1.Phase Ⅱ clinical trial of PD-1 inhibitor combined with chemotherapy for locally advanced resectable oral squamous cell carcinoma
Hongling WANG ; Kai YUE ; Yansheng WU ; Yuansheng DUAN ; Chao JING ; Xudong WANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(4):335-342
Objective:To explore the effectiveness and safety of programmed death 1(PD-1) inhibitory combined with chemotherapy as a neoadjuvant therapy for locally advanced resectable oral squamous cell carcinoma.Methods:This study was a randomized controlled phase Ⅱ trial. Patients recruited from Tianjin Medical University Cancer Institute and Hospital from July 2021 to February 2023 were randomly divided into two groups in a 1∶1 ratio: the experimental group (Toripalimab combined with albumin paclitaxel and cisplatin) and the control group (albumin paclitaxel and cisplatin); patients in both groups underwent three cycles of neoadjuvant therapy. After completion of neoadjuvant therapy, patients were evaluated and subsequent surgical treatment was performed. According to the completion of treatment, the analysis was conducted on both the full analysis set and the protocol set. The effectiveness and safety of treatments were evaluated. SPSS 20.0 software was used for statistical analysis.Results:A total of 41 cases with oral cancer were enrolled, including 26 males and 15 females, aged between 34 and 74 years old. There were 23 cases in the experimental group and 18 cases in the control group. A total of 23 cases completed neoadjuvant therapy and surgery according to the protocol. Experimental group and control group showed respectively the complete response rates of 1/19 and 0/17, the partial response rates of 13/19 and 8/17, the stage-down rates of 4/19 and 3/17, the pathologic complete response rate of 8/14 and 2/9, with no statistically significant differences in individual rates between two groups ( P>0.05). The major pathological response rate of 13/14 in experimental group was higher than that of 2/9 in control group ( P<0.05). The incidence of grade 3-4 adverse reactions related to treatment was low in both groups (4/23 vs. 3/18, χ 2=0.13, P=0.72), and the most common serious adverse reactions in the experimental group were granulocyte deficiency and electrolyte disorder. There were no adverse reactions that affected subsequent surgical treatment or caused death, and the safety and tolerability were good. The median follow-up time was 15 months, and the one-year disease-free survival rate of the experimental group was higher than that of control group (92.86% vs. 77.78%, χ 2=0.62, P=0.42), with a relative decrease of 87% in the risk of disease progression or death ( P=0.029). For patients with programmed death-ligand 1(PD-L1) protein expression combined positive score≥20, the experimental group showed higher major pathological response rate than control group (5/5 vs. 0/4, P=0.03). Conclusion:The neoadjuvant therapy of immunotherapy combined with chemotherapy can improve the pathological remission of oral squamous cell carcinoma and the long-term survival benefits and the prognosis of patients.
2.Clinical and genetic characteristics of four children with Kabuki syndrome due to de novo variants of KMT2D gene
Haizhen FAN ; Yanmei WANG ; Yunhong WU ; Lifang JIA ; Lihong WANG ; Yansheng SHEN
Chinese Journal of Medical Genetics 2024;41(5):546-550
Objective:To explore the clinical and genetic characteristics of four children with Kabuki syndrome (KS) due to variants of KMT2D gene. Methods:Four children with KS diagnosed at the Children′s Hospital of Shanxi Province between January 2020 and December 2022 were selected as the study subjects. Whole exome sequencing was carried out for the children and their family members. Candidate variants were verified by Sanger sequencing and pathogenicity analysis.Results:The KS phenotype scores for the four children were 7, 8, 6, and 6, respectively. Child 2 also presented with a rare solitary kidney malformation. Genetic testing revealed that all children had harbored novel de novo variants of the KMT2D gene, including c. 16472_16473del, c. 858dup, c. 11899C>T, and c. 12844C>T, respectively. Based on the guidelines from the American College of Medical Genetics and Genomics (ACMG), all of the variants were classified as pathogenic. Conclusion:For children showing phenotypes such as distinctive facial features, intellectual disability, developmental delay, cardiac abnormalities, and urinary system anomalies, KS should be considered. Early diagnosis and intervention can be achieved through genetic testing, especially in the presence of KMT2D gene mutations.
3.Early diagnosis of anastomotic leakage after anterior resection for rectal carcinoma
Yansheng ZHANG ; Pengjin SUN ; Zengqiang YANG ; Ming XU ; Weiqiang WU ; Feng GAO
Chinese Journal of General Surgery 2023;38(2):81-85
Objective:To search for valuable laboratory indexes of early diagnosis of anastomotic leakage after anterior resection for rectal carcinoma.Methods:From Sep 2017 to Jan 2019, 128 patients with colorectal cancer underwent anterior rectal resection at the Department of Colorectal & Anal Surgery, the 940 Hospital of the Joint Logistics Support Force.Results:Anastomotic leakage occurred in 16 of 128 patients (12.5%). Definite diagnosis of anastomotic leakage was made on between 2nd and 9th day, postopera tively averagign (6.13±2.00) days. Tumor location was a risk factor for anastomotic leakage with the incidence significantly lower when the distance from the lower edge of the tumor to the anal margin >7 cm than when the distance ≤7 cm ( χ 2=6.022, P=0.014). The percentage of increase in peripheral blood leukocytes, neutrophils, serum interleukin-6, C-reactive protein and procalcitonin in patients 3-5 days after surgery significantly related to the occurrence of anastomotic leakage (all P<0.05). The area under the working characteristic curve of the subjects with the percentage of C-reactive protein, procalcitonin, interleukin-6, leukocytes and neutrophils from the 3rd to the 5th day after operation was greater than 0.5. Conclusion:C-reactive protein, procalcitonin, interleukin-6, leukocyte and neutrophil percentage are risk factors predicting anastomotic leakage after anterior resection of rectal cancer.
4.A real-world study of low molecular weight heparin sodium in the treatment of severe and critical bite by Trimeresurus stejnegeri
Zhipeng ZHENG ; Yigang YU ; Yansheng WU ; Zeyuan ZHENG ; Qingbin LIN ; Meiling LIU ; Qingquan ZENG
Chinese Critical Care Medicine 2020;32(5):601-604
Objective:To investigate the clinical effect of low molecular weight heparin sodium combined with antivenin in the treatment of severe and critical bite by Trimeresurus stejnegeri.Methods:The clinical data of 48 patients with severe or critical bite by Trimeresurus stejnegeri admitted to emergency department of Southeast Hospital Affiliated to Xiamen University from March 2017 to May 2019 were retrospectively analyzed. On the basis of early treatment of antivenom serum, internal administration and external application of Jidesheng snake tablet, and wound incision and detoxification, the patients were divided into heparin treatment group and non-heparin treatment group according to whether the low molecular heparin sodium was used or not. The patients in the two groups were compared in terms of gender, age, clinical classification, swelling degree of injured limbs, change of coagulation function index, bleeding of skin, mucous membrane or digestive tract, blood transfusion, local symptoms of bite, length of hospital stay and prognosis.Results:There was no significant difference in terms of gender, age, clinical classification or swelling degree of injured limbs between the two groups. On the 3rd day of treatment, the platelet count (PLT) in the heparin treatment group was significantly higher than that in the non-heparin treatment group [×10 9/L: 210.0 (160.0, 252.0) vs. 136.0 (104.0, 198.5), P < 0.05]. However, there was no significant difference in the four coagulation test results between the two groups. On the 6th day of treatment, the plasma thrombin time (TT) in the heparin treatment group was significantly shorter than that on the 3rd day of treatment [s: 30.3 (20.4, 37.0) vs. 34.7 (24.0, 73.4), P < 0.05], and the fibrinogen (FIB) in the heparin treatment group was significantly higher than that in the non-heparin treatment group [g/L: 0.60 (0.31, 1.07) vs. 0.20 (0.14, 0.60), P < 0.01]. The incidence of bleeding in the heparin treatment group was significantly lower than that in the non-heparin treatment group [21.7% (5/23) vs. 64.0% (16/25), P < 0.01]; 11 patients in the heparin treatment group and 18 patients in the non-heparin treatment group received blood transfusion and prothrombin complex supplement respectively. There was no significant difference in the length of hospital stay between the heparin group and non-heparin treatment group (days: 6.91±1.92 vs. 7.48±2.27, P > 0.05). The patients in both groups were followed up for 1 week to 1 month after treatment, and no death or local necrosis of skin and soft tissue was found. Conclusions:For the patients with severe and critical bite by Trimeresurus stejnegeri, on the basis of injection of antivenom serum, internal administration and external application of Jidesheng snake tablet, and wound incision and detoxification, early application of low molecular weight heparin sodium anticoagulation and other comprehensive treatment is helpful to improve limb swelling and inflammation, reduce blood transfusion, promote the recovery of coagulation function, and shorten the length of hospitalization.
5.Diagnosis and prognosis of cervical lymph node metastases of squamous cell carcino-ma of unknown primary site
Mengqian ZHOU ; Lu ZHANG ; Yansheng WU ; Yuansheng DUAN ; Xudong WANG
Chinese Journal of Clinical Oncology 2019;46(7):346-350
Objective: To investigate the characteristics, diagnosis, primary detection, and prognosis of cervical lymph node metastases of squamous cell carcinoma of unknown primary site (SCCUP). Methods: This study retrospectively analyzed the clinical features and follow-up data of 262 patients with SCCUP. The Chi-square test were used to analyze the clinical performances, characteristics of pri-mary lesions, and sensitivity and specificity of examinations to identify original lesions. Factors related to the overall survival (OS) and progression-free survival (PFS) were also analyzed. Results: The 262 patients with SCCUP comprised more men, with a median age of 57 years. At the follow-up, 70 patients were diagnosed with primary lesions (26.7%), and the detection rates of primary lymph nodes in those who were male (30.1%), with a single lesion site (31%), and with levelⅣdisease (39.3%) were higher than those in patients who were female (17.4%), with multiple lesion sites (18.7%), and with levelⅡ/Ⅲdisease (20.8%). Compared with traditional imaging examinations, 18F-fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) had higher sensitivity and speci-ficity in detecting the primary tumor. Survival analysis showed that distant metastasis was an independent risk factor affecting OS and PFS, and the effect of N stage on PFS was statistically significant. Conclusions: In SCCUP patients, the proportion of patients who were male, with a single lesion site, and with cervicalⅣlymph node metastasis had higher rates of detection of the primary sites. PET/CT examination is important for the diagnosis of SCCUP, as well as the detection of primary lesions. Advanced N stage and distant metasta-sis indicated poor prognosis.
6.Quality assurance of computerized system for GLP laboratory
Hong LI ; Chunqi WU ; Gang HAN ; Yansheng DONG ; Qiaozhen GUO ; Jianjing WANG ; Shufang WAN ; Huazhi MA ; Quanjun WANG
Drug Evaluation Research 2017;40(4):433-436,491
In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.
7.Research progress of AIDS treatment
Yansheng YAN ; Pingping YAN ; Liang CHEN ; Shouli WU ; Meirong XIE ; Tingting WU ; Pincang XIA ; Yuefeng QIU
Chinese Journal of Zoonoses 2017;33(5):383-388
AIDS antiviral therapy (ART) has achieved great success.Originaly,AIDS had been regarded as a fatal disease,but it has become a kind of infectious disease that could be cured and administrated.Global HIV / AIDS cases were still up to about 38 million,but more than half have been effectively treated.In addition to drug treatment,at present,some new technologies and new methods,such as genome editing,have also been involved in the treatment of AIDS,and in the humanized animal experiment has shown very good results.There is no doubt that AIDS will eventually be stopped its epidemic.However,with the continuous development of AIDS antiviral treatment,the most fundamental problem is that HIV latent library has become increasingly prominent one,whether molecular therapy and hybrid cure have being developed for AIDS treatment,there are still such problem existence.Great efforts shoud be made to continuously search for new markers of latent viral cells and to reduce the latent pool.In addition,despite the prevention and treatment of AIDS has made great achievements,but the world still produces nearly 6000 cases of HIV/AIDS every day.Therefore,the development of safe and effective vaccine,whether in the field of prevention,or in clinical treatment,has its positive significance.
8.Role of syndromic surveillance program in the practice of early detection on disease outbreak.
Shenggen WU ; ; Yuwei WENG ; Wenjing YE ; Linglan WANG ; ; Yansheng YAN ; Rongtao HONG ; Jianming OU ; Wu CHEN ; Shaojian CAI
Chinese Journal of Epidemiology 2016;37(4):531-534
OBJECTIVEA Dengue outbreak was reported in Dongfen town Jianou county, Fujian province on September 19, 2014. The goal of this project was to explore the role of syndromic surveillance program in the practice of early detection on disease outbreak through the case mentioned above.
METHODSThe authors retrospectively collected data related to Outpatient log and Pharmacy drug use in Dongfen township hospital through the electronic information system of the hospital from August to November, 2014. All the abnormal events were recorded, according to related data on fever and drug use. Description of fever, syndromic characteristics, correlation and Linear regression analyses were conducted, using the surveillance data on fever syndrome and drug use from the pharmacy.
RESULTSA total of 1 102 cases with fever and 2 437 fever-related clinic visits were reported which showing an increased number of 19.6, 10.2 times respectively, when compared to the same period of the previous year in which men accounted for 45.3% (499/1 102) and female accounted for 54.7% (603/1 102). Age groups presented an atypical type " M" type. 5 and 10 year olds groups formed the largest proportion, accounted for 11.5% (127/1 102) of the total number os the patients. The correlation coefficient ranged from 0.85 to 0.97 (P<0.05). Data from the syndromic surveillance program showed an " outbreak" was occured in August 23, 2014.
CONCLUSIONSCompared to routine surveillance program, the syndromic surveillance program could detect the appearence of an outbreak, a month or even more earlier. The role of syndromic surveillance program needs to be further explored.
Data Collection ; Dengue ; diagnosis ; epidemiology ; prevention & control ; Disease Outbreaks ; prevention & control ; Drug Prescriptions ; statistics & numerical data ; Drug Utilization ; statistics & numerical data ; trends ; Early Diagnosis ; Female ; Fever ; etiology ; Health Information Systems ; Humans ; Male ; Pharmacy Service, Hospital ; Population Surveillance ; methods ; Retrospective Studies
9.Progress in self-renewal signal pathways of liver cancer stem cells and potential targets for therapy
Helei XU ; Chunqi WU ; Yansheng DONG ; Man LI ; Lihua XIE ; Quanjun WANG ; Xisha WANG
Chinese Journal of Pharmacology and Toxicology 2016;30(9):967-974
There is emerging evidence from clinical studies that the existence of liver cancer stem cells(CSCs)or tumor initiating cells is responsible for the high recurrence rates of tumor,generation of metastasis,and resistance to therapeutic regimens after therapy. Here,the characteristics of liver CSCs,clinical manifestation,molecular signaling Wnt/β-catenin,signal transducers and activators of transcription 3,NANOG,annexin A3/c-Jun N-terminal kinase,and chapter four-transmembrane 4 L six family member 5/CD44 in liver CSC self-renewal were briefly reviewed. In addition,potential targets for drug therapy were analyzed,providing some reference for drug discovery that selectively target liver CSC self-renewal signals.
10.Epidemiological investigation and follow-up study of different populations with indeterminate results of HIV antibody test in Fujian
Min GAO ; Shouli WU ; Pingping YAN ; Yansheng YAN
Chinese Journal of Microbiology and Immunology 2016;36(9):705-709
Objective To investigate the ratios and the distribution of subjects with indeterminate results of HIV antibody in different populations who were positive for HIV screening test in Fujian and to ana-lyze the features of Western blot bands for further understanding the relationships between the Western blot band patterns and HIV infection. Methods The subjects who were diagnosed with indeterminate results of HIV antibody at the first examination were re-tested with Western blot assay every month until the results turned into HIV antibody-positive or HIV antibody-negative. Results The detection rate of indeterminate results of HIV antibody was 3. 69% in Fujian in 2015. Higher rates were detected in blood donors, pregnant woman and other clinical patients. The most common band patterns of HIV antibody-indeterminate samples were p24, gp160+p24 and gp160. Results of the follow-up confirmatory tests showed that 76% of the sam-ples of p24 band pattern were HIV antibody-negative and 76. 47% of the samples of gp160+p24 band pattern were HIV antibody-positive. The nucleic acid test showed that positive results were detected in 29 samples whose band patterns were gp160+gp120+p24,gp160+gp120+p66andgp160+gp120+p31. Conclusion The detection rates of indeterminate results of HIV antibody varied in different populations. The most com-mon band patterns of HIV antibody-indeterminate samples were p24, gp160+p24 and gp160. The more bands the samples presented themselves in Western blot assay, the more likely they would be HIV antibody-positive. Follow-up should be strengthened to prevent the spread of HIV infection. Samples with the band pattern of gp160+gp120+p24 showed a low probability of false positive and they were more likely to be end-stage AIDS with immunosuppression.

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