1.Safety Evaluation of Tianzhi Granules in Treating Mild-to-moderate Vascular Dementia
Wenfang LIU ; Yang LIN ; Xianfeng LIU ; Fan BAI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(2):142-147
ObjectiveTo systematically evaluate the safety of Tianzhi granules used in the treatment of mild-to-moderate vascular dementia. MethodA randomized, double-blind, double-simulated, positive drug/placebo parallel controlled multi-center phase Ⅳ clinical trial and an open multi-center phase Ⅳ clinical trial of Tianzhi granules in the treatment of mild-to-moderate vascular dementia were conducted. Safety data of 1 492 patients were included and analyzed according to inclusion and exclusion criteria. The main evaluation measures were the incidence rate of adverse events/adverse reactions, laboratory indicators, vital signs, and electrocardiogram (ECG) results. ResultA total of six adverse events possibly related to the test drug occurred in 520 patients of the double-blind trial, and the symptoms were all mild and recovered. The incidence of adverse events was not statistically different among Tianzhi granules, donepezil, and placebo groups. Nine adverse events possibly related to the test drug were observed in 972 patients of the open trial, and the symptoms were mild and recovered. Laboratory tests (blood routine, urine routine, liver function, kidney function, and coagulation) and vital signs were compared before treatment (baseline) and after treatment of 12 and 24 weeks, respectively. There was no statistical significance in the main indicators before and after treatment. In the double-blinded trial, there was no significant difference in safety indicators between different groups before and after treatment. The most frequent adverse reaction was gastrointestinal discomfort, with an incidence rate of 6.64‰. ConclusionAdverse reactions occasionally occur in patients using Tianzhi granules, and it is safe to use Tianzhi granules to treat mild-to-moderate vascular dementia clinically.
2.A randomized controlled trial on the effect of early eschar dermabrasion combined with antimicrobial soft silicone foam dressing in the treatment of deep partial-thickness burn wounds in children
Yang SHEN ; Jun HE ; Junzhang LIU ; Xianfeng ZHANG ; Jie TAN ; Wenjun TANG ; Hao YANG ; Xu CHEN ; Xingwang LUO
Chinese Journal of Burns 2024;40(4):342-347
Objective:To explore the effect of early eschar dermabrasion combined with antimicrobial soft silicone foam dressing (hereinafter referred to as foam dressing) in treating the deep partial-thickness burn wounds in children.Methods:This study was a randomized controlled trial. From June 2021 to December 2022, 78 pediatric patients with deep partial-thickness burns who met the inclusion criteria were admitted to the Department of Burns in Guiyang Steel Plant Employees Hospital. According to the random number table, the pediatric patients were divided into two groups, with 38 cases left in combined treatment group (with 20 males and 18 females, aged 26.00 (16.75, 39.75) months) and 39 cases in foam dressing group (with 21 males and 18 females, aged 19.00 (14.00, 31.00) months) after the exclusion of one dropped-out child in follow-up. The pediatric patients in combined treatment group underwent eschar dermabrasion of the wound within 48 hours after injury, the wound was covered with foam dressing after operation, and the dressing was replaced once every 7 days; for the pediatric patients in foam dressing group, the wound was sterilized within 48 hours after injury and covered with foam dressing, and the dressing was replaced once every 2 to 3 days. After the wound healing, the children in both groups were routinely applied with silicone gel twice a day for 3 weeks before started wearing elastic sleeves for more than 18 hours a day, and continuously for over than 6 months. The degree of pain during dressing change was evaluated using the children's pain behavior inventory FLACC. The adverse reactions during the treatment period, number of dressing changes, and wound healing time were observed and recorded. Six months after wound healing, the Vancouver scar scale (VSS) was used to evaluate the condition of the wound scar.Results:When changing dressing, the FLACC score for pain of pediatric patients in combined treatment group was 3.5 (2.0, 5.0), which was significantly lower than 6.0 (5.0, 8.0) in foam dressing group ( Z=-5.40, P<0.05). During the treatment period, no adverse reactions such as wound edema, fluid accumulation, or peripheral skin rash allergies occurred in any pediatric patient in both groups. The number of dressing changes of pediatric patients in combined treatment group was 3 (3, 4) times, which was significantly less than 8 (7, 10) times in foam dressing group ( Z=-7.58, P<0.05). The wound healing time of pediatric patients in combined treatment group was (19±5) days, which was significantly shorter than (25±6) days in foam dressing group ( t=-4.48, P<0.05). Six months after wound healing, the VSS score for scar of pediatric patients in combined treatment group was 5 (2, 8), which was significantly lower than 7 (5, 10) in foam dressing group ( Z=-3.05, P<0.05). Conclusions:Compared with using foam dressings alone, early eschar dermabrasion combined with foam dressings can reduce the number of dressing changes, alleviate the pain during dressing changes, and shorten the wound healing time in treating children with deep partial-thickness burns, and effectively alleviate scar hyperplasia by combining with anti-scar treatment post burns.
3.Application value of diffusion-weighted imaging in dynamic evaluation of tumor necrosis rate of osteosarcoma after neoadjuvant chemotherapy
Sheng DING ; Jie HU ; Tingting CHEN ; Le CHENG ; Xianfeng YANG
Chinese Journal of Postgraduates of Medicine 2024;47(10):888-892
Objective:To explore the value of diffusion-weighted imaging (DWI) and apparent diffusion coefficient (ADC) of MRI in evaluating the response of osteosarcoma to neoadjuvant chemotherapy (NAC) in different cycles, and to analyze the diagnostic efficacy of each ADC and its difference.Methods:A total of 31 patients with pathologically confirmed osteosarcoma in the Nanjing Drum Tower Hospital, Nanjing University Medical School from January 2019 to December 2022 were retrospectively analyzed. All patients received NAC before surgery, and routine MRI and DWI were performed before and during chemotherapy. The ADC values were measured before, during and after chemotherapy (ADCpre, ADCmid, ADCpost), and the difference were calculated. According to whether the tumor necrosis rate was more than 90%, the patients were divided into good response group and poor response group. The differences of ADC values in each stage within the two groups were compared, and the differences of related parameters between the two groups were compared, and the diagnostic efficacy of each parameter in predicting tumor necrosis rate was analyzed by receiver operating characteristic(ROC) curve.Results:The ADC values of the two groups at different stages of NAC were compared. Except for the intermediate ADCmid and ADCpost in the poor response group ( P = 0.226), all the ADC values were statistical differences ( P<0.05). There were significant differences in ADCmid and ADCpost between the good response group and the poor response group (1.52 ± 0.39 vs. 1.39 ± 0.25, 1.65 ± 0.16 vs. 1.46 ± 0.44, P<0.05), but there was no significant difference in ADCpre between the two groups ( P>0.05). ROC curve showed that the area under the curve of ADCmid, ADCpost and △ADC3 (ADCpost -ADCpre) were 0.897, 0.810 and 0.714, respectively, and ADCmid had the best diagnostic efficiency. Conclusions:ADCmid, ADCpost and △ADC3 can be used to evaluate the efficacy of NAC in osteosarcoma. The ADCmid can provide some reference for the adjustment and improvement of clinical treatment.
4.Isolation and identification of feline calicivirus and preparation of its inactivated vaccine
Yanmei YANG ; Junnan KE ; Yu QI ; Honglin REN ; Guojun ZHANG ; Zengshan LIU ; Liheng ZHANG ; Zhaozhe WANG ; Xianfeng LIU
Chinese Journal of Veterinary Science 2024;44(9):1892-1897
A virus was successfully isolated from a sick cat exhibiting clinical signs such as oral mu-cosal ulceration,nasal mucosal redness,and increased nasal secretions utilizing F81 cells.Through a comprehensive analysis as such PCR amplication,sequencing,morphology,serology,and animal re-gression tests,the virus was identified as a feline calicivirus and named FCV-BJ,an inactivated vac-cine was developed from this isolated strain its safety and efficacy were assessed.The results re-vealed that the isolated FCV-BJ strain exhibited characteristic serological and morphological fea-tures consistent with caliciviruses.Furthermore,inoculation of cats with the FCV-BJ demonstrated the strain is highly virulent and the cats manifested the clinical signs of feline calicivirus infection.For the vaccination trial,domestic cats were immunized with inactivated fifth-generation virus cell culture at varying dilutions,followed by a booster immunization after 21 days.Fourteen days after the challenge with the virus,cats immunized with 107.0 TCID50/mL or higher remained largely healthy,while all cats in the control group developed clinical signs of FCV.These findings suggest that the inactivated vaccine derived from the FCV-BJ isolate exhibits strong immunogenicity and protective efficacy at a minimum immunization dose of 107.0 TCID50/mL.This strain holds promise as a candidate for vaccine production,providing a valuable reference and foundation for future re-search and development of feline calicivirus vaccines.
5.Ultra-fast scanning scheme based on deep learning reconstruction for cervical MR examination
Xianfeng RAO ; Shuwen YANG ; Jing CHEN ; Zhengwen KANG ; Jianwei CHEN ; Zetao WU ; Tong WANG ; Bo WANG ; Qiusheng ZHANG
Chinese Journal of Medical Imaging Technology 2024;40(6):843-847
Objective To explore the feasibility and diagnostic value of ultra-fast scanning scheme based on deep learning-based reconstruction(DLR)for cervical MR examination.Methods Thirty-six subjects were prospectively enrolled and underwent both conventional scheme(scan time:6 min 14 s)and ultra-fast scheme(2 min)cervical spine MR scanning to acquire encompassing sagittal T1WI,sagittal adipose suppression T2WI and axial T2WI.The ultra-fast MRI were reconstructed using DLR method.The subjective and objective evaluations on imaging qualities of different MRIs were compared,along with the inter-observer agreement for diagnosing intervertebral disc degeneration and herniation.Results Compared with conventional MRI,artifacts in ultra-fast DLR images significantly reduced(P<0.05).The subjective evaluation results of MRI had good agreement(all Kappa≥0.60).Compared with conventional MRI,the sagittal T1WI,T2WI and axial T2WI obtained with ultra-fast DLR showed significantly improved signal-to-noise ratio(SNR)of the spinal cord,cerebrospinal fluid(CSF)and vertebral body,as well as the spinal cord/CSF contrast(all P<0.001).The Kappa value of 2 physicians for diagnosing intervertebral disc degeneration based on ultra-fast DLR and conventional scheme images was 0.94 and 1.00,respectively,of intervertebral disc herniation was 0.96 and 0.98,respectively.Conclusion Compared with conventional scanning scheme,using ultra-fast DLR scheme in cervical MR examination could shorten scanning time while achieve similar image quality and diagnostic accuracy.
6.Imaging analysis and clinical follow-up of Ewing sarcoma of bone
Sheng DING ; Tingting CHEN ; Dongmei WANG ; Ying CHANG ; Xianfeng YANG
Chinese Journal of Postgraduates of Medicine 2023;46(4):293-296
Objective:To analyze and summarize the imaging characteristics and clinical follow-up results of Ewing sarcoma of bone.Methods:The imaging data of 23 patients with Ewing sarcoma confirmed by pathology who treatment in Drum Tower Hospital Affiliated to Nanjing University School of Medicine from May 2010 to October 2021 were retrospectively analyzed, and clinical follow-up was performed.Results:Of the 23 patients with Ewing sarcoma of the bone in this group, a total of 18 patients had follow-up results and 5 cases were lost to follow-up. Of the 18 cases, 6 cases died and 12 cases survived. The main cause of death was lung metastasis. There were 27 lesions in total, femoral diaphysis was the most common site of the disease; bone structure destruction and soft tissue mass shadows could be seen in the images of each lesion. Periosteal reaction could be seen in most of the lesions (92.59%, 25/27). There were certain differences in signs of bone destruction and periosteal reaction between different bone types.Conclusions:The imaging of Ewing sarcoma of bone mainly manifests various types of bone destruction, soft tissue masses and periosteal reactions. Ewing sarcoma of bone is mainly bone marrow metastasis and lung metastasis, and lung metastasis is the main cause of death.
7.Characteristics and postoperative recurrence factors of aneurysmal bone cyst in children′s limbs
Qizhe HU ; Xianfeng LI ; Tianjiu ZHANG ; Xiaohong YANG ; Yanpeng XU ; Xin LYU
Chinese Journal of Applied Clinical Pediatrics 2022;37(13):1006-1010
Objective:To analyze the characteristics of aneurysmal bone cysts (ABC) and related factors of postoperative recurrence, so as to improve the clinical diagnosis and treatment level of ABC in children.Methods:The clinical data of children pathologically diagnosed as ABC after surgery in the Affiliated Hospital of Zunyi Medical University from January 2010 to December 2018 were retrospectively analyzed.Clinical characteristics of the patients, including age, gender, lesion sites, and main clinical manifestations (pain, swelling, local tenderness, joint dysfunction and pathological fracture) were analyzed and summarized.Before operation, imaging Enneking staging was carried out, cyst volume was estimated, and the distance from cysts to the epiphyseal plate was measured.During surgery, patients received lesion curettage, local cautery and bone grafting, and the pathological fractures were treated with auxiliary internal fixation.Results were determined by Neer imaging grading after surgery, and grades Ⅰ and Ⅱ were postoperative recurrence.Possible recurrence factors were analyzed statistically by Fisher′ s exact test. Results:A total of 29 cases meeting the criteria were included, including 19 males and 10 females.The age ranged from 3.6 to 14.0 years old, averaging 9.2 years old; 12 patients were smaller than 10 years old and 17 patients were older than 10 years old.The cysts of 9 cases were located in proximal femur (31.0%), 5 cases in proximal humerus (17.2%), and 4 cases in proximal fibula (13.8%); The other 11 cases (37.9%) occurred in the middle and distal end; 26 cases (89.7%) had local tenderness, 25 cases (86.2%) showed varying degrees of pain, 18 cases (62.1%) presented local swelling, 15 cases (51.7%) were accompanied by joint dysfunction, and 12 cases (41.4%) were combined with pathological fractures.According to Enneking staging results, 18 cases (62.1%) were at rest stage, 7 cases (24.1%) at active stage, and 4 cases (13.8%) at invasive stage.Cyst volume was estimated to be 3.3-172.0 cm 3, with a median of about 50.8 cm 3.The distance from cysts to the epiphyseal plate was 0-85.0 mm, with a median of 20.8 mm.All children were followed up for 2.2-10.1 years (averaging 3.8 years). There were 6 cases (20.7%) of grades Ⅰ and Ⅱ according to Neer grading standard, and they suffered from recurrence about 2.5-20.3 months after surgery (averaging 12.5 months). The recurrence rate was higher in patients with cyst volume >50.8 cm 3 (42.9%, 6/14 cases) as well as in patients at active stage and invasive stage (45.5%, 5/11 cases) ( P<0.05). There was no statistical difference between the recurrence rate of ABC in different gender, age, the distance from cysts to the epiphyseal plate and pathological fractures. Conclusions:ABC is prone to occur in the proximal metaphysis of the long bones of children′s extremities.Main manifestations are pain, swelling, local tenderness and joint dysfunction, and ABC is frequently accompanied by pathological fractures.A higher postoperative recurrence rate is related to a larger cyst size and the active and invasion phases of the cyst, but gender, age, the distance from the cyst to the epiphyseal plate and pathological fractures are not significantly related to the postoperative recurrence rate.
8.Psychological condition and personality characteristics of patients with erectile dysfunction in various age groups
Songzhan GAO ; Xianfeng YANG ; Yangqing LIU ; Hao FENG
Chinese Journal of Urology 2021;42(1):48-53
Objective:To investigate the differences of psychological condition of erectile dysfunction (ED) patients in different age groups.Methods:The emotion, personality and interpersonal relationship outpatients with ED were evaluated by the method of Symptom Checklist-90 (SCL-90), State Trait Anxiety Inventory (STAI) and Eysenck Personality Questionnaire (EPQ). A retrospective analysis was conducted and a total of 401 ED patients (aged 20-60) were divided into 4 groups [20-29(n=158), 30-39(n=182), 40-49(n=38), 50-60 (n=23)years old] from July 2018 to July 2019. The erectile function of the patients was evaluated by the international erectile function scale (IIEF-5). The symptoms of hostility, anxiety, psychotic, horrible, paranoid, obsession, somatization, interpersonal relationship and depression were evaluated by SCL-90. Furthermore, STAI was used to distinguish whether the patients had state or trait anxiety. Then EPQ was used to analyze the personality types of patients. The differences of SCL-90, STAI and EPQ between the patients and the national norm group were analyzed by the two sample t-test. The variance analysis was conducted to compare the score differences of scales among different age groups of ED patients. The chi square test was conducted to compare the distribution differences of personality types among different age groups. Results:The scores of hostility(1.64±0.67, t=4.81, P<0.001), anxiety(1.58±0.66, t=6.83, P<0.001), psychotic(1.62±0.68, t=11.87, P<0.001), paranoid(1.55±0.66, t=3.58, P=0.0004), obsession(1.95±0.70, t=9.56, P<0.001), somatization(1.43±0.58, t=2.10, P=0.036), interpersonal relationship(1.74±0.74, t=2.79, P=0.005), depression (1.66±0.74, t=4.50, P<0.001)and the total scores (1.53±0.63, t=3.07, P=0.002)of SCL-90 in the patient group were significantly higher than those of the national norm group, and there were significant differences in the scores of interpersonal relationship among different age groups(1.72±0.78, 1.65±0.69, 1.58±0.92, 1.43±0.59, F=2.84, P=0.038). The scores of state anxiety( t=7.35, P<0.001), trait anxiety ( t=6.31, P<0.001)and the total scores ( t=8.41, P<0.001)of STAI in the patient group were significantly higher than those of the national norm, and there were significant differences in the scores of state anxiety( F=5.29, P=0.001), trait anxiety ( F=5.54, P<0.001)and total scores ( F=5.66, P<0.001)among different age groups. There were significant increases in the scores of psychoticism( t=30.56, P<0.001), emotion( t=45.94, P<0.001), extraversion and introversion( t=11.72, P<0.001), concealment factors ( t=29.16, P<0.001)and total scores ( t=30.56, P<0.001)in the patient group. The proportion of depressive personality was highest in the ED patients(n=183; 45.64%), but there was no significant difference in the distribution of personality types among different age groups[20-29(depressive, choleric, mucinous and sanguine): 76, 35, 26, 21; 30-39: 87, 40, 32, 23; 40-49: 14, 10, 6, 8; 50-60: 6, 9, 2, 6; χ 2=10.65, P=0.30]. Conclusions:ED patients have a series of abnormal emotions, somatized discomfort, sensitive interpersonal relationships, introverted and unstable emotionally personality characteristics. In addition, the younger the patients are, the more serious their anxiety are, the more sensitive their interpersonal relationships are, which may be related to their introverted personality characteristics and emotional instability.
9.Perioperative rehabilitation approaches based on the concept of Enhanced Recovery After Surgery for pelvic fractures: a prospective randomized control trial
Jinhui WANG ; Yufeng GE ; Xianfeng GUO ; Li TAO ; Xiaohua LIU ; Qiang LI ; Yuzhang WANG ; Minghui YANG ; Shiwen ZHU ; Zhenzhong WANG ; Lin JIN ; Zhiyong HOU ; Jian JIA ; Liancheng WANG ; Bin YU ; Xinbao WU
Chinese Journal of Orthopaedic Trauma 2021;23(10):850-855
Objective:To evaluate the efficacy and safety of perioperative rehabilitation approaches based on the concept of Enhanced Recovery After Surgery (ERAS) for pelvic fractures.Methods:A prospective randomized control trial was conducted to include 114 emergency patients who had been admitted to Department of Orthopaedic Trauma, Beijing Jishuitan Hospital for surgical treatment of pelvic fractures from June 2019 to December 2020. Of them, 57 were assigned into an intervention group according to a random digits table. They were 42 males and 15 females, aged from 18 to 77 years and subjected to management of pelvic fractures with tentative perioperative ERAS approaches which were adjusted at different stages. The other random 57 patients were assigned into a control group. They were 40 males and 17 females, aged from 17 to 70 years and subjected to management of pelvic fractures with conventional rehabilitation approaches which included postoperative in-hospital consultation and guidance by rehabilitation physicians. The 2 groups were compared in terms of Majeed pelvis scores and Barthel indexes at postoperative 2, 6, 12 and 24 weeks, and visual analogue scale (VAS) pain scores and SF36 scores at postoperative 12 and 24 weeks.Results:A total of 105 patients (55 in the intervention group and 50 in the control group) were completely followed up for 151 to 254 d (mean, 177 d). The 2 groups were comparable due to no significant difference between them in the preoperative general data ( P>0.05). The Majeed scores (44±13, 67±16, 86±14 and 98±7) and Barthel indexes (57±13, 79±16, 95±8 and 100±2) at postoperative 2, 6, 12 and 24 weeks in the intervention group were significantly higher than those in the control group [(35±16, 51±16, 73±14 and 91±12) and (45±19, 67±18, 86±12 and 98±4)] (all P<0.05). At postoperative 12 and 24 weeks, the SF-36 scores (129±15 and 141±6) in the intervention group were significantly higher than those in the control group (114±15 and 131±12) ( P<0.05). There was no significant difference in the pain degree between the 2 groups ( P>0.05). Conclusion:In management of pelvic fractures, compared with conventional perioperative rehabilitation approaches, the perioperative ERAS rehabilitation approaches may improve early functional outcomes and thus help the patients restore their activities of daily living earlier.
10.The protective effects of hydrogel implantation in prostate cancer patients for radiotherapy: a Meta-analysis
Ye YANG ; Yanjie HOU ; Shaojun XUE ; Huanru LIU ; Xianfeng LI
Chinese Journal of Radiological Medicine and Protection 2021;41(6):436-443
Objective:To evaluate the protective effects of hydrogel implantation in prostate cancer patients for radiotherapy.Methods:A search was performed in PubMed, Web of Science, Cochrane Library, Embase, CNKI and VIP to collect controlled clinical research literature concerning hydrogel implantation in prostate cancer for radiotherapy. The Revman 5.3 software was used to perform meta-analyses of rectal V70, rectal D2 cm 3, rectal toxicity effects and bowel symptoms. Results:The review included ten controlled clinical trials involving 1 360 patients (690 in the hydrogel group and 670 in the control group). The result of Meta-analysis showed that the rectal V70 and rectal D2 cm 3 of prostate cancer patients in the hydrogel group were significantly lower than those in the control group( MD=-4.5, 95% CI -7.11 to -1.90, P<0.001; MD=-19.78, 95% CI -25.92 to -13.63, P<0.001), early and late G1 rectal toxic effects in the hydrogel group were significantly lower than those in the control group ( OR=0.64, 95% CI 0.45-0.90, P=0.01; OR=0.28, 95% CI 0.13-0.60, P=0.001)and the late bowel quality of life in the hydrogel group was significantly improved compared with the control group( MD=5.13, 95% CI 3.29-6.98, P<0.001). However, there were no statistically significant differences in early and late ≥G2 rectal toxic effects( OR=0.46, 95% CI 0.17-1.25, P=0.13; OR=0.44, 95% CI 0.09-2.17, P=0.31)and the early bowel symptoms( MD=2.30, 95% CI -1.31-5.91, P=0.21)between the two groups. Conclusions:Hydrogel implantation inprostate cancer for radiotherapy can reduce rectal V70 and rectal D2 cm 3, lower the early and late G1 rectal toxic effects, and reduce improve the late bowel symptoms.

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