1.A Multi-dimensional Indicator-based Approach for Quality Evaluation of Chinese Patent Medicines
Shuangyan LI ; Siyuan LI ; Sha CHEN ; Yue GUO ; Jun ZHANG ; Cong GUO ; Yan LIU ; An LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):229-237
Chinese patent medicines are the core preparations for disease prevention and treatment in clinical traditional Chinese medicine (TCM). Their quality is the key to ensuring safe and effective medication and promoting the high-quality development of the TCM industry. At present, the quality evaluation of Chinese patent medicines faces prominent problems, such as inadequate control of quality consistency, over-reliance on single indicators, one-sided evaluation dimensions, unstable statistical methods, and poor implementability of research findings. These defects lead to insufficient scientificity of evaluation results, making it difficult to support the implementation of policies including centralized procurement, high quality, and favorable prices for Chinese patent medicines. According to the core requirements of quality evaluation for Chinese patent medicines, this study established a four-dimensional comprehensive evaluation system encompassing consistency index(CI), content index(MI), effect index(EI), and preparation index(PI). All evaluation indicators were normalized to achieve horizontal comparability. Meanwhile, an improved radar chart was introduced to realize the visualization of evaluation results. This method can systematically integrate four types of core quality attributes: Quality consistency, component content, biological activity, and preparation characteristics. It can effectively distinguish quality differences among products of the same specification from different manufacturers. The evaluation results are unique, stable, and not affected by the addition or reduction of samples, which takes scientificity, objectivity, and operability into account. This method can provide scientific and technical support for screening high-quality Chinese patent medicines and implementing policies of centralized procurement, high quality, and favorable prices. Moreover, it has important practical significance for improving the quality evaluation system of Chinese patent medicines and advancing the standard and modern development of TCM.
2.Quality Evaluation of Commercially Available Huoxiang Zhengqi Preparations
Yue GUO ; Siyuan LI ; Qingxia XU ; Sha CHEN ; Shuangyan LI ; Jipeng DI ; An LIU ; Yan LIU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(19):238-247
ObjectiveTo establish a comprehensive evaluation framework combining multi-component quantification with daily intake in response to the challenges posed by multiple coexisting dosage forms, single-faceted quality evaluation, and ambiguous clinical equivalence of Huoxiang Zhengqi preparations, and to compare the quality differences and superiority among eight commercially available dosage forms. MethodsA total of 75 batches of Huoxiang Zhengqi preparations from 25 manufacturers were investigated. Ultra-performance liquid chromatography-triple quadrupole-tandem mass spectrometry (UPLC-QqQ-MS/MS) coupled with gas chromatography-triple quadrupole-tandem mass spectrometry (GC-QqQ-MS/MS) was adopted to simultaneously quantify 20 core marker components. Normalization was performed based on equivalent raw herb concentrations to eliminate interferences from dosage forms, excipients, and specifications. Considering the specified clinical dosage, the actual daily intake level was calculated to comprehensively evaluate component retention, content uniformity, and potential differences in in vivo exposure among different dosage forms. ResultsThe quality of Huoxiang Zhengqi preparations differed greatly among dosage forms and manufacturers. On the basis of the recommended daily doses in the package inserts, the total daily intake of the 20 tested components ranged from 3.14 to 614.30 mg·d-1, while that of hesperidin, a quality-control marker, ranged from 0.03 to 40.65 mg·d-1. Atractylodin was detected only in tinctures and soft capsules, with concentrations ranging from (2.68±0.01) to (5.73±0.37) mg·L-1. The soft capsules from manufacturer M22 had the highest atractylodin level, while atractylodin was not detected in the other dosage forms. Nucleosides were most abundant in the oral liquids and tinctures (M4 to M13). The tincture from manufacturer M5 showed the highest nucleoside level of 29.12 mg·L-1, whereas the granules had the lowest nucleoside levels, with that of M23 being only 3.48 mg·L-1. Perillae Folium-related components varied greatly among batches, with an relative standard deviation (RSD) of 87.55%. The daily intake of hesperidin from all three granule products was below 3.6 mg·d-1, the reference value calculated for Huoxiang Zhengqi Shui according to the 2025 edition of the Chinese Pharmacopoeia. ConclusionThe levels of active components differed significantly among different dosage forms of Huoxiang Zhengqi preparations. Tinctures contained more types and higher overall levels of active components, while soft capsules were better at preserving volatile components. Granules and dripping pills had lower overall levels of active components. The comprehensive evaluation method established in this study can provide a basis for the quality control, process optimization, and the selection of high-quality products.
3.Identification and in vitro validation of causative proteins in metabolic dysfunction-associated fatty liver disease: A study based on proteome-wide Mendelian randomization
Jianyi CHEN ; Wentao HUANG ; Yang LI ; Zewei ZHUO ; Qinming LI ; Yu LONG ; Weihong SHA ; Hao CHEN
Journal of Clinical Hepatology 2026;42(9):2067-2074
ObjectiveTo identify protein biomarkers and potential therapeutic targets associated with metabolic dysfunction-associated fatty liver disease (MAFLD) through an integrative multi-omics analysis. MethodsLarge-scale plasma protein quantitative trait locus data were integrated with MAFLD genome-wide association study data, and a proteome-wide Mendelian randomization analysis was performed. Summary data-based Mendelian Randomization (SMR)/heterogeneity in dependent instruments (HEIDI) test and colocalization analysis were used to assess significant proteins. The independent samples t-test was used for comparison of continuous data with homogeneity of variance between two groups, and the Welch-corrected t-test was used for comparison of continuous data with heterogeneity of variance. The transcriptomic validation results were compared with the Mendelian randomization results to evaluate the changing trends of gene expression, and boxplots were used to display the expression distribution of candidate genes between groups. ResultsAmong 7 130 proteins analyzed, 40 showed a causal relationship with MAFLD, among which 26 increased the risk of MAFLD and 14 exerted a protective effect against MAFLD (FDR<0.05). Nine proteins were supported by SMR/HEIDI (PSMR<0.05, PHEIDI>0.05), and 14 showed a strong colocalization signal (PPH4>0.9). The transcriptomic analysis identified 5 differentially expressed proteins (all P<0.05), i.e., adenosine diphosphate-ribosylation factor-like GTPase 2, insulin-like growth factor binding protein 2, casein kinase 1 delta (CSNK1D), leucine-rich repeat neuronal 1, and moesin (MSN). In vitro validation showed upregulated expression levels of MSN (1.612±0.346 vs 0.569±0.077, P<0.05), 14-3-3 protein theta (YWHAQ) (1.267±0.126 vs 0.313±0.029, P<0.05), and CSNK1D (0.871±0.025 vs 0.431±0.080, P<0.05) and a downregulated expression level of histone deacetylase 8 (0.637±0.059 vs 1.097±0.260, P<0.05) in the MAFLD cell model. Functional annotation showed that CSNK1D participated in circadian and metabolic regulation, YWHAQ modulated the Hippo pathway and lipid signal transduction, and MSN was associated with cytoskeletal remodeling and fibrogenic responses. ConclusionThe integrative proteogenomic analysis in this study shows that CSNK1D, YWHAQ, and MSN may be key mediators in the pathogenesis of MAFLD. These proteins have the potential to serve as novel biomarkers and therapeutic targets, providing new directions for research on disease mechanisms and the development of intervention strategies.
4.Multidimensional Analysis of Mechanisms of Nuciferine Against Cerebral Ischemia Based on Transcriptomic Data
Yingying QIN ; Peng LI ; Sha CHEN ; Yan LIU ; Jintang CHENG ; Qingxia XU ; Guohua WANG ; Jing ZHOU ; An LIU ; Chang CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):184-191
ObjectiveStudies have shown that nuciferine has anti-cerebral ischemia effect, but the specific mechanism of action has not been elaborated. Based on the transcriptome results, the pharmacological mechanism of nuciferine against cerebral ischemia was analyzed from multiple dimensions including tissue, cell, pathological process, biological process and signaling pathway. MethodsThirty SD rats were randomly divided into the sham group, model group and nuciferine group(40 mg·kg-1) according to weight. Except for the sham group, the model of middle cerebral artery occlusion(MCAO) was established by thread embolization method after 30 min of administration in the other two groups. Twenty-four hours after surgery, transcriptome sequencing was used to detect the gene expression profiles in the cortex penumbra of rat cerebral tissue, and gene ontology(GO) and kyoto encyclopedia of genes and genomes(KEGG) pathway enrichment analysis were performed for differentially expressed genes. The mechanismof nuciferine against cerebral ischemia was analyzed from 5 dimensions of tissue, cell, pathological process, biological process and signaling pathway by the transcriptome-based multi-scale network pharmacology platform(TMNP). ResultsTranscriptome sequencing and gene quantitative analysis showed that 667 genes were significantly reversed by nuciferine. Further enrichment analysis of KEGG and GO suggested that the pathways of nuciferine involved regulating stress response, ion transport, cell proliferation and differentiation, and synaptic function. TMNP research found that at the tissue level, nuciferine could significantly improve the cerebral tissue injury caused by ischemia. At the cellular and pathological levels, nuciferine could play an anti-cerebral ischemia role by improving the state of various nerve cells, mobilizing immune cells, regulating inflammation. And at the level of biological processes and signaling pathways, nuciferine mainly acted on the processes such as vascular remodeling, inflammation-related signaling pathways, and synaptic signaling. ConclusionCombined with the results of transcriptome sequencing, gene quantitative analysis and TMNP, the mechanism of nuciferine against cerebral ischemia may be related to processes such as intervening in stress response and inflammation, affecting vascular remodeling and regulating synaptic function. These results can provide a basis and reference for further study of the pharmacological mechanism of nuciferine against cerebral ischemia.
5.Experiences of food avoidance behavior in patients with inflammatory bowel disease:a qualitative study
Qingyu WANG ; Meijing ZHOU ; Yang LEI ; Sha LI ; Junyi GU ; Zheng LIN ; Qiugui BIAN ; Jiefeng YANG ; Lichen TANG ; Jiali CHEN ; Hantian CHENG
Chinese Journal of Nursing 2025;60(11):1323-1329
Objective This study applies Roy adaptation theory to deeply explore the experience of food avoid-ance behavior in patients with inflammatory bowel disease(IBD),offering insights for developing dietary management strategies.Methods A descriptive qualitative research method was employed.By purposive sampling,24 IBD pa-tients hospitalized in the gastroenterology department of a tertiary hospital in Nanjing from July 2022 to December 2024 were selected for semi-structured interviews.Data were analyzed using a directed content analysis approach.Results This study identified 4 main themes and 11 sub-themes,encompassing overattribution leading to inappro-priate avoidance(recurrent symptoms triggering overattribution,disease staging triggering inappropriate avoidance),negative self-perception leading management struggles(illness fear diminishing self-efficacy,disease trauma eroding self-identity,knowledge deficiency constraining self-determination),functional impairment intensifying role challenges(role internalization undermining social function,social roles relinquishing dietary management),and external con-straints amplifying practical difficulties(family and friend oversight heightening dietary stress,healthcare gaps foster-ing practical helplessness,traditional beliefs restricting dietary exploration,economic hardship limiting balanced nu-trition).Conclusion The interplay of overattribution,negative self-perception,functional impairment,and external constraints in IBD patients hinders their ability to adapt to disease fluctuations,ensnaring them in the adaptive predicament of food avoidance behavior.Healthcare professionals should comprehensively address these factors by fostering accurate perceptions,enhancing psychological support,guiding effective coping strategies,and optimizing ex-ternal resources,thereby improving patients' overall adaptive capacity and promoting their recovery.
6.Efficacy of alanyl glutamine combined with octreotide in the treatment of acute pancreatitis associated lung injury
Honghua SHAO ; Liang ZHU ; Sha LI ; Qiaoqiao CHEN
China Modern Doctor 2025;63(7):67-70
Objective To investigate the efficacy of alanyl glutamine combined with octreotide in the treatment of acute pancreatitis(AP)associated lung injury.Methods A total of 94 patients with AP associated lung injury admitted to Jinhua Municipal Central Hospital from June 2022 to June 2024 were selected and divided into observation group and control group according to random number table method,with 47 patients in each group.Patients in control group were treated with octreotide,patients in observation group were treated with alanyl glutamine on the basis of control group.The efficacy,Balthazar CT grading,acute physiology and chronic health evaluation Ⅱ(APACHE Ⅱ)score,Murray lung injury score(MLIS),Toll-like receptor 4(TLR4),matrix metalloproteinase-9(MMP-9)and blood gas indexes[arterial partial pressure of oxygen(PaO2),arterial oxygen saturation(SaO2)and oxygenation index]were compared between two groups.Results The curative effect of observation group was significantly better than that of control group(x2=5.817,P=0.016).After treatment,the Balthazar CT grading,APACHE Ⅱ score,MLIS score,TLR4 and MMP-9 of patients in two groups were significantly lower than before treatment,while PaO2,SaO2 and oxygenation index were significantly higher than before treatment(P<0.05).Balthazar CT grading,APACHE Ⅱ score,MLIS score,TLR4 and MMP-9 in observation group were significantly lower than those in control group,while PaO2,SaO2 and oxygenation index were significantly higher than those in control group(P<0.05).Conclusion Alanyl glutamine combined with octreotide has a significant effect in the treatment of patients with AP associated lung injury,which can improve the clinical symptoms of patients,reduce lung injury and inflammation.
7.Evaluation of economic burden of ICU patients due to hospital-associated MDROs infection based on propensity score matching
Mengqi TANG ; Qian YU ; Zhenping SHA ; Xiaoqing LIU ; Furong GENG ; Shuo LI ; Zhongming CHEN
Chinese Journal of Nosocomiology 2025;35(21):3227-3231
OBJECTIVE To evaluate the economic burden of the intensive care unit(ICU)patients due to hospital-associated multidrug-resistant organisms(MDROs)infections based on propensity score matching(PSM)so as to provide evidence-based bases for prevention and control of hospital-associated MDROs infection and improvement of utilization efficiency of medical resources.METHODS A total of 2118 patients who were hospitalized in Zibo Central Hospital from Jan.1,2023 to Dec.31,2024 and conformed to the inclusion and exclusion criteria were re-cruited as the research subjects.The patients with hospital-associated MDROs infections were matched in a 1∶1 ratio by PSM(with the clamp value 0.02).Totally 309 pairs were successfully matched.The length of hospital stay and the costs were observed and compared between the MDROs group and the non-MDROs group.RESULTS The MDROs group was with the length of hospital stay 14.00 days longer than the non-MDROs group after the matching(Z=-5.750,P<0.001),with the total cost of hospitalization increased by 91,420.84 yuan(Z=-8.271,P<0.001).With the respect to the medical treatment expenses,the expenses of the MDROs group were higher than those of the non-MDROs group,covering the cost of medical service,therapeutic procedures,nursing,western medicine and TCM,and there were significant differences(P<0.05).Among the differences in the costs between the two groups,the difference in the cost of western medicine was the most signif-icant(22,182.91 yuan),followed by the cost of clinical laboratory test for diagnosis(19,529.60 yuan)and the cost of therapeutic procedures(16,333.50 yuan).CONCLUSIONS The hospital-associated MDROs infections may lead to the extension of hospital stay length of the ICU patients,which then increases the economic burden.There-fore,it is necessary to strengthen the multidisciplinary collaboration and formulate corresponding measures so as to reduce the risk of such infections among the ICU patients.
8.Sarcopenic obesity and mortality risk in nursing home residents: a prospective cohort study based on six obesity indicators
Xiaoyan CHEN ; Mei LI ; Sha HUANG ; Shuyue LUO ; Wenyi ZHANG ; Wenhua JIANG ; Ming YANG
Chinese Journal of Geriatrics 2025;44(7):943-950
Objective:To investigate the relationship between sarcopenic obesity(SO), defined by various obesity indicators, and mortality risk in older adults based on a prospective cohort from multiple nursing homes.Methods:Sarcopenia was diagnosed according to the 2019 consensus of the Asian Working Group for Sarcopenia.Obesity was defined using six different indicators: waist circumference(WC), waist-hip ratio(WHR), waist-height ratio(WHTR), body mass index(BMI), visceral fat area(VFA), and percentage of body fat(PBF).A prospective cohort of adults aged 60 and above was established across 15 nursing homes in Zigong City, with annual follow-ups on survival status conducted over two consecutive years.Cox proportional hazards regression models were employed to analyze the association between SO, defined by different obesity indicators, and mortality risk, calculating hazard ratios( HR)and their 95% confidence intervals( CI). Results:A total of 695 older adults were included in the study, of whom 67.1% were male.During the 2-year follow-up period, 88 participants died.The prevalence of SO as defined by WC, WHR, WHTR, BMI, VFA, PBF was found to be 17.6%, 30.1%, 48.9%, 3.0%, 28.3%, and 58.7%, respectively.When SO was defined using WC, WHR, WHTR, BMI, and VFA, there was no statistically significant difference in mortality rates between the SO and non-SO groups.However, when defined by PBF, the SO group exhibited a significantly higher mortality rate compared to the non-SO group(16.9% vs.6.6%, P<0.01).Cox proportional hazards regression analysis revealed that, compared to the non-SO group, the SO group defined by PBF had a significantly increased mortality risk( HR=2.81, 95% CI: 1.67-4.73, P<0.001).After adjusting for potential confounding factors, the mortality risk for the SO group remained significantly higher than that of the non-SO group( HR=1.97, 95% CI: 1.14-3.38, P=0.015). Conclusions:The prevalence of SO varies significantly across different obesity indicators.SO defined by PBF is significantly associated with mortality risk in nursing home residents.This study provides new evidence for further optimizing the diagnostic criteria for SO in this population.
9.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
10.Clinical research and application status of cervical sagittal parameters C 2-C 7 SVA
Zerui QIN ; Yu RAN ; Zongshuo SHA ; Xiaohong MU ; Jinyu LI ; Jiang CHEN
Chinese Journal of Orthopaedics 2025;45(7):454-462
The C 2-C 7 sagittal vertical axis (SVA) is an essential biomechanical parameter for evaluating cervical spine alignment, and it is integral to the pathogenesis, progression, and prognosis of cervical spine disorders. This parameter is widely used in evaluating cervical sagittal balance and functional status. Internationally, a C 2-C 7 SVA of less than 25 mm is considered within the cervical range for sagittal balance, while values exceeding 40 mm indicate cervical sagittal imbalance or deformity. An increased C 2-C 7 SVA disrupts cervical spine biomechanics, leading to heightened static and dynamic loads on the cervical musculature. This, in turn, results in muscle fatigue and discomfort. In the short term, patients may experience axial neck symptoms, while a sustained elevation in SVA over time significantly raises the risk of cervical disc degeneration, radiculopathy, and myelopathy. Additionally, a higher C 2-C 7 SVA postoperatively places excessive stress on adjacent spinal segments, which can accelerate degeneration of intervertebral discs and facet joints, contributing to adjacent segment degeneration. Both short-term and long-term postoperative evaluations have shown that an increase in C 2-C 7 SVA is typically associated with poorer surgical outcomes, whereas effective control of SVA values is closely linked to better functional recovery. Therefore, in clinical practice, maintaining C 2-C 7 SVA within the normal range (<25 mm) is critical not only for optimizing treatment results but also for significantly reducing postoperative complications and improving overall patient quality of life.

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