1.Comprehensive Clinical Evaluation of Xiaojie'an Capsules in Treatment of Uterine Fibroids with Qi Stagnation and Blood Stasis Syndrome
Yutong MA ; Zhenkai LU ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):235-243
ObjectiveTo systematically organize the relevant research on the treatment of uterine fibroids with Xiaojie'an capsules through clinical evidence evaluation and comprehensive value analysis in the "6+1" dimension,highlighting the efficacy and characteristics of Xiaojie'an capsules. MethodsBased on evidence-based medicine,epidemiology,pharmacoeconomics,health technology assessment (HTA), and other methodologies,this study adopted qualitative and quantitative evaluation methods. Through a questionnaire survey,official website data information,published literature, and secondary evaluation of real world data,a total of "6+1" dimensions were used to build an evaluation system for the safety,effectiveness,economy,innovation,suitability,accessibility of Chinese patent medicines, and characteristics of traditional Chinese medicines. Results① Safety:From January 2009 to March 2023,the National Adverse Drug Reaction Monitoring Center reported 159 cases (248 cases) of general adverse reactions and four cases of serious adverse reactions to Xiaojie'an capsules,all of which were classified as general adverse reactions after expert judgment. Through literature search,a total of 6 865 patients were treated with Xiaojie'an capsules,of which 26 articles reported adverse reactions to Xiaojie'an capsules,resulting in a total of 244 adverse reactions. The clinical manifestations of adverse reactions to Xiaojie'an capsules include nausea,vomiting,stomach discomfort,diarrhea,rash,itching,dizziness,headache,insomnia,etc. The prognosis was good, and the drug surveillance system was sound. Based on the evaluation of known risks and sufficient evidence,in terms of known risk assessment, according to the monitoring results of the spontaneous reporting system (SRS), there were four cases of serious adverse reactions to Xiaojie'an capsules. After expert discussion, the four cases of serious adverse reactions were finally judged as general adverse reactions, and the known risks were considered to be small in combination with the known risk evaluation criteria. According to the types of studies carried out on Xiaojie'an capsules (randomized controlled trial and its systematic review, SRS data analysis, real world human experience studies, and non-clinical safety studies) and the evaluation criteria of sufficient evidence, it was considered that Xiaojie'an capsules had sufficient evidence. The safety evidence of this variety was sufficient, and the result was confirmed. ② Effectiveness: Meta-analysis results showed that the combination of Xiaojie'an capsules and Mifepristone tablets had better clinical efficacy compared to Mifepristone tablets alone and had a better effect in reducing the maximum uterine fibroid volume. Due to limitations and imprecision caused by downgrading factors,the quality of evidence was evaluated as Grade C. Based on comprehensive effectiveness evidence and value evaluation,the effectiveness evidence of this variety was relatively sufficient, and the results were clear ③ Economy:The economic evaluation results showed that treating one more patient with uterine fibroid required an additional cost of 5 438.57 yuan by using the combination of Xiaojie'an capsules and Mifepristone tablets,which was lower than the patient's willingness to pay (36 883 yuan according to 2022 National Bureau of Statistics data). This suggested that compared with using Mifepristone tablets alone,the combination of Xiaojie'an capsules and Mifepristone tablets had a certain economy. The sensitivity analysis results were relatively robust,indicating that this variety had good economy ④ Innovation:Currently,most traditional Chinese medicine treatments for uterine fibroids advocate the method of attacking evil,which can easily harm the body. However,Xiaojie'an capsules not only soften and disperse nodules but also balance supporting the body and supplementing deficiency. The comprehensive evaluation showed sufficient evidence of the innovation of this variety,and the results were confirmed. ⑤ Suitability: The service information of Chinese patent medicines derived from the drug was complete,and the questionnaire survey results showed that the drug was suitable for clinicians,nurses,pharmacists, and patients in multiple dimensions such as individual compliance,system, and management. The comprehensive evaluation of the suitability of the product had sufficient evidence and clear results. ⑥ Accessibility:The daily cost of Xiaojie'an capsules was 16.97 yuan,and the treatment cost was 407.16 yuan. It was affordable for urban residents and rural residents and was available for sale in 23 provinces, cities,municipalities,and autonomous regions across the country. The medicinal resources were abundant and sustainably supplied,and there was sufficient evidence of accessibility with clear results. ⑦ Characteristics of traditional Chinese medicine:Xiaojie'an capsules were derived from the classic Dai medicine formula of Dr. CHEN Benshan,a renowned Dai doctor,and they have been clinically used for over 20 years. Dai medicine originated from Xishuangbanna,Yunnan province,with the core theory of "four pagodas and five elements". The comprehensive evaluation showed that this variety exhibited significant characteristics of traditional Chinese medicine. ⑧ Comprehensive evaluation of clinical value:Based on the "6+1" dimensions mentioned above,combined with the multi-criteria decision analysis (MCDA) model and calculations using CSC v2.0 software,the results showed that there was sufficient evidence for the clinical value of Xiaojie'an capsules,and the results were clear. ConclusionThe comprehensive evaluation of Xiaojie'an capsules has sufficient evidence of safety and innovation,and the results are confirmed. The evidence of effectiveness,suitability,and accessibility is relatively sufficient,with clear results. The economy is good,and the characteristics of traditional Chinese medicine are prominent. The comprehensive evaluation of clinical value believes that there is sufficient evidence of the clinical value of Xiaojie'an capsules,and the results are clear. In the future,it is recommended to focus on clinical value, conduct high-quality and effective research that is in line with the characteristics of traditional Chinese medicine, and improve acute toxicity testing to provide a scientific and objective basis for clinical efficacy and safety research.
2.Radiation dose and establishment of a regression model for dose estimation in pediatric chest CT
Ziyu ZHAO ; Yu LIANG ; Yutong ZHANG ; Zifan WEI ; Xinxing MA
Chinese Journal of Radiological Health 2025;34(5):654-659
Objective To investigate the differences in radiation dose during chest CT examinations among children of different age groups and establish dose estimation regression models. Methods Chest CT data from 135 children aged 4 to 15 years were retrospectively collected from the First Affiliated Hospital of Soochow University between January 2022 and December 2023. The children were divided into three age groups: 4-5 years, 6-10 years and 11-15 years. CT scanning parameters (tube voltage, tube current, scan range) and dosimetry parameters including volume CT dose index (CTDIvol) dose length product (DLP), and size-specific dose estimate (SSDE) were recorded. The Kruskal-Wallis test was used to compare intergroup differences. A Pearson correlation analysis was performed to assess the relationship between age and dose indicators. Both linear and nonlinear regression models were constructed. Results Age showed a weak positive correlation with CTDIvol (r = 0.27), a moderate positive correlation with DLP (r = 0.60), and a moderate negative correlation with SSDE (r = −0.55). Linear regression analysis revealed that DLP increased with age (y = 117.85 + 9.81x, R2 = 0.36), while SSDE decreased with age (y = 12.4 − 0.18x, R2 = 0.32). Using orthogonal distance regression, the goodness-of-fit of the nonlinear models for DLP and SSDE significantly improved (R2 = 0.99 and 0.94, respectively). Conclusion In pediatric chest CT dose assessment, CTDIvol underestimates radiation dose compared to SSDE and fails to account for patient body size. The dose estimation models constructed with orthogonal distance regression outperform those established using the least squares method, demonstrating higher fitting accuracy, and can serve as a reference for personalized dose management in pediatric CT examinations.
3.Correlation between lumbar spine and pelvic parameters in Lenke type 5 adolescent idiopathic scoliosis
Yutong HOU ; Chenglan HUANG ; Yunxiao YANG ; Ya LI ; Peiwu GUO ; Wenqiang YU ; Yu ZHAO ; Zanbo WANG ; Hong ZENG ; Zhenjiang MA ; Dezhi LU ; Jinwu WANG
Chinese Journal of Tissue Engineering Research 2024;28(36):5753-5758
BACKGROUND:The study of the lumbar spine and pelvis in patients with Lenke type 5 lordosis is limited to the coronal and sagittal planes,and the three-dimensional relationship between the scoliosis and the pelvis has not yet been clarified. OBJECTIVE:To analyze the effect of lumbar scoliosis on the pelvis in patients with Lenke type 5 lordosis and to study the correlation between the lumbar spine and the three-dimensional spatial position of the pelvis. METHODS:Imaging data of 60 patients with Lenke type 5 lordosis scoliosis admitted to the 3D Printing Reception Center of Shanghai Ninth People's Hospital,Shanghai Jiao Tong University School of Medicine from January 2019 to September 2023 were retrospectively analyzed,including Cobb angle,coronal pelvic tilt,lumbar lordosis,left and right pelvic hip width ratio(sacroiliac-anterior superior iliac spine),spinal rotation angle,pelvic tilt,sacral slope,pelvic incidence,coronal deformity angular ratio,sagittal deformity angular ratio,C7 plumb line-center sacral vertical line,apical vertebral translation,and coronal sacral inclination.The information was summarized as a database.SPSS 22.0 software was used to analyze the data related to the lumbar spine and pelvis of the patients with Lenke type 5 primary lumbar curvature adolescent idiopathic scoliosis using Spearman's correlation analysis and linear regression. RESULTS AND CONCLUSION:(1)Cobb angle was highly positively correlated with coronal deformity angular ratio,apical vertebral translation,and spinal rotation angle(r=0.91,r=0.841,r=0.736).(2)Coronal deformity angular ratio was highly positively correlated with apical vertebral translation(r=0.737),moderately positively correlated with C7 plumb line-center sacral vertical line(r=0.514),and moderately negatively correlated with sagittal deformity angular ratio(r=-0.595).(3)There was a high positive correlation between lumbar lordosis and sagittal deformity angular ratio(r=0.942)and a moderate negative correlation with coronal deformity angular ratio(r=-0.554).(4)There was a moderate positive correlation between Cobb angle with coronal pelvic tilt and coronal sacral inclination(r=0.522,r=0.534)and a moderate positive correlation between C7 plumb line-center sacral vertical line and coronal pelvic tilt(r=0.507).Apical vertebral translation with coronal pelvic tilt and coronal sacral inclination showed a moderate positive correlation(r=0.507,r=0.506).Lumbar lordosis with sacral slope and pelvic incidence showed a moderate positive correlation(r=0.512,r=0.538).Sagittal deformity angular ratio was moderately positively correlated with sacral slope and pelvic incidence(r=0.614,r=0.621).(5)Studies have found that the relative position of the lumbar spine and the pelvis is closely related in the horizontal,sagittal and coronal planes.When the lumbar spine affects scoliosis and is rotated,the relative position of the pelvis will also change to compensate,which indicates that while correcting scoliosis,the correction of the pelvis cannot be ignored.
4.Transcription factor Six1 regulates expression of nephrogenic molecules to promote repair of kidney injury
Manling ZHANG ; Tengfei XU ; Yutong WANG ; Xu MA ; Yong JIN
Journal of Army Medical University 2024;46(23):2608-2619
Objective To investigate the role and mechanism of sine oculis homeobox 1(Six1),a nephrogenic transcription factor,in regulating injury repair after acute kidney injury(AKI).Methods C57BL/6J mice were inflicted with renal ischemia reperfusion(IR)injury to establish AKI model,and then the serum samples and kidney tissues were collected at days 1,2,and 3 after modeling.Serum creatinine(Cr)and blood urea nitrogen(BUN)levels were measured and renal morphology was observed with HE staining.The expression and distribution of nephrogenic molecules(Six1 and Pax2,etc.)and cell proliferation/migration genes(Cyclin A1,MMP9,etc.)were detected with RT-PCR,Western blotting,and immunofluorescence assay and immunohistochemical assay.The expression of apoptosis pathway(Bc12,Caspase3,etc.)and cell proliferation related molecules were evaluated in Six1 overexpression/knockout human epithelial cells(HK2)with CoCl2-induced injury.Additionally,after the adeno-associated viruses carrying Six1 overexpression vector were used to overexpress the molecule in the mice,the expression of Six1 and other related molecules were detected after IR injury modeling.Results After renal IR injury,Six1 was significantly activated in epithelial cells,the expression of nephrogenic and cell proliferation/migration molecules(Pax2,Cyclin A1,MMP9,etc.)was obviously up-regulated(P<0.05),which was positively correlated with Six1 expression,while the proliferation/migration molecules(Ki67,MMP9)were also localized within the tubular epithelial cells.In cellular models of Six1 overexpression,the expression levels of nephrogenic and cell proliferation/migration molecules(Pax2,Cyclin A1,MMP9,etc.)were also notably up-regulated(P<0.05).In the mice with renal overexpression of Six1,the nephrogenic molecules as well as anti-apoptotic ones(Six2,Pax2,Bc12,etc.)were up-regulated,while the expression of kidney injury-related molecule(Kim1)in kidneys was reduced in the renal tissues.While,in 2 d after IR injury,the anti-apoptotic gene(Bc12,Stat3)was significantly up-regulated(P<0.05),and the apoptotic and injury molecules(Kim1,Caspase3)showed remarkable down-regulation(P<0.05)in the mice with renal Six1 overexpression.Furthermore,CoCl2-inducion significantly decreased the cell proliferation rate in the Six1 knockoutgroup(TCMK1-Six1-/-)(P<0.05)but increased the rate in the Six1 overexpression group(TCMK1-Six1)when compared to the control cells(P<0.05).And,the expression of nephrogenic,anti-apoptotic pathways and cell proliferation/migration molecules(Pax2,Bc12,Cyclin A1,MMP9,etc.)were reduced in TCMK1-Six1-/-group,and apoptosis and kidney injury molecules(Caspase3,Kim1)were significantly down-regulated in TCMK1-Six1 group(P<0.05).Conclusion Activation of Six1 after AKI can promote the proliferation/migration of renal tubular epithelial cells by up-regulating nephrogenic molecules and inducing anti-apoptotic pathway molecules,and then,participate in IR-induced renal injury repair.
5.A study on photothermal and antibacterial properties of silicified collagen coated with polydopamine
Jiangshan ZHANG ; Chen LEI ; Yutong FU ; Yuxuan MA ; Zhao MU ; Jihua CHEN
Journal of Practical Stomatology 2024;40(4):461-466
Objective:To construct polydopamine-coated silicified collagen(SC@PDA)by polymerization of dopamine,and to ex-plore its biological safety and photothermal antibacterial properties.Methods:Dopamine was coated on the surface of silicified colla-gen by polymerization reaction to construct SC@PDA.The surface morphology of SC@PDA was observed by SEM and TEM,the silic-ic acid release was detected by silicic acid release experiment,and the photothermal properties of SC@PDA were detected by 808 nm laser irradiation and infrared thermography.The biocompatibility of SC@PDA was evaluated by CCK-8 assay with rat bone marrow mesenchymal stem cells and acute systemic toxicity test in SD rats.The materials were co-cultured with Staphylococcus aureus(S.au-reus)and Escherichia coli(E.coli)respectively for 6 h followed by 808 nm laser irradiation and culture for 6 h,and then the antibac-terial rate of the materials was calculated by absorbance detection.Finally,the anti-infection effect was observed 7 days after implan-tation in the rat femoral defect infection model of SD rats.Results:SC@PDA maintained the silicic acid release characteristics of si-licified collagen and had good biocompatibility and good photothermal property.In vitro and in vivo antibacterial experiments showed that SC@PDA had good antibacterial activity without cytotoxicity and acut system toxicity.Conclusion:SC@PDA has biocompatibili-ty and the dopamine coating endows the silicified collagen scaffold with excellent photothermal antibacterial properties.
6.Clinical efficacy and safety of liposomal amphotericin B in the salvage treatment of invasive fungal disease in patients with hematological diseases
Yuanbing WU ; Shanshan JIANG ; Yaxue WU ; Bin LIU ; Yutong JING ; Haiyan BAO ; Xiao MA ; Depei WU ; Xiaohui HU
Chinese Journal of Hematology 2024;45(7):666-671
Objective:To investigate the efficacy and safety of liposomal amphotericin B (L-AmB) for the salvage treatment of invasive fungal disease (IFD) in patients with hematological diseases.Methods:Data were retrospectively collected from 80 patients with hematological issues treated with L-AmB between June 2023 and December 2023 after failure of previous antifungal therapy. Baseline patient information, clinical efficacy, and factors affecting the efficacy of L-AmB were analyzed by logistic regression. Moreover, adverse effects associated with L-AmB were evaluated.Results:Among the 80 patients, 9 (11.2%) had proven IFD, 43 (53.8%) had probable IFD, and 28 (35.0%) had possible IFD. The efficacy rate of L-AmB salvage therapy for IFD was 77.5%, with a median daily dose of 3 (range: 1-5) mg·kg -1·d -1 and a median dosing course of 14 (range: 8-25) days. Multivariate logistic regression analysis showed that the disease remission status ( OR=4.337, 95% CI 1.167-16.122, P=0.029) and duration of medication ( OR=1.127, 95% CI 1.029-1.234, P=0.010) were independent factors affecting the efficacy of L-AmB. The incidence of infusion reactions associated with L-AmB, including fever and chills, was 5.0%. The incidence of hypokalemia was 28.8% (predominantly grades 1-2), and the incidence of nephrotoxicity was 11.3% (predominantly grades 1-2) . Conclusion:L-AmB is safe and effective in the treatment of patients with IFD who are intolerant to or who have experienced no effect of previous antifungal therapy, with a low rate of adverse reactions.
7.Exploration on innovative education model of the integration of medicine and science for applied psychology major in medical colleges under the background of "New Medicine"
Xinyan MA ; Yanmin PU ; Yutong YING ; Herui SHANG ; Shengqiang CHEN ; Sha LIU ; Xueqin ZHANG
Chinese Journal of Medical Education Research 2024;23(7):877-881
The construction of "New Medicine" is the leader of the innovative development of medical education in China in the new era. Strengthening the cross-integration of medicine and science is helpful to promote the training of top-notch interdisciplinary innovative talents under the multidisciplinary background of "Medicine + X". The applied psychology major in medical colleges has unique advantages in education and teaching resources. How to combine the advantages to construct the education model of the integration of medicine and science is still in the exploration stage. This paper analyzes the current situation of talent training of the applied psychology major in medical colleges and the new requirements for discipline-major construction under the background of "New Medicine" construction, demonstrates the measures to strengthen the deep integration of medicine and science from the aspects of curriculum system setting, teacher team construction, practice teaching, and teaching method reform, and puts forward the innovative education model of the integration of medicine and science in applied psychology-medicine interdisciplinary training.
8.Summary of the best evidence for prevention and management of feeding intolerance in ICU patients with enteral nutrition
Wanting ZHANG ; Yutong XU ; Jia WANG ; Weiguang MA
Chinese Journal of Modern Nursing 2024;30(10):1292-1299
Objective:To summarize the evidence on preventing and managing feeding intolerance (FI) in ICU patients with enteral nutrition, providing a basis for clinical practice.Methods:Clinical practice guidelines, systematic reviews, evidence summaries, expert consensus, and randomized controlled trials related to the prevention and management of FI in ICU patients with enteral nutrition were systematically searched in Chinese and English databases, guideline websites, and professional association websites. The search period was from January 1, 2013, to March 29, 2023. Two researchers conducted quality evaluation, evidence extraction, and summarization of the included literature.Results:A total of 25 articles were included, including five clinical practice guidelines, three evidence summaries, 11 systematic reviews, one expert consensus, and five randomized controlled trials. Thirty-seven pieces of evidence were summarized from four aspects risk assessment, preventive measures, intervention measures, and evaluation.Conclusions:This study summarizes the best evidence for FI prevention and management in ICU patients with enteral nutrition. It is recommended that medical and nursing staff apply evidence based on clinical situations and patient preferences.
9.Guideline for risk assessment and prevention of pressure injury in neonates in NICU
Gansu Provincial Nursing Association ; School of Nursing of Lanzhou University ; Hospital Provincial GANSU ; Lin HAN ; Qiuxia YANG ; Yuxia MA ; Lin LÜ ; Hongyan ZHANG ; Hongxia TAO ; Jiali GUO ; Yutong CUI
Chinese Journal of Nursing 2024;59(16):1962-1965
Objective To develop"a guideline for pressure injury risk assessment and prevention of neonates in NICU",and to provide guidance and references for clinical staff in the implementation of pressure injury assessment and prevention for neonates in NICU.Methods Based on the World Health 0rganization Guideline Development Manual and the results of systematic search for identified clinical problems,the GRADE method was used to evaluate the evidence and grade the recommendations,and the RIGHT report specifications were referred to for writing,and the guideline was developed and revised according to the results and recommendations of the expert review,so as to form the official guideline.Results The guideline included 2 aspects of pressure injury risk assessment and prevention,resulting in 12 clinical questions and 19 recommendations.Conclusion The guideline for risk assessment and prevention of pressure injury of neonates in NICU is an evidence-based guideline based on the best available evidence,clinical practice,and professional judgment,and it can provide a practical basis for scientific decision-making by clinical staff and managers.
10.Hyperaldosteronism caused by drospirenone and ethinylestradiol tablets: a case report
Liling LIN ; An SONG ; Xiaoli MA ; Yutong ZOU ; Wei LUO ; Shaowei XIE ; Songlin YU ; Wei XIONG ; Ling QIU
Chinese Journal of Laboratory Medicine 2024;47(5):574-577
A young female patient with acne and elevated testosterone level underwent plasma steroid hormones testing and found a significant increase in aldosterone. We excluded testing interference and verified the absence of hypertension, hypokalemia, and adrenal occupancy, as well as primary and secondary hyperaldosteronism. During follow-up, a temporal correlation was found between aldosterone levels and the use of drospirenone and ethinylestradiol tablets. It was observed that the combination of drospirenone and ethinylestradiol could lead to the increase of aldosterone level and the concentration ratio of aldosterone to direct renin through different mechanisms. Drospirenone exerts an antagonistic effect on mineralocorticoid receptor to prevent the development of hypertension or hypokalemia. In clinical practice, it is necessary to pay attention to the effect of this drug on screening markers for primary aldosteronism. In the laboratory examination, when female patients with no symptoms of hypertension and hypokalemia but with elevated aldosterone levels are encountered, it can be verified whether they have a history of use of compound estrogen-progestin such as drospirenone and ethinylestradiol tablets, and appropriate tips are provided in the report.

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