1.Efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia: a prospective, randomized, double-blinded, multicenter, positive-controlled clinical trial
Gong CHEN ; Wen OUYANG ; Ruping DAI ; Xiaoling HU ; Huajing GUO ; Haitao JIANG ; Zhi-Ping WANG ; Xiaoqing CHAI ; Chunhui WANG ; Zhongyuan XIA ; Ailin LUO ; Qiang WANG ; Ruifeng ZENG ; Yanjuan HUANG ; Zhibin ZHAO ; Saiying WANG
Chinese Journal of Anesthesiology 2024;44(2):135-139
Objective:To evaluate the efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia in patients.Methods:The patients with moderate to severe pain (numeric pain rating scale ≥4) after abdominal surgery with general anesthesia from 14 hospitals between July 6, 2021 and November 9, 2021 were included in this study. The patients were assigned to either experiment group or control group using a random number table method. Experiment group received oliceridine, while control group received morphine, and both groups were treated with a loading dose plus patient-controlled analgesia and supplemental doses for 24 h. The primary efficacy endpoint was the drug response rate within 24 h after giving the loading dose. Secondary efficacy endpoints included early (within 1 h after giving the loading dose) drug response rates and use of rescue medication. Safety endpoints encompassed the development of respiratory depression and other adverse reactions during treatment.Results:After randomization, both the full analysis set and safety analysis set comprised 180 cases, with 92 in experiment group and 88 in control group. The per-protocol set included 170 cases, with 86 in experiment group and 84 in control group. There were no statistically significant differences between the two groups in 24-h drug response rates, rescue analgesia rates, respiratory depression, and incidence of other adverse reactions ( P>0.05). The analysis of full analysis set showed that the experiment group had a higher drug response rate at 5-30 min after giving the loading dose compared to control group ( P<0.05). The per-protocol set analysis indicated that experiment group had a higher drug response rate at 5-15 min after giving the loading dose than control group ( P<0.05). Conclusions:When used for treatment of moderate to severe pain after surgery with general anesthesia in patients, oliceridine provides comparable analgesic efficacy to morphine, with a faster onset.
2.Effect of Tongxie Yaofang on Expressions of Colon SERT and Liver 5-HT2AR Proteins in Rats with Ulcerative Colitis Model of Liver Stagnation and Spleen Deficiency
Yun-feng LUO ; Jie GAO ; Yi-hui CHAI ; Wen LI ; Zhong QIN ; Yun-zhi CHEN ; Yao YAO ; Jian-ping YUE ; Chang-wei LI ; Zhi-bin JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(2):15-21
Objective:To observe the effect of Tongxie Yaofang on the expressions of colon serotonin transporter (SERT), liver 5-hydroxytryptamine2A receptor (5-HT2AR) protein, serum 5-HT and inflammatory factors in ulcerative colitis (UC) model rats of liver stagnation and spleen deficiency, in order to explore the basis of syndrome of liver stagnation and spleen deficiency and the intervention mechanism of Tongxie Yaofang. Method:Fifty male SD rats were randomly divided into blank control group, model group, high, medium and low-dose Tongxie Yaofang group (10,5,2.5 g·kg-1), and salazosulacil group (0.3 g·kg-1). The ulcerative colitis model of liver depression and spleen deficiency was established by 2,4,6-trinitrobenzene sulfonic acid (TNBS)/ethanol solution enema + restraint stress + diet loss. After successful modeling, the samples were collected after 21 days of drug intervention. Htoxylin eosin (HE) staining and oil red staining were used to observe the pathological changes of colon and liver in each group. Serum interleukin-6 (IL-6), IL-9, 5-HT and superoxide dismutase (SOD) were detected by enzyme linked immunosorbent assay (ELISA). Protein expressions of SERT in the colons and 5-HT2AR in liver of rats were detected by Western blot. Result:Compared with the normal group, obvious ulcers were formed in the colon and lipid droplets in the liver increased in the model group, serum levels of IL-6, IL-9 and 5-HT in the model group increased, while the level of SOD decreased (
3.A multi-center retrospective study of perioperative chemotherapy for gastric cancer based on real-world data.
Xue Wei DING ; Zhi Chao ZHENG ; Qun ZHAO ; Gang ZHAI ; Han LIANG ; Xin WU ; Zheng Gang ZHU ; Hai Jiang WANG ; Qing Si HE ; Xian Li HE ; Yi An DU ; Lu Chuan CHEN ; Ya Wei HUA ; Chang Ming HUANG ; Ying Wei XUE ; Ye ZHOU ; Yan Bing ZHOU ; Dan WU ; Xue Dong FANG ; You Guo DAI ; Hong Wei ZHANG ; Jia Qing CAO ; Le Ping LI ; Jie CHAI ; Kai Xiong TAO ; Guo Li LI ; Zhi Gang JIE ; Jie GE ; Zhong Fa XU ; Wen Bin ZHANG ; Qi Yun LI ; Ping ZHAO ; Zhi Qiang MA ; Zhi Long YAN ; Guo Liang ZHENG ; Yang YAN ; Xiao Long TANG ; Xiang ZHOU
Chinese Journal of Gastrointestinal Surgery 2021;24(5):403-412
Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
Chemotherapy, Adjuvant
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Female
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Gastrectomy
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Humans
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Male
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Neoadjuvant Therapy
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Neoplasm Staging
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Prognosis
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Retrospective Studies
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Stomach Neoplasms/surgery*
4.Effect of Different Concentrations of Astragali Radix Containing Serum on CYP24A1,CYP27B1 mRNA and Protein in Osteogenic Differentiation of Aging Bone Marrow Mesenchymal Stem Cells
Qian LI ; Yong-zhen WU ; Lian-cheng GUAN ; Jie GAO ; Wen LI ; Zhong QIN ; Yun-zhi CHEN ; Yi-Hui CHAI
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(17):49-55
Objective:To investigate the effects of different concentrations of Astragali Radix containing serum on the expression of 24-hydroxylase(CYP24A1),1
5. Neuroprotective Mechanism of Buyang Huanwu Tang on Experimental Autoimmune Encephalomyelitis Mice
Jian-chun LIU ; Hong-zhen ZHANG ; Wen-juan GUO ; Zhi CHAI ; Jie-zhong YU ; Jing-wen YU ; Bao-guo XIAO ; Cun-gen MA
Chinese Journal of Experimental Traditional Medical Formulae 2019;25(14):55-61
Objective:To explore the neuroprotective effect and mechanism of Buyang Huanwu Tang (BYHWT) on experimental autoimmune encephalomyelitis (EAE) at different stages. Method:The 36 female C57BL/6 mice were immunized subcutaneously with myelin oligodendrocyte glycoprotein peptides (MOG35-55),then randomly divided into 9, 17, 28 d EAE control group. Each BYHWT group was orally given drugs on the 3rd day after immunization (50 g·kg-1·d-1), and EAE control group was given the same volume of normal saline in the same way once a day for 9, 17 and 28 d after immunization. The effect of BYHWT on EAE mice was observed with internationally accepted clinical score. Brain and spinal cord specimens were collected at 9, 17 and 28 d after immunization. The neuroprotective effect of BYHWT was observed by hematoxylin-eosin(HE)staining and solid blue staining (LFB). The expressions of BDNF and GAP-43 in spinal cord and brain were detected by Western blot. Result:After treatment, BYHWT can significantly inhibit myelitis cell infiltration and alleviate myelin loss. Compared with EAE group, the expression of Nogo-A in the spinal cord of each BYHWT group was significantly down-regulated (P<0.01), and the expression of BDNF in the spinal cord was significantly up-regulated (P<0.05, P<0.01) in the BYHWT group 17 and 28 d group compared with EAE group 17 and 28 d group. Compared with EAE 9, 17 d group, GAP-43 expression was significantly up-regulated in the spinal cord of BYHWT 9, 17 d group (P<0.01). Conclusion:BYHWT can improve the local nerve growth microenvironment and promote the expression of NTFs, reduce the expressions of neuroinhibitory factors, and play a role in neuroprotection.
6.Establishing a finite element model of the mandible containing the temporomandibular joint after bilateral-sagitta-split-ramus-osteotomy with internal fixation
Wen MA ; Min HOU ; Dali SONG ; Jingwen YANG ; Zhi DAI ; Jialong CHENG ; Guoliang CHAI ; Weiyuan ZHOU ; Ruize ZHANG
Chinese Journal of Tissue Engineering Research 2015;(42):6730-6734
BACKGROUND:Bilateral-sagitta-split-ramus-osteotomy (BSSRO) has become a conventional method to correct facial deformities, and the finite element method is a significant way to study biomechanics of the mandible and temporomandibular joint (TMJ) after BSSRO. OBJECTIVE: To establish a precise and high simulation model of mandible containing TMJ after BSSRO with internal fixation, which is the base to study the biomechanics of the mandible and TMJ after BSSRO. METHODS: Spiral CT scan was used to get the data of DICOM that were input into MIMICS to establish the three-dimensional model of the mandible. The three-dimensional model was wrapped into a single closed shel for mesh generation and conversion in ANSYS. Then, the model was input into the ANSYS software for temporomandibular joint reconstruction and simulation of BSSRO and internal fixation. RESULTS AND CONCLUSION: The three-dimensional finite element model of mandible containing TMJ after BSSRO was established using MIMICS and ANSYS. This model had biological similarity and geometric similarity in comparison with the human tissues. The model could undergo various internal fixations through antedisplacement, retroposition and rotational movement of the distal end. Based on different experimental purposes, the established model can apply a load to al parts to study changes in stress and displacement of different tissues after BSSRO and internal fixation, and it also can be used to study the effect of different fixation materials on the rear stability after internal fixation.
7.Low dose volume histogram analysis of the lungs in prediction of acute radiation pneumonitis in patients with esophageal cancer treated with three-dimensional conformal radiotherapy.
Wen-bin SHEN ; Shu-chai ZHU ; Hong-mei GAO ; You-mei LI ; Zhi-kun LIU ; Juan LI ; Jing-wei SU ; Jun WAN
Chinese Journal of Oncology 2013;35(1):45-49
OBJECTIVETo investigate the predictive value of low dose volume of the lung on acute radiation pneumonitis (RP) in patients with esophageal cancer treated with three-dimensional conformal radiotherapy (3D-CRT) only, and to analyze the relation of comprehensive parameters of the dose-volume V5, V20 and mean lung dose (MLD) with acute RP.
METHODSTwo hundred and twenty-two patients with esophageal cancer treated by 3D-CRT have been followed up. The V5-V30 and MLD were calculated from the dose-volume histogram system. The clinical factors and treatment parameters were collected and analyzed. The acute RP was evaluated according to the RTOG toxicity criteria.
RESULTSThe acute RP of grade 1, 2, 3 and 4 were observed in 68 (30.6%), 40 (18.0%), 8 (3.6%) and 1 (0.5%) cases, respectively. The univariate analysis of measurement data:The primary tumor length, radiation fields, MLD and lung V5-V30 had a significant relationship with the acute RP. The magnitude of the number of radiation fields, the volume of GTV, MLD and Lung V5-V30 had a significant difference in whether the ≥ grade 1 and ≥ grade 2 acute RP developed or not. Binary logistic regression analysis showed that MLD, Lung V5, V20 and V25 were independent risk factors of ≥ grade 1 acute RP, and the radiation fields, MLD and Lung V5 were independent risk factors of ≥ grade 2 acute RP. The ≥ grade 1 and ≥ grade 2 acute RP were significantly decreased when MLD less than 14 Gy, V5 and V20 were less than 60% and 28%,respectively. When the V20 ≤ 28%, the acute RP was significantly decreased in V5 ≤ 60% group. When the MLD was ≤ 14 Gy, the ≥ 1 grade acute RP was significantly decreased in the V5 ≤ 60% group. When the MLD was >14 Gy, the ≥ grade 2 acute RP was significantly decreased in the V5 ≤ 60% group.
CONCLUSIONSThe low dose volume of the lung is effective in predicting radiation pneumonitis in patients with esophageal cancer treated with 3D-CRT only. The comprehensive parameters combined with V5, V20 and MLD may increase the effect in predicting radiation pneumonitis.
Acute Disease ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Squamous Cell ; radiotherapy ; Dose-Response Relationship, Radiation ; Esophageal Neoplasms ; radiotherapy ; Female ; Follow-Up Studies ; Humans ; Lung ; radiation effects ; Male ; Middle Aged ; Radiation Pneumonitis ; etiology ; pathology ; Radiotherapy Dosage ; Radiotherapy, Conformal ; adverse effects ; Retrospective Studies
8.Experimental study on vascular bundle implantation combined with cellular transplantation in treating rabbit femoral head necrosis.
Shuang-Tao CHEN ; Wei-Ping ZHANG ; Chang-An LIU ; Jun-Jiang WANG ; Heng-Yi SONG ; Zhi-wen CHAI
China Journal of Orthopaedics and Traumatology 2013;26(3):223-226
OBJECTIVETo discuss the feasibility of vascular bundle implantation combined with allogeneic bone marrow stromal cells (BMSCs) transplantation in treating rabbit femoral head osteonecrosis and bone defect, in order to explore a new method for the treatment of femoral head necrosis.
METHODSThirty-six New Zealand rabbits were randomly divided into three groups,with 12 rabbits in each group. Bilateral femoral heads of the rabbits were studied in the experiment. The models were made by liquid nitrogen frozen, and the femoral heads were drilled to cause bone defect. Group A was the control group,group B was stem cells transplantaion group of allograft marrow stromal,and group C was stem cells transplantation group of allograft marrow stromal combined with vascular bundle implantation. Three rabbits of each group were sacrificed respectively at 2, 4, 8, 12 weeks after operation. All specimens of the femoral heads were sliced for HE staining. Furthermore ,vascular density and the percentage of new bone trabecula of femoral head coronary section in defect area were measured and analyzed statistically.
RESULTSIn group C,new bone trabecula and original micrangium formed at the 2nd week after operation; new bone trabecula was lamellar and interlaced with abundant micrangium at the 8th week;at the 12th week,the broadened,coarsened bone trabecula lined up regularly,and the mature bone trabecula and new marrow were visible. At the 2nd week after operation,there was no statistical significance in the percentage of new bone trabecula of femoral head coronary section in defect area between group B and C. While at 4, 8, 12 week after operation, vascular density and the percentage of new bone trabecula of femoral head coronary section in defect area of group C was higher than that of group B.
CONCLUSIONAllogeneic bone marrow stromal cells cultured in vivo can form new bone trabecula, and can be applied to allotransplant. Vascular bundle implanted into the bone defect area of femoral head necrosis could improve blood supply, and promote the formation of bone trabecula.
Animals ; Blood Vessels ; transplantation ; Combined Modality Therapy ; Female ; Femur Head Necrosis ; pathology ; surgery ; Male ; Mesenchymal Stem Cell Transplantation ; Mesenchymal Stromal Cells ; Rabbits ; Transplantation, Homologous
9.The effect of the adverse events with thiopurine S-methyltransferase gene mutation on outcome of childhood acute lymphoblastic leukemia.
Lan CAO ; Zhi-xiang ZHANG ; Yi-huan CHAI ; Shao-yan HU ; Yi WANG ; Wen-li ZHAO ; Hai-long HE ; Jun LU
Chinese Journal of Hematology 2013;34(3):247-252
OBJECTIVETo investigate thiopurine S-methyltransferase (TPMT) activity and gene promoter polymorphism to probe its significance of individual chemotherapy in acute lymphoblastic leukemia (ALL) children.
METHODSHPLC method was carried out to determine TPMT activity (n=100), which activity at newly diagnosed. At the same time determination of TPMT activity in healthy children (n=180), these children come from the health care clinic. Using online primer3 software design primers, PCR products were purified. To sequence TPMT gene of the patients with clinical events(n=30). According to the method to analysis of correlation between TPMT activity and toxicity.
RESULTSThe average TPMT activities were (31.72±10.31) nmol·g⁻¹Hb·h⁻¹ and (30.70±9.67) nmol·g⁻¹Hb·h⁻¹ in ALL and healthy groups respectively, without gender differences of TPMT activities (P=0.45) in both groups. The TPMT activity with clinical events in newly diagnosed ALL patients (n=30) was (24.07±11.43) nmol·g⁻¹Hb·h⁻¹. There are significant differences of TPMT activities between severe bone marrow suppression [(20.96±7.24) nmol·g⁻¹Hb·h⁻¹] and ALL patients with clinical events groups (P<0.05). The TPMT activity of (40.46±8.18) nmol·g⁻¹Hb·h⁻¹ in recurrence children was also significantly different (P<0.05). TPMT activity in severe liver toxicity group was not significantly different (P=0. 930). Of TPMT gene sequencing in ALL patients with clinical events, only 3 children were heterozygosity mutations of TPMT*3C, while others homozygous genotype. There were significant differences of TPMT activities between heterozygosity genotype [(11.99±1.32) nmol·g⁻¹Hb·h⁻¹] and homozygous genotype groups [(24.95±11.32) nmol·g⁻¹Hb·h⁻¹] (P<0.05). There were five kinds of variations at the vicinity of the promoter region of -100 of tandem repeats (VNTR) polymorphism(*V3/*V3、*V3/*V4、*V4/*V4、*V5/*V5、*V4/*V6)without significant differences of TPMT activities among five kinds (P=0.186).
CONCLUSIONTPMT activity was related to the gene polymorphism. TPMT activity determination had prognostic value and guided individualized treatment.
Child ; Child, Preschool ; Female ; Humans ; Male ; Methyltransferases ; genetics ; Mutation ; Polymorphism, Genetic ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; drug therapy ; genetics ; Prognosis ; Promoter Regions, Genetic
10.Relationship between genetic polymorphism of multidrug resistance 1 gene and the risk of childhood acute lymphocytic leukemia.
Hui LÜ ; Zhi-Zhuo DU ; Wei WANG ; Wei WANG ; Wen-li ZHAO ; Yi WANG ; Shao-yan HU ; Yi-huan CHAI
Chinese Journal of Pediatrics 2012;50(9):692-696
OBJECTIVETo investigate the relationship between genetic polymorphism in exon 12 C1236T, exon 21 G2677T/A and exon 26 C3435T of the multidrug resistance 1 (MDR1) gene and the risk of childhood acute lymphocytic leukemia (ALL).
METHODA total of 176 patients with ALL and a cohort of 170 matched healthy subjects were included. SNaPshot SNP typing was used to determine the genotypes of MDR1 C1236T, G2677T/A, C3435T. Based on the clinical data, the relationship between genetic polymorphism of MDR1 and the risk of childhood ALL was analyzed.
RESULTThere was significant difference in the distribution of genotype of MDR1 C3435T between the group of controls and cases. The mutant homozygous TT genotype was found to be associated with occurrence of ALL (P = 0.000; OR = 4.504). The data show evidence of pairwise linkage disequilibrium between the three common SNPs (C1236T-G2677T/A-C3435T). The haplotypes of TTT, TGC, CGC and CAC were predominant. The haplotype CGT distributed significantly differently between the groups of controls and cases (P = 0.034). The frequency of the haplotype TTT/TTT in the high risk group was higher than the other groups (P = 0.037).
CONCLUSIONThe present findings suggest that 3435C→T polymorphism in MDR1 gene may be a genetic susceptibility factor for ALL. The haplotype of MDR1 (C1236T-G2677T/A-C3435T) could be the clinical parameter at diagnosis.
ATP Binding Cassette Transporter, Sub-Family B ; ATP-Binding Cassette, Sub-Family B, Member 1 ; genetics ; Acute Disease ; Asian Continental Ancestry Group ; genetics ; Child, Preschool ; China ; ethnology ; Exons ; Female ; Gene Frequency ; Genetic Predisposition to Disease ; Genotype ; Haplotypes ; Humans ; Infant ; Linkage Disequilibrium ; Male ; Polymorphism, Single Nucleotide ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; genetics ; Risk Factors

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