1.Pharmacodynamic Substances and Mechanisms of Xinglou Chengqi Tang in Treating Post-stroke Complications: A Review
Yujin ZHANG ; Xiangzhuo LIU ; Zhouyang CHEN ; Zihao SONG ; Xinyi LIU ; Yizhi YAN ; Chaoya LI ; Yingyan FANG ; Shasha YANG ; Xueqin CHENG ; Zhou XIE ; Sijie TAN ; Peng ZENG ; Yue ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):327-337
Stroke is the leading cause of death and disability among adults in China, and its common complications include digestive system abnormalities, cognitive impairment, depression, stroke-associated pneumonia, and hemiplegia. The combination of traditional Chinese and Western medicine has great potential in treating post-stroke complications. Xinglou Chengqitang (XLCQT) is a representative prescription of alleviating the disease in the upper part by treating the lower part. It has definite therapeutic effect and high safety. Clinically, XLCQT is often used to treat stroke and its complications. However, the quantity and quality of clinical trials of XLCQT in treating post-stroke complications need to be improved. Additionally, since the basic research is weak, the material basis and multi-target mechanism for the efficacy of this prescription are unknown. This article reviews XLCQT in terms of the pharmacodynamic basis, medicinal properties, safety evaluation, and progress in clinical research and mechanisms in treating post-stroke complications. This article summarizes 22 key active ingredients of XLCQT in treating acute stroke complicated with syndrome of phlegm heat and fu-organ excess. Among these key active ingredients, resveratrol, kaempferol, luteolin, chrysoeriol, apigenin, (+)-catechin, and adenosine have good pharmacokinetic properties and high bioavailability. The mechanisms of XLCQT in treating post-stroke complications are complex, including inflammatory response, brain-gut axis, hypothalamic-pituitary-adrenal (HPA) axis, intestinal flora, neurotrophic factors, autophagy, oxidative stress, and free radical damage. This review helps to deeply understand the pharmacodynamic basis and mechanisms of XLCQT in treating post-stroke complications and provides a theoretical basis for the clinical application of XLCQT against post-stroke complications and the development of drugs.
2.Study on the correlation between HLA antibodies and pregnancy-related factors, and the predictive value of a random-forest model among female blood donors in Nanning
Fang LU ; Huihui MO ; Wujin SU ; Zhoulin ZHONG ; Hengcong LI ; Yuchen HUANG ; Yuxi CHEN ; Lilan LI ; Yan ZHOU
Chinese Journal of Blood Transfusion 2026;39(3):367-372
Objective: To explore the association between the HLA antibody positivity rate in female blood donors and pregnancy history, number of pregnancies, interval from the last pregnancy to blood donation, and age, to identify associated variables using a univariate generalized additive model (GAM), and to further analyze the predictive role of characteristic variables for HLA antibody positivity using a random forest model. Methods: HLA antibody detection was performed on 391 female blood donors using the Luminex immunomagnetic bead method. The correlation between pregnancy-related factors and HLA antibodies was analyzed using the Chi-square test. Based on R software, a univariate GAM was first constructed to analyze the association types between characteristic variables and the HLA antibody positivity rate, followed by the construction of a random forest model to evaluate the predictive value of the variables. Results: Among the 391 female blood donors without a transfusion history, the overall HLA antibody positivity rate was 26.34%. The positivity rate in donors with a pregnancy history was significantly higher than that in those without (30.09% vs 9.72%, P<0.05), and HLA antibody positivity rate increased linearly with the number of pregnancies (P<0.05). In the univariate GAM, age and number of deliveries exhibited a non-linear association with the HLA antibody positivity rate (the positivity rate increased sharply between 25-35 years of age and stabilized after 3 deliveries). Besides, the interval from the last pregnancy to blood donation showed a linear association with the HLA antibody positivity rate, and the positivity rate decreased as the interval prolonged (P<0.05). In the random forest model, age (mean decrease gini=29.26) and interval from the last pregnancy to blood donation (mean decrease gini=22.02) were core predictive variables: age was more conducive to identifying positive samples, while the interval from the last pregnancy to blood donation was more helpful for excluding negative samples. The number of deliveries (mean decrease accuracy=16.98) made a significant contribution to predicting positive samples, whereas the number of abortions had no impact. The model had an AUC of 0.583 (95% CI: 0.593 8-0.770 2), indicating a certain predictive value. Conclusion: The associated variables identified by the univariate GAM model, including age, interval from the last pregnancy to blood donation, and number of deliveries, provide a basis for key variables in the random forest model. All three variables have predictive value for HLA antibody positivity, which can provide evidence-based support for personalized transfusion management and stratified screening of female blood donors in this region.
3.Effect of Stattic on the survival of mouse heart allograft by regulating memory CD4+T cell-mediated acute rejection
Shiliang LI ; Yi FENG ; Ming FANG ; Yan ZHOU
Organ Transplantation 2025;16(1):74-82
Objective To investigate the effect and mechanism of the signal transducer and activator of transcription 3 (STAT3) inhibitor Stattic on the rejection of mouse heart allograft. Methods BALB/c mice (donors) were used to transplant skin onto C57BL/6 mice (recipients). Four weeks later, memory CD4+ T cells (CD4+Tm) were isolated from the recipient mice's spleens. Mixed lymphocyte reaction experiment was conducted with C57BL/6 mouse splenocytes and CD4+Tm, and the EdU method was used to detect the effect of Stattic on CD4+Tm cell proliferation. A C57BL/6 mouse heart transplant (HTx) model was constructed, and the experiment was divided into four groups: Non-HTx group, HTx group, Tm/HTx group, and Tm/HTx+Stattic group. The survival of heart allografts in mice was observed daily. Hematoxylin-eosin staining was used to observe the histopathology of the heart allografts. Real-time fluorescent quantitative polymerase chain reaction was used to detect the expression levels of interferon (IFN)-γ, interleukin (IL)-2, IL-10, and transforming growth factor-β1 (TGF-β1) messenger RNA (mRNA) in the heart allografts. Enzyme-linked immunosorbent assay was used to detect the levels of IFN-γ, IL-2, IL-10, and TGF-β1 in the serum. Flow cytometry was used to detect the levels of CD4+Tm (CD4+CD44+CD62L+) in splenic lymphocytes. And Western blotting was used to detect the expression levels of STAT3 and p-STAT3 proteins in the heart allografts. Results When the concentration of Stattic exceeded 2.5 μmol/L, it could inhibit the proliferation of CD4+Tm cells. Compared with the HTx group, the Tm/HTx group showed shorter survival time of heart grafts, more severe histopathological damage, increased serum IFN-γ and IL-2 levels, decreased IL-10 and TGF-β1 levels, increased relative expression of IFN-γ and IL-2 mRNA, decreased relative expression of IL-10 and TGF-β1 mRNA in the heart allografts, increased proportion of CD4+Tm in splenic lymphocytes, and increased p-STAT3/STAT3 ratio in the heart allografts (all P<0.05). Compared with the Tm/HTx group, the Tm/HTx+Stattic group showed longer survival time of heart grafts, less severe histopathological damage, decreased serum IFN-γ and IL-2 levels, increased IL-10 and TGF-β1 levels, decreased relative expression of IFN-γ and IL-2 mRNA, increased relative expression of IL-10 and TGF-β1 mRNA in the heart allografts, decreased proportion of CD4+Tm in splenic lymphocytes, and decreased p-STAT3/STAT3 ratio in the heart allografts (all P<0.05). Conclusions Stattic may prolong the survival time of mouse heart allografts, and its mechanism may be related to the inhibition of CD4+Tm- mediated acute rejection.
4.Changing antimicrobial resistance profiles of Burkholderia cepacia in hospitals across China:results from CHINET Antimicrobial Resistance Surveillance Program,2015-2021
Chunyue GE ; Yunjian HU ; Xiaoman AI ; Yang YANG ; Fupin HU ; Demei ZHU ; Yingchun XU ; Xiaojiang ZHANG ; Hui LI ; Ping JI ; Yi XIE ; Mei KANG ; Chuanqing WANG ; Pan FU ; Yuanhong XU ; Ying HUANG ; Ziyong SUN ; Zhongju CHEN ; Yuxing NI ; Jingyong SUN ; Yunzhuo CHU ; Sufei TIAN ; Zhidong HU ; Jin LI ; Yunsong YU ; Jie LIN ; Bin SHAN ; Yan DU ; Sufang GUO ; Lianhua WEI ; Fengmei ZOU ; Hong ZHANG ; Chun WANG ; Chao ZHUO ; Danhong SU ; Dawen GUO ; Jinying ZHAO ; Hua YU ; Xiangning HUANG ; Wen'en LIU ; Yanming LI ; Yan JIN ; Chunhong SHAO ; Xuesong XU ; Chao YAN ; Shanmei WANG ; Yafei CHU ; Lixia ZHANG ; Juan MA ; Shuping ZHOU ; Yan ZHOU ; Lei ZHU ; Jinhua MENG ; Fang DONG ; Zhiyong LÜ ; Fangfang HU ; Han SHEN ; Wanqing ZHOU ; Wei JIA ; Gang LI ; Jinsong WU ; Yuemei LU ; Jihong LI ; Jinju DUAN ; Jianbang KANG ; Xiaobo MA ; Yanping ZHENG ; Ruyi GUO ; Yan ZHU ; Yunsheng CHEN ; Qing MENG ; Shifu WANG ; Xuefei HU ; Jilu SHEN ; Wenhui HUANG ; Ruizhong WANG ; Hua FANG ; Bixia YU ; Yong ZHAO ; Ping GONG ; Kaizhen WENG ; Yirong ZHANG ; Jiangshan LIU ; Longfeng LIAO ; Hongqin GU ; Lin JIANG ; Wen HE ; Shunhong XUE ; Jiao FENG ; Chunlei YUE
Chinese Journal of Infection and Chemotherapy 2025;25(5):557-562
Objective To examine the changing prevalence and antimicrobial resistance profiles of Burkholderia cepacia in 52 hospitals across China from 2015 to 2021.Methods A total of 9 261 strains of B.cepacia were collected from 52 hospitals between January 1,2015 and December 31,2021.Antimicrobial susceptibility of the strains was tested using Kirby-Bauer method or automated antimicrobial susceptibility testing systems according to a unified protocol.The results were interpreted according to the breakpoints released in the Clinical & Laboratory Standards Institute(CLSI)guidelines(2023 edition).Results A total of 9 261 strains of B.cepacia were isolated from all age groups,especially elderly patients.The proportion was 11.1%(1 032 strains)in children,significantly lower than the proportion in adults.About half(46.5%,4 310/9 261)of the strains were isolated from patients at least 60 years old and 42.3%(3 919/9 261)of the strains were isolated from young adults.Most isolates(71.1%)were isolated from sputum and respiratory secretions,followed by urine(10.7%)and blood samples(8.1%).B.cepacia isolates were highly susceptible to the five antimicrobial agents recommended in the CLSI M100 document(33rd edition,2023).B.cepacia isolates showed relatively higher resistance rates to meropenem and levofloxacin.However,the resistance rates to ceftazidime,trimethoprim-sulfamethoxazole,and minocycline remained below 8.1%.The percentage of B.cepacia strains resistant to levofloxacin was the highest compared to other antibiotics in any of the three age groups(from 12.4%in the patients<18 years old to 20.6%in the patients aged 60 years or older).Conclusions B.cepacia is one of the clinically important non-fermenting gram-negative bacteria.Accurate and timely reporting of antimicrobial susceptibility test results and ongoing antimicrobial resistance surveillance are helpful for rational prescription of antimicrobial agents and proper prevention and control of nosocomial infections.
5.Role of the inflammatory reflex in the development and progression of organ injury in sepsis: a review
Xinyue ZHOU ; Yan WANG ; Xiangming FANG
Chinese Journal of Trauma 2025;41(3):318-324
Sepsis, a life-threatening organ dysfunction caused by an abnormal host response to infection, remains one of the leading causes of mortality in critically ill patients, but there is currently a lack of effective early warning systems and therapeutic strategies for sepsis. In recent years, the interaction between the nervous and immune systems has gained considerable attention. However, the precise mechanisms underlying sepsis-related organ damage and the complex interplay among different organs remain poorly understood. The inflammatory reflex, which involves the central nervous system integrating incoming inflammatory signals and reflexively modulating peripheral inflammatory responses, is a critical interface where the central nervous network regulates peripheral immunity. Modulating the inflammatory reflex to correct immune dysfunction may represent a promising therapeutic breakthrough for sepsis. Nevertheless, the precise mechanisms by which the inflammatory reflex induces changes in both the central nervous system and the peripheral immune system in sepsis, as well as its role in organ damage, remain to be elucidated. To this end, the authors reviewed the researches on the role of the inflammatory reflex in the development and progression of sepsis-related organ damage, aiming to provide novel insights into more effective therapeutic strategies for sepsis.
6.Proportions and clinical significance of myeloid-derived suppressor cell subsets in the peripheral blood of ovarian cancer pa-tients
Yepeng MAO ; Ting WANG ; Zhenzhen CAI ; Zhijie LIU ; Yuelu ZHANG ; Ziqi TAO ; Lingfei ZHOU ; Lina YAN ; Fang WANG
Chinese Journal of Clinical Laboratory Science 2025;43(3):179-184
Objective To investigate the proportions of myeloid-derived suppressor cells(MDSCs)and their subsets,including poly-morphonuclear MDSCs(PMN-MDSCs),early-stage MDSCs(e-MDSCs),monocytic MDSCs(M-MDSCs),and lectin-like oxidized low-density lipoprotein receptor-1(LOX-1)positive PMN-MDSCs,in the peripheral blood of ovarian cancer(OC)patients and ana-lyze their correlations with clinicopathological parameters of the patients.Methods The proportions of MDSCs and their subsets in the peripheral blood of 38 OC patients(OC group)and 46 healthy individuals(healthy control group)were detected by flow cytometry.The levels of serum IL-10 and TGF-β were detected using ELISA.The OC group was further divided into LOX-1 high and low expres-sion subgroups based on the median proportion of LOX-1+PMN-MDSCs in MDSCs.Results The proportions of MDSCs,PMN-MDSCs,and LOX-1+PMN-MDSCs in the peripheral blood mononuclear cells(PBMCs)of the OC group were significantly higher than those in the healthy control group(U=492,P<0.001;t=8.741,P<0.000 1;U=223,P<0.000 1).The proportions of M-MDSCs and e-MDSCs in the OC group were significantly lower than those in the healthy control group(t=4.366,P<0.000 1;t=6.927,P<0.000 1).The proportion of LOX-1+PMN-MDSCs in the lymph node metastasis group of OC patients was significantly higher than that in the non-metastasis group(t=2.249,P<0.05).The levels of serum IL-10 and TGF-β in the OC group were significantly higher than those in the healthy control group(P<0.05).In addition,the level of serum TGF-β in the LOX-1 high expression group was significantly higher than that in the LOX-1 low expression group(t=2.302,P<0.05).Conclusion The proportion of LOX-1+PMN-MDSCs in the peripheral blood of OC patients is significantly increased and closely related to lymph node metastasis.
7.The clinical significance of Th17 cell heterogeneity in myelodysplastic neoplasms
Yichen WANG ; Wenguang ZHOU ; Yanwen YAN ; Fang YI ; Lingsha QIN ; Wei LI ; Yuquan LI ; Xiangzong ZENG
Tianjin Medical Journal 2025;53(9):942-946
Objective To investigate the proportion of Th17 cells,Th1-like Th17 cells and FoxP3+Th17 cells in bone marrow of patients with myelodysplastic syndrome(MDS),the expression of interleukin-17A(IL-17A)in bone marrow supernatant and its clinical significance.Methods Forty MDS patients(MDS group)and 18 patients with nutritional anemia(control group)were selected.MDS patients were classified into the low blast(MDS-LB)group(19 cases)and the increased blast(MDS-IB)group(21 cases,including 11 cases of type IB1 and 10 cases of type IB2)based on morphological definition.The MDS patients were scored according to the revised International Prognostic Scoring System(IPSS-R),with 18 cases in the low-risk group(≤4.5)and 22 cases in the high-risk group(>4.5).Flow cytometry was used to detect the proportion of Th17 cells,Th1-like Th17 cells and FoxP3+Th17 cells in bone marrow of the MDS group and the control group.Enzyme-linked immunosorbent assay(ELISA)was used to detect the level of IL-17A in bone marrow supernatant of the above samples.Results The proportion of Th17 cells and the level of IL-17A were higher in patients of the MDS group than those in the control group(P<0.05).According to the median expression level of IL-17A,the MDS group was divided into the low-expression group(<13.71 ng/L,20 cases)and the high-expression group(≥13.71 ng/L,20 cases).Compared with the low-expression group,there were higher proportion of patients with blast cells<5%and low-risk patients(P<0.05)in the high-expression group.Compared with the IL-17A low-expression group,the IL-17A high-expression group had a higher proportion of patients with blast cells<5%and relatively low-risk patients(P<0.05).Compared with the low-risk patients,high-risk patients had a lower proportion of Th17 cells,IL-17A levels and Th1-like Th17 cells,and a higher proportion of FoxP3+Th17 cells(P<0.05).Compared with the MDS-LB group,the MDS-IB group had a lower proportion of Th17 cells,IL-17A levels and Th1-like Th17 cells,and a higher proportion of FoxP3+Th17 cells(P<0.05).Conclusion The proportion of Th17 cells and the level of IL-17A are significantly increased in MDS patients.The decreased proportion of Th1-like Th17 cells and the increased proportion of FoxP3+Th17 cells may be related to the increased proportion of blast cells and higher risk stratification in patients.
8.Analysis of the predictive value of early fluid balance in combination with daily average fluid intake for the prognosis of patients after spontaneous intracerebral hemorrhage hematoma evacuation
Xin HE ; Yan SUN ; Xiaoqi ZHOU ; Jie CHENG ; Qiqun TANG ; Xiaohua CHENG ; Fang CHEN
Chinese Journal of Cerebrovascular Diseases 2025;22(6):403-413
Objective To investigate the predictive value of early fluid balance combined with daily average fluid intake on the prognosis of patients who received hematoma evacuation for spontaneous intracerebral hemorrhage(sICH).Methods This study retrospectively and consecutively enrolled patients who underwent hematoma evacuation for sICH admitted to the Neurosurgical Intensive Care Unit of North China University of Science and Technology Affiliated Hospital between January 2023 and January 2025.Patients'baseline and clinical data were collected,including gender,age,admission vital signs(body temperature,respiratory rate,heart rate,systolic and diastolic blood pressure),medical history(hypertension,diabetes mellitus,coronary heart disease),admission Glasgow coma scale(GCS)score,admission laboratory parameters(including white blood cell count,red blood cell count,platelet count,urine bacterial levels,urine ketones,urine pH,homocysteine),hemorrhage location,hemorrhage volume,time from ictus to surgery,and hematoma evacuation rate(hematoma evacuation rate[%]=[preoperative hematoma volume-postoperative hematoma volume]/preoperative hematoma volume × 100%).Fluid intake,output,balance,daily average intake,and cumulative fluid balance during the early postoperative period(the first to seventh 24-hour periods)were assessed and recorded.Fluid intake comprised the sum of intravenously administered fluids(crystalloids,hypertonic fluids,colloids,blood products,and parenteral nutrition),enteral nutrition(nasogastric feeding solutions and water),and renal replacement therapy fluids.Fluid output comprised the sum of urine volume,vomitus,drainage fluid,and dialysis fluid losses.Fluid balance was defined as the difference between fluid intake and output.Daily average intake was calculated as the average of the fluid intake over the first seven postoperative 24-hour periods.Cumulative fluid balance was the sum of the fluid balances over the first seven postoperative 24-hour periods.Patient outcomes were assessed at 30 days postoperatively.Discharged patients underwent outpatient review or telephone follow-up,while inpatients were evaluated by neurosurgeons.Prognosis was evaluated using the 30-day modified Rankin scale(mRS)score:mRS scores 0-3 were classified as favorable prognosis,and mRS scores 4-6 as poor prognosis.Patients were subsequently divided into favorable prognosis and poor prognosis groups based on mRS scores.Factors with P<0.05 in univariate comparisons and without collinearity(multicollinearity was defined by:tolerance<0.1 and variance inflation factor>10)were included in multivariate Logistic regression analysis to identify independent risk factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Receiver operating characteristic(ROC)curve analysis was employed to evaluate the predictive value of relevant factors for poor 30-day prognosis after hematoma evacuation in sICH patients.Results A total of 320 patients who underwent hematoma evacuation for sICH were enrolled,including 192 males and 128 females,with an age range of 20-91 years(median age 62[53,68]years).Among them,144 patients were assigned to the favorable prognosis group and 176 to the poor prognosis group.The poor prognosis group exhibited significantly higher hemorrhage volume,homocysteine level,fluid intake at the 3rd,5th,6th,and 7th 24-hour periods,fluid balance at the 3rd,5th,6th,and 7th 24-hour periods,daily average intake,and cumulative fluid balance compared to the favorable prognosis group(all P<0.05).The favorable prognosis group had a significantly higher hematoma evacuation rate,GCS score,proportion of supratentorial hemorrhage and negative urine ketones than the poor prognosis group(all P<0.05).No significant differences were found in other clinical data(all P>0.05).Fluid balance over the first seven postoperative 24-hour periods displayed a rise-decline-rise pattern in the poor prognosis group and a rise-decline pattern in the favorable prognosis group.Both groups peaked at the 3rd 24-hour period.Multivariate Logistic regression analysis identified fluid balance at the 3rd 24-hour period(OR,2.013,95%CI 1.386-2.922,P<0.01)and daily average intake(OR,3.583,95%CI 1.793-7.161,P<0.01)as independent influencing factors for poor 30-day prognosis after hematoma evacuation in sICH patients.ROC curve analysis revealed that the area under the curve(AUC)for fluid balance at the 3rd 24-hour period and daily average intake in predicting poor 30-day prognosis were 0.699(95%CI 0.642-0.757)and 0.765(95%CI 0.712-0.819),respectively.The combined model of fluid balance at the 3rd 24-hour period and daily average intake achieved an AUC of 0.804(95%CI 0.756-0.853),demonstrating significantly superior predictive performance compared to either variable alone(both P<0.05).Conclusions The combination of fluid balance at the 3rd 24-hour period and daily average intake demonstrates modest predictive value for poor 30-day prognosis after hematoma evacuation in sICH patients.These findings require validation through multicenter,large-scale,prospective studies.
9.Establishment of TCM Comprehensive Control and Prevention Program of Elderly Hypertension with Early Renal Damage Based on Delphi Method
Rui FANG ; Yong YANG ; Le XIE ; Yan YANG ; Yue ZHOU ; Wenfeng XU ; Jinwen GE
World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(7):1867-1877
Objective To establish a scientific and feasible Chinese medicine(CM)comprehensive control and prevention program for elderly hypertension with early renal damage(EH-ERD)patients through high-level evidence-based medicine(EBM)evidence.Methods On the basis of literature research and evidence evaluation,we construct a database of specific prescriptions and implementation methods of CM comprehensive control and prevention program with EH-ERD.40 senior titled-experts were consulted in two rounds of questionnaires based on Delphi methods.We selected,evaluated,and revised specific CM comprehensive control and prevention program of EH-ERD through the analysis of multiple factors,such as expert's positive activity coefficient,authority coefficient,degree of opinion concentration and degree of coordination.Results In view of the CM appropriate intervention techniques with high-grade evidence(level Ⅰ and Ⅱ)and recommendation(level A and B),we have developed the CM comprehensive control and prevention plan items for EH-ERD.The activity coefficients in two-round consultation were 92.5%and 97.14%respectively,the overall authority coefficient(Cr)was exceeded 0.70,and the coordination coefficient was less than 0.25.With a sound activity coefficient,a relatively high Cr and a rather unified degree of opinion concentration and coordination,the CM comprehensive control and prevention program for EH-ERD was established,which included six primary indicators(CM compound preparation,acupuncture and massage,CM health education,medicinal diet therapy,health care exercise and foot bath)and seventeen secondary indicators.Conclusion The CM comprehensive control and prevention program for EH-ERD established in this study can provide a basis for the further formation of expert consensus or guidelines.Moreover,it can supply the strategy and paradigm for standardization of CM-based health management of EH-ERD.
10.Analysis and suggestions for the FDA drug labeling rules on cardiac safety risk warnings
Wei LIU ; Xiao-qing XING ; Yu-qing REN ; Qian SHEN ; Yue ZHOU ; Nan ZHANG ; Fu-meng LIANG ; Fang-fang WANG ; Hai-yan LI
The Chinese Journal of Clinical Pharmacology 2025;41(2):235-239
Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.Methods This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.

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