1.Protective Effect of Xuebijing on Lung Injury in Rats with Severe Acute Pancreatitis by Blocking FPRs/NLRP3 Inflammatory Pathway
Guixian ZHANG ; Dawei LIU ; Xia LI ; Xijing LI ; Pengcheng SHI ; Zhiqiao FENG ; Jun CAI ; Wenhui ZONG ; Xiumei ZHAO ; Hongbin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):113-120
ObjectiveTo explore the therapeutic effect of Xuebijing injection (XBJ) on severe acute pancreatitis induced acute lung injury (SAP-ALI) by regulating formyl peptide receptors (FPRs)/nucleotide-binding oligomerization domain-like receptor 3 (NLRP3) inflammatory pathway. MethodsSixty rats were randomly divided into a sham group, a SAP-ALI model group, low-, medium-, and high-dose XBJ groups (4, 8, and 12 mL·kg-1), and a positive drug (BOC2, 0.2 mg·kg-1) group. For the sham group, the pancreas of rats was only gently flipped after laparotomy, and then the abdomen was closed, while for the remaining five groups, SAP-ALI rat models were established by retrograde injection of 5% sodium taurocholate (Na-Tc) via the biliopancreatic duct. XBJ and BOC2 were administered via intraperitoneal injection once daily for 3 d prior to modeling and 0.5 h after modeling. Blood was collected from the abdominal aorta 6 h after the completion of modeling, and the expression of interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) in plasma was measured by enzyme-linked immunosorbent assay (ELISA). The amount of ascites was measured, and the dry-wet weight ratios of pancreatic and lung tissue were determined. Pancreatic and lung tissue was taken for hematoxylin-eosin (HE) staining to observe pathological changes and then scored. The protein expression levels of FPR1, FPR2, and NLRP3 in lung tissue were detected by the immunohistochemical method. Western blot was used to detect the expression of FPR1, FPR2, and NLRP3 in lung tissue. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of FPR1, FPR2, and NLRP3 in lung tissue. ResultsCompared with the sham group, the SAP-ALI model group showed significantly decreased dry-wet weight ratio of lung tissue (P<0.01), serious pathological changes of lung tissue, a significantly increased pathological score (P<0.01), and significantly increased protein and mRNA expression levels of FPR1, FPR2, and NLRP3 in lung tissue (P<0.01). After BOC2 intervention, the above detection indicators were significantly reversed (P<0.01). After treatment with XBJ, the groups of different XBJ doses achieved results consistent with BOC2 intervention. ConclusionXBJ can effectively improve the inflammatory response of the lungs in SAP-ALI rats and reduce damage. The mechanism may be related to inhibiting the expression of FPRs and NLRP3 in lung tissue, which thereby reduces IL-1β and simultaneously antagonize the release of inflammatory factors IL-6 and TNF-α.
2.Mechanism study of BOC2 alleviating SAP inflammatory damage by inhibiting N-formyl peptide/formyl peptide receptor pathway
Guixian ZHANG ; Dawei LIU ; Wenchang LI ; Jun CAI ; Wenhui ZONG ; Hongbin LIU ; Xiumei ZHAO
Tianjin Medical Journal 2024;52(10):1031-1037
Objective To observe the effect of BOC-Phe-Leu-Phe-Leu-Phe(BOC2)on the expression of six types of mitochondrial N-formyl peptides(NFPs)in blood and two formyl peptide receptors(FPRs)in pancreatic tissue of rats with severe acute pancreatitis(SAP),and to explore its mechanism of alleviating inflammatory damage of SAP.Methods Forty male SD rats were randomly divided into four groups:the sham group,the SAP model group,the BOC2 low-dose and the BOC2 high-dose group(0.1 and 0.2 mg/kg),with 10 animals in each group.The SAP model was prepared by retrograde injection of 5%sodium taurocholate(50 mg/kg)into biliary and pancreatic ducts in the last 3 groups.BOC2 was intraperitoneally injected at 0.5 hours after SAP modeling,and samples were taken 4 hours after modeling.HE staining was used to observe pathological changes in pancreas.Western blot assay was used to detect the expression of NFPs in plasma.IHC staining was used to detect the expression of FPRs in pancreatic tissue.ELISA was used to detect interleukin(IL)-1β,IL-6 and tumor necrosis factor(TNF)-α levels in plasma.qPCR was used to detect expression levels of inflammatory factors in local pancreatic tissue.Results Compared with the model group,the BOC2 high-dose group and the BOC2 low-dose group showed improvement in pathological phenomena,such as pancreatic bleeding,acinar cell necrosis,inflammatory cell infiltration and edema.The pancreatic injury score,pancreatic FPRs expression,plasma MT-ND1,MT-ND2,MT-ND3,MT-ND5,MT-ND6 expression,as well as expression levels of three inflammatory factors in plasma and local pancreatic tissue,were significantly reduced(P<0.05).Conclusion BOC2 can reduce the production of inflammatory factors and alleviate SAP inflammatory damage by antagonizing mitochondrial NFPs/FPRs signaling pathway.
3.Risk factors and predictive model of complicating urosepsis after percutaneous nephrolithotripsy
Dawei ZHANG ; Gaoping CAI ; Yangyang TAN ; Yuxiang LI ; Cheng YANG ; Bin ZHANG ; Xukai YANG
Chongqing Medicine 2024;53(2):180-187
Objective To explore the risk factors of complicating urogenic sepsis after percutaneous nephrolithotripsy(PCNL)and construct a nomogram prediction model.Methods The data of 291 patients with stage 1 PCNL in 940 Hospital of Joint Logistics Support Force from October 2016 to October 2021 were retrospectively analyzed.The patients were divided into the sepsis group and non-sepsis group according to whether complicating urogenic sepsis after operation.The general data,stone-related data,operation-related data and laboratory detection related data were included.The independent risk factors were screened by the univariate and multivariate logistic regression analysis,and the nomogram prediction model was constructed.Results The results of univariate and multivariate logistic regression analysis showed that age≥60 years old(OR=6.438,95%CI:1.548-26.769),urinary leukocyte 3+(OR=5.651,95%CI:1.614-31.766),urinary nitrite positive(OR=7.117,95%CI:1.190-42.561),operation time≥90 min(OR=4.626,95%CI:1.137-18.817)and perfusion volume 30 L(OR=3.312,95%CI:1.090-10.061)were the independent risk factors of postoperative complicating urogenic sepsis.C-index of the constructed nomogram prediction model in the modeling samples was 0.937,the calibrated C-index was 0.914,and the model predictive efficien-cy was good.Conclusion Age ≥60 years old,urinary leukocyte 3+,urinary nitrite positive,operation time 90 min and perfusion volume ≥30 L are the independent risk factors for complicating urogenic sepsis after PCNL;the constructed nomogram prediction model has a good predictive efficiency for the occurrence of post-operative urogenic sepsis.
4.Effects of traditional Chinese medicine on treatment outcomes in severe COVID-19 patients: a single-centre study.
Yongjiu XIAO ; Binbin LI ; Chang LIU ; Xiuyu HUANG ; Ling MA ; Zhirong QIAN ; Xiaopeng ZHANG ; Qian ZHANG ; Dunqing LI ; Xiaoqing CAI ; Xiangyong YAN ; Shuping LUO ; Dawei XIANG ; Kun XIAO
Chinese Journal of Natural Medicines (English Ed.) 2024;22(1):89-96
As the search for effective treatments for COVID-19 continues, the high mortality rate among critically ill patients in Intensive Care Units (ICU) presents a profound challenge. This study explores the potential benefits of traditional Chinese medicine (TCM) as a supplementary treatment for severe COVID-19. A total of 110 critically ill COVID-19 patients at the Intensive Care Unit (ICU) of Vulcan Hill Hospital between Feb., 2020, and April, 2020 (Wuhan, China) participated in this observational study. All patients received standard supportive care protocols, with a subset of 81 also receiving TCM as an adjunct treatment. Clinical characteristics during the treatment period and the clinical outcome of each patient were closely monitored and analysed. Our findings indicated that the TCM group exhibited a significantly lower mortality rate compared with the non-TCM group (16 of 81 vs 24 of 29; 0.3 vs 2.3 person/month). In the adjusted Cox proportional hazards models, TCM treatment was associated with improved survival odds (P < 0.001). Furthermore, the analysis also revealed that TCM treatment could partially mitigate inflammatory responses, as evidenced by the reduced levels of proinflammatory cytokines, and contribute to the recovery of multiple organic functions, thereby potentially increasing the survival rate of critically ill COVID-19 patients.
Humans
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COVID-19
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Medicine, Chinese Traditional
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SARS-CoV-2
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Critical Illness
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Treatment Outcome
5.The correlation between dietary nutrition and skeletal muscle mass in the elderly with advanced age
Xiaoxiao LIANG ; Shiyuan CAI ; Huijuan RUAN ; Jiaoyan HUANG ; Youyang HUANG ; Hanping SHI ; Dawei CHEN ; Xue LI
Shanghai Journal of Preventive Medicine 2024;36(6):589-595
ObjectiveThis research focused on examining the distinctive characteristics of nutrient intake and dietary patterns among long-lived elderly individuals. Additionally, the study was aimed to explore the specific dietary components that may impact the skeletal muscle mass in this particular group. MethodsThis study was conducted in the Chongming area of Shanghai, China. A total of 206 long-lived elderly individuals aged 90 or above were recruited. The 3-day 24-hour dietary recall method was used to collect dietary information and general demographic data through face-to-face interviews with professional nutritionists. The skeletal muscle mass index(SMI) was measured by bioelectrical impedance analysis(BIA), and low skeletal muscle mass was diagnosed based on the 2019 Asian Working Group for Sarcopenia criteria. T-test analysis, chi-square test, and logistic regression were used to analyze the relationship between dietary nutrient intake and skeletal muscle mass. ResultsIn terms of food intake categories, compared with the long-lived elderly people with normal muscle mass, the intake of cereals containing miscellaneous beans and vegetables in the long-lived elderly people with low muscle mass was significantly lower(P<0.05). In terms of the nutrient intake, compared with the long-lived elderly people with normal muscle mass, the intake of total energy, carbohydrate, dietary fiber, vitamin D, folic acid, phosphorus, potassium, magnesium, iron, and manganese in the long-lived elderly people with low muscle mass was significantly lower(P<0.05). After continuous adjustment for the covariates, multivariate logistic regression analysis found that the intake levels of folic acid and dietary fiber were important factors influencing skeletal muscle mass, Individuals with lower intake levels of folic acid and dietary fiber are at a higher risk of low muscle mass in long-lived elderly individuals [ORfolic acid T1, dietary fiber T1 (95%CI): 2.90 (1.11‒7.61); 4.09 (1.53‒10.91)]. ConclusionThe consumption of cereals that include a variety of beans and vegetables was noticeably lower in the long-lived elderly individuals with lower muscle mass when compared to those with normal muscle mass. Furthermore, low levels of folic acid and dietary fiber intake are associated with an increased risk of low skeletal muscle mass.
6.Clinical efficacy of liver transplantation for intrahepatic cholangiocarcinoma: a multicenter study
Dawei SUN ; Wentao JIANG ; Lin ZHONG ; Jinzhen CAI ; Wenzhi GUO ; Guoyue LYU
Chinese Journal of Digestive Surgery 2023;22(2):230-235
Objective:To investigate the clinical efficacy of liver transplantation for intra-hepatic cholangiocarcinoma.Methods:The retrospective cohort study was conducted. The clinico-pathological data of 22 patients with intrahepatic cholangiocarcinoma who underwent liver trans-plantation in the 5 medical centers, including First Hospital of Jilin University, et al, from September 2005 to December 2021 were collected. There were 18 males and 4 females, aged 57(range, 38?71)years. Observing indicators: (1) clinicopathological characteristics of patients with intrahepatic cholangiocarcinoma; (2) follow-up; (3) prognosis. Measurement data with skewed distribution were represented as M(range). Count data were described as absolute numbers or percentages. The Kaplan-Meier method was used to draw survival curves. The Log-Rank test was used for survival analysis. Results:(1) Clinicopathological characteristics of patients with intrahepatic cholangio-carcinoma. Of the 22 patients, 20 cases were diagnosed as intrahepatic cholangiocarcinoma before liver transplantation, 7 cases had viral hepatitis type B, 1 case had primary sclerosing cholangitis, 7 cases had tumor treatment before liver transplantation, 7 cases, 6 cases and 9 cases were classified as grade A, grade B and grade C of the Child-Pugh classification, 16 cases had preoperative CA19-9 >40 U/mL, 14 cases had single tumor, 11 cases with tumor located at right lobe of liver, 6 cases with tumor located at both left and right lobe of liver, 5 cases with tumor located at left lobe of liver, 9 cases with tumor vascular invasion. All 22 patients were diagnosed as moderate-poor differentiated tumor. There were 9 cases with liver cirrhosis, 4 cases with tumor lymph node metastasis, 10 cases with tumor burden within Milan criteria. The tumor diameter of 22 patients was 4.5(range, 1.5?8.0)cm. (2) Follow-up. All 22 patients were followed up for 15(range, 3?207)months. Of the 22 patients, 9 cases had tumor recurrence and 8 cases died. (3) Prognosis. The 1-year overall survival rate and 1-year disease-free survival rate of the 22 patients was 72.73% and 68.18%, respectively. Results of subgroup analysis showed there were significant differences in overall survival and disease-free survival between the 10 patients with tumor burden within Milan criteria and the 12 patients with tumor burden beyond Milan criteria who underwent liver transplantation ( hazard ratio=0.13, 0.26, 95% confidence interval as 0.03?0.53, 0.08?0.82, P<0.05). Results of further analysis of the 12 patients with tumor burden beyond Milan criteria showed there were significant differences in overall survival and disease-free survival between the 5 patients with preoperative tumor down-staging treatment and the 7 patients without preoperative tumor down-staging treatment ( hazard ratio=0.18, 0.14, 95% confidence interval as 0.04?0.76, 0.04?0.58, P<0.05). Conclusions:Intrahepatic cholangiocarcinoma patients with tumor burden within Milan criteria have a better prognosis than patients with tumor burden beyond Milan criteria after liver transplantation. For patients with tumor burden beyond Milan criteria, active tumor down-staging treatment before liver transplantation can improve the prognosis.
7.Effects and mechanism of astragalus polysaccharide on wound healing of deep partial-thickness burns in rats
Fan ZHENG ; Yu'e CAI ; Li LI ; Dawei HAN
Chinese Journal of Burns 2023;39(3):256-263
Objective:To investigate the effects and mechanism of astragalus polysaccharide (APS) on wound healing of deep partial-thickness burns in rats.Methods:The experimental study method was used. Fifty 7-week-old male Sprague-Dawley rats were divided into normal group, simple burn group, APS group, inhibitor group, and inhibitor+APS group according to the random number table, with 10 rats in each group. Except for normal group, rats in the other 4 groups were inflicted with a deep partial-thickness burn wound on the back. Rats in normal group and simple burn group were intraperitoneally injected with normal saline, and rats in the other three groups were injected with APS and/or integrin-linked kinase (ILK) inhibitor, respectively. After 7 days of injection, the wound healing rate of rats with burns in the four groups was calculated, and the serum content of interferon-γ, interleukin-2 (IL-2), and tumor necrosis factor α (TNF-α) in rats in 5 groups was determined by enzyme-linked immunosorbent assay (ELISA). The normal skin tissue of rats in normal group and wound tissue of rats with burns in the four groups were taken, the water content was determined and the water ratio was calculated, the content of interferon-γ, IL-2, and TNF-α was detected by ELISA, the mRNA expressions of epidermal growth factor (EGF), basic fibroblast growth factor (bFGF), and ILK were detected by real-time fluorescence quantitative reverse transcription polymerase chain reaction, and the protein expressions of ILK, protein kinase B (Akt), phosphorylated Akt (p-Akt), glycogen synthetic kinase-3β (GSK-3β), and phosphorylated GSK-3β (p-GSK-3β) were detected by Western blotting. Data were statistically analyzed with one-way analysis of variance and least significant difference test.Results:After 7 days of injection, the wound healing rate of rats in APS group was (67±5)%, which was significantly higher than (52±4)% in simple burn group and (59±5)% in inhibitor+APS group (with all the P values <0.05). The wound healing rate of rats in inhibitor+APS group was significantly higher than (48±4)% in inhibitor group ( P<0.05). After 7 days of injection, compared with those in serum or normal skin tissue of rats in normal group, the serum content of interferon-γ, TNF-α, IL-2 and the water ratio of wound tissue of rats in simple burn group were significantly increased ( P<0.05); compared with those in APS group, the serum content of interferon-γ, TNF-α, IL-2 and the water ratio of wound tissue of rats in simple burn group and inhibitor+APS group were significantly increased ( P<0.05); compared with those in inhibitor group, the serum content of interferon-γ, TNF-α, IL-2 and the water ratio of wound tissue of rats in inhibitor+APS group were significantly decreased ( P<0.05). After 7 days of injection, compared with that in normal skin tissue of rats in normal group, the content of interferon-γ, TNF-α, and IL-2 in wound tissue of rats in simple burn group was significantly increased ( P<0.05); compared with that in APS group, the content of interferon-γ, TNF-α, and IL-2 in wound tissue of rats in simple burn group and inhibitor+APS group was significantly increased ( P<0.05); compared with that in inhibitor group, the content of interferon-γ, TNF-α, and IL-2 in wound tissue of rats in inhibitor+APS group was significantly decreased ( P<0.05). After 7 days of injection, compared with those in normal skin tissue of rats in normal group, the mRNA expressions of EGF, bFGF, ILK and protein expressions of ILK, p-Akt, p-GSK-3β in wound tissue of rats in simple burn group were significantly increased ( P<0.05); compared with those in APS group, the mRNA expressions of EGF, bFGF, ILK and protein expressions of ILK, p-Akt, p-GSK-3β in wound tissue of rats in simple burn group and inhibitor+APS group were significantly decreased ( P<0.05); compared with those in inhibitor group, the mRNA expressions of EGF, bFGF, ILK and protein expressions of ILK, p-Akt, p-GSK-3β in wound tissue of rats in inhibitor+APS group were significantly increased ( P<0.05). There were no statistically significant differences in the protein expressions of Akt and GSK-3β in normal skin tissue of rats in normal group and wound tissue of rats with burns in the four groups ( P>0.05). Conclusions:APS can alleviate systemic and local inflammation, alleviate tissue edema, and promote the expressions of healing factors in rats with deep partial-thickness burns, thus to promote the wound healing, possibly by activating ILK/Akt/GSK-3β signaling pathway.
8.The effects of repetitive transspinal magnetic stimulation on neurogenic bladder after suprasacral spinal cord injury
Yuanyuan TAO ; Dawei ZHANG ; Xiaoyan FENG ; Xinwei ZHU ; Le JIAO ; Ping CAI ; Qingmei CHEN ; Liying HAN ; Hongjun ZHU
Chinese Journal of Physical Medicine and Rehabilitation 2023;45(10):899-903
Objective:To observe any effect of repeated magnetic stimulation of the spine on lower urinary tract function and the life quality of patients with neurogenic bladder after suprasacral spinal cord injury (SCI).Methods:Fifteen suprasacral SCI patients whose lower urinary tract function was not improving were enrolled. In the first 2 weeks, all received water drinking management and intermittent catheterization, while in the following 4 weeks they were additionally provided with daily transspinal magnetic stimulation at the level of the spinous process of the first lumbar vertebra five times a week. The stimulation frequency was 1Hz. The patients kept voiding diaries. Their urodynamics were quantified using neurogenic bladder symptom scoring (NBSS) and a life quality scale.Results:The frequency of catheterization and the average voided volume, as well as the maximum detrusor pressure during the storage phase, maximum bladder capacity, maximum urethral pressure during the voiding phase and voiding efficiency at the end of the sixth week were significantly different from those at the end of the second week and before the intervention. The average NBSS and life quality scores then showed significant differences from the earlier time points.Conclusion:Repeteitive transspinal magnetic stimulation of the spine can improve lower urinary tract functioning and the life quality of persons with neurogenic bladder after a suprasacral SCI.
9.Effect of Pangshi Antai Zhixue Decoction on Th1/Th2 Balance in Decidua and Membrane of Spontaneous Abortion Rats with Heat Syndrome by Regulating p38 MAPK Signal Pathway
Liya MA ; Yuanyuan CAI ; Xuelin ZHANG ; Yitong YANG ; Mengyuan JIA ; Danya WANG ; Jingyi WANG ; Dawei ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(18):62-69
ObjectiveTo explore the anti-abortional effect of Pangshi Antai Zhixue decoction and its mechanism in helper T lymphocyte 1 (Th1)/Th2 balance in the decidual tissues of spontaneous abortion rats with heat syndrome, based on the p38 mitogen-activated protein kinase (p38 MAPK) signaling pathway. MethodAconiti Lateralis Radix Praeparata, Zingiberis Rhizoma, and Cinnamomi Cortex decoction was used to replicate the rat model of spontaneous abortion with heat syndrome. The spontaneous abortion rats with heat syndrome were randomly divided into model group, aspirin group (5.25 mg·kg-1), dydrogesterone group (3.02 mg·kg-1), Pangshi Antai Zhixue decoction high-dose (44 g·kg-1), medium-dose (22 g·kg-1), and low-dose (11 g·kg-1) groups, with ten rats in each group. Ten normal rats were divided into a normal group. Rats in each group were given corresponding drugs, Once a day for 12 d. After 24 h of the last administration, blood was collected from the abdominal aorta. The enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of β-human chorionic gonadotropin (β-HCG), progesterone (P), estradiol (E2), γ interferon (IFN-γ), and interleukin-4 (IL-4) in rat serum. The uterus and meconium tissues of rats were collected to determine the number and rate of miscarriages. Western blot was used to detect GATA3, T-bet, p38 MAPK, and its phosphorylation in the decidual tissue. ResultAs compared with the normal group, the number of live births, the β-HCG, P, E2, and IL-4 in the serum, and the GATA3 protein expression in the decidual tissue in the model group were reduced (P<0.01), whereas the number and rate of miscarriages, IFN-γ in the serum, and the expression of p-p38 MAPK and T-bet protein levels in the demolded tissues increased (P<0.01). As compared with the model group, the number of live births, the β-HCG, P, E2, and IL-4 in the serum, and the GATA3 protein expression in the decidual tissue in the Pangshi Antai Zhixue decoction medium-dose group increased (P<0.01), whereas the number and rate of miscarriages, IFN-γ in the serum, and the expression of p-p38 and T-bet protein levels in the demolded tissues reduced (P<0.01). As compared with the aspirin group, the P, E2, and IL-4 in the serum of rats in the dydrogesterone group and the Pangshi Antai Zhixue decoction high-dose and medium-dose groups increased (P<0.01), the number of live births in the Pangshi Antai Zhixue decoction medium-dose group increased (P<0.01), and the β-HCG and IFN-γ in the serum of rats in the dydrogesterone group decreased (P<0.01). The number and rate of miscarriages, IFN-γ in the serum, and T-bet and GATA3 levels in the decidual tissues of rats in the Pangshi Antai Zhixue decoction medium-dose group decreased (P<0.05). Compared with the Pangshi Antai Zhixue decoction medium-dose group, the low-dose group, high-dose group, and dydrogesterone group showed increased number and rate of miscarriages (P<0.05), and the high-dose group and dydrogesterone group decreased the number of live birth (P<0.01). The IFN-γ in the serum and p-p38 MAPK and T-bet protein in the decidual tissue in the low-dose group, and the p-p38 MAPK and T-bet protein in the decidual tissue in the high-dose group all increased (P<0.05). The β-HCG, P, and E2 in the serum of rats in the Pangshi Antai Zhixue decoction low-dose group, dydrogesterone group, and aspirin group decreased (P<0.01), and the IL-4 in the serum and GATA3 in the decidual tissue of rats in the Pangshi Antai Zhixue decoction low-dose and high-dose group and the dydrogesterone group decreased (P<0.01). ConclusionPangshi Antai Zhixue decoction realizes the effect of fetal protection by regulating the activation of p38 MAPK signal pathways and Th1/Th2 balance.
10.Progress on clinical trials of cancer drugs in China, 2020
Dawei WU ; Huiyao HUANG ; Yu TANG ; Haixue WANG ; Jun WANG ; Shuhang WANG ; Hong FANG ; Xueyuan YANG ; Jing LI ; Xin WANG ; Lijun LIU ; Yan YAN ; Qing WANG ; Ning LI ; Cai CAO ; Binghe XU ; Yan SUN ; Jie HE
Chinese Journal of Oncology 2021;43(2):218-223
Objective:To explore the latest progress of oncology drug clinical trials in China under COVID-19, as well as to provide decision-making evidence for related stakeholders. Research progress of oncology drug trials and approved cancer drugs in China in 2020 were systematically summarized and compared with 2019.Methods:Information Disclosure Platform for Drug Clinical Studies and China Food and Drug Administration Query System for Domestic and Imported Drug were searched for registered clinical trials and approved oncology drugs, respectively. The trial scope, stage, drug type, effect and mechanism of domestic and global pharmaceutical enterprises were compared between 2019 and 2020.Results:A total of 722 cancer drug trials registered in China in 2020, with an annual growth rate of 52.3%, accounting for 28.3% of all registered trials. Among them, 603 (83.5%) trials were initiated by domestic pharmaceutical enterprises, and 105 (14.5%) were international multicenter trials, phase I trials accounted for 44.5%. For all those trials, there were 458 cancer drug varieties, with an annual growth rate of 36.7%, and 361 (85.8%) were developed by domestic enterprises. Most of the investigational products were therapeutic innovative drugs (77.1%), major in tumor treatment (92.8%). In terms of mechanism, targeted drugs were the most popular, accounting for 76.6%, and programmed cell death-1 (PD-1) and epithelial growth factor receptor (EGFR) were the most common targets. In addition, there were 19 anticancer drugs from 17 companies approved in China in 2019, with 10 drugs from domestic companies. Lung cancer and breast cancer are the most common indications for both registered trials and marketed drugs. No statistically significant differences were found between 2020 and 2019 in terms of the distribution of trial sponsor, scope and stage, as well as the distribution of drug type, effect and mechanism ( P>0.05). Conclusions:During the Covid-19 epidemic period, clinical trials of oncology drugs in China progress smoothly and maintain a high growth rate. Series of innovative products obtained by domestic enterprises in 2020 is the main driving force of development of oncology drug clinical trials in China.

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