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
;
Female
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Humans
;
Male
;
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.Sirtuin 3 Attenuates Acute Lung Injury by Decreasing Ferroptosis and Inflammation through Inhibiting Aerobic Glycolysis.
Ke Wei QIN ; Qing Qing JI ; Wei Jun LUO ; Wen Qian LI ; Bing Bing HAO ; Hai Yan ZHENG ; Chao Feng HAN ; Jian LOU ; Li Ming ZHAO ; Xing Ying HE
Biomedical and Environmental Sciences 2025;38(9):1161-1167
3.Research Progress in the Impact of Accelerated Rehabilitation on Bone Tunnel Enlargement After Anterior Cruciate Ligament Reconstruction.
Wen-Bo TANG ; Feng GAO ; Xiao-Han ZHANG ; Bing-Ying ZHANG ; Hao DUAN ; Jing-Bin ZHOU
Acta Academiae Medicinae Sinicae 2025;47(4):634-643
This paper explores the impacts of accelerated rehabilitation protocols following anterior cruciate ligament reconstruction(ACLR)on bone tunnel enlargement(BTE).While accelerated rehabilitation can shorten the recovery time and improve the knee function,it may increase the risk of BTE.In the early rehabilitation phase after ACLR,excessive early weight-bearing and rapid progression of knee flexion angles should be avoided,along with the proper use of braces.Continuous passive motion is not recommended in the early phase post-ACLR to prevent potential effects on BTE.Further research is needed to investigate the mechanisms of BTE and develop more effective rehabilitation strategies.This will help to select appropriate rehabilitation protocols for patients and balance functional recovery with the risk of BTE,thereby reducing the revision rate and improving postoperative outcomes.
Humans
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Anterior Cruciate Ligament Reconstruction/rehabilitation*
4.Research progress of proprotein convertase subtilisin/kexin type 9 in myocardial infarction and ische-mia reperfusion
Chinese Journal of cardiovascular Rehabilitation Medicine 2024;33(1):100-103
At present,proprotein convertase subtilisin/kexin type 9(PCSK9)inhibitor has been widely used in clinical field as a fast and effective drug to reduce low density lipoprotein cholesterol(LDL-C),in addition to regulating LDL-C to affect the process of atherosclerosis.Clinical data show that PCSK9 is upregulated in ischemic heart,and downregulation of PCSK9 expression can benefit infarct size,post-infarct inflammation and remodeling,and cardiac dysfunction after ische-mia/reperfusion.In subjects with increased cardiovascular risk,PCSK9 inhibition was associated with reduced incidence rates of myocardial infarction,stroke,and coronary revascularization,as well as improved endothelial function.This article reviews the role of PCSK9 in myocardial infarction and ischemia-reperfusion after myocardial infarction.
5.Assessment of respiratory protection competency of staff in healthcare facilities
Hui-Xue JIA ; Xi YAO ; Mei-Hua HU ; Bing-Li ZHANG ; Xin-Ying SUN ; Zi-Han LI ; Ming-Zhuo DENG ; Lian-He LU ; Jie LI ; Li-Hong SONG ; Jian-Yu LU ; Xue-Mei SONG ; Hang GAO ; Liu-Yi LI
Chinese Journal of Infection Control 2024;23(1):25-31
Objective To understand the respiratory protection competency of staff in hospitals.Methods Staff from six hospitals of different levels and characteristics in Beijing were selected,including doctors,nurses,medical technicians,and servicers,to conduct knowledge assessment on respiratory protection competency.According to exposure risks of respiratory infectious diseases,based on actual cases and daily work scenarios,content of respira-tory protection competency assessment was designed from three aspects:identification of respiratory infectious di-seases,transmission routes and corresponding protection requirements,as well as correct selection and use of masks.The assessment included 6,6,and 8 knowledge points respectively,with 20 knowledge points in total,all of which were choice questions.For multiple-choice questions,full marks,partial marks,and no mark were given respective-ly if all options were correct,partial options were correct and without incorrect options,and partial options were correct but with incorrect options.Difficulty and discrimination analyses on question of each knowledge point was conducted based on classical test theory.Results The respiratory protection competency knowledge assessment for 326 staff members at different risk levels in 6 hospitals showed that concerning the 20 knowledge points,more than 60%participants got full marks for 6 points,while the proportion of full marks for other questions was relatively low.Less than 10%participants got full marks for the following 5 knowledge points:types of airborne diseases,types of droplet-borne diseases,conventional measures for the prevention and control of healthcare-associated infec-tion with respiratory infectious diseases,indications for wearing respirators,and indications for wearing medical protective masks.Among the 20 knowledge questions,5,1,and 14 questions were relatively easy,medium,and difficult,respectively;6,1,4,and 9 questions were with discrimination levels of ≥0.4,0.30-0.39,0.20-0.29,and ≤0.19,respectively.Conclusion There is still much room for hospital staff to improve their respiratory protection competency,especially in the recognition of diseases with different transmission routes and the indications for wearing different types of masks.
6.Structure-activity Omics on Anti-inflammatory and Analgesic Effect of Paeoniae Radix Alba in Qizhi Weitong Granules
Bing QI ; Xi LUO ; Ying ZHENG ; Ying MENG ; Shuai WANG ; Yongrui BAO ; Tianjiao LI ; Ling HAN ; Xinying SHU ; Xiansheng MENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):169-175
ObjectiveTo elucidate the active compounds for the anti-inflammatory and analgesic effects of Paeoniae Radix Alba from structure-activity omics. MethodOn the basis of the previous in vitro efficacy study by our research group, a mouse model of foot swelling was induced by methyl aldehyde and used to study the anti-inflammatory and analgesic effects of total glycosides of Paeoniae Radix Alba in vivo. The core targets of the active compounds for the anti-inflammatory and analgesic effects of Paeoniae Radix Alba were retrieved from the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP), Online Mendelian Inheritance in Man (OMIM), and Search Tool for Recurring Instances of Neighbouring Genes (STRING). Molecular docking was conducted for the total glucosides of Paeoniae Radix Alba with the core targets, and the key core targets with high binding affinity were screened out according to the comprehensive score of each target and active structure. The structure-activity relationship was analyzed with targets as a bridge through the combination of compound structures and pharmacological effects. ResultThe total glucosides of Paeoniae Radix Alba had good anti-inflammatory and analgesic effects in vivo. The core targets of 23 active components of Paeoniae Radix Alba were epidermal growth factor receptor (EGFR), signal transducer and activator of transcription 3 (STAT3), vascular endothelial growth factor A (VEGFA), cellular tumor antigen p53 (TP53), and proto-oncogene transcription factor (JUN). According to the structure of the parent nucleus, there were 16 pinane monoterpene glycosides, 4 pinene monoterpene glycosides, 2 monoterpene lactone glycosides, and 1 monoterpene ketone. The key core targets screened out by molecular docking were EGFR and STAT3. The structure-activity analysis of the active compound structures and the key core targets showed that the introduction of ketone group and benzene ring group on the parent nucleus affected the binding activity. ConclusionThis study analyzed the material basis for the anti-inflammatory and analgesic effects of total glycosides of Paeoniae Radix Alba from structure-activity omics, providing new ideas and methods for revealing the pharmacodynamic substances in traditional Chinese medicine.
7.Study on the effect of different administration regimens of iprrazole enteric-coated tablets on inhibiting gastric acid secretion
Ting-Yuan PANG ; Zhi WANG ; Zi-Shu HU ; Zi-Han SHEN ; Yue-Qi WANG ; Ya-Qian CHEN ; Xue-Bing QIAN ; Jin-Ying LIANG ; Liang-Ying YI ; Jun-Long LI ; Zhi-Hui HAN ; Guo-Ping ZHONG ; Guo-Hua CHENG ; Hai-Tang HU
The Chinese Journal of Clinical Pharmacology 2024;40(1):92-96
Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH>3 after 20 mg qd and 10 mg bid were 82.64%and 61.92%,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.
8.Comparison of intracellular uptake and target protein binding characteristics of two BTK inhibitors with different selectivities
Teng ZHANG ; Ting-Fei TAN ; Ying-Li ZHAO ; Gong-Wei HAN ; Zi-Tong XIA ; Han-Bing SHI ; He-Ying LIU ; Jun-Ping WANG ; Quan XIA
Chinese Pharmacological Bulletin 2024;40(10):1899-1905
Aim To investigate the intracellular up-take and target protein binding characteristics of two Bruton's tyrosine kinase inhibitors(BTKi)with differ-ent selectivities to provide further insights into the mechanisms of drug off-target-related bleeding risk.Methods Ibrutinib(non-selective BTKi)and za-nubrutinib(selective BTKi)were used as study drugs.After incubation of MEC-1 cells and human platelets with drugs,the cellular thermal shift assay(CETSA)was combined with Western blot to obtain the melting curve and isothermal curve to analyze the binding char-acteristics of the two drugs with the target protein BTK.After incubation of MEC-1 cells and human platelets with drugs,the concentrations of the two drugs were detected by liquid chromatography-tandem mass spectrometry(LC-MS/MS)to analyze the intracellular uptake of the two drugs.Results CETSA analysis confirmed that zanubrutinib was more selective for the target protein BTK compared to ibrutinib.LC-MS/MS analysis showed that both drugs were uptaken intracel-lularly by MEC-1 cells and platelets in a concentration-dependent manner.Conclusions While BTKi targe-ting BTK to B lymphocytes exerts therapeutic effects,off-target effects on platelets due to differences in their intracellular uptake,and target-binding characteristics may be one of the reasons for the differences in bleed-ing risk across selective BTKi.
9.The effect evaluation of revision operation for cubital tunnel syndrome followed surgical treatment
Bing XIONG ; Guoqiang HAN ; Chouzhong LI ; Ying TAN ; Beijin YAO
Chinese Journal of Nervous and Mental Diseases 2024;50(4):232-235
Objective To explore the causes of postoperative revision for cubital tunnel syndrome(CTS),summarize the details of revision surgery for CTS and evaluate the efficacy,in order to reduce the revision probability of the disease.Methods The data of 14 patients undergoing revision surgery for CTS in our hospital from March 2019 to August 2022 were collected and analyzed.By comparing the first-stage surgical incision,examining the tension and shape of ulnar nerve,the compression site and the improvement of postoperative symptoms,the reasons for revision were summarized and the curative effect was evaluated.Result The reasons for revision included the poor outcome of the initial operation and no improvement of symptoms or symptom worsen within 3 months after surgery.The main cause for revision was irregular incision design(14/14),the secondary cause was incomplete release of nerve entrapment points(12/14),and the rare cause was insufficient hemostasis in the operative area(1/14)and insufficient protection of sensory nerve(1/14).According to Gu's functional evaluation criteria for CTS,the excellent rate of revision surgery was 9/14.Conclusion The main reason for revision after primary surgery for CTS is the inadequate management of surgical details in the first operation,and the revision rate of CTS can be reduced by standardized operation.Revision surgery is still effective after the failure of the initial operation.
10.Research Progress in Treatment Principles of Acute Closed Soft Tissue Injuries.
Bing-Ying ZHANG ; Xiao-Han ZHANG ; Yi QIAN ; Wen-Bo TANG ; Feng GAO ; Jing-Bin ZHOU
Acta Academiae Medicinae Sinicae 2024;46(6):828-835
This article comprehensively reviews the research progress in the management principles of acute closed soft tissue injuries,summarizing the retention and updates of the four main principles (RICE,PRICE,POLICE,and PEACE&LOVE) at different stages.Traditional methods such as compression,elevation,rest,and protection remain valuable.However,with the advancement in rehabilitation philosophy,early active rehabilitation plays an increasingly important role in the tissue healing process.Traditional cold therapy remains a choice because of its benefits.Non-steroidal anti-inflammatory drugs play a positive role in relieving the acute pain and swelling and improving the function of soft tissue,being preferred by both patients and medical practitioners.Therefore,advantages outweigh disadvantages in the clinical application of non-steroidal anti-inflammatory drugs.Finally,modern medical models have begun to incorporate more social and psychological factors,focusing on patients' mental state and social environment,while guiding patients to actively participate in the rehabilitation process,which can accelerate the recovery process and improve treatment outcomes.
Humans
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Soft Tissue Injuries/therapy*
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Anti-Inflammatory Agents, Non-Steroidal/therapeutic use*

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