2.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
;
Child
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
3.Exploring in vivo existence forms of Notoginseng Radix et Rhizoma in rats.
Meng-Ge FENG ; Lin-Han XIANG ; Jing ZHANG ; Wen-Hui ZHAO ; Yang LI ; Li-Li LI ; Guang-Xue LIU ; Shao-Qing CAI ; Feng XU
China Journal of Chinese Materia Medica 2025;50(9):2539-2562
The study aims to elucidate the existence forms(original constituents and metabolites) of Notoginseng Radix et Rhizoma in rats and reveal its metabolic pathways. After Notoginseng Radix et Rhizoma was administered orally once a day for seven consecutive days to rats, all urine and feces samples were collected for seven days, while the blood samples were obtained 6 h after the last administration. Using the ultra high performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry(UHPLC-Q-TOF-MS/MS) technique, this study identified 6, 73, and 156 existence forms of Notoginseng Radix et Rhizoma in the rat plasma, urine, and feces samples, respectively. Among them, 101 compounds were identified as new existence forms, and 13 original constituents were identified by comparing with reference compounds. The metabolic reactions of constituents from Notoginseng Radix et Rhizoma were mainly deglycosylation, dehydration, hydroxylation, hydrogenation, dehydrogenation, acetylation, and amino acid conjugation. Furthermore, the possible in vivo metabolic pathways of protopanaxatriol(PPT) in rats were proposed. Through comprehensive analysis of the liquid chromatography-mass spectrometry(LC-MS) data, isomeric compounds were discriminated, and the planar chemical structures of 32 metabolites were clearly identified. According to the literature, 48 original constituents possess antitumor and cardiovascular protective bioactivities. Additionally, 32 metabolites were predicted to have similar bioactivities by SuperPred. This research lays the foundation for further exploring the in vivo effective forms of Notoginseng Radix et Rhizoma.
Animals
;
Rats
;
Drugs, Chinese Herbal/pharmacokinetics*
;
Rhizome/metabolism*
;
Male
;
Rats, Sprague-Dawley
;
Chromatography, High Pressure Liquid
;
Panax notoginseng/chemistry*
;
Tandem Mass Spectrometry
;
Feces/chemistry*
4.Clinical advances in Ilizarov technique for foot and ankle trauma.
Peng CAI ; Xiang FANG ; Jia LI ; Yaxing LI ; Hui ZHANG
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(8):950-957
OBJECTIVE:
To summarize the clinical application value and progress of Ilizarov technique in the treatment of foot and ankle trauma.
METHODS:
The related literature of Ilizarov technique in the treatment of foot and ankle trauma was extensively reviewed, and the fundamental principles of Ilizarov technique and its clinical application in the treatment of complex foot and ankle trauma such as Pilon fractures, lateral malleolus defects, calcaneal fractures, and talus fractures were reviewed, and its efficacy and complications were analyzed.
RESULTS:
The Ilizarov technique demonstrates significant advantages in treating open fractures, bone defects, and cases with poor soft tissue conditions, achieving high rates of bone defect repair, effective infection control, and improved functional scores. However, complications such as pin tract infections remain notable.
CONCLUSION
The Ilizarov technique is an effective approach for managing complex foot and ankle trauma, particularly in high-risk cases. Its dynamic fixation mechanism combines mechanical stability with biological repair. Future advancements should focus on integrating three-dimensional printing and smart sensor technologies to enhance precision.
Humans
;
Ilizarov Technique/instrumentation*
;
Ankle Injuries/surgery*
;
Foot Injuries/surgery*
;
Fracture Fixation, Internal/instrumentation*
;
Fractures, Bone/surgery*
;
Printing, Three-Dimensional
;
Ankle Fractures/surgery*
5.Clinical and genetic characteristics of congenital adrenal hyperplasia: a retrospective analysis.
Cai-Jun WANG ; Ya-Wei ZHANG ; Da-Peng LIU ; Juan JIN ; Zhao-Hui LI ; Jing GUO ; Yao-Dong ZHANG ; Hai-Hua YANG ; Wen-Qing KANG
Chinese Journal of Contemporary Pediatrics 2025;27(11):1367-1372
OBJECTIVES:
To study the clinical and genetic characteristics of children with congenital adrenal hyperplasia (CAH).
METHODS:
Clinical data, laboratory findings, and genetic test results of 63 children diagnosed with CAH at Henan Children's Hospital from January 2017 to December 2024 were retrospectively reviewed.
RESULTS:
Of the 63 patients, the mean age at the first visit was (21 ± 14) days; 29 (46%) were of male sex and 34 (54%) were of female sex. The predominant clinical manifestations were poor weight gain or weight loss (92%, 58/63), poor feeding (84%, 53/63), skin hyperpigmentation (83%, 52/63), and female external genital anomalies (100%, 34/34). Laboratory abnormalities included hyponatremia (87%, 55/63), hyperkalemia (68%, 43/63), metabolic acidosis (68%, 43/63), and markedly elevated 17-hydroxyprogesterone (92%, 58/63), testosterone (89%, 56/63), and adrenocorticotropic hormone (81%, 51/63). Among 49 patients who underwent genetic testing, CYP21A2 variants were identified in 90% (44/49), with c.293-13A/C>G (33%, 30/91) and large deletions/gene conversions (29%, 26/91) being the most frequent; STAR (8%, 4/49) and HSD3B2 (2%, 1/49) variants were also detected. Following hormone replacement therapy, electrolyte disturbances were corrected in 57 cases, with significant reductions in 17-hydroxyprogesterone, adrenocorticotropic hormone, and testosterone levels (P<0.001).
CONCLUSIONS
CAH presenting in neonates or young infants is characterized by electrolyte imbalance, external genital anomalies, and abnormal hormone levels. Genetic testing enables definitive subtype classification; in CYP21A2-related CAH, c.293-13A/C>G is a hotspot variant. These findings underscore the clinical value of genetic testing for early diagnosis and genetic counseling in CAH. Citation:Chinese Journal of Contemporary Pediatrics, 2025, 27(11): 1367-1372.
Humans
;
Adrenal Hyperplasia, Congenital/diagnosis*
;
Male
;
Female
;
Retrospective Studies
;
Infant
;
Infant, Newborn
6.Effects of Down-regulation of NCL Expression on the Biological Behavior of Acute Myeloid Leukemia Kasumi-1 Cells.
Hui-Li LIU ; Wen-Xin XU ; Yang-Yan CAI ; Hong-Mei LI
Journal of Experimental Hematology 2025;33(5):1312-1317
OBJECTIVE:
To investigate the role of nucleolin (NCL) in acute myeloid leukemia (AML) Kasumi-1 cells and its underlying mechanism.
METHODS:
The Kasumi-1 cells were infected with lentivirus carrying shRNA to downregulate NCL expression. Cell proliferation was detected by CCK-8 assay, and cell apoptosis and cell cycle were determined by flow cytometry. Transcriptome next-generation sequencing (NGS) was performed to predict associated signaling pathways, the expression levels of related genes were measured by RT-PCR.
RESULTS:
Down-regulation of NCL expression significantly inhibited the proliferation of Kasumi-1 cells (P <0.01) and markedly increased the apoptosis rate (P <0.001). Cell cycle analysis showed significant changes in the distribution of cells in the G1 and S phases after NCL knockdown (P <0.05), while no significant difference was observed in the G2 phase (P >0.05). Transcriptome sequencing analysis demonstrated that differentially expressed genes in Kasumi-1 cells with low expression of NCL were primarily enriched in key signaling pathways, including ribosome, spliceosome, RNA transport, cell cycle, and amino acid biosynthesis. qPCR validation showed that the expression of BAX, CASP3, CYCS, PMAIP1, TP53 , and CDKN1A was significantly upregulated after NCL downregulation (P <0.05), with CDKN1A exhibiting the most pronounced difference.
CONCLUSION
NCL plays a critical role in regulating the proliferation, apoptosis, and cell cycle progression of Kasumi-1 cells. The mechanism likely involves suppressing cell cycle progression through activation of the TP53-CDKN1A pathway and promoting apoptosis by upregulating apoptosis-related genes.
Humans
;
Leukemia, Myeloid, Acute/pathology*
;
Down-Regulation
;
Cell Proliferation
;
Apoptosis
;
RNA-Binding Proteins/genetics*
;
Nucleolin
;
Cell Line, Tumor
;
Phosphoproteins/metabolism*
;
Cell Cycle
;
Signal Transduction
;
RNA, Small Interfering
7.Effects of Hot Night Exposure on Human Semen Quality: A Multicenter Population-Based Study.
Ting Ting DAI ; Ting XU ; Qi Ling WANG ; Hao Bo NI ; Chun Ying SONG ; Yu Shan LI ; Fu Ping LI ; Tian Qing MENG ; Hui Qiang SHENG ; Ling Xi WANG ; Xiao Yan CAI ; Li Na XIAO ; Xiao Lin YU ; Qing Hui ZENG ; Pi GUO ; Xin Zong ZHANG
Biomedical and Environmental Sciences 2025;38(2):178-193
OBJECTIVE:
To explore and quantify the association of hot night exposure during the sperm development period (0-90 lag days) with semen quality.
METHODS:
A total of 6,640 male sperm donors from 6 human sperm banks in China during 2014-2020 were recruited in this multicenter study. Two indices (i.e., hot night excess [HNE] and hot night duration [HND]) were used to estimate the heat intensity and duration during nighttime. Linear mixed models were used to examine the association between hot nights and semen quality parameters.
RESULTS:
The exposure-response relationship revealed that HNE and HND during 0-90 days before semen collection had a significantly inverse association with sperm motility. Specifically, a 1 °C increase in HNE was associated with decreased sperm progressive motility of 0.0090 (95% confidence interval [ CI]: -0.0147, -0.0033) and decreased total motility of 0.0094 (95% CI: -0.0160, -0.0029). HND was significantly associated with reduced sperm progressive motility and total motility of 0.0021 (95% CI: -0.0040, -0.0003) and 0.0023 (95% CI: -0.0043, -0.0002), respectively. Consistent results were observed at different temperature thresholds on hot nights.
CONCLUSION
Our findings highlight the need to mitigate nocturnal heat exposure during spermatogenesis to maintain optimal semen quality.
Humans
;
Male
;
Semen Analysis
;
Adult
;
Sperm Motility
;
Hot Temperature/adverse effects*
;
China
;
Middle Aged
;
Spermatozoa/physiology*
;
Young Adult
8.Analysis of metastasis and survival after different treatment in patients with T1 stage colonic neuroendocrine tumors
Bin BAI ; Heng LI ; Jun WANG ; Hua XIAO ; Hui CAI
Chinese Journal of Clinical Medicine 2024;31(2):192-199
Objective To explore the metastasis rate and related risk factors of T1 stage colonic neuroendocrine tumor(C-NET),and to compare the long-term survival outcomes of patients with non-metastatic(T1N0M0 stage)C-NET after local excision(LE)or radical surgery(RS).Methods Clinical information of 433 patients diagnosed with C-NET in the SEER database from January 1,2004 to December 31,2015 were analyzed.Cox regression was used to analyze the influencing factors of metastasis of C-NET.The patients without metastasis were divided into LE group and RS group,and assigned in a 1∶1 ratio using propensity score matching(PSM)according to gender,age,tumor largest diameter,and infiltration depth,with a caliper value set to 0.02.Kaplan-Meier survival curve was used to analyze 5-year cancer-specific survival(CSS)and overall survival(OS)of patients.Cox regression analysis was used to evaluate the influence of metastasis on survival.Results Among 419 C-NET patients,19(4.52%)had distant metastases.Cox regression analysis showed that 11-20 mm of tumor large diameter(HR=9.264,95%CI 3.322-25.835,P<0.001),right colon location(HR=0.116,95%CI 0.042-0.321,P<0.001),and submucosal invasion(HR=5.842,95%CI 1.858-18.371,P=0.003)were independent risk factors for distant metastasis of T1 stage C-NET.The 5-year OS rates of non-metastatic and metastatic patients were 94.5%and 47.4%,respectively(χ2=79.762,P<0.001),and their 5-year CSS rates were 99.5%and 55.7%,respectively(χ2=164.604,P<0.001).Before PSM,the 5-year OS rates of non-metastatic C-NET patients after LE and RS were 95.8%and 90.1%(χ2=2.679,P=0.063),and the 5-year CSS rates were 100.0%and 97.2%(χ2=0.579,P=0.038);after PSM,the 5-year OS rates of non-metastatic patients after LE and RS were 96.8%and 92.1%(χ2=3.606,P=0.058),and the 5-year CSS rates were 100.0%and 98.5%(χ2=1.015,P=0.314).After PSM,there was no significant difference in the 5-year OS and CSS of patients with defferent tumor location,tumor large diameter,or submucosal invasion between the LE and RS groups.Conclusions 11-20 mm of tumor diameter,right colon location,and submucosal invasion might be independent risk factors for distant metastasis of T1 stage C-NET,and LE could be an appropriate treatment option for non-metastatic C-NET.
9.Development of a Three-Wavelength Brain Tissue Oxygen Monitoring System Based on Near Infrared Spectrum
Zexi LI ; Hanlin LI ; Qi YIN ; Shijie CAI ; Jilun YE ; Xu ZHANG ; Hui YU ; Dahai GOU
Chinese Journal of Medical Instrumentation 2024;48(1):26-29,37
In the past 20 years,near infrared spectrum technology has been widely used in human body monitoring due to its non-invasive and real-time characteristics.Oxygen,as the main metabolic substance of the human body,is consumed the most in brain tissue.In order to prevent complications caused by a decrease in brain tissue oxygen during treatment,the patient's brain tissue blood oxygen saturation needs to be monitored in real time.Currently,most of the clinically used non-invasive cerebral blood oxygen detection equipments use dual wavelengths.Other substances on the detection path will cause errors in the measurement results.Therefore,this article proposes a three-wavelength method based on the basic principle of non-invasive monitoring of cerebral blood oxygen using near-infrared spectrum.The brain tissue oxygen saturation monitoring method of detecting light sources was initially verified through the built system,laying the foundation for subsequent system engineering.
10.Epidemiological characteristics of human respiratory syncytial virus among acute respiratory infection cases in 16 provinces of China from 2009 to 2023
Aili CUI ; Baicheng XIA ; Zhen ZHU ; Zhibo XIE ; Liwei SUN ; Jin XU ; Jing XU ; Zhong LI ; Linqing ZHAO ; Xiaoru LONG ; Deshan YU ; Bing ZHU ; Feng ZHANG ; Min MU ; Hui XIE ; Liang CAI ; Yun ZHU ; Xiaoling TIAN ; Bing WANG ; Zhenguo GAO ; Xiaoqing LIU ; Binzhi REN ; Guangyue HAN ; Kongxin HU ; Yan ZHANG
Chinese Journal of Preventive Medicine 2024;58(7):945-951
Objective:To understand the epidemiological characteristics of human respiratory syncytial virus (HRSV) among acute respiratory infection (ARI) cases in 16 provinces of China from 2009 to 2023.Methods:The data of this study were collected from the ARI surveillance data from 16 provinces in China from 2009 to 2023, with a total of 28 278 ARI cases included in the study. The clinical specimens from ARI cases were screened for HRSV nucleic acid from 2009 to 2023, and differences in virus detection rates among cases of different age groups, regions, and months were analyzed.Results:A total of 28 278 ARI cases were enrolled from January 2009 to September 2023. The age of the cases ranged from<1 month to 112 years, and the age M ( Q1, Q3) was 3 years (1 year, 9 years). Among them, 3 062 cases were positive for HRSV nucleic acid, with a total detection rate of 10.83%. From 2009 to 2019, the detection rate of HRSV was 9.33%, and the virus was mainly prevalent in winter and spring. During the Corona Virus Disease 2019 (COVID-19) pandemic, the detection rate of HRSV fluctuated between 6.32% and 18.67%. There was no traditional winter epidemic peak of HRSV from the end of 2022 to the beginning of 2023, and an anti-seasonal epidemic of HRSV occurred from April to May 2023. About 87.95% (2 693/3 062) of positive cases were children under 5 years old, and the difference in the detection rate of HRSV among different age groups was statistically significant ( P<0.001), showing a decreasing trend of HRSV detection rate with the increase of age ( P<0.001). Among them, the HRSV detection rate (25.69%) was highest in children under 6 months. Compared with 2009-2019, the ranking of HRSV detection rates in different age groups changed from high to low between 2020 and 2023, with the age M (Q1, Q3) of HRSV positive cases increasing from 1 year (6 months, 3 years) to 2 years (11 months, 3 years). Conclusion:Through 15 years of continuous HRSV surveillance analysis, children under 5 years old, especially infants under 6 months old, are the main high-risk population for HRSV infection. During the COVID-19 pandemic, the prevalence and patterns of HRSV in China have changed.

Result Analysis
Print
Save
E-mail