1.Clinical trial of recombinant human growth hormone in the treatment of children with idiopathic short stature
Dong-guang ZHANG ; Yu YANG ; Li YANG ; Hai-ying ZOU ; Yun HU
The Chinese Journal of Clinical Pharmacology 2025;41(2):169-173
Objective To observe the clinical efficacy and safety of recombinant human growth hormone injection(rhGH)in the treatment of children with idiopathic short stature(ISS)and its influence on levels of insulin-like growth factor 1(IGF-1),alkaline phosphatase(AKP)and insulin-like growth factor binding protein 3(IGFBP-3).Methods Children with ISS were randomized into control group and treatment group.The control group was subcutaneously injected with 0.15 U·kg-1 of rhGH injection,while the treatment group was given subcutaneous injection of 0.20 U·kg-1 of rhGH injection,and both groups were continuously treated for 6 months.The clinical efficacy,growth status[growth velocity,height standard deviation score(HtSDS),predicted adult height(PAH)],bone metabolism indicators { AKP,osteocalcin(OC),25-hydroxyvitamin D[25(OH)D]} and serum IGF-1 and IGFBP3 levels were compared,and the safety was assessed.Results In the treatment group,46 cases were enrolled,6 cases were lost,and 40 cases were finally included in the statistical analysis.In the control group,46 cases were enrolled,1 case was lost,and 45 cases were finally included in the statistical analysis.The total effective rates in treatment group and control group after 6 months treatment were 85.00%(34 cases/40 cases)and 64.44%(29 cases/45 cases),respectively,with a statistical significance(P<0.05).After 6 months treatment,the growth rates in treatment group and control group were(7.96±1.62)and(6.84±1.56)cm·year-1;HtSDS values were-2.38±0.24 and-2.61±0.28;PAH values were(156.86±4.18)and(155.02±4.25)cm;serum AKP levels were(278.42±47.46)and(257.14±42.79)U·L-1;OC levels were(76.92±10.17)and(72.43±10.32)μg·L-1;25(OH)D levels were(59.96±4.74)and(55.52±4.69)nmol·L-1;serum IGF-1 levels were(296.77±28.32)and(251.47±24.96)ng·mL-1;serum IGFBP3 levels were(5.76±1.22)and(4.86±0.89)μg·mL-1,respectively.Compared with the control group,the above indexes in the treatment group were statistically significant(all P<0.05).The adverse drug reactions in treatment and control group were mainly headache,rash and joint pain,rash and joint pain.The incidence rates of adverse reactions in treatment group and control group were 12.50%(5 cases/40 cases)and 6.67%(3 cases/45 cases),without significant difference(P>0.05).Conclusion The clinical efficacy of rhGH injection in the treatment of children with ISS is definite;and the improvement of IGF-1,AKP and IGFBP3 levels by 0.20 U·kg-1 rhGH is significantly better than that by 0.15 U·kg-1 rhGH,which is more conducive to promoting bone development and accelerating growth without increasing the incidence of adverse drug reactions.
2.Clinical trial of recombinant human growth hormone in the treatment of children with idiopathic short stature
Dong-guang ZHANG ; Yu YANG ; Li YANG ; Hai-ying ZOU ; Yun HU
The Chinese Journal of Clinical Pharmacology 2025;41(2):169-173
Objective To observe the clinical efficacy and safety of recombinant human growth hormone injection(rhGH)in the treatment of children with idiopathic short stature(ISS)and its influence on levels of insulin-like growth factor 1(IGF-1),alkaline phosphatase(AKP)and insulin-like growth factor binding protein 3(IGFBP-3).Methods Children with ISS were randomized into control group and treatment group.The control group was subcutaneously injected with 0.15 U·kg-1 of rhGH injection,while the treatment group was given subcutaneous injection of 0.20 U·kg-1 of rhGH injection,and both groups were continuously treated for 6 months.The clinical efficacy,growth status[growth velocity,height standard deviation score(HtSDS),predicted adult height(PAH)],bone metabolism indicators { AKP,osteocalcin(OC),25-hydroxyvitamin D[25(OH)D]} and serum IGF-1 and IGFBP3 levels were compared,and the safety was assessed.Results In the treatment group,46 cases were enrolled,6 cases were lost,and 40 cases were finally included in the statistical analysis.In the control group,46 cases were enrolled,1 case was lost,and 45 cases were finally included in the statistical analysis.The total effective rates in treatment group and control group after 6 months treatment were 85.00%(34 cases/40 cases)and 64.44%(29 cases/45 cases),respectively,with a statistical significance(P<0.05).After 6 months treatment,the growth rates in treatment group and control group were(7.96±1.62)and(6.84±1.56)cm·year-1;HtSDS values were-2.38±0.24 and-2.61±0.28;PAH values were(156.86±4.18)and(155.02±4.25)cm;serum AKP levels were(278.42±47.46)and(257.14±42.79)U·L-1;OC levels were(76.92±10.17)and(72.43±10.32)μg·L-1;25(OH)D levels were(59.96±4.74)and(55.52±4.69)nmol·L-1;serum IGF-1 levels were(296.77±28.32)and(251.47±24.96)ng·mL-1;serum IGFBP3 levels were(5.76±1.22)and(4.86±0.89)μg·mL-1,respectively.Compared with the control group,the above indexes in the treatment group were statistically significant(all P<0.05).The adverse drug reactions in treatment and control group were mainly headache,rash and joint pain,rash and joint pain.The incidence rates of adverse reactions in treatment group and control group were 12.50%(5 cases/40 cases)and 6.67%(3 cases/45 cases),without significant difference(P>0.05).Conclusion The clinical efficacy of rhGH injection in the treatment of children with ISS is definite;and the improvement of IGF-1,AKP and IGFBP3 levels by 0.20 U·kg-1 rhGH is significantly better than that by 0.15 U·kg-1 rhGH,which is more conducive to promoting bone development and accelerating growth without increasing the incidence of adverse drug reactions.
3.Impact of childhood maltreatment and sleep quality on depressive symptoms among middle school students
Chinese Journal of School Health 2025;46(1):73-77
Objective:
To explore the impact of sleep quality, experience of childhood maltreatment, and their interaction on depressive symptoms among middle school students, so as to provide the reference for early intervention of depressive symptoms among middle school students.
Methods:
From September to December 2023, a questionnaire survey was conducted among 1 231 students from two secondary schools in Harbin, Heilongjiang Province by a convenient sampling method. The survey included general demographic information, Childhood Trauma Questionnaire Short Form, Pittsburgh Sleep Quality Index and Short Version of Center for Epidemiological Studies Depression Scale. The Chi square test was used to analyze the differences in depressive symptom, sleep quality and childhood maltreatment among students with different demographic characteristics. Correlation analysis was conducted using Logistic regression, and interaction analysis was performed by both additive and multiplicative interaction models.
Results:
The detection rate of depressive symptoms among middle school students was 22.7%, and the rate for high school students (35.2%) was significantly higher than that for middle school students (17.0%) ( χ 2=50.35, P <0.01). The detection rates of depressive symptoms among middle school students with a history of childhood maltreatment and poor sleep quality were 45.8% and 44.0%, respectively. Multivariate Logistic regression analysis showed that compared to students without a history of childhood maltreatment, students with a history of childhood maltreatment had a higher risk of depressive symptoms ( OR =4.49,95% CI =3.31~ 6.09 , P <0.01);students with poor sleep quality had a higher risk of depressive symptoms than students with good sleep quality ( OR = 5.99,95% CI =4.37~8.22, P <0.01).The interaction results showed that the presence of childhood maltreatment and poor sleep quality had an additive interaction on the occurrence of depression in middle school students. Compared with students without childhood maltreatment and having good sleep quality, students with childhood maltreatment and poor sleep quality had a 22.49 times higher risk of developing depression ( OR =22.49,95% CI =14.22~35.59, P <0.01).
Conclusion
Depressive symptoms among middle school students are associated with childhood maltreatment and poor sleep quality, and there is an additive interaction between childhood maltreatment and poor sleep quality on the impact of depressive symptoms.
5.Research on Targeted Screening of Diflorasone Components in Health Products Using Feature Ion Guided Strategy Combined with High-Resolution Mass Spectrometry
Shuo-Jun OU ; Yin-Yin LIN ; Hai-Tao ZHANG ; Jian-Bin CEN ; Zhi-Yuan WANG ; Xin-Dong GUO ; Jia-Jun ZHANG ; Zhi-Sen LIANG ; Guang-Feng ZENG
Chinese Journal of Analytical Chemistry 2025;53(8):1320-1330,中插88-中插92
A method for determination and targeted screening of diflorasone components in health products using ultra performance liquid chromatography-quadrupole time of flight mass spectrometry(UPLC-Q-TOF/MS)was established.Four representative diflorasone and esters(diflorasone,diflorasone diacetate,diflorasone-17-propionate,and diflorasone-21-propionate)were selected to optimize the pretreatment conditions,and 10 mL of extraction solvent dosage,15 min of extraction time and 5 g of salting-out agent as the optimal conditions were selected by response surface methodology.The results showed that the four analytes exhibited good linearity within the concentration range of 2.0?100 μg/L with the chromatographic peak area,and the correlation coefficients(R2)were all greater than 0.9990,while the results of recovery and relative standard deviation could satisfy the requirements of determination.The common characteristic ions of diflorasone and esters werem/z121 andm/z335,and their specific structures were obtained by analyzing the cleavage pathway based on the optimized determination conditions.A targeted screening method for other esters of diflorasone based on characteristic ions guidance strategy was established.This method had many advantages such as high efficiency,high sensitivity and good reproducibility,and could be used for targeted screening of diflorasone and esters in health products.The developed characteristic ion guided strategy could be employed to construct mass spectral databases for various glucocorticoids,enabling comprehensive targeted screening across a broad range of compounds.
6.Observation on the therapeutic effect of a modified Devine procedure with subcutaneous sliding fixation method for concealed penis.
Mohammed Abdulkarem AL-QAISI ; Hai-Fu TIAN ; Jia-Jin FENG ; Ke-Ming CHEN ; Jin ZHANG ; Yun-Shang TUO ; Xue-Hao WANG ; Bin-Cheng HUANG ; Muhammad Arslan Ul HASSAN ; Rui HE ; Guang-Yong LI
Asian Journal of Andrology 2025;27(4):470-474
To evaluate the therapeutic effect of a modified Devine procedure with a subcutaneous sliding fixation method for the treatment of congenital concealed penis, we retrospectively selected 45 patients with congenital concealed penises who were admitted to General Hospital of Ningxia Medical University (Yinchuan, China) between September 2020 and November 2023. In all cases, the penis was observed to be short, and retracting the skin at the base revealed a normal penile body, which immediately returned to its original position upon release. All patients underwent the modified Devine procedure with subcutaneous sliding fixation and completed a 12-week postoperative follow-up. A statistically significant increase in penile length was observed postoperatively, with the median length increasing from 4.0 (interquartile range [IQR]: 3.5-4.8; 95% confidence interval [CI]: 3.9-4.4) cm to 8.0 (IQR: 7.8-8.0; 95% CI: 7.7-7.9) cm, with P < 0.001. The parents were satisfied with the outcomes, including increased penile length, improved hygiene, and enhanced esthetics. Except for mild foreskin edema in all cases, no complications (such as infections, skin necrosis, or penile retraction) were observed. The edema was resolved within 4 weeks after the operation. This study demonstrates that the modified Devine procedure utilizing the subcutaneous sliding fixation method yields excellent outcomes with minimal postoperative complications, reduced penile retraction, and high satisfaction rates among patients and their families.
Humans
;
Male
;
Penis/abnormalities*
;
Retrospective Studies
;
Urologic Surgical Procedures, Male/methods*
;
Treatment Outcome
;
Child
;
Plastic Surgery Procedures/methods*
7.Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.
Fan WANG ; Hai-Qing GAO ; Zhe LYU ; Xiao-Ming WANG ; Hui HAN ; Yong-Xia WANG ; Feng LU ; Bo DONG ; Jun PU ; Feng LIU ; Xiu-Guang ZU ; Hong-Bin LIU ; Li YANG ; Shao-Ying ZHANG ; Yong-Mei YAN ; Xiao-Li WANG ; Jin-Han CHEN ; Min LIU ; Yun-Mei YANG ; Xiao-Ying LI
Chinese journal of integrative medicine 2025;31(3):195-205
OBJECTIVE:
To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:
This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:
A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS
Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans
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Amlodipine/adverse effects*
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Hypertension/complications*
;
Middle Aged
;
Treatment Outcome
;
Drug Therapy, Combination
;
Adult
;
Blood Pressure/drug effects*
;
Double-Blind Method
;
Aged
;
Antihypertensive Agents/adverse effects*
8.A novel dual-targeting strategy of nanobody-driven protein corona modulation for glioma therapy.
Yupei ZHANG ; Shugang QIN ; Tingting SONG ; Zhiying HUANG ; Zekai LV ; Yang ZHAO ; Xiangyu JIAO ; Min SUN ; Yinghan ZHANG ; Guang XIE ; Yuting CHEN ; Xuli RUAN ; Ruyue LIU ; Haixing SHI ; Chunli YANG ; Siyu ZHAO ; Zhongshan HE ; Hai HUANG ; Xiangrong SONG
Acta Pharmaceutica Sinica B 2025;15(9):4917-4931
Glioma represents the most prevalent malignant tumor of the central nervous system, with chemotherapy serving as an essential adjunctive treatment. However, most chemotherapeutic agents exhibit limited ability to penetrate the blood-brain barrier (BBB). This study introduced a novel dual-targeting strategy for glioma therapy by modulating the formation of nanobody-driven protein coronas to enhance the brain and tumor-targeting efficiency of hydrophobic cisplatin prodrug-loaded lipid nanoparticles (C8Pt-Ls). Specifically, nanobodies (Nbs) with fibrinogen-binding capabilities were conjugated to the surface of C8Pt-Ls, resulting in the generation of Nb-C8Pt-Ls. Within the bloodstream, Nb-C8Pt-Ls could bound more fibrinogen, forming the protein corona that specifically interacted with LRP-1, a receptor highly expressed on the BBB. This interaction enabled a "Hitchhiking Effect" mechanism, facilitating efficient trans-BBB transport and promoting effective brain targeting. Additionally, the protein corona interacted with LRP-1, which is also overexpressed in glioma cells, achieving precise tumor targeting. Computational simulations and SPR detection clarified the molecular interaction mechanism of the Nb-fibrinogen-(LRP-1) complex, confirming its binding specificity and stability. Our results demonstrated that this strategy significantly enhanced C8Pt accumulation in brain tissues and tumors, induced apoptosis in glioma cells, and improved therapeutic efficacy. This study provides a novel framework for glioma therapy and underscores the potential of protein corona modulation-based dual-targeting strategies in advancing treatments for brain tumors.
9.Hippocampal Extracellular Matrix Protein Laminin β1 Regulates Neuropathic Pain and Pain-Related Cognitive Impairment.
Ying-Chun LI ; Pei-Yang LIU ; Hai-Tao LI ; Shuai WANG ; Yun-Xin SHI ; Zhen-Zhen LI ; Wen-Guang CHU ; Xia LI ; Wan-Neng LIU ; Xing-Xing ZHENG ; Fei WANG ; Wen-Juan HAN ; Jie ZHANG ; Sheng-Xi WU ; Rou-Gang XIE ; Ceng LUO
Neuroscience Bulletin 2025;41(12):2127-2147
Patients suffering from nerve injury often experience exacerbated pain responses and complain of memory deficits. The dorsal hippocampus (dHPC), a well-defined region responsible for learning and memory, displays maladaptive plasticity upon injury, which is assumed to underlie pain hypersensitivity and cognitive deficits. However, much attention has thus far been paid to intracellular mechanisms of plasticity rather than extracellular alterations that might trigger and facilitate intracellular changes. Emerging evidence has shown that nerve injury alters the microarchitecture of the extracellular matrix (ECM) and decreases ECM rigidity in the dHPC. Despite this, it remains elusive which element of the ECM in the dHPC is affected and how it contributes to neuropathic pain and comorbid cognitive deficits. Laminin, a key element of the ECM, consists of α-, β-, and γ-chains and has been implicated in several pathophysiological processes. Here, we showed that peripheral nerve injury downregulates laminin β1 (LAMB1) in the dHPC. Silencing of hippocampal LAMB1 exacerbates pain sensitivity and induces cognitive dysfunction. Further mechanistic analysis revealed that loss of hippocampal LAMB1 causes dysregulated Src/NR2A signaling cascades via interaction with integrin β1, leading to decreased Ca2+ levels in pyramidal neurons, which in turn orchestrates structural and functional plasticity and eventually results in exaggerated pain responses and cognitive deficits. In this study, we shed new light on the functional capability of hippocampal ECM LAMB1 in the modulation of neuropathic pain and comorbid cognitive deficits, and reveal a mechanism that conveys extracellular alterations to intracellular plasticity. Moreover, we identified hippocampal LAMB1/integrin β1 signaling as a potential therapeutic target for the treatment of neuropathic pain and related memory loss.
Animals
;
Laminin/genetics*
;
Hippocampus/metabolism*
;
Neuralgia/metabolism*
;
Cognitive Dysfunction/etiology*
;
Male
;
Peripheral Nerve Injuries/metabolism*
;
Extracellular Matrix/metabolism*
;
Integrin beta1/metabolism*
;
Pyramidal Cells/metabolism*
;
Signal Transduction
10.Research progress on materials of patent foramen ovale occlader
Guang-tai ZHOU ; Chao ZHOU ; Hai-jun ZHANG
Chinese Journal of Interventional Cardiology 2024;32(12):709-716
Patent foramen ovale(PFO)is an important risk factor for cardiogenic stroke.With the rapid development of cardiac interventional techniques,PFO occluder has become the first choice for the treatment of PFO.The biocompatibility,mechanical stability of the occluder material and its adaptability to the patient's anatomical structure are key factors in determining the therapeutic effect.Remarkable progress has been made in its research.In the early stage,the occluder was mainly made of metal material.Although it has high sealing effect and operation convenience,there is potential risk of long-term retention in the body.In recent years,biodegradable materials have been widely used in the field of sealers,such sealers are made of biomedical polymer materials,implanted into the human body to play a temporary bridge role,guide self-tissue bioremediation,and gradually degrade into harmless substances discharged from the body,avoiding the long-term retention of metal sealers.This paper reviews the research progress of PFO occluder materials,including the application of non-degradable materials and biodegradable materials,and discusses the limitations of the current research and the possible development trend in the future,so as to provide reference for clinical application.


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