1.Review considerations on the design and evaluation of the oral sensory features in pediatric medications
Yan-zhe SUN ; Duan-duan CONG ; Ying GENG ; Zhi-min YANG
Acta Pharmaceutica Sinica 2023;58(11):3160-3164
Recent years, China has released a series of policies to encourage drug research and development in pediatric populations, aiming to meet pediatric populations' medical needs. Because of the physical and psychological developmental characteristics, tolerance of aversive feelings when taking medications are different between pediatric population and adults. So pediatric populations are at a relatively higher risk of not taking medications as prescribed when the medication tasted unpleasant. Therefore, sound design and evaluation of oral sensory features have important clinical significance and value in developing pediatric medications. "Technical guidance for the design and evaluation of the oral sensory features of pediatric drugs (trial version) " was released in November 2022, by Centre for Drug Evaluation, National Medical Products Administration of China. Based on the guidance, this article will introduce the drafting background and review considerations, hoping to provide reference for the design and evaluation of oral sensory features, and promote drug developing in pediatric population.
2.Design and simulation of interference current therapeutic instruments based on FPGA.
Qian WANG ; Zhe-Min DUAN ; De-Ming MAO
Chinese Journal of Medical Instrumentation 2008;32(2):100-104
This paper applies the DDFS theory, uses the method based on the Look-Up-Table, and designs an interference current therapeutic instrument with the automatic frequency scanning module and DDFS module to generate two different interference currents. The design of every module and the whole system are simulated by quartus II, the result shows that the design principle is correct and feasible, and worthy of applications.
Electric Stimulation Therapy
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instrumentation
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Equipment Design
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Signal Processing, Computer-Assisted
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instrumentation
3.Comparison of dose distribution in gamma knife radiotherapy plan, conformal radiotherapy plan and intensity modulated radiotherapy plan for patients with small mass in lung
Ge SHEN ; Weijing ZHANG ; Zhenshan ZHOU ; Zhe JI ; Xiaoping DUAN ; Yanrong LI ; Dapeng DONG ; Min ZHOU ; Junliang WANG ; Yuqin GUO
Chinese Journal of Radiation Oncology 2011;20(1):60-63
Objective To compare dose distribution in gamma knife radiotherapy plan, conformal radiotherapy(CRT)plan and intensity modulated radiotherapy(MRT)plan for patients with small mass in lung, and evaluate their characters. Methods Fourteen patients with small mass in lung participated in the study. Gamma knife radiotherapy plan(plan 1), CRT plan(plan 2)and IMRT plan(plan 3)were made for each mass. The planning target volume(PTV)and the dose include 95% PTV were consistent.Conformal index(CI), homogeneity index(HI), lung V5 ,V10 ,V20 ,V30 and the max dose of esophagus and spinal cord were analyzed. Paired samples t-test was used for comparison between each two plans. Results The CI of the plan 1,2 and 3 were 0. 58,0. 46 and 0. 63, respectively. CI of the plan 1 > that of the plan 2 (t= -3.95,P =0.000),plan 3 > plan 2(t = -6.01 ,P =0.000),plan 1 =plan 3(t =1.64,P =0.116);HI of the plan 1,2 and 3 were 1.66,1.10 and 1.07 respectively. HI of the plan 1 > plan 2 ,plan 1 > plan 3(t= -20.52,21.41 respectively, both P=0. 000),plan 2 = plan 3(t= -1.08,P=0.294). The wholelung V5 ,V10 ,V20 and V30 were 10.0% ,5.6% ,2. 4% and 1.2%, respectively, in plan 1 ;20. 2% ,13. 4%,6. 9% ,3.0%, respectively, in plan 3; and 26. 5%, 18. 0%, 11.4% and 4. 6%, respectively, in plan 2.The V5, V10, V20 and V 30 of the plan 1 < in plan 2(t = 9. 68,8. 41,5. 45,5. 14, all P = 0. 000), the V5,V10,V20 and V30 of the plan 1 < in plan 3(t=7.58,8.95,6. 15,4.78, respectively, all P=0.000),the V5 ,V10, V20andV30 oftheplan2 > inplan3(t =9. 71,5. 91,4. 13,3.91, respectively, allP =0.000).The max dose of esophagus in plan 1 ,2 and 3 were 24.93 ± 21.54, 31.90 ± 18. 75, 29. 19 ± 23.09 Gy,respectively, plan 1 < plan 2(t = -2. 71 ,P=0.013),plan 1 = plan 3(t = - 1.49,P =0. 152),plan 2 =plan 3(t = 1.35, P = 0. 193). The max dose of spinal cord in plan 1,2 and 3 were 12.07 ± 10. 67,17.70 ±11.35 and 8.92 :± 10. 04 Gy, respectively, plan 2 > plan 1 >plan 3(t = -2. 38,2. 29,4. 83,P=0. 1027,0.033,0.000);All three plans of each mass meet the needs that the max dose of the esophagus≤60 Gy and the max dose of spinal cord ≤40 Gy. Conclusions The dose of the normal lung was lower, but the HI and the max dose of spinal cord were higher in Gamma knife radiotherapy plan than those in the CRT and the IMRT plan of the small mass in lung.
4.Intestinal tissue injury and gut microbiome changes in mice treated with whole body irradiation by gamma rays
Min DUAN ; Zhe YANG ; Ying LIU ; Yongyi WANG ; Yumeng YE ; Yanhui HAO ; Hongyan ZUO ; Yang LI
Military Medical Sciences 2024;48(9):641-649
Objective To investigate the effects of 0.5 Gy 60Co γ-ray irradiation on intestinal tissue injury and intestinal microflora in mice.Methods C57BL/6N mice were irradiated with 0.5 Gy 60Co γ-ray at 1 d,3 d,7 d and 14 d after irradiation.Jejunum tissues were fixed and frozen,and feces were frozen.Hematoxylin-eosin staining was used to observe the pathological injury to jejunum after irradiation,ki67 immunohistochemical staining was adopted to detect the proliferation of jejunum crypt cells,and TdT-mediated dUTP nick end labeling was employed to detect the apoptosis of jejunum crypt cells.The expressions of TNF-α,IL-1β,IL-6 and IL-10 cytokines in small intestines were detected via radioimmunoassay.The changes of intestinal flora in mice after irradiation were analyzed by metagenomic sequencing,and LEfSe analysis and ROC analysis were used to screen the bacteria with significant differences.Results After 0.5 Gy 60Co γ-ray irradiation,the proliferative cells of the jejunal crypt were significantly decreased at 1 d after irradiation(P<0.05),while the apoptotic cells were significantly increased at 1 and 3 d after irradiation(P<0.01).The expression of TNF-α at 7 and 14 d after irradiation,that of IL-1 β at 1,3,7 and 14 d after irradiation and that of IL-6 at 3,7 and 14 d after irradiation were significantly increased(P<0.05),while the expression of IL-10 at 7 and 14 d after irradiation was significantly decreased(P<0.05).After 0.5 Gy 60Co γ-ray irradiation,intestinal flora composition changed significantly at phylum,genus and species levels,and Lactobacillus murinus,Lactobacillus johnsonii,Alistipes-unclassified,Mucispirillum schaedleri underwent the most significant changes and had higher LDA scores.Conclusion The whole body irradiation of 0.5 Gy 60Co γ-ray can cause intestinal tissue damage and change the composition of intestinal flora in mice.
5.Research on Rapid Detection Technology for Quality Control of Emergency Ventilator.
Shi-Ning XU ; Can DONG ; Wen-Zhe LI ; Hui-Min DUAN ; Wan-Jun SHUAI ; Yong CHAO
Chinese Journal of Medical Instrumentation 2022;46(3):336-341
OBJECTIVE:
In order to grasp the quality status of the first-aid ventilator in pre-hospital and field environment in time, the quality control and detection items of invasive ventilator were optimized to form a rapid detection operation process of first-aid ventilator and ensure the safety of patient treatment.
METHODS:
Based on the quality control detection data of invasive ventilator in hospital in recent years, methods such as narrowing the range of qualified criteria and analyzing confidence interval were adopted to extract indicators prone to deviation and verify their correlation with similar indicators, so as to form an optimized rapid detection portfolio.
RESULTS:
Compared with the original quality control detection procedures, the detection indicators of the rapid detection procedures were reduced from 5 categories of 24 indicators to 3 categories of 7 indicators. The detection time was shortened by 56.1% and the coincidence rate of the detection results was 100% after the actual measurement and verification.
CONCLUSIONS
Under the premise of ensuring the testing quality, the operating procedure for rapid detection of emergency ventilator can greatly reduce the detection time, and realize the rapid and high frequency quality control detection, so as to ensure the quality and safety of the equipment.
Home Care Services
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Humans
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Quality Control
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Ventilators, Mechanical
6. G6PD Regulates Cyclin E1 and CDK2 to Promote Cell Proliferation and Its Prognostic Value in Clear Cell Renal Cell Carcinoma
Zhe YANG ; Yue-Li NI ; Yu-Zhi ZHU ; Yue-Chun ZHU ; Qiao ZHANG ; Zhe YANG ; Shu-Jie WANG ; Wen-Jing LIU ; Rong CHE ; Shu-Jie WANG ; Rong CHE ; You-Bin DUAN ; Ying-Min KUANG
Chinese Journal of Biochemistry and Molecular Biology 2022;38(5):658-670
Clear cell renal cell carcinoma (ccRCC) has been proved to be a metabolic disease with high
7.Characteristic dysbiosis of gut microbiota of Chinese patients with diarrhea-predominant irritable bowel syndrome by an insight into the pan-microbiome.
Zhe WANG ; Cong-Min XU ; Yi-Xuan LIU ; Xiao-Qi WANG ; Lu ZHANG ; Mo LI ; Shi-Wei ZHU ; Zhong-Jie XIE ; Pei-Hong WANG ; Li-Ping DUAN ; Huai-Qiu ZHU
Chinese Medical Journal 2019;132(8):889-904
BACKGROUND:
Irritable bowel syndrome (IBS) is reported associated with the alteration of gut microbial composition termed as dysbiosis. However, the pathogenic mechanism of IBS remains unclear, while the studies of Chinese individuals are scarce. This study aimed to understand the concept of dysbiosis among patients with Chinese diarrhea-predominant IBS (IBS-D), as a degree of variance between the gut microbiomes of IBS-D population and that of a healthy population.
METHODS:
The patients with IBS-D were recruited (assessed according to the Rome III criteria, by IBS symptom severity score) from the Outpatient Department of Gastroenterology of Peking University Third Hospital, and volunteers as healthy controls (HCs) were enrolled, during 2013. The 16S rRNA sequences were extracted from fecal samples. Ribosomal database project resources, basic local alignment search tool, and SparCC software were used to obtain the phylotype composition of samples and the internal interactions of the microbial community. Herein, the non-parametric test, Wilcoxon rank-sum test was carried out to find the statistical significance between HC and IBS-D groups. All the P values were adjusted to q values to decrease the error rate.
RESULTS:
The study characterized the gut microbiomes of Chinese patients with IBS-D, and demonstrated that the dysbiosis could be characterized as directed alteration of the microbiome composition leading to greater disparity between relative abundance of two phyla, Bacteroidetes (Z = 4.77, q = 1.59 × 10) and Firmicutes (Z = -3.87, q = 5.83 × 10). Moreover, it indicated that the IBS symptom features were associated with the dysbiosis of whole gut microbiome, instead of one or several certain genera even they were dominating. Two genera, Bacteroides and Lachnospiracea incertae sedis, were identified as the core genera, meanwhile, the non-core genera contribute to a larger pan-microbiome of the gut microbiome. Furthermore, the dysbiosis in patients with IBS-D was associated with a reduction of network complexity of the interacted microbial community (HC vs. IBS-D: 639 vs. 154). The disordered metabolic functions of patients with IBS-D were identified as the potential influence of gut microbiome on the host (significant difference with q < 0.01 between HC and IBS-D).
CONCLUSIONS
This study supported the view of the potential influence of gut microbiome on the symptom of Chinese patients with IBS-D, and further characterized dysbiosis in Chinese patients with IBS-D, thus provided more pathological evidences for IBS-D with the further understanding of dysbiosis.
Diarrhea
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microbiology
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Dysbiosis
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microbiology
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Feces
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microbiology
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Gastrointestinal Microbiome
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genetics
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Humans
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Irritable Bowel Syndrome
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microbiology
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Models, Theoretical
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RNA, Ribosomal, 16S
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genetics