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.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.
3.A study on the construction of communication strategies for informing patients with advanced cancer
Yutong LIU ; Zhenqi LU ; Xiaoju ZHANG ; Zhe HUANG
Chinese Journal of Practical Nursing 2024;40(13):1000-1008
Objective:To construct a communication strategy and implementation method for advanced cancer patients based on two communication models widely used at home and abroad, so as to reduce the difficulty of clinical disease notification.Methods:From January to October 2022, based on the communication model of SPIKES (Setting, Perception, Invitation, Knowledge, Empathy, Summary) and NURSE(Name, Understand, Respect, Support, Explore), combined with literature analysis, qualitative interviews, and expert argumentation, the communication strategy items of advanced cancer patients were constructed.Results:A total of 18 articles were included in the literature analysis. Qualitative interviews were conducted with 20 interviewees (including 4 doctors, 11 nurses, and 5 patients),6 males, 14 females, aged (35.94 ± 8.03) years old. A total of 8 experts participated in the demonstration, 2 males and 6 females, aged (41.88 ± 6.58) years old. Finally, the specific items and words of the disease notification process and communication strategies of advanced cancer patients in line with China ′s clinical practice were constructed. A total of 3 first-level items, 16 second-level items, 53 third-level items, and speech techniques were constructed, including pre-communication preparation, regular communication strategies, and poor communication disposal strategies. The importance score of the item was 4.50 to 5.00, and the coefficient of variation of the item was 0 to 0.12. Conclusions:The communication strategy of advanced cancer patients based on the communication model is scientific and feasible, and can be used as a tool to inform advanced cancer patients.
4.Retrospect and prospect of the development of pediatric education in China
Can ZHANG ; Yuhan ZHANG ; Yutong PAN ; Liqun LU
Chinese Journal of Medical Education Research 2024;23(6):742-747
Facing the opportunities and challenges of pediatric education in the situation of talent emergency, this article aims to present the history of pediatric education development, offer considerations in pediatric talent cultivation from the perspective of the government, society/industry, and school in current social contexts, and provide ideas about seeking a path that can not only address the talent dilemma but also nurture pediatric talents in accordance with educational attributes. Strategies for the development of pediatric education should be guided by values and highlight child development as a priority; macro-regulate the number of enrollments based on the demand for pediatric care; and improve teaching curricula according to the development direction of the discipline. We hope to provide theoretical support for the future development of pediatric education as well as the cultivation of pediatric talents and high-quality development of child health in China.
5.Auto-HSCT bridging to CAR-T for follicular lymphoma transformed to B-lymphoblastic leukemia/lymphoma: report of 1 case and review of literature
Xiangping ZONG ; Hao NI ; Jin ZHOU ; Yutong LU ; Shuangzhu LIU ; Caixia LI ; Depei WU
Journal of Leukemia & Lymphoma 2023;32(11):662-666
Objective:To investigate the effect of autologous hematopoietic stem cell transplantation (auto-HSCT) bridging to chimeric antigen receptor T cell (CAR-T) immunotherapy for follicular lymphoma (FL) transformed to B-lymphoblastic leukemia/lymphoma (B-LBL).Methods:The diagnosis and treatment of 1 patient with FL transformed to B-LBL admitted to the First Hospital of Soochow University in August 2020 were retrospectively analyzed and the literature was reviewed.Results:The male patient was 65 years old, and was diagnosed as FL (stage Ⅳ group A, FL international prognostic index -1 score 3 points, high-risk group) in August 2020. And then he was given 6 courses of RB (rituximab combined with bendamustine) regimen, with complete remission (CR) at mid-term and end-stage PET-CT, followed by regular maintenance therapy with rituximab every 2 months, and disease progressed after 4 courses of maintenance therapy. According to the results of histopathology and bone marrow aspiration in December 2021, he was diagnosed B-LBL involving the bone marrow. Partial remission was achieved after induction therapy with zanubnulindb combined with hyper CVAD (cyclophosphamide + doxorubicin + vindesine + dexamethasone) regimen, followed by auto-HSCT bridging to CAR-T treatment targeting CD19 and CD22, which proceeded smoothly with cytokine release syndrome grade 0, immune effector cell-associated neurotoxicity syndrome grade 0. The patient successfully underwent hematopoietic reconstruction and orally taken ibrutinib after discharge. PET-CT indicated CR 2 months after transplantation and he was still in disease-free survival state.Conclusions:The prognosis of FL transformed to B-LBL is poor, and auto-HSCT bridging to CAR-T can improve the prognosis and prolong the survival time of patients who cannot undergo allogeneic hematopoietic stem cell transplantation.
6.The echocardiographic characteristics and risk stratification of patients with above grade 3+ mitral regurgitation: Based on the preliminary findings of echo core-lab
Yutong KE ; Zhinan LU ; Wenhui WU ; Xinmin LIU ; Jing YAO ; Yihua HE ; Guangyuan SONG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(02):205-213
Objective To analyze the echocardiographic characteristics of above grade 3+ mitral regurgitation (MR) patients by 3D transesophageal echocardiography (3D-TEE) in transcatheter edge-to-edge repair (TEER) and compare the intervention rate of TEER treatment in patients with different risk stratification. Methods We retrospectively analyzed the clinical data of 91 patients with above grade 3+ MR in Anzhen Hospital between June 2021 and April 2022. There were 45 males and 46 females aged 66.5±15.9 years. According to pathogenesis, the patients were divided into different anatomical groups and risk stratification groups. There were 34 patients in a simple degenerative group (simple DMR group), 28 patietns in a complex disease group (Complex group), 14 patients in a simple ventricular functional reflux group (simple VFMR group), 9 patients in a simple atrial functional reflux group (simple AFMR group), and 6 patients in a mixed functional reflux group (mixed FMR group). All patients were examined with a unified standard of transthoracic echocardiography (TTE) and 3D-TEE to compare the characteristic three-dimensional structural changes of the mitral valve in each group. According to the three partition strategy of preoperative anatomical evaluation of TEER, the risk stratification was conducted for the enrolled patients, which was divided into three regions from light to heavy: green area, yellow area, and red area. TEER treatment intervention rate of patients with different risk stratification was calculated. Results Ant leaf angle and post leaf angle were negative in the simple DMR and Complex groups, and non-planar angle, prolapse height and prolapse volume were higher than those of the other groups (P=0.000). Ant leaf angle and post leaf angle were positive in the VFMR group and the mixed FMR group. Anterior and posterior (AP) diameter of valve ring (P=0.036), tenting height and tenting volume were higher than those of other groups (P=0.000). AP diameter, tenting height and tenting volume were changed mildly in patients with simple AFMR. MR patients in red and yellow zone achieved a 28.1% TEER intervention rate. Conclusion Standardized TTE and TEE examinations are crucial for the qualitative and quantitative diagnosis of MR in the echo core-lab. 3D-TEE mitral valve parameter can help determine the exact pathogenesis of MR and to improve the interventional rate of challenging MR patients.
7.Micropeptides: origins, identification, and potential role in metabolism-related diseases.
Yirui LU ; Yutong RAN ; Hong LI ; Jiao WEN ; Xiaodong CUI ; Xiaoyun ZHANG ; Xiumei GUAN ; Min CHENG
Journal of Zhejiang University. Science. B 2023;24(12):1106-1122
With the development of modern sequencing techniques and bioinformatics, genomes that were once thought to be noncoding have been found to encode abundant functional micropeptides (miPs), a kind of small polypeptides. Although miPs are difficult to analyze and identify, a number of studies have begun to focus on them. More and more miPs have been revealed as essential for energy metabolism homeostasis, immune regulation, and tumor growth and development. Many reports have shown that miPs are especially essential for regulating glucose and lipid metabolism and regulating mitochondrial function. MiPs are also involved in the progression of related diseases. This paper reviews the sources and identification of miPs, as well as the functional significance of miPs for metabolism-related diseases, with the aim of revealing their potential clinical applications.
Humans
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Open Reading Frames
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Peptides
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Glucose
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Genome
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Metabolic Diseases
8.Continuation, reduction, or withdrawal of tofacitinib in patients with rheumatoid arthritis achieving sustained disease control: a multicenter, open-label, randomized controlled trial.
Mengyan WANG ; Yu XUE ; Fang DU ; Lili MA ; Liang-Jing LU ; Lindi JIANG ; Yi-Li TAO ; Chengde YANG ; Hui SHI ; Honglei LIU ; Xiaobing CHENG ; Junna YE ; Yutong SU ; Dongbao ZHAO ; Sheng-Ming DAI ; Jialin TENG ; Qiongyi HU
Chinese Medical Journal 2023;136(3):331-340
BACKGROUND:
Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.
METHODS:
The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.
RESULTS:
Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.
CONCLUSION:
Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.
TRIAL REGISTRATION
Chictr.org, ChiCTR2000039799.
Humans
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Quality of Life
;
China
;
Arthritis, Rheumatoid/drug therapy*
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Piperidines/therapeutic use*
;
Treatment Outcome
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Antirheumatic Agents/therapeutic use*
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Pyrroles/therapeutic use*
9.Corrective effect of 3D printed scoliosis orthoses
Wenqiang YU ; Yutong HOU ; Chenglan HUANG ; Yunxiao YANG ; Dezhi LU ; Caiping WANG ; Jinwu WANG
Chinese Journal of Rehabilitation Theory and Practice 2023;29(4):390-395
ObjectiveTo investigate the in-brace and short-term correction of 3D-printed scoliosis orthoses. MethodsFrom July to December 2021, 36 patients with adolescent idiopathic scoliosis from Ninth People's Hospital, Shanghai Jiaotong University School of Medicine were selected to complete full-length radiographs of the spine before and immediately after wearing the orthosis. They wore the orthosis more than 20 hours a day, and took radiographs six months later. Cobb angle was calculated. They were assessed with Chinese version of the Scoliosis Research Society's outcomes instrument 22 (SRS-22) before wearing and six months follow-up. ResultsThe mean Cobb angle was (22.10±6.29)° before wearing, and it was (7.85±10.90)° immediately after wearing (t = 4.775, P < 0.01) and (14.33±0.74)° six months follow-up (t = 4.189, P < 0.01). The score of functional status of SRS-22 increased six months follow-up (Z = -2.676, P < 0.01). The Cobb angle immediately after wearing correlated with the Cobb angle six months follow-up (r = 0.826, P < 0.05). Conclusion3D-printed scoliosis orthoses can correct the scoliosis satisfactorily, in-brace and in short-term.
10.Artificial tumor microenvironment regulated by first hemorrhage for enhanced tumor targeting and then occlusion for synergistic bioactivation of hypoxia-sensitive platesomes.
Wenhui TAO ; Dongyang ZHAO ; Guanting LI ; Lingxiao LI ; Songhao LI ; Hao YE ; Chutong TIAN ; Yutong LU ; Shuying LI ; Yinghua SUN ; Zhonggui HE ; Jin SUN
Acta Pharmaceutica Sinica B 2022;12(3):1487-1499
The unique characteristics of the tumor microenvironment (TME) could be exploited to develop antitumor nanomedicine strategies. However, in many cases, the actual therapeutic effect is far from reaching our expectations due to the notable tumor heterogeneity. Given the amplified characteristics of TME regulated by vascular disrupting agents (VDAs), nanomedicines may achieve unexpected improved efficacy. Herein, we fabricate platelet membrane-fusogenic liposomes (PML/DP&PPa), namely "platesomes", which actively load the hypoxia-activated pro-prodrug DMG-PR104A (DP) and physically encapsulate the photosensitizer pyropheophorbide a (PPa). Considering the different stages of tumor vascular collapse and shutdown induced by a VDA combretastatin-A4 phosphate (CA4P), PML/DP&PPa is injected 3 h after intraperitoneal administration of CA4P. First, CA4P-mediated tumor hemorrhage amplifies the enhanced permeation and retention (EPR) effect, and the platesome-biological targeting further promotes the tumor accumulation of PML/DP&PPa. Besides, CA4P-induced vascular occlusion inhibits oxygen supply, followed by photodynamic therapy-caused acute tumor hypoxia. This prolonged extreme hypoxia contributes to the complete activation of DP and then high inhibitory effect on tumor growth and metastasis. Thus, such a combining strategy of artificially-regulated TME and bio-inspired platesomes pronouncedly improves tumor drug delivery and boosts tumor hypoxia-selective activation, and provides a preferable solution to high-efficiency cancer therapy.

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