1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Application of 3D-printing patient-specific instruments combined with customized locking plate in opening wedge high tibial osteotomy
Chi MA ; Ning WANG ; Yong CHEN ; Zhihan WEI ; Fengji LIU ; Chengzhe PIAO
Chinese Journal of Tissue Engineering Research 2025;29(9):1863-1869
BACKGROUND:The use of 3D-printed patient-specific instruments in opening wedge high tibial osteotomy has advantages such as shorter operative time,fewer fluoroscopic exposures,and higher correction accuracy.However,previous studies have reported issues such as significant damage to surrounding soft tissues and improper fixation of the plates. OBJECTIVE:To investigate the clinical efficacy of using 3D-printed patient-specific instruments combined with customized locking plate in opening wedge high tibial osteotomy for the treatment of knee osteoarthritis. METHODS:A total of 20 patients diagnosed with knee osteoarthritis were divided into the 3D group(n=10)and the conventional group(n=10)according to surgical methods.The 3D group underwent opening wedge high tibial osteotomy using 3D-printed patient-specific instruments combined with customized locking plate,while the conventional group underwent opening wedge high tibial osteotomy using conventional methods.The operative time,fluoroscopic exposures,incision length,pre-and postoperative hip-knee-ankle angle,medial proximal tibial angle,posterior tibial slope,the difference between the planned and actual correction angle,preoperative and 1,3,6 months postoperative knee range of motion and Lysholm score,and incidence of complications were analyzed and compared between the two groups. RESULTS AND CONCLUSION:(1)The operative time and fluoroscopic exposures were significantly shorter in the 3D group compared to the conventional group,with a statistically significant difference(P<0.001).(2)Both groups showed a significant improvement in postoperative hip-knee-ankle angle and medial proximal tibial angle compared to preoperative values,with a statistically significant difference(P<0.001),while there was no significant change in posterior tibial slope.In the 3D group,the postoperative hip-knee-ankle angle,medial proximal tibial angle,and posterior tibial slope differed from their respective preoperative planned values by(-0.22±0.72)°,(-0.20±0.73)°,and(0.23±0.37)°,but the differences were not statistically significant.The difference between the planned and actual correction angle of 3D group was significantly smaller than that of conventional group(P<0.05).(3)Both groups showed a gradual increase in knee range of motion and Lysholm scores after surgery(P<0.001).Compared to the conventional group,the 3D group had superior knee range of motion at 1 and 3 months postoperatively,as well as a higher Lysholm score at 1 month postoperatively,with statistically significant differences(P<0.05).There were no statistically significant differences in Lysholm score at 3 months and knee range of motion and Lysholm score at 6 months between the two groups(P>0.05).(4)Complications occurred in neither groups.(5)The above results indicate that both 3D-printed patient-specific instruments combined with customized locking plate and conventional methods have good clinical efficacy.However,the former has a shorter operative time,fewer fluoroscopic exposures,and faster postoperative recovery of knee joint function.Additionally,3D-printed patient-specific instruments can achieve preoperative planning accurately.
3.Association of habitual reading and writing postures with common diseases and comorbidities among children and adolescents in Ningxia
WEI Rong, LUO Haiyan, MA Ning, ZHAO Yu, YANG Yi, CHEN Yaogeng
Chinese Journal of School Health 2025;46(5):723-727
Objective:
To investigate the association between habitual reading/writing postures and the co-occurrence of common health conditions (overweight/obesity, visual impairment, hypertension, and scoliosis) and comorbidities among children and adolescents, in order to provide data support for the joint prevention of common diseases and comorbidities among children and adolescents.
Methods:
From September 2021 to June 2022, a multi-stage cluster random sampling method was used to select a total of 4 577 children and adolescents from 16 primary and secondary schools in Ningxia: Jinfeng District of Yinchuan City, Shapotou District of Zhongwei City, Yanchi County of Wuzhong City, and Pingluo County of Shizuishan City. A weighted complex sampling design was used to investigate the association of habitual reading and writing postures with common comorbidities in children and adolescents.
Results:
The prevalence rates of common diseases among children and adolescents in Ningxia were as follows: overweight/obesity was 22.87%, visual impairment was 62.52%, scoliosis was 2.30%, and hypertension was 1.30%. The prevalence of multimorbidity (co-occurrence of ≥2 conditions) among Ningxia children and adolescents was 15.95%. Multivariate unconditional Logistic regression analysis showed that frequent/always collapsing waist and sitting forward with head lowered increased the risk of common comorbidities in children and adolescents ( OR =1.90, P <0.05). Compared with the corresponding reference group, male children and adolescents aged 9 to 12 years and boys had relatively lower risks of overweight/obesity ( OR =0.71, 0.70); the risk of poor vision among children and adolescents aged 9 to 12 years, male, and urban was relatively low ( OR =0.59, 0.60, 0.73)( P < 0.05 ). Children and adolescents who often/always sat leaning to the left or right were at higher risk of poor vision ( OR =1.78); urban children and adolescents had a higher risk of developing scoliosis ( OR =3.71); children and adolescents aged 9 to 12 had a relatively low risk of developing hypertension ( OR =0.09), and children and adolescents who often/always bent their backs and sat forward on their knees had a higher risk of hypertension ( OR =5.03)( P <0.05).
Conclusions
Ningxia has a high incidence of common diseases and multiple diseases among children and adolescents, frequent or always collapsing waist and sitting forward with head lowered is associated with common comorbidities in children and adolescents in Ningxia. Proper postural measures for reading and writing should be carried out as soon as possible to encourage children and adolescents to develop good reading and writing habits for effectively preventing and controlling the occurrence of common diseases.
4.Effects of combined use of active ingredients in Buyang Huanwu Decoction on oxygen-glucose deprivation/reglucose-reoxygenation-induced inflammation and oxidative stress of BV2 cells.
Tian-Qing XIA ; Ying CHEN ; Jian-Lin HUA ; Qin SU ; Cun-Yan DAN ; Meng-Wei RONG ; Shi-Ning GE ; Hong GUO ; Bao-Guo XIAO ; Jie-Zhong YU ; Cun-Gen MA ; Li-Juan SONG
China Journal of Chinese Materia Medica 2025;50(14):3835-3846
This study aims to explore the effects and action mechanisms of the active ingredients in Buyang Huanwu Decoction(BYHWD), namely tetramethylpyrazine(TMP) and hydroxy-safflor yellow A(HSYA), on oxygen-glucose deprivation/reglucose-reoxygenation(OGD/R)-induced inflammation and oxidative stress of microglia(MG). Network pharmacology was used to screen the effective monomer ingredients of BYHWD and determine the safe concentration range for each component. Inflammation and oxidative stress models were established to further screen the best ingredient combination and optimal concentration ratio with the most effective anti-inflammatory and antioxidant effects. OGD/R BV2 cell models were constructed, and BV2 cells in the logarithmic growth phase were divided into a normal group, a model group, an HSYA group, a TMP group, and an HSYA + TMP group. Enzyme-linked immunosorbent assay(ELISA) was used to detect the levels of inflammatory cytokines such as interleukin-1β(IL-1β), tumor necrosis factor-α(TNF-α), and interleukin-6(IL-6). Oxidative stress markers, including superoxide dismutase(SOD), nitric oxide(NO), and malondialdehyde(MDA), were also measured. Western blot was used to analyze the protein expression of both inflammation-related pathway [Toll-like receptor 4(TLR4)/nuclear factor-kappa B(NF-κB)] and oxidative stress-related pathway [nuclear factor erythroid 2-related factor 2(Nrf2)/heme oxygenase-1(HO-1)]. Immunofluorescence was used to assess the expression of proteins such as inducible nitric oxide synthase(iNOS) and arginase-1(Arg-1). The most effective ingredients for anti-inflammatory and antioxidant effects in BYHWD were TMP and HSYA. Compared to the normal group, the model group showed significantly increased levels of IL-1β, TNF-α, IL-6, NO, and MDA, along with significantly higher protein expression of NF-κB, TLR4, Nrf2, and HO-1 and significantly lower SOD levels. The differences between the two groups were statistically significant. Compared to the model group, both the HSYA group and the TMP group showed significantly reduced levels of IL-1β, TNF-α, IL-6, NO, and MDA, lower expression of NF-κB and TLR4 proteins, higher levels of SOD, and significantly increased protein expression of Nrf2 and HO-1. Additionally, the expression of the M1-type MG marker iNOS was significantly reduced, while the expression of the M2-type MG marker Arg-1 was significantly increased. The results of the HSYA group and the TMP group had statistically significant differences from those of the model group. Compared to the HSYA group and the TMP group, the HSYA + TMP group showed further significant reductions in IL-1β, TNF-α, IL-6, NO, and MDA levels, along with significant reductions in NF-κB and TLR4 protein expression, an increase in SOD levels, and elevated Nrf2 and HO-1 protein expression. Additionally, the expression of the M1-type MG marker iNOS was reduced, while the M2-type MG marker Arg-1 expression increased significantly in the HSYA + TMP group compared to the TMP or HSYA group. The differences in the results were statistically significant between the HSYA + TMP group and the TMP or HSYA group. The findings indicated that the combined use of HSYA and TMP, the active ingredients of BYHWD, can effectively inhibit OGD/R-induced inflammation and oxidative stress of MG, showing superior effects compared to the individual use of either component.
Oxidative Stress/drug effects*
;
Drugs, Chinese Herbal/pharmacology*
;
Animals
;
Mice
;
Glucose/metabolism*
;
Cell Line
;
Inflammation/genetics*
;
Oxygen/metabolism*
;
Pyrazines/pharmacology*
;
Microglia/metabolism*
;
NF-E2-Related Factor 2/immunology*
;
NF-kappa B/immunology*
;
Toll-Like Receptor 4/immunology*
;
Anti-Inflammatory Agents/pharmacology*
;
Humans
5.Application of functional perforator flap transplantation with chimeric iliac bone flap in reconstruction of composite tissue defects of hand or foot.
Junjie LI ; Huihui GUO ; Bin LUO ; Huihai YAN ; Mingming MA ; Tengfei LI ; Tao NING ; Wei JIAO
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(9):1098-1105
OBJECTIVE:
To evaluate the effectiveness of functional perforator flaps utilizing the superficial circumflex iliac artery as a vascular pedicle, as well as chimeric iliac bone flaps, in the reconstruction of composite tissue defects in the hand and foot.
METHODS:
A retrospective review of the clinical data from 13 patients suffering from severe hand or foot injuries, treated between May 2019 and January 2025, was conducted. The cohort comprised 8 males and 5 females, with ages ranging from 31 to 67 years (mean, 48.5 years). The injuries caused by mechanical crush incidents (n=9) and traffic accidents (n=4). The distribution of injury sites included 8 cases involving the hand and 5 cases involving the foot. Preoperatively, all patients exhibited bone defects ranging from 2.0 to 6.5 cm and soft tissue defects ranging from 10 to 210 cm2. Reconstruction was performed using functional perforator flaps based on the superficial circumflex iliac artery and chimeric iliac bone flaps. The size of iliac bone flaps ranged from 2.5 cm×1.0 cm×1.0 cm to 7.0 cm×2.0 cm×1.5 cm, while the size of the soft tissue flaps ranged from 4 cm×3 cm to 15 cm×8 cm. In 1 case with a significant hand defect, a posterior interosseous artery perforator flap measuring 10.0 cm×4.5 cm was utilized as an adjunct. Likewise, an anterolateral thigh perforator flap measuring 25 cm×7 cm was combined in 1 case involving a foot defect. All donor sites were primarily closed. Postoperative flap survival was monitored, and bone healing was evaluated through imaging examination. Functional outcomes were assessed based on the location of the defects: for hand injuries, grip strength, pinch strength, and flap two-point discrimination were measured; for foot injuries, the American Orthopaedic Foot & Ankle Society (AOFAS) score, visual analogue scale (VAS) score, Maryland Foot Score, plantar pressure distribution and gait symmetry index (GSI) were evaluated.
RESULTS:
All flaps survived completely, with primary healing observed at both donor and recipient sites. All patients were followed up 6-18 months (mean, 12.2 months). No significant flap swelling or deformity was observed. Imaging examination showed a bone callus crossing rate of 92.3% (12/13) at 3 months after operation, and bone density recovered to more than 80% of the healthy side at 6 months. The time required for bone flap integration ranged from 2 to 6 months (mean, 3.2 months). One patient with a foot injury exhibited hypertrophic scarring at the donor site; however, no major complication, such as infection or bone nonunion, was noted. At 6 months after operation, grip strength in 8 patients involving the hand recovered to 75%-90% of the healthy side (mean, 83.2%), while pinch strength recovered to 70%-85% (mean, 80%). Flap two-point discrimination ranged from 8 to 12 mm, approaching the sensory capacity of the healthy side (5-8 mm). Among the 5 patients involving the foot, the AOFAS score at 8 months was 80.5±7.3, VAS score was 5.2±1.6. According to the Maryland Foot Score, 2 cases were rated as excellent and 3 as good. Gait analysis at 6 months after operation showed GSI above 90%, with plantar pressure distribution closely resembling that of the contralateral foot.
CONCLUSION
The use of functional perforator flaps based on the superficial circumflex iliac artery, combined with chimeric iliac bone flaps, provides a reliable vascular supply and effective functional restoration for the simultaneous repair of composite bone and soft tissue defects in the hand or foot. This technique represents a viable and effective reconstructive option for composite tissue defects in these anatomical regions.
Humans
;
Male
;
Middle Aged
;
Female
;
Perforator Flap/transplantation*
;
Adult
;
Plastic Surgery Procedures/methods*
;
Hand Injuries/surgery*
;
Aged
;
Retrospective Studies
;
Foot Injuries/surgery*
;
Ilium/transplantation*
;
Iliac Artery/surgery*
;
Soft Tissue Injuries/surgery*
;
Bone Transplantation/methods*
;
Treatment Outcome
6.Clinical characteristics of congenital and acquired middle ear cholesteatoma in children.
Jianbo SHAO ; Min CHEN ; Jinsheng HAO ; Yang YANG ; Wei LIU ; Bing LIU ; Ning MA ; Xiao ZHANG ; Xiaoxu WANG ; Jie ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(2):133-136
Objective:To retrospectively analyze the clinical features and surgical efficacy of congenital cholesteatoma (CC) and acquired cholesteatoma (AC) in children. Methods:Clinical data of 169 children with middle ear cholesteatoma were reviewed in the Department of Otorhinolaryngology Head and Neck Surgery, Beijing Children's Hospital, Capital Medical University from January 2010 to July 2020. The clinical characteristics, stages, surgical methods, and postoperative recurrence rates were analyzed and summarized. Results:The age distribution of enrolled children ranged from 2 to 14 years. The mean age of the CC group was (5.60±2.48) years compared with (6.45±2.48) years in the AC group, and the difference was statistically significant (P<0.05). Preoperative hearing in the CC group was (40.06±13.52) dB HL, which was better than in the AC group at (48.40±13.84) dB HL (P<0.05). The proportion of stage Ⅰ in the CC group was lower than that in the AC group according to EAONO/JOS staging (P<0.05). The recurrence rate after primary surgery was 19.23% (10/52) in the CC group compared with 36.29% (45/124) in the AC group (P<0.05). The mastoid retention rates after all operations were 28.85% (15/52) in the CC group and 5.65% (7/124) in the AC group (P<0.05). Conclusion:Compared with congenital cholesteatoma, acquired cholesteatoma in children is more aggressive and has more complications, higher postoperative recurrence rate, and less possibility of mastoid retention. Early clinical detection and treatment are required, and canal wall-down tympanoplasty should be considered in surgery.
Humans
;
Cholesteatoma, Middle Ear/congenital*
;
Child
;
Retrospective Studies
;
Child, Preschool
;
Adolescent
;
Male
;
Female
;
Recurrence
;
Cholesteatoma/congenital*
;
Tympanoplasty
;
Treatment Outcome
7.Celastrol directly targets LRP1 to inhibit fibroblast-macrophage crosstalk and ameliorates psoriasis progression.
Yuyu ZHU ; Lixin ZHAO ; Wei YAN ; Hongyue MA ; Wanjun ZHAO ; Jiao QU ; Wei ZHENG ; Chenyang ZHANG ; Haojie DU ; Meng YU ; Ning WAN ; Hui YE ; Yicheng XIE ; Bowen KE ; Qiang XU ; Haiyan SUN ; Yang SUN ; Zijun OUYANG
Acta Pharmaceutica Sinica B 2025;15(2):876-891
Psoriasis is an incurable chronic inflammatory disease that requires new interventions. Here, we found that fibroblasts exacerbate psoriasis progression by promoting macrophage recruitment via CCL2 secretion by single-cell multi-omics analysis. The natural small molecule celastrol was screened to interfere with the secretion of CCL2 by fibroblasts and improve the psoriasis-like symptoms in both murine and cynomolgus monkey models. Mechanistically, celastrol directly bound to the low-density lipoprotein receptor-related protein 1 (LRP1) β-chain and abolished its binding to the transcription factor c-Jun in the nucleus, which in turn inhibited CCL2 production by skin fibroblasts, blocked fibroblast-macrophage crosstalk, and ameliorated psoriasis progression. Notably, fibroblast-specific LRP1 knockout mice exhibited a significant reduction in psoriasis like inflammation. Taken together, from clinical samples and combined with various mouse models, we revealed the pathogenesis of psoriasis from the perspective of fibroblast-macrophage crosstalk, and provided a foundation for LRP1 as a novel potential target for psoriasis treatment.
9.Long-term auditory monitoring in children with Alport syndrome based on different degrees of renal injury.
Lining GUO ; Wei LIU ; Min CHEN ; Jiatong XU ; Ning MA ; Xiao ZHANG ; Qingchuan DUAN ; Shanshan LIU ; Xiaoxu WANG ; Junsong ZHEN ; Xin NI ; Jie ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2024;38(1):44-49
Objective:To investigate long-term auditory changes and characteristics of Alport syndrome(AS) patients with different degrees of renal injury. Methods:Retrospectively analyzing clinical data of patients diagnosed AS from January 2007 to September 2022, including renal pathology, genetic detection and hearing examination. A long-term follow-up focusing on hearing and renal function was conducted. Results:This study included 70 AS patients, of which 33(25 males, 8 females, aged 3.4-27.8 years) were followed up, resulting in a loss rate of 52.9%.The follow-up period ranged from 1.1to 15.8 years, with 16 patients followed-up for over 10 years. During the follow-up, 10 patients presenting with hearing abnormalities at the time of diagnosis of AS had progressive hearing loss, and 3 patients with new hearing abnormalities were followed up, which appeared at 5-6 years of disease course. All of which were sensorineural deafness. While only 3 patients with hearing abnormalities among 13 patients received hearing aid intervention. Of these patients,7 developed end-stage renal disease(ESRD), predominantly males (6/7). The rate of long-term hearing loss was significantly different between ESRD group and non-ESRD group(P=0.013). There was no correlation between the progression of renal disease and long-term hearing level(P>0.05). kidney biopsies from 28 patients revealed varying degrees of podocyte lesion and uneven thickness of basement membrane. The severity of podocyte lesion was correlated with the rate of long-term hearing loss(P=0.048), and there was no correlation with the severity of hearing loss(P>0.05). Among 11 cases, theCOL4A5mutationwas most common (8 out of 11), but there was no significant correlation between the mutation type and hearing phenotype(P>0.05). Conclusion:AS patients exhibit progressive hearing loss with significant heterogeneity over the long-term.. THearing loss is more likely to occur 5-6 years into the disease course. Hearing abnormalities are closely related to renal disease status, kidney tissue pathology, and gene mutations, emphasizing the need for vigilant long-term hearing follow-up and early intervention.
Male
;
Child
;
Female
;
Humans
;
Nephritis, Hereditary/pathology*
;
Retrospective Studies
;
Kidney
;
Deafness
;
Hearing Loss/genetics*
;
Kidney Failure, Chronic/pathology*
;
Mutation
10.Discussion on the Diagnosis and Treatment of Thyroid Nodules Based on the Theory of"One Qi Peripheral Flow"
Zhoujun NING ; Zhiyao MA ; Wei LIU ; Lili WU ; Lingling QIN ; Tonghua LIU
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(1):252-258
The concept of"one qi peripheral flow"originates from the ancient Chinese philosophy of"qi monism"and the theory of yin and yang chi chemistry in the Yellow Emperor's Classic of Internal Medicine,and was formally proposed in Huang Yuanyu's The Origin of the Four Sacred Hearts,which elaborates on the theory of one qi circumference in which the earth pivots on four signs and the left rises and the right descends.Based on this theory,this paper discusses the diagnosis and treatment of thyroid nodules,believes that the development of thyroid nodules is closely related to the deficiency of the earth and qi,and the disorder of the liver and lungs,and combines the evidence of modern research to argue that the deficiency of the earth and qi,and the disorder of the liver and lungs are the important pathomechanisms of the thyroid nodules,proposes to refer to the results of ultrasound elasticity imaging of the thyroid gland for staging and typing treatment of thyroid nodules.It also summarizes the clinical use of medicines in different stages and types,aiming at estoring the"one qi peripheral flow"in the body,and provides a new diagnostic and therapeutic idea for the clinical diagnosis and treatment of thyroid nodules.


Result Analysis
Print
Save
E-mail