1.Data Mining and Analysis on Adverse Drug Events of Novel Agents for Anti-multidrug-resistant Tuberculosis Based on FAERS
Liling ZHAO ; Junxia LI ; Shuang CHEN ; Weiwei ZHAO ; Haipeng YANG ; Ruohan XIE ; Li ZENG
Herald of Medicine 2025;44(9):1456-1464
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
3.Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data
Yumiao SHEN ; Xiaohong ZHU ; Yi WANG ; Ya'nan ZHANG ; Ruohan ZHAO ; Fangqi MA ; Yan XU ; Lin ZENG ; Mingjie CHEN ; Aiguang ZHAO
China Cancer 2025;34(5):408-415
[Purpose]To evaluate the liver and kidney safety of traditional Chinese medicine(TCM)compounds in the treatment of gastric cancer.[Methods]The clinical data of gastric cancer patients who attended in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2012 to February 2022 were collected.The results of liver and renal func-tion tests were rated according to National Cancer Institute-Common Terminology Criteria for Ad-verse Events(NCI-CTCAE)V5.0.The patients were divided into 4 groups:TCM group,TCM+chemotherapy/targeted/antivascular therapy group,TCM+TCM preparation group and TCM+chemotherapy/targeted/antivascular therapy+TCM preparation group,and the effects of TCM on liver and renal functions were analyzed.[Results]A total of 7 943 patients were included in the analysis,of which 2 941 cases receiving TCM ≥12 months,1 468 months ≥36 months,and 687 months≥60 months.The highest incidence rate of liver function abnormality was 13.71%,the highest in-cidence rate of grade 3/4 abnormality was 2.58%;the highest incidence of creatinine abnormality was 2.32%,the highest incidence rate of grade 3/4 abnormality was 0.37%in patients with differ-ent duration of taking TCM.Most of liver and renal function abnormalities occurred in the early stage of drug taking.The incidence of liver and renal function abnormalities in the TCM group was lower than that of the other three groups.The incidence of grade 3/4 abnormality for direct biliru-bin(DBIL)in the TCM group was 0.14%,for aspartate transaminase(AST)was 0.11%,for alka-line phosphatase(ALP)was 0.16%,for alanine aminotransferase(ALT)was 0.06%and for total bilirubin(TBIL)was 0.07%,and there was no grade 3/4 creatinine abnormality observed.The ab-normal liver and renal function indexes were not increased with the increase of the length of herbal medicine taking.[Conclusion]The study shows that long term taking TCM drugs and stan-dardized prescriptions for gastric cancer patients are safe.
4.Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data
Yumiao SHEN ; Xiaohong ZHU ; Yi WANG ; Ya'nan ZHANG ; Ruohan ZHAO ; Fangqi MA ; Yan XU ; Lin ZENG ; Mingjie CHEN ; Aiguang ZHAO
China Cancer 2025;34(5):408-415
[Purpose]To evaluate the liver and kidney safety of traditional Chinese medicine(TCM)compounds in the treatment of gastric cancer.[Methods]The clinical data of gastric cancer patients who attended in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2012 to February 2022 were collected.The results of liver and renal func-tion tests were rated according to National Cancer Institute-Common Terminology Criteria for Ad-verse Events(NCI-CTCAE)V5.0.The patients were divided into 4 groups:TCM group,TCM+chemotherapy/targeted/antivascular therapy group,TCM+TCM preparation group and TCM+chemotherapy/targeted/antivascular therapy+TCM preparation group,and the effects of TCM on liver and renal functions were analyzed.[Results]A total of 7 943 patients were included in the analysis,of which 2 941 cases receiving TCM ≥12 months,1 468 months ≥36 months,and 687 months≥60 months.The highest incidence rate of liver function abnormality was 13.71%,the highest in-cidence rate of grade 3/4 abnormality was 2.58%;the highest incidence of creatinine abnormality was 2.32%,the highest incidence rate of grade 3/4 abnormality was 0.37%in patients with differ-ent duration of taking TCM.Most of liver and renal function abnormalities occurred in the early stage of drug taking.The incidence of liver and renal function abnormalities in the TCM group was lower than that of the other three groups.The incidence of grade 3/4 abnormality for direct biliru-bin(DBIL)in the TCM group was 0.14%,for aspartate transaminase(AST)was 0.11%,for alka-line phosphatase(ALP)was 0.16%,for alanine aminotransferase(ALT)was 0.06%and for total bilirubin(TBIL)was 0.07%,and there was no grade 3/4 creatinine abnormality observed.The ab-normal liver and renal function indexes were not increased with the increase of the length of herbal medicine taking.[Conclusion]The study shows that long term taking TCM drugs and stan-dardized prescriptions for gastric cancer patients are safe.
5.Research progress in Rhinovirus and associated respiratory diseases
Ruohan ZHAO ; Baicheng XIA ; Zhibo XIE ; Xizhu XU ; Yan ZHANG
Chinese Journal of Experimental and Clinical Virology 2025;39(2):254-258
Rhinovirus (RV) has been reported as one of the main viral causes of human respiratory infections and has received increasing attention in recent years due to its strong association with various respiratory diseases. Studies have shown that RV not only causes the common cold but also plays a critical role in lower respiratory tract conditions such as bronchiolitis, pneumonia, and asthma. Notably, RV is implicated in both the onset and exacerbation of asthma. This review systematically summarizes a wide range of RV-associated respiratory diseases in the available literature. Although there are currently no specific antiviral therapies or vaccines targeting RV, advances in the development of polyvalent vaccines and antiviral drugs provide promising directions for future prevention and treatment. Clarifying the relationship between RV and diseases will provide strong support for optimizing treatment strategies and preventing and controlling respiratory diseases.
6.Data Mining and Analysis on Adverse Drug Events of Novel Agents for Anti-multidrug-resistant Tuberculosis Based on FAERS
Liling ZHAO ; Junxia LI ; Shuang CHEN ; Weiwei ZHAO ; Haipeng YANG ; Ruohan XIE ; Li ZENG
Herald of Medicine 2025;44(9):1456-1464
Objective To mine and analyze adverse drug events(ADEs)of novel agents for multi-drug-resistant tuberculosis(MDR-TB)based on the FDA Adverse Event Reporting System(FAERS)database,to explore the signals of ADEs,and to provide reference for clinical use.Methods The FAERS database was searched and extracted from Q1 of 2015 to Q4 of 2023,and the ADE reports about bedaquiline,delamanid,and pretomanid were collected.Data mining and analysis were carried out on relevant reports of the drug using the reporting odds ratio(ROR),proportional reporting ratio(PRR),medicines and healthcare products regulatory agency(MHRA),and the Bayesian confidence progressive neural network(BCPNN).Results The number of ADE reports for the target drugs bedaquiline,delamanid,and pretomanid were 2 477,1 630,and 173,respectively.ADE of the target drugs involved multiple organ systems.Positive signals detected by the ROR,PRR,MHRA,and BCPNN methods were 246,246,215,204 for bedaquiline;251,251,224,200 for delamanid;and 25,25,24,22 for pretomanid.Clinically significant high-risk signals include prolonged QT interval on ECG,anemia,liver toxicity,peripheral neuropathy,etc.Conclusions The signal mining of ADEs based on the FAERS database indicates that close attention should be paid to risks such as prolonged QT interval on ECG,anemia,liver toxicity,and peripheral neuropathy during the clinical use of bedaquiline,delamanid,and pretomanid.In addition,monitoring of new potential ADE signals(such as acute heart failure,respiratory failure,acute kidney injury,etc.)should be strengthened,and timely intervention measures should be taken to ensure medication safety.
7.Literature case analysis of myelopathy induced by intrathecal chemotherapy of methotrexate and/or cytarabine
Weiwei ZHAO ; Liling ZHAO ; Ruohan XIE
Adverse Drug Reactions Journal 2025;27(2):91-98
Objective:To understand the clinical characteristics of myelopathy induced by intrathecal chemotherapy of methotrexate (MTX) and/or cytarabine (Ara-C).Methods:Relevant databases at home and abroad (up to February 18, 2024) were searched and case reports of myelopathy induced by intrathecal chemotherapy of MTX and/or Ara-C were collected. The patients′ general situation (gender, age, primary disease, etc.), use of MTX and/or Ara-C, previous radiotherapy, and occurrence time, clinical manifestations, spinal magnetic resonance imaging (MRI) results, cerebrospinal fluid test results, treatments and outcomes of myelopathy were extracted and analyzed descriptively and statistically.Results:A total of 75 articles were enrolled, involving 104 patients, with 62 males, 35 females, and 7 unknown genders. Their ages ranged from 1 to 74 years, with a median age of 26 years. The primary diseases included hematological malignancy in 101 cases, and other solid tumors in 3 cases. Before the occurrence of myelopathy, 42 cases had central nervous system tumor infiltration. Seventy-three patients received intrathecal injection of MTX combined with Ara-C, 21 patients received single MTX therapy, 10 patients received single Ara-C therapy. The number of intrathecal injections ranged from 1 to 62, with a median of 5 injections. Twenty-nine patients had received radiotherapy before. When myelopathy occurred, the cumulative dose of MTX was 7.5-480.0 mg, with a median cumulative dose of 60.0 mg; the cumulative dose of Ara-C was 15-1 599 mg, with a median cumulative dose of 280 mg. The onset time of myelopathy was from immediately to 365 days after the last intrathecal injection, with a median time of 2 days. The main clinical manifestations were weakness of both lower limbs, urinary and fecal incontinence or retention, paresthesia, and paraplegia, etc. Fifty-three patients had spinal abnormality in MRI examination, 32 had abnormal cerebrospinal fluid protein quantity, intrathecal basic protein, or homocysteine. After the diagnosis of myelopathy, 86 patients were treated with drugs, radiotherapy, plasma exchange, and cerebrospinal fluid exchange, and 18 patients had no record of treatment situation. Therapeutic agents included glucocorticoids, B vitamins, folic acid, immunoglobulin, leucovorin, S-adenosylmethionine, and dextromethorphan. Of the 104 patients, 20 achieved complete remission, with a median remission time of 30 hours; 25 experienced partial remission, with a median duration of 120 days; 32 showed no significant improvement; 26 died; one patient′s prognosis and outcome were unknown.Conclusions:The median occurrence time of myelopathy induced by intrathecal injection of MTX and/or Ara-C is 2 days. The main clinical manifestations are bilateral lower extremity weakness, urinary and bowel incontinence or retention, paresthesia, and paraplegia, etc. Abnormal spinal in MRI examination, quantitative cerebrospinal fluid protein, intrathecal basic protein occurred in some patients. Intrathecal injection should be stopped immediately after diagnosis of myelopathy, and the treatments such as drug and cerebrospinal fluid replacement should be given. The clinical outcome of myelopathy induced by intrathecal MTX and/or Ara-C was poor.
8.Literature case analysis of myelopathy induced by intrathecal chemotherapy of methotrexate and/or cytarabine
Weiwei ZHAO ; Liling ZHAO ; Ruohan XIE
Adverse Drug Reactions Journal 2025;27(2):91-98
Objective:To understand the clinical characteristics of myelopathy induced by intrathecal chemotherapy of methotrexate (MTX) and/or cytarabine (Ara-C).Methods:Relevant databases at home and abroad (up to February 18, 2024) were searched and case reports of myelopathy induced by intrathecal chemotherapy of MTX and/or Ara-C were collected. The patients′ general situation (gender, age, primary disease, etc.), use of MTX and/or Ara-C, previous radiotherapy, and occurrence time, clinical manifestations, spinal magnetic resonance imaging (MRI) results, cerebrospinal fluid test results, treatments and outcomes of myelopathy were extracted and analyzed descriptively and statistically.Results:A total of 75 articles were enrolled, involving 104 patients, with 62 males, 35 females, and 7 unknown genders. Their ages ranged from 1 to 74 years, with a median age of 26 years. The primary diseases included hematological malignancy in 101 cases, and other solid tumors in 3 cases. Before the occurrence of myelopathy, 42 cases had central nervous system tumor infiltration. Seventy-three patients received intrathecal injection of MTX combined with Ara-C, 21 patients received single MTX therapy, 10 patients received single Ara-C therapy. The number of intrathecal injections ranged from 1 to 62, with a median of 5 injections. Twenty-nine patients had received radiotherapy before. When myelopathy occurred, the cumulative dose of MTX was 7.5-480.0 mg, with a median cumulative dose of 60.0 mg; the cumulative dose of Ara-C was 15-1 599 mg, with a median cumulative dose of 280 mg. The onset time of myelopathy was from immediately to 365 days after the last intrathecal injection, with a median time of 2 days. The main clinical manifestations were weakness of both lower limbs, urinary and fecal incontinence or retention, paresthesia, and paraplegia, etc. Fifty-three patients had spinal abnormality in MRI examination, 32 had abnormal cerebrospinal fluid protein quantity, intrathecal basic protein, or homocysteine. After the diagnosis of myelopathy, 86 patients were treated with drugs, radiotherapy, plasma exchange, and cerebrospinal fluid exchange, and 18 patients had no record of treatment situation. Therapeutic agents included glucocorticoids, B vitamins, folic acid, immunoglobulin, leucovorin, S-adenosylmethionine, and dextromethorphan. Of the 104 patients, 20 achieved complete remission, with a median remission time of 30 hours; 25 experienced partial remission, with a median duration of 120 days; 32 showed no significant improvement; 26 died; one patient′s prognosis and outcome were unknown.Conclusions:The median occurrence time of myelopathy induced by intrathecal injection of MTX and/or Ara-C is 2 days. The main clinical manifestations are bilateral lower extremity weakness, urinary and bowel incontinence or retention, paresthesia, and paraplegia, etc. Abnormal spinal in MRI examination, quantitative cerebrospinal fluid protein, intrathecal basic protein occurred in some patients. Intrathecal injection should be stopped immediately after diagnosis of myelopathy, and the treatments such as drug and cerebrospinal fluid replacement should be given. The clinical outcome of myelopathy induced by intrathecal MTX and/or Ara-C was poor.
9.Research progress in Rhinovirus and associated respiratory diseases
Ruohan ZHAO ; Baicheng XIA ; Zhibo XIE ; Xizhu XU ; Yan ZHANG
Chinese Journal of Experimental and Clinical Virology 2025;39(2):254-258
Rhinovirus (RV) has been reported as one of the main viral causes of human respiratory infections and has received increasing attention in recent years due to its strong association with various respiratory diseases. Studies have shown that RV not only causes the common cold but also plays a critical role in lower respiratory tract conditions such as bronchiolitis, pneumonia, and asthma. Notably, RV is implicated in both the onset and exacerbation of asthma. This review systematically summarizes a wide range of RV-associated respiratory diseases in the available literature. Although there are currently no specific antiviral therapies or vaccines targeting RV, advances in the development of polyvalent vaccines and antiviral drugs provide promising directions for future prevention and treatment. Clarifying the relationship between RV and diseases will provide strong support for optimizing treatment strategies and preventing and controlling respiratory diseases.
10.Ideas and Methods of Acupuncture for Guillain-Barré Syndrome based on the Core Principle of “To Treat Flaccidity, Select the Yangming (阳明) Channel only”
Huan LI ; Hailun JIANG ; Hao CHEN ; Hui QU ; Ruohan TANG ; Jie JI ; Yuzheng DU ; Qi ZHAO
Journal of Traditional Chinese Medicine 2024;65(4):362-367
This study explored the ideas and methods of acupuncture for Guillain-Barré Syndrome (GBS) with the core principle of “to treat flaccidity, select the yangming (阳明) channel only”. The main pathological mechanism of GBS is deficiency of qi and blood in the yangming channel, malnutrition of all sinews, diminished spleen and stomach function leading to the production of pathogenic damp-heat qi, which obstructs the meridians, and gradually affects the liver and kidneys, consuming essence and damaging blood. Concurrently, dysfunction of the dumai (督脉) pivotal mechanism and lack of moisture in sinews and vessels result in symptoms such as skin numbness, paralysis, and muscle wastage. In clinical diagnosis and treatment, a combination of syndrome and channel differentiation is taken. Treatment primarily focuses on acupoints of yangming channel, aiming to supplement qi and blood, and acupoints of du mai are combined to open the vessel and fill the marrow. Specific acupoints are selected based on syndrome differentiation, providing comprehensive regulation to promote harmonization of qi and blood, relieve meridians, and the smooth generation and circulation of whole body fluids. This, in turn, enhances the strength of muscles and bones, and fosters a robust and freely moving body.

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