1.Analysis of the effect of different doses of sufentanil in pediatric tonsil adenoidectomy
Chengsheng DING ; Rong LIU ; Changsheng YE
The Journal of Practical Medicine 2025;41(17):2734-2739
Objective To analyze the effect of different doses of sufentanil in pediatric tonsil adenoidectomy(referred to as tonsil surgery).Methods 111 cases of children who underwent pediatric squamous gland surgery were selected,and the cases were included from January 2023 to October 2024,and the collection site was Ganzhou Maternal and Child Health Hospital,the selected children were divided into the group A,B,and C by randomized numerical table method,each with 37 cases.0.25 μg/kg of sufentanil was given to group A,0.30 μg/kg of sufentanil was given to group B,0.35 μg/kg of sufentanil was given to group C.The perioperative times,the pain and agitation conditions in the early postoperative period(Within 30 min after extubation),the hemodynamics before the induction of anesthesia(T0),the immediate moment of endotracheal intubation(T1),the immediate start of the surgery(T2),and hemodynamics at extubation(T3),the adverse effects during observation and the parental satisfaction at discharge of the three groups were compared.Results The times of extubation,autonomic respiration recovery,awakening and anesthesia recovery room stay were shorter in the group A,B than in the group C(P<0.05).Early postoperative period,the scores of face legs activity crying consolability(FLACC)and pediatric anesthesia agitation during awakening(PAED)were lower in the groups B,C than in the group A(P<0.05);and the incidence of pain and agitation in the groups B,C(5.41%,8.11%;2.70%,5.41%)was lower than in the group A(40.54%,45.95%)(P<0.05).Compared with that at T0,the mean arterial pressure(MAP) and heart rate(HR)at T1,T2,and T3 were elevated in the group A(P<0.05);MAP and HR at T1,T2 and T3 were lower in the groups B,C than in the group A(P<0.05).During the observation period,the incidence of choking and coughing in the groups B,C(16.22%,13.51%)was lower than that in the group A(51.35%)(P<0.05);the incidence of nausea and vomiting and drowsiness in the groups A,B(2.70%,16.22%;5.41%,18.92%)was lower than that in the group C(24.32%,62.16%)(P<0.05).At the time of discharge,the parental satisfaction score in the group B was(9.12±0.25),which was higher than that in the groups A and C[(7.91±0.33),(7.93±0.41)](P<0.05).Conclusions The application of 0.30 μg/kg sufentanil in pediatric squamous gland surgery is more effective,which could shorten the time of each perioperative period,maintain hemodynamic stability,reduce the occurrence of postoperative pain,agitation,choking,nausea and vomiting,and somnolence,and improve the safety,as well as enhance the parental satisfaction of the children.
2.Analysis of the effect of different doses of sufentanil in pediatric tonsil adenoidectomy
Chengsheng DING ; Rong LIU ; Changsheng YE
The Journal of Practical Medicine 2025;41(17):2734-2739
Objective To analyze the effect of different doses of sufentanil in pediatric tonsil adenoidectomy(referred to as tonsil surgery).Methods 111 cases of children who underwent pediatric squamous gland surgery were selected,and the cases were included from January 2023 to October 2024,and the collection site was Ganzhou Maternal and Child Health Hospital,the selected children were divided into the group A,B,and C by randomized numerical table method,each with 37 cases.0.25 μg/kg of sufentanil was given to group A,0.30 μg/kg of sufentanil was given to group B,0.35 μg/kg of sufentanil was given to group C.The perioperative times,the pain and agitation conditions in the early postoperative period(Within 30 min after extubation),the hemodynamics before the induction of anesthesia(T0),the immediate moment of endotracheal intubation(T1),the immediate start of the surgery(T2),and hemodynamics at extubation(T3),the adverse effects during observation and the parental satisfaction at discharge of the three groups were compared.Results The times of extubation,autonomic respiration recovery,awakening and anesthesia recovery room stay were shorter in the group A,B than in the group C(P<0.05).Early postoperative period,the scores of face legs activity crying consolability(FLACC)and pediatric anesthesia agitation during awakening(PAED)were lower in the groups B,C than in the group A(P<0.05);and the incidence of pain and agitation in the groups B,C(5.41%,8.11%;2.70%,5.41%)was lower than in the group A(40.54%,45.95%)(P<0.05).Compared with that at T0,the mean arterial pressure(MAP) and heart rate(HR)at T1,T2,and T3 were elevated in the group A(P<0.05);MAP and HR at T1,T2 and T3 were lower in the groups B,C than in the group A(P<0.05).During the observation period,the incidence of choking and coughing in the groups B,C(16.22%,13.51%)was lower than that in the group A(51.35%)(P<0.05);the incidence of nausea and vomiting and drowsiness in the groups A,B(2.70%,16.22%;5.41%,18.92%)was lower than that in the group C(24.32%,62.16%)(P<0.05).At the time of discharge,the parental satisfaction score in the group B was(9.12±0.25),which was higher than that in the groups A and C[(7.91±0.33),(7.93±0.41)](P<0.05).Conclusions The application of 0.30 μg/kg sufentanil in pediatric squamous gland surgery is more effective,which could shorten the time of each perioperative period,maintain hemodynamic stability,reduce the occurrence of postoperative pain,agitation,choking,nausea and vomiting,and somnolence,and improve the safety,as well as enhance the parental satisfaction of the children.
3.Efficacy,metabolic characteristics,safety and immunogenicity of AK-HER2 compared with reference trastuzumab in patients with metastatic HER2-positive breast cancer:a multicenter,randomized,double-blind phase Ⅲ equivalence trial
Yang LUO ; Tao SUN ; Zhimin SHAO ; Jiuwei CUI ; Yueyin PAN ; Qingyuan ZHANG ; Ying CHENG ; Huiping LI ; Yan YANG ; Changsheng YE ; Guohua YU ; Jingfen WANG ; Yunjiang LIU ; Xinlan LIU ; Yuhong ZHOU ; Yuju BAI ; Yuanting GU ; Xiaojia WANG ; Binghe XU ; Lihua SONG
China Oncology 2024;34(2):161-175
Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.
4.Progress of transcriptomics and proteomics in triple-negative breast cancer prognosis assessment
Pingmei HUANG ; Xiaolei HU ; Changsheng YE
Chinese Journal of Clinical Oncology 2019;46(16):865-868
s Triple-negative breast cancer (TNBC), a heterogeneous tumor that lacks the expression of estrogen receptor (ER), proges-terone receptor (PR), and human epidermal growth factor receptor 2 (HER2), is more aggressive and tends to recur or metastasize. In contrast to other breast cancer subtypes, no approved endocrine or targeted treatments exist for TNBC. Therefore, identification of the prognosis characteristisics and potential therapeutic targets of TNBC could facilitate early personalized treatment. Owing to the rapid development of various technologies, researchers are increasingly focusing on the integration of "big data" and biological sys-tems, which is referred to "omics," as means of resolving it . Here, we review the recent progress in transcriptomics and proteomics re-search on TNBC.
5.Inhibition effect of curcumin on proliferation and invasion of breast cancer cell by decreasing expression of MT1-MMP
Junqing YU ; Guangyu YAO ; Xiaolei HU ; Lujia CHEN ; Changsheng YE
The Journal of Practical Medicine 2017;33(9):1394-1396
Objective To investigate whether MT1-MMP is involved in the inhibition effect of curcumin on the proliferation and invasion of breast cancer cell and the mechanism . Methods Firstly, MCF-7 cell lines transfected by MT1-MMP eukaryotic expression vector was established. We divided all cells into 3 groups,including null vector transfection group, non-transfected and transfected group with different concentrations of curcumin. The expression of MT1-MMP protein, the proliferation and invasion ability were respectively analyzed by western blot, transwell method, and cell counting kit-8 (CCK-8). Results The expression of MT1-MMP was inhibited by curcumin. Transwell and CCK-8 experiment indicated the proliferation and invasion abilities of MT1-MMP transfected MCF-7 cells were inhibited by curcumin in a concentration dependent manner. Conclusion The inhibition value of curcumin on proliferation and invasion is probably due to its ability to inhibit the expression of MT1-MMP.
6.Expression pattern of membrane type-1 matrix metalloproteinase in primary breast carcinomas.
Guangyu YAO ; Lujia CHEN ; Xiaolei HU ; Wenji LI ; Changsheng YE
Journal of Southern Medical University 2016;36(1):94-97
OBJECTIVETo examine the expression pattern of membrane type-1 matrix metalloproteinase (MT1-MMP) in breast carcinomas.
METHODSForty-three breast cancer tissues were collected and examined for MT1-MMP protein and mRNA expressions using immunohistochemistry, semi-quantitative RT-PCR and in situ hybridization.
RESULTSImmunohistochemistry of the breast cancer specimens showed MT1-MMP immunoreactivity on the cancer cell membrane. MT1-MMP mRNA was located in the stromal cells surrounding the breast cancer nest as shown by in situ hybridization. MT1-MMP mRNA expression was detected in all of the carcinomas, but its level was significantly lower in immunohistochemically negative specimens than in positive ones (0.547=0.0886 vs 0.759=0.0802, Plt;0.01).
CONCLUSIONMT1-MMP is very likely produced by stromal cells surrounding the breast cancer nest and anchored on the cell membrane after activation.
Breast Neoplasms ; genetics ; metabolism ; Female ; Humans ; Immunohistochemistry ; In Situ Hybridization ; Matrix Metalloproteinase 14 ; genetics ; metabolism ; RNA, Messenger ; genetics ; metabolism ; Tumor Cells, Cultured
7.The intervention studies of merely elevated serum tumor markers in advanced breast cancer ;posttreatment
Yahong CAI ; Guangyu YAO ; Lujia CHEN ; Xiaolei HU ; Changsheng YE
The Journal of Practical Medicine 2016;32(12):1975-1979
Objective To evaluate the clinical value of early intervention of second-line treatment for advanced breast cancer patients who experienced elevated tumor marker without any evidence for progress on imaging after effective first-line treatment. Methods We recruited 42 metastatic breast cancer patients experiencing elevated tumor marker (CEA or CA-153) meanwhile, who had merely increased tumor markers again in regular review after effective first-line treatment. Patients were divided into two groups: 20 patients in treatment group were given second-line treatment (palliative chemotherapy); 22 patients in observation group insisted on regular follow-up without any changing of treatment strategy. We mainly evaluated PFSmarker , which was defined as the time between tumor markers increase and disease progression. Results CEA and CA-153 in patients with advanced breast cancer showed a tendency to decrease after first-line chemotherapy , which can be reduced again by second-line treatment while increased in regular review , and the observation group continued to rise until disease progressed. The PFSmarker in treatment group was 13.65 (6 ~ 24) months while that of the observation group was 8.18 (3 ~ 15) months. The difference of PFS between these two groups was statistically significant (P < 0.05) and the median time to disease progression in treatment group was significantly longer than that in observation group. Conclusions Early intervention of second-line treatment for advanced breast cancer patients who only experienced elevated tumor marker after effective first-line treatment could slow down disease progression and improve the quality of life.
8.Advances in studies on metabolic syndrome and breast cancer.
Li CAO ; Guangyu YAO ; Xiaolei HU ; Lujia CHEN ; Changsheng YE ; Email: YECHANGSHENG2015@126.COM.
Chinese Journal of Surgery 2015;53(12):966-969
Breast cancer is one of the most common malignancies in women. Over these years, the morbidity of metabolic syndrome (MS) has also been increasing in China, probably due to changes in economies and lifestyles. As a result, the association to between these two diseases has at tracted much attention. Results demonstrated the presence of MS was associated with breast cancer risk, and the risk became higher when more MS components were present compared to no components. Moreover, a specific association was indicated between MS and breast cancer recurrence and metastasis to some extent as well. Further, for breast cancer patients, being diagnosed with MS can increase the mortality and lead to poor prognosis. The mechanisms underlying the association is not clear yet, but several factors are speculated to be the possible causes, including the elevated level of insulin, insulin like growth factor-1, leptin and pro-inflammatory cytokines, the decreased level of adiponectin as well as the interaction between DBC1 and SIRT1. The prognosis of patients with breast cancer combined MS can be improved by means of changing diet habits, increasing physical activities and drug-intervention. Although the specific mechanisms underlying the association are still need to be elucidated, better understanding of the association must help us with new strategies for the prevention and treatment of breast cancer.
Adiponectin
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Breast Neoplasms
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Humans
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Insulin
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Metabolic Syndrome
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Prognosis
9.Incidence and risk factors of anemia in 400 patients with early breast cancer treated by chemotherapy
Gengxi CAI ; Qing LIU ; Guangyu YAO ; Lujia CHEN ; Changsheng YE
The Journal of Practical Medicine 2015;31(23):3898-3900
Objective To explore the incidence and predictive factors of anemia induced by chemothera-py in early breast cancer patients. Methods 400 early breast cancer patients treated by taxane-based regimens from 2009 to 2011 in our hospital were analyzed to obtain the incidence of anemia. Univariate analysis and multivariate logistic regression analysis were used to search for risk factors linked to the occurrence of anemia. Results Incidence of anemia was 72.2% in early breast cancer patients undergoing chemotherapy. The occur-rence of anemia was related to 5 risk factors: chemotherapy regiments, Hb at baseline < 135.0 g/L, age > 60 years old, BMI ≤ 25 kg/m2 and HBV antigen positive. Conclusion The anemia incidence during chemothera-py is high in early breast cancer patients. Such factors,as chemotherapy regiments, Hb at baseline, age, BMI and HBV antigen, should be taken into account in identifying high risk patients and prevent anemia.
10.Review on taxanes-induced peripheral neuropathy
Rui CHEN ; Guangyu YAO ; Lujia CHEN ; Xiaolei HU ; Changsheng YE
Chinese Journal of Biochemical Pharmaceutics 2015;37(4):185-188
As a tubulin stabilizer, taxanes are widely used in the treatment of breast cancer, ovarian cancer, non-small-cell lung cancer (NSCLC),and part of head and neck malignant tumors, and were confirmed to be significantly effective.However, taxanes-induced peripheral neuropathy(TIPN) still affects the quality of life and psychological status of patients to varying degrees, severe cases can lead to dose reduction, and even chemotherapy interruption.In this paper, we summarize the pathogenesis, risk factors, clinical assessment, the progress of prevention and treatment of TIPN, to provide the basis for the prediction and early prevention of TIPN in the clinical administration, thus we can improve patients’ quality of life while extending their survival.

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