1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.Clinical analysis of 6 cases of diffuse panbronchiolitis in children.
Li-Xin DENG ; De-Hui CHEN ; Yu-Neng LIN ; Shang-Zhi WU ; Jia-Xing XU ; Zhan-Hang HUANG ; Ying-Ying GU ; Jun-Xiang FENG
Chinese Journal of Contemporary Pediatrics 2025;27(3):334-339
OBJECTIVES:
To analyze the clinical characteristics of diffuse panbronchiolitis (DPB) in children and to enhance the clinical diagnosis and treatment of this disease.
METHODS:
A retrospective analysis was conducted on the clinical data of 6 children diagnosed with DPB who were hospitalized at The First Affiliated Hospital of Guangzhou Medical University from January 2011 to December 2019.
RESULTS:
Among the 6 patients, there were 2 males and 4 females; the age at diagnosis ranged from 7 to 12 years. All patients presented with cough, sputum production, and exertional dyspnea, and all had a history of sinusitis. Two cases showed positive serum cold agglutinin tests, and 5 cases exhibited pathological changes consistent with chronic bronchiolitis. High-resolution chest CT in all patients revealed centrilobular nodules diffusely distributed throughout both lungs with a tree-in-bud appearance. Five patients received low-dose azithromycin maintenance therapy, but 3 showed inadequate treatment response. After empirical anti-tuberculosis treatment, non-tuberculous Mycobacteria were found in the bronchoalveolar lavage fluid. Follow-up over 2 years showed 1 case cured, 3 cases significantly improved, and 2 cases partially improved.
CONCLUSIONS
The clinical presentation of DPB is non-specific and can easily lead to misdiagnosis. In cases where DPB is clinically diagnosed but does not show improvement with low-dose azithromycin treatment, special infections should be considered.
Humans
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Male
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Female
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Bronchiolitis/drug therapy*
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Retrospective Studies
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Child
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Haemophilus Infections/diagnosis*
3.Three-dimensional Heterogeneity and Intrinsic Plasticity of the Projection from the Cerebellar Interposed Nucleus to the Ventral Tegmental Area.
Chen WANG ; Si-Yu WANG ; Kuang-Yi MA ; Zhao-Xiang WANG ; Fang-Xiao XU ; Zhi-Ying WU ; Yan GU ; Wei CHEN ; Ying SHEN ; Li-Da SU ; Lin ZHOU
Neuroscience Bulletin 2025;41(1):159-164
4.Photoaffinity probe-enabled discovery of sennoside A reductase in Bifidobacterium pseudocatenulatum.
Yang XU ; Shujing LV ; Xiang LI ; Chuanjia ZHAI ; Yulian SHI ; Xuejiao LI ; Zhiyang FENG ; Gan LUO ; Ying WANG ; Xiaoyan GAO
Journal of Pharmaceutical Analysis 2025;15(1):101108-101108
Sennoside A (SA), a typical prodrug, exerts its laxative effect only after its transformation into rheinanthrone catalyzed by gut microbial hydrolases and reductases. Hydrolases have been identified, but reductases remain unknown. By linking a photoreactive group to the SA scaffold, we synthesized a photoaffinity probe to covalently label SA reductases and identified SA reductases using activity-based protein profiling (ABPP). From lysates of an active strain, Bifidobacterium pseudocatenulatum (B. pseudocatenulatum), 397 proteins were enriched and subsequently identified using mass spectrometry (MS). Among these proteins, chromate reductase/nicotinamide adenine dinucleotide (NADH) phosphate (NADPH)-dependent flavin mononucleotide (FMN) reductase/oxygen-insensitive NADPH nitroreductase (nfrA) was identified as a potent SA reductase through further bioinformatic analysis and The Universal Protein Resource (UniProt) database screening. We also determined that recombinant nfrA could reduce SA. Our study contributes to further illuminating mechanisms of SA transformation to rheinanthrone and simultaneously offers an effective method to identify gut bacterial reductases.
5.Echocardiographic two-dimensional strain evaluation of right ventricular function in healthy adults
Yi LI ; Ying GUO ; Chenxi XIA ; Xuyang MENG ; Xiang WANG ; Tao XU ; You ZHONG ; Fang WANG
Chinese Journal of Cardiology 2024;52(1):58-63
Objective:To explore the feasibility of using two-dimensional speckle tracking echocardiography for measuring right ventricular strain and function in healthy adults, and to analyze the impact of age and gender.Methods:This study is a cross-sectional study. Healthy adults who underwent physical examination in the Physical Examination Center of Beijing Hospital from January 1, 2020 to January 1, 2021 were included. Two researchers independently measured various right ventricular longitudinal strain indices using the Echopac software, including (global longitudinal strain (GLS), apical longitudinal strain (ALS), midventricle longitudinal strain (MLS), basal longitudinal strain (BLS), free wall GLS (FWGLS), free wall ALS (FWALS), free wall MLS (FWMLS) and free wall BLS (FWBLS)) as well as tricuspid annular plane systolic excursion (TAPSE) and right ventricle-fraction of area change (RVFAC). The above indicators were taken as the average of two physicians. The consistency of the measurements by two physicians was evaluated by the within-group correlation coefficient ( ICC). Results:A total of 233 subjects were included, including 137 males, aged (58.5±14.2) years. ICC values was all above 0.8 with excellent agreement. The values of FWGLS and GLS in healthy adults were -26.63% and -21.89%, respectively. There was no statistically significant difference in TAPSE ((2.06±0.41)cm vs. (2.10±0.39)cm, P=0.510) and RVFAC ((51.17±9.91)% vs. (50.89±8.65)%, P=0.826) between males and females. The values of various right ventricular long axis strain indicators (GLS, ALS, MLS, BLS, FWGLS, FWMLS, FWMLS, FWBLS) in females aged 18 to 40 and 41 to 65 years were higher than those in males of the same age (all P<0.05), while there was no statistically significant difference in the values of various right ventricular long axis strain indicators between the sexes in subjects aged 65 years and above (all P>0.05). In females, the right ventricular GLS, ALS, MLS, FWGLS, FWALS, FWMLS, and FWBLS values in the groups aged 18 to 40 and 41 to 65 years were significantly higher than those in the group aged 65 years and above (all P<0.05). In contrast, no significant differences were found in these indices among different age groups in males (all P>0.05). Conclusions:Using two-dimensional speckle tracking technology in echocardiography to measure right ventricular strain indicators is feasible and highly reproducible. Gender and age have an impact on right ventricular strain indicators.
6.Clinical trial of lanthanum carbonate and calcium carbonate in the treatment of maintenance hemodialysis patients with end-stage renal disease
Xu-Xiang MA ; Han WANG ; Xiao-Ying ZONG ; Yu-Ye ZHOU ; Miao-Miao SANG
The Chinese Journal of Clinical Pharmacology 2024;40(18):2665-2669
Objective To explore the differences in curative effect of lanthanum carbonate and calcium carbonate on hyperphosphatemia in patients with end-stage renal disease(ESRD)after maintenance hemodialysis(MHD).Methods Patients with hyperphosphatemia after MHD treatment of ESRD were divided into treatment group and control group.Treatment group was given lanthanum carbonate chewable tablet orally,250 mg each time,tid;the control group was given calcium carbonate chewable tablets orally,500 mg each time,bid.Both groups were treated continuously for 3 months.The clinical efficacy,calcium and phosphorus metabolism,vascular sclerosis indexes[brachial ankle pulse wave conduction velocity(baPWV),ankle brachial index(ABI),homocystine(Hcy)],serum renal function indexes[[32 microglobulin(β2-MG),serum creatinine(SCr),blood urea nitrogen(BUN)],serum inflammation indexes[hypersensitive C-reactive protein(hs-CRP),tumor necrosis factor-α(TNF-α),interleukin-6(IL-6)],and the safety was evaluated.Results There were 104 cases in the treatment group and 96 cases in the control group.After treatment,the effective rate of the treatment group was 94.23%(98 cases/104 cases)higher than that of the control group 85.42%(82 cases/96 cases),and the difference was statistically significant(P<0.05).After treatment,the serum phosphorus levels of treatment group and control group were(1.42±0.19)and(1.68±0.20)mmol·L-1,respectively;the serum calcium levels were(2.32±0.30)and(2.49±0.24)mmol·L-1,respectively;the product of calcium and phosphorus were(49.28±6.25)and(52.05±5.60)mg2·dL-2,respectively;the baPWV levels were(1 560.72±114.90)and(1 613.49±109.77)cm·s-1,respectively;ABI levels were 1.20±0.09 and 1.17±0.07,respectively;Hcy levels were(32.02±3.21)and(34.84±2.89)μmol·L-1,respectively.Compared with the control group,there were statistically significant differences in the above indexes in treatment groups(all P<0.05).After treatment,there was no significant difference in levels of renal function indexes(β2-MG,SCr,BUN)and inflammatory indexes(hs-CRP,TNF-α,IL-6)between the two groups(all P>0.05).The adverse drug reactions of the treatment group were mainly diarrhea and rash;and the adverse drug reactions of the control group were mainly diarrhea and hypercalcemia.The difference in incidence of adverse drug reactions between control group and treatment group was not statistically significant(2.88%vs 3.13%,P>0.05).Conclusion Compared with calcium carbonate,improvement effect of lanthanum carbonate is better on phosphorus and calcium-phosphorus metabolism in MHD patients with ESRD and hyperphosphatemia,which can delay the progression of vascular sclerosis.
7.Structure-based development of potent and selective type-II kinase inhibitors of RIPK1.
Ying QIN ; Dekang LI ; Chunting QI ; Huaijiang XIANG ; Huyan MENG ; Jingli LIU ; Shaoqing ZHOU ; Xinyu GONG ; Ying LI ; Guifang XU ; Rui ZU ; Hang XIE ; Yechun XU ; Gang XU ; Zheng ZHANG ; Shi CHEN ; Lifeng PAN ; Ying LI ; Li TAN
Acta Pharmaceutica Sinica B 2024;14(1):319-334
Receptor-interacting serine/threonine-protein kinase 1 (RIPK1) functions as a key regulator in inflammation and cell death and is involved in mediating a variety of inflammatory or degenerative diseases. A number of allosteric RIPK1 inhibitors (RIPK1i) have been developed, and some of them have already advanced into clinical evaluation. Recently, selective RIPK1i that interact with both the allosteric pocket and the ATP-binding site of RIPK1 have started to emerge. Here, we report the rational development of a new series of type-II RIPK1i based on the rediscovery of a reported but mechanistically atypical RIPK3i. We also describe the structure-guided lead optimization of a potent, selective, and orally bioavailable RIPK1i, 62, which exhibits extraordinary efficacies in mouse models of acute or chronic inflammatory diseases. Collectively, 62 provides a useful tool for evaluating RIPK1 in animal disease models and a promising lead for further drug development.
8.The experience on the construction of the cluster prevention and control system for COVID-19 infection in designated hospitals during the period of "Category B infectious disease treated as Category A"
Wanjie YANG ; Xianduo LIU ; Ximo WANG ; Weiguo XU ; Lei ZHANG ; Qiang FU ; Jiming YANG ; Jing QIAN ; Fuyu ZHANG ; Li TIAN ; Wenlong ZHANG ; Yu ZHANG ; Zheng CHEN ; Shifeng SHAO ; Xiang WANG ; Li GENG ; Yi REN ; Ying WANG ; Lixia SHI ; Zhen WAN ; Yi XIE ; Yuanyuan LIU ; Weili YU ; Jing HAN ; Li LIU ; Huan ZHU ; Zijiang YU ; Hongyang LIU ; Shimei WANG
Chinese Critical Care Medicine 2024;36(2):195-201
The COVID-19 epidemic has spread to the whole world for three years and has had a serious impact on human life, health and economic activities. China's epidemic prevention and control has gone through the following stages: emergency unconventional stage, emergency normalization stage, and the transitional stage from the emergency normalization to the "Category B infectious disease treated as Category B" normalization, and achieved a major and decisive victory. The designated hospitals for prevention and control of COVID-19 epidemic in Tianjin has successfully completed its tasks in all stages of epidemic prevention and control, and has accumulated valuable experience. This article summarizes the experience of constructing a hospital infection prevention and control system during the "Category B infectious disease treated as Category A" period in designated hospital. The experience is summarized as the "Cluster" hospital infection prevention and control system, namely "three rings" outside, middle and inside, "three districts" of green, orange and red, "three things" before, during and after the event, "two-day pre-purification" and "two-director system", and "one zone" management. In emergency situations, we adopt a simplified version of the cluster hospital infection prevention and control system. In emergency situations, a simplified version of the "Cluster" hospital infection prevention and control system can be adopted. This system has the following characteristics: firstly, the system emphasizes the characteristics of "cluster" and the overall management of key measures to avoid any shortcomings. The second, it emphasizes the transformation of infection control concepts to maximize the safety of medical services through infection control. The third, it emphasizes the optimization of the process. The prevention and control measures should be comprehensive and focused, while also preventing excessive use. The measures emphasize the use of the least resources to achieve the best infection control effect. The fourth, it emphasizes the quality control work of infection control, pays attention to the importance of the process, and advocates the concept of "system slimming, process fattening". Fifthly, it emphasizes that the future development depends on artificial intelligence, in order to improve the quality and efficiency of prevention and control to the greatest extent. Sixth, hospitals need to strengthen continuous training and retraining. We utilize diverse training methods, including artificial intelligence, to ensure that infection control policies and procedures are simple. We have established an evaluation and feedback mechanism to ensure that medical personnel are in an emergency state at all times.
9.Application of OSCE-guided Scenario-based Practical Teaching Model in Clinical Pharmacist Training
Tiantian TANG ; Yiwen XIAO ; Haiyan YUAN ; Qiong LU ; Ying WANG ; Wenhui LIU ; Shenglan TAN ; Bikui ZHANG ; Daxiong XIANG ; Yan CHENG ; Yangang ZHOU ; Ping XU
Chinese Journal of Modern Applied Pharmacy 2024;41(10):1409-1414
OBJECTIVE
To explore the specific application and evaluation effect of objective structured clinical examination(OSCE)-guided scenario-based practical teaching mode in training clinical pharmacists.
METHODS
Fifty-six trainees who participated in the clinical pharmacist training program in the Second Xiangya Hospital of Central South University from October 2020 to September 2022 were selected as the research objects. OSCE-guided teaching was conducted, and the application effect of OSCE-guided teaching mode in clinical pharmacist training was explored and analyzed by using theoretical examination results and OSCE assessment results as evaluation indicators.
RESULTS
Through comparative analysis, it was found that the OSCE-guided teaching mode not only enabled students to better grasp the theoretical knowledge points required by the training outline, but also improved their clinical thinking ability, problem-solving ability, and communication and coordination skills to varying degrees.
CONCLUSION
For clinical pharmacist trainees, the OSCE teaching mode is conducive to the comprehensive improvement of clinical pharmacist skills and is suitable for cultivating clinical pharmacists who are capable of independently carrying out clinical pharmacy services in the new situation.
10.Analysis of epidemiological and clinical characteristics of 1247 cases of infectious diseases of the central nervous system
Jia-Hua ZHAO ; Yu-Ying CEN ; Xiao-Jiao XU ; Fei YANG ; Xing-Wen ZHANG ; Zhao DONG ; Ruo-Zhuo LIU ; De-Hui HUANG ; Rong-Tai CUI ; Xiang-Qing WANG ; Cheng-Lin TIAN ; Xu-Sheng HUANG ; Sheng-Yuan YU ; Jia-Tang ZHANG
Medical Journal of Chinese People's Liberation Army 2024;49(1):43-49
Objective To summarize the epidemiological and clinical features of infectious diseases of the central nervous system(CNS)by a single-center analysis.Methods A retrospective analysis was conducted on the data of 1247 cases of CNS infectious diseases diagnosed and treated in the First Medical Center of PLA General Hospital from 2001 to 2020.Results The data for this group of CNS infectious diseases by disease type in descending order of number of cases were viruses 743(59.6%),Mycobacterium tuberculosis 249(20.0%),other bacteria 150(12.0%),fungi 68(5.5%),parasites 18(1.4%),Treponema pallidum 18(1.4%)and rickettsia 1(0.1%).The number of cases increased by 177 cases(33.1%)in the latter 10 years compared to the previous 10 years(P<0.05).No significant difference in seasonal distribution pattern of data between disease types(P>0.05).Male to female ratio is 1.87︰1,mostly under 60 years of age.Viruses are more likely to infect students,most often at university/college level and above,farmers are overrepresented among bacteria and Mycobacterium tuberculosis,and more infections of Treponema pallidum in workers.CNS infectious diseases are characterized by fever,headache and signs of meningeal irritation,with the adductor nerve being the more commonly involved cranial nerve.Matagenomic next-generation sequencing improves clinical diagnostic capabilities.The median hospital days for CNS infectious diseases are 18.00(11.00,27.00)and median hospital costs are ¥29,500(¥16,000,¥59,200).The mortality rate from CNS infectious diseases is 1.6%.Conclusions The incidence of CNS infectious diseases is increasing last ten years,with complex clinical presentation,severe symptoms and poor prognosis.Early and accurate diagnosis and standardized clinical treatment can significantly reduce the morbidity and mortality rate and ease the burden of disease.


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