1.Expert consensus on quality assurance for SPECT and SPECT/CT equipment with CZT detectors
China Medical Equipment 2025;22(6):1-6
The quality assurance(QA)of cadmium zinc telluride(CZT)detector-based Single Photon Emission Computed Tomography(SPECT)and Single Photon Emission Computed Tomography/X-ray Computed Tomography(SPECT/CT)systems is critical to the quality and safety of diagnosis and treatment for patients.Currently,there are no dedicated standards or guidelines for QA of specifically tailored for CZT detector equipment within the industry,resulting in uncertainties regarding their performance and operational safety.To address this gap,the Nuclear Medical Equipment and Technology Committee of China Association of Medical Equipment has convened a panel of experts to formulate a consensus on the QA for CZT detector-based SPECT and SPECT/CT equipment.This expert consensus aims to define the scope,protocols,and performance standards for QA about CZT detector-based SPECT and SPECT/CT equipment,so as to ensure that the equipment can reach to the performance indicators designed by the original factory in clinical application,and reach to the safe and reliable operation of equipment,and can meet requirements of clinical diagnosis.
2.Postoperative radiotherapy-related symptoms as predictors of acute radiation dermatitis in breast cancer
Zhou YANHONG ; Geng WENHUI ; Gao YANG ; Pan SHUO ; Li SHANSHAN ; Zhang FANG
Chinese Journal of Clinical Oncology 2025;52(1):24-28
Objective:To observe the longitudinal changes of symptoms in the irradiation area of patients with postoperative radiotherapy for breast cancer,and investigate the correlative symptom indexes for predicting acute radiation dermatitis during radiotherapy.Methods:This study was designed as a prospective longitudinal study.A total of 103 patients with breast cancer who received three-dimensional con-formal radiotherapy in The Fourth Hospital of Hebei Medical University from May 2022 to December 2022 were enrolled using convenience and purposive sampling methods.The patients received a total of 50 Gy/25 radiotherapy sessions.We conducted weekly observations of five symptoms-itching,pain,swelling,burning,and tightness-in the irradiated area,for a total of six weeks.The incidence of symptoms associ-ated with radiation dermatitis across different severity levels was compared.We calculated the optimal number of symptoms for the occur-rence of grade 2 or higher radiation dermatitis,evaluated the predictive effect using the subject's work characteristic curve(ROC),and com-pared the risk of radiation dermatitis with the number of symptoms by applying a binary Logistic regression.Results:A total of 103 patients were included in the study.The total severity scores of symptoms were 0(0,0),0(0,0),0(0,1),1(0,2),2(1,3),3(2,4),respectively,show-ing a gradually increasing trend.From the 20 Gy/10-fraction radiotherapy point onward to the completion of radiotherapy,symptom scores exhibited statistically significant deviations from baseline values(P<0.001).From the beginning of 30 Gy/15 sessions to the end of radiother-apy,symptom scores were higher in patients with grade 2 and above dermatitis compared to those with dermatitis of less than grade 2(Z=2.12,2.81,4.08,P=0.034,0.005,0.001);at the end of 50Gy/25 sessions,the incidence rates of pruritus,pain,swelling,tightness,and burning were 68.9%(71 cases),68.9%(71 cases),46.6%(48 cases),36.9%(38 cases),and 15.5%(16 cases),respectively.At the 30 Gy/15 and 40 Gy/20 radiotherapy sessions,the optimal number of predicted symptoms were two and three,respectively.The corresponding areas under the ROC curve were 0.632 and 0.666.Sensitivity values were 48.6%and 43.2%,while specificity values reached 77.3%and 81.8%,re-spectively(95%CI:0.517-0.746,0.558-0.775,P=0.027,0.005).The subjects were assigned into low-risk and high-risk groups using the op-timal cut-off values,and binary Logistic regression showed that the risks of grade 2 and higher radiation dermatitis in the high-risk group were 3.39 and 3.58 times higher than that in the low-risk group(OR=3.388,95%CI:1.400-8.197,P=0.007;OR=3.584,95%CI:1.430-8.985,P=0.006).Conclusions:The symptoms of radiation dermatitis have appeared early and worsened with the severity of dermatitis.We should closely observe these symptoms throughout treatment.The risk of grade 2 and above radiation dermatitis increased when the number of symptoms was≥2 at 30 Gy/15 times and≥3 at 40 Gy/20 times.
3.Expert consensus on quality assurance for SPECT and SPECT/CT equipment with CZT detectors
China Medical Equipment 2025;22(6):1-6
The quality assurance(QA)of cadmium zinc telluride(CZT)detector-based Single Photon Emission Computed Tomography(SPECT)and Single Photon Emission Computed Tomography/X-ray Computed Tomography(SPECT/CT)systems is critical to the quality and safety of diagnosis and treatment for patients.Currently,there are no dedicated standards or guidelines for QA of specifically tailored for CZT detector equipment within the industry,resulting in uncertainties regarding their performance and operational safety.To address this gap,the Nuclear Medical Equipment and Technology Committee of China Association of Medical Equipment has convened a panel of experts to formulate a consensus on the QA for CZT detector-based SPECT and SPECT/CT equipment.This expert consensus aims to define the scope,protocols,and performance standards for QA about CZT detector-based SPECT and SPECT/CT equipment,so as to ensure that the equipment can reach to the performance indicators designed by the original factory in clinical application,and reach to the safe and reliable operation of equipment,and can meet requirements of clinical diagnosis.
4.Clinical trial of budesonide and formoterol fumarate powder for inhalation in the treatment of elderly patients with cough variant asthma
Ying SUN ; Xin SONG ; Jia WANG ; Yan-fang HOU ; Qun FU ; Qi ZHANG ; Jie LAI ; Tao GENG ; Chang-xin LI ; Jia-hui HUO ; Ying ZHANG ; Yan WENG
The Chinese Journal of Clinical Pharmacology 2025;41(1):1-5
Objective To compare the effects of different doses of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet in the treatment of cough variant asthma(CVA)and the improvement of airway function and inflammatory factors.Methods Elderly patients with cough variant asthma were randomly divided into group A and group B.Both groups of patients received budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet.Group A was given budesonide and formoterol fumarate powder for inhalation(Ⅱ),2 inhalation per time,twice a day;Group B was given budesonide and formoterol fumarate powder for inhalation,4 inhalation per time,twice a day;budesonide fumatrol inhalation powder mist for continuous treatment for 6 months,and montelukast sodium tablet 10 mg once a day for at least 3 months.The nighttime cough scores of the two groups were compared before treatment and after treatment.The percentage of forced expiratory volume in one second(FEV1)in the predicted value,the maximum mid expiratory flow(MMEF),the fractional exhaled nitric oxide(FeNO),interleukin-5(IL-5)and eosinophils were compared between the two groups.The incidence of adverse drug reactions and the recurrence rate within 1 year were compared between the two groups.Results A total of 45 cases were enrolled in both the group A and the group B.At 9 months after treatment,the nocturnal cough scores of the group A and the group B were(0.93±0.42)and(0.65±0.29)points,respectively;the percentage of FEV1 in the predicted value were(97.75±9.67)%and(100.93±11.06)%,respectively;the MMEF values were(2.81±1.04)and(3.08±1.09)L·s-1,respectively;the FeNO values were(18.94±9.75)and(15.94±7.96)ppb,respectively;the IL-5 levels were(10.88±7.06)and(8.11±5.56)pg·mL-1,respectively.The above indicators in group B showed statistically significant differences compared to group A(all P<0.05).The total incidence of adverse drug reactions in group A and group B were 8.89%(5 cases/45 cases)and 13.33%(6 cases/45 cases),respectively.The recurrence rates was 15.56%(7 cases/45 cases)and 13.33%(6 cases/45 cases),respectively.There was no statistically significant difference in the above indicators between group B and group A(all P>0.05).Conclusion For elderly patients with CVA,higher dose of budesonide and formoterol fumarate powder for inhalation combined with montelukast sodium tablet can better improve cough symptoms,reduce the level of airway hyperresponsiveness and inflammatory factors,reduce the recurrence rate,and the patients are well tolerated.
5.Clinical efficacy and safety of a domestic calcipotriol/betamethasone dipropionate ointment in the treatment of stable plaque psoriasis: a multicenter, randomized, double-blind, controlled study
Lixin XIA ; Guang XIANG ; Qingchun DIAO ; Kun HUANG ; Shoumin ZHANG ; Shanshan LI ; Yumei LI ; Zhiqiang SONG ; Qing SUN ; Xiumin YANG ; Meng PAN ; Yuling SHI ; Shuping GUO ; Huiping WANG ; Tiechi LEI ; Xiaoyong ZHOU ; Songmei GENG ; Suchun HOU ; Juan SU ; Yong CUI ; Rixin CHEN ; Yanyan FENG ; Hongxia FENG ; Rushan XIA ; Zudong MENG ; Fang YIN ; Jingjing WANG ; Xinghua GAO
Chinese Journal of Dermatology 2025;58(11):1020-1026
Objective:To evaluate the clinical equivalence between a domestic calcipotriol/betamethasone dipropionate ointment and the originator product in the treatment of stable plaque psoriasis.Methods:A multicenter, randomized, double-blind, three-arm, parallel-group, active- and placebo-controlled study was conducted, and 449 patients aged 18 - 65 years with stable plaque psoriasis were enrolled from 25 hospitals (such as the First Affiliated Hospital of China Medical University). Eligible patients had a baseline physician's global assessment (PGA) score of ≥ 3 points, baseline body surface area (BSA) involvement of 5% - 30%, and a target lesion psoriasis area and severity index (TL-PASI) for plaque elevation of ≥ 3 points. Participants were randomly assigned in a 2:2:1 ratio to the test group ( n = 179), reference group ( n = 180), and placebo group ( n = 90), and applied the domestic calcipotriol/betamethasone dipropionate ointment, originator product, and ointment base respectively, once daily in the evening for 4 weeks. Efficacy and safety were assessed at weeks 1, 2, and 4. The primary efficacy endpoints were the treatment success rates and clinical success rates in each group at week 4. The per-protocol set (PPS) was used for the primary efficacy analysis, and the intention-to-treat (ITT) set for supplementary efficacy analysis. Equivalence between the test and reference preparations was tested using the Cochran-Mantel-Haenszel method adjusted for randomization strata. Superiority of the test and reference preparations over the placebo was also tested. Measurement data were compared among the 3 groups using analysis of variance or non-parametric tests, while treatment success rates, clinical success rates, and incidence rates of adverse reactions were compared using the chi-square test. Results:The ITT, PPS, and safety sets included 447, 420, and 448 patients, respectively. In the ITT set, patients were aged 43.6 ± 12.8 years, including 320 (71.6%) males and 127 (28.4%) females, and the disease duration was 11.21 ± 9.05 years; 316 (70.7%) had a PGA score of 3 points and 131 (29.3%) had a PGA score of 4 - 5 points. No significant differences in the baseline characteristics (including age, sex, disease duration and disease severity) were observed among the 3 groups (all P > 0.05). Based on the PPS analysis, the treatment success rates were 57.9% (99/171) in the test group, 50.3% (86/171) in the reference group, and 7.7% (6/78) in the placebo group, and the clinical success rates were 57.9% (99/171), 50.3% (86/171), and 10.3% (8/78), respectively; both the test and reference groups were superior to the placebo group in both treatment and clinical success rates (all P < 0.001) ; the rate differences for treatment success (90% confidence interval [ CI]: -1.3% - 16.4%) and clinical success (90% CI: -1.3% - 16.3%) between the test and reference groups were entirely within the pre-defined equivalence margin (-20% - 20%). Subgroup analyses by baseline PGA scores: for patients with a baseline PGA score of 3 points, the treatment success rates in the test, reference, and placebo groups were 60.8% (73/120), 52.1% (62/119), and 11.1% (6/54), respectively, and the corresponding clinical success rates were 61.7% (74/120), 53.8% (64/119), and 13% (7/54), respectively; the test and reference groups did not differ significantly in treatment or clinical success rates (both P > 0.05), but both showed higher success rates than the placebo group (all P < 0.001) ; the results of statistical comparisons among the 3 groups in patients with a baseline PGA score of 4 - 5 points were consistent with those observed in patients with a baseline PGA score of 3 points. The percentage reductions in PGA and TL-PASI scores from baseline to weeks 1, 2, and 4 showed significant differences among the 3 groups, which were significantly higher in the test and reference groups than in the placebo group (all P < 0.001), but did not differ between the test and reference groups (all P > 0.05). The primary adverse reactions were local skin reactions, such as pruritus, pain, and erythema. The incidence rates of adverse reactions were 8.9% (16/179) in the test group, 7.3% (13/179) in the reference group, and 7.8% (7/90) in the placebo group, with no significant difference among the 3 groups ( P > 0.05) . Conclusions:The domestic calcipotriol/betamethasone dipropionate ointment demonstrated clinical equivalence to the originator product in the treatment of stable plaque psoriasis, and the two agents exhibited comparable efficacy for patients with varying degrees of disease severity, and were comparable in the speed and degree of clinical improvement, with similar favorable safety profiles.
6.Postoperative radiotherapy-related symptoms as predictors of acute radiation dermatitis in breast cancer
Zhou YANHONG ; Geng WENHUI ; Gao YANG ; Pan SHUO ; Li SHANSHAN ; Zhang FANG
Chinese Journal of Clinical Oncology 2025;52(1):24-28
Objective:To observe the longitudinal changes of symptoms in the irradiation area of patients with postoperative radiotherapy for breast cancer,and investigate the correlative symptom indexes for predicting acute radiation dermatitis during radiotherapy.Methods:This study was designed as a prospective longitudinal study.A total of 103 patients with breast cancer who received three-dimensional con-formal radiotherapy in The Fourth Hospital of Hebei Medical University from May 2022 to December 2022 were enrolled using convenience and purposive sampling methods.The patients received a total of 50 Gy/25 radiotherapy sessions.We conducted weekly observations of five symptoms-itching,pain,swelling,burning,and tightness-in the irradiated area,for a total of six weeks.The incidence of symptoms associ-ated with radiation dermatitis across different severity levels was compared.We calculated the optimal number of symptoms for the occur-rence of grade 2 or higher radiation dermatitis,evaluated the predictive effect using the subject's work characteristic curve(ROC),and com-pared the risk of radiation dermatitis with the number of symptoms by applying a binary Logistic regression.Results:A total of 103 patients were included in the study.The total severity scores of symptoms were 0(0,0),0(0,0),0(0,1),1(0,2),2(1,3),3(2,4),respectively,show-ing a gradually increasing trend.From the 20 Gy/10-fraction radiotherapy point onward to the completion of radiotherapy,symptom scores exhibited statistically significant deviations from baseline values(P<0.001).From the beginning of 30 Gy/15 sessions to the end of radiother-apy,symptom scores were higher in patients with grade 2 and above dermatitis compared to those with dermatitis of less than grade 2(Z=2.12,2.81,4.08,P=0.034,0.005,0.001);at the end of 50Gy/25 sessions,the incidence rates of pruritus,pain,swelling,tightness,and burning were 68.9%(71 cases),68.9%(71 cases),46.6%(48 cases),36.9%(38 cases),and 15.5%(16 cases),respectively.At the 30 Gy/15 and 40 Gy/20 radiotherapy sessions,the optimal number of predicted symptoms were two and three,respectively.The corresponding areas under the ROC curve were 0.632 and 0.666.Sensitivity values were 48.6%and 43.2%,while specificity values reached 77.3%and 81.8%,re-spectively(95%CI:0.517-0.746,0.558-0.775,P=0.027,0.005).The subjects were assigned into low-risk and high-risk groups using the op-timal cut-off values,and binary Logistic regression showed that the risks of grade 2 and higher radiation dermatitis in the high-risk group were 3.39 and 3.58 times higher than that in the low-risk group(OR=3.388,95%CI:1.400-8.197,P=0.007;OR=3.584,95%CI:1.430-8.985,P=0.006).Conclusions:The symptoms of radiation dermatitis have appeared early and worsened with the severity of dermatitis.We should closely observe these symptoms throughout treatment.The risk of grade 2 and above radiation dermatitis increased when the number of symptoms was≥2 at 30 Gy/15 times and≥3 at 40 Gy/20 times.
7.Expert consensus on peri-implant keratinized mucosa augmentation at second-stage surgery.
Shiwen ZHANG ; Rui SHENG ; Zhen FAN ; Fang WANG ; Ping DI ; Junyu SHI ; Duohong ZOU ; Dehua LI ; Yufeng ZHANG ; Zhuofan CHEN ; Guoli YANG ; Wei GENG ; Lin WANG ; Jian ZHANG ; Yuanding HUANG ; Baohong ZHAO ; Chunbo TANG ; Dong WU ; Shulan XU ; Cheng YANG ; Yongbin MOU ; Jiacai HE ; Xingmei YANG ; Zhen TAN ; Xiaoxiao CAI ; Jiang CHEN ; Hongchang LAI ; Zuolin WANG ; Quan YUAN
International Journal of Oral Science 2025;17(1):51-51
Peri-implant keratinized mucosa (PIKM) augmentation refers to surgical procedures aimed at increasing the width of PIKM. Consensus reports emphasize the necessity of maintaining a minimum width of PIKM to ensure long-term peri-implant health. Currently, several surgical techniques have been validated for their effectiveness in increasing PIKM. However, the selection and application of PIKM augmentation methods may present challenges for dental practitioners due to heterogeneity in surgical techniques, variations in clinical scenarios, and anatomical differences. Therefore, clear guidelines and considerations for PIKM augmentation are needed. This expert consensus focuses on the commonly employed surgical techniques for PIKM augmentation and the factors influencing their selection at second-stage surgery. It aims to establish a standardized framework for assessing, planning, and executing PIKM augmentation procedures, with the goal of offering evidence-based guidance to enhance the predictability and success of PIKM augmentation.
Humans
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Consensus
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Dental Implants
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Mouth Mucosa/surgery*
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Keratins
8.Diagnosis and malignant analysis of mass versus pneumonia type of primary pulmonary mucinous adenocarcinoma
Yihui FENG ; Xiaolei ZHU ; Shaohan FANG ; Xiaowen ZHANG ; Ning LI ; Guojun GENG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):360-365
Objective To investigate the relationship between primary pulmonary mucinous adenocarcinoma (PPMA) mass type and pneumonia type and their difference in malignant degree, and to analyze the role of clinical manifestations and CT features in the diagnosis of this disease. Methods The clinical data of PPMA patients admitted in the First Affiliated Hospital of Xiamen University from May 2011 to March 2022 were retrospectively analyzed. According to CT features, they were divided into a mass type group and a pneumonia type group. The clinical manifestations, CT features and the degree of malignancy between the two groups were analyzed and compared. Results A total of 57 PPMA patients were enrolled. There were 17 males and 40 females, with an average age of (53.82±10.65) years, and 28 (49%) patients had reversed hato-like sign. There were 42 patients in the mass type group and 15 patients in the pneumonia type group. PPMA often occurs in both lower lungs, with clinical manifestations mainly of coughing and expectorating white mucoid sputum. There were statistical differences between the two groups in the maximum diameter of tumor (P<0.001), boundary condition (P<0.001) and pleural indentation sign (P=0.019). There was no statistical difference between the two groups in Ki-67 index (P>0.05). Conclusion There is no statistical difference in the degree of malignancy between the two types of PPMA. Considering their clinical manifestations and differences in imaging features, it is supported that the pneumonia type is just a progression of the mass type. CT can present various manifestations, among which the reversed hato-like sign is expected to become an important imaging feature. Combined with a high proportion of solid components, pleural indentation sign, and vacuole sign, reversed hato-like sign can play a significant role in the diagnosis of PPMA.
9.Longitudinal Associations between Vitamin D Status and Systemic Inflammation Markers among Early Adolescents.
Ting TANG ; Xin Hui WANG ; Xue WEN ; Min LI ; Meng Yuan YUAN ; Yong Han LI ; Xiao Qin ZHONG ; Fang Biao TAO ; Pu Yu SU ; Xi Hua YU ; Geng Fu WANG
Biomedical and Environmental Sciences 2025;38(1):94-99
10.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer's disease(2025)
Nan ZHI ; Jinwen XIAO ; Rujing REN ; Binyin LI ; Jintao WANG ; Jieli GENG ; Wenwei CAO ; Yaying SONG ; Hualong WANG ; Shuguang CHU ; Guoping PENG ; Jun LIU ; Xiaoyun LIU ; Fang YUAN ; Wen WANG ; Ronghua DOU ; Xia LI ; Ling YUE ; Wenshi WEI ; Xiaoling PAN ; Xiangyang ZHU ; Dian HE ; Weinü FAN ; Jingping SHI ; Nan ZHANG ; Hui ZHAO ; Qin CHEN ; Cuibai WEI ; Xiaochun CHEN ; Gang WANG
Journal of Chongqing Medical University 2025;50(9):1133-1140
In recent years,significant breakthroughs have been achieved in the immunotherapy for Alzheimer's disease.In line with global advancements,two anti-amyloid-β monoclonal antibodies have been approved and successfully launched in China for clinical use.Lecanemab and Donanemab were officially used in June 2024 and April 2025 in China,respectively.In order to standardize the rational and safe application of anti-amyloid-β monoclonal antibodies for Alzheimer's disease in China,this article integrates recom-mendations from the clinical trials and real-world experience from the author's team and domestic peers to further update the recom-mendations for the clinical use of anti-amyloid-β monoclonal antibody based on the 2024 version.It includes indications for therapy,pre-treatment evaluation and preparation,administration protocols and safety measures during treatment,and post-treatment monitor-ing strategies.

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