1.Development of Patient Self-Reported Core Outcome Set in Community Studies on Heat-Sensitive Moxibustion for Primary Hypertension
Jianyu YOU ; Shuqing LI ; Guihua DENG ; Xu ZHOU
Journal of Traditional Chinese Medicine 2025;66(1):34-41
ObjectiveTo establish the self-reported core outcome set (COS) for patients with an example of a community study on heat-sensitive moxibustion for primary hypertension (PH), to provide a reference for the selection of effectiveness evaluation indicators in community study on heat-sensitive moxibustion. MethodsA systematic literature search was conducted to collect outcomes used in randomized controlled trials and systematic review of heat-sensitive moxibustion for PH (Jan 2021), and additional outcomes were added through patient and expert questionnaires (Feb 2021) to create a pool of outcome entries. A multidisciplinary expert Delphi survey was conducted to screen outcomes applicable to patient self-reporting (Apr 2021), and the importance of outcome indicators was rated on a 5-Point Likert Scale. Finally, patient self-reported COS was determined through a consensus conference (June 2021). ResultsA pool of patient self-reported indicators in the community study of heat-sensitive moxibustion treatment for PH was generated by standardizing and combining the outcome indicators based on the results of the literature search and the questionnaire survey, which consisted of totally 100 measurement tools or contents, excluding 51 indicators or measurement tools required measurement by specialized physicians or hospital equipment, and 49 items were retained to enter the initial list of indicator entries. For the first round of Delphi survey, the mean score for expert familiarity was 0.819, the mean score for basis of judgment was 0.710, and the expert authority coefficient was 0.765, with a total of 21 indicator measurement tools or contents deleted (significance score ≤ 75 or coefficient of variation > 0.25), 28 retained, and 3 new expert-added indicator entries added. In the second round of Delphi survey, the average score for expert familiarity was 0.859, the average score for basis for judgment was 0.763, and the expert authority coefficient was 0.811, with a total of 11 indicator measurement tools or contents deleted and 20 retained involving 5 domains. Following an expert consensus meeting, 8 outcome indicators were finalized for inclusion in the patient self-reported COS, including 6 indicators of effectiveness evaluation such as quality-of-life scores, blood pressure, traditional Chinese medicine symptom scores, cost-benefit, cardiovascular and cerebrovascular events, and adverse reactions/events, and 2 indicators of factors influencing effectiveness such as sensation of heat-sensitive moxibustion, and adherence. ConclusionIn this study, we initially established a criteria for evaluating the effectiveness in the community study on heat-sensitive moxibustion by constructing patient self-reported COS in the community study on heat-sensitive moxibustion for PH, which can provide a scientific research paradigm for the subsequent development of the community study on heat-sensitive moxibustion.
2.Identification strategy of cold and hot properties of Chinese herbal medicines based on artificial intelligence and biological experiments.
Lin LIN ; Pengcheng ZHAO ; Zhao CHEN ; Bin LIU ; Yuexi WANG ; Qi GENG ; Li LI ; Yong TAN ; Xiaojuan HE ; Li LI ; Jianyu SHI ; Cheng LU
Chinese Medical Journal 2025;138(6):745-747
3.Integrated evidence chain-based effectiveness evaluation of traditional Chinese medicines (Eff-iEC): A demonstration study.
Ye LUO ; Xu ZHAO ; Ruilin WANG ; Xiaoyan ZHAN ; Tianyi ZHANG ; Tingting HE ; Jing JING ; Jianyu LI ; Fengyi LI ; Ping ZHANG ; Junling CAO ; Jinfa TANG ; Zhijie MA ; Tingming SHEN ; Shuanglin QIN ; Ming YANG ; Jun ZHAO ; Zhaofang BAI ; Jiabo WANG ; Aiguo DAI ; Xiangmei CHEN ; Xiaohe XIAO
Acta Pharmaceutica Sinica B 2025;15(2):909-918
Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.
4.Chemical knockdown of Keap1 and homoPROTAC-ing allergic rhinitis.
Jianyu YAN ; Tianyu WANG ; Ruizhi YU ; Lijuan XU ; Hongming SHAO ; Tengfei LI ; Zhe WANG ; Xudong CHA ; Zhenyuan MIAO ; Chengguo XING ; Ke XU ; Huanhai LIU ; Chunlin ZHUANG
Acta Pharmaceutica Sinica B 2025;15(8):4137-4155
Allergic rhinitis (AR), a globally prevalent immune-mediated inflammatory condition, is still an incurable disease. In the present study, we have validated the impact of the Kelch-like ECH associated protein 1 (Keap1)-related oxidative stress and inflammatory response in clinical AR patient peripheral blood and nasal swab samples, emphasizing the biological relevance of Keap1 and AR. Targeting Keap1 -nuclear factor erythroid 2-related factor 2 (Nrf2) related anti-oxidative stress may be effective for AR intervention. Drawing inspiration from the Keap1 homodimerization and the E3 ligase characteristics, we herein present a design of novel bivalent molecules for chemical knockdown of Keap1. For the first time, we characterized ternary complexes of Keap1 dimer and one molecule of bivalent compounds. The best bivalent molecule 8 encompasses robust capacity to degrade Keap1 as a homoPROTACKEAP1. It efficaciously suppresses inflammatory cytokines in extensively different cells, including human nasal epithelial cells. Moreover, in an AR mouse model, we confirmed that the chemical degradation induced by homoPROTACKEAP1 led to therapeutic benefits in managing AR symptoms, oxidative stress and inflammation. In summary, our findings underscore the efficacy of targeting the Keap1 system through the homoPROTAC-ing technology as an innovative and promising treatment strategy for the incurable allergic disorders.
5.Establishment and evaluation of method for rapid detection of Bacillus cereus cytK and nhe toxin genes by dual nucleic acid test strips
Jifei YANG ; Beizhen PAN ; Yan LIU ; Yujiao ZHOU ; Jianyu YANG ; Xianyu ZHANG ; Wenbo DING ; Haoyu LI ; Liyuan SUN
Journal of Jilin University(Medicine Edition) 2025;51(2):516-525
Objective:To establish a method of dual nueleic acid test strips for rapid detection of Bacillus cereus cytK and nhe toxin genes based on polymerase chain reaction(PCR)and colloidal gold technique,and to evaluate its specificity,sensitivity,repeatability and stability.Methods:Bacillus cereus DNA was extracted by boiling method.Specific primers were designed with Bacillus cereus cytK and nhe as the target genes.Clonal transformation was used to identify the PCR products.The optimal labeling amounts of colloidal gold-labeled streptavidin,quality control line(C line),cytK detection line(T1)and nhe detection line(T2)were determined.The nucleic acid test strips were assembled and its specificity,sensitivity,reproducibility and stability were evaluated.Results:The DNA concentration of Bacillus cereus was 248 mg·L-1,and the purities were 1.8-2.0.After cloning and plasmid sequencing,the similarities between the PCR products and the sequences of cytK and nhe registered in the GenBank database were 100%.Under the condition of pH 7.0,the optimal amount of streptavidin labeling per 200 μL of colloidal gold solution was 6.0 μL;the optimal marking amount was 2.00 g·L-1 for the quality control line(C line),0.550 g·L-1 for cytK gene detection line(T1)and 0.2 g·L-1 for nhe gene detection line(T2).In the specificity test,positive result on the test strips was seen only for Bacillus cereus,and no cross-reactivity was observed for Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa and Bacillus subtilis,which were consistent with the electrophoresis results.Sensitivity assay showed that even when DNA concentration was reduced to 10-2 mg·L-1,three bands(C line,T1 line and T2 line)could be observed,and the detection limit of the test strip was one-tenth of agarose gel electrophoresis(10-1 mg·L-1).The nucleic acid test strips were verified by different operators in different laboratories,and the results were consistent.The stability of the test strips was verified at the 6th,9th and 12th months,and the results showed good stability.Conclusion:The dual nucleic acid test strip method established in this study can simutaneously detect the cytK and nhe toxin genes of Bacillus cereus with high sensitivity and specificity,achieving short-term visual detection.
6.Childhood schwannoma with back pain as initial manifestation:a case report
Lei LI ; Dagan FU ; Jianyu DUAN ; Yan XU ; Wei ZHOU
Journal of Clinical Medicine in Practice 2025;29(16):103-105,111
Back pain is relatively common in pediatric clinical practice and often exhibits benign and self-limiting characteristics.However,persistent back pain may be secondary to inflammation,in-fection,tumors,or congenital diseases,warranting sufficient attention.This article reported a case of childhood back pain primarily presenting as nocturnal scapular region pain,who was diagnosed as in-traspinal cellular schwannoma via magnetic resonance imaging(MRI)and postoperative pathology.In this case,it is suggested that clinicians should pay attention to special clinical features of back pain in children,be vigilant for potential organic lesions,reasonably select imaging examinations,and en-hance diagnostic accuracy through multidisciplinary collaboration,thereby enabling early intervention and favorable prognosis.
7.Effects of polystyrene microplastics on growth and development and hepatic lipid metabolism in mice
Xinxue GAO ; Jiaxin GAO ; Jianyu ZHU ; Xinqi SHI ; Bocheng TAO ; Ning LI ; Lijuan CHEN
Chinese Journal of Tissue Engineering Research 2024;28(29):4634-4638
BACKGROUND:Plastic as a durable,inexpensive,easy to manufacture organic synthetic polymer materials are widely used.At the same time,plastic resistance to high temperatures,acid and alkali resistance,corrosion-resistant properties make it difficult to degrade in nature,and ultimately forming a huge number of microplastic pollution threatening human health. OBJECTIVE:To investigate the effects of microplastic exposure on growth and development and hepatic lipid metabolism in mice. METHODS:Twenty C57BL/6J male mice were adaptively fed for one week,and then randomly divided into normal and microplastic groups(n=10 per group).Mice in the normal group were given a normal diet and water,for 4 weeks.Mice in the microplastic group were given a normal diet and free drinking of microplastic(polystyrene)water with a concentration of 1 000 μg/L,for 4 weeks.At 2 and 4 weeks of drinking,body mass and grip strength,blood lipids and liver and kidney function,ultrasonic morphology and pathological morphology of liver and lipid deposition were detected. RESULTS AND CONCLUSION:(1)With the extension of time,the body mass of mice in the two groups gradually increased,and the body mass of mice in the microplastic group was greater than that in the normal group after 2,4 weeks of drinking water(P<0.05).With the extension of time,the grip strength of mice in the normal group gradually increased,and the grip strength of mice in the microplastic group first decreased and then increased,and the grip strength of mice in the microplastic group was lower than that in the normal group after drinking water for 4 weeks(P<0.05).(2)Liver ultrasound examination showed that compared with the normal group,the ultrasonic echo signal of the liver in the microplastic group was enhanced after 2 and 4 weeks of drinking water.(3)Hematoxylin-eosin staining showed that the morphology of liver cells in the microplastic group did not change significantly after 2 and 4 weeks of drinking water,but inflammatory cell infiltration could be seen.Oil red O staining showed that obvious lipid deposition was observed in the liver of microplastic group after 2 and 4 weeks of drinking water.(4)Compared with the normal group,the levels of serum high density lipoprotein cholesterol,triacylglycerol,and aspartate aminotransferase in the microplastic group were decreased after 2 weeks of drinking water(P<0.05),and the serum triacylglycerol concentration was decreased after 4 weeks of drinking water(P<0.05).(5)These findings confirm that microplastics may cause weight gain,loss of physical strength,and abnormal hepatic lipid metabolism in mice.
8.Comparison of clinical efficacy between a novel antireflux sleeve gastrectomy and sleeve gastrectomy combined with esophageal hiatal hernia repair surgery
Jianyu CUI ; Xin LI ; Hao WANG
Chinese Journal of General Surgery 2024;39(6):450-455
Objective:To evaluate a novel anti-reflux sleeve gastrectomy (LSGFD) in comparison with laparoscopic sleeve gastrectomy combined with hiatal hernia repair (LSG+HHR) for the treatment of obesity-combined gastroesophageal reflux disease (GERD).Method:Seventy-three patients admitted at Xinjiang Uygur Autonomous Region People's Hospital from Jan 2020 to Jan 2022 underwent LSGFD(41 cases) or LSG+HHR(32 cases), and the patients' preoperative and 1-year postoperative GERD questionnaire scores (Gerd-Q), acidometry and manometry and other relevant clinical data were collected and compared.Results:The postoperative BMI of the two groups was significantly lower than that of the preoperative period, and the difference was statistically significant ( P<0.05); the comparison of the percentage of postoperative body mass loss between the two groups was not statistically significant ( P>0.05). Differences in postoperative Gerd-Q score, acid reflux analysis and esophageal dynamics analysis of the two groups were statistically significant compared with the preoperative period ( P<0.05), DeMeester score of LSGFD decreased significantly compared with that of LSG+HHR ( P<0.05). There was no significant difference in intraoperative blood loss, hospitalization time and duration of the operation between the two groups ( P>0.05) The incidence of post-discharge complications (nausea or vomiting, anemia) and the recurrence rate of GERD were lower in the LSGFD group,though there was no statistically significant difference ( P>0.05). Conclusion:LSGFD is better than LSG+HHR in treating obesity combined with GERD.
9.Efficacy and safety comparison of azacitidine combined with venetoclax or CAG regimen in the treatment of newly treated elderly patients with acute myeloid leukemia
Wenjun GE ; Songyu GE ; Xiangchen ZHANG ; Xia LI ; Li WANG ; Jianyu DUAN ; Jing YANG ; Yidong MA
Cancer Research and Clinic 2024;36(5):356-360
Objective:To compare the efficacy and safety of azacitidine combined with venetoclax or CAG regimen in the treatment of newly treated elderly patients with acute myeloid leukemia (AML).Methods:A retrospective cohort study was conducted. The clinical data of 34 newly treated elderly patients with AML treated in the Fifth People's Hospital of Datong from May 2018 to August 2023 were retrospectively analyzed. According to the treatment regimen, all patients were divided into venetoclax group (azacitidine + venetoclax, 17 cases) and CAG group (azacitidine + CAG regimen, 17 cases). The clinicopathological characteristics, efficacy, adverse reactions and survival of the both groups were compared.Results:There were no statistically significant differences in the clinical data of both groups (all P > 0.05). The complete remission (CR) rate and the objective response rate (ORR) in venetoclax group were higher than those in CAG group [CR: 70.6%(12/17) vs. 47.1% (8/17); ORR: 82.4% (14/17) vs. 64.7% (11/17)],while the differences in CR and ORR were not statistically significant (χ 2 = 2.00, P = 0.163; χ 2 = 2.00, P = 0.244). The follow-up time[ M ( Q1, Q3)] was 25.4 months (7.2 months, 60.3 months). At the end of follow-up, 19 of 34 patients survived (13 cases in venetoclax group and 6 cases in CAG group); 15 died (4 cases in venetoclax group and 11 cases in CAG group). The median overall survival (OS) time was 14.22 months (95% CI: 8.2-60.3 months) and 10.56 months (95% CI: 7.2-50.2 months), respectively in venetoclax group and CAG group;the median progression-free survival (PFS) time was 9.97 months (95% CI: 5.4-40.5 months) and 6.82 months (95% CI: 5.0-36.2 months), respectively, and there were no statistically significant differences in OS and PFS between the two groups (all P > 0.05). Grade 3-4 hematological adverse reactions occurred in 16 and 14 patients in venetoclax group and CAG group, respectively. There were no significant differences in granulocyte deficiency time, platelet deficiency time, infection and bleeding incidence between the two groups (all P > 0.05). Conclusions:Azacitidine combined with venetoclax or CAG regimen have better clinical efficacy and safety for newly treated elderly patients with AML.
10.Laparoscopic Roux-en-Y gastric bypass in the treatment of obese diabetes:an analysis of 20 cases
Aikebaier·Aili ; Jianyu CUI ; Pierdiwasi·Maimaitiyusupu ; Maimaitiaili·Maimaitiming ; Yibitihaer·Maimaitiaili ; Huiling LI ; Xiuli DENG ; Yusujiang·Tusuntuoheti ; Xin LI ; Kelimu·Abudureyimu
Journal of Clinical Surgery 2024;32(7):733-735
Objective To investigate the effect of laparoscopic Roux-en-Y gastric bypass surgery(LRYGB)in the treatment of obese diabetes.Methods The clinical data of 20 obese diabetic patients who received LRYGB from 2012 to 2018 in the Minimally Invasive and Herniac Abdominal Surgery Center of Xinjiang People's Hospital were retrospectively analyzed.Result The all 20 surgeries were successfully completed,and 1 case was converted to open surgery.The surgical time ranged from 60 to 420 minutes,with an average of(150±105.64)minutes,the intraoperative blood loss ranged from 20 to 100,with an average of(37.5±20.99)ml,and the postoperative hospital stay ranged from 5 to 15,with an average of(8.25±2.51)days.Complications occurred in 7 cases(35.00%)within 5 years after surgery,all of which were Clavien Dindo grade Ⅱ.The body weight,BMI,glycosylated blood glucose,fasting blood glucose,and the percentage of total weight loss(TWL%)at 1,3,and 5 postoperatively improved compared with those before surgery(P<0.05).15 cases(75.00%)of type 2 diabetes were completely relieved by LRYGB 5 years after operation.Conclusion Laparoscopic gastric bypass surgery is an effective way to reduce weight and blood sugar in obese patients with type 2 diabetes.

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