Progressive pulmonary fibrosis (PPF) is a progressive and lethal condition with few effective treatment options. Improvements in quality of life for patients with PPF remain limited even while receiving treatment with approved antifibrotic drugs. Traditional Chinese medicine (TCM) has the potential to improve cough, dyspnea and fatigue symptoms of patients with PPF. TCM treatments are typically diverse and individualized, requiring urgent development of efficient and precise design strategies to identify effective treatment options. We designed an innovative Bayesian adaptive two-stage trial, hoping to provide new ideas for the rapid evaluation of the effectiveness of TCM in PPF. An open-label, two-stage, adaptive Bayesian randomized controlled trial will be conducted in China. Based on Bayesian methods, the trial will employ response-adaptive randomization to allocate patients to study groups based on data collected over the course of the trial. The adaptive Bayesian trial design will employ a Bayesian hierarchical model with "stopping" and "continuation" criteria once a predetermined posterior probability of superiority or futility and a decision threshold are reached. The trial can be implemented more efficiently by sharing the master protocol and organizational management mechanisms of the sub-trial we have implemented. The primary patient-reported outcome is a change in the Leicester Cough Questionnaire score, reflecting an improvement in cough-specific quality of life. The adaptive Bayesian trial design may be a promising method to facilitate the rapid clinical evaluation of TCM effectiveness for PPF, and will provide an example for how to evaluate TCM effectiveness in rare and refractory diseases. However, due to the complexity of the trial implementation, sufficient simulation analysis by professional statistical analysts is required to construct a Bayesian response-adaptive randomization procedure for timely response. Moreover, detailed standard operating procedures need to be developed to ensure the feasibility of the trial implementation. Please cite this article as: Zhang C, Nie YS, Zhang CT, Yang HJ, Zhang HR, Xiao W, Cui GF, Li J, Li SJ, Huang QS, Yan SY. An adaptive Bayesian randomized controlled trial of traditional Chinese medicine in progressive pulmonary fibrosis: Rationale and study design. J Integr Med. 2025; 23(2): 138-145.
Female ; Humans ; Male ; Bayes Theorem ; Disease Progression ; Drugs, Chinese Herbal/therapeutic use* ; Medicine, Chinese Traditional/methods* ; Pulmonary Fibrosis/therapy* ; Quality of Life ; Randomized Controlled Trials as Topic ; Research Design ; Adaptive Clinical Trials as Topic

Objective:To investigate the surgical technique and clinical outcomes of the tri-lobed chain medial plantar perforator flaps for reconstruction of soft tissue defects in palmar hand.Methods:A retrospective analysis was conducted on 6 patients (4 males and 2 females; aged 21-63 years with mean age of 39.2 years) who had soft tissue defects in palmar hands and were reconstructed with tri-lobed chain medial plantar perforator flaps in the Department of Plastic Surgery and Burns, the Affiliated Hospital of Zunyi Medical University between July 2024 and April 2025. All defects were located on palmar aspect of the injured hands. Following admission, debridement, fracture reduction and fixation and tendon repairs were carried out in primary surgery for 5 patients who had traumatic injuries with digital or metacarpal fractures and tendon ruptures, and stage-II surgery for soft tissue reconstruction was conducted at 7-9 days later. The patient with scar contracture received preoperative evaluation then followed by a scar excision and release surgery, prior to a reconstructive surgery for soft tissue defects. Four patients presented with multi-site defects, of whom, 1 patient had proximal phalangeal defects of index and middle fingers and a defect of metacarpophalangeal joint of ring finger, 1 patient had a defect of metacarpophalangeal joint of index finger and defects of proximal phalanges of middle and ring fingers, 1 patient had defects of proximal phalanges of index, middle and little fingers, and 1 patient had defects of proximal phalanges of middle, ring and little fingers. Of the patients with finger defects, the sizes of defect ranged from 2.0 cm ×1.8 cm to 6.0 cm×2.8 cm and the defects were reconstructed with individually harvested tri-lobed chain medial plantar perforator flaps. Two patients had soft tissue defects in palmar hands and they were measured at 6.0 cm×5.5 cm and 6.0 cm×7.0 cm in size. The palmar defects were reconstructed using combined tri-lobed chain flaps with the sizes of individual lobulated flap ranging from 2.1 cm×1.9 cm to 6.0 cm×2.9 cm. All foot donor sites were primarily closed with interrupted sutures. Postoperative management included routine anti-inflammatory, anticoagulant and antispasmodic treatment. Patients were discharged at 8-10 days after surgery and the postoperative follow-ups were conducted at outpatient clinic to monitor flap survival, contour, hand function, donor site healing, scar formation and foot function.Results:All flaps survived with primary healing of donor sites. Over the 1 to 9 (mean 6.1) months of postoperative follow-up, all flaps survived well with colour and thickness matching with the surrounding hand skin. At 6 months after surgery, two-point discrimination (TPD) of flaps achieved to 8-11 (mean 8.6) mm. According to the Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association, 4 patients achieved function recovery of fingers in excellent and 2 in good. Donor sites exhibited linear scars without painful scarring or paraesthesia, with normal ankle function and gaits.Conclusion:Tri-lobed medial plantar perforator flaps can be used to reconstruct soft tissue defects in palmar hand with primary and direct closure of the flap donor sites. They can simultaneously reconstruct multiple or a large defects, and provide satisfactory aesthetic and functional outcomes. It is a feasible surgical option.

Objective To compare the efficacy and complications of cupric ion electrochemical therapy and selective suprahemorrhoid resection and stapling surgery for the treatment of grade Ⅲ-Ⅳhemorrhoids.Methods 204 patients with grade Ⅲ-Ⅳ mixed hemorrhoids admitted to our hospital from September 2022 to October 2023 were included as the study subjects.They were divided into two groups using numerical method,with 102 cases in each group.The observation group received copper ion electrochemical therapy,while the control group received selective hemorrhoid mucosal resection and stapling surgery.Compare the surgical outcomes,efficacy,pain scores,anal function scores,quality of life index scores,and incidence of complications between two groups.Results There was no statistically significant difference in gender,age,hemorrhoid grade,surgical time,and hospitalization period between the observation group and the control group(P＞0.05),but the intraoperative blood loss in the observation group was less than that in the control group[(11.37±5.32)ml and(26.72±14.24)ml],and the difference between the two groups was statistically significant(P＜0.05).The severity of pain in the observation group was lower than that in the control group on the 1st and 7th day after surgery(P＜0.05);There was no statistically significant difference in the Wexner anal incontinence scores between the two groups at 1 and 8 weeks after surgery(P＞0.05).The observation group had a better gastrointestinal quality of life index(GIQLI)score than the control group at 2 weeks after surgery[(20.92±4.63)and(26.77±5.03)scores,P＜0.05],and there was no statistically significant difference between the two groups at 8 weeks[(4.38±0.90)and(4.68±1.41)mm,P＞0.05].The total incidence of postoperative complications in both groups was statistically significant(8.8％vs 20.6％,P＜0.05).An average follow-up of six months showed no recurrence.Conclusion Cupric ion electrochemical therapy for mixed hemorrhoids is safe,effective,and has no serious complications,providing a more convenient and minimally invasive treatment method.

Targeting drug delivery systems mediated by nanoparticles has shown great potential in the diagnosis and treatment of cancer. However, influences of different tumor progressions on the accumulation of nanoparticles, especially the ligand-modified active targeting nanoparticles are seldom exploited. In this work, the accumulation and penetration of RGD-modified gold nanoparticles (active AuNPs) with different sizes were investigated in orthotopic breast cancer with different tumor progressions. The results showed that the smallest active AuNPs had better accumulation and permeation effects in early tumor tissues with the relatively looser extracellular matrix, larger gaps, lower interstitial fluid pressure, and less receptor expression, which was due to size effects. However, the larger active AuNPs had better accumulation and penetration effects in late tumor tissues with highly expressed target receptors integrin α _v β ₃ because of the multivalent interactions between larger active nanoparticles and integrin α _v β ₃. In the midterm, tumor accumulation of active AuNPs was equally influenced by size effects and multivalent interactions. Therefore, RGD-modified nanoparticles with sizes of 7 and 90 nm accumulated more in tumors. This study will guide a rational design of active targeting nanoparticles for enhancing the diagnosis and treatment of tumors based on their progressions.

Radiochemotherapy-induced oral mucositis (OM) is a common oral complication in patients with tumors following head and neck radiotherapy or chemotherapy. Erosion and ulcers are the main features of OM that seriously affect the quality of life of patients and even the progress of tumor treatment. To date, differences in clinical prevention and treatment plans for OM have been noted among doctors of various specialties, which has increased the uncertainty of treatment effects. On the basis of current research evidence, this expert consensus outlines risk factors, clinical manifestations, clinical grading, ancillary examinations, diagnostic basis, prevention and treatment strategies and efficacy indicators for OM. In addition to strategies such as basic oral care, anti-inflammatory and analgesic agents, anti-infective agents, pro-healing agents, and photobiotherapy recommended in previous guidelines, we also emphasize the role of traditional Chinese medicine in OM prevention and treatment. This expert consensus aims to provide references and guidance for dental physicians and oncologists in formulating strategies for OM prevention, diagnosis, and treatment, standardizing clinical practice, reducing OM occurrence, promoting healing, and improving the quality of life of patients.
Humans ; Chemoradiotherapy/adverse effects* ; Consensus ; Risk Factors ; Stomatitis/etiology*

Early postoperative hypoxemia,a common adverse event following general anesthesia,is closely associated with pathophysiological changes in patients,prolonging stays in the post-anesthesia care unit(PACU)and intensive care unit(ICU),and correlating with increased one-year postoperative mortality rate.Nevertheless,due to differences in definitions of hypoxemia,heterogeneity of study populations,and variations in postoperative monitoring methods,the reported incidence and duration of early postoperative hypoxemia in the literature vary significantly.This review systematically summarizes relevant literature to elucidate the definition and characteristic indicators of early postoperative hypoxemia,and explores its correlations with postoperative respiratory complications,cardiovascular complications,and surgical site infections.By analyzing existing research evidence,this review aims to identify early-warning indicators of postoperative hypoxemia with predictive value,thereby providing a reference for future research in this field.

With the continuous advancement of modern medical technology,wearable patch ultrasound technology is emerging as a crucial tool for real-time and dynamic monitoring of visual information within the human body.This technology seamlessly integrates the precision of ultrasound with the convenience of wearable devices,enabling continuous and dynamic monitoring of internal physiological parameters,and providing a more accurate and efficient method for medical diagnosis and health monitoring.Wearable patch ultrasound can obtain the image information of human body in real time,including the structure and functional status of the heart,blood vessels,muscles,and bones,facilitating early disease detection and diagnosis.This review summarizes the major clinical application scenarios and frontier research advances of wearable patch ultrasound and discusses the opportunities and challenges in the future.

OBJECTIVE To evaluate the efficacy of oral and facial muscle functional training in treating adult obstructive sleep apnea(OSA)and to identify clinical indicators influencing treatment outcomes.METHODS Through a prospective cohort study,patients diagnosed with OSA in the study unit were recruited to undergo a 3-month myofunctional therapy,including soft palate-related muscles,tongue muscles,buccal muscles,and labial muscles in multiple muscle groups,once a day,five times a week,with the use of offline clinic guidance,and the APP program video follow up training for effective training.Data were collected on multiple dimensions including physical signs,sleep breathing monitoring parameters,and airway measurements from imaging studies.Treatment efficacy was assessed by comparing subjective and objective sleep indicators before and after training.Patients were categorized into effective and ineffective groups based on treatment outcomes.Differences in baseline clinical indicators between these groups were analyzed using univariate and multivariate regression analyses.RESULTS The study finally included 58 people,51 males and 7 females,age(38.36±8.96)years,BMI(27.14±3.68)kg/m2,AHI of the enrolled patients was reduced from(31.27±22.28)times/h pre-training to(26.27±21.38)times/h post-training,the minimum oxygen saturation was increased from(78.43±10.07)%to(80.50±10.06)%,snoring index decreased from(62.80±75.20)times/h to(36.40±43.19)times/h,and ESS score decreased from 7.00±5.31 pre-training to 5.50±3.17.By comparing the effective and ineffective groups,it was found that there was a statistically significant difference in the tongue position and ESS scores between the two groups(both P<0.05),while no significant differences were found in gender,age,neck circumference,posterior soft palate area,uvula area,posterior tongue area,or posterior epiglottic area(all P>0.05).Univariate logistic regression analysis indicated that tongue position,AHI,and ESS scores were factors affecting the efficacy of oral and facial muscle function training.Multivariate regression analysis revealed that AHI was an independent prognostic factor for this training in OSA patients.CONCLUSION Oral and facial muscle function training can improve both subjective and objective sleep breathing indices in OSA patients.Tongue position,AHI,and ESS scores may serve as prognostic factors for OSA treatment,aiding in guiding subsequent individualized intervention therapies.

Objective:To investigate the relationship between the Palatopharyngeal Arch Staging System（PASS） and the severity of Obstructive Sleep Apnea（OSA）, as well as the patterns of airway collapse, while further assessing its clinical applicability. Methods:A total of 98 patients diagnosed with OSA at the Department of Otorhinolaryngology Head and Neck Surgery, Shenzhen University Affiliated Shenzhen Hospital, were recruited for this study. Data collected included basic demographic information, oropharyngeal laryngoscopy videos, results from awake laryngoscopy Muller tests, and indicators from sleep respiratory monitoring. The distribution of each PASS stage among patients with varying severities of OSA was compared. Additionally, both objective and subjective sleep indicators along with occurrences of airway collapse in OSA patients across different PASS stages were analyzed. Results:In total, 98 patients participated in this study. Statistically significant differences were observed in neck circumference, weight, Body Mass Index（BMI）, tongue position, and PASS stage when comparing mild-to-moderate OSA patients to those with severe OSA（P<0.05）. Furthermore, there were statistically significant variations in Apnea-Hypopnea Index（AHI）, minimum blood oxygen saturation levels, average blood oxygen saturation levels, oxygen desaturation index values, and total oxygen desaturation indices among OSA patients categorized by different PASS stages. Multiple comparisons revealed statistically significant differences in AHI as well as minimum and average blood oxygen saturation levels between patients at PASS 1 versus those at PASS 3（P<0.05）. Additionally, notable differences regarding oropharyngeal collapse rates among OSA patients across various PASS stages were identified; specifically between those at PASS stage 1 and those at PASS stage 3. Conclusion:The proportion of PASS stages for OSA varies across different severity levels. The severity of OSA and the degree of airway collapse in patients with varying PASS stages also exhibit significant differences. Patients classified as PASS 3 demonstrate a more severe form of OSA compared to those at PASS 1, with stage 3 being more susceptible to oropharyngeal collapse than its stage 1 counterpart. This assessment system is anticipated to address the current limitations in evaluating the lateral pharyngeal wall within the oropharynx.
Humans ; Sleep Apnea, Obstructive/pathology* ; Male ; Severity of Illness Index ; Female ; Middle Aged ; Polysomnography ; Adult ; Pharynx/physiopathology* ; Aged

Objective: To explore the learning curve of transurethral 450 nm blue light vaporization of the prostate (TUBVP) in a district hospital，in order to provide reference for clinicians who plan to perform TUBVP. Methods: The clinical data of 56 patients with benign prostatic hyperplasia (BPH) who received TUBVP performed by the same group of surgeons in Chang'an District Hospital during Jun. and Dec. 2023 were retrospectively analyzed. Cumulative sum (CUSUM) was used to fit the learning curve of ratio of volume to operating time (RVOT) of prostate volume /450 nm blue light. The learning curve was divided into different stages according to the inflection points，and the clinical data of patients operated at different stages were analyzed and compared. Results: The learning curve of TUBVP was 21 cases，including 1-21 cases in the learning stage，22-38 cases in the improvement stage and 39-56 cases in the maturity stage. With the increase of cases，the postoperative bladder irrigation time reduced \[40.00 (26.00，44.50) h vs. 23.00(20.50，34.00) h vs. 23.50(14.75，40.75) h\]，with statistical difference (P<0.05). The surgical efficiency increased \[(0.51±0.14) vs. (0.55±0.17) vs. (0.63±0.23)\]，while the reduction of hemoglobin \[(6.43±7.35) g/L vs. (5.65±10.91) g/L vs. (2.61±7.36) g/L\]，catheter indwelling time \[70.0 (66.0，106.0) h vs. 71.0 (66.0，89.0) h vs. 66.0 (58.5，78.5) h\]，and incidence of complications (9.5% vs. 5.9% vs. 0) in the three stages showed a gradually decreasing trend，but with no statistical significance (P>0.05). Conclusion: The learning curve of TUBVP is 21 cases. For clinicians in district hospitals，TUBVP is a worthy choice.