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Herb induced liver injury by Xianling Gubao Tablets: A case assessed for causality using updated RUCAM and integrated evidence chain

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Chinese Herbal Medicines 2024年第2期16卷 301-309页

作者： Chunyu Li Yingying Li zhaofang bai Jiabo Wang Guohui Li Xiaohe Xiao National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021China Senior Department of Hepatology The Fifth Medical Center of PLA General HospitalBeijing 100039China School of Traditional Chinese Medicine Capital Medicinal UniversityBeijing 100069China

Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the ***:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the *** on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was *** patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular *** relationship was considered“highly probable”(score of 9)using the updated RUCAM of ***,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another ***-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were *** of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese ***:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and ***,this study provides scientif

关键词： chemical analysis compound preparations of traditional chinese medicines integrated evidence chain liver injury Roussel Uclaf Causality Assessment Method Xianling Gubao Tablets

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Asari Radix et Rhizoma consumption lacks relevance for hepatocellular carcinoma in patients:A retrospective cohort study

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Chinese Herbal Medicines 2022年第3期14卷 470-475页

作者： Zhi-e Fang Yuming Guo Zhilei Wang Tingting He Jiabo Wang zhaofang bai Xiaohe Xiao Department of Hepatology Fifth Medical Center of Chinese PLA General HospitalBeijing 100039China China Military Institute of Chinese Materia Fifth Medical Center of Chinese PLA General HospitalBeijing 100039China

Objective:Although some studies have linked Asari Radix et Rhizoma(Asari Radix)administration to hepatocellular carcinoma(HCC),few studies have examined the association between the development of HCC and use of Asari Radix among patients in China's *** study aimed to evaluate the realworld association between Asari Radix and HCC in patients to strengthen the understanding of Asari Radix ***:A retrospective cohort study among hepatitis B virus(HBV)-monoinfected patients and nonHBV-monoinfected patients were *** over 18 years of age were eligible for *** records of inpatients and outpatients were inquired to distinguish Asari Radix users and *** risk of developing HCC among Asari Radix users and nonusers in the HBV cohort and the non-HBV cohort was ***:There were 49500 HBV and 133148 non-HBV patients involved in the two *** HBV patients(2901 users;46599 nonusers),the prevalence of HCC in Asari Radix users was lower than that in nonusers(145.70 vs.265.43 per 105).Among non-HBV patients(5042 users;128106 nonusers),the prevalence of HCC in Asari Radix users was lower than that in nonusers(81.62 vs.134.11 per 105).None of the hazard ratios(HRs)of Asari Radix exposure ranging from 1 g to 200 g in the two cohorts showed correlation between Asari Radix exposure and ***:An obvious irrelevancy was found between the consumption of Asari Radix and HCC development both in patients with and in those without HBV *** of Asari Radix under 200 g appears safe in terms of HCC risk in the Chinese population;further prospective studies are needed to confirm our results.

关键词： aristolochic acid Asari Radix et Rhizoma hepatitis B virus(HBV) hepatocellular carcinoma safety awareness

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Cardamonin from a medicinal herb protects against LPS-induced septic shock by suppressing NLRP3 inflammasome

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Acta Pharmaceutica Sinica B 2019年第4期9卷 734-744页

作者： Zhilei Wang Guang Xu Yuan Gao Xiaoyan Zhan Nan Qin Shubin Fu Ruisheng Li Ming Niu Jiabo Wang Youping Liu Xiaohe Xiao zhaofang bai School of Pharmacy Chengdu University of Traditional Chinese MedicineChengdu 611137China China Military Institute of Chinese Materia the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China School of Chinese Materia Medica Beijing University of Chinese MedicineBeijing 100029China School of Pharmacy Jiangxi University of Traditional Chinese MedicineNanchang 330004China Research Center for Clinical and Translational Medicine the Fifth Medical CentreChinese PLA General HospitalBeijing 100500China Integrative Medical Center the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China

Aberrant activation of NLRP3 inflammasome has been implicated in the pathogenesis of diverse inflammation-related diseases, and pharmacological molecules targeting NLRP3 inflammasome are of considerable value to identifying potential therapeutic interventions. Cardamonin(CDN), the major active ingredient of the traditional Chinese medicinal herb Alpinia katsumadai, has exerted an excellent anti-inflammatory activity, but the mechanism underlying this role is not fully understood. Here, we show that CDN blocks canonical and noncanonical NLRP3 inflammasome activation triggered by multiple stimuli. Moreover, the suppression of CDN on inflammasome activation is specific to NLRP3, not to NLRC4 or AIM2 inflammasome. Besides, the inhibitory effect is not dependent on the expression of NF-κB-mediated inflammasome precursor proteins. We also demonstrate that CDN suppresses the NLRP3 inflammasome through blocking ASC oligomerization and speckle formation in a dose-dependent ***, CDN improves the survival of mice suffering from lethal septic shock and attenuates IL-1βproduction induced by LPS in vivo, which is shown to be NLRP3 dependent. In conclusion, our results identify CDN as a broad-spectrum and specific inhibitor of NLRP3 inflammasome and a candidate therapeutic drug for treating NLRP3 inflammasome-driven diseases.

关键词： Cardamonin NLRP3 inflammasome IL-1β Caspase-1 Septic shock

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Clinical characteristics of 96 patients with drug-induced acute liver failure:a comparison between Traditional Chinese and Western Medicine

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Journal of Traditional Chinese Medicine 2017年第3期37卷 286-297页

作者： He Tingting Zhu Yun Wang Jiabo Gong Man Wang Ruilin Niu Ming Jing Jing Wang Lifu Wang Zhongxia Zhang Ning bai zhaofang bai Yunfeng Li Yonggang Xiao Xiaohe Medical School of Chinese PLA Integrative Medicine Center 302 Military HospitalBeijing 100039China Integrative Medicine Center 302 Military HospitalBeijing 100039China China Military Institute of Chinese Medicine 302 Military HospitalBeijing 100039China Medical School of Chinese People's LiberationArmy China Military Institute of Chinese Medicine 302 Military HospitalBeijing 100039China

OBJECTIVE: To compare the causes, clinical symptoms, laboratory test results, and prognosis in patients with acute liver failure(ALF) induced by traditional Chinese medicines(TCM) and by Western Medicines(WM).METHODS: The medical histories of patients who were diagnosed with drug-induced ALF(DALF)(n =96) after hospitalization in the 302 Military Hospital between January 2010 and December 2015 were retrospectively ***: Fifty-eight of the 96 DALF patients(60.4%) had a hepatocellular pattern of DALF, 16 patients(16.7%) had a cholestatic pattern, and 22 patients(22.9%) had a mixed pattern. DALF resolved in 24 patients(25.0%). Twenty-five patients(26.0%)developed chronic liver injury, 43 patients(44.8%)died, and 4 patients(4.2%) underwent liver transplantation. There were 42 ALF patients(43.8%) who received WM, and 32 ALF patients(33.3%) who received TCM. TCM-induced ALF patients had a higher average age [42.4 ± 18.4) vs(33.5 ± 17.9) years,P = 0.04] and higher creatinine and urine nitrogen levels [(155.2 ± 108.8) vs(97.5 ± 130.4) mmol/L, P =0.047;(9.1 ± 7.7) vs(4.3 ± 5.0) mmol/L, P = 0.002, respectively]. Patients with TCM-induced ALF exhibited an increased risk of renal injury [odds ratio(OR),3.75; 95% confidence interval(CI), 1.330-10.577].The 14 patients with TCM-induced ALF who died exhibited higher creatinine levels than the 18 patients with TCM-induced ALF patients who survived[(218.7 ± 111.6) vs(105.8 ± 78.4) mmol/L, P =0.002]. They were also more likely to exhibit ascites(85.7% vs 44.4%, P = 0.017) and hepatorenal syndrome(78.6% vs 22.2%, P = 0.002).CONCLUSION: TCM-induced ALF was more likely to be accompanied by renal injury than was WM-induced ALF, especially in TCM-induced ALF patients who died.

关键词： Drug-induced liver injury Jaundice, ob-structive Medicine, Chinese traditional Creatinine Hepatorenal syndrome

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New incompatible pair of TCM:Epimedii Folium combined with Psoraleae Fructus induces idiosyncratic hepatotoxicity under immunological stress conditions

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Frontiers of Medicine 2020年第1期14卷 68-80页

作者： Yuan Gao Zhilei Wang Jinfa Tang Xiaoyi Liu Wei Shi Nan Qin Xiaoyan Wang Yu Pang Ruisheng Li Yaming Zhang Jiabo Wang Ming Niu zhaofang bai Xiaohe Xiao School of Chinese Materia Medica Beijing University of Chinese MedicineBeijing 100029China China Military Institute of Chinese Materia the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China School of Pharmacy Chengdu University of Traditional Chinese MedicineChengdu 611137China The First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou 450000China School of Pharmacy Jiangxi University of Traditional Chinese MedicineJiangxi 330004China National Institutes for Food and Drug Control Beijing 100050China Research Center for Clinical and Translational Medicine the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China Integrative Medical Centre the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China

Epimedii Folium(EF)combined with Psoraleae Fructus(PF)is a common modern preparation,but liver injury caused by Chinese patent medicine preparations containing EF and PF has been frequently reported in recent *** pills(ZGW),which contain EF and PF,could induce immune idiosyncratic liver injury according to clinical case reports and a nonhepatotoxic dose of lipopolysaccharide(LPS)*** present study evaluated the liver injury induced by EF or PF alone or in combination and investigated the related mechanism by using the LPS *** function indexes and pathological results showed that either EF or PF alone or in combination led to liver injury in normal rats;however,EF or PF alone could lead to liver injury in LPS-treated ***,EF combined with PF could induce a greater degree of injury than that caused by EF or PF alone in LPS-treated ***,EF or PF alone or in combination enhanced the LPS-stimulated inflammatory cytokine production,implying that IL-1β,which is processed and released by activating the NLRP3 inflammasome,is a specific indicator of EF-induced immune idiosyncratic ***,EF may induce liver injury through enhancing the LPS-mediated proinflammatory cytokine production and activating the NLRP3 *** addition,the metabolomics analysis results showed that PF affected more metabolites in glycerophospholipid and sphingolipid metabolic pathways compared with EF in LPS model,suggesting that PF increased the responsiveness of the liver to LPS or other inflammatory mediators via modulation of multiple metabolic ***,EF and PF combination indicates traditional Chinese medicine incompatibility,considering that it induces idiosyncratic hepatotoxicity under immunological stress conditions.

关键词： Epimedii Folium Psoraleae Fructus idiosyncratic hepatotoxicity traditional Chinese medicine incompatibility

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Immunological synergistic mechanisms of trans-/cis-stilbene glycosides in Heshouwu-related idiosyncratic liver injury

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Science Bulletin 2017年第11期62卷 748-751页

作者： Lanzhi He Ping Yin Yakun Meng Jinfa Tang Tingting He Ming Niu Yuming Guo Yun Zhu Jing Jing Chunyu Li Zhijie Ma Jiabo Wang zhaofang bai Xiaohe Xiao China Military Institute of Chinese Medicine 302 Military Hospital Beijing 100039 China School of Pharmacy Hunan University of Traditional Chinese Medicine Changsha 410208 China Integrative Medical Center 302 Military Hospital Beijing 100039 China

Heshouwu is a traditional non-toxic Chinese medicine commonly used in the clinical setting;however,clinical cases of Heshouwu-induced hepatotoxicity have been frequently reported^([1]).Pharmacoepidemiological studies have found that Heshouwu-induced liver injury occurs only in a small fraction of individuals taking the drug;these patients presented with the typ-

关键词：肝损伤二苯乙烯苷增效机制异性反式免疫临床病例毒性剂量

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Icariside Ⅱ, a main compound in Epimedii Folium, induces idiosyncratic hepatotoxicity by enhancing NLRP3 inflammasome activation

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Acta Pharmaceutica Sinica B 2020年第9期10卷 1619-1633页

作者： Zhilei Wang Guang Xu Hongbo Wang Xiaoyan Zhan Yuan Gao Nian Chen Ruisheng Li Xueai Song Yuming Guo Ruichuang Yang Ming Niu Jiabo Wang Youping Liu Xiaohe Xiao zhaofang bai School of Pharmacy Chengdu University of Traditional Chinese MedicineChengdu 611137China China Military Institute of Chinese Materia the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China Department of Hepatobiliary Surgery Center the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China School of Chinese Materia Medica Capital Medical UniversityBeijing 100029China Research Center for Clinical and Translational Medicine the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China Integrative Medical Center the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China

Idiosyncratic drus-induced liver injury(IDILI)is an intrequent but potentially serious disease that develops the main reason for post-marketing safety warnings and withdrawals of *** Folium(EF),the widely used herbal medicine,has shown to cause idiosyncratic liver injury,but the underlying mechanisms are poorly *** evidence has indicated that most cases of IDILI are immune ***,we report that icarisideⅡ(ICSⅡ),the major active and metabolic constituent of EF,causes idiosyncratic liver injury by promoting NLRP3 inflammasome ***Ⅱexacerbates NLRP3 inflammasome activation triggered by adenosine triphosphate(ATP)and nigericin,but not silicon dioxide(SiO2),monosodium urate(MSU)crystal or cytosolic lipopolysaccharide(LPS).Additionally,the activation of NLRC4 and AIM2 inflammasomes is not affected by ICSⅡ.Mechanistically,synergistic induction of mitochondrial reactive oxygen species(mtROS)is a crucial contributor to the enhancing effect of ICSⅡon ATP-or nigericin-induced NLRP3 inflammasome ***,in vivo data show that a combination of non-hepatotoxic doses of LPS and ICSⅡcauses the increase of aminotransferase activity,hepatic inflammation and pyroptosis,which is attenuated by Nlrp3 deficiency or pretreatment with MCC950(a specific NLRP3 inflammasome inhibitor).In conclusion,these findings demonstrate that ICSⅡcauses idiosyncratic liver injury through enhancing NLRP3 inflammasome activation and suggest that ICSⅡmay be a risk factor and responsible for EF-induced liver injury.

关键词： Epimedii Folium IcarisideⅡ Idiosyncratic drug-induced liver injury NLRP3 inflammasome Reactive oxygen species Mitochondria

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T cell–associated immunoregulation and antiviral effect of oxymatrine in hydrodynamic injection HBV mouse model

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Acta Pharmaceutica Sinica B 2017年第3期7卷 311-318页

作者： Xiuxiu Sang Ruilin Wang Yanzhong Han Cong’en Zhang Honghui Shen Zhirui Yang Yin Xiong Huimin Liu Shijing Liu Ruisheng Li Ruichuang Yang Jiabo Wang Xuejun Wang zhaofang bai Xiaohe Xiao Chengde Medical College China Military Institute of Chinese Medicine 302 Military Hospital Integrative Medical Center 302 Military Hospital Department of Biotechnology Beijing Institute of Radiation Medicine Faculty of Life Science and Technology Kunming University of Science and Technology Research Center for Clinical&Translational Medicine 302 Military Hospital

Although oxymatrine(OMT) has been shown to directly inhibit the replication of hepatitis B virus(HBV) in vitro, limited research has been done with this drug in vivo. In the present study, the antiviral effect of OMT was investigated in an immunocompetent mouse model of chronic HBV *** infection was achieved by tail vein injection of a large volume of DNA solution. OMT(2.2, 6.7 and20 mg/kg) was administered by daily intraperitoneal injection for 6 weeks. The efficacy of OMT was evaluated by the levels of HBV DNA, hepatitis B surface antigen(HBs Ag), hepatitis B e antigen(HBe Ag)and hepatitis B core antigen(HBc Ag). The immunoregulatory activity of OMT was evaluated by serum ELISA and flow cytometry. Results shows that OMT at 20 mg/kg inhibited HBV replication, and it was more efficient than entecavir(ETV) in the elimination of serum HBs Ag and intrahepatic HBc Ag. Inaddition, OMT accelerated the production of interferon-γ(IFN-γ) in a dose-dependent manner in CD4^+T cells. Our findings demonstrate the beneficial effects of OMT on the enhancement of immunological function and in the control of HBV antigens. The findings suggest this drug to be a good antiviral therapeutic candidate for the treatment of HBV infection.

关键词： HBV Oxymatrine CD4+ T cell IFN-γ Mouse

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Bavachin enhances NLRP3 inflammasome activation induced by ATP or nigericin and causes idiosyncratic hepatotoxicity

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Frontiers of Medicine 2021年第4期15卷 594-607页

作者： Nan Qin Guang Xu Yan Wang Xiaoyan Zhan Yuan Gao Zhilei Wang Shubin Fu Wei Shi Xiaorong Hou Chunyu Wang Ruisheng Li Yan Liu Jiabo Wang Haiping Zhao Xiaohe Xiao zhaofang bai China Military Institute of Chinese Materia the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China Department of Pharmacy Nantong Hospital of Traditional Chinese MedicineNantong 226300China School of Pharmacy Henan University of Chinese MedicineZhengzhou 450046China School of Traditional Chinese Medicine Capital Medical UniversityBeijing 100069China Research Center for Clinical and Translational Medicine the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China School of Traditional Chinese Medicine Jiangxi University of Traditional Chinese MedicineNanchang 330004China Integrative Medical Centre the Fifth Medical CentreChinese PLA General HospitalBeijing 100039China

Psoraleae Fructus(PF)is a well-known traditional herbal medicine in China,and it is widely used for osteoporosis,vitiligo,and other diseases in clinical ***,liver injury caused by PF and its preparations has been frequently reported in recent *** previous studies have demonstrated that PF could cause idiosyncratic drug-induced liver injury(IDILI),but the mechanism underlying its hepatotoxicity remains *** paper reports that bavachin isolated from PF enhances the specific stimuli-induced activation of the NLRP3 inflammasome and leads to *** boosts the secretion of IL-ip and caspase-1 caused by ATP or nigericin but not those induced by poly(I:C),monosodium urate crystal,or intracellular *** does not affect AIM2 or NLRC4 inflammasome ***,bavachin specifically increases the production of nigericin-induced mitochondrial reactive oxygen species among the most important upstream events in the activation of the NLRP3 *** increases the levels of aspartate transaminase and alanine aminotransferase in serum and hepatocyte injury accompanied by the secretion of IL-ip via a mouse model of lipopolysaccharide-mediated susceptibility to *** results suggest that bavachin specifically enhances the ATP-or nigericin-induced activation of the NLRP3 *** also potentially contributes to PF-induced idiosyncratic ***,bavachin and PF should be evaded among patients with diseases linked to the ATP-or nigericin-mediated activation of the NLRP3 inflammasome,which may be a dangerous factor for liver injury.

关键词： Psoraleae Fructus bavachin idiosyncratic drug-induced liver injury caspase-1 IL-lp NLRP3 inflammasome

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Guidance for the clinical evaluation of traditional Chinese medicine-induced liver injury Issued by China Food and Drug Administration

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Acta Pharmaceutica Sinica B 2019年第3期9卷 648-658页

作者： Xiaohe Xiao Jianyuan Tang Yimin Mao Xiuhui Li Jiabo Wang Chenghai Liu Kewei Sun Yong’an Ye Zhengsheng Zou Cheng Peng Ling Yang Yuming Guo zhaofang bai Tingting He Jing Jing Fengyi Li Na An China Military Institute of Chinese Medicine Beijing302Hospital of ChinaBeijing100039China Center for Drug Evaluation China Food and Drug AdministrationBeijing100022China Renji Hospital of Shanghai Jiaotong University Shanghai200127China Beijing Youan Hospital of Capital Medical University Beijing100069China Shuguang Hospital of Shanghai University of Traditional Chinese Medicine Shanghai200127China First Affiliated Hospital of Hunan University of Traditional Chinese Medicine Changsha410007China Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine Beijing100700China Center for Non-infectious Liver Diseases Beijing302Hospital of ChinaBeijing100039China College of Pharmacy Chengdu University of Traditional Chinese MedicineChengdu610075China College of Pharmacy Shanghai University of Traditional Chinese MedicineShanghai201203China Center for Infectious Liver Diseases Beijing302Hospital of ChinaBeijing100039China

1. Introduction Drug-induced liver injury (DILI), defined as liver injury caused by a drug and/or its metabolites, is a common clinical adverse drug reaction1–4. This type of injury can cause acute liver failure and ... 详细信息

关键词： TCM PTA Guidance for the clinical evaluation of traditional Chinese medicine-induced liver injury Issued by China Food and Drug Administration China

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