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 compare the clinical efficacy of acupuncture with yin-yang regulation method versus local acupuncture in treating chronic low back pain (CLBP) in elderly patients with lumbar disc herniation (LDH), and to evaluate the changes in the multifidus muscle before and after treatment using musculoskeletal ultrasound. METHODS: A total of 128 elderly patients with CLBP due to LDH were randomly assigned to an observation group (64 cases, 2 cases dropped out) and a control group (64 cases, 2 cases dropped out). The control group received local acupuncture at bilateral L₃-L₅ Jiaji points (EX-B2), Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Yaoyangguan (GV3), and ashi points. The observation group received acupuncture with yin-yang regulation method, which included an abdominal protocol with Baihui (GV20), Zhongwan (CV12), Qihai (CV6), Guanyuan (CV4), bilateral Tianshu (ST25), and Dahe (KI12), etc., and a lumbar protocol with Baihui (GV20), Dazhui (GV14), Jizhong (GV6), Yaoyangguan (GV3), and ashi points, etc., alternated bilaterally. Both groups were treated once every other day, three times per week, for a total of 12 sessions. The visual analogue scale (VAS) score, Oswestry disability index (ODI) score, and the indexs of musculoskeletal ultrasound multifidus muscle (resting and functional thickness and Young's modulus values) were observed before and after treatment, and the clinical efficacy was evaluated in the two groups. RESULTS: After 1 and 4 weeks of treatment, both groups showed lower VAS scores compared to baseline (P<0.05), the VAS scores in the observation group were lower than those in the control group (P<0.001). ODI scores in both groups were decreased after 1 and 4 weeks of treatment compared to baseline (P<0.05), with a further reduction at 4 weeks of treatment compared to 1 week of treatment (P<0.05); the observation group showed lower ODI score than the control group after 1 week of treatment (P<0.001). After treatment, both groups demonstrated increased resting and functional multifidus muscle thickness bilaterally compared to baseline (P<0.01), with an increased right-side thickness change rate (P<0.01), though no significant difference was observed between groups (P>0.05). Compared to baseline, after treatment, the observation group exhibited decreased Young's modulus values for bilateral resting and functional multifidus muscle (P<0.01), while the control group showed reductions only in bilateral resting and right-side functional Young's modulus values (P<0.01). After treatment, the bilateral functional Young's modulus values in the observation group were lower than that in the control group (P<0.05), and the bilateral resting and functional changes in Young's modulus values were greater in the observation group than those in the control group (P<0.01). The overall effective rate was 93.5% (58/62) in the observation group, which was higher than 79.0% (49/62) in the control group (P<0.05). CONCLUSION Acupuncture with yin-yang regulation method effectively alleviates pain, improves functional disability, increases multifidus muscle thickness, and reduces Young's modulus values in elderly patients with CLBP due to LDH, which has superior therapeutic effect compared to local acupuncture.
Humans ; Low Back Pain/physiopathology* ; Male ; Acupuncture Therapy ; Female ; Aged ; Intervertebral Disc Displacement/physiopathology* ; Middle Aged ; Yin-Yang ; Lumbar Vertebrae ; Acupuncture Points ; Treatment Outcome

Following the release of the Technical Requirements on Quality Control and Standard Establishment of Traditional Chinese Medicine Formula Granules by the National Medical Products Administration in 2021, Chinese Pharmacopoeia Commission has promulgated 296 national drug standards so far, and most provinces have started the work of establishing provincial standards as supplements. The promulgation of standards fostered high-quality development of the industry. Since the implementation of national and provincial standards for more than three years, enterprises have gained deep understanding and hands-on experiences on the characteristics, technical requirements, production process, and quality control of traditional Chinese medicine(TCM) formula granules. Meanwhile, challenges have emerged restricting the high-quality development of this industry, including how to formulate quality control strategies for medicinal materials and decoction pieces, how to reduce manufacturing costs, and how to improve the pass rate and product stability under high standards. Based on the work experiences from standard management and process research, this article analyzed the distribution of sources, processing methods, dry extract rate ranges, process requirements for volatile oil-containing decoction pieces, control measures of safety indices, characteristics and trends of setting characteristic chromatograms or fingerprints, characteristics and trends of setting content ranges, and main differences between national standards and provincial standards. On the one hand, this article aims to present main characteristics for deeply understanding different indicators in standards and provide basic ideas for establishing quality and process control systems. On the other hand, from the perspective of industrial practice, suggestions are put forward on the important aspects that need to be focused on in the quality and process control of TCM formula granules.
Drugs, Chinese Herbal/chemistry* ; Quality Control ; Medicine, Chinese Traditional/standards* ; China ; Drug Industry/standards*

Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards* ; Humans ; Consensus ; Drugs, Chinese Herbal/therapeutic use* ; Surveys and Questionnaires

OBJECTIVE: To compare the therapeutic efficacy and safety of local anesthesia and spinal anesthesia for the patients with varicocele (VC) who underwent microsurgical varicocelectomy (MV). METHODS: We retrospectively analyzed the data of VC patients who underwent MV treatment at the Andrology Department of the Affiliated Ruikang Hospital of Guangxi University of Chinese Medicine from May 2020 to March 2023. Cases with complete clinical data and follow-up evaluation were selected and divided into a control group (spinal anesthesia) and an observation group (local anesthesia) according to different anesthesia methods. The surgical time (including anesthesia time), visual analogue scale (VAS) score for pain, hospital stay, treatment cost, sperm concentration, forward motile sperm rate, and normal sperm morphology rate after three months of surgery, as well as postoperative complications and recurrence rate were compared between the two groups. RESULTS: A total of 107 eligible cases were included, with 56 cases in the control group and 51 cases in the observation group. There was no significant difference in the VAS score for pain during and after four hours of surgery, as well as postoperative complications, and recurrence rate between the two groups (P> 0.05). There was an significant increase in sperm concentration, forward motile sperm rate, and normal sperm morphology rate in both of two groups after three months of surgery (P<0.05). However, there was no significant difference between the two groups three months after surgery (P>0.05). The surgical time and hospital stay were shorter than those of the control group (P<0.05). And the treatment cost in observation group was lower than that of the control group (P<0.05). CONCLUSION Both local anesthesia and lumbar anesthesia for MV treatment of VC have good efficacy and safety. However, patients treated with MV under local anesthesia for VC have obvious advantages in terms of operation time (including anesthesia time), hospital stay, and treatment cost, which is worthy of clinical promotion and application.
Humans ; Male ; Varicocele/surgery* ; Retrospective Studies ; Microsurgery ; Anesthesia, Spinal ; Adult ; Treatment Outcome ; Anesthesia, Local

Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans ; Dental Cementum/injuries* ; Consensus ; Diagnosis, Differential ; Cone-Beam Computed Tomography ; Tooth Fractures/therapy*

Objective To investigate the relationship between 9 immunoinflammatory indicators derived from complete blood count and the severity of Mycoplasma pneumoniae pneumonia(MPP)in children of different ages.Methods Totally 2 132 children with MPP who were hospitalized in the Department of Pediatrics of The First Affiliated Hospital of Naval Medical University from Jul.1,2023,to Dec.31,2024 were enrolled,and were assigned to severe MPP(SMPP)or non-severe MPP(NSMPP)groups.According to age and gender 1∶1 matching,the children were assigned to 2 subgroups according to age(1-6 years old and＞6-16 years old).The basic data,laboratory examination and immunoinflammatory indicators from complete blood count of each group were collected and compared.The influencing factors of SMPP were analyzed by univariate and multivariate Cox proportional hazards regression models.Receiver operating characteristic curves were used to analyze the predictive value of indicators that showed statistically significant differences for SMPP.Results There were 220 patients with SMPP,accounting for 10.3%of MPP.In children aged 1-6 years,compared with the NSMPP group,the SMPP group had a longer hospital stay,higher platelet(PLT)count,platelet-to-lymphocyte ratio(PLR),neutrophil-to-lymphocyte ratio,derived neutrophil-to-lymphocyte ratio and systemic immune-inflammation index(all P＜0.05).PLR was an independent risk factor for SMPP(odds ratio=1.010,95%confidence interval[CI]1.003-1.018,P=0.007).The area under curve predicted by PLR for SMPP was 0.635(95%CI 0.560-0.711,P＜0.001),the best cut-off value was 125.04,and the corresponding sensitivity and specificity were 57.7%and 70.2%,respectively.All the children were assigned to low PLR group or high PLR group using the best cut-offvalue as the boundary,and the severe disease rate in the high PLR group was significantly higher than that in the low PLR group(65.9%[60/91]vs 37.6%[44/117],P＜0.001).All the children were assigned to Q1-Q4 groups by quartile,and the severe disease rate of the Q4 group(71.2%,37/52)was significantly higher than that of the Q1-Q3 group(all P＜0.05).In children aged＞6-16 years,compared with the NSMPP group,the PLT and PLR in the SMPP group were higher(both P＜0.05),but neither was an independent risk factor.All the children were assigned to low PLR group or high PLR group using the best cut-offvalue(137.03)as the boundary,and the severe disease rate in the high PLR group was significantly higher than that in the low PLR group(57.0%[77/135]vs 40.2%[39/97],P=0.011).All the children were assigned to Q1-Q4 groups by quartile,and the severe disease rate of the Q4 group(65.5%,38/58)was significantly higher than that of the Q1-Q3 group(all P＜0.05).Conclusion The immunoinflammatory indicators derived from complete blood count,especially PLR,have certain application value in predicting the severity of MPP children in different ages.

Objective To observe the repair effect and mechanism of Danhuang Powder-containing serum on high glucose-induced vascular endothelial cell injury.Methods Danhuang Powder-containing serum was prepared.Human umbilical vein endothelial cells(HUVECs)were cultured to be divided into control group,recombinant human epidermal growth factor(called"growth factor"for short)group,Danhuang Powder group,high glucose group,high glucose+growth factor group,and high glucose+Danhuang Powder group.After corresponding intervention in each group for 48 hours,the cell ultrastructure and autophagy were observed under transmission electron microscope,apoptosis was detected by flow cytometry,and the protein expression levels of vascular endothelial growth factor(VEGF),epidermal growth factor(EGF)and basic fibroblast growth factor(bFGF)in the cells were detected by Western Blot.Results(1)The intra-mitochondrial ridges in the control group were clearly visible,autophagosomes and autolysosomes were fewer;mitochondria in the high glucose group were swollen and irregular,and appeared vacuolated;and the more typical autophagy-like structures were seen in the high glucose+Danhuang Powder group.(2)Compared with the high glucose group and high glucose+growth factor group,the apoptosis rate of cells in the high glucose+Danhuang Powder group was significantly decreased(P<0.05).(3)Compared with the high glucose group and the high glucose+growth factor group,the protein expression levels of VEGF,EGF and bFGF in the cells of the high glucose+Danhuang Powder group were significantly increased(P<0.05).Conclusion Danhuang Powder-containing serum can reduce the high glucose-induced damage in HUVEC cells,and its mechanism may be related to the activation of mitochondrial autophagy,and the inhibition of apoptosis,as well as the up-regulation of the expression of VEGF,EGF and bFGF.

Objective To investigate the clinicopathological and prognostic characteristics of intestinal inflammatory myofibroblastic tumours(IMT)in middle-aged and elderly patients.Methods The clinical,pathologi-cal morphology,immunophenotype and follow-up results of 5 cases of intestinal IMT in middle-aged and elderly patients were retrospectively analyzed.Results 4 cases of IMT occurred in the right half colon and 1 in the ileum.Most patients(3/5)had a history of intestinal injury,starting the digestive tract symptoms and increased leukocytes.The tumor tissue was composed of fusiform myofibroblasts and fibroblasts arranged in storiform pattern,with an infiltrative growth pattern,accompanied by a large number of lymphocytes and plasma cells infiltration,collagen formation and myxedema.One case was atypically large and deformed.Immunophenotype:vimentin(5cases),SMA(5 cases),desmin(3 cases),ALK(3 cases),CK(2 cases)were positive.Caldesmon,CD34,β-catenin,MC,CD117,DOG1,S-100,BCL-2,CD99,CD68 were negative,and Ki-67 proliferation index was 1.28%to 10.01%.All the 5 cases underwent complete tumor resection and were followed up for 48.5 to 133 months.Among them,1 patient aged 83 was considered to have tumor recurrence 27 months after surgery.The other patient survived 122 months without tumor and died of other causes.All the others survived without tumor and were in good condition.Conclusion(1)Intestinal IMT in the middle-aged and elderly people in this group was more common in the right half colon,and most of them had a history of intestinal injury,first gastrointestinal symptoms and elevated white blood cells;(2)Vimentin and SMA were positive at the same time,and ALK was more positive;(3)4/5 patients had good surgical resection,and 1/5 patients could relapse 2～3 years after surgery;old age,ALK-positive,Ki67 up to 10%,atypia may be an important risk factor for intestinal IMT recurrence in the elderly,of which ALK-positive patients may have a recurrence risk of 1/3.