1.Efficacy and safety of recombinant human anti-SARS-CoV-2 monoclonal antibody injection(F61 injection)in the treatment of patients with COVID-19 combined with renal damage:a randomized controlled exploratory clinical study
Ding-Hua CHEN ; Chao-Fan LI ; Yue NIU ; Li ZHANG ; Yong WANG ; Zhe FENG ; Han-Yu ZHU ; Jian-Hui ZHOU ; Zhe-Yi DONG ; Shu-Wei DUAN ; Hong WANG ; Meng-Jie HUANG ; Yuan-Da WANG ; Shuo-Yuan CONG ; Sai PAN ; Jing ZHOU ; Xue-Feng SUN ; Guang-Yan CAI ; Ping LI ; Xiang-Mei CHEN
Chinese Journal of Infection Control 2024;23(3):257-264
Objective To explore the efficacy and safety of recombinant human anti-severe acute respiratory syn-drome coronavirus 2(anti-SARS-CoV-2)monoclonal antibody injection(F61 injection)in the treatment of patients with coronavirus disease 2019(COVID-19)combined with renal damage.Methods Patients with COVID-19 and renal damage who visited the PLA General Hospital from January to February 2023 were selected.Subjects were randomly divided into two groups.Control group was treated with conventional anti-COVID-19 therapy,while trial group was treated with conventional anti-COVID-19 therapy combined with F61 injection.A 15-day follow-up was conducted after drug administration.Clinical symptoms,laboratory tests,electrocardiogram,and chest CT of pa-tients were performed to analyze the efficacy and safety of F61 injection.Results Twelve subjects(7 in trial group and 5 in control group)were included in study.Neither group had any clinical progression or death cases.The ave-rage time for negative conversion of nucleic acid of SARS-CoV-2 in control group and trial group were 3.2 days and 1.57 days(P=0.046),respectively.The scores of COVID-19 related target symptom in the trial group on the 3rd and 5th day after medication were both lower than those of the control group(both P<0.05).According to the clinical staging and World Health Organization 10-point graded disease progression scale,both groups of subjects improved but didn't show statistical differences(P>0.05).For safety,trial group didn't present any infusion-re-lated adverse event.Subjects in both groups demonstrated varying degrees of elevated blood glucose,elevated urine glucose,elevated urobilinogen,positive urine casts,and cardiac arrhythmia,but the differences were not statistica-lly significant(all P>0.05).Conclusion F61 injection has initially demonstrated safety and clinical benefit in trea-ting patients with COVID-19 combined with renal damage.As the domestically produced drug,it has good clinical accessibility and may provide more options for clinical practice.
2.Investigation on the Latent Categories of Traditional Chinese Medicine Constitution in 1 097 College Students and Their Moderating Effects on the Associations Between Self-Efficacy and Depression-Anxiety
Wen-Na LIAO ; Xiang-Han LUO ; Yong-Peng SUN ; Zeng-Jie YE
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(7):1653-1661
Objective To analyze the latent categories of traditional Chinese medicine(TCM)constitution of college students,and to explore the moderating effects of latent categories of TCM constitution on the the associations between self-efficacy and depression-anxiety symptoms.Methods An investigation was carried out in two universities of Guangdong Province with 30-item TCM constitution scale,General Self-Efficacy Scale(GSES)and Kessler Psychological Distress Scale,and then a total of 1 097 valid samples were obtained.Correlation analysis,latent profile analysis,and hierarchical regression analysis were used for statistical analysis.Results(1)Four latent categories of TCM constitution were obtained in the college students:generally-balanced type(32.0%),highly-balanced type(17.4%),generally-biased type(36.9%)and highly-biased type(13.7%).There were statistically significant differences in the subscale scores of TCM constitution scale among the college students with various latent categories of TCM constitution(all P<0.001).(2)Hierarchical regression analysis showed that the self-efficacy negatively predicted the symptoms of depression and anxiety(β value being-0.268,-0.161 respectively,P<0.001);with the generally-balanced type as reference,the generally-biased type and the highly-biased type positively predicted the symptoms of depression and anxiety,and the highly-balanced type negatively predicted the symptoms of depression and anxiety(all P<0.001).(3)The latent categories of TCM constitution had moderating effects on the self-efficacy and depression-anxiety symptoms:the depression-anxiety symptoms were relieved with the increase of self-efficacy in the college students with the TCM constitution being generally-biased type,highly-biased type and generally-balanced type(all P<0.01);in the college students with highly-balanced type,the symptoms of depression(β=0.005,P=0.907)and anxiety(β=0.007,P=0.878)did not change with the increase of self-efficacy.Conclusion Obvious heterogeneity of TCM constitution is presented in the population of college students.The measures of enhancement of self-efficacy and the correction of TCM to promote the psychological health of college students should be performed with reference to the characteristics of their TCM constitution types.
3.Analysis on infection sources and transmission chains of three outbreaks caused by 2019-nCoV Omicron variant in Beijing, China.
Shuang Sheng WU ; Ying SUN ; Xiang Feng DOU ; Zhen Yong REN ; Jiao Jiao ZHANG ; Lei JIA ; Peng YANG ; Xing Huo PANG
Chinese Journal of Epidemiology 2023;44(3):373-378
Objective: To investigate the infection sources and the transmission chains of three outbreaks caused by 2019-nCoV Omicron variant possibly spread through cross-border logistics in Beijing. Methods: Epidemiological investigation and big data were used to identify the exposure points of the cases. Close contacts were traced from the exposure points, and the cases' and environmental samples were collected for nucleic acid tests. Positive samples were analyzed by gene sequencing. Results: The Omicron variant causing 3 outbreaks in Beijing from January to April, 2022 belonged to BA.1, BA.1.1 and BA.2. The outbreaks lasted for 8, 12 and 8 days respectively, and 6, 42 and 32 cases infected with 2019-nCoV were reported respectively. International mail might be the infection source for 1 outbreak, and imported clothes might be the infection sources for another 2 outbreaks. The interval between the shipment start time of the imported goods and the infection time of the index case was 3-4 days. The mean incubation period (Q1, Q3) was 3 (2,4) days and the mean serial interval (Q1, Q3) was 3 (2,4)days. Conclusions: The 3 outbreaks highlighted the risk of infection by Omicron variant from international logistics-related imported goods at normal temperature. Omicron variant has stronger transmissibility, indicating that rapid epidemiological investigation and strict management are needed.
Humans
;
Beijing
;
SARS-CoV-2
;
COVID-19
;
Disease Outbreaks
;
China/epidemiology*
4.Establishment and validation of a preoperative nomogram model for predicting the risk of hepatocellular carcinoma with microvascular invasion.
Rui Qian GAO ; Kun LI ; Jing Han SUN ; Yong Hui MA ; Xiang Yu XU ; Yu Wei XIE ; Jing Yu CAO
Chinese Journal of Surgery 2023;61(1):41-47
Objective: To establish and validate a nomogram model for predicting the risk of microvascular invasion(MVI) in hepatocellular carcinoma. Methods: The clinical data of 210 patients with hepatocellular carcinoma who underwent hepatectomy at Department of Hepatobiliary and Pancreatic Surgery,the Affiliated Hospital of Qingdao University from January 2013 to October 2021 were retrospectively analyzed. There were 169 males and 41 females, aged(M(IQR)) 57(12)years(range:30 to 80 years). The patients were divided into model group(the first 170 cases) and validation group(the last 40 cases) according to visit time. Based on the clinical data of the model group,rank-sum test and multivariate Logistic regression analysis were used to screen out the independent related factors of MVI. R software was used to establish a nomogram model to predict the preoperative MVI risk of hepatocellular carcinoma,and the validation group data were used for external validation. Results: Based on the modeling group data,the receiver operating characteristic curve was used to determine that cut-off value of DeRitis ratio,γ-glutamyltransferase(GGT) concentration,the inverse number of activated peripheral blood T cell ratio (-aPBTLR) and the maximum tumor diameter for predicting MVI, which was 0.95((area under curve, AUC)=0.634, 95%CI: 0.549 to 0.719), 38.2 U/L(AUC=0.604, 95%CI: 0.518 to 0.689),-6.05%(AUC=0.660, 95%CI: 0.578 to 0.742),4 cm(AUC=0.618, 95%CI: 0.533 to 0.703), respectively. Univariate and multivariate Logistic regression analysis showed that DeRitis≥0.95,GGT concentration ≥38.2 U/L,-aPBTLR>-6.05% and the maximum tumor diameter ≥4 cm were independent related factors for MVI in hepatocellular carcinoma patients(all P<0.05). The nomogram prediction model based on the above four factors established by R software has good prediction efficiency. The C-index was 0.758 and 0.751 in the model group and the validation group,respectively. Decision curve analysis and clinical impact curve showed that the nomogram model had good clinical benefits. Conclusions: DeRitis ratio,serum GGT concentration,-aPBTLR and the maximum tumor diameter are valuable factors for preoperative prediction of hepatocellular carcinoma with MVI. A relatively reliable nomogram prediction model could be established on them.
Female
;
Humans
;
Male
;
Carcinoma, Hepatocellular/pathology*
;
Liver Neoplasms/pathology*
;
Neoplasm Invasiveness
;
Nomograms
;
Retrospective Studies
;
Risk Factors
;
Adult
;
Middle Aged
;
Aged
;
Aged, 80 and over
5.Advances in the research of HIV-1 envelope glycoprotein gp120 inhibitors
Ming-hui XIE ; Zhao WANG ; Yan-ying SUN ; Xiang-yi JIANG ; Peng ZHAN ; Xin-yong LIU ; Dong-wei KANG
Acta Pharmaceutica Sinica 2023;58(3):616-628
From the process of human immunodeficiency virus-1 (HIV-1) invading cells, the combination of gp120 and CD4 is the first step for HIV-1 to invade cells. Interfering with this process can prevent HIV from recognizing target cells and inhibit virus replication. Therefore, HIV-1 gp120 is an important part of the HIV-1 life cycle. Fostesavir, a phosphatate prodrug derived from the gp120 inhibitor BMS-626529 modified by the prodrug strategy, was approved for the treatment of adult patients with multidrug resistant HIV-1 infection by the US FDA and the European Medicines Agency in 2020 and 2021, respectively. In this review, we focus on the research progress of small molecule inhibitors targeting the interaction of gp120-CD4 from the perspective of medicinal chemistry, in order to provide reference for the subsequent research of gp120 inhibitors.
6. Treatment advice of small molecule antiviral drugs for elderly COVID-19
Min PAN ; Shuang CHANG ; Xiao-Xia FENG ; Guang-He FEI ; Jia-Bin LI ; Hua WANG ; Du-Juan XU ; Chang-Hui WANG ; Yan SUN ; Xiao-Yun FAN ; Tian-Jing ZHANG ; Wei WEI ; Ling-Ling ZHANG ; Jim LI ; Fei-Hu CHEN ; Xiao-Ming MENG ; Hong-Mei ZHAO ; Min DAI ; Yi XIANG ; Meng-Shu CAO ; Xiao-Yang CHEN ; Xian-Wei YE ; Xiao-Wen HU ; Ling JIANG ; Yong-Zhong WANG ; Hao LIU ; Hai-Tang XIE ; Ping FANG ; Zhen-Dong QIAN ; Chao TANG ; Gang YANG ; Xiao-Bao TENG ; Chao-Xia QIAN ; Guo-Zheng DING
Chinese Pharmacological Bulletin 2023;39(3):425-430
COVID-19 has been prevalent for three years. The virulence of SARS-CoV-2 is weaken as it mutates continuously. However, elderly patients, especially those with underlying diseases, are still at high risk of developing severe infections. With the continuous study of the molecular structure and pathogenic mechanism of SARS-CoV-2, antiviral drugs for COVID-19 have been successively marketed, and these anti-SARS-CoV-2 drugs can effectively reduce the severe rate and mortality of elderly patients. This article reviews the mechanism, clinical medication regimens, drug interactions and adverse reactions of five small molecule antiviral drugs currently approved for marketing in China, so as to provide advice for the clinical rational use of anti-SARS-CoV-2 in the elderly.
7.Clinical Characteristics and Diagnostic Experience of Adult Thyroid Langerhans Cell Histiocytosis with Diabetes Insipidus
Qian WANG ; Quanya SUN ; Min HE ; Shuo ZHANG ; Boni XIANG ; Qiufan LI ; Yong WANG ; Xialing ZHANG ; Tianling DING ; Hongying YE
JOURNAL OF RARE DISEASES 2023;2(3):346-352
8.The suppression of cervical cancer ferroptosis by macrophages: The attenuation of ALOX15 in cancer cells by macrophages-derived exosomes.
Yanlin LUO ; Yibing CHEN ; Huan JIN ; Benxin HOU ; Hongsheng LI ; Xiang LI ; Lingfeng LIU ; Yuan ZHOU ; Yonghua LI ; Yong Sang SONG ; Quentin LIU ; Zhengzhi ZOU
Acta Pharmaceutica Sinica B 2023;13(6):2645-2662
Induction of cancer cell ferroptosis has been proposed as a potential treatment in several cancer types. Tumor-associated macrophages (TAMs) play a key role in promoting tumor malignant progression and therapy resistance. However, the roles and mechanisms of TAMs in regulating tumor ferroptosis is still unexplored and remains enigmatic. This study shows ferroptosis inducers has shown therapeutic outcomes in cervical cancer in vitro and in vivo. TAMs have been found to suppress cervical cancer cells ferroptosis. Mechanistically, macrophage-derived miRNA-660-5p packaged into exosomes are transported into cancer cells. In cancer cells, miRNA-660-5p attenuates ALOX15 expression to inhibit ferroptosis. Moreover, the upregulation of miRNA-660-5p in macrophages depends on autocrine IL4/IL13-activated STAT6 pathway. Importantly, in clinical cervical cancer cases, ALOX15 is negatively associated with macrophages infiltration, which also raises the possibility that macrophages reduce ALOX15 levels in cervical cancer. Moreover, both univariate and multivariate Cox analyses show ALOX15 expression is independent prognostic factor and positively associated with good prognosis in cervical cancer. Altogether, this study reveals the potential utility of targeting TAMs in ferroptosis-based treatment and ALOX15 as prognosis indicators for cervical cancer.
9.Treatment of palbociclib in hormone receptor positive breast cancer: a real-world study and efficacy prediction model.
Yi Qi YANG ; Chun Xiao SUN ; Xiang HUANG ; Wei LI ; Yong Mei YIN
Chinese Journal of Oncology 2023;45(4):348-357
Objective: To summarize the clinical use of palbociclib and evaluate its efficacy and safety in hormone-receptor (HR)-positive advanced breast cancer patients. Methods: We retrospectively analyzed data from 66 HR-positive metastatic breast cancer patients treated with palbociclib and endocrine therapy at the Department of Oncology in the First Affiliated Hospital with Nanjing Medical University between 2018 and 2020. We evaluated the factors affecting the efficacy of palbociclib using Kaplan-Meier method and Log-rank test for survival analysis and Cox regressions for multivariate analysis. Nomogram model was built for predicting prognosis among HR-positive breast cancer patients who received palbociclib. Concordance index (C-index) and calibration curve were used for internal validation to assess the predictive ability and conformity of the model. Results: Of the 66 patients treated with palbociclib, 33.3%(22), 42.4%(28) and 24.2%(16) patients were treated without endocrine therapy, first-line endocrine therapy, second-line or above endocrine therapy after recurrence, respectively. 36.4%(24) patients had hepatic metastasis, 16.7% (11) patients were sensitive to previous endocrine therapy, 27.3%(18/66) patients had primary resistance to endocrine therapy, while 56.1% (37) patients had secondary resistance to endocrine therapy. The overall response rate was 14.3% (95% CI: 6.7%, 25.4%) and clinical benefit rate was 58.7% (95% CI: 45.6%, 71.0%). Better clinical outcomes were associated with non-hepatic metastasis (P=0.001), sensitive/secondary resistant to previous endocrine therapy (P=0.004), no or only one line of chemotherapy for metastatic breast cancer (P=0.004), recent pathological confirmation of immunohistochemical analysis (P=0.025). Hepatic metastasis (P=0.005) and primary resistance to endocrine therapy (P=0.016) were the independent risk factors of progression free survival. The C-index of predictive probability for the nomogram constructed from the patient clinical characteristics (whether liver metastasis, whether primary endocrine resistance, lines of chemotherapy after metastasis, lines of endocrine therapy, number of metastatic sites, and time to last immunohistochemistry) to predict the progression-free survival at 6 and 12 months for patients was 69.7% and 72.1%, respectively. The most common adverse events were hematologic toxicities. Conclusions: Our report indicates that palbociclib combined with endocrine therapy for HR-positive recurrent metastatic breast cancer is effective and safe; patients with hepatic metastases and primary resistance to endocrine therapy have worse prognoses and are independent risk factors for progression after palbociclib therapy. The constructed nomogram could help predict the survival and guide the use of palbociclib.
Humans
;
Female
;
Breast Neoplasms/pathology*
;
Retrospective Studies
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Receptor, ErbB-2/analysis*
10.Consensus on prescription review of commonly used H 1-antihistamines in pediatrics
Lihua HU ; Lu LIU ; Huiying CHEN ; Heping CAI ; Wentong GE ; Zhiying HAN ; Huijie HUANG ; Xing JI ; Yuntao JIA ; Lingyan JIAN ; Nannan JIANG ; Zhong LI ; Li LI ; Hua LIANG ; Chuanhe LIU ; Qinghong LU ; Xu LU ; Jun′e MA ; Jing MIAO ; Yanli REN ; Yunxiao SHANG ; Kunling SHEN ; Huajun SUN ; Jinqiao SUN ; Yanyan SUN ; Jianping TANG ; Hong WANG ; Lianglu WANG ; Xiaochuan WANG ; Lei XI ; Hua XU ; Zigang XU ; Meixing YAN ; Yong YIN ; Shengnan ZHANG ; Zhongping ZHANG ; Xin ZHAO ; Deyu ZHAO ; Wei ZHOU ; Li XIANG ; Xiaoling WANG
Chinese Journal of Applied Clinical Pediatrics 2023;38(10):733-739
H 1-antihistamines are widely used in the treatment of various allergic diseases, but there are still many challenges in the safe and rational use of H 1-antihistamines in pediatrics, and there is a lack of guidance on the prescription review of H 1-antihistamines for children.In this paper, suggestions are put forward from the indications, dosage, route of administration, pathophysiological characteristics of children with individual difference and drug interactions, so as to provide reference for clinicians and pharmacists.

Result Analysis
Print
Save
E-mail