1.Safety evaluation of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma
Hao ZHONG ; Hang LIN ; Yaxin LU ; Haiyan MAI
China Pharmacy 2025;36(4):482-485
OBJECTIVE To assess the safety profile of sintilimab in combination with chemotherapy for the treatment of cholangiocarcinoma. METHODS The data of patients with cholangiocarcinoma from January 1st, 2021 to December 31st, 2022 were collected and divided into control group (29 cases) and observation group (18 cases) based on different medication regimens. Patients in the control group were treated with Gemcitabine hydrochloride for injection+Cisplatin for injection or Oxaliplatin for injection, the observation group was treated with Sintilimab injection based on the control group. Patients in each group underwent blood routine, liver and kidney function, biochemical and other examinations before and after each treatment cycle to observe the occurrence of adverse drug reactions. The correlation of adverse drug reactions with drugs was evaluated with Naranjo’s scale. RESULTS The correlation between blood toxicity and drug use was deemed “probable” in both groups; however, the observation group exhibited a significantly higher score, indicating a stronger correlation. In the control group, hepatotoxic reactions were classified as “suspicious” whereas in the observation group, they were categorized as “probable”. The correlation of gastrointestinal symptoms between the two groups was considered “possible”. Systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity and renal toxicity were all classified as having a “suspicious” correlation with drug use. The total incidence of blood toxicity in the observation group was significantly higher than control group (P=0.014). There was no statistically significant difference in the total incidences of hepatotoxic, gastrointestinal symptoms, systemic symptoms, skin toxicity, musculoskeletal toxicity, endocrine toxicity, renal toxicity, or the incidence of grade 3 or higher blood toxicity, hepatotoxic between the two groups (P>0.05). For the patients experiencing adverse drug reactions, the symptoms were alleviated following drug discontinuation or symptomatic supportive treatment. No fatalities occurred during the treatment period. CONCLUSIONS Sintilimab combined with chemotherapy may significantly increase the risk of blood toxicity in patients with cholangiocarcinoma, especially thrombocytopenia, but the adverse reactions are within a controllable range, and the overall safety is good.
2.Quality analysis of Pinghuo tea standard decoction
Xinmei ZHAO ; Hongyang SANG ; Chunjing YANG ; Jingwei LEI ; Haiyan GONG ; Caixia XIE ; Chunya ZHANG ; Haohan DUAN ; Hao YU
China Pharmacy 2025;36(1):71-78
OBJECTIVE To establish the fingerprint of Pinghuo tea standard decoction and a method for determination of multi-component to clarify the transfer relationship of quantities and quality from pieces and standard decoction. METHODS Fifteen batches of Pinghuo tea standard decoction were prepared and the extract rate was determined; the fingerprint of the preparation was established by using high-performance liquid chromatography(HPLC); the similarity evaluation and the determination of common peaks were performed, and chemometric analysis was performed; the same method was used to determine the content of indicator components and the transfer rate was calculated. The chromatographic column was Venusil C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid solution (gradient elution); the column temperature was 30 ℃, and the detection wavelengths were 238 nm (0-37 min, 85-102 min) and 330 nm (37-85 min) at a flow rate of 1.0 mL/min with an injection volume of 10 μL. RESULTS The similarity of HPLC fingerprints for 15 batches of Pinghuo tea standard decoction was not lower than 0.968. A total of 24 common peaks were calibrated and 9 peaks were recognized, which were as follows neochlorogenic acid (peak 3), chlorogenic acid (peak 6), geniposide (peak 9), glycyrrhizin (peak 10), galuteolin (peak 11), isochlorogenic acid A (peak 14), luteolin (peak 21), kaempferol (peak 23) and glycyrrhizic acid (peak 24). Cluster analysis, principal component analysis and orthogonal partial least squares discriminant analysis showed consistent results, all of which could classify the 15 batches of samples into three categories. The linear range of indicator components in 15 batches of Pinghuo tea standard decoction, such as geniposide, luteolin, isochlorogenic acid A, glycyrrhizin, and glycyrrhizic acid, were 0.020 580-0.411 600, 0.001 617-0.080 850, 0.006 076-0.607 600, 0.005 125-0.071 740, and 0.017 288-0.432 200 mg/mL, respectively; RSDs of precision, repeatability, stability and recovery rate tests were all not higher than 4% (n=6). The mass fractions ranged 3.227 9-10.002 2, 0.297 4-0.554 6, 3.350 1-6.159 6, 0.720 6-1.073 3, 2.003 1-3.030 1 mg/g; transfer rates from the pieces and standard decoction were 19.762 8%-35.840 5%, 12.123 3%-21.254 0%, 46.097 2%-82.869 4%, 58.708 8%-91.629 6%, 39.114 3%-63.710 6%. The transfer rates of the extract from 15 batches of Pinghuo tea standard decoction ranged from 61.15%-84.68%. CONCLUSIONS Established HPLC fingerprint and content determination methods in this study are simple and accurate, which can provide reference for the quantitative value transfer study, quality control, clinical application and the development of subsequent formulations of Pinghuo tea standard decoction.
3.Epidemiological characteristics of scrub typhus in Huai'an, Jiangsu Province in 2006 - 2024
Lei XU ; Zhizhen CUI ; Qiang GAO ; Hao JU ; Chuanyu WAN ; Ranfeng HANG ; Shiyao WU ; Ben CAI ; Zheng ZHANG ; Haiyan GE
Journal of Public Health and Preventive Medicine 2025;36(6):39-42
Objective To describe and analyze the epidemiological characteristics of scrub typhus in Huai'an, Jiangsu Province from 2006 to 2024 and explore the long-term incidence trend and distribution of high-risk areas, and to formulate targeted prevention and control strategies. Methods The scrub typhus case report data of Huai'an from 2006 to 2024 in the Chinese Disease Prevention and Control Information System were extracted for descriptive analysis. Results A total of 898 cases of scrub typhus were reported in Huai'an, with an average annual incidence rate of 0.96 per 100 000 from 2006 to 2024. There was a turning point in the incidence trend of scrub typhus in 2011. From 2006 to 2011, the annual percentage change (APC) was 47.09% (95% CI: 7.53 - 859.39), and the upward trend was statistically significant (P < 0.05). From 2012 to 2024, the APC was -2.12% (95% CI: -29.09 - 3.75), and the downward trend was not statistically significant. October and November were the high-incidence months, and the total concentration from 2006 to 2024 was 0.93, indicating that scrub typhus had strict seasonality. The circular distribution method estimated that the peak period of the epidemic was from October 11th to November 25th, and the peak day of incidence was November 3rd. Jinhu County was a high-incidence area. The ratio of male to female cases was 1.03. The age group with the highest reported incidence was 40 to < 80 years old. The occupation with the highest proportion was farmers, accounting for 78.03%. Conclusion From 2006 to 2024, scrub typhus in Huai'an shows a peak every 3 - 4 years. Middle-aged and elderly farmers are the key population at risk, and Jinhu County is a key area. In the future, targeted health education should be carried out to effectively control the prevalence of scrub typhus.
4.Clinical characteristics and prognosis analysis of T-lymphoblastic lymphoma
Xiyu LI ; Min ZHANG ; Jingjing ZHANG ; Chunyan YANG ; Qian HUANG ; Haiyan WANG ; Lu JIA ; Lulu CHEN ; Hao ZHANG
Journal of Leukemia & Lymphoma 2025;34(1):30-33
Objective:To investigate the clinical characteristics and prognosis of T-lymphoblastic lymphoma (T-LBL).Methods:A retrospective case series study was conducted. Clinical data of patients diagnosed with T-LBL at the Affiliated Hospital of Jining Medical University from January 2013 to March 2023 were retrospectively analyzed, and their clinical characteristics and prognosis were statistically analyzed.Results:A total of 22 T-LBL patients were included. Among them, there were 19 males (86.4%) and 3 females (13.6%), and the median age at onset was 19.5 (15, 28) years old. Based on Ann Arbor staging, 3 cases (13.6%) were classified as stage Ⅰ-Ⅱ, while 19 cases (86.4%) were stage Ⅲ-Ⅳ; 10 cases (45.5%) presented with B symptoms, 12 cases (54.5%) without B symptoms; 16 cases (72.7%) showed elevated lactic dehydrogenase (LDH) level. At onset, 7 patients (31.8%) had mediastinal masses, 3 patients (13.6%) had central nervous system involvement, and 17 patients (77.3%) had bone marrow involvement. The overall response rate (ORR) and complete remission rate among the 22 patients were 81.82% (18/22) and 31.82% (7/22), respectively. The ORR was 84.21% (16/19) in 19 patients treated with ALL-like regimens. Among 3 patients treated with NHL-like regimens, 1 case achieved complete remission and 1 case achieved partial remission. Seven patients received allogeneic hematopoietic stem cell transplantation, with a median overall survival (OS) time of 22 months; the median OS time of patients without allogeneic hematopoietic stem cell transplantation was 14 months. The 3-year OS rates in the allogeneic hematopoietic stem cell transplantation group and group without allogeneic hematopoietic stem cell transplantation were 64.30% and 16.00%, and the difference in OS between the two groups was statistically significant ( P = 0.043). Two patients with disease progression prior to transplantation died of multidrug-resistant bacterial infections after transplantation. Conclusions:T-LBL is rare, and it is a highly aggressive tumor that predominantly occurs in adolescent males. Allogeneic hematopoietic stem cell transplantation can prolong OS, reduce relapse and improve the prognosis of patients.
5.Clinical performance of fecal syndecan 2/tissue factor pathway inhibitor 2 gene methylation assay in colorectal cancer screening
Tiao ZHANG ; Yutong HAO ; Haiyan WEN ; Qijun LIU
Journal of Chongqing Medical University 2025;50(7):983-987
Objective:To investigate the clinical performance of fecal syndecan 2(SDC2)/tissue factor pathway inhibitor 2(TFPI2)gene methylation assay in prospective colorectal cancer screening.Methods:The individuals who underwent routine physical examina-tion were enrolled as subjects,and their fecal samples were collected and tested with fecal SDC2/TFPI2 gene methylation assay.In addition,enteroscopy was recommended for the subjects with positive results.Results:A total of 1215 subjects received fecal SDC2/TFPI2 gene methylation assay,among whom there were 708 male subjects and 507 female subjects,with a mean age of(44.7±13.9)years.Among all subjects,28 had positive test results,resulting in a positive rate of 2.30%,and among these 28 subjects,27(96.43%)underwent enteroscopy,among whom 16(59.26%)had abnormal findings.With enteroscopy and/or pathological examination as diag-nostic criteria,fecal SDC2/TFPI2 gene methylation assay had a positive predictive value of 7.41%for colorectal cancer,22.22%for progressive precancerous lesion,and 7.41%for non-progressive precancerous lesion.Conclusion:Fecal SDC2/TFPI2 gene methyla-tion assay shows good clinical performance in prospective colorectal cancer screening and thus provides a noninvasive method for the screening and auxiliary diagnosis of colorectal cancer.
6.Value of neuregulin 4 combined with γ-aminobutyric acid in predicting cognitive dysfunction among patients with severe obstructive sleep apnea-hypopnea syndrome
Hui WANG ; Haiyan XIAO ; Ping CHEN ; Hao ZHANG ; Yuanfang GONG ; Jinhong ZHANG ; Shuyan ZHANG ; Yongfei WEN
Journal of Clinical Medicine in Practice 2025;29(3):51-56
Objective To investigate the predictive value of neuregulin 4(Nrg4)combined withγ-aminobutyric acid(GABA)in cognitive dysfunction among patients with severe obstructive sleep apnea-hypopnea syndrome(OSAHS).Methods A total of 169 patients with severe OSAHS were se-lected as study subjects and divided into normal cognitive function group(n=89)and cognitive dys-function group(n=80)based on cognitive function assessment results.General information of the pa-tients was collected,and the levels of Nrg4 and GABA were detected by enzyme-linked immunosor-bent assay(ELISA).Receiver operating characteristic(ROC)curve analysis was used to evaluate the predictive value of Nrg4 and GABA for cognitive dysfunction in OSAHS patients.Results The proportions of patients with a history of hypertension and diabetes,as well as the levels of diastolic blood pressure,total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),and low-density lipoprotein cholesterol(LDL-C)were significantly higher in the cognitive dysfunction group than those in the normal cognitive function group(P<0.05).The levels of Nrg4 and GABA were significantly lower in the cognitive dysfunction group than in the normal cognitive function group(P<0.05).The Montreal Cognitive Assessment(MoCA)score in the cognitive dys-function group was significantly lower than that in the normal cognitive function group[(12.36±2.35)versus(28.25±1.02),P<0.05].Multivariate Logistic regression analysis revealed that a history of hypertension and diabetes,diastolic blood pressure,TC,TG,HDL-C,and LDL-C were risk factors for cognitive dysfunction in patients with severe OSAHS(P<0.05),while Nrg4,GABA,and MoCA scores were protective factors(P<0.05).ROC curve analysis showed that combined de-tection of Nrg4 and GABA had a higher predictive value for cognitive dysfunction in patients with se-vere OSAHS compared with either marker alone(P<0.05).Conclusion A history of hyperten-sion and diabetes,diastolic blood pressure,TC,TG,HDL-C,LDL-C,Nrg4,GABA,and MoCA scores are all factors influencing cognitive dysfunction in patients with severe OSAHS.Combined de-tection of Nrg4 and GABA can effectively predict cognitive dysfunction in these patients.
7.Comparison of Quality Change During Processing Process of Achyranthis Bidentatae Radix from Different Origins Based on Color-component Correlation Analysis
Haohan DUAN ; Hao JIA ; Jingwei LEI ; Chunjing YANG ; Caixia XIE ; Haiyan GONG ; Beibei ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(5):143-151
ObjectiveTaking Achyranthis Bidentatae Radix(ABR) from different origins as samples, to quantitatively analyze the chemical composition and chromaticity of ABR with different processing degrees, and clarify the correlation and change law between color and composition in the processing process of ABR, so as to provide reference for the quality evaluation of processed products of ABR. MethodThe colorimeter is used to measure the chromaticity values of three kinds of processing degrees of ABR in different origins to show the color value change trend during the processing process, and the color parameters of wine-processed and salt-processed products of ABR with different processing degrees were analyzed by principal component analysis(PCA), orthogonal partial least squares-discriminant analysis(OPLS-DA) and other analysis methods. The contents of eight representative components of ABR were measured by high performance liquid chromatography(HPLC), the correlation between chromaticity and each representative component was analyzed by Pearson correlation analysis, and the applicability of the selected eight representative components was further verified by Fisher linear discriminant analysis, and the wine-processed and salt-processed products of ABR with different processing degrees were grouped according to the degree of processing, and 48 samples of wine-processed and salt-processed products with different processing degrees were used as training samples. Taking the contents of 5-hydroxymethylfurfural, polypodine B, β-ecdysterone, 25R-inokosterone, 25S-inokosterone, ginsenoside Ro, chikusetsusaponin Ⅳa and polysaccharides as variables, the discriminant function was established respectively, and 12 samples of wine-processed and salt-processed products of ABR with different processing degrees were back-tested to verify the discriminant function and test the reliability of the function. ResultPCA and OPLS-DA results showed that ABR samples with different processing degrees were classified into clusters, and the results could significantly distinguish different processed products. During the process of wine and salt processing, the contents of 5-hydroxymethylfurfural, ginsenoside Ro, and chikusetsusaponin Ⅳa gradually increased with the deepening of the processing degree, while the contents of polypodine B, β-ecdysterone, 25R-inokosterone, 25S-inokosterone and polysaccharides showed a gradual decreasing trend, indicating these 8 components increased and decreased to different degrees in the process of wine and salt processing. The results of Pearson correlation analysis showed that the 5-hydroxymethylfurfural content of the samples with different processing degrees of wine-processed and salt-processed products were negatively correlated with the brightness value(L*) and the total color difference value(E*ab)(P<0.01), and positively correlated with the red-green value(a*) and the yellow-blue value(b*)(P<0.01), and that the content of polypodine B and polysaccharides were positively correlated with L* and E*ab(P<0.01). The discriminant functions of wine-processed and salt-processed products of ABR were established by Fisher linear discriminant analysis, and their accuracy rates in the training samples were 93.75% and 95.83%, respectively. Twelve test samples of wine-processed and salt-processed products with different processing degree were back substitution, and the correct rate was 100%. ConclusionThe trend of composition and color changes of ABR with different processing degrees in different production areas is relatively consistent, and the color value can better distinguish ABR with different processing degrees, and the color of ABR is related to some representative components in the processing process, indicating that the color can provide reference for the identification of the processing degree of ABR and the prediction of component content.
8.Design and innovation of a utility model patent for tracheal cannula fixation belt
Hao LIU ; Changle FENG ; Mengli YANG ; Haiyan XIE ; Qianqian LIANG
Chinese Critical Care Medicine 2024;36(1):90-92
Tracheostomy is a very common airway procedure in the treatment of critically ill neurological patients. At present, the traditional tracheal cannula fixation belt is easy to be contaminated, difficult to disinfect, and needs to be replaced regularly. It is prone to infection, skin injury, unplanned extubation and other adverse events, which cannot meet the clinical treatment effect and patient safety management. In order to overcome the above problems, the medical staff of the neurology intensive care unit of Henan Provincial People's Hospital designed a new type of tracheal cannula fixation belt to increase patient comfort and reduce complications, and obtained a National Utility Model Patent of China (ZL 2022 2 0855188.8). The main structure of the device includes a following shaped bending plate, a fastening belt, a locking pin, and a distance adjustment hole. The left and right sides of the shaped bending plate are equipped with fastening belts with breathable and anti-wear pads. The inner side of the left fastening belt is equipped with two sets of locking pins, and the outer surface of the right fastening belt and breathable and anti-wear pad is equipped with multiple sets of distance adjustment holes. Additionally, the back of the shaped bending plate is equipped with breathable buffer pads. The fastening belt can drive the following bending plate to stick tightly to the patient's neck. The operator installs the locking pin card into the distance adjustment hole according to the "one back" principle, and the fastening belts on both sides fix the device with the cooperation of the locking pin, greatly reducing the probability of excessive displacement of the tracheal tube during use, effectively improving the fixation effect of the device, strengthening the adaptability of the device to different personnel, and thus enhancing the practicality of the device. The new type of tracheal cannula fixation band is convenient, safe and efficient, which can increase patient comfort, reduce complications. It has certain clinical value and is suitable for clinical promotion.
9.Characteristics and significance of age-related changes in cervical uncinate process-related angle
Dezhou ZHANG ; Chaoqun WANG ; Jun SHI ; Kun LI ; Shaojie ZHANG ; Yuan MA ; Erfei HOU ; Danyang ZHAO ; Yunteng HAO ; Simin WANG ; Xiaohe LI ; Haiyan WANG ; Zhijun LI ; Xing WANG
Chinese Journal of Tissue Engineering Research 2024;28(36):5766-5772
BACKGROUND:As a unique structure of the cervical spine,the occurrence,development and progression of the uncovertebral joint directly affect the stability and range of motion of the cervical spine,and are also closely related to the pathogenesis of cervical spondylosis.A thorough understanding of the developmental characteristics of the uncovertebral joint is of great significance for the pathogenesis,diagnosis,and treatment of cervical spondylosis. OBJECTIVE:By using imaging and three-dimensional reconstruction technology to measure and observe the cervical uncinate process-related angle in a large sample of different age groups,the aim is to reveal the characteristics of its changes with age and vertebral growth,as well as its relationship with cervical spine stability. METHODS:Using a retrospective research design,we collected 1 447 cases of raw CT imaging data that meet the study requirements for complete cervical spine segments.The raw data were imported into Mimics 21.0 software in DICOM format for post-processing and measurement of angle of uncinate process and sagittal angle of uncinate process.The data were grouped based on gender,age,and side. RESULTS AND CONCLUSION:(1)With the increase of vertebral sequence,the angle of uncinate process increased in a V-shaped shape,and the lowest peak was at C5.The overall population showed a sharp peak with the increase of age,and the peak value mostly occurred in the age range of 30-39 years.(2)The sagittal angle of the uncinate process increased like a fishhook with the increase of the vertebral sequence,and the overall angle of the uncinate process increased with age,and the peak value mostly occurred in the age range of 20-29 years.The uncinate process angle and sagittal angle showed only partial significant differences between sides and genders(P<0.05).(3)It is concluded that the angle of the uncinate process increased with the increase of vertebral sequence in a V-shaped manner.The sagittal angle of the uncinate process increases like a fish hook with increasing vertebral order,while the two angles generally peak with increasing age.The angle of the uncinate process is about 131°,which may be closely related to the stability of the cervical spine,while the sagittal angle of the uncinate process is about 14°,and its function may play a certain role in limiting the excessive rotation of the cervical spine.
10.Effect of Sinisan on Oxidative Stress in Cholestatic Hepatitis Rats Based on Nrf2/HO-1 Signaling Pathway
Dan CAO ; Qi CHEN ; Xiaolu CHEN ; Linzhen CHEN ; Haiyan WANG ; Juhui HAO ; Wei ZHANG ; Zhiqiang MA
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(12):1-7
ObjectiveBased on the nuclear factor erythroid 2 related factor 2 (Nrf2)/heme oxygenase-1 (HO-1) signaling pathway, this paper explores the effect of Sinisan (SNS) on liver oxidative stress injury in cholestatic hepatitis rats and its mechanism. MethodThirty 6-week-old male SD rats were randomly divided into a control group, model group, low and high dose groups of SNS (2.5 and 5 g·kg-1) and ursodeoxycholic acid group (UDCA, 63 mg·kg-1), with six rats in each group. Rats were administrated for seven consecutive days. On the 5th day, the control group was given olive oil of 10 mL·kg-1, and the other groups were given alpha-naphthalene isothiocyanate (ANIT) of 80 mg·kg-1. The serum biochemical indicator levels of cholestasis and the content of antioxidant factors in rat liver were detected by enzyme-linked immunosorbent assay (ELISA). Hematoxylin-eosin (HE) staining was used to observe the pathological changes in liver tissue. The relative mRNA and protein expressions of Nrf2, HO-1, and quinone oxidoreductase 1 (NQO1) in liver tissue were detected by real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) and Western blot. ResultCompared with the control group, the model group showed a significant increase in the serum biochemical indicator levels of cholestasis and the content of antioxidant factors in liver tissue (P<0.01). There were obvious pathological changes in the model group such as the disordered arrangement of hepatocytes, obvious congestion and necrosis in the portal area, infiltration of inflammatory cells, and destruction of the interlobular bile duct. The relative mRNA and protein expressions of Nrf2, HO-1, and NQO1 in liver tissue were significantly down-regulated in the model group (P<0.05, P<0.01). Compared with the model group, the groups of SNS showed a significant decrease in the serum biochemical indicator levels of cholestasis and the content of antioxidant factors in liver tissue (P<0.01), and the pathological liver injury was obviously improved. The necrotic area was reduced, and the infiltration of inflammatory cells was decreased. In addition, there was a small amount of extravasated blood in the interlobular vein. The relative mRNA and protein expressions of Nrf2, HO-1, and NQO1 in liver tissue were significantly up-regulated (P<0.05, P<0.01). ConclusionSNS can significantly improve liver injury in cholestatic hepatitis rats, and its mechanism may be related to the inhibition of oxidative stress response mediated by the Nrf2/HO-1 signaling pathway.


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