1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
2.Male genital system lymphoma: Clinicopathological analysis of 80 cases.
Xiao-Die ZHOU ; Rong-Xin QI ; Bo YU ; Xuan WANG ; Qun-Li SHI ; Qiu RAO ; Wei BAO
National Journal of Andrology 2025;31(2):138-143
OBJECTIVE:
To investigate the clinicopathological features and differential diagnosis of male genital system lymphoma (MGSL).
METHODS:
We retrospectively analyzed the clinicopathological and immunophenotypic features and prognosis of 80 cases of MGSL.
RESULTS:
The onset age of the MGSL patients ranged from 4 to 85 (median 62) years old. All the cases showed non-specificity of the imaging features and clinical manifestations. MGSL was located mainly in the testis (n = 66), followed by the prostate (n = 7), epididymis (n = 3), scrotum (n = 3) and penile glans (n = 1). Diffused large B cell lymphoma (DLBCL) was the most common pathological type (n = 62), next came extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT) (n = 7) and other rare types (n = 12). During the 1-112-month follow-up of 10 of the 19 patients, 1 died at 1 month after diagnosed with prostatic B-lymphoblastic lymphoma (B-LBL) and another 1 died at 50 months after diagnosed with testicular DLBCL.
CONCLUSION
MGSL is rare clinically, mainly of the DLBCL type pathologically, lacking specificity in clinical symptoms and imaging manifestation. The definite diagnosis of the malignancy depends on histopathology combined with related molecular examination and immunohistochemical labeling, and R-CHOP chemotherapy is the first choice for its treatment.
Humans
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Male
;
Middle Aged
;
Aged
;
Retrospective Studies
;
Adult
;
Aged, 80 and over
;
Young Adult
;
Adolescent
;
Child
;
Child, Preschool
;
Genital Neoplasms, Male/diagnosis*
;
Prognosis
;
Lymphoma, Large B-Cell, Diffuse/diagnosis*
;
Lymphoma/diagnosis*
3.Design and finite element analysis of experimental device for simulating interface micro motion of bone trabecular prosthesis
Guang-Hui SHI ; Xiao-Guang ZHANG ; Xuan LI ; Lin-Wei LYU ; Chun-Qiu ZHANG
Chinese Medical Equipment Journal 2024;45(1):25-30
Objective To design an experimental device for simulating the interface micro motion of bone trabecular prosthesis and carry out the finite element analysis.Methods The experimental device was composed of a screw-in cylinder with threads,a flexible hinge,a micro-motion rod,a trabecular prosthesis,a connecting rod and a fixation post.A model of the experimental device was constructed with SolidWorks software,and then imported into ABAQUS software to establish a finite element model.An axial displacement load was applied to the femur to analyze the effects of the position of the flexible hinge,the gap between the prosthesis and the femur and the length of the connecting rod on the micro motion.Results The interface micro motion produced by the experimental device increased with the distance of the flexible hinge from the lower end of the screwed-in cylinder;the gap between the prosthesis and the femur did not affect the interface micro motion when the gap was not lower than 20 μm;the interface micro motion rose with the length of the connecting rod.Conclusion The experimental device can accurately simulate the micro motion of different bone trabecular prosthesis interfaces,and can be used for studying the effect of the interface micro motion on osseointegration.[Chinese Medical Equipment Journal,2024,45(1):25-30]
4.Correlation between changes of sagittal spinopelvic parameters after hip arthroplasty and facet joint-derived low back pain
Xuan WANG ; Wei-Guo BIAN ; Hong-Bo QIU ; Guo-Dong JIN ; Fei GUO ; Lin-Juan ZHANG ; Xue-Zhe HAN
Journal of Regional Anatomy and Operative Surgery 2024;33(5):444-447
Objective To study the relationship between the changes of sagittal spinopelvic parameters and facet joint-derived low back pain in patients with hip osteoarthritis after hip arthroplasty.Methods The clinical data of 30 patients with facet joint-derived low back pain induced by hip osteoarthritis who underwent unilateral hip arthroplasty(observation group)from June 2019 to November 2020 in our hospital were retrospectively analyzed,and 50 healthy subjects who underwent lumbar X-ray examination in the physical examination center of our hospital at the same time were randomly selected as the control group.The sagittal spinopelvic parameters were measured based on the X-ray,including pelvic incidence(PI),pelvic tilt(PT),sacral slope(SS),lumbar lordosis(LL),sacrum pubic incidence(SPI)and sacrum pubic posterior angle(SPPA).The correlation between the changes of sagittal spinopelvic parameters and facet joint-derived low back pain was analyzed by multiple linear regression,and its diagnostic efficacy to facet joint-derived low back pain was analyzed by receiver operating characteristic(ROC)curve.Results The PI,LL,SPI or SPA before and 1 year after surgery of the observation group had no significant difference combined with those of the control group(P>0.05).The PT before surgery of the observation group was smaller than that of the control group(P<0.05),and the SS before surgery was larger than that of the control group(P<0.05).Multiple linear regression analysis showed that PT and SS before surgery were correlated with facet joint-derived low back pain(P<0.05).The sensitivity of PT and SS before surgery in diagnosing facet joint-derived low back pain were 50.00%and 73.30%,with the specificity of 88.00%and 78.00%,respectively.ROC curve analysis showed that the area under the curve of PT and SS before surgery in diagnosing facet joint-derived low back pain were 0.708(95%CI:0.595 to 0.822)and 0.775(95%CI:0.673 to 0.877),respectively.Conclusion Patients with hip osteoarthritis pain have significantly larger SS and significantly smaller PT.Hip arthroplasty can alleviate the symptoms of low back pain without affecting the sagittal spinopelvic balance;the PT and SS before surgery are correlated with the facet joint-derived low back pain,and they are of high value in the diagnosing facet joint-derived low back pain.
5.Expressions of androgen receptor and human epidermal growth factor receptor 2 in urinary bladder urothelial carcinoma with incidental prostate cancer and clinicopathological features of the malignancy.
Xiao-Die ZHOU ; Na SHI ; Jian-Jun WANG ; Xuan WANG ; Bo YU ; Qun-Li SHI ; Qiu RAO ; Wei BAO
National Journal of Andrology 2024;30(12):1081-1085
OBJECTIVE:
To investigate the clinicopathological features and prognosis of urinary bladder urothelial carcinoma (UBUC) with incidental prostate cancer (IPCa).
METHODS:
We retrospectively analyzed the clinicopathological features of 65 cases of UBUC and 38 cases of UBUC + IPCa after radical cystoprostatectomy (RCP) from January 2017 to February 2020. We compared their expressions of the immunohistochemical markers androgen receptor (AR) and (human epidermal growth factor receptor 2,HER2) between the two groups of patients, and analyzed their clinicopathological characteristics by chi-square test and their survival rates using the Kaplan-Meier method and log-rank test.
RESULTS:
The detection rate of UBUC + IPCa was 16.5%, and that of clinically significant IPCa was 39.5%, with preoperative PSA≥4 μg/L in 23.7% of the patients. Compared with the patients with UBUC, most of the UBUC + IPCa cases had no smoking history (73.8% vs 92.1%, P = 0.024), and fewer had histological variants (43.1% vs 10.5%, P = 0.003). The incidence rate of vascular invasion was significantly higher in the UBUC than in the UBUC + IPCa group (49.2% vs 21.1%, P = 0.005), and so was the rate of advanced cases (67.7% vs 31.6%, P<0.001). In comparison with the patients of the UBUC group, those of the UBUC + IPCa group showed remarkably higher expressions of AR (9.2% vs 31.6%, P = 0.004) and HER2 (43.1% vs 71.1%, P = 0.006). The mean overall survival time was longer in the UBUC + IPCa than in the UBUC group (48.8 mo [95% CI: 2.5-42.6 mo] vs 39.9 mo [95% CI: 2.8-34.5 mo]), but with no statistically significant difference between the two groups (P = 0.608).
CONCLUSION
Standardized sampling of prostate samples after RCP helps to improve the detection rate of IPCa. Preoperative level of PSA is not a good predictor of IPCa. Few patients with UBUC + IPCa have a history of cigarette smoking, and the predominant histological type of the malignancy is high-grade invasive urothelial carcinoma, which is not significantly different from UBUC in prognosis. The expressions of HER2 and AR are significantly higher in UBUC + IPCa than in UBUC, suggesting that UBUC + IPCa may benefit from HER2- and AR-targeted therapy.
Humans
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Male
;
Urinary Bladder Neoplasms/metabolism*
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Receptors, Androgen/metabolism*
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Prostatic Neoplasms/metabolism*
;
Retrospective Studies
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Receptor, ErbB-2/metabolism*
;
Prognosis
;
Middle Aged
;
Aged
;
Survival Rate
;
Prostatectomy
6.Study of microscopic effects of low-intensity pulsed ultrasound on bone lacunar-canalicular system
Jia-Ming WANG ; Xiao-Guang ZHANG ; Xuan LI ; Lin-Wei LYU ; Chun-Qiu ZHANG
Chinese Medical Equipment Journal 2023;44(11):27-33
Objective To explore the microscopic effects of low-intensity pulsed ultrasound(LIPUS)on bone lacunar-canalicular system(LCS).Methods Three consecutive bone cells from the real bone tissue were selected and used to build a LCS model with SolidWorks software,then the LCS model was imported into finite element analysis software COMSOL.LIPUS irradiation was performed on the top of the LCS model to analyze the distribution of the acoustic and thermal fields of the model under different conditions.Results After ultrasonic irradiation of the LCS model,the farther away from the ultrasonic incidence surface,the lower the acoustic field sound pressure was,and the distribution of the sound pressure inside the model had left-right symmetry;the acoustic field sound pressure inside the LCS model increased with the enhancement of the excitation sound pressure;the closer to the ultrasound focusing region,the denser the temperature contours.Conclusion The distribution laws of acoustic and thermal fields within the LCS are revealed from a microscopic point of view,and theoretical references are provided for LIPUS experiments and treatment.[Chinese Medical Equipment Journal,2023,44(11):27-33]
7.A Case Report of Blau Syndrome
Guozhuang LI ; Kexin XU ; Sen ZHAO ; Jianguo ZHANG ; Guixing QIU ; Ruifang SUI ; Tao WANG ; Min SHEN ; Xuejun ZENG ; Wei WANG ; Mingsheng MA ; Min WEI ; Xiao LONG ; Ke LYU ; Li HUO ; Lei XUAN ; Nan WU
JOURNAL OF RARE DISEASES 2023;2(4):547-553
Blau syndrome is a rare genetic disorder characterized by the a mix of granulomatous arthritis, uveitis, and dermatitis. Patients typically manifest multisystem involvement, including ocular, skin, and skeletal abnormalities. Blau syndrome is extremely rare, with a global incidence of less than one in a million among children. In this multidisciplinary consultation, we present a case of a 21-year-old young female patient having multisystemic involvement since early childhood. She was presented with multiple joint swelling, skin lesions, increased eye discharge, and accompanied by hypertension and arterial abnormalities, and received a diagnosis of uveitis. The patient had been receiving steroid treatment since the age of 6 and has tried various medications, with some improvement in joint swelling and ocular symptoms. Through this rare disease multidisciplinary consultation, we aim to provide guidance in the molecular diagnosis of the patient, multisystem assessment, and the selection and formulation of treatment plans. Additionally, we hope that by reporting this case, clinical physicians can gain a better understanding of the diagnosis and comprehensive treatment strategies for Blau syndrome, thereby improving the management and treatment of rare diseases.
8.Epidemiological characteristics of a 2019-nCoV outbreak caused by Omicron variant BF.7 in Shenzhen.
Yan Peng CHENG ; Dong Feng KONG ; Jia ZHANG ; Zi Quan LYU ; Zhi Gao CHEN ; Hua Wei XIONG ; Yan LU ; Qing Shan LUO ; Qiu Ying LYU ; Jin ZHAO ; Ying WEN ; Jia WAN ; Fang Fang LU ; Jian Hua LU ; Xuan ZOU ; Zhen ZHANG
Chinese Journal of Epidemiology 2023;44(3):379-385
Objective: To explore the epidemiological characteristic of a COVID-19 outbreak caused by 2019-nCoV Omicron variant BF.7 and other provinces imported in Shenzhen and analyze transmission chains and characteristics. Methods: Field epidemiological survey was conducted to identify the transmission chain, analyze the generation relationship among the cases. The 2019-nCoV nucleic acid positive samples were used for gene sequencing. Results: From 8 to 23 October, 2022, a total of 196 cases of COVID-19 were reported in Shenzhen, all the cases had epidemiological links. In the cases, 100 were men and 96 were women, with a median of age, M (Q1, Q3) was 33(25, 46) years. The outbreak was caused by traverlers initial cases infected with 2019-nCoV who returned to Shenzhen after traveling outside of Guangdong Province.There were four transmission chains, including the transmission in place of residence and neighbourhood, affecting 8 persons, transmission in social activity in the evening on 7 October, affecting 65 persons, transmission in work place on 8 October, affecting 48 persons, and transmission in a building near the work place, affecting 74 persons. The median of the incubation period of the infection, M (Q1, Q3) was 1.44 (1.11, 2.17) days. The incubation period of indoor exposure less than that of the outdoor exposure, M (Q1, Q3) was 1.38 (1.06, 1.84) and 1.95 (1.22, 2.99) days, respcetively (Wald χ2=10.27, P=0.001). With the increase of case generation, the number and probability of gene mutation increased. In the same transmission chain, the proportion of having 1-3 mutation sites was high in the cases in the first generation. Conclusions: The transmission chains were clear in this epidemic. The incubation period of Omicron variant BF.7 infection was shorter, the transmission speed was faster, and the gene mutation rate was higher. It is necessary to conduct prompt response and strict disease control when epidemic occurs.
Male
;
Humans
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Female
;
SARS-CoV-2
;
COVID-19/epidemiology*
;
Disease Outbreaks
;
Epidemics
;
China/epidemiology*
9.Analysis of the clinical characteristics and misdiagnosis of area postrema syndrome manifesting as intractable nausea, vomiting, and hiccups in neuromyelitis optica spectrum disorders.
Shi Min ZHANG ; Feng QIU ; Xuan SUN ; Hui SUN ; Lei WU ; De Hui HUANG ; Wei Ping WU
Chinese Journal of Internal Medicine 2023;62(6):705-710
Objective: To investigate the misdiagnosis of area postrema syndrome (APS) manifesting as intractable nausea, vomiting and hiccups in neuromyelitis optic spectrum disease (NMOSD) and reduce the risk of misdiagnosis. Methods: We retrospectively analyzed data from NMOSD patients attending the Department of Neurology at the First Medical Center of PLA General Hospital between January 2019 and July 2021. SPSS25.0 was then used to analyze the manifestations, misdiagnosis, and mistreatment of APS. Results: A total of 207 patients with NMOSD were included, including 21 males and 186 females. The mean age of onset was 39±15 years (range: 5-72 years). The proportion of patients who were positive for serum aquaporin 4 antibody was 82.6% (171/207). In total, 35.7% (74/207) of the NMOSD patients experienced APS during the disease course; of these patients, 70.3% (52/74) had APS as the first symptom and 29.7% (22/74) had APS as a secondary symptom. The misdiagnosis rates for these conditions were 90.4% (47/52) and 50.0% (11/22), respectively. As the first symptom, 19.2% (10/52) of patients during APS presented only with intractable nausea, vomiting and hiccups; 80.8% (42/52) of patients experienced other neurological symptoms. The Departments of Gastroenterology and General Medicine were the departments that most frequently made the first diagnosis of APS, accounting for 54.1% and 17.6% of patients, respectively. The most common misdiagnoses related to diseases of the digestive system and the median duration of misdiagnosis was 37 days. Conclusions: APS is a common symptom of NMOSD and is associated with a high rate of misdiagnosis. Other concomitant symptoms often occur with APS. Gaining an increased awareness of this disease/syndrome, obtaining a detailed patient history, and performing physical examinations are essential if we are to reduce and avoid misdiagnosis.
Male
;
Female
;
Humans
;
Child, Preschool
;
Child
;
Adolescent
;
Young Adult
;
Adult
;
Middle Aged
;
Aged
;
Neuromyelitis Optica/diagnosis*
;
Area Postrema
;
Retrospective Studies
;
Hiccup/complications*
;
Vomiting/etiology*
;
Nausea/etiology*
;
Inflammation
;
Syndrome
;
Autoantibodies
;
Diagnostic Errors
;
Aquaporin 4
10.Pituicytoma: a clinicopathological analysis of twenty-one cases.
Xiao FENG ; Wei BAO ; Xuan WANG ; Qiu RAO ; Qun Li SHI ; Zhen YUE
Chinese Journal of Pathology 2022;51(4):314-318
Objective: To investigate the clinicopathological features and treatment strategies of pituicytoma. Methods: Twenty-one cases of pituicytoma were collected at the First Affiliated Hospital of Nanjing Medical University and Jinling Hospital, Nanjing, China from 2009 to 2020. The clinical data of 21 pituicytoma patients was retrospectively analyzed, and the relevant literature was reviewed. Results: Twenty-one patients aged 4 to 68 years, including 8 males and 13 females. All patients underwent surgical treatment. Histologically, the tumor was consisted almost entirely of elongate, bipolar spindle cells arranged in a fascicular or storiform pattern. Mitotic figures were rare. Immunohistochemically, tumor cells were diffusely positive for S-100 protein (21/21), vimentin (15/15) and TTF1 (14/14), while they were weakly or focally positive for GFAP (13/16) and EMA (6/12). CKpan was negative in all cases and Ki-67 proliferation index was low (<5%). Among the 18 patients with follow-up, all survived and 2 relapsed after surgery. Conclusions: Pituicytoma is a rare low-grade glioma of the sellar area. It is easily confused with other sellar tumors. Preoperative diagnosis is difficult. It needs to be confirmed by histopathology and immunohistochemistry. Microsurgery is the main treatment method at present.
Adolescent
;
Adult
;
Aged
;
Child
;
Child, Preschool
;
Craniopharyngioma
;
Female
;
Glioma/pathology*
;
Humans
;
Immunohistochemistry
;
Male
;
Middle Aged
;
Pituitary Neoplasms/pathology*
;
Retrospective Studies
;
Young Adult

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