1.Near-infrared Spectroscopic Quality Control on Coating Process of Vitamin C Yinqiao Tablets
Qing TAO ; Li JIANG ; Youbing ZHONG ; Zhengji JIN ; Xiaoyong RAO ; Wei LIU ; Yan HE ; Yongkun GUO ; Xiaojian LUO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(14):184-190
ObjectiveTo construct a quantitative prediction model of three indicators(moisture absorption rate, film thickness and coating weight gain) during the coating process of Vitamin C Yinqiao tablets(VCYT) by near-infrared spectroscopy(NIRS), and to realize the endpoint judgment. MethodReal-time NIRS data of 4 batches of VCYT during the coating process were collected by diffuse reflection method. The coating method employed was the rolling coating method, and the samples were obtained at the spray stage from the coater's sampling port every 10 minutes, and 57 batches of samples(about 1 800 tablets) were collected at various coating times, the tablets were embedded in molten paraffin, cut longitudinally, and observed by stereomicroscope. The film thickness, with a target value of 38 μm, was then measured using Motic Images Advanced 3.2 software. Furthermore, the mositure absorption rate of samples, aiming for a target value of 3%, was determined in accordance with guiding principles for drug hygroscopicity testing in the 2020 edition of Chinese Pharmacopoeia, and 3 samples were randomly selected from each batch(10 tablets per batch), and the coating weight gain was calculated(target value of 4%). Partial least squares regression(PLSR) was used to construct a quantitative model of the 3 coating indicators, and the predicted values of the coating indicators were smoothed using the moving average method and used to determine the coating endpoints. ResultThe prediction determination coefficients(Rp2) for moisture absorption rate, film thickness and coating weight gain were 0.933 4, 0.932 6 and 0.965 9, the root mean square errors of prediction(RMSEP) were 0.163 5%, 1.870 9 μm and 0.240 3%, the relative percent deviations(RPD) were 3.711 0, 2.760 7 and 5.415 8, respectively. The results of the external validation set demonstrated that the real-time predicted values obtained by the models exhibited the same trend as the measured values, and the coating endpoint could be accurately predicted(with a prediction error of less than 7.32 min and a relative error of less than 5.63%). ConclusionThe established NIRS model exhibits excellent predictive performance and can be used for quality control of VCYT during the coating process.
2.Improved unilateral puncture PVP based on 3D printing technology for the treatment of osteoporotic vertebral com-pression fracture
Wei-Li JIANG ; Tao LIU ; Qing-Bo ZHANG ; Hui CHEN ; Jian-Zhong BAI ; Shuai WANG ; Jia-Wei CHENG ; Ya-Long GUO ; Gong ZHOU ; Guo-Qi NIU
China Journal of Orthopaedics and Traumatology 2024;37(1):7-14
Objective To investigate the clinical effect of unilateral percutaneous vertebroplasty(PVP)combined with 3D printing technology for the treatment of thoracolumbar osteoporotic compression fracture.Methods A total of 77 patients with thoracolumbar osteoporotic compression fractures from October 2020 to April 2022 were included in the study,all of which were vertebral body compression fractures caused by trauma.According to different treatment methods,they were di-vided into experimental group and control group.Thirty-two patients used 3D printing technology to improve unilateral transpedicle puncture vertebroplasty in the experimental group,there were 5 males and 27 females,aged from 63 to 91 years old with an average of(77.59±8.75)years old.Forty-five patients were treated with traditional bilateral pedicle puncture vertebroplasty,including 7 males and 38 females,aged from 60 to 88 years old with an average of(74.89±7.37)years old.Operation time,intraoperative C-arm X-ray times,anesthetic dosage,bone cement injection amount,bone cement diffusion good and good rate,complications,vertebral height,kyphotic angle(Cobb angle),visual analogue scale(VAS),Oswestry disability index(ODI)and other indicators were recorded before and after surgery,and statistically analyzed.Results All patients were followed up for 6 to 23 months,with preoperative imaging studies,confirmed for thoracolumbar osteoporosis com-pression fractures,two groups of patients with postoperative complications,no special two groups of patients'age,gender,body mass index(BMI),time were injured,the injured vertebral distribution had no statistical difference(P>0.05),comparable data.Two groups of patients with bone cement injection,bone cement dispersion rate,preoperative and postoperative vertebral body height,protruding after spine angle(Cobb angle),VAS,ODI had no statistical difference(P>0.05).The operative time,intra-operative fluoroscopy times and anesthetic dosage were statistically different between the two groups(P<0.05).Compared with the traditional bilateral puncture group,the modified unilateral puncture group combined with 3D printing technology had shorter operation time,fewer intraoperative fluoroscopy times and less anesthetic dosage.The height of anterior vertebral edge,kyphosis angle(Cobb angle),VAS score and ODI of the affected vertebrae were statistically different between two groups at each time point after surgery(P<0.05).Conclusion In the treatment of thoracolumbar osteoporotic compression fractures,3D printing technology is used to improve unilateral puncture PVP,which is convenient and simple,less trauma,short operation time,fewer fluoroscopy times,satisfactory distribution of bone cement,vertebral height recovery and kyphotic Angle correction,and good functional improvement.
3.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
4.A case report of primary Müllerian adenosarcoma of the ovary and literature review
Tao PU ; Fang-Fang ZHONG ; Xiao-Yan ZHANG ; Dong-Dong SHI ; Cong-Jian XU ; Hong-Yuan JIANG ; Ling-Ling FAN
Fudan University Journal of Medical Sciences 2024;51(5):850-856
This article reports a case of primary Müllerian adenosarcoma(MA)of the ovary admitted to the Obstetrics and Gynecology Hospital,Fudan University in 2022,reviews the literature on this rare disease,and shares the experience of its diagnosis and treatment.The patient was a 29-year-old unmarried woman who underwent laparoscopic resection of an ovarian lesion in another hospital.Intraoperatively,it was observed that"the right ovary was enlarged with a cauliflower-shaped mass at the lower pole,measuring about 11 cm×8 cm,unencapsulated,with a fish-like texture,which was completely excised and sent for examination."Postoperative consultation with a(tertiary)hospital in Beijing and our pathology department suggested the diagnosis of ovarian adenosarcoma.Therefore,we performed a comprehensive staged surgery for the patient,i.e.,laparoscopic right salpingo-oophorectomy,cystectomy of the left ovary,omentectomy,multiple peritoneal biopsies,and hysteroscopic resection of cervical canal lesions.The patient received four cycles of postoperative chemotherapy with paclitaxel and ifosfamide.After chemotherapy,the patient has been regular followed up and showed no signs of recurrence during the almost 2-year postoperative follow-up period.
5.Association of abnormal early postoperative blood glucose concentration with short-term prognosis and establishment of a prediction model in patients undergoing non-small cell lung cancer surgery
Gang ZHONG ; Nian-Ping MO ; Zheng-Yao YANG ; Tao JIANG ; Dong-Fang TANG ; Xiao-Yong SHEN
Fudan University Journal of Medical Sciences 2024;51(6):949-956
Objective To investigate the effect of early postoperative abnormal blood glucose on the short-term prognosis of non-small cell lung cancer(NSCLC),and to analyze the clinical characteristics and risk factors related to poor early prognosis.Methods A total of 897 patients with NSCLC who underwent thoracoscopic surgery in Huadong Hospital,Fudan University from Jan 2020 to Aug 2021 were divided into hyperglycemia(HG)group(>7.8 mmol/L)and normal blood glucose(NG)group(≤7.8 mmol/L and≥3.9 mmol/L)according to the early postoperative blood glucose values.Additionally,the patients were divided into higher blood glucose fluctuation group(≥4 mmol/L)and the group with lower blood glucose fluctuation(<4 mmol/L)basing on the fasting blood glucose.Using Logistic regression models,column line charts,ROC curves and other methods,we aimed to clarify the impact of early postoperative blood glucose abnormalities on short-term prognosis,explore clinical characteristics associated with poor short-term outcomes,identify other high-risk factors,and establish relevant risk prediction models.Results Compared with the NG group,the incidence of postoperative pneumonia,thromboembolism,ICU admission rate,total length of hospital stay and hospital cost were significantly higher in the HG group(P<0.05).Higher blood glucose fluctuation group had a greater risk of ICU admission(P=0.003).Logistic regression analysis showed that age,preoperative fasting glucose,white blood cell count and cytokeratin 19 fragment antigen 21-1(CYFRA21-1)were risk factors for postoperative hyperglycemia(P<0.05).Contrary to the effect of BMI,diabetes,male patients,higher blood glucose fluctuation,white blood cell count and age were the risk factors for postoperative adverse events(P<0.05).The AUC of the column line chart model was 0.661(95%CI:0.624-0.698),indicating good discriminative ability for predicting poor short-term prognosis postoperatively.Calibration curves also demonstrated good consistency between predicted and actual probabilities.Conclusion Early postoperative blood glucose fluctuations independently impact the short-term prognosis of thoracoscopic NSCLC patients.Blood glucose combined with gender,BMI,white blood cell count,age and diabetes history can serve as predictive factors for poor short-term prognosis postoperatively.Additionally,a column line chart constructed based on these factors may aid clinicians in early intervention for NSCLC patients with indications.
6.Development of a Prognostic Model for Overall Survival Adult Patients with Core Binding Factor Acute Myeloid Leukaemia
Lu-Yao SHI ; Ling-Ling LI ; Tao LI ; Ya-Fei LI ; Yan-Fang LIU ; Zhong-Xing JIANG ; Shu-Juan WANG ; Chong WANG
Journal of Experimental Hematology 2024;32(3):693-701
Objective:To analyze the factors affecting overall survival(OS)of adult patients with core-binding factor acute myeloid leukemia(CBF-AML)and establish a prediction model.Methods:A total of 216 newly diagnosed patients with CBF-AML in the First Affiliated Hospital of Zhengzhou University from May 2015 to July 2021 were retrospectively analyzed.The 216 CBF-AML patients were divided into the training and the validation cohort at 7:3 ratio.The Cox regression model was used to analyze the clinical factors affecting OS.Stepwise regression was used to establish the optimal model and the nomogram.Receiver operating characteristic(ROC)curve,calibration curve and decision curve analysis(DCA)were used to evaluate the model performance.Results:Age(≥ 55 years old),peripheral blood blast(≥80%),fusion gene(AML1-ETO),KIT mutations were identified as independent adverse factors for OS.The area under the ROC curve at 3-year was 0.772 and 0.722 in the training cohort and validation cohort,respectively.The predicted value of the calibration curve is in good agreement with the measured value.DCA shows that this model performs better than a single factor.Conclusion:This prediction model is simple and feasible,and can effectively predict the OS of CBF-AML,and provide a basis for treatment decision.
7.Associations of the magnesium depletion score and magnesium intake with diabetes among US adults: an analysis of the National Health and Nutrition Examination Survey 2011-2018
Zhong TIAN ; Shifang QU ; Yana CHEN ; Jiaxin FANG ; Xingxu SONG ; Kai HE ; Kexin JIANG ; Xiaoyue SUN ; Jianyang SHI ; Yuchun TAO ; Lina JIN
Epidemiology and Health 2024;46(1):e2024020-
OBJECTIVES:
The magnesium depletion score (MDS) is considered more reliable than traditional approaches for predicting magnesium deficiency in humans. We explored the associations of MDS and dietary magnesium intake with diabetes.
METHODS:
We obtained data from 18,853 participants in the National Health and Nutrition Examination Survey 2011-2018. Using multivariate regression and stratified analysis, we investigated the relationships of both MDS and magnesium intake with diabetes. To compute prevalence ratios (PRs), we employed modified Poisson or log-binomial regression. We characterized the non-linear association between magnesium intake and diabetes using restricted cubic spline analysis.
RESULTS:
Participants with MDS ≥2 exhibited a PR of 1.26 (95% confidence interval [CI], 1.19 to 1.34) for diabetes. Per-standard deviation (SD) increase in dietary magnesium intake was associated with a lower prevalence of diabetes (PR, 0.91; 95% CI, 0.87 to 0.96). Subgroup analyses revealed a positive association between MDS ≥2 and diabetes across all levels of dietary magnesium intake, including the lowest (PR, 1.35; 95% CI, 1.18 to 1.55), middle (PR, 1.23; 95% CI, 1.12 to 1.35), and highest tertiles (PR, 1.25; 95% CI, 1.13 to 1.37; pinteraction<0.001). Per-SD increase in magnesium intake was associated with lower diabetes prevalence in participants with MDS <2 (PR, 0.92; 95% CI, 0.87 to 0.98) and those with MDS ≥2 (PR, 0.91; 95% CI, 0.84 to 0.98; pinteraction=0.030).
CONCLUSIONS
MDS is associated with diabetes, particularly among individuals with low magnesium intake. Adequate dietary magnesium intake may reduce diabetes risk, especially in those with high MDS.
8.Clinical treatment guideline for pulmonary blast injury (version 2023)
Zhiming SONG ; Junhua GUO ; Jianming CHEN ; Jing ZHONG ; Yan DOU ; Jiarong MENG ; Guomin ZHANG ; Guodong LIU ; Huaping LIANG ; Hezhong CHEN ; Shuogui XU ; Yufeng ZHANG ; Zhinong WANG ; Daixing ZHONG ; Tao JIANG ; Zhiqiang XUE ; Feihu ZHOU ; Zhixin LIANG ; Yang LIU ; Xu WU ; Kaican CAI ; Yi SHEN ; Yong SONG ; Xiaoli YUAN ; Enwu XU ; Yifeng ZHENG ; Shumin WANG ; Erping XI ; Shengsheng YANG ; Wenke CAI ; Yu CHEN ; Qingxin LI ; Zhiqiang ZOU ; Chang SU ; Hongwei SHANG ; Jiangxing XU ; Yongjing LIU ; Qianjin WANG ; Xiaodong WEI ; Guoan XU ; Gaofeng LIU ; Junhui LUO ; Qinghua LI ; Bin SONG ; Ming GUO ; Chen HUANG ; Xunyu XU ; Yuanrong TU ; Liling ZHENG ; Mingke DUAN ; Renping WAN ; Tengbo YU ; Hai YU ; Yanmei ZHAO ; Yuping WEI ; Jin ZHANG ; Hua GUO ; Jianxin JIANG ; Lianyang ZHANG ; Yunfeng YI
Chinese Journal of Trauma 2023;39(12):1057-1069
Pulmonary blast injury has become the main type of trauma in modern warfare, characterized by externally mild injuries but internally severe injuries, rapid disease progression, and a high rate of early death. The injury is complicated in clinical practice, often with multiple and compound injuries. Currently, there is a lack of effective protective materials, accurate injury detection instrument and portable monitoring and transportation equipment, standardized clinical treatment guidelines in various medical centers, and evidence-based guidelines at home and abroad, resulting in a high mortality in clinlcal practice. Therefore, the Trauma Branch of Chinese Medical Association and the Editorial Committee of Chinese Journal of Trauma organized military and civilian experts in related fields such as thoracic surgery and traumatic surgery to jointly develop the Clinical treatment guideline for pulmonary blast injury ( version 2023) by combining evidence for effectiveness and clinical first-line treatment experience. This guideline provided 16 recommended opinions surrounding definition, characteristics, pre-hospital diagnosis and treatment, and in-hospital treatment of pulmonary blast injury, hoping to provide a basis for the clinical treatment in hospitals at different levels.
9.Application of flipped classroom combined with problem-based learning in the teaching of diagnostic audiology
Wenqi ZUO ; Lizhu JIANG ; Yi QIAN ; Tao CHEN ; Shixun ZHONG ; Houyong KANG ; Guohua HU
Chinese Journal of Medical Education Research 2023;22(9):1343-1347
Objective:To investigate the teaching effect of flipped classroom combined with problem-based learning (PBL) in the teaching of the Diagnostic Audiology course.Methods:A total of 72 undergraduate students majoring in audiology and speech rehabilitation in the classes of 2019 and 2020 in Chongqing Medical University were enrolled as subjects, and three chapters of the Diagnostic Audiology course were selected for teaching reform. The 34 students in the class of 2019 were enrolled as control group and received lecture-based learning (LBL), and the 38 students in the class of 2020 were enrolled as experimental group and received flipped classroom combined with PBL. The teaching effect was evaluated by comparing the two groups in terms of classroom test scores, classroom participation scores, degree of satisfaction with teaching effect, and overall satisfaction with teaching. SPSS 23.0 software was used to perform the t-test, the chi-square test, and the Mann-Whitney U test. Results:The experimental group had a significantly higher classroom test score than the control group (25.95±1.21 vs. 23.21±1.55, P<0.001). In terms of classroom participation scores, the experimental group had significantly higher scores of participation in class discussion, cooperative and collaborative abilities, and questioning skills than the control group (all P<0.001). In terms of the degree of satisfaction with teaching, compared with the control group, the experimental group had significantly higher degrees of satisfaction in the dimensions such as interest in learning, mastery of theoretical knowledge, teamwork and collaboration abilities, self-learning ability, and self-presentation ( P=0.005, 0.009, 0.001, 0.016, and 0.005). In addition, the experimental group had a significantly higher degree of overall satisfaction with teaching than the control group ( P=0.006). Conclusion:Flipped classroom combined with PBL has a good teaching effect in the Diagnostic Audiology course and thus holds promise for further application.
10.Survival of Non-small Cell Lung Cancer Patients Treated with Fuzheng Gushe Therapy: A Real World Study
Tao YANG ; Zhong LI ; Lizheng HAO ; Jian CHEN ; Xueying ZHU ; Min JIANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(9):188-195
ObjectiveTo analyze the long-term survival of non-small cell lung cancer (NSCLC) patients treated with Fuzheng Gushe therapy in the real world. MethodA retrospective cohort study was carried out with the NSCLC patients treated with Fuzheng Gushe therapy from January 2014 to December 2018 in Dongzhimen Hospital, Beijing University of Chinese Medicine as the integrated traditional Chinese medicine (TCM) and western medicine cohort. The NSCLC data from January 2011 to December 2015 in the Surveillance, Epidemiology, and End Results (SEER) database were downloaded as the western medicine cohort. The propensity score matching (PSM) was employed to balance the confounding factors between the groups, and comparable samples were obtained from the two groups. The Log-rank test was conducted to compare the overall survival between the groups and the survival curves were established. ResultThe integrated TCM and western medicine cohort and the western medicine cohort included 511 and 5 022 NSCLC patients, respectively. The age, sex, and chemotherapy had no significant differences between the two cohorts, while pathological type, lymph node metastasis (N), distant metastasis (M), surgery, and radiotherapy were different between the two cohorts (P<0.05). After PSM, 122 comparable samples were obtained. The overall survival analysis showed that the total survival of the integrated TCM and western medicine cohort was better than that of the western medicine cohort (P<0.05). The stratified survival analysis showed that the integrated TCM and western medicine cohort had survival advantages in females, males, the young, and adenocarcinoma, N+, and M+ patients (P<0.05). ConclusionFuzheng Gushe therapy can significantly improve the overall survival of NSCLC patients, especially in the females, the males, the young, and the patients with adenocarcinoma, lymph node metastasis, and distant metastasis.

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