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Efficacy of Tounongsan decoction(透脓散方)on pyogenic liver abscess:network pharmacology and clinical trial validation

Journal of Traditional Chinese Medicine 2024年第1期44卷 145-155页

作者： ZHANG Qi CHEN Dexuan ZHU Guixiang ZHANG Shihu FENG Xiao MA Chaoqun ZHANG Yi Department of General Surgery Affiliated Hospital of Nanjing University of Chinese MedicineJiangsu Provincial Hospital of Traditional Chinese MedicineNanjing 210029China Zhuzhou Orthopaedic Hospital of Traditional Chinese Medicine Zhuzhou 412300China Department of General Surgery Jiangsu Province Hospital on Integration of Chinese and Western MedicineNanjing 210029China

OBJECTIVE:To elucidate the molecular mechanisms governing the effect of Tounongsan decoction(透脓散方,TNS)on the pyogenic liver abscess.METHODS:Based on oral bioavailability and druglikeness,the main active components of TNS were screened using the Traditional Chinese Medicine Systems Pharmacology platform.The Gene Card and Uni Prot databases were used to establish a database of pyogenic liver abscess targets.The interactive network map of drug-ingredients-target-disease was constructed using Cytoscape software(Version 3.7.2).A proteinprotein interaction network was constructed using the STRING database,and the related protein interaction relationships were analyzed.biological process of gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)enrichment analyses were performed for the core targets.Finally,a clinical trial was performed to verify the reliability of the network pharmacology.RESULTS:Forty active components of TNS decoction were obtained,and 61 potential targets and 11 proteins were identified.Pathways involved in the treatment of pyogenic liver abscess include the phosphatidylinositide 3-kinases-protein kinase B(PI3K-AKT),advanced glycation end products-receptor for advanced glycation end products(AGE-RAGE),and tumor necrosis factor(TNF)signaling pathways.The results of network pharmacology analysis combined with clinical trials validated that TNS decoction could alleviate the inflammatory response of pyogenic liver abscesses by decreasing interleukin 6(IL-6)levels.CONCLUSIONS:TNS decoction has the characteristics of being multi-system,multi-component,and multi-target.Active ingredients in TNS,such as quercetin,kaempferol,fisetin,andβ-sitosterol,have strong potential to be candidate drugs for treating pyogenic liver abscesses.The possible mechanism of TSN decoction includes regulating immune and inflammatory responses and reducing IL-6 production to control inflammatory development.

关键词： network pharmacology clinical trial liver abscess pyogenic Tounongsan decoction

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Problems and Countermeasures to Improve clinical trial Participants’Compensation Rights in China

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Asian Journal of Social Pharmacy 2024年第1期19卷 58-63页

作者： Yang Xiuqiao Wen Ping Lin Hong Chen Wenhuan Chen Yuwen Department of clinical Trail Management Shenzhen Maternity&Child Healthcare HospitalShenzhen 518028China School of Business Administration Shenyang Pharmaceutical UniversityShenyang 110016China Jincheng Tongda&Neal Shenzhen 518000China

Objective To discuss the problems existing in the compensation of Chinese clinical trial participants and propose some suggestions for improving their rights.Methods The literature related to the participants’right to compensation at home and abroad was searched to study the inadequacy of the compensation right for clinical trial participants in China from four aspects:insurance system,principle of attribution,legal relationship and compensation regulations.Then,some suggestions to improve the participants’right to compensation were proposed.Results and Conclusion China lacks clear legal norms for participants’right to compensation.There are problems such as unclear insurance rules and compensation rules,unclear contractual relationships between parties to clinical trials,and no laws and regulations to rely on for attribution and compensation.China should issue regulatory guidelines related to the right to compensation of participants in clinical trials,so that all parties in clinical trials can have rules to follow if there is the occurrence of injury,which can better protect the rights and interests of the participants.

关键词： clinical trial participant compensation right

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Injectable collagen scaffold with human umbilical cordderived mesenchymal stem cells promotes functional recovery in patients with spontaneous intracerebral hemorrhage:phase Ⅰ clinical trial

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Neural Regeneration Research 2023年第9期18卷 1999-2004页

作者： Xiao-Yin Li Wu-Sheng Deng Zi-Qi Wang Zheng-Chao Li Shu-Lian Chen Zhen Song Quan Zhang Jin Liang Xu-Yi Chen Characteristic Medical Center of Chinese People’s Armed Police Force Tianjin Key Laboratory of Neurotrauma RepairTianjinChina Department of Neurosurgery Dazhou Second People’s HospitalDazhouSichuan ProvinceChina Graduate School of Tianjin University of Traditional Chinese Medicine TianjinChina

Animal expe riments have shown that injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can promote recovery from spinal cord injury.To investigate whether injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells can be used to treat spontaneous intracerebral hemorrhage,this non-randomized phase I clinical trial recruited patients who met the inclusion criteria and did not meet the exclusion crite ria of spontaneous intracerebral hemorrhage treated in the Characteristic Medical Center of Chinese People’s Armed Police Force from May 2016 to December 2020.Patients were divided into three groups according to the clinical situation and patient benefit:control(n=18),human umbilical cord-derived mesenchymal stem cells(n=4),and combination(n=8).The control group did not receive any transplantation.The human umbilical cord-derived mesenchymal stem cells group received human umbilical cord-derived mesenchymal stem cell transplantation.The combination group received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells.Patients who received injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells had more remarkable improvements in activities of daily living and cognitive function and smaller foci of intra cerebral hemorrhage-related encephalomalacia.Severe adve rse events associated with cell transplantation were not observed.Injectable collagen scaffold with human umbilical cord-derived mesenchymal stem cells appears to have great potential treating spontaneous intracerebral hemorrhage.

关键词： clinical trial collagen scaffold efficacy human umbilical cord-derived mesenchymal stem cells human safe neurological recovery spontaneous intracerebral hemorrhage transplantation

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Role of CD36 in central nervous system diseases

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Neural Regeneration Research 2024年第3期19卷 512-518页

作者： Min Feng Qiang Zhou Huimin Xie Chang Liu Mengru Zheng Shuyu Zhang Songlin Zhou Jian Zhao School of Health Science and Engineering University of Shanghai for Science and TechnologyShanghaiChina Department of Orthopedic Oncology Second Affiliated Hospital of Naval Medical UniversityShanghaiChina Key Laboratory of Neuroregeneration of Jiangsu and Ministry of Education NMPA Key Laboratory for Research and Evaluation of Tissue Engineering Technology ProductsJiangsu Clinical Medicine Center of Tissue Engineering and Nerve Injury RepairCo-Innovation Center of NeuroregenerationNantong UniversityNantongJiangsu ProvinceChina Department of Stomatology Affiliated Hospital of Nantong UniversityNantongJiangsu ProvinceChina Medical College of Nantong University NantongJiangsu ProvinceChina

CD36 is a highly glycosylated integral membrane protein that belongs to the scavenger receptor class B family and regulates the pathological progress of metabolic diseases.CD36 was recently found to be widely expressed in various cell types in the nervous system,including endothelial cells,pericytes,astrocytes,and microglia.CD36 mediates a number of regulatory processes,such as endothelial dysfunction,oxidative stress,mitochondrial dysfunction,and inflammatory responses,which are involved in many central nervous system diseases,such as stroke,Alzheimer’s disease,Parkinson’s disease,and spinal cord injury.CD36 antagonists can suppress CD36 expression or prevent CD36 binding to its ligand,thereby achieving inhibition of CD36-mediated pathways or functions.Here,we reviewed the mechanisms of action of CD36 antagonists,such as Salvianolic acid B,tanshinone IIA,curcumin,sulfosuccinimidyl oleate,antioxidants,and small-molecule compounds.Moreover,we predicted the structures of binding sites between CD36 and antagonists.These sites can provide targets for more efficient and safer CD36 antagonists for the treatment of central nervous system diseases.

关键词： animal experiments antagonists CD36 antagonist central nervous system diseases clinical trial curcumin microRNA salvianolic acid B small-molecule drugs sulfosuccinimidyl oleate

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Long-term tadalafil once daily in Chinese men witherectile dysfunction:a 2-year final analysis of apost-marketing,multicenter,randomized,open-labeltrial

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Asian Journal of Andrology 2024年第3期26卷 282-287页

作者： Hui Jiang Lian-Ming Zhao Su Yan Ji-Hong Liu Zhao-Hui Zhu Jin-Dan Luo Yu-Tian Dai Fu-Biao Li Hao-Cheng Lin Zhi-Chao Zhang Department of Urology Peking University First HospitalBeijing 100000China Department of Urology Peking University Third HospitalBeijing 100191China Department of Urology Peking Union Medical College HospitalBeijing 100730China Department of Urology Tongji HospitalTongji Medical CollegeHuazhongUniversity of Science and TechnologyWuhan 430030China Department of Urology Union Hospital of Tongji Medical CollegeHuazhong University of Science andTechnologyWuhan 430022China Department of Urology The First Affiliated HospitalZhejiang University School of MedicineHangzhou 310003China Departmentof Andrology Nanjing Drum Tower HospitalNanjing 210008China Department of Andrology The First Hospital of Jilin UniversityChangchun 130021China Andrology Center Department of UrologyPeking University First HospitalBeijing 100034China.

The long-term safety and effectiveness of once-daily tadalafil is crucial,but limited data are available in Chinese patients witherectile dysfunction(ED).In this post-marketing,multicenter,randomized,open-label trial with 2-year follow-up,635 ED caseswere randomized to receive daily oral tadalafil 2.5 mg or 5 mg for 3 months,of whom 580 continued once-daily tadalafil 5 mg for21 months.Treatment-emergent adverse events in the 12-month and 24-month period were similar,with the most common beingviral upper respiratory tract infection,upper respiratory tract infection,and headache.Significant improvement from baseline inthe International Index of Erectile Function-Erectile Function(IIEF-EF)score was detected at month 12(least squares mean[LSM]change:7.9,95%confidence interval[CI]:7.5–8.4,P<0.001)and was maintained to month 24(LSM change:8.6,95%CI:8.1–9.0,P<0.001).The proportions of patients regaining normal erectile function(IIEF-EF score≥26)were 43.7%and 48.0%at months 12 and 24,respectively.Global Assessment Questionnaire results showed improved erection function in 97.5%ofpatients and improved ability to engage in sexual activity in 95.9%of patients at month 12;these values were 96.1%and 95.0%at month 24,respectively.The quality of sexual life score based on the Sexual Life Quality Questionnaire(SLQQ)was increased by52.2%at month 12 and by 55.3%at month 24(both P<0.001).The treatment satisfaction score determined by SLQQ(mean±standard deviation)was 62.4±21.0 at month 12 versus 65.9±20.2 at month 24.Two-year daily application of tadalafil 5mg in Chinese men with ED showed a favorable safety profile and durable improvement in sexual performance and satisfaction.

关键词： clinical trial erectile dysfunction long-term safety once-daily dosing tadalafil

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A randomized clinical trial assessing the efficacy of single and multiple intralesional collagenase injections for treating contracted scars

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中国整形与重建外科(英文) 2023年第3期5卷 120-125页

作者： Shuangbai Zhou Poh-Ching Tan Cheng-An Chiang Yun Xie Peiqi Zhang Qingfeng Li Kai Liu Department of Plastic and Reconstructive Surgery Shanghai Ninth People’s HospitalShanghai Jiao Tong University School of MedicineShanghai 200011China

Background:Scar contractions caused by trauma or burns can cause secondary physical dysfunction and disfigurement.Many minimally invasive methods for scar contraction have shown limited applicability and efficacy.This study investigated the feasibility and efficacy of intralesional collagenase injections for scar contraction treatment.Methods:Patients with contracted scars who had limited joint movement and physical disfiguration for>1 year were enrolled in this single-blind,randomized clinical trial from July 2017 to February 2018 at Shanghai Ninth People’s Hospital.Collagenase was injected into the firm-contracted scar(15 U/cm^(2))three times at 4-week intervals in the multiple treatment group and once in the single treatment group,and a placebo injection was performed in the control group.Scar length and skin texture were documented at the 4-and 12-week follow-ups.The safety of the collagenase treatment was also evaluated.Results:The contracted scar was significantly elongated after both single and multiple collagenase treatments.The results showed that,compared to a one-time treatment,repeated injections were more effective at 12 weeks,with an average improvement of 26.83(15.79%).At 12 weeks,78.9% of the patients in the multiple group and 52.9%in the single group achieved significant improvement at 12 weeks.No severe adverse events were observed.Conclusion:Intralesional collagenase injection showed promising results in improving scar contraction and provides an alternative treatment for patients.

关键词： Contracted scar Collagenase Intralesional injection Functional improvement clinical trial

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Detachable string magnetically controlled capsule endoscopy for the noninvasive diagnosis of esophageal diseases:A prospective,blind clinical study

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World Journal of Gastroenterology 2024年第9期30卷 1121-1131页

作者： Yan-Ling Yang Huang-Wen Qin Zhao-Yu Chen Hui-Ning Fan Yi Yu Wei Da Jin-Shui Zhu Jing Zhang Department of Gastroenterology Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200233China

BACKGROUND Traditional esophagogastroduodenoscopy(EGD),an invasive examination method,can cause discomfort and pain in patients.In contrast,magnetically controlled capsule endoscopy(MCE),a noninvasive method,is being applied for the detection of stomach and small intestinal diseases,but its application in treating esophageal diseases is not widespread.AIM To evaluate the safety and efficacy of detachable string MCE(ds-MCE)for the diagnosis of esophageal diseases.METHODS Fifty patients who had been diagnosed with esophageal diseases were pros-pectively recruited for this clinical study and underwent ds-MCE and conven-tional EGD.The primary endpoints included the sensitivity,specificity,positive predictive value,negative predictive value,and diagnostic accuracy of ds-MCE for patients with esophageal diseases.The secondary endpoints consisted of visualizing the esophageal and dentate lines,as well as the subjects'tolerance of the procedure.RESULTS Using EGD as the gold standard,the sensitivity,specificity,positive predictive value,negative predictive value,and diagnostic accuracy of ds-MCE for esophageal disease detection were 85.71%,86.21%,81.82%,89.29%,and 86%,respectively.ds-MCE was more comfortable and convenient than EGD was,with 80%of patients feeling that ds-MCE examination was very comfortable or comfortable and 50%of patients believing that detachable string v examination was very convenient.CONCLUSION This study revealed that ds-MCE has the same diagnostic effects as traditional EGD for esophageal diseases and is more comfortable and convenient than EGD,providing a novel noninvasive method for treating esophageal diseases.

关键词： clinical trial Detachable string magnetically controlled capsule endoscopy Esophagogastroduodenoscopy Noninvasive diagnosis Esophageal diseases

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Mechanism of Huashi Xingyu Qingre recipe(化湿行淤清热方)in treating oral lichen planus based on network pharmacology and clinical trial verification

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Journal of Traditional Chinese Medicine 2022年第2期42卷 304-313页

作者： DENG Qianlan LU Yueting YAN Lijuan LU Hualin JIN Ruizhe XU Yanzhi SONG Jing LIU Tiejun Department of Stomatology the Fourth Hospital of Hebei Medical UniversityShijiazhuang 050000China Department of Stomatology Hebei Children's HospitalShijiazhuang 050000China Department of Stomatology Shijiazhuang Third HospitalShijiazhuang 050000China

OBJECTIVE:To identify the main active components and targets of Huashi Xingyu Qingre recipe(化湿行淤清热方,HXQR)and to investigate its mechanism in the treatment of oral lichen planus(OLP).METHODS:The Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform was searched to identify the active ingredients and corresponding targets of HXQR.Disease genes were obtained from the Gene Cards database,and a“drugdisease regulatory network”was constructed using Cytoscape software and PERL programming language.The STRING database was used to build a protein-protein interaction network.Gene ontology(GO)and Kyoto Encyclopedia of Genes and Genomes(KEGG)terms were analyzed using R software with a Bioconducter plugin.Finally,the results and the efficacy of HXQR in treating OLP were validated in a clinical trial that included enzyme-linked immunosorbent assay(ELISA)testing and observations of the post-treatment changes in clinical symptoms.RESULTS:HXQR contained 167 active components and 261 targets,with 391 disease targets.The intersection of these two categories in a Venn diagram revealed 57 drugdisease common targets.A compound-target network was constructed and revealed that the six key pharmaceutical ingredients of HXQR were quercetin,luteolin,wogonin,kaempferol,beta-carotene,and baicalein.The protein-protein interaction network mainly involved core proteins such as ALB,interleukin-6,and AKT1.Drug-disease common targets were enriched in 1628 GO terms and 117 KEGG terms,mainly involving inflammatory responses,viral infections,and tumorrelated pathways.ELISA testing indicated that HXQR inhibited the tumor necrosis factor(TNF)signaling pathway by reducing the expression of interleukin-6,matrix metalloproteinase-9,and intercellular adhesion molecule-1.The clinical symptoms of the patients with OLP were significantly improved after 8 weeks of treatment with HXQR.CONCLUSION:HXQR treats OLP by regulating the TNF signaling pathway,resulting in a marked treatment effect with few adverse effects.

关键词： lichen planus oral network pharmacology clinical trial Huashi Xingyu Qingre recipe

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Effects of Shuanghuanglian oral liquids on patients with COVID-19:a randomized,open-label,parallel-controlled,multicenter clinical trial

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Frontiers of Medicine 2021年第5期15卷 704-717页

作者： Li Ni Zheng Wen Xiaowen Hu Wei Tang Haisheng Wang Ling Zhou Lujin Wu Hong Wang Chang Xu Xizhen Xu Zhichao Xiao Zongzhe Li Chene Li Yujian Liu Jialin Duan Chen Chen Dan Li Runhua Zhang Jinliang Li Yongxiang Yi Wei Huang Yanyan Chen Jianping Zhao Jianping Zuo Jianping Weng Hualiang Jiang Dao Wen Wang Division of Cardiology Department of Internal Medicine and Hubei Key Laboratory of Genetics and Molecular Mechanisms of Cardiological DisordersTongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China The First Affiliated Hospital of University of Science and Technology of China Hefei 230026China State Key Laboratory of Drug Research Shanghai Institute of Materia MedicaChinese Academy of SciencesShanghai 201203China Harbin Pharmaceutical Group Co. Ltd.Harbin 150070China The Sixth Hospital of Harbin Harbin 150036China The Second Hospital of Nanjing and the Affiliated Hospital of Nanjing University of Chinese Medicine Nanjing 210003China Department of Cardiology Chinese People’s Liberation Army Central War Command General HospitalWuhan 430010China Department of Information Management Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Division of Respiratory Department of Internal MedicineTongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Shanghai Institute for Advanced Immunochemical Studies and School of Life Science and Technology ShanghaiTech UniversityShanghai 201210China

We conducted a randomized,open-label,parallel-controlled,multicenter trial on the use of Shuanghuanglian(SHL),a traditional Chinese patent medicine,in treating cases of COVID-19.A total of 176 patients received SHL by three doses(56 in low dose,61 in middle dose,and 59 in high dose)in addition to standard care.The control group was composed of 59 patients who received standard therapy alone.Treatment with SHL was not associated with a difference from standard care in the time to disease recovery.Patients with 14-day SHL treatment had significantly higher rate in negative conversion of SARS-CoV-2 in nucleic acid swab tests than the patients from the control group(93.4%vs.73.9%,P=0.006).Analysis of chest computed tomography images showed that treatment with high-dose SHL significantly promoted absorption of inflammatory focus of pneumonia,which was evaluated by density reduction of inflammatory focus from baseline,at day 7(mean difference(95%CI),−46.39(−86.83 to−5.94)HU;P=0.025)and day 14(mean difference(95%CI),−74.21(−133.35 to−15.08)HU;P=0.014).No serious adverse events occurred in the SHL groups.This study illustrated that SHL in combination with standard care was safe and partially effective for the treatment of COVID-19.

关键词： COVID-19 SARS-CoV-2 Shuanghuanglian oral liquid clinical trial

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Directed shift of vaginal flora after topical application of sucrose gel in a phase Ⅲ clinical trial： a novel treatment for bacterial vaginosis

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Chinese Medical Journal 2010年第15期123卷 2051-2057页

作者： ZENG Zhong-ming LIAO Qin-pin YAO Chen GENG Li FENG Li-hua SHI Hui-rong XIN Xiao-yan LI Ping WANG Hui-lan PANG Yi-cun LIU Shu-wen JIANG Shi-bo Division of Infectious Diseases Affiliated Nanshan Hospital of Guangdong Medical College Shenzhen 518052 China Division of Obstetrics & Gynecology First Hospital of Beijing University Beijing 100034 China Department of Medical Statistics First Hospital of Beijing University Beijing 100034 China Division of Obstetrics & Gynecology Third Hospital of Beijing University Beijing 100083 China Division of Obstetrics & Gynecology First Affiliated Hospital of Jilin University Changchun Jilin 130021 China Division of Obstetrics & Gynecology First Affiliated Hospital of Zhengzhou University Zhengzhou Henan 450052 China Division of Obstetrics & Gynecology Affiliated Xijing Hospital of the Fourth Military Medical University Xi'an Shaanxi 710032China Division of Obstetrics & Gynecology First Hospital of NanjingNanjing Jiangsu 210029 China Division of Obstetrics & Gynecology Second Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei 050000 China Division of Obstetrics & Gynecology Third Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei 050051 China Antiviral Research Center School of Pharmaceutical SciencesSouthern Medical University Guangzhou Guangdong 510515China Viral Immunology Laboratory Lindsley F.Kimball Research Institute New York Blood Center New York NY 10065 USA

Background Bacterial vaginosis （BV） is one of the most common infectious diseases among sexually active women and is associated with the increased acquisition of a variety of sexually transmitted diseases.This study aimed to compare the efficacy of a non-antibiotic sucrose gel against an antibiotic metronidazole gel for the treatment of BV.Methods A randomized, double-blinded, multi-center, parallel-group, placebo-controlled phase Ⅲ clinical trial was conducted at eight hospitals in China.A total of 560 subjects with clinically diagnosed BV were randomly assigned into three groups for vaginally receiving sucrose, metronidazole, and placebo gels, respectively, twice daily for five consecutive days.The efficacy of therapeutic cure, defined as an achievement of both microbiologic cure （a Nugent score of 3 or less） and clinical cure （a resolution of the clinical findings from the baseline visit）, was evaluated at the 1st and 2nd test-of-cure （TOC） visits at 7-10 and 21-35 days after the start of treatment, respectively.Results Therapeutic cure rates for sucrose, metronidazole, and placebo gel groups were 83.13%, 71.30% and 0.92%,at the 1st TOC, and 61.04%, 66.67% and 7.34%, at the 2nd TOC, respectively.While there was no significant difference between the sucrose and metronidazole gel groups at the 2nd TOC （P=0.305）, and sucrose gel was more effective than metronidazole gel at the 1st TOC （P=0.009）.Conclusion These findings suggest that sucrose gel restores normal vaginal flora more rapidly than metronidazole gel and can be used as a novel treatment for BV.

关键词： bacterial vaginosis vaginal flora sucrose metronidazole clinical trial

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