1.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
Fang LU ; Ping WANG ; Liqun BIAN ; Lin LYU ; Mengli XIAO ; Tai ZHANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):498-503
Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless, given the unique characteristics of traditional Chinese medicine (TCM) and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM, the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design, evaluation, and platform construction, compares domestic and international research landscapes, and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established, and further innovation is needed in TCM research design and methodologies, leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover, standardized and shared platforms for TCM clinical data should be accelerated, so as to provide references for the design, implementation, and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.
2.Molecular characterization of FGFR fusion in a large real-world population and clinical utility of bidirectional fusion.
Xinyi ZHANG ; Jing ZHAO ; Ling MA ; Yitong TIAN ; Jiaguang ZHANG ; Hejian ZHENG ; Junling ZHANG ; Runyu HE ; Luhang JIN ; Jing MA ; Mengli HUANG ; Xiao LI ; Xiaofeng CHEN
Chinese Medical Journal 2025;138(12):1510-1512
3.Relationship between autonomous rehabilitation behavior and related symptoms of middle-aged stroke patients
Yuting TAN ; Zhixia ZHANG ; Mengli XU ; Peiran GUO ; Qin XIAO ; Linru QIAO ; Feiyun SONG ; Qiaojun YU
Chinese Journal of Nursing 2025;60(7):773-778
Objective To explore the time-varying characteristics and correlation degree of autonomous rehabili-tation behavior and related symptoms of middle-aged stroke patients,and to provide a basis for clinical transitional nursing and precise rehabilitation.Methods Ecological momentary assessment was used to select 57 middle-aged stroke patients who underwent rehabilitation treatment in the Rehabilitation Medicine Department of a tertiary com-prehensive hospital in Wuhan from March 15 to August 30,2024,using convenience sampling method.Their au-tonomous rehabilitation behavior and related symptoms(fatigue,pain,emotion,sensation)were continuously monitored for 2 weeks.A hierarchical linear model was used to analyze the correlation between behavior and symptoms.Results The autonomous rehabilitation behavior of middle-aged stroke patients showed a fluctuating increasing trend,and the symptom score showed a slow decreasing trend.The hierarchical linear model showed that compared with female patients,male patients have longer duration of autonomous rehabilitation behavior(P<0.05).The number and duration of autonomous rehabilitation behaviors in patients without fatigue were higher(P<0.05).The number of autonomous rehabilitation behaviors in patients without pain was higher than that in patients with pain(P<0.05).The number of autonomous rehabilitation behavior items among patients who perceived more pleasure in rehabilitation was higher than that among patients with greater difficulty in rehabilitation challenges(P<0.05).Patients with high rehabilitation confidence have higher numbers and duration of autonomous rehabilitation behaviors compared to pa-tients with low rehabilitation confidence(P<0.05).Conclusion There are significant individual differences and dy-namic changes in the autonomous rehabilitation behavior and related symptoms of middle-aged stroke patients.Nurs-ing staff should accurately implement personalized rehabilitation services during the transition period,enhance pa-tients'autonomy and self-management ability in home-based rehabilitation,in order to improve the overall rehabilita-tion effect.
4.Relationship between autonomous rehabilitation behavior and related symptoms of middle-aged stroke patients
Yuting TAN ; Zhixia ZHANG ; Mengli XU ; Peiran GUO ; Qin XIAO ; Linru QIAO ; Feiyun SONG ; Qiaojun YU
Chinese Journal of Nursing 2025;60(7):773-778
Objective To explore the time-varying characteristics and correlation degree of autonomous rehabili-tation behavior and related symptoms of middle-aged stroke patients,and to provide a basis for clinical transitional nursing and precise rehabilitation.Methods Ecological momentary assessment was used to select 57 middle-aged stroke patients who underwent rehabilitation treatment in the Rehabilitation Medicine Department of a tertiary com-prehensive hospital in Wuhan from March 15 to August 30,2024,using convenience sampling method.Their au-tonomous rehabilitation behavior and related symptoms(fatigue,pain,emotion,sensation)were continuously monitored for 2 weeks.A hierarchical linear model was used to analyze the correlation between behavior and symptoms.Results The autonomous rehabilitation behavior of middle-aged stroke patients showed a fluctuating increasing trend,and the symptom score showed a slow decreasing trend.The hierarchical linear model showed that compared with female patients,male patients have longer duration of autonomous rehabilitation behavior(P<0.05).The number and duration of autonomous rehabilitation behaviors in patients without fatigue were higher(P<0.05).The number of autonomous rehabilitation behaviors in patients without pain was higher than that in patients with pain(P<0.05).The number of autonomous rehabilitation behavior items among patients who perceived more pleasure in rehabilitation was higher than that among patients with greater difficulty in rehabilitation challenges(P<0.05).Patients with high rehabilitation confidence have higher numbers and duration of autonomous rehabilitation behaviors compared to pa-tients with low rehabilitation confidence(P<0.05).Conclusion There are significant individual differences and dy-namic changes in the autonomous rehabilitation behavior and related symptoms of middle-aged stroke patients.Nurs-ing staff should accurately implement personalized rehabilitation services during the transition period,enhance pa-tients'autonomy and self-management ability in home-based rehabilitation,in order to improve the overall rehabilita-tion effect.
5.New mutation of ACADVL-related very long chain acyl-CoA dehydrogenase deficiency
Xiaohua LI ; Baiyu CHEN ; Rui XIAO ; Mengli ZHUANG ; Hang YU ; Lijun YANG
Chinese Journal of Applied Clinical Pediatrics 2018;33(20):1568-1572
Objective According to the clinical and gene mutation characteristics of ACADVL-related very long chain acyl-CoA dehydrogenase deficiency(VLCADD),the types that contribute to the gene mutation of ACADVL were summarized.Methods By analyzing clinical,laboratory and genetic data of 1 case with ACADVL-related very long chain acyl-CoA dehydrogenase deficiency diagnosed from Department of Pediatrics,the Affiliated Hospital of Inner Mongolia Medical University in August 2016,based on the agreement signed by both the litde patient's parents and the hospital,plus the high-throughput sequencing analysis and PCR sequencing test for the 2 generation genes,some presented mutation sites were analyzed and concluded,in addition to taking "ACADVL" as key words to search the databases from CNKI,Wanfang(updated in 2016) as well as PubMed and related documents from On-line Mendal Inheritant databases of Man (OMIM) and HGMD.Results Through physical examination,VLCADD was diagnosed.After being given Levocamitine and the diet likemedium-chain fatty acid food for a week,the metabolism returned to normal.Tracking him for 3 months,his hepatitis obviously rebounded,within the reach of 3 cm under the right rib and 1 cm under the xiphoid.The exome sequencing study (trios) was identified the novel heterozygous mutation according to the statistics below A CAD VL (N M_000018.3) Exon7:c.608 C > T;p.(Pro203 Leu) (heterozygous) and A CAD VL (NM _000018.3) Exon18:c.1748C > T;p.(Ser583Leu) (heterozygous) in ACADVL.Relevant literature reported suggest these two mutations from both the parents are pathogenic genes,which can account for the reason why the boy got ill.However,these two mutations had not been reported in ACADVL-related VLCADD so far.Up to now,73 types of mutations from documents index were related to the VLCADD,but the clinical case included 75 kinds of gene mutations.Conclusions The apparent symptoms of the boy with the gene mutation were reflected in abnormal heart rates,hepatomegaly and hypoglycemia.VLCADD was diagnosed through genetic testing,and systematic treatment can partly control the development of the disease.In conclusion,the findings (exon 7 and 18) show that according to the genetic tests,disease-causing genes from both parents are new mutations of ACADVL and they are pathogenic.
6.Protective effects of total flavonoid from Mori folium on renalfibrosis in type 1 diabetic mice and specific mechanisms of these effects
Wenwen WANG ; Sai ZHANG ; Xiaohui ZHU ; Xinran QIU ; Zhongxuan MA ; Mengli SHEN ; Xingyu LIU ; Yanan ZHONG ; Xiao ZHANG ; Xiaoxing YIN ; Qian LU
Chinese Pharmacological Bulletin 2017;33(9):1278-1285
Aim To observe the effect of total flavonoid from Mori folium(TFMF) on renal interstitial fibrosis in type 1 diabetic mice and its possible mechanism.Methods Diabetic mice were induced by intraperitoneal injection of streptozotocin(STZ) dissolved in 0.01 mol·L-1 citrate buffer(pH 4.5) at 150 mg·kg-1 body weight after 12 h of food deprivation.Forty model mice were divided randomly into four groups: model group, and low-(0.25 g·kg-1), moderate-(0.5 g·kg-1), high-dose groups(1 g·kg-1) fed with TFMF once daily.In addition, eight normal mice were used as normal group.After 12 weeks, the fasting blood glucose(FBG), serum creatinine(Cr), blood urea nitrogen(BUN) and microalbuminuria(mAlb) were measured.Masson staining, Sirius red staining and collagen type Ⅳ immunohistochemical staining were used to detect the expression of collagen protein in the cortex, while laminin staining to assess the degree of glomerular and renal tubular basement membrane thickening.The protein expressions related to epithelial-mesenchymal transition and PI3K/Akt/mTOR in the renal cortex of mice were detected by Western blot.Results The moderate and high dose of TFMF could significantly decrease the levels of FBG, Cr, BUN and mAlb in diabetic mice, meanwhile decreasing the expression of α-SMA protein by inhibiting the activation of PI3K/Akt/mTOR signaling pathway, which led to the amelioration of the pathological alterations of renal tissue.Conclusions The moderate and high dose of TFMF can reduce the level of renal interstitial fibrosis in type 1 diabetic mice, and its mechanism may be related to the inhibition of activation of PI3K/Akt/mTOR signaling pathway.
7.Central composite design-response surface method optimize of fang-bing nasal inhalant from components of traditional Chinese medicine for sedative and sleep aiding.
Suyun LI ; Mengli JIANG ; Lihong ZHANG ; Xiaojin XIAO ; Xiaodong LI
Acta Pharmaceutica Sinica 2013;48(4):573-9
To obtain the optimal preparation technology of Fang-bing nasal inhalant from components of traditional Chinese medicine by central composite design, with an apparatus containing nasal inhalant that simulated the expiration and inspiration of nose, the dissolution in vitro of different optimized inhalant samples designed through central composite design were investigated. The accumulative release of linalool, borneol, menthol was detected with GC. Response surface methodology was used to optimize the conditions of preparation technology by establishing multiple linear regression and second-order quadratic models. Then, deviation was carried out through comparing the observed and predicted values. It was showed that the coefficient of correlation of second-order quadratic model was high. The related coefficient reached 0.999 3, 0.998 0, 0.944 9, separately. The optimum conditions of preparation technology were as following: 84.39% of alcohol concentration, the weight of starch 1.45 g and the weight of carmellose sodium (CMC-Na for short) 1.22 g. The deviations between observed and predicated values showed -0.36%, 1.52%, 2.40%, separately. In this experiment, the established model can describe the good relation between factors and indexes from preparation technology of Fang-bing nasal inhalant and the outcome of prediction is well. This optimal Fang-bing nasal inhalant was used to study its in vivo effect on model rats deprived from sleep and showed sedative and sleep aiding, which will bring an instruction on inhalants of components from traditional Chinese medicine.

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