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
;
Child
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Child, Preschool
;
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.Study on mechanism of naringin in alleviating cerebral ischemia/reperfusion injury based on DRP1/LRRK2/MCU axis.
Kai-Mei TAN ; Hong-Yu ZENG ; Feng QIU ; Yun XIANG ; Zi-Yang ZHOU ; Da-Hua WU ; Chang LEI ; Hong-Qing ZHAO ; Yu-Hong WANG ; Xiu-Li ZHANG
China Journal of Chinese Materia Medica 2025;50(9):2484-2494
This study aims to investigate the molecular mechanism by which naringin alleviates cerebral ischemia/reperfusion(CI/R) injury through DRP1/LRRK2/MCU signaling axis. A total of 60 SD rats were randomly divided into the sham group, the model group, the sodium Danshensu group, and low-, medium-, and high-dose(50, 100, and 200 mg·kg~(-1)) naringin groups, with 10 rats in each group. Except for the sham group, a transient middle cerebral artery occlusion/reperfusion(tMCAO/R) model was established in SD rats using the suture method. Longa 5-point scale was used to assess neurological deficits. 2,3,5-Triphenyl tetrazolium chloride(TTC) staining was used to detect the volume percentage of cerebral infarction in rats. Hematoxylin-eosin(HE) staining and Nissl staining were employed to assess neuronal structural alterations and the number of Nissl bodies in cortex, respectively. Western blot was used to determine the protein expression levels of B-cell lymphoma-2 gene(Bcl-2), Bcl-2-associated X protein(Bax), cleaved cysteine-aspartate protease-3(cleaved caspase-3), mitochondrial calcium uniporter(MCU), microtubule-associated protein 1 light chain 3(LC3), and P62. Mitochondrial structure and autophagy in cortical neurons were observed by transmission electron microscopy. Immunofluorescence assay was used to quantify the fluorescence intensities of MCU and mitochondrial calcium ion, as well as the co-localization of dynamin-related protein 1(DRP1) with leucine-rich repeat kinase 2(LRRK2) and translocase of outer mitochondrial membrane 20(TOMM20) with LC3 in cortical mitochondria. The results showed that compared with the model group, naringin significantly decreased the volume percentage of cerebral infarction and neurological deficit score in tMCAO/R rats, alleviated the structural damage and Nissl body loss of cortical neurons in tMCAO/R rats, inhibited autophagosomes in cortical neurons, and increased the average diameter of cortical mitochondria. The Western blot results showed that compared to the sham group, the model group exhibited increased levels of cleaved caspase-3, Bax, MCU, and the LC3Ⅱ/LC3Ⅰ ratio in the cortex and reduced protein levels of Bcl-2 and P62. However, naringin down-regulated the protein expression of cleaved caspase-3, Bax, MCU and the ratio of LC3Ⅱ/LC3Ⅰ ratio and up-regulated the expression of Bcl-2 and P62 proteins in cortical area. In addition, immunofluorescence analysis showed that compared with the model group, naringin and positive drug treatments significantly decreased the fluorescence intensities of MCU and mitochondrial calcium ion. Meanwhile, the co-localization of DRP1 with LRRK2 and TOMM20 with LC3 in cortical mitochondria was also decreased significantly after the intervention. These findings suggest that naringin can alleviate cortical neuronal damage in tMCAO/R rats by inhibiting DRP1/LRRK2/MCU-mediated mitochondrial fragmentation and the resultant excessive mitophagy.
Animals
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Rats, Sprague-Dawley
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Reperfusion Injury/genetics*
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Flavanones/administration & dosage*
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Rats
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Dynamins/genetics*
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Male
;
Brain Ischemia/genetics*
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Protein Serine-Threonine Kinases/genetics*
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Signal Transduction/drug effects*
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Humans
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Drugs, Chinese Herbal/administration & dosage*
3.Short-term Effects of Fine Particulate Matter and its Constituents on Acute Exacerbations of Chronic Bronchitis: A Time-stratified Case-crossover Study.
Jing Wei ZHANG ; Jian ZHANG ; Peng Fei LI ; Yan Dan XU ; Xue Song ZHOU ; Xiu Li TANG ; Jia QIU ; Zhong Ao DING ; Ming Jia XU ; Chong Jian WANG
Biomedical and Environmental Sciences 2025;38(3):389-393
4.Impact of human papillomavirus and coinfection with other sexually transmitted pathogens on male infertility.
Xin FAN ; Ya XU ; Li-Feng XIANG ; Lu-Ping LIU ; Jin-Xiu WAN ; Qiu-Ting DUAN ; Zi-Qin DIAN ; Yi SUN ; Ze WU ; Yun-Hua DONG
Asian Journal of Andrology 2025;27(1):84-89
This study primarily aimed to investigate the prevalence of human papillomavirus (HPV) and other common pathogens of sexually transmitted infections (STIs) in spermatozoa of infertile men and their effects on semen parameters. These pathogens included Ureaplasma urealyticum, Ureaplasma parvum, Chlamydia trachomatis, Mycoplasma genitalium , herpes simplex virus 2, Neisseria gonorrhoeae, Enterococcus faecalis, Streptococcus agalactiae, Pseudomonas aeruginosa , and Staphylococcus aureus . A total of 1951 men of infertile couples were recruited between 23 March 2023, and 17 May 2023, at the Department of Reproductive Medicine of The First People's Hospital of Yunnan Province (Kunming, China). Multiplex polymerase chain reaction and capillary electrophoresis were used for HPV genotyping. Polymerase chain reaction and electrophoresis were also used to detect the presence of other STIs. The overall prevalence of HPV infection was 12.4%. The top five prevalent HPV subtypes were types 56, 52, 43, 16, and 53 among those tested positive for HPV. Other common infections with high prevalence rates were Ureaplasma urealyticum (28.3%), Ureaplasma parvum (20.4%), and Enterococcus faecalis (9.5%). The prevalence rates of HPV coinfection with Ureaplasma urealyticum, Ureaplasma parvum, Chlamydia trachomatis, Mycoplasma genitalium , herpes simplex virus 2, Neisseria gonorrhoeae, Enterococcus faecalis, Streptococcus agalactiae , and Staphylococcus aureus were 24.8%, 25.4%, 10.6%, 6.4%, 2.4%, 7.9%, 5.9%, 0.9%, and 1.3%, respectively. The semen volume and total sperm count were greatly decreased by HPV infection alone. Coinfection with HPV and Ureaplasma urealyticum significantly reduced sperm motility and viability. Our study shows that coinfection with STIs is highly prevalent in the semen of infertile men and that coinfection with pathogens can seriously affect semen parameters, emphasizing the necessity of semen screening for STIs.
Humans
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Male
;
Infertility, Male/epidemiology*
;
Coinfection/microbiology*
;
Papillomavirus Infections/virology*
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Adult
;
Sexually Transmitted Diseases/complications*
;
China/epidemiology*
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Staphylococcus aureus/isolation & purification*
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Chlamydia trachomatis/isolation & purification*
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Prevalence
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Mycoplasma genitalium/isolation & purification*
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Ureaplasma urealyticum/isolation & purification*
;
Neisseria gonorrhoeae/isolation & purification*
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Enterococcus faecalis/isolation & purification*
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Streptococcus agalactiae/isolation & purification*
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Herpesvirus 2, Human/genetics*
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Pseudomonas aeruginosa/isolation & purification*
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Semen/virology*
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Sperm Motility
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Spermatozoa/microbiology*
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Human Papillomavirus Viruses
5.Accessory cavitated uterine malformation:one case report and literature review
Bai-juan DING ; Li-wei ZHANG ; Yan-qiu WEI ; Xiu-juan CUI
Fudan University Journal of Medical Sciences 2025;52(5):747-751
Accessory cavitated uterine malformation(ACUM)is a rare unique congenital Müllerian duct malformation.Its main clinical manifestations are abdominal pain shortly after menarche and progressive aggravation,also may present as chronic periodic lower abdominal pain or abnormal uterine bleeding.Because it occurs rarely,it is easy to cause misdiagnosis or delay diagnosis.This paper reports the clinical manifestations,diagnosis and treatment of a young patient with ACUM,and reviews the literature to deepen the understanding of this rare genital tract malformation.
6.Protective effects of Shuangyi Qushi Tongluo Capsules on dexamethasone-induced osteoporosis in mice
Yi LI ; Jian-bin HE ; Jia-xiu XIE ; Quan-mou LUO ; Dong-mei LI ; Jun-hui HE ; Dong-mei WEI ; Chao WEI ; Hong-cong QIU ; Gui-ning WEI ; Bo WANG
Chinese Traditional Patent Medicine 2025;47(6):1834-1842
AIM To investigate the protective effects of Shuangyi Qushi Tongluo Capsules(Shuangyi Capsules)on Dexamethasone(Dex)induced osteoporosis in mice.METHODS The C57BL/6J mice were randomly divided into the control group,the model group,the Xianling Gubao Capsules group(1.5 g/kg),and the low-dose,moderate-dose,and high-dose Shuangyi Capsules groups(0.6,1.2,and 2.4 g/kg).The mouse model of osteoporosis was induced by 8-week intraperitoneal injection of Dex sodium phosphate injection(5 mg/kg).The mice had their femur osteogenesis observed with hematoxylin and eosin(HE)staining and tartrate-resistant acid phosphatase(TRAP)staining;their serum alkaline phosphatase(ALP)and osteocalcin(BGP)activities detected by ELISA;their femoral mRNA expressions of Col-Ⅰ,OCN,and OPN detected by RT-qPCR;and their femoral protein expressions of OPG and RANKL detected by Western blot.Upon the MC3T3-E1 cells exposed to Dex and Shuangyi Capsules,their viability was evaluated by CCK-8 assay;their mineralization determined by alkaline phosphatase staining and alizarin red staining(ARS);and their intracellular ROS level detected using DCFH-DA probe.RESULTS Compared with the model group,Shuangyi Capsules groups demonstrated improved fracture of femoral trabeculae and reduced number of osteoclasts;increased serum ALP and BGP activities(P<0.05,P<0.01);increased femoral expressions of Col-Ⅰ mRNA and OPG protein(P<0.05,P<0.01);and decreased RANKL protein expression(P<0.05).Compared with the MC3T3-E1 cells stimulated by Dex,those underwent further treatment of Shuangyi Capsules demonstrated increased cell viability and ALP activity(P<0.05,P<0.01);increased mineralization and calcium nodule formation;increased expressions of Col-Ⅰ,OCN,OPN mRNA and OPG protein(P<0.05,P<0.01);decreased RANKL protein expression(P<0.05,P<0.01);and reduced ROS levels.CONCLUSION Shuangyi Capsules ameliorate Dex-induced osteoporosis in mice by suppressing osteoclast overactivation,enhancing osteoblast activity,and stimulating bone formation through modulation of Col-Ⅰ,OCN,OPN mRNA and OPG/RANKL protein levels.
7.Protective effects of Shuangyi Qushi Tongluo Capsules on dexamethasone-induced osteoporosis in mice
Yi LI ; Jian-bin HE ; Jia-xiu XIE ; Quan-mou LUO ; Dong-mei LI ; Jun-hui HE ; Dong-mei WEI ; Chao WEI ; Hong-cong QIU ; Gui-ning WEI ; Bo WANG
Chinese Traditional Patent Medicine 2025;47(6):1834-1842
AIM To investigate the protective effects of Shuangyi Qushi Tongluo Capsules(Shuangyi Capsules)on Dexamethasone(Dex)induced osteoporosis in mice.METHODS The C57BL/6J mice were randomly divided into the control group,the model group,the Xianling Gubao Capsules group(1.5 g/kg),and the low-dose,moderate-dose,and high-dose Shuangyi Capsules groups(0.6,1.2,and 2.4 g/kg).The mouse model of osteoporosis was induced by 8-week intraperitoneal injection of Dex sodium phosphate injection(5 mg/kg).The mice had their femur osteogenesis observed with hematoxylin and eosin(HE)staining and tartrate-resistant acid phosphatase(TRAP)staining;their serum alkaline phosphatase(ALP)and osteocalcin(BGP)activities detected by ELISA;their femoral mRNA expressions of Col-Ⅰ,OCN,and OPN detected by RT-qPCR;and their femoral protein expressions of OPG and RANKL detected by Western blot.Upon the MC3T3-E1 cells exposed to Dex and Shuangyi Capsules,their viability was evaluated by CCK-8 assay;their mineralization determined by alkaline phosphatase staining and alizarin red staining(ARS);and their intracellular ROS level detected using DCFH-DA probe.RESULTS Compared with the model group,Shuangyi Capsules groups demonstrated improved fracture of femoral trabeculae and reduced number of osteoclasts;increased serum ALP and BGP activities(P<0.05,P<0.01);increased femoral expressions of Col-Ⅰ mRNA and OPG protein(P<0.05,P<0.01);and decreased RANKL protein expression(P<0.05).Compared with the MC3T3-E1 cells stimulated by Dex,those underwent further treatment of Shuangyi Capsules demonstrated increased cell viability and ALP activity(P<0.05,P<0.01);increased mineralization and calcium nodule formation;increased expressions of Col-Ⅰ,OCN,OPN mRNA and OPG protein(P<0.05,P<0.01);decreased RANKL protein expression(P<0.05,P<0.01);and reduced ROS levels.CONCLUSION Shuangyi Capsules ameliorate Dex-induced osteoporosis in mice by suppressing osteoclast overactivation,enhancing osteoblast activity,and stimulating bone formation through modulation of Col-Ⅰ,OCN,OPN mRNA and OPG/RANKL protein levels.
8.Accessory cavitated uterine malformation:one case report and literature review
Bai-juan DING ; Li-wei ZHANG ; Yan-qiu WEI ; Xiu-juan CUI
Fudan University Journal of Medical Sciences 2025;52(5):747-751
Accessory cavitated uterine malformation(ACUM)is a rare unique congenital Müllerian duct malformation.Its main clinical manifestations are abdominal pain shortly after menarche and progressive aggravation,also may present as chronic periodic lower abdominal pain or abnormal uterine bleeding.Because it occurs rarely,it is easy to cause misdiagnosis or delay diagnosis.This paper reports the clinical manifestations,diagnosis and treatment of a young patient with ACUM,and reviews the literature to deepen the understanding of this rare genital tract malformation.
9.Recommendations for the timing, dosage, and usage of corticosteroids during cytokine release syndrome (CRS) caused by chimeric antigen receptor (CAR)-T cell therapy for hematologic malignancies.
Sanfang TU ; Xiu LUO ; Heng MEI ; Yongxian HU ; Yang LIU ; Ping LI ; Dehui ZOU ; Ting NIU ; Kailin XU ; Xi ZHANG ; Lugui QIU ; Lei GAO ; Guangxun GAO ; Li ZHANG ; Yimei FENG ; Ying WANG ; Mingfeng ZHAO ; Jianqing MI ; Ming HOU ; Jianmin YANG ; He HUANG ; Jianxiang WANG ; Yu HU ; Weili ZHAO ; Depei WU ; Jun MA ; Yuhua LI ; Wenbin QIAN ; Xiaojun HUANG ; Weidong HAN ; Aibin LIANG
Chinese Medical Journal 2024;137(22):2681-2683
10.Expert consensus on ethical requirements for artificial intelligence (AI) processing medical data.
Cong LI ; Xiao-Yan ZHANG ; Yun-Hong WU ; Xiao-Lei YANG ; Hua-Rong YU ; Hong-Bo JIN ; Ying-Bo LI ; Zhao-Hui ZHU ; Rui LIU ; Na LIU ; Yi XIE ; Lin-Li LYU ; Xin-Hong ZHU ; Hong TANG ; Hong-Fang LI ; Hong-Li LI ; Xiang-Jun ZENG ; Zai-Xing CHEN ; Xiao-Fang FAN ; Yan WANG ; Zhi-Juan WU ; Zun-Qiu WU ; Ya-Qun GUAN ; Ming-Ming XUE ; Bin LUO ; Ai-Mei WANG ; Xin-Wang YANG ; Ying YING ; Xiu-Hong YANG ; Xin-Zhong HUANG ; Ming-Fei LANG ; Shi-Min CHEN ; Huan-Huan ZHANG ; Zhong ZHANG ; Wu HUANG ; Guo-Biao XU ; Jia-Qi LIU ; Tao SONG ; Jing XIAO ; Yun-Long XIA ; You-Fei GUAN ; Liang ZHU
Acta Physiologica Sinica 2024;76(6):937-942
As artificial intelligence technology rapidly advances, its deployment within the medical sector presents substantial ethical challenges. Consequently, it becomes crucial to create a standardized, transparent, and secure framework for processing medical data. This includes setting the ethical boundaries for medical artificial intelligence and safeguarding both patient rights and data integrity. This consensus governs every facet of medical data handling through artificial intelligence, encompassing data gathering, processing, storage, transmission, utilization, and sharing. Its purpose is to ensure the management of medical data adheres to ethical standards and legal requirements, while safeguarding patient privacy and data security. Concurrently, the principles of compliance with the law, patient privacy respect, patient interest protection, and safety and reliability are underscored. Key issues such as informed consent, data usage, intellectual property protection, conflict of interest, and benefit sharing are examined in depth. The enactment of this expert consensus is intended to foster the profound integration and sustainable advancement of artificial intelligence within the medical domain, while simultaneously ensuring that artificial intelligence adheres strictly to the relevant ethical norms and legal frameworks during the processing of medical data.
Artificial Intelligence/legislation & jurisprudence*
;
Humans
;
Consensus
;
Computer Security/standards*
;
Confidentiality/ethics*
;
Informed Consent/ethics*

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