OBJECTIVE To systematically evaluate risk prediction models for chemotherapy-induced myelosuppression in breast cancer， and provide a scientific reference for clinical healthcare workers in selecting or developing effective predictive models. METHODS A systematic search was conducted for studies on predictive models of the risk of chemotherapy-induced myelosuppression in breast cancer across the CNKI， VIP， Wanfang， PubMed， Web of Science， Cochrane Library， Embase， and Scopus databases， with a time frame of the establishment of the database to May 7， 2024. Literature was independently screened by 2 investigators， data were extracted according to critical appraisal and data extraction for systematic reviews of predictive model studies， and the risk of bias evaluation tool for predictive model studies was used to analyze the risk of bias and applicability of the included studies. RESULTS There were totally 7 studies， comprising 12 models. Among them， 11 models indicated an area under the subject operating characteristic curve of 0.600-0.908； 2 models indicated calibration. The common predictor variables of the included models were age， pre-chemotherapy neutrophil count， pre-chemotherapy lymphocyte count， and pre-chemotherapy albumin. The overall risk of bias of the 7 studies was high， which was mainly attributed to the flaws in the study design， insufficient sample sizes， inappropriate treatment of variables， non-reporting of missing data， and the lack of indicators for the assessment of the models， but the applicability was good. CONCLUSIONS The predictive performance of risk predictive models for chemotherapy-induced myelosuppression in breast cancer remains to be further enhanced， and the overall risk of model bias is high. Future studies should follow the specifications of model development and reporting， then combine machine learning algorithms to develop risk predictive models with good predictive performance， high stability， and low risk of bias， so as to provide a decision-making basis for the clinic.

The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

OBJECTIVE To analyze clinical switching patterns and reasons between bevacizumab biosimilar and originator drugs. METHODS The data were collected from 1 175 cancer patients treated with bevacizumab at Ruijin Hospital， Shanghai Jiao Tong University School of Medicine from January 1， 2018， to December 31， 2023. The patients were divided into originator group （n＝250） and biosimilar group （n＝925）. The switching rate， switching type and reasons of the two groups were compared. RESULTS There were no statistically significant differences in the switching rate， switching types， and the number of switches between the two groups （P＞0.05）. Single， one-way switches were the switching type in both groups. The proportion of patients in the biosimilar group who switched due to adverse events was significantly higher than originator group， while the proportion of patients who switched due to treatment costs was significantly lower than originator group （P＜0.05）. There were no statistically significant differences in the proportions of patients who switched due to efficacy and drug accessibility between the two groups （P＞0.05）. CONCLUSIONS The switching between bevacizumab biosimilar and the originator drugs mainly involves single， one- way switches. Treatment costs and drug accessibility are the main factors for the switches among users of originator drugs， while drug accessibility and adverse events are the main factors for the switches among users of biosimilar.

Objective To observe the effect of nasal packing with merocel on postoperative com-fort in patients undergoing endoscopic sinus surgery for chronic sinusitis.Methods Patients with chronic sinusitis who underwent endoscopic sinus surgery were selected and randomly divided into ob-servation group(packed with merocel for hemostasis)and control group(packed with gelatin sponge for hemostasis)using a random number table method,with 71 cases in each group.The degrees of nasal swelling pain and headache,nasal ventilation status(nasal airway resistance,degree of nasal obstruction),nasal bleeding,compliance scores,total discomfort scores[Visual Analogue Scale(VAS)],endoscopic Lund-Kennedy scores,and scores of related treatment indicators(infection,nasal meatal adhesion,patency of ostium,granulation hyperplasia)were compared between the two groups.Results The degrees of nasal swelling pain,headache and the degree of nasal obstruction at 24 h postoperatively in the observation group were milder than those in the control group,the nasal airway resistance was lower,and degree of nasal bleeding at 48 h postoperatively in the observation group was milder than that in the control group(P＜0.05).There was no statistically significant difference in postoperative compliance scores between the two groups(P＞0.05).The total discomfort VAS score and endoscopic Lund-Kennedy score in the observation group were lower than those in the control group(P＜0.05).There were no statistically significant differences in the scores of indica-tors related to infection,patency of ostium,and granulation hyperplasia at 4 weeks postoperatively between the two groups(P＞0.05).The score of nasal meatal adhesion in the observation group was lower than that in the control group(P＜0.05).Conclusion As a nasal packing material af-ter endoscopic sinus surgery,merocel can more effectively alleviate postoperative discomfort such as pain and nasal obstruction,reduce the risk of early bleeding and long-term nasal meatal adhesion,and improve postoperative comfort.

Objective To investigate the impact of myeloid cell-specific knockout of the granulocyte colony-stimulating factor receptor(G-CSFR)on the progression of acute radiation pneumonitis.Methods Myeloid cell-specific G-CSFR knockout(G-CSFR-/-,Lyz2-cre)mice were constructed.G-CSFR-/-,Lyz2-cre and C57BL/6N mice underwent a single whole-body irradiation with 6.5 Gy of 60Co γ-rays to establish a model of radiation injury.The lung function of mice was assessed using a mouse lung function test system at 3,7 and 14-days post γ-ray irradiation.Pathological changes in the lung tissue were analyzed via hematoxylin and eosin(HE)staining of paraffin sections.Tumor necrosis factor-α(TNF-α)and interleukin-10(IL-10)levels were measured via radioimmunoassay.IL-8 and its receptor CXCR2 were quantified using enzyme-linked immunosorbent assay(ELISA).The infiltration of neutrophils in lung tissue was evaluated by immunohistochemical detection of myeloperoxidase.Results At 3-,7-and 14-days post-irradiation with 6.5 Gy of 60Co γ-rays,there were no significant differences observed in lung function or interstitial inflammatory lesions between G-CSFR-/-,Lyz2-cre mice and C57BL/6N mice.However,the infiltration of neutrophils in lung tissue of G-CSFR-/-,Lyz2-cre mice was significantly reduced(P＜0.01),and the levels of IL-8,CXCR2 and TNF-α in lung tissues were markedly lower than in C57BL/6N mice(P＜0.05).Conclusion The myeloid cell-specific knockout of G-CSFR can effectively diminish neutrophil infiltration as well as inflammatory cytokine levels in lung tissues following radiation exposure.

Objective:To study a comprehensive evaluation method for the operational benefits of large-scale medical equipment that can construct comprehensive evaluation model,in order to improve the operational efficiency of equipment.Methods:An index system of comprehensive evaluation for the operational efficiency of large-scale medical equipment was established.Rough set theory and analytic hierarchy process were used to calculate the weight of the comprehensive evaluation index for operational efficiency.Grey comprehensive evaluation method combined with the weight of indicator was used to construct comprehensively evaluation model of the operational efficiency of large-scale medical equipment,so as to conduct comprehensive evaluation for operational efficiency from 6 aspects included medical quality,equipment efficiency,scientific research and teaching,equipment procurement,equipment use,and maintenance.A total of 12 using large medical equipment in the clinical practice of People's Hospital of Xinjiang Uygur Autonomous Region from January 2022 to December 2023 were selected.The changes of yield rate of monthly investment of large-scale medical equipment in the department were compared between before and after the application of the comprehensive evaluation method based on the comprehensive evaluation model for the operational efficiency of large-scale medical equipment.A self-made questionnaire survey was adopted to investigate the satisfaction ratings of leaders and department heads for this method in hospital,and the"scores>6"was considered as higher satisfaction.Results:After the comprehensive evaluation method based on the comprehensive evaluation model for operational efficiency of large-scale medical equipment was applied,the yield rate of averagely monthly investment of large-scale medical equipment increased from 4.364%to 8.688%within each department.The satisfaction score of leaders of hospital was the highest(10 points)in terms of the promotion of equipment,while department heads had the highest satisfaction scores in terms of practicality and accuracy,and both of them were at 10 points.Conclusion:The comprehensive evaluation method based on the comprehensive evaluation model for the operational efficiency of large-scale medical equipment can accurately evaluate the quality and efficiency of the operation of equipment,and find the potential problems and improvement directions,and improve the yield rate of investment for large-scale medical equipment,and enhance the satisfaction of users.

Objective To evaluate the quality of the reports of randomized controlled trials(RCT)on acupuncture treatment of dysmenorrhea.Methods RCT English and Chinese literature about acupuncture for the treatment of dysmenorrhea was systematically retrieved from PubMed,EMbase,Cochrane Library,CNKI,SinoMed,Wanfang Data and VIP from the establishment of the databases to March 31,2024.Based on the CONSORT statement,STRICTA,and SHARE,RCTs for acupuncture treatment of dysmenorrhea that met the inclusion criteria were evaluated and statistically analyzed.Results Totally 28 RCTs were included.According to the analysis and statistics,although the reporting rate of the basic implementation points of RCT was satisfactory,reporting rates of the CONSORT statement,STRICTA and SHARE related to the implementation details of blind method,the demarcation of outcome indicators and statistical analysis,the determination method of sample size,the rationality analysis of sham acupuncture and the implementation details were still below 50%or even 0%.Among them,the items with a reporting rate less than 30%were mainly the identification of the title,the integrity of the trial design,the comprehensiveness of the outcome indicators,the comprehensiveness of the statistical analysis,the rationality analysis of acupuncture treatment,the operation details of false acupuncture,and the full report of the trial information.Conclusion At present,the quality of RCT reports on the treatment of dysmenorrhea with sham acupuncture as control at home and abroad is generally low,especially in the rationality of sham acupuncture,implementation methods and statistical analysis of outcome indicators,etc.It is suggested that the CONSORT statement,STRICTA and SHARE should be strictly followed when designing clinical trial protocols in the future,with multi-stage self-evaluation,timely adjustment and improvement of the program design,in order to improve the safety,authenticity and scientificity of the program.

OBJECTIVE: To observe the clinical effect of Tiaoshen Guben holistic therapy of acupuncture and moxibustion (holistic treatment with acupuncture and moxibustion by adjusting the mind and consolidating the root) on comorbidity of depression and insomnia. METHODS: Twenty-four patients with comorbidity of depression and insomnia were included and treated with Tiaoshen Guben holistic therapy of acupuncture and moxibustion. Acupuncture was applied to Baihui (GV20), Guanyuan (CV4), bilateral Neiguan (PC6), etc. The refined moxibustion therapy was delivered at Zhongwan (CV12), Qihai (CV6), bilateral Yongquan (KI1), etc. Subcutaneous embedding therapy with thumb-tack needle was adopted at bilateral Xinshu (BL15), bilateral Pishu (BL20), etc. The intervention was operated once every other day, 3 treatments a week, and for 6 consecutive weeks. Before and after treatment completion, and in 1 month after treatment, Pittsburgh sleep quality index (PSQI) and Hamilton's depression scale (HAMD-17) were adopted to assess sleep quality and depression symptoms in the patients, respectively. Before and after treatment completion, using functional magnetic resonance imaging (fMRI), the functional connectivity (FC) of locus coeruleus (LC) in brain regions was evaluated; and the levels of serum norepinephrine (NE), cortisol (CORT), adrenocorticotropic hormone (ACTH) and corticotropin releasing hormone (CRH) were detected. RESULTS: Compared with the scores before treatment, PSQI and HAMD-17 scores after treatment completion and in 1 month after treatment were reduced (P<0.01); and strengthened FC was revealed between the right LC and the pars opercularis of the left inferior frontal gyrus, as well as the lateral occipital lobe region. After treatment completion, serum NE was elevated (P<0.01), the levels of CORT, ACTH and CRH were reduced (P<0.01). Before and after treatment completion, the difference in FC between the right LC and the pars opercularis of the left inferior frontal gyrus was negatively correlated with the differences in PSQI score (r = -0.484, P = 0.016) and HAMD-17 score (r = -0.233, P = 0.027). CONCLUSION Tiaoshen Guben holistic therapy of acupuncture and moxibustion can effectively alleviate depression symptoms and improve sleep quality in the patients with comorbidity of depression and insomnia, which is obtained probably through reducing the levels of serum CORT, ACTH and CRH, increasing serum NE, strengthening the FC of the right LC with the pars opercularis of the left inferior frontal gyrus and the lateral occipital lobe region.
Humans ; Moxibustion ; Sleep Initiation and Maintenance Disorders/therapy* ; Male ; Female ; Middle Aged ; Adult ; Acupuncture Therapy ; Depression/complications* ; Aged ; Young Adult ; Acupuncture Points ; Comorbidity

BACKGROUND: Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic inflammation and joint destruction. Iguratimod (IGU) is a novel conventional synthetic disease-modifying antirheumatic drugs (csDMARD) with good efficacy and safety for the treatment of active RA in China and Japan. However, the long-term effects of IGU on the progression of bone destruction or radiographic progression in patients with active RA remain unknown. We aimed to investigate the efficacy and safety of iguratimod (IGU), a combination of methotrexate (MTX) and IGU, and IGU in patients with active rheumatoid arthritis (RA) who were naïve to MTX. METHODS: This multicenter, double-blind, randomized, non-inferiority clinical trial was conducted at 28 centers for over 52 weeks in China. In total, 911 patients were randomized (1:1:1) to receive MTX monotherapy (10-15 mg weekly, n = 293), IGU monotherapy (25 mg twice daily, n = 297), or IGU + MTX (10-15 mg weekly for MTX and 25 mg twice daily for IGU, n = 305) for 52 weeks. The patients' clinical characteristics, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), disease activity score in 28 joints-C-reactive protein (DAS28-CRP) level, and disease activity score in 28 joints-erythrocyte sedimentation rate (DAS28-ESR) were assessed at baseline. The primary endpoints were the proportion of patients with ≥20% improvement according to the American College of Rheumatology (ACR20) response and changes in the van der Heijde-modified total Sharp score (vdH-mTSS) at week 52. RESULTS: The proportions of patients achieving an ACR20 response at week 52 were 77.44%, 77.05 %, and 65.87% for IGU monotherapy, IGU + MTX, and MTX monotherapy, respectively. The non-inferiority of IGU monotherapy to MTX monotherapy was established with the ACR20 (11.57%; 95% confidence interval [CI], 4.35-18.79%; P <0.001) and vdH-mTSS (-0.37; 95% CI, -1.22-0.47; P = 0.022). IGU monotherapy was also superior to MTX monotherapy in terms of ACR20 ( P = 0.002) but not the vdH-mTSS. The superiority of IGU + MTX over MTX monotherapy was confirmed in terms of the ACR20 (11.18%; 95% CI, 3.99-18.37%; P = 0.003), but not in the vdH-mTSS (-0.68; 95% CI, -1.46-0.11; P = 0.091). However, the difference in the incidence rates of adverse events was not statistically significant. CONCLUSIONS: IGU monotherapy/IGU + MTX showed a more favorable clinical response than did MTX monotherapy. IGU may have some clinical benefits over MTX in terms of radiographic progression, implying that IGU may be considered as an initial therapeutic option for patients with active RA. TRIAL REGISTRATION https://classic.clinicaltrials.gov/ , NCT01548001.
Adult ; Aged ; Female ; Humans ; Male ; Middle Aged ; Antirheumatic Agents/therapeutic use* ; Arthritis, Rheumatoid/drug therapy* ; Chromones/adverse effects* ; Double-Blind Method ; Drug Therapy, Combination ; Methotrexate/adverse effects* ; Treatment Outcome ; Sulfonamides