1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Randomized controlled trial of the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium for the children with bacterial pneumonia
Zhen DA ; Wenbin HOU ; Siyi WANG ; Youyou ZHENG ; Yuanxi LI ; Huilan LIU ; Yuxin SUN ; Zhaolan LIU
International Journal of Traditional Chinese Medicine 2021;43(12):1174-1178
Objective:To evaluate the clinical effectiveness and safety of Jiuwei-Zhuhuang San plus amoxilcillin sodium and sulbactam sodium in the treatment of bacterial pneumonia in children. Methods:A total of 120 patients with bacterial pneumonia in children from 1 year to 14 years old were randomly divided into the study group ( n=90) and the control group ( n=30) with ratio 3 to 1, the random sequence created by SAS software. Both groups were treated with amoxilcillin sodium for basic treatment, the observation group was treated with Jiuwei-Zhuhuang San. Both groups were treated for 1 week and followed up for 1 week. The cough frequency, clinical effective rate, symptoms and signs score, Traditonal Chinese medicine (TCM) pattern scores and adverse event rate were observed. Results:Eighteen cases were dropped and eliminated in the observation group, and 4 cases were dropped and eliminated in the control group, so 72 of observation group and 26 of control group were analyzed. After treatment, the clinical effective rate of the observation group was 27.8% (20/72), and the control group was 0% (0/26), where the difference was significant ( χ2=7.445, P=0.006). The difference of TCM syndrome score before and after treatment in the observation group (-16.8 ± 8.2 vs. -11.0 ± 5.8, t=-3.858) was lower than that of the control group ( P<0.01). There was significant difference between the two groups ( Z=-2.347, P= 0.019) in the TCM syndrome. The cough frequency of the observation group was 41.7% (30/72), and the control group was 26.9% (7/26). There wasn’t any significant differences in the cough frequency between two groups ( P>0.05). There was no statistical difference in symptoms and signs score or adverse event rate between two groups ( P>0.05). Conclusion:On the basis of amoxicillin sodium and sulbactam sodium, combined use of Jiuwei-Zhuhuang San can improve the clinical effectiveness of children with bacterial pneumonia.
3.Research progress in the treatment of liver cancer with disulfiram
Yang XIAO ; Jinhui ZHANG ; Qinwen TAI ; Ninglei LI ; Liquan CAI ; Heng ZHANG ; Jinhua HUANG ; Feng GAO ; Yuanxi WANG
Chinese Journal of Hepatobiliary Surgery 2020;26(9):714-717
Disulfiram, a drug that has been used for alcohol dependence. As an approved drug in clinical medicine, disulfiram can be used as the anticancer drug in the treatment of breast cancer, prostate cancer, glioblastoma, lung cancer, etc. This paper summarized the mechanism of disulfiram for anticancer treatment and the function for liver cancer therapy, and we also analyzed the potential mechanism of disulfiram for the treatment of liver cancer and its’ value in the clinical application.
4.Therapeutic effect of propafenone and amiodarone on paroxysmal supraventricular tachycardia and their safety
Biyun QIAN ; Liangchuan CHEN ; Mingwei WANG ; Yuanxi ZHENG ; Rui QIAO
Chinese Journal of cardiovascular Rehabilitation Medicine 2019;28(2):221-224
Objective :To compare therapeutic effect of propafenone and amiodarone on paroxysmal supraventricular tachycardia (PSVT) and their safety .Methods : A total of 90 PSVT patients ,who were treated in our hospital from Jan 2013 to May 2018 ,were selected .Patients were randomly and equally divided into propafenone group and amio—darone group ,each group received corresponding medication based on routine treatment for 24h.Blood pressure , heart rate ,cardiac function indexes :LVEDV ,LVESV and LVEF before and after treatment ,cardioversion time , successful cardioversion rate within 60 min and incidence of adverse reactions during treatment were observed and compared between two groups .Results : There was no significant difference in successful cardioversion rate (propafenone group 91.11% vs.amiodarone group 93.33%, P=1.000) between two groups .Compared with be—fore treatment ,on 24h after treatment ,there were significant reductions in blood pressure and heart rate in two groups , P=0. 001 all ;but there was no significant difference between two groups before and after treatment , P>0.05 all.Cardioversion time of propafenone group was significantly shorter than that of amiodarone group [ (12. 66 ± 2.06) min vs .(22. 80 ± 2.28 ) min ] , P= 0. 001 .Compared with propafenone group on 24h after treatment , there was significant rise in LVEF [ (63. 24 ± 3.67)% vs.(66. 83 ± 4.01)%] ,significant reductions in LVEDV [ (96.65 ± 5.24) ml vs.(92. 09 ± 4.37) ml] and LVESV [ (38.40 ± 2.87) ml vs.(30. 13 ± 7.34) ml] in amioda—rone group , P= 0. 001 all.Total incidence rate of adverse reactions in amiodarone group was significantly lower than that of propafenone group (8.89% vs.24. 44%) , P=0. 048. Conclusion : Propafenone and amiodarone possess significant therapeutic effect on PSVT .Propafenone possesses shorter cardioversion time ,while amiodarone posses— ses less adverse reactions and improve cardiac function .Therefore ,medication should be selected properly according to patient′s specific condition in clinic .
5.Quantitative evaluation on puborectalis function in patients with pelvic organ prolapse using shear wave elastography
Wang NIU ; Tiemei SHI ; Yuanxi ZHANG
Chinese Journal of Medical Imaging Technology 2018;34(2):270-274
Objective To evaluate the contraction function of puborectalis (PR) with shear wave elastography (SWE).Methods Twenty-eight patients with pelvic organ prolapse (POP-Q Ⅲ group and POP-Q Ⅳ group,each n=14) and 28 healthy volunteers (control group) were enrolled.The Young's modulus of PR in the front,middle and back of pubic rectal muscles of each group at resting and maximal rectal state were measured with shear wave elastography,and then were statistically analyzed.Results Youngs modulus of maximum rectal state of each group was higher than that of resting state (all P<0.05).At resting and maximal rectal state,the Young's modulus and their differences in POP-Q Ⅲ group and POP-Q Ⅳ group were significantly different compared with control group (all P<0.05),but those in POP-Q Ⅲ group and POP-Q Ⅳ group were not (all P>0.05).Conclusion Decrease of PR systolic function can be observed in patients with pelvic organ prolapse,and SWE can be used to detect abnormal function of PR systolic function.
6.Application progresses of real-time shear wave elastography in skeletal muscles
Wang NIU ; Tiemei SHI ; Yuanxi ZHANG
Chinese Journal of Medical Imaging Technology 2017;33(10):1583-1586
The central nervous system disease and musculoskeletal diseases often involve skeletal muscles.Quantitative evaluation of strength and hardness of a single muscle accurately and rapidly are basis for causation analysis of movement dysfunction.Real-time shear wave elastography (SWE) is a new ultrasonic imaging technique developed in recent years,and still has a preliminary application in the skeletal muscle system.The application and research progresses of SWE in auxiliary diagnosis of disease in skeletal muscles were reviewed in this article.
7.Effect of different delivering methods on pelvic floor function in vaginal delivery
Zheng ZHOU ; Tiemei SHI ; Xinlu WANG ; Chen LIU ; Wang NIU ; Yuanxi ZHANG
Chinese Journal of Medical Imaging Technology 2017;33(3):433-436
Objective To explore the effect of different delivering methods on the pelvic floor function in vaginal delivery by transvaginal three-dimensional ultrasound.Methods Eighty-four patients delivered transvaginal were classified into three groups according to the mode of delivery (perineal integrity group [n=32],episiotomy group [n=30] and forceps delivery group [n=22]).The hiatal images at resting,Valsalva,levator ani muscle maximum contraction were obtained and compared in three groups.Results There were no differences between perineal integrity group and episiotomy group in hiatal diameter and area (P>0.05).There were significantly differences between perineal integrity group and forceps delivery group in hiatal diameter,area and change in hiatal area from rest to pelvic floor muscle contraction and from rest to Valsalva (all P<0.05).Conclusion The injury of the pelvic floor of forceps delivery group is bigger than perineal integrity.And episiotomy is no significant difference with pelvic floor function injury.
8.The combination of sephedex and docetaxel used in intervention for clinical treatment of primary liver cancer
Jingxian LI ; Yanping JIANG ; Jiaping WANG ; Li GUO ; Li ZHU ; Rui LIU ; Ruimin ZHAO ; Yuyun TONG ; Yuanxi JIAN
Journal of Practical Radiology 2017;33(5):739-741,753
Objective To study the clinical efficacy of the combination of sephedex and docetaxel used in transcatheter arterial chemoembolization (TACE) for clinical treatment of primary liver cancer.Methods 120 patients with primary liver cancer in our hospital were divided into the experimental group and the control group randomly and equally, the 60 cases in experimental group were treated with sephedex suspensoid (Sephedex, G-50, 300-500 μm) and docetaxel-iodized oil, while other 60 cases in control group were treated with docetaxel-iodized oil suspension liquid.Results The success rate of surgical intubation in the two groups was 100%.After an average follow-up of 12 months, the postoperative tumor diameter of the experimental group was reduced by (4.4±1.4) cm, while that of the control group was (1.8±1.0) cm;The overall response rate was 70% in the experimental group in contrast to 30% in the control group;the alpha fetal protein (AFP) value was decreased by (33.2±15.2) μg/L in the experimental group and (10.4±9.8) μg/L in the control group.Conclusion The combination of sephedex, docetaxel suspensoid and iodized oil shows great potential in TACE treatment of primary liver cancer, from which the treatment effect can be improved significantly.
9.Transplant of bone marrow mesenchymal stem cells via renal artery route in experimental rats with adriamycin-induced nephropathy: comparison of the repair effect on renal function between different times of transplant
Yiyuan XING ; Jiaping WANG ; Facheng LU ; Yuanxi JIN ; Shanshan WAN ; Lei HAN
Journal of Interventional Radiology 2017;26(7):641-645
Objective To compare the repair effect on renal function between different times of bone marrow mesenchymal stem cells (BMSCs) transplant via renal artery route in experimental rats with adriamycininduced nephropathy.Methods Adriamycin-induced nephropathy model was established in 32 rats through injection of adriamycin though the caudal vein.Based on the scheduled times of BMSCs transplant,the experimental rats were randomly and equally divided into M0 group (zero time),M1 group (one time),M2group (2 times) and M3 group (3 times) with 8 rats in each group.Other 8 SD rats were used as normal control group (N group).Single dose of 0.5 rnl BMSC suspension (2×106 cells/ml) was transplanted to the rats of M0 group (zero time),M1 group (one time),M2 group (2 times) and M3 group (3 times),for the rats of the groups not receiving BMSC transplant a single dose of 0.5 ml L-DMEM culture medium,used as a placebo,was adopted to replace BMSC suspension.The transplant interval was one week.Before transplant as well as one and two weeks after last time of transplant,the serum urea nitrogen,serum creatinine,24 h urine protein and 24 h urine microprotein were tested,and one week after last time of transplant pathological sections were made for laser focusing microscope examination to observe renal pathological changes and the distribution of BMSC cells in the kidney.Results The values of serum urea nitrogen,serum creatinine,24 h urine protein and 24 h urine microprotein determined at each observation time point in M0 group,M1 group,M2 group and M3 group were significantly higher than those in N group (P<0.001).The values of 24 h urine protein and 24 h urine microprotein determined at one week after last time of transplant in M2 group and M3 group were strikingly lower than those in M1 group (P<0.05),but these differences between M2 group and M3 group were not statistically significant (P=0.063).Conclusion For the treatment of adriamycin-induced nephropathy in experimental rats,two times of using BMSCs transplant via renal artery route can achieve optimal curative effect.
10.Protective effects of TAK-242 against coronary microembolization in rat associated with involvement of TLR4/NF-κB signaling pathway
Xiantao WANG ; Lang LI ; Yuanxi LU ; Yuhan SUN ; Wenkai HE ; Jiabao LIANG
Chinese Journal of Emergency Medicine 2017;26(7):745-750
Objective To investigate the role of TLR4/NF-κB signaling pathway under the action of TAK-242 in the cardiomyocyte apoptosis after coronary micro-embolism (CME) in rats.Methods Fortyfive rats were randomized (random number) into three groups:sham operation,CME and CME plus TAK242 groups (n =15 per group).CME was induced by injecting polyethylene microspheres (42 μm) into the left ventricle except the sham group.CME plus TAK-242 group was treated with TAK-242 (2 mg/kg) via the tail vein of mice 30 min before CME modeling.Cardiac function was evaluated 6 h after operation.Tissue biopsy was stained with HBFP to measure the size of infarction area.TUNEL assay was used to detect cardiomyocyte apoptosis.Western blot and qPCR were used to evaluate the protein levels and mRNA expressions of TLR4,NF-κB p65 and cleaved caspase-3,respectively.Statistical analysis was performed using one-way analysis of variance followed by LSD-t test.Results Compared with the sham group,left ventricular ejection fraction (LVEF) in the CME group was significantly decreased [(68.91 ± 4.12) % vs.(84.80 ± 2.51) %,P < 0.05],and the infarction area (P < 0.05),the apoptosis index [(3.36 ± 0.63) % vs.(0.19 ± 0.08) %,P <0.05],the mRNA expressions of TLR4,NF-κB p65 and cleaved caspase-3 in CME group were increased significantly (all P < 0.05).Compared with CME group,LVEF in the CME plus TAK-242 group was significantly improved [(75.58 ± 5.01) % vs.(68.91 ± 4.12) %,P<0.05],and the infarction area [(8.58 ± 2.12) % vs.(14.65 ± 4.23) %,P<0.05],the apoptosis index [(1.43 ± 0.51) % vs.(3.36 ± 0.63) %,P < 0.05],the mRNA expressions of TLR4,NF-κB p65 and cleaved caspase-3 in CME + TAK-242 group were decreased significantly (all P < 0.05).Conclusions TAK-242 effectively improved CME-induced cardiac dysfunction by regulating TLR4/NF-κB signaling pathway and then reducing the cardiomyocyte apoptosis.

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