1.Efficacy of high-flow nasal cannula oxygen therapy for respiratory support after tracheal extubation under general anesthesia in neonates
Menglin SUN ; Jianwei GE ; Bo YANG ; Bo LIU ; Guangchao ZHU ; Tao WANG ; Yuxia WANG ; Changsheng LI ; Lihua JIANG
Chinese Journal of Anesthesiology 2024;44(10):1217-1220
Objective:To assess the efficacy of high-flow nasal cannula oxygen therapy for the respiratory support after tracheal extubation under general anesthesia in neonates.Methods:This was a prospective randomized controlled study. Ninety-four neonates undergoing general surgery under general anesthesia with endotracheal intubation and endotracheal tube removal following surgery from December 2022 to November 2023 in the Third Affiliated Hospital of Zhengzhou University were selected and divided into 2 groups ( n=47 each) by the random number table method: conventional oxygen therapy group (group C) and high-flow nasal cannula oxygen therapy group (group H). After the endotracheal tube was removed, group H underwent high-flow nasal cannula oxygen therapy: oxygen flow was 2 L·kg -1·min -1, the concentration and humidity of oxygen were both 100%, and the temperature was 37 ℃. Group C underwent conventional mask ventilation with the oxygen flow rate 5 L/min, oxygen concentration 100%, ventilation frequency about 25-35 times/min. The outcome measures were recorded from the time after extubation to the time before discharge from the operating theatre. The main outcome measures were the minimum SpO 2 and hypoxemia (SpO 2<90%), choking, laryngospasm and asphyxia. The secondary outcome measures were respiratory rate (immediate extubation, immediate discharge), minimum HR, and time to discharge from the operating theatre. Results:Compared with group C, the lowest SpO 2 was significantly increased, the incidence of hypoxemia and respiratory rate immediately after discharge from the operating room was decreased ( P<0.05), and no significant changes were found in the incidence of choking, laryngospasm and asphyxia, the lowest heart rate, respiratory rate immediately after tracheal extubation and time to discharge from the operating theatre in group H( P>0.05). Conclusions:High-flow nasal cannula oxygen therapy can improve oxygenation and significantly reduce the risk of hypoxemia when used for the respiratory support after tracheal extubation under general anesthesia in neonates.
2.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.
3.Bibliometrics Analysis of Studies on Hypertrophic Cardiomyopathy From 2018 to 2022
Tao LU ; Zhengyang LU ; Yanhai MENG ; Changsheng ZHU ; Zining WU ; Shuiyun WANG
Acta Academiae Medicinae Sinicae 2024;46(3):377-383
Objective To analyze the research progress and hot topics in hypertrophic cardiomyopathy from 2018 to 2022.Methods The publications in the field of hypertrophic cardiomyopathy from January 1,2018 to December 31,2022 were retrieved from Web of Science core collection database and included for a bibliomet-ric analysis.Results A total of 6355 publications were included,with an average citation frequency of 7 times.The year 2021 witnessed the most publications(1406).The analysis with VOSviewer showed that the re-search on sudden death related to hypertrophic cardiomyopathy,especially the predictive value of late gadolini-um-enhanced cardiac MRI in sudden death,was a hot topic.In addition,gene detection and the new drug mava-camten became hot research topics.The United States was the country with the largest number of publications and the highest citation frequency in this field.Chinese scholars produced the second largest number of publications,which,however,included few high-quality research results.Conclusions Risk stratification and prevention of sudden death is still an important and hot research content in the field of hypertrophic cardiomyopathy.Chinese scholars should carry out multi-center cooperation in the future to improve the research results.
4.The effects of a half palm ankle-foot orthosis and a hollow-heel ankle-foot orthosis on the gait of stroke survivors
Zhe MENG ; Zhiping LIAO ; Fangchao WU ; Yang YU ; Changsheng LI ; Jingyan TAO
Chinese Journal of Physical Medicine and Rehabilitation 2022;44(10):902-906
Objective:To observe any effect of a half palm ankle-foot orthosis and a hollow-heel ankle-foot orthosis on the gait of stroke survivors.Methods:The walking of twenty-five stroke survivors was quantified using a gait analysis system. They walked barefoot, wearing a half palm ankle-foot orthosis and wearing a hollow-heel ankle-foot orthosis. Walking speed, step frequency, duration of the swing phase on the healthy and affected sides, risk of falling and Timed Up and Go (TUG) test times were recorded and analyzed.Results:The average gait frequency when wearing the hollow-heel ankle-foot orthosis was significantly faster than that in the other two conditions. The gait asymmetry coefficient was significantly different when the subjects wore the hollow-heel ankle-foot orthosis compared with walking barefoot. Compared with being barefoot, the average TUG time was significantly shorter when wearing either orthosis and the risk of falling was significantly less. The fall risk was significantly lower when wearing the hollow-heel orthosis compared to the half palm orthosis.Conclusion:Wearing either ankle-foot orthosis can significantly correct the gait of stroke survivors and lower their risk of falling, with better effect when wearing the hollow-heel ankle-foot orthosis.
5.Optimized strategy of anesthesia for modified radical mastectomy for breast cancer: single-injection thoracic paravertebral block with multiple adjuvants combined with general anesthesia
Zhijia ZHAO ; Jia LIU ; Changsheng MA ; Tao YANG ; Xiaoming DENG
Chinese Journal of Anesthesiology 2021;41(1):63-66
Objective:To evaluate the optimized efficacy of single-injection thoracic paravertebral block (TPVB) with multiple adjuvant drugs combined with general anesthesia for modified radical mastectomy (MRM) for breast cancer.Methods:Sixty American Society of Anesthesiologists physical statusⅠ or Ⅱ patients, aged 20-60 yr, with body mass index<30 kg/m 2, scheduled for elective primary modified radical mastectomy for breast cancer under general anesthesia, were divided into 2 groups ( n=30 each) using a random number table method: single-injection TPVB with multiple adjuvants group (group PV-SI) and continuous infusion via TPVB group (group PV-CI). In group PV-SI, single-injection TPVB was performed with 0.25% ropivacaine 25 ml, dexamethasone 3 mg, buprenorphine 120 μg, and adrenaline 2.5 μg/ml, and general anesthesia was performed after induction of anesthesia.In group PV-CI, the mixture of 0.25% ropivacaine 25 ml and epinephrine 2.5 μg/ml was injected after induction of anesthesia, and then 0.125% ropivacaine 8 ml/h was continuously infused via TPVB until 48 h after operation.At the end of operation, a patient-controlled intravenous analgesic pump was connected and programmed to deliver a bolus dose of morphine 2 mg with a lockout interval of 10 min and no loading dose and background infusion.The duration of postoperative analgesia, total consumption of morphine within 48 h after operation, occurrence of nausea and vomiting, and patient′s recommendation and satisfaction were recorded. Results:There was no significant difference in the duration of postoperative analgesia, total consumption of morphine within 48 h after operation, incidence of nausea and vomiting, and rates of patient′s recommendation and satisfaction between PV-SI group and PV-CI group ( P>0.05). Conclusion:Single-injection TPVB with multiple adjuvants combined with general anesthesia can be used as an optimized strategy to improve the postoperative analgesia in the patients undergoing MRM for breast cancer.
6.Silence of cytoskeleton-associated protein 2 represses cell proliferation and migration and promotes apoptosis in liver cancer cell lines.
Changsheng ZHANG ; Xuezhen ZHANG ; Zongming HAN ; Hongbo ZHU ; Tao WAN
Journal of Central South University(Medical Sciences) 2020;45(4):365-371
OBJECTIVES:
To investigate the roles of cytoskeleton-associated protein 2 (CKAP2) in proliferation, apoptosis, and migration in liver cancer cells and the potential mechanisms.
METHODS:
Human normal hepatocyte L02 and liver cancer cell lines HepG2, Huh7, and SMMC-7721 were cultured. The CKAP2 expression was detected by real-time PCR and Western blotting. HepG2 cells were randomly divided into a control group, a negative control (NC) group, and a CKAP2 silencing (siCKAP2) group. CCK-8 and BrdU assays were used to evaluate cell viability and proliferation, respectively. Transwell assay was employed to determine cell migration and invasion. The protein levels of cleaved-caspase 3, Bax, E-cadherin, N-cadherin, Vimentin, phosphorylated Janus kinase 2 (p-JAK2), and phosphorylated signal transducer and activator of transcription 3 (p-STAT3) were determined by Western blotting.
RESULTS:
Compared with normal hepatocyte L02, CKAP2 was highly expressed in liver cancer cell lines HepG2, Huh7, and SMMC-7721 (all <0.05). Compared with the NC group, cell viability and proliferation rate of the siCKAP2 group were decreased (both <0.05). The apoptotic rate, protein expression of cleaved-caspase 3 and Bax in the siCKAP2 group were significantly higher than those in the NC group (all <0.05). Compared with the NC group, cell migration and invasion rates of the siCKAP2 group were significantly attenuated (both <0.05). Compared with the NC group, E-cadherin protein expression in siCKAP2 group was increased, while protein expression levels of Vimentin, N-cadherin, p-JAK2, and p-STAT3 were decreased (all <0.05).
CONCLUSIONS
CKAP2 gene silence inhibits proliferation, migration, and invasion, and promotes apoptosis in liver cancer cells, while JAK2/STAT3 signaling pathway may be involved in these processes.
Apoptosis
;
Cell Line, Tumor
;
Cell Movement
;
Cell Proliferation
;
Cytoskeleton
;
Humans
;
Liver Neoplasms
;
genetics
7. Clinical analysis of 2019 coronavirus disease (COVID-19) on one case with living-related kidney transplantation
Xia LU ; Changsheng MING ; Zhixiang WEN ; Liru QIU ; Shuyun XU ; Tao CHEN ; Qin NING ; Xiaoping LUO ; Zhishui CHEN ; Nianqiao GONG
Chinese Journal of Organ Transplantation 2020;41(0):E006-E006
Objective:
To analyze the clinical characteristics of one living-related kidney transplant recipient infected with 2019 coronavirus disease (COVID-19) .
Method:
The clinical diagnosis and treatment of one relative renal transplant recipient after the occurrence of COVID-19 were analyzed retrospectively, including the course of onset, clinical manifestations, blood routine test, renal function, lung CT scan, nucleic acid detection, outpatient and inpatient therapies and outcomes.
Result:
The case was diagnosed as COVID-19 (severe type) with influenza A virus infection. The clinical symptoms were gradually relieved and the lung lesions were absorbed through the treatment of reduce and stop taking immunosuppressant, antiviral therapy of abidol/oseltamivir, prevention of bacterial infection, hormone anti-inflammatory, oxygen inhalation, nutritional support and adequate rest.
Conclusion
This case present typical characteristics of COVID-19 in epidemiological investigation, clinical manifestation, examination, pulmonary imaging and etiology. After comprehensive treatment including reduce and stop immunosuppressive therapy, clinical cure was achieved. The long-term effect of COVID-19 on this immunosuppressive patient remains follow-up.
8.Clinical case analysis of 2019 coronavirus disease (COVID-19) with living-related kidney transplantation
Xia LU ; Changsheng MING ; Zhixiang WEN ; Liru QIU ; Shuyun XU ; Tao CHEN ; Qin NING ; Xiaoping LUO ; Zhishui CHEN ; Nianqiao GONG
Chinese Journal of Organ Transplantation 2020;41(3):148-151
Objective:To explore the clinical characteristics of one living-related kidney transplant recipient infected with 2019 coronavirus disease(COVID-19).Methods:The clinical diagnosis and treatment of one living-related kidney transplant recipient after the occurrence of COVID-19 were analyzed retrospectively. Course of onset, clinical manifestations, laboratory and image enamination, outpatient and inpatient therapies and outcomes.Results:The renal transplant recipient was diagnosed as COVID-19(severe) with influenza A virus infection based upon epidemiological survey, clinical manifestations, laboratory examinations, imaging findings and etiological tests. The clinical symptoms were gradually relieved and lung lesions became absorbed after tapering and withdrawing immunosuppressants, antiviral therapy of abidol/oseltamivir, antibiotic therapy, hormonal anti-inflammation, oxygen inhalation, nutritional supports and adequate rest.Conclusions:Living-related kidney transplant recipients have specific immunosuppressive states.The long-term effect of covid-19 on recipients should be determined through long-term follow-ups.
9.Application of liner-accelerator two-degrade collimator in the treatment of breast cancer after radical mastectomy with intensity-modulated radiotherapy
Guifang ZHANG ; Jie LU ; Changsheng MA ; Tao SUN ; Dali HAN ; Yong YIN
Chinese Journal of Radiological Medicine and Protection 2017;37(8):594-598
Objective To evaluate the dosimetric imnpact of the fixed position of two-degrade collimator in the treatment of breast cancer after radical mastectomy using intensity-modulated radiotherapy (IMRT) technique.Methods A total of ten patients with breast cancer were treated with radical mastectomy and radiotherapy sequaciously involving the supraclavicular region and the chest wall.Two different IMRT treatment plans were designed for each patient:0°,40° and two tangential field.There was no restriction on the position of two-degrade collimator(IMRT-1) (P > 0.05).The beam angles and the parameters were as same as IMRT-1,but fixed the position of the two-degrade collimator of 0° and 40° at the inferior border of the supraclavicular (IMRT-2).The dose distribution of target volume and normal tissues,conformal index (CI),and heterogeneous index (HI) were estimated with the dose volume histogram (DVH) for the two intensity modulated modes.Results The CI were 0.79 and 0.73 (Z =-2.316,P<0.05),and the HI of the IMRT-2 plans was not different from IMRT-1 (P > 0.05).Considering the dose volunes of the ipsilateral lung in two plans,the values of V5,V10,D of IMRT-2 were significantly less than those of IMRT-1 (Z =-2.805,-2.812,-2.521,P < 0.05).Meanwhile,the D of the contralateral lung,D of heart and D of the contralateral breast from the IMRT-2 were all lower than those oflMRT-1 (Z=-2.666,-2.701,-2.310,P<0.05).There was no significant difference in the values of V20,V30 of the ipsilateral lung,V30 of heart and between IMRT-1 and IMRT-2 (P >0.05).Conclusions Compared with IMRT-1,IMRT-2 with fixed position of the two-degrade collimator could significantly reduce the low dose region of the lung and heart.It may be used as an effective alternative for breast cancer after radical mastectomy irradiation.
10.Effects of maternal behaviors in rats with neuropathic pain on emotions of offspring rats and the relationship with DNA methylation in amygdala
Yong YANG ; Yanfeng ZHANG ; Qulian GUO ; Jianqin YAN ; Tao ZHONG ; Wangyuan ZOU ; Changsheng HUANG
Chinese Journal of Anesthesiology 2016;36(7):831-834
Objective To investigate the effects of maternal behaviors in the rats with neuropathic pain (NP) on emotions of offspring rats and the relationship with DNA methylation in the amygdala.Methods Forty-eight healthy adult Sprague-Dawley rats (24 males and 24 females),weighing 200-250 g,were used in the study.Twelve female and 12 male rats were randomly selected,and NP was induced by chronic constriction injury (CCI).Each female rat was mated with one male rat at 10 days after CCI.Fortyeight F1 generation rats of maternal rats with NP were randomly divided into 2 groups (n =24 each) using a random number table:NP1 group and NP2 group.Forty-eight F1 generation rats of normal maternal rats were randomly divided into 2 groups (n=24 each) using a random number table:S1 group and S2 group.The F1 generation rats were cross-fed immediately after birth between group NP2 and group S2,and fed by their own mother rats in NP1 and S1 groups.All the offspring rats were fed to 21 days after birth by the maternal rats selected,and separately fed to 30 days after birth,and then subjected to behavioral testing.Retrieving and licking pups were recorded after delivery in maternal rats to evaluate the maternal behaviors.The mechanical and thermal paw withdrawal thresholds were measured in the offspring rats.Elevated plus maze and open field tests were conducted to detect anxiety and depression behaviors in the offspring rats.At 1 day after completion of behavioral testing,the expression of DNA methyltransferase 1 (DNMT1) and DNA methyltransferase 3a and 3b in the amygdala was detected by Western blot analysis.Results Compared with S1 or S2 groups,the latency to lick pups,latency to retrieve pups,and total retrieval time were significantly prolonged,and the total time spent licking pups was significantly shortened in NP1 group or NP2 group (P<0.05 or 0.01).There was no significant difference in the mechanical and thermal paw withdrawal thresholds in the offspring rats between the four groups (P>0.05).Compared with group S1,the ratios of time spent in the open arm to the closed arm and of time spent in the central square to the peripheral square were significantly decreased,DNMT1 expression in the amygdala was significantly up-regulated,and the total DNA methylation was increased in the offspring rats in S2 and NP1 groups (P<0.05).Compared with group NP2,the ratios of time spent in the open arm to the closed arm and of time spent in the central square to the peripheral square were significantly decreased,DNMT1 expression in the amygdala was significantly up-regulated,and the total DNA methylation was increased in the offspring rats in S2 and NP1 groups (P<0.05).Conclusion Decreased maternal behaviors in the rats with NP results in negative emotions including anxiety and depression in the offspring rats,and the mechanism is related to increased DNA methylation in the amygdala of the offspring rats.

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