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.Role of DHA in long-term cognitive impairment after multiple sevoflurane anesthesia in newborn mice
Sufang JIANG ; Jiaqi LI ; Tianyu CAO ; Jiaqi YUE ; Lichao DI ; Shizhao WANG ; Fuzhen ZHANG ; Rongtian KANG ; Huan CHEN ; Huixian CUI ; Sha LI ; Lining HUANG
Chinese Journal of Anesthesiology 2025;45(5):559-563
Objective:To evaluate the role of docosahexaenoic acid (DHA) in long-term cognitive impairment after multiple sevoflurane anesthesia in newborn mice.Methods:Clean-grade healthy male C57BL/6 mice, aged 6 days, were used in this study. Ten mice were divided into 2 groups ( n=5 each) by the random number table method: control group (group C) and sevoflurane group (group S). The animals inhaled 3% sevoflurane for 2 h at 6, 7 and 8 days after birth. The DHA content was detected by ultra-high performance liquid chromatography-mass spectrometry at 9 days of age. Fifty-two mice were selected and divided into 4 groups ( n=13 each) by a random number table method: control+ normal saline group (group C+ S), sevoflurane anesthesia + normal saline group (group S+ S), control+ DHA group (group C+ D), and sevoflurane anesthesia+ DHA group (group S+ D). The sevoflurane anesthesia method was the same as the one mentioned above. DHA 50 mg/kg was administered by intragastric gavage from postnatal days 6-19 (at 6, 7 and 8 days after birth, 2 h before anesthesia) in C+ D and S+ D groups. The equal volume of normal saline was given instead in C+ S group and S+ S group. The novel object recognition test was conducted at 37 days of age, and the Morris water maze test was performed at 42 days of age. The corpus callosum and hippocampal tissues were isolated at 47 days of age for examination of the ultrastructure of myelin (with a transmission electron microscope) and for determination of the expression of myelin basic protein (MBP) in hippocampal tissues (by Western blot). The G-ratio was calculated. Results:Compared with group C, the content of DHA in hippocampal tissues was significantly decreased in group S ( P<0.05). Compared with group C+ S, the discrimination index was significantly decreased, the percentage of duration of staying at the target platform quadrant and the number of crossing the original platform were decreased, the expression of MBP was down-regulated, and the G-ratio in the original platform and hippocampus was increased in S+ S group ( P<0.05). Compared with group S+ S, the discrimination index was significantly increased, the percentage of duration of staying at the target platform quadrant and the number of crossing the original platform were increased, the expression of MBP was up-regulated, and the G-ratio in the original platform and hippocampus was decreased in S+ D group ( P<0.05). Conclusions:The mechanism of long-term cognitive impairment following multiple sevoflurane anesthesia may be related to a decrease in the content of DHA, which subsequently leads to myelin structural damage in neonatal mice.
5.Relationship between preoperative gut microbiota and postoperative ventilator-associated pneumonia in patients undergoing coronary artery bypass grafting
Peiying HUANG ; Lichao DI ; Sichen CUI ; Tianyu CAO ; Shizhao WANG ; Huan CHEN ; Sha LI ; Lining HUANG
Chinese Journal of Anesthesiology 2025;45(11):1422-1426
Objective:To evaluate the relationship between preoperative gut microbiota and post-operative ventilator-associated pneumonia (VAP) in patients undergoing coronary artery bypass grafting.Methods:This was a secondary analysis of a previous research project study. Patients who received invasive mechanical ventilation treatment after elective off-pump coronary artery bypass grafting at the Second Hospital of Hebei Medical University from April to September 2023 were selected and divided into VAP group and non-VAP group based on whether VAP occurred after surgery. Fecal samples were collected from patients before surgery, and 16S rRNA gene sequencing was used to analyze the characteristics of preoperative gut microbiota in the two groups. The differences in the diversity of gut microbiota between the two groups were compared. The linear discriminant analysis was used to identify the gut microbiota with significant differences between groups (differential bacteria), and logistic regression analysis was conducted to assess the association between differential bacteria and VAP. Receiver operating characteristic curves were drawn to analyze the predictive value of the differential bacteria for VAP.Results:A total of 79 patients were finally included, with 25 in VAP group and 54 in non-VAP group. The Beta diversity analysis showed statistically significant differences between VAP group and non-VAP group (pseudo- F=2.00, P=0.002). The linear discriminant analysis indicated that Bifidobacterium, Blautia and Megamonas were enriched in non-VAP group, while Klebsiella was enriched in VAP group. Multivariate logistic regression analysis showed that the relative abundance of Bifidobacterium was a protective factor for postoperative VAP ( OR=0.32, 95% confidence interval [ CI] 0.15-0.71, P=0.005), and the relative abundance of Klebsiella was a risk factor for postoperative VAP ( OR=2.49, 95% CI 1.143-5.43, P=0.022). The area under the receiver operating characteristic curve of the relative abundance of Bifidobacterium for predicting VAP was 0.80 (95% CI 0.69-0.90, P<0.001) and of the relative abundance of Klebsiella was 0.70 (95% CI 0.57-0.83, P=0.005). Conclusions:Bifidobacterium is a protective factor, while Klebsiella is a risk factor for postoperative VAP in patients undergoing coronary artery bypass grafting, and the relative abundance of both bacteria has a certain predictive value for VAP.
6.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.
7.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.
8.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.
9.Characteristics and prognosis of patients with primary sclerosing cholangitis
Sha CHEN ; Tongtong MENG ; Weijia DUAN ; Shuxiang LI ; Tingting LYU ; Yu WANG ; Jidong JIA ; Yuanyuan KONG ; Hong YOU
Chinese Journal of Internal Medicine 2025;64(3):206-211
Objective:Primary sclerosing cholangitis (PSC) is a rare autoimmune disease. This study aims to describe the baseline characteristics and clinical outcomes of Chinese PSC patients and explore risk factors associated with prognosis, addressing the lack of long-term prognostic analysis in China.Methods:Clinical data of PSC patients were retrospectively collected from May 2009 to June 2023 in Beijing Friendship Hospital Affiliated to Capital Medical University, and patient follow-up was conducted through outpatient visits, telephone calls, and medical record reviews. The Cox proportional hazards model and the Kaplan-Meier method were employed to identify risk factors and estimate transplant-free survival.Results:A total of 65 PSC patients were enrolled, with male patients accounting for 50.8% and an average age of onset of 44 years. The disease types primarily included large duct PSC (57.9%) and whole duct PSC (22.8%). Most patients (78.5%) sought medical attention due to symptoms, with common clinical manifestations including jaundice (32.3%), fatigue (23.1%), abdominal discomfort (21.5%), pruritus (16.9%), and fever (10.8%). A total of 19 patients (29.2%) had concomitant ulcerative colitis. Compared to large duct PSC or whole duct PSC, small duct PSC showed a lower proportion of concomitant ulcerative colitis ( P<0.001) and milder baseline disease severity. After a median follow-up of 29 months (interquartile range: 11,53), 19 patients experienced liver transplantations and/or liver disease-related deaths. The overall 2-year and 5-year transplant-free survival rates for PSC patients were 76.0% and 59.5%, respectively. Elevated bile acid levels were identified as an independent risk factor for poor outcomes in PSC patients. Conclusion:The study population of Chinese PSC patients predominantly consisted of middle-aged males, characterized by a low ratio of asymptomatic cases, a low incidence of associated inflammatory bowel disease, and a low rate of transplant-free survival. Elevated bile acid level was identified as an independent risk factor for poor outcomes in PSC patients.
10.Trends in the global burden of neonatal infections from 1990 to 2021: Joinpoint regression analysis based on the GBD database
Yu DAI ; Shushu LI ; Xiaohui CHEN ; Shuping HAN ; Li SHA
International Journal of Pediatrics 2025;52(9):634-639
Objective:To systematically evaluate the global disease burden of neonatal sepsis and other neonatal infections(NSNIs),providing scientific basis for their prevention and control.Methods:Using the Global Burden of Disease(GBD)2021 database,this article calculated the incidence,mortality,and age-standardized rates for NSNIs. Trends were evaluated with Joinpoint regression model,and compared at different socio-demographic index(SDI)levels.Results:From 1990 to 2021,the global age-standardized incidence rate(ASIR)of NSNIs decreased from 78.98 to 62.70 per 100 000 with an with average annual percentage change(AAPC)of -0.73%( P<0.01). The age-standardized mortality rate(ASMR)declined from 4.77 to 3.76 per 100 000 with an AAPC of -0.76%( P<0.01). In particular,the disease burden was consistently higher among male neonates. Low birth weight was the primary risk factor globally,followed by preterm birth. Regions with lower SDI levels exhibited higher ASIR and ASMR,and household solid fuel air pollution contributed more to NSNIs-related mortality. Conclusion:Although the overall disease burden of NSNIs has declined,male neonates and low-SDI regions still face substantial challenges. Continuous efforts to improve air quality are warranted,and low-SDI regions should further strengthen healthcare infrastructure to enhance diagnostic and treatment quality.

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