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 Characteristics and Prognostic Analysis of Childhood Acute Lymphoblastic Leukemia with Positive E2A-PBX1 Fusion Gene.
Ming JIA ; Bo-Fei HU ; Xiao-Jun XU ; Wei-Qun XU ; Jing-Ying ZHANG ; Yong-Min TANG
Journal of Experimental Hematology 2025;33(2):319-324
OBJECTIVE:
To explore the clinical characteristics, therapeutic responses and prognostic features of E2A-PBX1 fusion gene for childhood acute lymphoblastic leukemia (ALL).
METHODS:
A total of 837 pediatric patients with ALL who were initially diagnosed in our hospital from July 2010 to November 2017 were retrospectively analyzed, 48 children with positive E2A-PBX1 fusion gene were detected by the real-time quantitative PCR techniques and their data were retrospectively collected for analysis.
RESULTS:
Among 48 cases with positive E2A-PBX1 fusion gene, there were 26 males and 22 females, with onset ages ranging from 9 months to 13 years old. There were 2 cases (4.2%) in the low-risk group, 32 cases (66.7%) in the intermediate-risk group, and 14 cases (29.1%) in the high-risk group at initial diagnosis. The white blood cell (WBC) counts of 25 cases (53.2%) at initial diagnosis were <50×109/L, 11 cases (23.4%) were (50-100)×109/L, and 11 cases (23.4%) ≥100×109/L. The main immunophenotype was common-B ALL (44 cases, 91.7%). Other leukemia fusion genes such as BCR-ABL1, MLL-AF4, and TEL-AML1 were not observed in this cohort of patients. All patients received the treatment of NPCLC-ALL2008 protocol, and 5 cases (10.4%) occurred poor prednisone response. All the 48 cases achieved complete remission (CR) after the induction treatments. The last follow-up date was April 30, 2023. A total of 5 children relapsed, including 1 case with intermediate risk and 4 cases with high risk. The recurrence rate in the high-risk group was significantly higher than that in the intermediate- and low-risk groups (both P < 0.05). Most relapsed children had elevated WBC counts at initial diagnosis. Among them, WBC counts ≥100×109/L was observed in 4 cases. The recurrence rate among children with WBC counts ≥100×109/L was significantly higher than that with WBC counts <100×109/L (P < 0.01). Four deaths occurred in this cohort, of which 3 died of leukemia recurrence. The 10-year event-free survival rate and 10-year overall survival rate of the 48 children with positive E2A-PBX1 fusion gene were 87.5%±4.8% and 91.7%±4.0%, respectively.
CONCLUSION
In ALL children with positive E2A-PBX1 fusion gene, those with elevated WBC counts and high risk stratification at initial diagnosis are more likely to experience recurrence. Recurrence is the main cause of death in this group. It is suggested that such kind of children receive more intensive chemotherapy or undergo hematopoietic stem cell transplantation as early as possible to further improve prognosis.
Humans
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Precursor Cell Lymphoblastic Leukemia-Lymphoma/diagnosis*
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Oncogene Proteins, Fusion/genetics*
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Prognosis
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Child
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Male
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Female
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Child, Preschool
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Adolescent
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Retrospective Studies
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Infant
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Homeodomain Proteins
4.Expert consensus on the application of nasal cavity filling substances in nasal surgery patients(2025, Shanghai).
Keqing ZHAO ; Shaoqing YU ; Hongquan WEI ; Chenjie YU ; Guangke WANG ; Shijie QIU ; Yanjun WANG ; Hongtao ZHEN ; Yucheng YANG ; Yurong GU ; Tao GUO ; Feng LIU ; Meiping LU ; Bin SUN ; Yanli YANG ; Yuzhu WAN ; Cuida MENG ; Yanan SUN ; Yi ZHAO ; Qun LI ; An LI ; Luo BA ; Linli TIAN ; Guodong YU ; Xin FENG ; Wen LIU ; Yongtuan LI ; Jian WU ; De HUAI ; Dongsheng GU ; Hanqiang LU ; Xinyi SHI ; Huiping YE ; Yan JIANG ; Weitian ZHANG ; Yu XU ; Zhenxiao HUANG ; Huabin LI
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(4):285-291
This consensus will introduce the characteristics of fillers used in the surgical cavities of domestic nasal surgery patients based on relevant literature and expert opinions. It will also provide recommendations for the selection of cavity fillers for different nasal diseases, with chronic sinusitis as a representative example.
Humans
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Nasal Cavity/surgery*
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Nasal Surgical Procedures
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China
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Consensus
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Sinusitis/surgery*
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Dermal Fillers
5.Effects of knocking down miR-221-3p expression on the stemness maintenance and angiogenesis in breast cancer cells under hypoxia conditions
Qian ZHANG ; Qi LI ; Nan MA ; Wei-qun ZHANG
Journal of Regional Anatomy and Operative Surgery 2025;34(6):471-477
Objective To investigate the expression of microRNA-221-3p(miR-221-3p)in breast cancer cells under hypoxia conditions,and the effects of knocking down its expression on the stemness maintenance and angiogenesis in breast cancer cells.Methods Human breast cancer cell line MCF-7 were cultured under normoxic and hypoxic conditions,and the expression of miR-221-3p in cells was detected by quantitative real-time polymerase chain reaction(RT-qPCR).MCF-7 cells were divided into normoxic group(MCF-7 cells were cultured under normoxic conditions),hypoxic group(MCF-7 cells were cultured under hypoxic conditions),hypoxia+miR-221-3p NC group(MCF-7 cells were cultured under hypoxic conditions and transfected with miR-221-3p NC),hypoxia+miR-221-3p inhibitor group(MCF-7 cells were cultured under hypoxic conditions and transfected with miR-221-3p inhibitor).The proliferation activity of cells in each group was detected by CCK-8 method;the number of cell tumor spheres in each group was detected by tumor sphere formation assay;the proportion of cells labeled with the stemness marker aldehyde dehydrogenase 1(ALDH1)in each group was detected by flow cytometry;the expression of cluster of differentiation 133(CD133),cluster of differentiation 44(CD44)and sex determination region Y-box protein 2(SOX2)of cells in each group was detected by Western blot;the number of human umbilical vein endothelial cells(HUVEC)tubes formed by cell supernatant culture in each group was detected by in vitro tube formation experiment;the expression of hypoxia-inducible factor-1α(HIF-1α)and vascular endothelial growth factor(VEGF)of cells in each group was detected by Western blot.Results Compared with normoxic group,the expression levels of miR-221-3p,and CD133,CD44,SOX2,HIF-1α,VEGF protein of cells in hypoxic group were significantly up-regulated(P<0.05),and the cell proliferation activity,the number of tumor spheres,the proportion of ALDH1+cells and the number of HUVEC tubes were significantly increased(P<0.05).Compared with hypoxia+miR-221-3p NC group,the expression levels of miR-221-3p,and CD133,CD44,SOX2,HIF-1α,VEGF protein of cells in hypoxia+miR-221-3p inhibitor group were significantly down-regulated(P<0.05),and the cell proliferation activity,the number of tumor spheres,the proportion of ALDH1+cells,and the number of HUVEC were significantly decreased(P<0.05).Conclusion Under hypoxic conditions,the expression of miR-221-3p in breast cancer cells is up-regulated,and knocking down the expression of miR-221-3p can reduce the stemness and angiogenesis ability of breast cancer cells.
6.Nine cases report of lymphoproliferative diseases after liver transplantation
Hongjing DONG ; Qiuju TIAN ; Qun ZHANG ; Fengchao LIU ; Jinzhen CAI ; Wei RAO
Chinese Journal of Organ Transplantation 2025;46(11):797-800
This study retrospectively reviewed the clinical data of 9 recipients with post-transplant lymphoproliferative disorder (PTLD) after liver transplantation admitted to the Organ Transplantation Center of the Affiliated Hospital of Qingdao University from January 2020 to June 2024, and summarized their clinical manifestations, pathological features, treatment regimens, and prognostic conditions, so as to provide a reference for clinical diagnosis and treatment.
7.Guidelines for Medical Examination for Cancer in Health Examination Agency(2025 Edition)
Wanqing CHEN ; Zhijian XU ; Qiang ZENG ; Ni LI ; Wei CAO ; Kexin CHEN ; Feng SUN ; Yuping LIU ; Yutong HE ; Peng WANG ; Shiqi TANG ; Qun ZHANG ; Kaifeng PAN ; Jie HE
China Cancer 2025;34(9):667-697
Cancer incidence in China has been rising steadily,with a particularly heavy burden from several high-prevalence malignancies.Medical examination for cancer plays a critical role in the early detection of cancer,precancerous lesions,and precursor conditions,thereby facilitating timely diagnosis and intervention.Such examination also addresses the growing demand for person-alized cancer screening services among diverse population groups.The development of evidence-based,context-specific cancer screening guidelines is essential to enhance the standardization,quality,and equity of preventive screening practices across the country,ultimately improving out-comes in early cancer detection and treatment.Guided by the Department of Medical Emergency Response of the National Health Commission,the Guidelines for Medical Examination for Cancer in Health Examination Agency(2025 Edition)were developed under the leadership of the National Cancer Center.A multidisciplinary panel of experts formulated the guidelines in accordance with the principles and methodology of the World Health Organization Handbook for Guideline Deve-lopment.The guidelines provide evidence-based recommendations on key clinical domains:target cancers and populations,overall screening workflow,screening protocols,diagnostic technolo-gies,result interpretation,follow-up procedures,and quality control.The primary objective is to standardize cancer screening practices in health examination agency and strengthen China's ca-pacity for prevention and control of high-burden cancers.
8.Retrospective study of diclofenac sodium in combination with tramadol for preemptive analgesia in outpatient menopausal women undergoing IUD removal
Qun WANG ; Qing ZHANG ; Wei HUANG
Chinese Journal of Pharmacoepidemiology 2025;34(2):151-156
Objective To evaluate the preemptive analgesic effect of diclofenac sodium combined with tramadol in outpatient intrauterine device(IUD)removal surgery for postmenopausal women,and to explore its feasibility and effectiveness in clinical application.Methods The clinical data of postmenopausal women who underwent IUD removal surgery at the obstetrics and gynecology outpatient department of the Hunan Schistosomiasis Prevention and Control Institute from February 2022 to January 2023 were retrospectively collected.A propensity score matching(PSM)method for 1∶1 matching was applied.The combination group received diclofenac sodium suppositories combined with tramadol for analgesia,while the control group received diclofenac sodium suppositories combined with lidocaine.Surgical duration,analgesic effect,adverse reactions,cervical softening,and success rate of IUD removal were compared between the two groups.Results Data from 142 patients were collected.After PSM,there were 53 patients in each group.The surgery time in the combination group was significantly shorter than in the control group(2.58±0.51 vs.4.76±1.37 minutes,P<0.001).The numeric rating scale(NRS)scores in the combination group was better than in the control group(1.43±0.75 vs.3.87±1.33,P<0.001).The cervical softening rate in the combination group was 94.34%,significantly higher than the 71.70%in the control group(P<0.05),while the success rate of IUD removal in the combination group was 96.23%,also significantly higher than 84.91%in the control group(P<0.05).There was no statistically significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion Diclofenac sodium combined with tramadol provides significant preemptive analgesic effects in IUD removal surgery for postmenopausal women.It helps to shorten surgical duration,alleviate intraoperative pain,promote cervical softening,and increase the success rate of IUD removal,demonstrating high clinical value.
9.Safety of teriflunomide in Chinese adult patients with relapsing multiple sclerosis: A phase IV, 24-week multicenter study.
Chao QUAN ; Hongyu ZHOU ; Huan YANG ; Zheng JIAO ; Meini ZHANG ; Baorong ZHANG ; Guojun TAN ; Bitao BU ; Tao JIN ; Chunyang LI ; Qun XUE ; Huiqing DONG ; Fudong SHI ; Xinyue QIN ; Xinghu ZHANG ; Feng GAO ; Hua ZHANG ; Jiawei WANG ; Xueqiang HU ; Yueting CHEN ; Jue LIU ; Wei QIU
Chinese Medical Journal 2025;138(4):452-458
BACKGROUND:
Disease-modifying therapies have been approved for the treatment of relapsing multiple sclerosis (RMS). The present study aims to examine the safety of teriflunomide in Chinese patients with RMS.
METHODS:
This non-randomized, multi-center, 24-week, prospective study enrolled RMS patients with variant (c.421C>A) or wild type ABCG2 who received once-daily oral teriflunomide 14 mg. The primary endpoint was the relationship between ABCG2 polymorphisms and teriflunomide exposure over 24 weeks. Safety was assessed over the 24-week treatment with teriflunomide.
RESULTS:
Eighty-two patients were assigned to variant ( n = 42) and wild type groups ( n = 40), respectively. Geometric mean and geometric standard deviation (SD) of pre-dose concentration (variant, 54.9 [38.0] μg/mL; wild type, 49.1 [32.0] μg/mL) and area under plasma concentration-time curve over a dosing interval (AUC tau ) (variant, 1731.3 [769.0] μg∙h/mL; wild type, 1564.5 [1053.0] μg∙h/mL) values at steady state were approximately similar between the two groups. Safety profile was similar and well tolerated across variant and wild type groups in terms of rates of treatment emergent adverse events (TEAE), treatment-related TEAE, grade ≥3 TEAE, and serious adverse events (AEs). No new specific safety concerns or deaths were reported in the study.
CONCLUSION:
ABCG2 polymorphisms did not affect the steady-state exposure of teriflunomide, suggesting a similar efficacy and safety profile between variant and wild type RMS patients.
REGISTRATION
NCT04410965, https://clinicaltrials.gov .
Humans
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Crotonates/adverse effects*
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Toluidines/adverse effects*
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Nitriles
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Hydroxybutyrates
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Female
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Male
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Adult
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ATP Binding Cassette Transporter, Subfamily G, Member 2/genetics*
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Middle Aged
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Multiple Sclerosis, Relapsing-Remitting/genetics*
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Prospective Studies
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Young Adult
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Neoplasm Proteins/genetics*
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East Asian People
10.Therapeutic efficacy and its mechanism of methylprednisolone on smoke inhalation-induced acute lung injury in rats
Hu-Ming LI ; Xu-Xin CHEN ; Yong-Qun LI ; Chun-Yang ZHANG ; Yan ZHANG ; Wei CHEN ; Zhi-Hai HAN
Medical Journal of Chinese People's Liberation Army 2025;50(7):890-896
Objective To observe the therapeutic effects of different doses of methylprednisolone(MP)on smoke inhalation-induced acute lung injury(SI-ALI)in rats,and to explore the changes in the expression of aquaporins(AQPs)and the underlying mechanisms for alleviating lung injury.Methods A total of 86 healthy adult male Sprague-Dawley(SD)rats were randomly divided into five groups:control group(n=6),smoke inhalation injury(SI)group(n=20),low-dose MP group(LMP,SI+0.4 mg/kg MP,n=20),medium-dose MP group(MMP,SI+4 mg/kg MP,n=20),and high-dose MP group(HMP,SI+40 mg/kg MP,n=20).A model of smoke inhalation-induced lung injury was established.The survival status of the rats in each group was monitored.Lung tissues were collected 24 hours after injury to determine the wet-to-dry(W/D)ratio of the lung tissues,arterial oxygen partial pressure(PaO2),and the expression levels of inflammatory cytokines TNF-α and IL-6.The degree of lung injury was evaluated using HE staining,and the mRNA and protein expression levels of AQP1 and AQP5 in the lung tissues were detected.Results Compared with control group,the survival rate of the rats in SI group was significantly decreased(P<0.05);compared with SI group,the survival rates of the rats in MMP and HMP groups were significantly increased(P<0.05).Compared with control group,the PaO2 of the Rats in SI group was significantly decreased(P<0.05),and the wet-to-dry(W/D)ratio and lung injury scores were significantly increased(P<0.05).Compared with SI group,the PaO2 of the rats in LMP,MMP,and HMP groups(P<0.05)was significantly increased(P<0.05),and the lung W/D ratio and injury scores in MMP and HMP groups were significantly decreased(P<0.05).ELISA results showed that compared with control group,the serum concentrations of TNF-α and IL-6 in SI group were significantly increased(P<0.05);compared with SI group,the concentrations of TNF-α and IL-6 in MMP and HMP groups were significantly decreased(P<0.05).HE staining revealed that the alveolar structure of the rats in SI group was severely damaged;compared with SI group,the damage to the alveolar structure in MMP and HMP groups was alleviated.Real-time PCR and Western blotting analysis results showed that compared with control group,the mRNA and protein expression levels of AQP1 and AQP5 in lung tissues in SI group were significantly decreased(P<0.05);however,compared with SI group,these levels in LMP,MMP,and HMP groups were significantly increased(P<0.05).Conclusions Smoke inhalation can induce acute lung injury in rats and down-regulate the expression levels of AQP1 and AQP5 in the lung tissues.Methylprednisolone can alleviate pulmonary edema and tissue damage in rats caused by smoke inhalation,and induce the up-regulation of the expression of AQP1 and AQP5.

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