1.Current Status and Optimization Strategies for Setting Objective Performance Criteria in Clinical Trials of Traditional Chinese Medicine
Jiaqi LAI ; Qian HUANG ; Xueyin CHEN ; Shaonan LIU ; Lihong YANG ; MIMAZHUOGA ; DAWA ; Zhijian LI ; Tuerxun WUFUER ; Xinfeng GUO
Journal of Traditional Chinese Medicine 2026;67(13):1461-1464
Current formulation of objective performance criteria (OPC) in traditional Chinese medicine (TCM) faces methodological challenges, including poor reporting quality, insufficient standardization of methods, limited comparability of study populations, and inadequate consideration of the genetic and environment particularities of ethnic minority populations. In response to these issues, this paper proposes optimization strategies for setting OPC in TCM, with particular attention to ethnic minority medicine. These include improving methodological techniques and statistical descriptions, ensuring transparency in meta-analyses and data sources; standardizing the estimation of point estimates and confidence intervals, and incorporating multidisciplinary expert consensus for value determination; introducing local real-world data from the same period, especially cohort study evidence, to compensate for the lack of high-quality randomized controlled trial data. Through process transparency and dynamic updating mechanisms, the credibility of OPC method can be enhanced, thereby providing methodological support for strengthening evidence-based research capacity in this field.
2.Injection of platelet-rich plasma at the fracture site combined with microfracture surgery for the treatment of delayed fracture healing
Junbo TU ; Xiaowu HUANG ; Xingwang LI ; Xiaoqing LI
Chinese Journal of Blood Transfusion 2025;38(2):194-200
[Objective] To report a new technique that combines microfracture surgery under local anesthesia with injection of platelet-rich plasma (PRP) at the fracture site, so as to improve fracture healing rates. [Methods] Data from patients who visited our hospital from March 2020 to June 2023 and underwent the treatment for delayed union of limb fractures were retrospectively analyzed. Under local infiltrative anesthesia, with the assistance of a C-arm X-ray machine or ultrasound, percutaneous loosening was done at the fracture site and the medullary cavity, followed by cortical drilling around the fracture. The previously prepared PRP was then injected locally at the fracture site. Patients were followed up and their postoperative recovery was recorded. [Results] All patients were followed up, and the fracture healing rate was 94.12% (16/17), with an average healing duration of (5.88±2.50) months. None of the patients experienced any neural or vascular injuries, nor adverse events such as wound infections or osteomyelitis. Before the operation and at the last follow-up, the patients' pain visual analogue scores were (5.12±1.11) vs (0.71±1.21) respectively. The postoperative VAS scores showed a significant decrease compared to preoperative values (P<0.05). The excellent and good rate for limb function on the affected side was 88.24% (14/17) at the last follow-up, which was a significant increase from 0.00% before surgery (P<0.05). [Conclusion] The injection of PRP at the fracture site combined with microfracture surgery at the fracture site is minimally invasive, simple to perform, and well-accepted by patients. It has demonstrated some clinical efficacy in treating delayed fracture healing.
3.Effect of transient receptor potential vanilloid type 1 gene polymorphism on postoperative analgesic efficacy of alfentanil in patients undergoing radical mastectomy
Liying BAI ; Xinfeng LI ; Lihua YANG
Chinese Journal of Anesthesiology 2025;45(11):1461-1464
Objective:To evaluate the effect of transient receptor potential vanilloid type 1 (TRPV1) gene polymorphism on the postoperative analgesic efficacy of alfentanil in patients undergoing radical mastectomy.Methods:In this prospective study, adult female patients diagnosed with breast cancer who underwent surgical treatment at the First Affiliated Hospital of Zhengzhou University were selected as case group ( n=162), while age-matched healthy adult females were selected as control group ( n=80). All subjects had a body mass index of 18-30 kg/m 2. The genotype and allele frequencies of TRPV1 rs8065080 and rs222747 were compared between the two groups, and the consumption of alfentanil and requirement for rescue analgesia within 48 h after surgery were recorded in breast cancer patients with different TRPV1 rs222747 genotypes. Results:Three genotypes of CC, GC, and GG were detected at rs222747 locus of TRPV1 gene, and there was no significant difference in the genotype distribution between the two groups ( P>0.05). Three genotypes of CC, TC and TT were detected at rs8065080 locus of TRPV1 gene, and there was significant difference in the genotype distribution between the two groups ( P<0.05). There was no significant difference in the basic data of patients with different genotypes of TRPV1 gene rs222747 locus ( P>0.05). There were significant differences in the consumption of alfentanil during 0-24 h after surgery and during 24-48 h after surgery and rate of rescue analgesia within 48 h after surgery among patients with different genotypes of TRPV1 gene rs222747 locus ( P<0.05). Conclusions:The polymorphism at the TRPV1 gene rs222747 locus can influence the postoperative analgesic efficacy of alfentanil in breast cancer patients undergoing radical mastectomy, suggesting that genetic factors may be one of the reasons for the inter-individual variability in alfentanil efficacy.
4.Endovascular Treatment for Acute Posterior Circulation Tandem Lesions: Insights From the BASILAR and PERSIST Registries
Wei LI ; Mohamed F. DOHEIM ; Zhongming QIU ; Tan WANG ; Zhibin CHEN ; Wenjie ZI ; Qingwu YANG ; Haitao GUAN ; Hongyu QIAO ; Wenhua LIU ; Wei HU ; Xinfeng LIU ; Jinbo HUANG ; Zhongkui HAN ; Zhonglun CHEN ; Zhenqiang ZHAO ; Wen SUN ; Raul G. NOGUEIRA
Journal of Stroke 2025;27(1):75-84
Background:
and Purpose Limited evidence exists on the effectiveness of endovascular treatment (EVT) for acute posterior circulation tandem lesion (PCTL). This study aimed to explore the role of extracranial vertebral artery (VA) stenting in patients with PCTL stroke undergoing EVT.
Methods:
Individual patient data were pooled from the BASILAR (EVT for Acute Basilar Artery Occlusion Study) and PERSIST (Posterior Circulation Ischemic Stroke) registries. Patients with PCTLs who underwent EVT were included in the present cohort and divided into the stenting and nonstenting groups based on the placement of extracranial VA stents. The primary efficacy outcome was the modified Rankin Scale (mRS) scores at 90 days and 1 year. Safety outcomes included 24-hour symptomatic intracranial hemorrhage (sICH) and all-cause mortality at 90 days and 1 year post-surgery.
Results:
A combined dataset of 1,320 patients with posterior circulation artery occlusion, including 263 (19.9%) with tandem lesions, of whom 217 (median age, 65 years; 82.9% male) met the inclusion criteria for the analysis. The stenting group had 84 (38.7%) patients, while the non-stenting group had 133 (61.3%). After adjustment for the potential confounders, extracranial VA stenting was associated with favorable shifts in mRS scores at both 90 days (adjusted common odds ratio [OR], 2.30; 95% confidence interval [CI], 1.23–4.28; P<0.01) and 1 year (adjusted OR [aOR], 2.04; 95% CI [1.05–3.97]; P=0.04), along with lower rate of mortality at both 90 days (aOR, 0.45; 95% CI [0.21–0.93]; P=0.01) and 1 year (aOR, 0.36; 95% CI [0.16–0.79]; P=0.01), with no significant difference in sICH incidence (aOR, 0.35; 95% CI [0.06–1.98]; P=0.24).
Conclusion
Extracranial VA stenting during EVT may improve functional outcomes and reduce mortality in patients with PCTL strokes.
5.Application of three-dimensional U-shaped residual coordinated attention network in early detection of small intestinal polyps
Zijun GAO ; Xinfeng ZHANG ; Xiao CHEN ; Xiangsheng LI ; Xiaomin LIU
Chinese Journal of Preventive Medicine 2025;59(10):1756-1762
Objective:To establish a three-dimensional U-shaped residual coordinated attention network (URCA-Net) based on enhanced CT images for small bowel polyp detection and analyze its application effectiveness in intelligent detection of small bowel polyps.Methods:Abdominal CT data of patients with small bowel polyps were collected from the Air Force Medical Center between June 2019 and July 2023. All patients underwent bowel preparation followed by thin-slice spiral CT scanning to obtain enhanced CT arterial phase images. The data were randomly divided into training, validation and test sets in an 8∶1∶1 ratio. The URCA-Net deep learning model was used for small bowel polyp segmentation. The training set was used for model parameter training, the validation set for hyperparameter adjustment and monitoring of model generalization performance and the test set for final unbiased evaluation of the model. An early intelligent detection model for small bowel polyps was constructed, and its performance was evaluated. Evaluation metrics included pixel-level metrics for the segmentation task [Dice Similarity Coefficient (DSC)], as well as sensitivity and precision for polyp detection. A two-stage segmentation strategy was adopted: the first stage segmented the small bowel region to remove external interference, and the second stage performed polyp segmentation within the small bowel region.Results:A total of 78 subjects were included in the study, with an average age of (54±7) years. A total of 23 400 scan images were extracted, including 136 hyperplastic polyps, 298 hamartomatous polyps, 14 adenomatous polyps, and 4 cancerous polyps. On the test set, the average DSC for the first stage (small bowel segmentation) and the second stage (polyp segmentation) was 0.790 and 0.314, respectively. In the second stage task (polyp segmentation based on small bowel region), the polyp segmentation DSC increased to 0.701, with a precision of 0.836 (95% CI: 0.700-0.972) and a sensitivity of 0.759 (95% CI: 0.631-0.888) for polyp detection. Conclusion:The URCA-Net deep learning technique demonstrates good auxiliary diagnostic effectiveness in small bowel polyp detection and can provide a reference for screening and detection of small bowel polyps. The model is capable of generating high-quality segmentation results, which could facilitate evaluating polyp lesion morphology and provide support for downstream tasks such as preoperative navigation and risk prediction.
6.Construction of Core Outcome Set for Clinical Research on Uyghur Medicine in Treating Psoriasis
Ruifang YU ; Abuduwaiti JULAITI ; Shaonan LIU ; Genghang CHEN ; Qian HUANG ; Wufuer ZAITUGULI ; Upur TURSON ; Zhijian LI ; Xinfeng GUO
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(6):1334-1339
Objective To construct the core outcome set(COS)for clinical research on Uyghur medicine in treating psoriasis by using internationally-recognized research methods,thus to aid the researchers in choosing the standardized outcomes and to enhance the quality of evidence from research findings.Methods A systematic retrieval of Chinese and English databases was conducted to collect outcomes from clinical studies,systematic reviews,and registered protocols of Uyghur medicine for treating psoriasis.An outcome pool was constructed based on the results of literature review.The outcomes were supplemented after qualitative surveys of patients and physicians,and then an initial list of outcomes was formed.Two rounds of Delphi surveys on the initial list were conducted for obtaining Likert scale ratings from different stakeholder groups to evaluate the importance of outcomes.After that,a consensus meeting was held to finalize the COS for clinical research on Uyghur medicine in treating psoriasis.Results The COS for clinical research on Uyghur medicine in treating psoriasis comprises six domains,totaling 14 outcomes.The 14 outcomes were psoriasis symptoms(psoriasis area and area severity index),skin manifestations(erythema,scaling,infiltration,etc.),investigator global assessment,patient global assessment,treatment satisfaction,health-related quality of life,recurrence rate,adverse events,drug adverse reactions,blood routine,urine routine,liver and kidney function,Uyghur medicine symptom assessment,and fluid changes.Conclusion The COS for clinical research on Uyghur medicine in treating psoriasis has been constructed,and will provide a reference for the selection of efficacy-evaluation outcomes and for the reporting of outcomes in related studies.
7.Development of Core Outcome Set for Clinical Research on Vitiligo Treated with Uyghur Medicine
Qian HUANG ; Xinfeng GUO ; Lihong YANG ; Genghang CHEN ; Wufuer TUERSON ; Yiming Maimaiti TURSUNTAI ; Abuduwayiti JULAITI ; Zhijian LI ; Shaonan LIU
Journal of Guangzhou University of Traditional Chinese Medicine 2025;42(10):2595-2602
Objective To develop a core outcome set(COS)for treatment of progressive vitiligo in Uyghur medicine,and to standardize the selection and reporting of outcome measures in relevant studies.Methods Based on the existing core outcome domain set of randomized controlled trials for vitiligo,additional outcome indicators reflecting the advantages and characteristics of Uyghur medical treatment were developed.Specific indicators for Uyghur medical treatment of progressive vitiligo were collected through literature review and semi-structured questionnaire surveys,and then a list of indicators were formed.The Delphi survey and consensus meetings were used to select core indicators.Results A total of 54 studies were included,and 86 questionnaires were collected.Through literature review and questionnaire surveys,a list of 28 indicators were obtained.After two rounds of Delphi survey and one consensus meeting,12 outcome indicators in 7 domains were finally determined,including vitiligo lesion area,repigmentation,disease control time,maintenance of repigmentation,recurrence rate,immune indicators,psychological health,patients' quality of life,adverse events,adverse reaction incidence,liver and kidney function monitoring,and Uyghur medicine syndrome differentiation of mucus.Additionally,some measurement tools for certain indicators were recommended.Conclusion The development of the COS for vitiligo treatment in Uyghur medicine helps to comprehensively evaluate the efficacy of Uyghur medicine,and will provide a model for establishing efficacy evaluation methods that conform to the characteristics of ethnic minority medicine.
8.Effect of transient receptor potential vanilloid type 1 gene polymorphism on postoperative analgesic efficacy of alfentanil in patients undergoing radical mastectomy
Liying BAI ; Xinfeng LI ; Lihua YANG
Chinese Journal of Anesthesiology 2025;45(11):1461-1464
Objective:To evaluate the effect of transient receptor potential vanilloid type 1 (TRPV1) gene polymorphism on the postoperative analgesic efficacy of alfentanil in patients undergoing radical mastectomy.Methods:In this prospective study, adult female patients diagnosed with breast cancer who underwent surgical treatment at the First Affiliated Hospital of Zhengzhou University were selected as case group ( n=162), while age-matched healthy adult females were selected as control group ( n=80). All subjects had a body mass index of 18-30 kg/m 2. The genotype and allele frequencies of TRPV1 rs8065080 and rs222747 were compared between the two groups, and the consumption of alfentanil and requirement for rescue analgesia within 48 h after surgery were recorded in breast cancer patients with different TRPV1 rs222747 genotypes. Results:Three genotypes of CC, GC, and GG were detected at rs222747 locus of TRPV1 gene, and there was no significant difference in the genotype distribution between the two groups ( P>0.05). Three genotypes of CC, TC and TT were detected at rs8065080 locus of TRPV1 gene, and there was significant difference in the genotype distribution between the two groups ( P<0.05). There was no significant difference in the basic data of patients with different genotypes of TRPV1 gene rs222747 locus ( P>0.05). There were significant differences in the consumption of alfentanil during 0-24 h after surgery and during 24-48 h after surgery and rate of rescue analgesia within 48 h after surgery among patients with different genotypes of TRPV1 gene rs222747 locus ( P<0.05). Conclusions:The polymorphism at the TRPV1 gene rs222747 locus can influence the postoperative analgesic efficacy of alfentanil in breast cancer patients undergoing radical mastectomy, suggesting that genetic factors may be one of the reasons for the inter-individual variability in alfentanil efficacy.
9.Treatment of extensive wound of Degree IV burns in limbs with free anterolateral thigh perforator flap: a report of 9 cases
Pancheng SHI ; Shuping ZHOU ; Shimin LI ; Liwu ZHENG ; Junjie CHEN ; Xinfeng XING ; Sen LI ; Huanpeng WANG ; Chaonan CHANG ; Dong ZHANG
Chinese Journal of Microsurgery 2025;48(5):511-516
Objective:To explore the clinical efficacy of anterolateral thigh perforator flap (ALTPF) in treatment of extensive wound of Degree IV burns in limbs.Methods:A retrospective analysis was conducted on 9 patients who had extensive wound of Degree IV burns in limbs caused by stove burns admitted to Department of Burns and Plastic Surgery, the 988th Hospital of the Joint Logistics Support Force of the Chinese PLA between January 2017 and January 2024. Among the patients, there were 8 males and 1 female, aged between 36 and 63 years. Three patients had the wound from anterior leg to dorsal foot, 3 from leg down to ankle, 1 from forearm to hand and 2 from arm to forearm. Area of burns ranged from 20 cm × 15 cm to 30 cm × 25 cm, and all patients were treated by free ALTPF. According to whether the main artery at the recipient site was feasible for direct anastomosis with the vessels carried in flap, 4 patients were treated by bilateral parallel ALTPFs, and 5 were treated by unilateral ultra-long internally supercharged ALTPF. A total of 13 ALTPFs were harvested, with individual flap size at 20 cm × 8 cm to 46 cm × 12 cm. Donor sites were directly sutured. Time for flap harvesting, flap survival and wound healing time were records. Scheduled postoperative follow-up was conducted at outpatient clinic and via telephone interviews to evaluate functional recovery. Follow-up assessments included evaluation of flap condition, two-point discrimination (TPD), recovery of joint function at recipient sites, flap appearance and donor site recovery.Results:The time for flap harvest was 1.0 to 4.5 hours. All 13 ALTPFs successfully survived. The time from surgery to healing of recipient sites was 18 to 72 days, and all donor sites healed. Over the postoperative follow-up that lasted for 6 to 34 months, the recipient sites had found with good cosmetic outcomes, without osteomyelitis or deep tissue infection. Four ALTPFs in 2 patients were found swelling, which were revised at 6 months after surgery. Four ALTPFs in other 2 patients had pigment deposition at edges. One ALTPF was scalded, which healed after dressing changes but left with patchy scars. The remaining ALTPFs were soft, elastic, free from pain and well-perfused, with regained protective sensation at S 3. However, all of the ALTPFs failed to detect TPD. Six patients with lower limb injuries were evaluated using the American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scoring system: 2 patients were rated as excellent and 4 were rated as good. Three patients with upper limb injuries were evaluated using Evaluation Trial Standards of Upper Limb Partial Functional of Hand Surgery of Chinese Medical Association: 1 patient was rated as excellent and 2 were rated as good. Only linear scars left at the 13 donor sites, with normal blood supply to the distal limbs, and without restrictions in range of motion of knee joints nor muscle strength of quadriceps. Conclusion:The ALTPF offers advantages such as anatomical consistency, reliable blood supply and flexible combination in treatment of extensive wound of Degree Ⅳ burns in limbs. It is an ideal surgical procedure for treatment of large soft tissue defects of extremities.
10.Application of three-dimensional U-shaped residual coordinated attention network in early detection of small intestinal polyps
Zijun GAO ; Xinfeng ZHANG ; Xiao CHEN ; Xiangsheng LI ; Xiaomin LIU
Chinese Journal of Preventive Medicine 2025;59(10):1756-1762
Objective:To establish a three-dimensional U-shaped residual coordinated attention network (URCA-Net) based on enhanced CT images for small bowel polyp detection and analyze its application effectiveness in intelligent detection of small bowel polyps.Methods:Abdominal CT data of patients with small bowel polyps were collected from the Air Force Medical Center between June 2019 and July 2023. All patients underwent bowel preparation followed by thin-slice spiral CT scanning to obtain enhanced CT arterial phase images. The data were randomly divided into training, validation and test sets in an 8∶1∶1 ratio. The URCA-Net deep learning model was used for small bowel polyp segmentation. The training set was used for model parameter training, the validation set for hyperparameter adjustment and monitoring of model generalization performance and the test set for final unbiased evaluation of the model. An early intelligent detection model for small bowel polyps was constructed, and its performance was evaluated. Evaluation metrics included pixel-level metrics for the segmentation task [Dice Similarity Coefficient (DSC)], as well as sensitivity and precision for polyp detection. A two-stage segmentation strategy was adopted: the first stage segmented the small bowel region to remove external interference, and the second stage performed polyp segmentation within the small bowel region.Results:A total of 78 subjects were included in the study, with an average age of (54±7) years. A total of 23 400 scan images were extracted, including 136 hyperplastic polyps, 298 hamartomatous polyps, 14 adenomatous polyps, and 4 cancerous polyps. On the test set, the average DSC for the first stage (small bowel segmentation) and the second stage (polyp segmentation) was 0.790 and 0.314, respectively. In the second stage task (polyp segmentation based on small bowel region), the polyp segmentation DSC increased to 0.701, with a precision of 0.836 (95% CI: 0.700-0.972) and a sensitivity of 0.759 (95% CI: 0.631-0.888) for polyp detection. Conclusion:The URCA-Net deep learning technique demonstrates good auxiliary diagnostic effectiveness in small bowel polyp detection and can provide a reference for screening and detection of small bowel polyps. The model is capable of generating high-quality segmentation results, which could facilitate evaluating polyp lesion morphology and provide support for downstream tasks such as preoperative navigation and risk prediction.

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