1.Optimization of Processing Technology of Honey Bran-fried Rosae Laevigatae Fructus and Analysis of Its Mechanism in Treatment of Ulcerative Colitis
Bin LIU ; Lingyun ZHONG ; Hongbing LUO ; Qi DENG ; Fuyu XU ; Simin ZHONG ; Ying ZHOU ; Xide YE ; Feipeng GONG ; Yuncheng GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(16):216-224
		                        		
		                        			
		                        			ObjectiveTo optimize the processing technology of honey bran-fried Rosae Laevigatae Fructus(h-RLF), formulate relevant quality standards, and explore its improving effect and mechanism on mice with ulcerative colitis(UC) induced by dextran sodium sulfate(DSS). MethodsTaking the content of polysaccharides and water-soluble extract as the indexes, L9(34) orthogonal test was used to optimize parameters of the amount of honey bran, frying time and frying temperature. The quality of 15 batches of h-RLF decoction pieces was evaluated according to the optimized process, and the inspection limit standard was preliminarily drawn up. Eighty SPF male Kunming mice were randomly divided into 8 groups, including the blank group, model group, mesalazine group(0.13 g·kg-1), RLF group(3.77 g·kg-1), bran-fried RLF group(3.77 g·kg-1), h-RLF low, medium and high dose groups(1.89, 3.77, 7.54 g·kg-1), with 10 mice in each group. The mice in the blank group were free to drink pure water, and the other groups were free to drink 3% DSS solution for 7 days to prepare UC mouse model. Each treatment group was given corresponding drugs by intragastric administration, and the blank and model groups were given equal volume of normal saline. The body weight of mice was recorded daily and the disease activity index(DAI) was calculated. After the administration, the colon tissues of mice were collected to observe the pathological changes by hematoxylin-eosin(HE) staining. The levels of tumor necrosis factor(TNF)-α, interleukin(IL)-1β, IL-6 and IL-10 in the colon of mice were detected by enzyme-linked immunosorbent assay(ELISA). Western blot was used to detect the expression levels of phosphorylation nuclear transcription factor-κB p65(p-NF-κB p65), Toll-like receptor 4(TLR4), p-p38 mitogen-activated protein kinase(p-p38 MAPK), p-extracellular signal-regulated kinase(p-ERK) and p-c-Jun N-terminal kinase(p-JNK) proteins in colon tissues. ResultsThe optimum processing technology of h-RLF was 20 g honey bran per 100 g RLF, and stir-frying at 200 ℃ for 8 min. The limit standard under the examination of h-RLF was preliminarily formulated as follows:the polysaccharide content should not be less than 25% based on anhydrous glucose(C6H12O6), the content of water-soluble extract should not be less than 38%, the moisture content should not be more than 12.0%, the total ash content should not be more than 5.0%, and the acid-insoluble ash content should not be more than 1.0%. The cluster heat map analysis showed that the quality of RLF from Huanggang, Hubei province was better. Animal experiments showed that compared with the blank group, the DAI score of the model group was significantly increased, the levels of TNF-α, IL-1β and IL-6 in the colon tissue were significantly increased, the IL-10 level was significantly decreased, the colonic mucosa was seriously damaged, accompanied by a large number of inflammatory cell infiltration, tissue congestion and a significant reduction in glands, and the expression levels of p-NF-κB p65, TLR4, p-p38 MAPK, p-ERK and p-JNK proteins were significantly increased(P<0.01). Compared with the model group, each administration group could alleviate the symptoms of colonic ulcer, the structure of colonic crypt was basically intact, and the glands were arranged in an orderly manner. Among them, the high-dose group of h-RLF had a better effect, which could significantly reduce the DAI score and the levels of TNF-α, IL-1β and IL-6 in colon tissue(P<0.01), and significantly increase the level of IL-10(P<0.01), alleviate the colonic mucosal injury, and effectively inhibit the expression levels of p-NF-κB p65, TLR4, p-p38 MAPK, p-ERK and p-JNK proteins(P<0.01). ConclusionThe key parameters of the processing technology of h-RLF are determined, and the optimized technology is stable and feasible. The established quality standard is simple and reliable, and can be used for the quality control. h-RLF can effectively alleviate DSS-induced UC, and its mechanism may be related to inhibiting the activation of NF-κB/TLR4/MAPK pathway. 
		                        		
		                        		
		                        		
		                        	
2.Analysis of pharmaceutical clinic service in our hospital over the past five years
Li FAN ; Shuyan QUAN ; Xuan WANG ; Menglin LUO ; Fei YE ; Lang ZOU ; Feifei YU ; Min HU ; Xuelian HU ; Chenjing LUO ; Peng GU
China Pharmacy 2025;36(6):748-751
		                        		
		                        			
		                        			OBJECTIVE To summarize the current situation of pharmaceutical clinic service in our hospital over the past five years, and explore sustainable development strategies for service models of pharmaceutical clinics. METHODS A retrospective analysis was conducted on the consultation records of patients who registered and established files at the pharmaceutical clinic in our hospital from January 2019 to December 2023. Statistical analysis was performed on patients’ general information, medication- related problems, and types of pharmaceutical services provided by pharmacists. RESULTS A total of 963 consultation records were included, among which females aged 20-39 years accounted for the highest proportion (66.04%); obstetrics and gynecology- related consultations accounted for the largest number of cases. Additionally, 80 patients attended follow-up visits at our hospital’s pharmaceutical clinic. A total of 1 029 medication-related issues were resolved, including 538 cases of drug consultations (52.28%), 453 medication recommendations (44.02%), 22 medication restructuring(2.14%), and 16 medication education (1.55%); the most common types of medication-related problems identified were adverse drug events(70.07%). CONCLUSIONS Although the pharmaceutical clinic has achieved recognition from clinicians and patients, challenges such as low awareness among healthcare providers and the public persist. Future efforts should focus on strengthening information technology construction, enhancing pharmacist training, and establishing various forms of outpatient pharmaceutical service models.
		                        		
		                        		
		                        		
		                        	
3.Analysis of the current situation of retinopathy of prematurity in Xiamen region and its influencing factors
Shuangshuang YE ; Wenhui LI ; Baozhu XU ; Tingyu GU ; Ruirui SUN ; Hexie CAI
International Eye Science 2025;25(7):1195-1200
		                        		
		                        			
		                        			 AIM: To investigate the current status of retinopathy of prematurity(ROP)in premature infants in Xiamen and analyze its influencing factors, aiming to provide a scientific basis for clinical treatment and preventive strategies.METHODS: A retrospective study was conducted on the case data of 363 preterm infants with a gestational age of <32 wk who underwent fundus examination at Xiang'an Hospital of Xiamen University from February 11, 2020 to February 25, 2023. The incidence of ROP was statistically analyzed based on the screening results. All premature infants were divided into ROP group(37 cases, 64 eyes)and non-ROP group(326 cases, 652 eyes). General clinical data and perinatal-related information of the two groups were compared, and multivariate Logistic regression analysis was used to identify factors influencing the occurrence of ROP in premature infants.RESULTS: A total of 363 premature infants were included in this study. The fundus screening results showed that a total of 37 cases(64 eyes)of premature infants were detected with ROP, including 10 cases(10 eyes)monocular and 27 cases(54 eyes)binocular, with an overall incidence of 10.2%(37/363). The severity was determined according to the ROP international classification standard(ROP is divided into 5 stages, with stage I being the least severe and stage V the most severe). Among the 64 eyes, 30 eyes(46.9%)were in stage I, 20 eyes(31.3%)were in stage II, 10 eyes(15.6%)were in stage III, 4 eyes(6.3%)were in stage IV, and there were no cases in stage V. By comparing the clinical data of the two groups, no significant differences were found in gender, mode of delivery, singleton or multiple births, premature rupture of membranes, history of asphyxia, patent ductus arteriosus(PDA), or neonatal respiratory distress syndrome(NRDS)between the two groups(all P>0.05). However, premature infants in the ROP group had significantly younger gestational age and lower birth weight compared to those in the non-ROP group(all P<0.05). Additionally, the ROP group had higher proportions of longer hospital stays, bronchopulmonary dysplasia(BPD), neonatal sepsis, anemia, oxygen therapy for more than 1 wk, oxygen concentration above 40%, and blood transfusion treatment(all P<0.05). Multivariate Logistic regression analysis revealed that combined neonatal sepsis(OR=166.985, 95% CI: 35.239-791.277, P<0.001), anemia(OR=8.111, 95% CI: 2.064-31.871, P=0.003), oxygen use time >1 wk(OR=10.216, 95% CI: 2.543-41.039, P=0.001), oxygen therapy concentration >40%(OR=7.647, 95% CI: 1.913-30.566, P=0.004), and receiving blood transfusion therapy(OR=5.879, 95% CI: 1.412-24.470, P=0.015)were the main risk factors affecting the occurrence of ROP in preterm infants, and the higher birth weight of preterm infants was a protective factor for ROP(OR=0.093, 95% CI: 0.022-0.394, P=0.001).CONCLUSION: The incidence of ROP in premature infants is relatively high, and there are multiple influencing factors. Low birth weight, neonatal sepsis, anemia, oxygen therapy, and blood transfusion treatment are high-risk factors for ROP in premature infants. Clinical attention should be given to such infants, and fundus screening should be conducted in a standardized manner to provide early treatment, thereby further reducing the risk of ROP in premature infants. 
		                        		
		                        		
		                        		
		                        	
4.Research progress on animal models of combined radiation-wound injury
Ruolin HAO ; Guifang DOU ; Zhiyun MENG ; Tong YE ; Nanxi LI ; Xiaoxia ZHU ; Ruolan GU ; Zhuona WU ; Hui GAN
Chinese Journal of Radiological Health 2024;33(2):209-214
		                        		
		                        			
		                        			A combined radiation-wound injury refers to a radiation injury combined with a traumatic wound, with the characteristics of repeated ulceration and a long and difficult healing process, which is a focus in the field of research on difficult-to-heal wounds. To research combined radiation-wound injuries, the establishment of animal models is a key part, and appropriate animal models are a guarantee of reliable experimental results. This review summarizes the current research progress on various animal models of combined radiation-wound injuries in terms of radiation types, animal species, and injury types and location, aiming to provide a scientific basis for establishing standardized animal models, studying injury mechanisms, and evaluating prevention and treatment efficacy for combined radiation-wound injuries.
		                        		
		                        		
		                        		
		                        	
5.Diagnosis and treatment of 131 adult patients with bronchopulmonary sequestration: A retrospective analysis
Xiaobo GU ; Qiankun CHEN ; Ziwei WAN ; Cong YE ; Yuming ZHU ; Shijian DU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(01):105-110
		                        		
		                        			
		                        			Objective    To explore the safety and feasibility of uni-portal video-assisted thoracic surgery (VATS) for the treatment of bronchopulmonary sequestration (BPS). Methods    The clinical data of BPS patients with surgical resection in Shanghai Pulmonary Hospital from February 2010 to June 2021 were reviewed. The patients were divided into a VATS group and a thoracotomy group according to the operation method. The operation time, intraoperative blood loss, hospital stay and postoperative complication rate were compared between the two groups. The VATS group was subdivided into a uni-portal VATS group and a multi-portal VATS group for subgroup analysis. Results    Finally 131 patients were enrolled, including 62 males and 69 females with an average age of 39.3±13.2 years. There were 103 patients in the VATS group and 28 patients in the thoracotomy group. A total of 104 patients were diagnosed with left lower BPS, 26 with right lower BPS and 1 with bilateral lower BPS. The main symptom was cough (88 patients, 67.2%). There were 119 patients diagnosed by thoracic enhanced CT before operation. Compared with the thoracotomy group, the operation time was not statistically different (P=0.717), but the blood loss was less, the rate of postoperative complication was lower and hospital stay was shorter in the VATS group (P<0.05). The rate of conversion to open surgery in the uni-portal VATS group and multi-portal VATS group was 11.8% and 13.5%, respectively. Meanwhile, patients in the uni-portal VATS group had shorter operation time and postoperative hospital stay, less blood loss and lower postoperative complication rate than those in the multi-portal VATS group (P<0.05). Conclusion     In order to improve the rate of diagnosis, the lung enhanced CT scan should be selected as an optimal noninvasive method in adult suspected patients (especially those with solid cystic and solid lesions in the lower lobe). Uni-portal VATS is a safe and feasible method for BPS which can be widely promoted.
		                        		
		                        		
		                        		
		                        	
6.Establishment of rapid detection method for zika virus based on direct amplification RT-PCR technique
Lang LI ; Libing GU ; Li ZHU ; Jianan HE ; Ying YE ; Ran ZHANG ; Huawen LI ; Fuyuan LI ; Dayong GU
International Journal of Laboratory Medicine 2024;45(3):358-364
		                        		
		                        			
		                        			Objective To establish a rapid detection method for zika virus based on direct amplification re-al-time fluorescent quantitative reverse transcription polymerase chain reaction(RT-PCR)technique.Methods A direct amplification RT-PCR technique for the rapid detection of zika virus in 5 samples(whole blood,serum,saliva,throat swab and urine)was established by using a special function DNA polymerase and a preferred PCR enhancer.Results The detection limits of the 5 samples were 103 PFU/mL in serum,102 PFU/mL in urine,throat swab,and saliva,and 104 PFU/mL in whole blood.The coefficient of goodness-fit of stand-ard curves was above 0.98,and the amplification efficiency was 90%-110%.Zika virus nucleic acid was suc-cessfully amplified,but non-zika virus nucleic acid was not amplified.Based on the repeatable detection of sam-ples from urine,whole blood,and saliva,the variation coefficient of 6 repeated Ct values at 106 PFU/mL and 102 PFU/mL concentrations were all<5%.The zika virus detection method established by the direct amplifi-cation RT-PCR technique was consistent with the detection results of conventional RT-PCR technique.Only two serum samples were detected in eight zika virus samples,and the remaining 62 non-zika virus samples and 12 negative samples were not amplified.Conclusion A rapid detection method for zika virus based on direct ampli-fication RT-PCR technique is successfully established.The method is simple,rapid,sensitive and specific.
		                        		
		                        		
		                        		
		                        	
7.Effects of ginkgolide B on neurological recovery and Wnt/β-catenin pathway after ischemic stroke in mice
Shaozhuang CHEN ; Qiying TANG ; Yanrong YE ; Yun SHEN ; Kehui YI ; Furong GU ; Jia LIU
International Journal of Biomedical Engineering 2024;47(1):66-72
		                        		
		                        			
		                        			Objective:To investigate the effects of ginkgolide B on neurological function recovery and the Wnt/β-catenin pathway after ischemic stroke in mice.Methods:Fifty-five C57/BL6 mice were selected, of which 10 mice were kept as the sham group and the remaining 45 mice were constructed as the ischemic stroke model. There were 40 mice who finally completed the modeling, and then they were randomly divided into the blank control group (GB0w), short-course administration group (GB1w), long-term administration group (GB2w), and long-term administration+antagonist group (GB2w+PRI-724), with 10 mice in each group. There was no drug intervention after MCAO in GB0w. The mice in GB1w were given ginkgolide B (10 mg/kg) 0.1 ml within 1 week after MCAO; in GB2w were given ginkgolide B (10 mg/kg) 0.1 ml within 2 weeks after MCAO; and in GB2w+PRI-724 were nasally fed ginkgolide B (10 mg/kg) 0.1 ml within 2 weeks after MCAO; and selective antagonist PRI-724 was given 3 h before administration of ginkgolide B on days 8 to 14. Neurological function scores, walking on rotor bar test scores, expression of transforming growth factor-β1 (TGF-β1), fibroblast growth factor 4 (FGF4), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), malondialdehyde (MDA), glutathione peroxidase (GSH-Px), superoxide dismutase (SOD), Wnt, β-catenin, and glycogen synthase kinase-3β (GSK-3β) were compared among the groups.Results:Compared with the sham group, the expressions of MDA, TNF-α, IL-6, FGF4, and GSK-3β in GB0w, GB1w, GB2w, and GB2w+ PRI-724 were increased, and the expressions of GSH-Px, SOD, TGF-β1, β-catenin, and Wnt were decreased (all P < 0.001). Compared with GB0w, the expressions of SOD, GSH-Px, TGF-β1, Wnt, and β-catenin were increased in GB1w, GB2w, and GB2w+PRI-724, and the expressions of MDA, TNF-α, IL-6, FGF4, and GSK-3β were decreased (all P < 0.001). Compared with GB1w, the expressions of GSH-Px, SOD, TGF-β 1, Wnt, and β-catenin were increased in GB2w and GB2w+PRI-724, and the expressions of IL-6, TNF-α, MDA, FGF4, and GSK-3β were decreased (all P < 0.001). Compared with GB2w, the neural function score, walking on the stick test score, and expressions of IL-6, TNF-α, FGF4, MDA, and GSK-3β were increased in GB2w+PRI-724, while the expressions of GSH-Px, TGF-β1, SOD, Wnt, and β-catenin were decreased (all P < 0.001). Conclusions:Ginkgolide B can effectively improve the neurological function of ischemic stroke mice and may be related to the Wnt/β-catenin pathway.
		                        		
		                        		
		                        		
		                        	
8.Relationship between the Expression of LncRNA CTBP1-AS2 and miR-140-5p Levels in Nasopharyngeal Carcinoma Tissues and Radiotherapeutic Effect and Prognosis
Liulei GU ; Pei GU ; Guanghao JIN ; Ye TIAN ; Yong TAO
Journal of Modern Laboratory Medicine 2024;39(2):23-27,156
		                        		
		                        			
		                        			Objective To investigate the relationship between the expression of long non-coding RNA C-terminal binding protein 1 antisense RNA2(LncRNA CTBP1-AS2)and microRNA-140-5p(miR-140-5p)levels in nasopharyngeal carcinoma tissues and the radiotherapeutic effect and prognosis.Methods A total of 222 nasopharyngeal carcinoma patients diagnosed in Nantong Cancer Hospital from March 2018 to March 2020 were collected as the nasopharyngeal carcinoma group.The clinical data of these patients were recorded,the radiotherapeutic effect and prognosis were evaluated,and they were grouped into the survival group(n=194)and the death group(n=28).Meanwhile,another 219 patients with nasopharyngeal inflammation were collected as the control group.Correlation between LncRNA CTBP1-AS2 and miR-140-5p expression levels in nasopharyngeal carcinoma patients was calculated using Pearson correlation analysis.Kaplan-Meier survival curve was applied to analyze the relationship between the expression levels of LncRNA CTBP1-AS2 and miR-140-5p in nasopharyngeal carcinoma tissue and prognosis.Multivariate analysis was conducted on the prognosis of nasopharyngeal carcinoma patients using Cox proportional risk regression model.Results The expression level of LncRNA CTBP1-AS2 in the tissues of patients in nasopharyngeal carcinoma group(2.25±0.46)was higher than that in the control group(1.02±0.22),while the expression level of miR-140-5p(0.67±0.19)was lower than that in the control group(1.01±0.23),and the differences were statistically significant(t=35.742,16.934,all P<0.001).There was a negative correlation between LncRNA CTBP1-AS2 and miR-140-5p expression levels in nasopharyngeal carcinoma patients(r=-0.624,P<0.001).The total effective rate(74.11%)and 3-year survival rate(77.68%)of nasopharyngeal carcinoma patients with high expression of LncRNA CTBP1-AS2 after radiotherapy were lower than those with low expression(93.64%,97.27%),and the differences were statistically significant(χ2=15.578,19.331,all P<0.001).The total effective rate(93.58%)and 3-year survival rate(96.33%)of patients with high expression of miR-140-5p after radiotherapy were higher than those of patients with low expression(74.34%,78.76%),and the differences were statistically significant(χ2=15.119,15.538,all P<0.001).The magnetic resonance amide proton transfer(APT)value(2.10±0.26),the proportion of patients with radiotherapy failure(85.71%),high expression of LncRNA CTBP1-AS2(89.29%),and low expression of miR-140-5p(85.71%)in the death group were higher than those in the survival group(1.82±0.31,6.19%,44.85%,45.88%),and the differences were statistically significant(t/χ2=4.551,108.127,19.331,15.538,all P<0.001).The level of LncRNA CTBP1-AS2 was a risk factor for mortality within 3 years in nasopharyngeal carcinoma patients(HR=2.762,95%CI:1.510~5.051,P=0.001),while the level of miR-140-5p was a protective factor for mortality within 3 years in nasopharyngeal carcinoma patients(HR=0.817,95%CI:0.718~0.930,P=0.002).Conclusion LncRNA CTBP1-AS2 was highly expressed,while miR-140-5p was lowly expressed in nasopharyngeal carcinoma tissue,indicating the two may be closely related to the radiotherapeutic effect and prognosis.
		                        		
		                        		
		                        		
		                        	
9.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.
		                        		
		                        		
		                        		
		                        	
10.Mutation characteristics of rpoB gene in rifampicin-resistant Brucella strains
Ying ZHENG ; Xiaojing MA ; Liya LIU ; Feng YE ; Wenxi GU ; Xinping YI
Chinese Journal of Endemiology 2024;43(2):94-97
		                        		
		                        			
		                        			Objective:To analyze the mutation characteristics of rpoB gene in rifampicin-resistant Brucella strains. Methods:DNA of 4 rifampicin-resistant Brucella strains (JSY-26, G-9, WSY-13 and AW-3) isolated from Xinjiang Uygur Autonomous Region was selected, rifampicin rpoB gene was amplified by PCR and its nucleotide sequence was sequenced. The rpoB gene sequences of rifampicin-resistant Brucella standard strain (RB51) and sensitive strain (ALT-8) were used as reference, the mutation sites and types of the rpoB gene inside and outside the rifampicin resistance determination region (RRDR) of the 4 rifampicin-resistant Brucella strains were analyzed by Mega 7.0 software. Results:Through sequence alignment, both JSY-26 and WSY-13 strains underwent a single base point mutation at the RRDR 1 576 bp of the rpoB gene, with the base changing from guanine (G) to adenine (A). The G-9 strain underwent a single base point mutation at the RRDR 1 606 bp of the rpoB gene, with the base changing from cytosine (C) to A. The AW-3 strain showed 5 mutations of 3 types outside rpoB gene RRDR at 2 536, 2 537, 2 626, 2 636 and 2 654 bp, namely 3 insertion mutations [thymine (T) insertion once and C insertion twice], 1 deletion mutation (C deletion), and 1 single base point mutation (from G to C mutation).Conclusion:The RRDR mutations in the rpoB gene of the rifampicin-resistant Brucella strains are mainly characterized by single base point mutations, while multiple insertion and deletion mutations occur outside the RRDR.
		                        		
		                        		
		                        		
		                        	
            
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