1.Clinical efficacy of camrelizumab combined with apatinib versus camrelizumab combined with chemotherapy regimens as first-line treatment for advanced gastric cancer
Ran JU ; Qi MIAO ; Jun YANG ; Yonggui WANG ; Xiangning DONG
China Pharmacy 2025;36(18):2307-2311
OBJECTIVE To compare the clinical efficacy and safety of camrelizumab combined with apatinib versus camrelizumab combined with chemotherapy as first-line treatment for advanced gastric cancer. METHODS A prospective randomized controlled trial was conducted, enrolling 99 patients with advanced gastric cancer admitted to the Chuzhou First People’s Hospital from March 2022 to December 2024. Patients were randomly assigned using a random number table: 48 received camrelizumab plus chemotherapy (control group), and 51 received camrelizumab plus apatinib (observation group). Clinical efficacy, serum tumor marker[carcinoembryonic antigen(CEA),carbohydrate antigen(CA)724,CA199,CA242]levels, immune function indicators(CD3+,CD4+,CD8+,CD4+/CD8+) levels before and after treatment, and adverse drug reaction (ADR) during treatment were compared between the 2 groups. RESULTS A total of 2 patients in the observation group and 3 in the control group were lost to follow-up. The disease control rate and objective response rate in the observation group were 95.92% and 85.71%, respectively, both significantly higher than 80.00% and 55.56% in the control group (P<0.05). The median progression-free survival was 9.61 months in the observation group, significantly longer than 6.72 months in the control group (P=0.011). Before treatment, there was no statistically significant difference in the levels of serum tumor markers and immune function indicators between the 2 groups (P>0.05). After treatment, the levels of CEA, CA724, CA199 and CA242 in 2 groups were significantly lower than before treatment, while the levels of CD3⁺, CD4⁺ and CD4 ⁺/CD8 ⁺ were significantly higher than before treatment, with greater improvements in the observation group (all P<0.05). The overall incidences of ADR and severe ADR showed no statistically significant difference between the 2 groups (P>0.05). CONCLUSIONS Camrelizumab combined with apatinib as first-line therapy for advanced gastric cancer may offer advantages over camrelizumab plus chemotherapy in terms of clinical efficacy and immune function improvement of patients, with an acceptable safety profile.
2.Epidemiological Investigation of Dampness Syndrome Manifestations in the Population at Risk of Cerebrovascular Disease
Xiao-Jia NI ; Hai-Yan HUANG ; Qing SU ; Yao XU ; Ling-Ling LIU ; Zhuo-Ran KUANG ; Yi-Hang LI ; Yi-Kai ZHANG ; Miao-Miao MENG ; Yi-Xin GUO ; Xiao-Bo YANG ; Ye-Feng CAI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(3):531-539
Objective To make an epidemiological investigation on traditional Chinese medicine(TCM)dampness syndrome manifestations in the population at risk of cerebrovascular diseases in Guangdong area.Methods A cross-sectional study was conducted to analyze the clinical data related to the risk of cerebrovascular diseases in 330 Guangdong permanent residents.The diagnosis of dampness syndrome,quantitative scoring of dampness syndrome and rating of the risk of stroke were performed for the investigation of the distribution pattern of dampness syndrome and its influencing factors.Results(1)A total of 306(92.73%)study subjects were diagnosed as dampness syndrome.The percentage of dampness syndrome in the risk group was 93.82%(258/275),which was slightly higher than that of the healthy group(48/55,87.27%),but the difference was not statistically significant(χ2 = 2.91,P = 0.112).The quantitative score of dampness syndrome in the risk group was higher than that of the healthy group,and the difference was statistically significance(Z =-2.24,P = 0.025).(2)Among the study subjects at risk of cerebrovascular disease,evaluation time(χ2 = 26.11,P = 0.001),stroke risk grading(χ2= 8.85,P = 0.031),and history of stroke or transient ischemic attack(TIA)(χ2 = 9.28,P = 0.015)were the factors influencing the grading of dampness syndrome in the population at risk of cerebrovascular disease.Conclusion Dampness syndrome is the common TCM syndrome in the population of Guangdong area.The manifestations of dampness syndrome are more obvious in the population with risk factors of cerebrovascular disease,especially in the population at high risk of stroke,and in the population with a history of stroke or TIA.The assessment and intervention of dampness syndrome should be taken into account for future project of stroke prevention in Guangdong.
3.68 Ga-DOTATOC,a new diagnostic agent for localization of somatostatin receptor positive neuroendocrine tumors
Si-Miao ZHAO ; Chao-Yang CHEN ; Ran WEI ; Xuan-Ling ZHANG ; Ying ZHOU
The Chinese Journal of Clinical Pharmacology 2024;40(11):1654-1657
68Ga-DOTATOC injection is a radiopharmaceutical agent for positron emission tomography localization of somatostatin receptor positive neuroendocrine tumors(NETs)in adult and pediatric patients.68 Ga-DOTATOC binds to cells that express somatostatin receptors(SSTRs),including malignant neuroendocrine cells that overexpress SSTR2 receptor.Gallium-68 is a radionuclide used in positron emission tomography for tumor diagnosis.This paper introduces its the mechanism of action,pharmacokinetics,usage and dosage,clinical evaluation,safety and use in specific populations.
4.Impact of body mass index on postoperative complications of open pancreaticoduodenectomy
Yating ZHU ; Yiwei REN ; Zhiquan LIU ; Kunpeng LI ; Ran MIAO ; Xiangui HU ; Liu OUYANG
Chinese Journal of Pancreatology 2024;24(5):350-357
Objective:To investigate the impact of body mass index (BMI) on the postoperative complications of open pancreaticoduodenectomy (OPD).Methods:The preoperative, operative and postoperative data of 234 patients who underwent OPD in the Department of the Hepatobiliary and Pancreatic Surgery of First Affiliated Hospital affiliated to Naval Medical University from January 2015 to June 2016 were analyzed retrospectively. According to the Asian BMI standard, the patients were divided into three groups: underweight group (BMI<18.5 kg/m 2, n=32), normal weight group (18.5 kg/m 2≤BMI<23.0 kg/m 2, n=110) and overweight group (BMI≥23.0 kg/m 2, n=92). Normal weight group was compared with underweight group and overweight group, respectively, to analyze the relationship between BMI and intraoperative parameters and major postoperative complications of OPD. Results:The incidence of diabetes in underweight group was lower than that in normal weight group, and the proportion of ASA score 3 in underweight group was higher than that in normal weight group, and there were significantly statistical differences (both P value <0.05). There was no significant difference on the other variables between underweight group, normal weight group and overweight group. The operation time, intraoperative hemorrhage volume >800 ml and intraoperative blood transfusion rate were not statistically different between underweight group and normal weight group, but overweight group had obviously higher intraoperative blood transfusion rate than normal weight group and the difference was statistically significant ( P<0.05). Underweight group had more postoperative intraperitoneal hemorrhage and postoperative blood transfusion rate than normal weight group, and the readmission rate in underweight group was less than that in normal weight group; the incidence of clinically related-post operative pancreatic fistula, postoperative infection, gastrointestinal bleeding and delayed gastric emptying in overweight group were significantly higher than those in normal weight group, and there were significantly statistical differences (all P value <0.05). In underweight group, normal weight group and overweight group, the average length of hospital stay were 9.9 days, 11.3 days, 15 days, and the total hospitalization expenses were 63663.04 yuan, 66241.78 yuan and 80484.31 yuan, respectively. Conclusions:Compared to normal weight patients, the difficulty of OPD in underweight patients does not increase, while the difficulty of OPD in overweight patients increases. Underweight and overweight could both increase the postoperative complications of OPD to some extent.
5.Study on the Characteristics of Gut Flora Related to Dampness Syndrome in Population at Risk of Cerebrovascular Disease and Their Influencing Factors
Hai-Yan HUANG ; Zhuo-Ran KUANG ; Xiao-Jia NI ; Qing SU ; Miao-Miao MENG ; Xiao-Bo YANG ; Ye-Feng CAI
Journal of Guangzhou University of Traditional Chinese Medicine 2024;41(10):2636-2647
Objective To investigate the characteristics of gut flora related to dampness syndrome in the population at risk of cerebrovascular disease and to explore their influencing factors.Methods Based on the results of epidemiological investigation of damp syndrome in at-risk population of cerebrovascular disease in Guangdong from October 2021 to February 2023,60 subjects(including 41 at-risk cases of cerebrovascular disease and 19 healthy controls)were included in the study.The identification of dampness syndrome and the risk rating of stroke were carried out for the subjects,and fecal samples were collected.High-throughput 16S rRNA sequencing technology and bioinformatics methods were used to analyze the characteristics of gut flora.Results(1)A total of 53 cases(88.33%)were identified as dampness syndrome.There was significant difference in the quantitative score of dampness syndrome between the risk group and the healthy group,and between the low-,medium-and high-risk groups(P=0.016;P=0.041).(2)There was no statistical difference in the species and abundance of gut flora between the dampness syndrome group and the non-dampness syndrome group.(3)In the population identified as dampness syndrome,there was no significant difference in Alpha diversity between the healthy group and the risk group,but there was significant difference in Beta diversity analysis;LEfSe analysis found that Fusobacterium and Lactobacillus were enriched in the risk group;correlation analysis showed that the differential bacteria were related to the three risk factors of diabetes,dyslipidemia and obesity and carotid intima-media thickness(IMT).(4)In the population identified as dampness syndrome and having the risk of cerebrovascular disease,there was no significant difference in Alpha diversity among three groups with different levels of risks,while significant difference in Beta diversity was observed;LEfSe analysis showed that Acidaminococcaceae,Phascolarctobacterium and Butyricimonas were enriched in the low-risk group,Veillonellaceae was enriched in the medium-risk group,and Ruminococcus 2 and Alloprevotella were enriched in the high-risk group;correlation analysis showed that the differential bacteria were associated with high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),white blood cell count(WBC),and neutrophil count(NEUT).Conclusion In the Guangdong population predominated by dampness syndrome,the severity of dampness syndrome is related to the risk of stroke,and the specific flora associated with sub-clinical atherosclerosis,inflammatory response and lipid metabolism are presented.
6.Evaluation of life cycle management system on patients'prognosis after transcatheter aortic valve replacement
Ruo-Yun LIU ; Ran LIU ; Mei-Fang DAI ; Yue-Miao JIAO ; Yang LI ; San-Shuai CHANG ; Ye XU ; Zhi-Nan LU ; Li ZHAO ; Cheng-Qian YIN ; Guang-Yuan SONG
Chinese Journal of Interventional Cardiology 2024;32(6):311-316
Objective With the widespread of transcatheter aortic valve replacement(TAVR)in patients with severe symptomatic aortic stenosis(AS),the life-cycle management has become a major determinant of prognosis.Methods A total of 408 AS patients who underwent successfully TAVR from June 2021 to August 2023 were consecutively enrolled in Hospital Valve Intervention Center.Patients were assigned to the Usual Care(UC)group between June 2021 and October 2022,while patients were assigned to the Heart Multi-parameter Monitoring(HMM)group between November 2022 and August 2023.The primary endpoint was defined as composite endpoint within 6 months post-TAVR,including all-cause death,cardiovascular death,stroke/transient ischemic attack,conduction block,myocardial infarction,heart failure rehospitalization,and major bleeding events.Secondary endpoints were the time interval(in hours)from event occurrence to medical consultation or advice and patient satisfaction.Statistical analysis was performed using Kaplan-Meier and multivariable Cox proportional hazards models.Results The incidence of primary endpoint in HMM group was significantly lower than that in UC group(8.9%vs.17.7%,P=0.016),the driving event was the rate of diagnosis and recognition of conduction block.The average time intervals from event occurrence to receiving medical advice were 3.02 h in HHM group vs.97.09 h in UC group(P<0.001).Using cardiac monitoring devices and smart healthcare platforms provided significant improving in patients long-term management(HR 0.439,95%CI 0.244-0.790,P=0.006).Conclusions The utilization of cardiac monitoring devices and smart healthcare platforms effectively alerted clinical events and improved postoperative quality of life during long-term management post TAVR.
7.Clinical Efficacy and Safety of Ixazomib-Containing Regimens in the Treatment of Patients with Multiple Myeloma
Ran CHEN ; Lian-Guo XUE ; Hang ZHOU ; Tao JIA ; Zhi-Mei CAI ; Yuan-Xin ZHU ; Lei MIAO ; Ji-Feng WEI ; Li-Dong ZHAO ; Jian-Ping MAO
Journal of Experimental Hematology 2024;32(2):483-492
Objective:To investigate the clinical efficacy and safety of ixazomib-containing regimens in the treatment of patients with multiple myeloma(MM).Methods:A retrospective analysis was performed on the clinical efficacy and adverse reactions of 32 MM patients treated with a combined regimen containing ixazomib in the Hematology Department of the First People's Hospital of Lianyungang from January 2020 to February 2022.Among the 32 patients,15 patients were relapsed and refractory multiple myeloma(R/RMM)(R/RMM group),17 patients who responded to bortezomib induction therapy but converted to ixazomib-containing regimen due to adverse events(AE)or other reasons(conversion treatment group).The treatment included IPD regimen(ixazomib+pomalidomide+dexamethasone),IRD regimen(ixazomib+lenalidomide+dexamethasone),ICD regimen(ixazomib+cyclophosphamide+dexamethasone),ID regimen(ixazomib+dexamethasone).Results:Of 15 R/RMM patients,overall response rate(ORR)was 53.3%(8/15),among them,1 achieved complete response(CR),2 achieved very good partial response(VGPR)and 5 achieved partial response(PR).The ORR of the IPD,IRD,ICD and ID regimen group were 100%(3/3),42.9%(3/7),33.3%(1/3),50%(1/2),respectively,there was no statistically significant difference in ORR between four groups(x2=3.375,P=0.452).The ORR of patients was 50%after first-line therapy,42.9%after second line therapy,60%after third line therapy or more,with no statistically significant difference among them(x2=2.164,P=0.730).In conversion treatment group,ORR was 88.2%(15/17),among them,6 patients achieved CR,5 patients achieved VGPR and 4 patients achieved PR.There was no statistically significant difference in ORR between the IPD(100%,3/3),IRD(100%,6/6),ICD(100%,3/3)and ID(60%,3/5)regimen groups(x2=3.737,P=0.184).The median progression-free survival(PFS)time of R/RMM patients was 9 months(95%CI:6.6-11.4 months),the median overall survival(OS)time was 18 months(95%CI:11.8-24.4 months).The median PFS time of conversion treatment group was 15 months(95%CI:7.3-22.7 months),the median OS time not reached.A total of 10 patients suffered grade 3-4 adverse event(AE).The common hematological toxicities were leukocytopenia,anemia,thrombocytopenia.The common non-hematological toxicities were gastrointestinal symptoms(diarrhea,nausea and vomit),peripheral neuropathy,fatigue and infections.Grade 1-2 peripheral neurotoxicity occurred in 7 patients.Conclusion:The ixazomib-based chemotherapy regimens are safe and effective in R/RMM therapy,particularly for conversion patients who are effective for bortezomib therapy.The AE was manageable and safe.
8.Research Progress of Traditional Chinese Medicine Compound in Prevention and Treatment of Type 2 Diabetes Based on Cell Signaling Pathway
Chuan PENG ; Siyan RAN ; Miao HE ; Zhengtao CHEN ; Yuli HU ; Mei LI ; Lili WU ; Lingling QIN ; Tonghua LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(6):1497-1504
As a chronic metabolic disease,type 2 diabetes poses a significant threat to human health with increasing incidence.An increasing number of studies confirm that the pathogenesis of diabetes is closely related with alterations in multiple cellular signaling pathways.Although numerous studies have reported that traditional Chinese medicine compounds prevent diabetes by modulating cell signaling pathways,asystematic review of the mechanism of action of traditional Chinese medicine compounds in modulating cell signaling pathways is still lacking.Therefore,this paper summarizes the research of type 2 diabetes prevention and treatment,which was found mainly related to the signaling pathways such as PI3K/AKT,AMPK,MAPK,NF-κB,PPAR,TGF-β.This family of signaling pathways can treat type 2 diabetes by inhibiting pancreatic islet cell apoptosis,protecting pancreatic β-cell function,ameliorating insulin resistance,inhibiting hepatic gluconeogenesis,promoting glycogen synthesis,attenuating inflammation,and resisting oxidative stress.At the same time,we analyze the problems in current research and the future development trend,in order to provide a scientific theoretical basis for the drug development and clinical application of traditional Chinese medicine compound in the prevention and treatment of diabetes.
9.Trends of Incidence and Age Characteristics of Gastric Cancer in Cancer Registration Areas of Jiangsu Province from 2009 to 2019
Yubao QIU ; Lei YU ; Lei CHEN ; Jinyi ZHOU ; Ran TAO ; Renqiang HAN ; Bijia JIANG ; Weigang MIAO
China Cancer 2024;33(12):961-969
[Purpose]To analyze the trend of gastric cancer incidence and age characteristics in Jiangsu cancer registration areas from 2009 to 2019.[Methods]Cancer registration data from 2009 to 2019 meeting quality control requirements were collected from 16 cancer registries in Jiangsu Province.The crude incidence rate and age-standardized incidence rate by Chinese standard population in 2000(ASIRC)were calculated by gender,urban/rural areas and age groups.The inci-dence trends were analyzed by Joinpoint.A birth cohort model was constructed to calculate the in-cidence rate of gastric cancer for men and women born between 1929 and 2019.The age composi-tion of gastric cancer incidence in Jiangsu Province between 2009 and 2019 was calculated and compared.[Results]The crude incidence rate and ASIRC of gastric cancer in Jiangsu cancer regi-stration areas from 2009 to 2019 showed a significant decreasing trend in both male and female or urban and rural areas,in which the decrease in male(AAPC=-1.28%,P<0.001)was higher than that of female(AAPC=-1.17%,P=0.030),and the decrease in urban(AAPC=-1.66%,P<0.001)was higher than that of rural(AAPC=-0.72%,P<0.001).The incidence rates of gastric cancer in age groups of 40~79 years old showed a significant decreasing trend from 2009 to 2019 with the AAPC ranging from-6.75%to-3.54%(all P<0.05).In age groups of 40~79 years old,the inci-dence rates of gastric cancer among people with different years of birth showed a decreasing trend with the increase of the birth year.For ASIRC,the composition of patients aged 60 years old above increased by 0.63%(95%CI:0.46%~0.81%)per year from 2009 to 2019.[Conclusion]The inci-dence rate of gastric cancer in cancer registration areas of Jiangsu Province from 2009 to 2019 showed a decreasing trend,the average age of incidence showed a trend of backward moving,and for age-standardized incidence the proportion of patients over 60 years old was increased.
10.Trends of Incidence and Age at Onset of Female Breast Cancer in Jiangsu Cancer Registration Areas from 2009 to 2019
Yingying HAN ; Bo CAI ; Ling LIN ; Jinyi ZHOU ; Ran TAO ; Weigang MIAO ; Renqiang HAN
China Cancer 2024;33(12):970-976
[Purpose]To investigate the trends of incidence and age at onset of female breast can-cer in Jiangsu cancer registration areas from 2009 to 2019.[Methods]The continuous monitoring data of female breast cancer from 2009 to 2019 were collected from 16 cancer registries in Jiangsu Province.All datasets were checked and evaluated based on data quality control criteria and were included in the analysis.Crude rate(CR),age-standardized incidence rate by Chinese standard population(ASIRC),the average annual percentage change(AAPC),crude and adjusted mean age at onset were calculated.Incidence rates stratified by regions and age groups were calculated.Age-period-cohort model was used to analyze the changes of cancer incidence and age-adjusted mean ages.[Results]The incidence CR of female breast cancer was significantly increased from 24.39/105 in 2009 to 46.72/105 in 2019 with an AAPC in CR of 6.97%(95%CI:5.26%~8.70%)and AAPC in ASIRC of 4.67%(95%CI:3.00%~6.37%).The crude mean age and adjusted mean age at onset increased from 54.10 and 52.89 years old in 2009 to 56.23 and 53.36 years old in 2019,respectively.Crude mean age at onset increased significantly over time in all registry areas(β=0.21,P<0.001),urban(β=0.1 8,P<0.001)and rural(β=0.25,P<0.001)areas,while adjusted mean age at onset remained stable in all registry areas(β=0.05,P=0.024)and rural areas(β=0.09,P=0.008).From 2009 to 2019,the incidence rate of female breast cancer of all age groups showed upward trends,with an average annual growth rate of 3.26%to 7.79%(all P<0.05),and the incidence rate in rural areas increased faster than that in urban areas.The age composition of breast cancer onset and standardized age composition of onset in women over 60 years old showed an upward trend(all P<0.05).[Conclusion]The incidence rate of female breast cancer in Jiangsu Province in-creased from 2009 to 2019,and the mean age of onset showed a backward trend.

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