1.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
2. Mechanism of ellagic acid improving cognitive dysfunction in APP/PS double transgenic mice based on PI3K/AKT/GSK-3β signaling pathway
Li-Li ZHONG ; Xin LU ; Ying YU ; Qin-Yan ZHAO ; Jing ZHANG ; Tong-Hui LIU ; Xue-Yan NI ; Li-Li ZHONG ; Yan-Ling CHE ; Dan WU ; Hong LIU
Chinese Pharmacological Bulletin 2024;40(1):90-98
Aim To investigate the effect of ellagic acid (EA) on cognitive function in APP/PS 1 double- transgenic mice, and to explore the regulatory mechanism of ellagic acid on the level of oxidative stress in the hippocampus of double-transgenic mice based on the phosphatidylinositol 3-kinase/protein kinase B/glycogen synthase kinase-3 (PI3K/AKT/GSK-3 β) signaling pathway. Methods Thirty-two SPF-grade 6-month-old APP/PS 1 double transgenic mice were randomly divided into four groups, namely, APP/PS 1 group, APP/PS1 + EA group, APP/PS1 + LY294002 group, APP/PS 1 + EA + LY294002 group, with eight mice in each group, and eight SPF-grade C57BL/6J wild type mice ( Wild type) were selected as the blank control group. The APP/PS 1 + EA group was given 50 mg · kg
3.Clinical observation of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia
Ling ZHOU ; Qiuyuan PENG ; Pan ZHAO ; Jin WEI ; Xiaojing LIN ; Xingli ZOU ; Wenfeng LUO ; Jing WANG ; Kunying XIE ; Xianglong LI ; Yang LIU ; Xun NI
China Pharmacy 2024;35(14):1743-1747
OBJECTIVE To observe the short-term efficacy and safety of venetoclax combined with homoharringtonine and cytarabine in the treatment of acute myeloid leukemia (AML). METHODS The data of 40 newly diagnosed AML patients admitted to our hospital from October 2022 to November 2023 were retrospectively collected and divided into observation group and control group according to treatment plan, with 20 cases in each group. The patients in the control group were given Daunorubicin hydrochloride for injection+Cytarabine for injection, and the patients in the observation group were given Venetoclax tablets+ Homoharringtonine injection+Cytarabine for injection. The patients in both groups were given relevant medicine, with 28 days as one cycle. The short-term efficacy, negative rate of minimal residual disease (MRD), duration of granulocyte deficiency, duration of platelet (PLT) <20×109 L-1, transfusion volume of suspended red blood cells and platelet, and the occurrence of adverse drug reactions were evaluated in both groups after 1 cycle of induction chemotherapy. RESULTS The complete remission or complete remission with incomplete hematologic recovery (CR/CRi) rate in the observation group was significantly higher than control group (P<0.05), and the negative rate of MRD in the observation group was also significantly higher than control group (P<0.05). However, in low-, medium- and high-risk patients, there was no statistical significance in CR/CRi rates between the two groups (P>0.05). There were no significant differences in the duration of agranulocytosis, the duration of PLT <20×109 L-1, the amount of suspended red blood cell transfusion, the amount of platelet transfusion, the incidence of hematologic toxicity and the incidence of non-hematologic toxicity between 2 groups (P>0.05). CONCLUSIONS Venetoclax combined with homoharringtonine and cytarabine show good short-term efficacy and safety in the treatment of AML.
4.Decision characteristics in adolescents with mood disorders and suicide attempts
Tingjuntao NI ; Mengzhe LI ; Wanrong LI ; Hanqing ZHAO ; Qingjiu CAO ; Li AN
Chinese Mental Health Journal 2024;38(3):247-253
Objectives:To analyze the performance and characteristics of adolescent suicide attempters in dif-ferent dimensions of decision making,a computational model was used in this study.Methods:A total of 70 adoles-cent suicide attempters with mood disorders meeting the International Statistical Classification of Diseases and Re-lated Health Problems,Tenth Revision(ICD-10)diagnosis,40 non-suicide attempters with mood disorder,and 49 normal controls were included.By using the MCQ and IGT and through computational model analysis,the adoles-cent suicide attempters'performance and underlying cognitive components in impulsive decision making and value-and learning-based decision making were analyzed.Results:The overall delay discounting rates showed no signifi-cant differences(P>0.05)among the group of suicide attempters,patient controls,and normal controls in the MCQ.This rate was significantly higher in suicide attempters and non-suicide attempters than in normal controls(P<0.05);there was no significant difference between the three groups of subjects'decision making performance in the IGT(P>0.05).Computational model analysis revealed that compared to non-suicide attempters and normal controls,suicide attempters showed reduced sensitivity to the outcome as well as reduced exploratory behavior(Pa-rameter estimate with non-overlapping 80%HDI).Conclusion:Adolescent suicide attempters may not be able to learn from the outcome of the decision and explore more possible options to resolve the crisis,as well as impulsive decision-making impairment may be associated with depressed states rather than suicide attempts.
5.Prediction of Ki-67 expression status in breast cancer based on ultrasound radiomics combined with clinicopathologic features
Heng ZHANG ; Sai ZHANG ; Tong ZHAO ; Xiaoqin LI ; Xiaoli ZHOU ; Xinye NI
Chinese Journal of Ultrasonography 2024;33(2):165-173
Objective:To investigate the prediction of the tumor proliferation antigen(Ki-67) expression status in breast cancer patients based on ultrasound radiomics combined with clinicopathologic features.Methods:Breast cancer patients who underwent 2D ultrasound and Ki-67 examination from January 2018 to February 2022 in Changzhou Second People′s Hospital, Nanjing Medical University were retrospectively analyzed. Among them, 427 patients from Chengzhong campus were randomly divided into training and validation sets in the ratio of 8∶2, and 229 patients from Yanghu campus were used as an independent external test set. Radiomics features were extracted from the region of interest of 2D ultrasound images, and the Mann-Whitney U test, recursive feature elimination, and minimum absolute shrinkage and selection operators were used to perform feature dimensionality reduction and to establish a radiomics score(Rad-score). Subsequently, single/multifactor logistic regression regression analyses were used to construct a joint prediction model based on Rad-score and clinicopathological features. Model performance and utility were assessed using the subject operating characteristic area under the curve (AUC), calibration curve, and decision curve analyses. Results:The AUCs of the joint model for predicting Ki-67 expression status in breast cancer in the training, validation, and test sets were 0.858, 0.797, and 0.802, respectively, which were superior to those of the radiomics (0.772, 0.731, and 0.713) and clinical models (0.738, 0.750, and 0.707). Calibration curve and decision curve analyses indicated that the joint model had good calibration and clinical value.Conclusions:A joint model based on ultrasound radiomics and clinicopathological features can effectively predict the Ki-67 expression status of breast cancer, which is expected to become a non-invasive tool for Ki-67 detection and provide clinicians with an important auxiliary diagnostic and therapeutic decision-making basis.
6.The effect of treatment duration with human urinary kallidinogenase on the efficacy and safety of acute ischemic stroke: a subgroup analysis of RESK study
Jun NI ; Ming YAO ; Lihua WANG ; Ming YU ; Runhui LI ; Lihong ZHAO ; Jiachun WANG ; Yinzhou WANG ; Xin WANG ; Haiqing SONG ; Benyan LUO ; Jiawei WANG ; Yining HUANG ; Liying CUI
Chinese Journal of Neurology 2024;57(3):225-232
Objective:To explore the impact of treatment duration with human urinary kallidinogenase (HUK) on the efficacy and safety of acute ischemic stroke (AIS).Methods:In this subgroup analysis of RESK study, a total of 990 AIS patients recruited from 65 centers in China between August 2015 and June 2020 were included and divided into short medication group (HUK for 8 days, n=185) or long medication group (HUK for 15 days or 21 days, n=805). The proportions of patients with modified Rankin Scale (mRS) score of 0, 0-1, 0-2 at 90 days, National Institutes of Health Stroke Scale (NIHSS) score change from baseline to 22 days, the proportions of patients with Barthel index (BI)≥95 at 90 days, and the incidences of adverse events were analyzed. Comparisons between groups were conducted using chi-square test, single factor and multivariate Logistic regression analysis, etc. Results:Multivariate regression analysis showed that the proportions of patients with 90-day mRS score of 0-2 [74.1% (137/185) vs 75.0% (604/805); OR=1.047, 95% CI 0.676-1.620, P=0.838] and 22-day NIHSS score change from baseline (4.60±2.00 vs 4.26±2.80; OR=-0.390, 95% CI -1.125-0.344, P=0.297) showed no statistically significant difference between the short medication and long medication groups; the proportions of patients with 90-day mRS score of 0-1 [48.1% (89/185) vs 59.1% (476/805); OR=0.674, 95%CI 0.463-0.983, P=0.041] and 90-day BI≥95 [43.6% (79/181) vs 55.1% (442/802); OR=0.614, 95%CI 0.420-0.897, P=0.012] were significantly lower in the short medication group than in the long medication group. There was no statistically significant difference in the incidences of adverse events between these 2 groups. Conclusions:In AIS patients, consecutive 8-day dosing of HUK improved immediate (22-day NIHSS score) and long-term outcome (90-day mRS score 0-2) and was safely tolerated. When applicable, extended duration of HUK could improve long-term disability-free rate (90-day mRS score 0-1) and quality of life (90-day BI) without increasing the risk of adverse events.
7.Influence of PVE and PVE combined with TACE on secondary hepatectomy and prognosis of hepatocellular carcinoma
Junsheng NI ; Yao LI ; Xue LIU ; Guojun HOU ; Linghao ZHAO ; Yuan YANG ; Yefa YANG ; Weiping ZHOU
Chinese Journal of Digestive Surgery 2024;23(2):257-264
Objective:To investigate the influencing of portal vein embolization (PVE) and PVE combined with transcatheter arterial chemoembolization (TACE) on secondary hepatectomy and prognosis of patients with initially unresectable hepatocellular carcinoma (HCC).Methods:The retrospective cohort study was conducted. The clinicopathological data of 102 patients with initially unresectable HCC who were admitted to the Third Affiliated Hospital of Naval Medical University from October 26,2015 to December 31,2022 were collected. There were 82 males and 20 females, aged 52(range,25?73)years. Of 102 patients, 72 cases undergoing PVE combined with TACE were set as the PVE+TACE group, and 30 cases undergoing PVE were set as the PVE group. Observation indicators: (1) surgical resection rate of secondary hepatectomy and increase of future liver remnant (FLR); (2) situations of secondary hepatectomy; (3) follow-up. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Count data were described as absolute numbers, and comparison between groups was conducted using the chi-square test or Fisher exact probability. Comparison of ordinal data was conducted using the Mann-Whitney U test. The Kaplan-Meier method was used to calculate survival rate and draw survival curve, and Log-Rank test was used for survival analysis. Results:(1) Surgical resection rate of secondary hepatectomy and increase of FLR. The surgical resection rate of secondary hepatectomy in the PVE+TACE group and the PVE group were 72.2%(52/72) and 53.3%(16/30), respectively, showing no significant difference between the two groups ( χ2=3.400, P>0.05). The surgical waiting time, increasing volume of FLR, growth rate of FLR in the 52 patients of PVE+TACE group receiving secon-dary hepatectomy were 20(range, 14?140)days, 140(range, 62?424)mL, 9.8(range, 1.5?26.5)mL/day, respectively. The above indicators in the 16 patients of PVE group receiving secondary hepatectomy were 16(range, 12?35)days, 160(range, 95?408)mL, 10.5(range, 1.2?28.0)mL/day, respectively. There was no significant difference in the above indicators between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( Z=1.830, 1.498, 1.266, P>0.05). (2) Situations of secondary hepatectomy. The operation time, rate of tumor necrosis (>90%, 60%?90%,<60%), cases with complications ≥ grade Ⅲa in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 200(range, 125?420)minutes, 8, 4, 40, 28, respectively. The above indicators in the 16 patients of PVE group receiving secondary hepatectomy were 170(range, 105?320)minutes, 0, 0, 16, 4, respectively. There were significant differences in the above indicators between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( Z=2.132, ?2.093, χ2=4.087, P<0.05). (3) Follow-up. Sixty-eight patients who completed the surgery were followed up for 40(range, 10?84)months. The 1-, 3-, 5-year recurrence free survival rate in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 73.0%, 53.3%, 35.4%, respectively. The above indicators in the 16 patients of PVE group were 62.5%, 37.5%, 18.8%, respectively. There was a significant difference in the recurrence free survival rate between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( χ2=4.035, P<0.05). The 1-, 3-, 5-year overall survival rate in the 52 patients of PVE+TACE group receiving secondary hepatectomy were 82.5%, 61.2%, 36.6%, respectively. The above indica-tors in the 16 patients of PVE group receiving secondary hepatectomy were 68.8%, 41.7%,20.8%, respectively. There was a significant difference in the overall survival rate between the 52 patients of PVE+TACE group and the 16 patients of PVE group ( χ2=4.767, P<0.05). Conclusion:Compared with PVE, PVE+TACE as stage Ⅰ surgery can increase the surgical resection rate of secondary hepatec-tomy and the recurrence free survival rate of patients with initially unresectable HCC, prolong the long-term survival time, but not influence the growth rate of FLR.
8.Expressions of cytokines and procalcitonin in infective endocarditis
Ruo-Xin WANG ; Liang FU ; Jin-Long ZHAO ; Zong-Hui CHEN ; Yin-Kai NI ; Feng LI
Journal of Regional Anatomy and Operative Surgery 2024;33(1):55-58
Objective To investigate the expressions of 12 cytokines(IL-1β,IL-2,IL-4,IL-5,IL-6,IL-8,IL-10,IL-12p70,IL-17,IFN-α,IFN-γ,TNF-α)and procalcitonin in patients with infective endocarditis(IE).Methods Ten IE patients admitted to our hospital from December 2021 to December 2022 were included into the IE group,10 patients with non-infectious and non-rheumatic valvular diseases who were admitted to our hospital at the same period were randomly selected as the control group,and blood sampling of all patients were conducted at admission.The expressions of 12 cytokines and blood routine indexes were detected by flow cytometry,and the level of procalcitonin was detected by ELISA.The correlations among the expression levels of cytokines in IE patients were analyzed by Pearson method and the correlations of IL-8 level and white blood cell count with procalcitonin in IE patients were analyzed by Spearman method.Results Compared with the control group,the levels of cytokines of IL-1β,IL-2,IL-6,IL-10,TNF-α,IFN-α,IFN-γ and IL-12p70 in the IE group were significantly increased(P<0.05),the white blood cell count,neutrophil percentage and procalcitonin were significantly increased(P<0.05).There was no significant difference in the percentage of monocytes between the two groups(P>0.05).IFN-α of IE patients was positively correlated with IL-2,TNF-α,IL-1β and IL-12p70,IL-2 was positively correlated with TNF-α and IL-1β,IL-12p70 was positively correlated with IFN-γ,and procalcitonin was significantly positively correlated with IL-8 and white blood cell count,with statistically significant differences(P<0.05).Conclusion The levels of IL-1β,IL-2,IL-6,IL-10,TNF-α,IFN-α,IFN-γ,IL-12p70 and procalcitonin in IE patients are significantly higher than those in the normal population,and the detections of these indicators are of guiding significance for the early diagnosis of IE and the evaluation of the severity of the disease.
9.Effect of Jiuxin Pill (救心丸)on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris:A Randomized,Double-Blind,Placebo-Controlled,Multi-Center Clinical Trial
Xianliang WANG ; Mingjun ZHU ; Daimei NI ; Jianguang WU ; Yitao XUE ; Chenglong WANG ; Xiaohua DAI ; Qian LIN ; Jun LI ; Zhiqiang ZHAO ; Shuai WANG ; Yingfei BI ; Tongzuo LIU ; Zhou ZHOU ; Jingyuan MAO
Journal of Traditional Chinese Medicine 2024;65(24):2549-2557
ObjectiveTo evaluate the effect and safety of Jiuxin Pill (救心丸) on exercise tolerance and quality of life in patients with stable angina pectoris (SAP). MethodsA randomised, double-blind, placebo-controlled, multicentre study design was used to enroll 170 patients of SAP from nine centres, which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan, and added Jiuxin Pill or placebo respectively, 2 pills (0.05 g) each time twicely for 28 days. The main outcomes were total exercise time (TED) in the exercise treadmill test and Seattle Angina Questionnaire (SAQ) scores including physical limitation (PL), angina stability (AS), angina frequency (AF), treatment satisfaction (TS), and disease perception (DP). The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min (HRR1), metabolic equivalents (METs), maximum magnitude of ST-segment depression, and the Borg rating of perceived exertion scale, the average number of angina attacks per week, withdrawal and reduction rate of nitroglycerin, traditional Chinese medicine syndrome scores, incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment, day 28±2 in treatment period, and follow-up at day 56 which is 28±2 days after treatment period finished. ResultsEighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set (FAS) and safety analysis set (SS). Compared with the group before treatment and with the control group after treatment, the trial group had higher TED, HRR1, and METs, and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment (P<0.01). Compared with the group before treatment and with the control group after treatment and at follow-up, the total SAQ score and scores of AS, AF, TS and DP of the trial group after treatment and at follow-up elevated, while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced (P<0.01). There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups (P>0.05). Major adverse cardiovascular events occurred in 1 case (1/84, 1.19%) in the trial group and 1 case (1/85, 1.18%) in the control group, and the difference between groups was not statistically significant (P>0.05). A total of 3 cases of adverse events occurred in the trial group (3/84, 3.57%), and a total of 6 cases of adverse events occurred in the control group (6/85, 7.06%), and there was no statistically significant difference in the incidence of adverse events between groups (P>0.05). ConclusionIn the treatment of SAP, Jiuxin Pill combined with conventional western medicine can further enhance exercise tolerance, improve quality of life, and demonstrate great safety.
10.Effects of Different Pellet Feed Hardness on Growth and Reproduction,Feed Utilization Rate,and Environmental Dust in Laboratory Mice
Dong WU ; Rui SHI ; Peishan LUO ; Ling'en LI ; Xijing SHENG ; Mengyang WANG ; Lu NI ; Sujuan WANG ; Huixin YANG ; Jing ZHAO
Laboratory Animal and Comparative Medicine 2024;44(3):313-320
Objective To study the effects of different pellet feed hardness on the growth and reproduction,feed utilization rate,and environmental dust in laboratory mice.Methods One hundred of fifty 50 3-week-old SPF-grade C57BL/6JGpt and 150 ICR laboratory mice were randomly divided into three groups,with an equal number of males and females.They were fed diets with different hardness of 18.62 kg,23.15 kg,and 27.89 kg.Body weight,feed utilization rate,and dust levels in cages were recorded and calculated for mice aged 3-10 weeks.Forty-five 6-week-old male mice and ninety 4-week-old female mice from each strain were randomly divided into three groups and fed pellet feeds with three different hardness levels.After 2 weeks of adaptation to the same hardness feed,the mice were paired at a 1:2 male-to-female ratio and monitored for reproductive data for 3 months.Results At the age of 4 weeks,the body weight of male C57BL/6JGpt mice in 23.15 kg group was significantly higher than that in the 18.62 kg and 27.89 kg groups(P<0.01),and the body weight of females in the 18.62 kg group was significantly higher than that in the 27.89 kg group(P<0.05).There was no significant difference in body weight among ICR mice aged 3-10 weeks across different feed hardness groups(P>0.05).For both strains,feed utilization rate for males was higher than that for females across different feed hardness groups at all weeks of age(P<0.01).Compared to the 27.89 kg group,both the 18.62 kg and 23.15 kg groups showed a significant increase in the 50-mesh dust levels in cages for both strains aged 4-8 weeks(except for 7-week-old C57BL/6JGpt mice)(P<0.05).For both C57BL/6JGpt and ICR mice,there was no significant difference in basic reproductive performance such as interval between the first litter and the monthly production index among the three feed hardness groups during the experimental period(P>0.05).However,the monthly production index of C57BL/6JGpt mice first increased and then decreased with the increase of feed hardness,while that of ICR mice increased with increasing feed hardness,though these differences were not statistically significant(P>0.05).Conclusion Different strains and genders had different tolerance to feed hardness.C57BL/6JGpt mice are more adapted to lower hardness feeds,while ICR mice are better suited to slightly higher hardness feeds.

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