1.Analysis of the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders
Xueqin WANG ; Hongqiang SUN ; Yiting LI ; Lin LU
Chinese Medical Ethics 2025;38(1):23-30
The ethical review of clinical research involving mental disorders in the ethical governance of scientific and technological has obvious particularities, especially in the field of artificial intelligence and brain-computer interfaces which are reflected in the impact on mental autonomy, the impaired informed consent ability of participants with severe mental disorders in research, and other aspects. In addition, the stigma of illness, the use of placebo, and psychological assessment methods in clinical research have also drawn attention to the ethical review of psychiatry. In 2020, the Beijing Municipal Health Commission issued the Guidelines for Ethical Review of Clinical Research Involving Mental Disorders (Guidelines). Shen Yucun’s Psychiatry, compiled in 2023, revised the application of the Guidelines in the context of ethical governance. An analysis was conducted on the purpose and significance of its issuance and revision, its scope of application, the principal responsibility of ethical review in medical and health institutions, and the key content of ethical review in psychiatry, to improve the quality of ethical review in clinical research involving mental disorders and promote the standardized development of clinical research in psychiatry.
2.Construction and validation of a clinical prediction model for central lymph node metastasis in patients with high age-risk papillary thyroid cancer
Hanlin SUN ; Keyu YIN ; Hongqiang LI ; Yifeng TANG ; Weihao LIU ; Yifei ZHANG ; Detao YIN
Chinese Journal of Endocrine Surgery 2024;18(1):45-50
Objective:To analyze the risk factors for central lymph node metastasis (CLNM) in patients with papillary thyroid cancer (PTC) aged 55 years and above, and to construct a predictive model with columnar graph.Methods:This retrospective study included 406 PTC patients aged 55 and above, treated at the First Affiliated Hospital of Zhengzhou University from Nov. 2019 to Feb. 2022. Data on demographic characteristics, disease features, and laboratory test results were collected. Univariate and multivariate logistic regression analyses were used to identify risk factors for CLNM and develop a clinical prediction model and nomogram.Results:The study involved 406 patients, divided into a modeling group (285 patients) and a validation group (121 patients). The predictive model identified independent risk factors for CLNM. In the modeling group, the model demonstrated a ROC AUC of 0.769, with 82.6% sensitivity, 63.0% specificity, and 67.7% accuracy. The validation group showed 66.7% sensitivity, 74.5% specificity, and 72.7% accuracy, with an AUC of 0.760. Hosmer-Lemeshow tests indicated good fit in both groups. Decision curve analysis confirmed the model's clinical decision-making value, showing better performance than traditional strategies and good generalizability and reliability.Conclusions:Sex, maximum tumor diameter, bilateral involvement of thyroid lobes, clinically evident cervical lymph nodes, and local invasion are independent predictive factors for CLNM in patients over 55 with papillary thyroid carcinoma (PTC). A clinical risk stratification nomogram model based on these risk factors demonstrates good predictive performance.
3.Current status of radiological Kashin-Beck disease among school-aged children in Chamdo City, Tibet
Jiaxiang GAO ; Hu LI ; Liyi ZHANG ; Zihao HE ; Ziyi YANG ; Zhichang LI ; Kai WANG ; Yan KE ; Qiang LIU ; Shu ZHANG ; Xiaobo CHENG ; Shuai CHAI ; Zhaoyang MENG ; Lipeng SUN ; Qunwei LI ; Hongqiang GONG ; Jianhao LIN
Chinese Journal of Orthopaedics 2024;44(1):33-40
Objective:This study aimed to explore the status of radiological Kashin-Beck disease (KBD) among school-aged children in Chamdo City, Tibet, through a 3-year monitoring survey, providing epidemiological evidence for prevention and control strategies.Methods:The target areas for this study were Luolong, Bianba, and Basu counties in Chamdo City, Tibet Autonomous Region, identified as having the most severe historical cases of KBD. Children aged 7-12 years attending school were enrolled as study subjects. Anteroposterior X-ray films of the right-hand were taken, and radiological diagnoses were made based on the "Diagnosis of Kashin-Beck Disease" criteria (WS/T 207-2010). Two experienced researchers independently reviewed the X-rays, and intra- and inter-group consistency were assessed using weighted Kappa values and percentage agreement. Cross-sectional surveys were conducted in 2017 and 2020 to describe the X-ray detection rates of KBD, and logistic regression analysis was employed to construct a predictive model of risk factors for radiological KBD cases.Results:In 2017, a total of 5,711 children aged 7-12 years in Chamdo City, Tibet, participated in the baseline cross-sectional survey (average age 9.2 years, 48.0% female), with 28 cases of radiological KBD. The age- and gender-standardized prevalence rate was 0.527%. In 2020, 6,771 participants (average age 9.3 years, 49.5% female) underwent a second cross-sectional survey, with 9 cases of radiological KBD and a standardized prevalence rate of 0.134%. Logistic regression analysis indicated that older age [ OR=2.439, 95% CI(1.299, 4.580), P=0.006] and female gender [ OR=8.157, 95% CI(1.016, 65.528), P=0.048] were independent risk factors for radiological KBD cases. Conversely, higher residential altitude, under the premise of Tibet's high altitude, was a protective factor [ OR=0.995, 95% CI(0.990, 0.999), P=0.032). Conclusion:The radiographically positive detection rate of KBD among school-aged children in Chamdo City, Tibet Autonomous Region, is at an extremely low level and showing a declining trend, reaching the historical standard in 2020. Considering the absence of positive signs in affected children, it suggests that local KBD has been effectively eliminated.
4.Chinese consensus guidelines for therapeutic drug monitoring of polymyxin B, endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society.
Xiaofen LIU ; Chenrong HUANG ; Phillip J BERGEN ; Jian LI ; Jingjing ZHANG ; Yijian CHEN ; Yongchuan CHEN ; Beining GUO ; Fupin HU ; Jinfang HU ; Linlin HU ; Xin LI ; Hongqiang QIU ; Hua SHAO ; Tongwen SUN ; Yu WANG ; Ping XU ; Jing YANG ; Yong YANG ; Zhenwei YU ; Bikui ZHANG ; Huaijun ZHU ; Xiaocong ZUO ; Yi ZHANG ; Liyan MIAO ; Jing ZHANG
Journal of Zhejiang University. Science. B 2023;24(2):130-142
Polymyxin B, which is a last-line antibiotic for extensively drug-resistant Gram-negative bacterial infections, became available in China in Dec. 2017. As dose adjustments are based solely on clinical experience of risk toxicity, treatment failure, and emergence of resistance, there is an urgent clinical need to perform therapeutic drug monitoring (TDM) to optimize the use of polymyxin B. It is thus necessary to standardize operating procedures to ensure the accuracy of TDM and provide evidence for their rational use. We report a consensus on TDM guidelines for polymyxin B, as endorsed by the Infection and Chemotherapy Committee of the Shanghai Medical Association and the Therapeutic Drug Monitoring Committee of the Chinese Pharmacological Society. The consensus panel was composed of clinicians, pharmacists, and microbiologists from different provinces in China and Australia who made recommendations regarding target concentrations, sample collection, reporting, and explanation of TDM results. The guidelines provide the first-ever consensus on conducting TDM of polymyxin B, and are intended to guide optimal clinical use.
Humans
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Anti-Bacterial Agents/therapeutic use*
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China
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Drug Monitoring/methods*
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Polymyxin B
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Practice Guidelines as Topic
5.Clinical characteristic of aortitis in cardiac surgery in a single center
Junjiang LIU ; Li YUAN ; Quanlin YANG ; Huan LIU ; Hongqiang ZHANG ; Shouguo YANG ; Hao LAI ; Xiaoning SUN ; Chunsheng WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(09):1290-1294
Objective To review and analyze the clinical manifestations of common aortitis in cardiac surgery. Methods We screened 41 552 patients who were hospitalized in the Department of Cardiac Surgery of Zhongshan Hospital, Fudan University from 2010 to 2020, analyzed the patients' clinical data, and classified according to the type of diseases. Then we summarized all their clinical manifestations. Results In our center 145 patients were operated for aortitis diseases, including 75 males and 70 females, with the age of 24-76 (45.6±11.3) years. There were 61 patients of Takayasu's arteritis, 51 patients of Behcet's disease, 8 patients of syphilitic aortitis, 8 patients of systemic lupus erythematosus, 2 patients of Kawasaki disease, 4 patients of ankylosing spondylitis, 10 patients of dry syndrome, and 1 patient of scleroderma. Conclusion Aortitis is not uncommon in cardiac surgery, and awareness of the disease should be enhanced. So that we can distinguish various types of aortitis and to make proper management to improve patients' prognosis.
6.The dosimetric effect of random six-dimensional setup error in intensity-modulated radiotherapy planning for rectal cancer
Jiajun ZHENG ; Hongqiang YOU ; Geng XU ; Zhenyu ZHAI ; Xia HE ; Li SUN
Chinese Journal of Radiological Medicine and Protection 2023;43(11):881-887
Objective:To design a method to introduce random six-dimensional setup error (6D-SE) into the intensity-modulated radiotherapy (IMRT) planning for rectal cancer and evaluate its dosimetric effect.Methods:A total of 21 IMRT plans for patients with rectal cancer were randomly selected as reference plans [2 Gy per fraction for a total of 50 Gy; a 5 mm uniform margin around the clinical target volume (CTV) was taken as the planning target volume (PTV)]. For each fraction of the reference plan, a randomly generated 6D-SE was introduced by adjusting the geometrical parameters of the radiation field, and the dose was recalculated. The overall dose distribution with 6D-SE was obtained by adding up the dose of each fraction. A treatment simulation program that could complete the above workflow was developed using the Varian Eclipse scripting API (ESAPI). 6D-SEs that obey two preset distributions [distribution 1: translational error obey N(0, 4 2), and rotational error obey N(0, 2 2); distribution 2: translational error obey N(0, 2 2), and rotational error obey N(0, 1 2)] were introduced into the reference plans, and the dosimetric effects were assessed. Results:When the reference plans, error distribution 1, and error distribution 2 were applied, the Dmin values of the CTV were (49.4±0.41), (47.56±0.76), and (49.17±0.64) Gy, respectively; the D98% values of the CTV were (50.23±0.07), (49.98±0.10), and (50.27±0.09) Gy, respectively; the D98% values of the primary target area (the kernel part of the target area, excluding the margins) were (50.25±0.08), (50.42±0.13), and (50.33±0.10) Gy, respectively; the D98% values of the marginal area were (50.22±0.10), (49.88±0.11), and (50.26±0.10) Gy, respectively. In addition, compared with the result of the reference plans, the result of errors 1 and 2 showed no significant changes in the mean dose of the bladder and femoral heads ( P>0.05), despite slight decreases in the conformity index of the dose distribution with limited clinical significance. Conclusion:The proposed method and the treatment simulation program developed thereupon can introduce the 6D-SE obeying different distributions into the IMRT plans for rectal cancer on demand and provide overall dosimetric changes.
7.Biometry of width between labial transitional line angles in anterior teeth:an observational study
Chao WEN ; Hongqiang YE ; Hu CHEN ; Yongsheng ZHOU ; Mingming HUANG ; Yuchun SUN
The Journal of Advanced Prosthodontics 2022;14(1):1-11
PURPOSE:
The maximum width between the mesial and distal labial transitional line angles, described as “esthetic width” herein, could significantly influence the visual perception of the teeth and smile. This study aimed to conduct biometric research on esthetic width and to explore whether regular distribution exists in the esthetic width of human teeth.
MATERIALS AND METHODS:
A total of 4,264 maxillary and mandibular anterior teeth were measured using the Geomagic studio software program. The proportions of maxillary to mandibular homonymous teeth and proportions between the adjacent teeth were calculated. Bilateral symmetry and the correlation between the esthetic and mesiodistal widths were both accounted for during the measurement procedures.
RESULTS:
The mean esthetic widths were 6.773 ± 0.518 mm and 4.329 ± 0.331 mm for maxillary and mandibular central incisors, respectively, 5.451 ± 0.487 mm and 5.008 ± 0.351 mm for maxillary and mandibular lateral incisors, respectively, and 3.340 ± 0.353 mm and 5.958 ± 0.415 mm for maxillary and mandibular canines, respectively. Except for the mandibular canines, no significant difference in esthetic width was found among homonymous teeth from the same jaw. A high linear correlation was found between the esthetic and mesiodistal widths of the same tooth, except for the maxillary canines. Esthetic width proportions among different tooth categories showed some regular patterns, which were similar to those of the mesiodistal width.
CONCLUSION
Esthetic width is regularly distributed among the teeth in the Chinese population. This could provide an important reference for anterior dental restorations and dimension recovery in esthetic reconstruction of anterior teeth.
8.Status and correlates of sleep quality in schizophrenia inpatients
Yun CHEN ; Lüfeng ZHANG ; Hongle ZHANG ; Di WANG ; Qiufu ZHANG ; Rao CHEN ; Zhi CHU ; Sifan HU ; Hongqiang SUN
Chinese Journal of Health Management 2022;16(5):318-324
Objective:To explore the status and correlates of sleep quality in hospitalized patients with schizophrenia.Methods:A total number of 269 schizophrenia inpatients were recruited from 7 hospitals including Peking University Sixth Hospital, Zhumadian Second People′s Hospital and Liaocheng Fourth People′s Hospital from August 2019 to March 2021. The Brief Psychiatric Rating Scale (BPRS), the Pittsburgh Sleep Quality Index (PSQI), the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder Scale (GAD-7) and the suicide module of Mini-International Neuropsychiatric Interview were evaluated. Poor sleep quality was determined by the score of more than 5 according to PSQI, all patients were divided into groups of poor and normal sleep quality. The general demographic data and clinical characteristics of two groups were compared, and the correlates of sleep quality were obtained by Spearman correlations and multiple logistic regression.Results:The prevalence of poor sleep quality in schizophrenia inpatients was up to 44.6% (120/269). Compared with normal sleep quality group, inpatients with poor sleep quality had higher rates of alcohol consumption history, use of benzodiazepines (BZDs) and current suicide risk, and BPRS total score, factor scores (thinking disorders, anxious-depression, hostile-suspiciousness and activation), PHQ-9 and GAD-7 scores were also higher (all P<0.05). Spearman correlation analyses showed that PSQI total score were significantly positively correlated with BPRS total score ( r=0.323), PHQ-9 score ( r=0.553), GAD-7 score ( r=0.456) and current suicide risk level ( r=0.320) (all P<0.001). Multiple logistic regression showed that history of alcohol consumption ( OR=2.897, 95% CI: 1.002-8.372), use of BZDs ( OR=3.181, 95% CI: 1.548-6.534), thinking disorders ( OR=1.563, 95% CI: 1.015-2.406), comorbidity with depression ( OR=4.968, 95% CI: 1.869-13.202), and current suicide risk ( OR=2.496, 95% CI: 1.360-4.581) were independently correlated with poor sleep quality (all P<0.05). Conclusion:Poor sleep quality is common in hospitalized patients with schizophrenia, and history of alcohol consumption, use of BZDs, thinking disorders, comorbidity with depression and current suicide risk are independent correlates of poor sleep quality.
9.Challenges and countermeasures in building national regional medical centers for mental health
Yankun SUN ; Yimiao GONG ; Yuehua LIU ; Yujie CUI ; Yao YAO ; Siwei SUN ; Xiuhua LI ; Hongqiang SUN ; Lin LU
Chinese Journal of Hospital Administration 2022;38(10):736-739
As guided by the policy of building national regional medical centers, it is imperative to advance the construction of the national regional medical centers for mental health to achieve the sustainable and balanced development of the mental health cause of the country. The authors summarized the current status of national regional medical centers, and analyzed challenges faced in management and operation mode, government investment and compensation mechanism, expansion of high-quality psychiatric medical resources, as well as research and innovation of mental diseases of these centers. On such basis, the authors put forward corresponding countermeasures and suggestions for the next stage of development.
10.Analysis of the cause of varicocele recurrence and the application of sub-inguinal microsurgical varicocelectomy in recurrent varicocele
Shuzhi SUN ; Lei YU ; Hongqiang WANG ; Wei WANG ; Hongmei ZHANG ; Site XU ; Yunchao ZHANG ; Peitao WANG ; Yaowu GAO ; Shenqian LI ; Qiang LI ; Tao JING
Chinese Journal of Urology 2021;42(3):208-213
Objective:To analyze the cause of varicocele (VC) recurrence and investigate the efficacy of sub-inguinal microsurgical varicocelectomy (MV) for recurrent VC.Methods:All of 16 inpatients diagnosed as recurrent VC, in the Department of Andrology of the Affiliated Hospital of Qingdao University from 2015 April to 2019 April, were performed sub-inguinal MV. The age of the inpatients was 18-36 years old, median 27 years old.5 cases were originally performed retroperitoneal high ligation of spermatic vein and other 11 cases were originally performed laparoscopic varicocelectomy. During the review one to three years after the previous operation, all of 16 patients were diagnosed as VC recurrence. The complains of these patients during the review included male subfertility (10 cases) and scrotal pain (12 cases), in which 6 cases’ complains were male subfertility with scrotal pain. After admission, 13 patients were classified as Grade Ⅲ (left in 8 cases, bilateral in 5 cases) and 3 patients as Grade Ⅱ (all left). The median of their visual analogue scale (VAS) was 2.5. Color doppler flow imaging (CDFI) grading showed: Grade Ⅲ in 12 cases (left in 7 cases, bilateral in 5 cases), Grade Ⅱ in 4 cases (all left). Particularly, 12 of them were Graded as Ⅲ simultaneously accompanying with Nut-cracker Phenomenon (NCP). Preoperative tests showed that the average serum testosterone was (16.2±4.9)nmol/ml, the average sperm concentration was (11.8±3.9)×10 6/ml and the progressive motility rate (PR) was (24.4±4.2)%. All of the patients were performed sub-inguinal MV using general anesthesia and supine position. The spermatic cords were clearly exposed and padded up by inserting gauze strips under them. During the operation, the field was magnified 4-6 times with the microscope. Then all of the dilated external and internal spermatic veins were ligated, at the same time the internal spermatic artery and lymph vessels were well preserved. During these operations, 11 patients underwent left-side MV, while other 5 did bilateral MVs. During these MVs, we found twisted and dilated external and internal spermatic veins in all cases and well preserved the internal spermatic arteries and lymph vessels. The number of ligated left and right external spermatic veins were(2.1±0.6) and (1.4±0.5)respectively and the number of ligated left and right internal spermatic veins were (10.1±1.1) and (6.6±0.5) respectively. We also found out(1.3±0.5) internal spermatic arteries and (3.0±1.0)lymph-vessels on left side. On right side, there were (1.4±0.5) internal spermatic arteries and (2.6±0.5) lymph-vessels respectively. At last, we summarily analyzed the pre-operative and post-operative VAS, serum testosterone, CDFI and semen analysis data. Results:All of the 16 sub-inguinal MVs were successfully performed. All patients were reviewed comprehensively 6 months after MV. The reviewed results showed that the post-operative VAS was significantly reduced ( Z=-2.994, P<0.05), palpable scrotal vessels disappeared and Valsalva tests were negative. No obvious reflux of internal spermatic veins were detected by CDFI. Interestingly, the sperm concentration and motility were both significantly improved 6 months after MV ( P<0.05), while there was not remarkable increase of the serum testosterone after MV ( P>0.05). During the follow up, no testicular atrophy, hydrocele and other complications were found. Up to submission, five of the ten patients who presented for male subfertility have impregnated their wives. Conclusions:The most possible cause of VC recurrence could be the omission of the external and internal spermatic veins, particularly in the grade Ⅲ VC patients or VC accompanied with NCP. The sub-inguinal MV, which can discover more twisted spermatic veins and at the same time preserve the spermatic artery and lymph-vessels, shows better clinical efficacy than other procedures.

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