(1.300 ± 0.475) points] (both P values < 0.05), and higher serum IL-1β [(151.586 ± 20.492)] pg/mL and TNF-α levels [(180.207 ± 23.379) pg/mL] were detected in the infection and normal diet group than in the normal control group [IL-1β: (103.226 ± 3.366) pg/mL; TNF-α: (144.807 ± 1.348) pg/mL] and the infection and high-fat diet group [IL-1β: (110.131 ± 12.946) pg/mL; TNF-α: (131.764 ± 27.831) pg/mL] (all P values < 0.05). In addition, lower CYP 4A1 mRNA (3.00 ± 0.81) and protein expression (0.40 ± 0.02) was quantified in lung specimens in the infection and normal diet group than in the normal control group [(5.03 ± 2.05) and (0.84 ± 0.14)] and the infection and high-fat diet group [(11.19 ± 3.51) and (0.68 ± 0.18)] (all P values < 0.05). Conclusion High-fat intake may alleviate lung injuries caused by P. proliferus infection in rats through up-regulating CYP 4A1 expression in lung tissues at both translational and transcriptional levels.

Clinical features and diagnostic approaches for abdominal tuberculosis: five-year experience from a non-tuberculosis-designated hospital in China

Background and purpose: abdominal tuberculosis (TB) is a common form of extrapulmonary TB but it is still a diagnostic dilemma in clinical practice. This study aimed to highlight the clinical features and diagnostic approaches for abdominal TB.Methods: seventy cases of diagnosed abdominal TB were retrospectively collected between August 1st, 2015 and June 30th, 2020. They were classified as peritoneal TB, lymph node TB, gastrointestinal TB, visceral TB or mixed TB.Results: eighteen patients were diagnosed with peritoneal TB, nine with lymph node TB, five with gastrointestinal TB, two with visceral TB and 36 with mixed TB. More than 65 % of the patients had tuberculosis of other sites except the abdomen. The median diagnosis time was 60 days. Ascites (58.6 %), abdominal distension (48.6 %), weight loss (44.3 %) and fever (42.9 %) were the most common symptoms. The overall microbiological and histological detection rates were 70.0 % and 38.6 %, respectively. The non-ascite samples yielded a higher microbiological confirmation rate (63.6 %) than the total samples (40.8 %). Diagnosis was confirmed histologically in 18 patients (69.2 %). Forty-five cases (64.3 %) were clinically diagnosed. Invasive procedures such as surgery (6/7), percutaneous biopsy (7/7) and endoscopy in lymph node TB (4/5) had high confirmation rates.Conclusions: the diagnosis of abdominal TB should be reached by a combination of clinical, laboratory, radiological, microbiological and pathological findings. (AU)

Clinical features and diagnostic approaches for abdominal tuberculosis: five-year experience from a non-tuberculosis-designated hospital in China.

BACKGROUND AND PURPOSE: abdominal tuberculosis (TB) is a common form of extrapulmonary TB but it is still a diagnostic dilemma in clinical practice. This study aimed to highlight the clinical features and diagnostic approaches for abdominal TB. METHODS: seventy cases of diagnosed abdominal TB were retrospectively collected between August 1st, 2015 and June 30th, 2020. They were classified as peritoneal TB, lymph node TB, gastrointestinal TB, visceral TB or mixed TB. RESULTS: eighteen patients were diagnosed with peritoneal TB, nine with lymph node TB, five with gastrointestinal TB, two with visceral TB and 36 with mixed TB. More than 65 % of the patients had tuberculosis of other sites except the abdomen. The median diagnosis time was 60 days. Ascites (58.6 %), abdominal distension (48.6 %), weight loss (44.3 %) and fever (42.9 %) were the most common symptoms. The overall microbiological and histological detection rates were 70.0 % and 38.6 %, respectively. The non-ascite samples yielded a higher microbiological confirmation rate (63.6 %) than the total samples (40.8 %). Diagnosis was confirmed histologically in 18 patients (69.2 %). Forty-five cases (64.3 %) were clinically diagnosed. Invasive procedures such as surgery (6/7), percutaneous biopsy (7/7) and endoscopy in lymph node TB (4/5) had high confirmation rates. CONCLUSIONS: the diagnosis of abdominal TB should be reached by a combination of clinical, laboratory, radiological, microbiological and pathological findings.

Discussion of data problems and improvement measures in clinical trials: Based on CRC work assessment in a grade A tertiary hospital / 中华医学科研管理杂志

Objective:The Clinical Research Coordinator (CRC) is responsible for transcribing and verifying clinical trial data, and making recommendations to research institutions and sponsors on clinical trial data through analyzing and discussing data problems found in CRC work assessment, thereby improving the quality of clinical trials.Methods:Based on the ALOCA+ Principle, this study analyzed the data problems found in CRC assessment based on clinical trial quality conducted in a grade A tertiary hospital in Beijing from November 2018 to December 2021, and discussed improvement measures for clinical trial data problems.Results:Among the clinical trial data problems, data integrity is the most prominent, followed by accuracy.Conclusions:Research institutions and sponsors should improve the data management system and SOP, strengthen the training for clinical trial participants, optimize a trial plan and process design, strengthen supervision and inspection, and establish a risk-based quality control system, etc., so as to make clinical trial data conform to the international ALOCA+ principle and make clinical trial results accurate and reliable.

Research progress of photothermal therapy and its synergistic therapy in the treatment of hepatocellular carcinoma / 国际生物医学工程杂志

Primary liver cancer is the sixth most commonly diagnosed cancer and the third leading cause of cancer death worldwide, and hepatocellular carcinoma is the main type of primary liver cancer. HCC is insidious and asymptomatic at an early stage, and when clinically relevant, the disease is often in the middle to late stages. As a result, most patients miss out on radical treatment at the time of diagnosis, leading to high recurrence and metastasis rates and poor prognosis. At present, there are more and more methods in the treatment of hepatocellular carcinoma. Photothermal therapy, as an emerging cancer treatment, has attracted widespread attention due to its minimally invasive, low-cost, high efficiency, low side effects and strong targeting. Research progress of photothermal therapy and its synergistic therapy in the treatment of hepatocellular carcinoma were reviewed in this paper, aiming to explore new ideas and strategies for the treatment of hepatocellular carcinoma.

Representative analysis of elderly subjects in clinical trials of prostate cancer drugs / 中华老年医学杂志

Objective:To analyze whether the sample of elderly subjects in clinical trials of prostate cancer drugs is representative.Methods:From the level of trial design, the age distribution of subjects in clinical trials of prostate cancer drugs for elderly patients from January 2019 to December 2021 was inquired on the platform of drug clinical trial registration and information disclosure.From the actual enrollment level, the prostate cancer drug clinical trials initiated and completed by a hospital from January 2010 to June 2022 were collected.The age information of subjects in all centers was collected for multicenter trials with a summary report, and the age data of subjects in the center was collected for trials without a summary report or single-center trials.The average age of prostate cancer onset and the incidence of prostate cancer in different age groups were compared with the Chinese Cancer Registry System, so as to compare whether the two were consistent.Results:Most of the trials(72.1%、44/61)did not set upper age limit at the protocol design level.Phase Ⅲ and phase Ⅳ trials did not set an upper age limit for enrolled subjects in the protocol.From the actual enrollment level, a total of 19 studies were included in this study, with 1 402 subjects, and the average age of subjects was 67.1±8.6 years old, which was significantly different from the average age of prostate cancer in China and Beijing(all P<0.001). The age group with the largest number of participants was 60-64 years old(34.2%、479/1 402). The population aged ≥75 years was the least(21.5%, 301/1 402), which was different from the high incidence age group of prostate cancer in China in 2017(421.77/100 000). Conclusions:Clinical trials of prostate cancer drugs are designed to cover all age groups of elderly patients, but the actual sample representation of the enrolled elderly subjects is insufficient.Under the premise of protecting the safety of subjects, the trial population who are matched for the average age of prostate cancer onset and the incidence of prostate cancer in age groups, should be gradually increased.

Study on the influencing factors of clinical trial initiation efficiency / 中华医学科研管理杂志

Objective:To analyze the time cost in the start-up stages of clinical trials and to investigate the influencing factors of the initiation efficiency.Methods:We retrospectively analyzed time-cost of the review and approval of drug clinical trials initiated in Beijing Hospital from January 2020 to June 2021.The contract signing time and trial starting time of drug clinical trials in different situations were compared.Results:The mean time to sign the contract in our hospital was 19(11~26) days, and the mean time to start experiment was 235(175~317) days. There was no significant difference in the contract signature time between clinical trials with different stages, different sponsors, different types of drugs and whether to be the leading site ( P>0.05). Compared with other phases, phase Ⅲ drug trials took the longest time to start, and the mean initiation time of clinical trials initiated by foreign pharmaceutical companies was 136 days longer than that initiated by domestic pharmaceutical companies ( P<0.05). Conclusions:Clinical trial institutions should optimize the project management process, better organize the contract review and ethics review, encourage the sponsor to use our template document. Every department may set up a GCP contact to be responsible for clinical trials; The sponsor should improve the efficiency of internal circulation and communication, submit the review materials as soon as possible according to the requirements of the institution, and establish a good communication and feedback mechanism between both sides, may shorten the start-up time of clinical trials and improve the initiation efficiency.

The clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point / 中华医学科研管理杂志

Objective:To build an investigator-initiated clinical research process management indicator system based on the theory of Hazard Analysis and Critical Control Point(HACCP).Methods:A plan was developed according to HACCP principles, and 23 experts were invited to form an expert advisory group. Literature research, panel discussion, and Delphi method were used to collect clinical research process management indicators, and the weight of each indicator was calculated via Analytic Hierarchy Process(AHP).Results:Two rounds of expert consultation were carried out with a high positive coefficient and a high expert authority level, and finally formed 3 primary indicators and 14 secondary indicators. The primary indicators were project establishment, project process management, and project implementation assessment, with weights of 0.142 8, 0.714 4, and 0.142 8, respectively.Conclusions:This study established a clinical research process management system based on HACCP theory from 3 dimensions: project establishment, project process management, and project implementation assessment, carried out precise management of clinical research according to the weights of secondary indicators, focusing on the content of indicators with great weight, and provided an important reference for the management of investigator-initiated clinical research.

Factors influencing pH value of umbilical arterial blood gas analysis in preterm infants / 中华围产医学杂志

Objective:To analyze the factors influencing pH value in umbilical arterial blood gas (UABG) analysis in preterm infants.Methods:A retrospective study was conducted on live singleton preterm infants ( n=573) who received UABG analysis in Peking University Third Hospital from January 2017 to February 2019. Analysis of variance, independent sample t-test, Spearman's or Pearson's correlation analysis, or linear regression analysis was used to analyze the influencing factors. Results:There was no significant difference in UABG pH value between preterm infants of different gestational ages (F=1.74, P=0.077). Spearman's correlation analysis found no correlation between gestational age and UABG pH value in premature infants ( r=0.003, P=0.940), and neither did Pearson's correlation between birth weight and pH value ( r=0.025, P=0.548). UABG pH value in preterm infants was linearly correlated with vaginal delivery ( t=－5.72, P<0.001), gestational hypertension ( t=－3.99, P<0.001) and placental abruption ( t=－4.52, P<0.001). Conclusions:Preterm infants at different gestational ages show a similar pH value in UABG. For those born to mothers with gestational hypertension or placental abruption, when vaginal delivery is pending, close monitoring and full preparation for resuscitation are necessary.

Primary angiitis of the central nervous system / 中华神经科杂志

Primary angiitis of the central nervous system is relatively rare. In recent years, research of the disease in neuroimaging, differential diagnosis, treatment and other aspects advanced greatly. This paper provided a systematic review of this disease entity in order to promote neurologists, neurosurgeons and radiologists′ experience in the diagnosis and treatment of the disease.

Application of Mini-CEX in the clinical performance evaluation of residents in pediatrics department / 中华医学教育探索杂志

Objective:To explore the feasibility and application effect of Mini-CEX in pediatric clinical practice.Methods:Residents who received standardized residency training in pediatrics department of Peking University Third Hospital from March 2016 to September 2017 were selected as research objects. The clinical ability of the residents were evaluated by application of the Mini-CEX structured form. Its effectiveness as a training guide and assessment method was also evaluated. SPSS 25.0 was used for t test. Results:The Mini-CEX scale was refined according to the characteristics of pediatrics. In this study, a total of 36 residents participated in the evaluation and 110 cases were completed by introducing Mini-CEX structured form in 7 examinations. Compared with 2016, the Mini-CEX scores of the residents in the 2017 showed different degrees of improvement in information gathering [(7.4±0.9) vs. (7.7±0.7)], clinical examination [(7.5±1.1) vs. (7.6±0.9)], clinical judgment [(7.5±0.9) vs. (7.6±0.9)], organizational effectiveness [(7.4±0.9) vs. (7.7±0.9)], and overall clinical competency [(7.5±0.9) vs. (7.7±0.9)], without significant differences ( P > 0.05). A total of 17 residents completed the assessments more than or equal to 3 times. Compared with 2016, the mean scores of the 17 individuals' Mini-CEX scales in 2017 were significantly improved in terms of information gathering, organizational effectiveness, and overall clinical competency. Conclusion:The results have shown that the Mini-CEX scale is simple and easy to operate, it maybe helpful to improve the clinical ability of pediatric residents, and it can be used as a method to evaluate the clinical ability of pediatric residents.