1.STAR Guideline Terminology(Ⅱ): Clinical Question Formulation, Evidence Retrieval and Appraisal, and Recommendation Development
Di ZHU ; Haodong LI ; Zijun WANG ; Qianling SHI ; Hui LIU ; Yishan QIN ; Yuanyuan YAO ; Zhewei LI ; Hongfeng HE ; Jinhui TIAN ; Long GE ; Yaolong CHEN ;
Medical Journal of Peking Union Medical College Hospital 2025;16(3):756-764
To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development. A systematic search was conducted in guideline development manuals and relevant methodological literature, covering publications up to October 25, 2024. Terminology related to the three aforementioned stages of related to guideline development was extracted from the included literature, standardized, and refined through consensus meetings to finalize a comprehensive terminology list and definitions. A total of 30 guideline development manuals and 15 methodological articles were included, and 23 core terms were identified. It is recommended to develop a standardized and scientifically sound guideline terminology system with unified naming, clear definitions, and alignment with the linguistic environment and usage habits in China. At the same time, it is essential to strengthen terminology training for both guideline developers and users based on this system, in order to deepen their correct understanding and proper application of guideline terminology.
2.Clinical characteristics of severe acute respiratory syndrome coronavirus 2 vaccine breakthrough infections in children
Fu WEI ; Jian WANG ; Xiaofeng LI ; Xinyuan HE ; Yishan LIU ; Xiaoqin HU ; Huan DENG ; Ying WANG ; Ning GAO ; Hong DU ; Sirui MA ; Fanpu JI
Chinese Journal of Infectious Diseases 2023;41(1):58-63
Objective:To analyze the clinical characteristics of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine breakthrough infections in children, and to provide reference basis for the SARS-CoV-2 vaccination in children.Methods:A total of 97 children aged 3 to 14 years and diagnosed with coronavirus disease 2019 (COVID-19) admitted to Xi′an People′s Hospital (Xi′an Fourth Hospital) from December 27, 2021 to February 7, 2022 were included. According to the COVID-19 vaccination status, the enrolled children were divided into unvaccinated group, partially vaccinated group and fully vaccinated group, and the clinical data of the children in the three groups were collected and compared. Chi-square test, two independent sample t-test and Kruskal-Wallis H test were used for statistical analysis. Results:Totally 97 children including 49 males and 48 females were enrolled, with 87(89.7%) children of mild type, 10(10.3%) children of common type, and no severe or critical case. The proportions of unvaccinated, partially vaccinated and fully vaccinated preschool-aged children (3 to 6 years old) were 56.5%(13/23), 30.8%(12/39) and 17.1%(6/35), respectively, while those of school-aged children (7 to 14 years old) were 43.5%(10/23), 69.2%(27/39) and 82.9%(29/35), respectively. The vaccination proportion in preschool-aged children was significantly lower than that in school-age children ( χ2=9.94, P=0.007). The proportion of the children with fever in fully vaccinated group was 17.1%(6/35), which was lower than that in unvaccinated group (43.5%, 10/23), and the difference was statistically significant ( χ2=4.82, P=0.028). The cycle threshold (Ct) values of the open reading frame ( ORF)1 ab gene in the unvaccinated, partially vaccinated and fully vaccinated groups were 33.77(26.87, 36.58), 35.23 (33.45, 38.57) and 37.12 (34.91, 39.39), respectively, and there was a statistically significant difference among the groups ( H=7.76, P=0.021). The Ct values of the nucleocapsid protein ( N) gene in the three groups were 32.26(25.85, 36.18), 35.12(33.18, 37.96) and 37.26(34.27, 39.24), respectively, and the difference among the groups was statistically significant ( H=7.84, P=0.020). The Ct values of ORF1 ab gene and N gene in fully vaccinated group were higher than those in unvaccinated group, and the differences were statistically significant ( Z=-2.69, P=0.007 and Z=-2.39, P=0.017, respectively). The duration of viral shedding in fully vaccinated children was (9.9±4.1) d, which was shorter than that in unvaccinated children ((12.8±3.7) d), and the difference was statistically significant ( t=2.72, P=0.009). Conclusions:The majority of children with breakthrough infections with SARS-CoV-2 are mild. Vaccination may effectively shorten the duration of viral shedding. And fully vaccination is associated with mild clinical symptoms and lower serum viral load compared to unvaccinated children.
3.Aristolochic acids exposure was not the main cause of liver tumorigenesis in adulthood.
Shuzhen CHEN ; Yaping DONG ; Xinming QI ; Qiqi CAO ; Tao LUO ; Zhaofang BAI ; Huisi HE ; Zhecai FAN ; Lingyan XU ; Guozhen XING ; Chunyu WANG ; Zhichao JIN ; Zhixuan LI ; Lei CHEN ; Yishan ZHONG ; Jiao WANG ; Jia GE ; Xiaohe XIAO ; Xiuwu BIAN ; Wen WEN ; Jin REN ; Hongyang WANG
Acta Pharmaceutica Sinica B 2022;12(5):2252-2267
Aristolochic acids (AAs) have long been considered as a potent carcinogen due to its nephrotoxicity. Aristolochic acid I (AAI) reacts with DNA to form covalent aristolactam (AL)-DNA adducts, leading to subsequent A to T transversion mutation, commonly referred as AA mutational signature. Previous research inferred that AAs were widely implicated in liver cancer throughout Asia. In this study, we explored whether AAs exposure was the main cause of liver cancer in the context of HBV infection in mainland China. Totally 1256 liver cancer samples were randomly retrieved from 3 medical centers and a refined bioanalytical method was used to detect AAI-DNA adducts. 5.10% of these samples could be identified as AAI positive exposure. Whole genome sequencing suggested 8.41% of 107 liver cancer patients exhibited the dominant AA mutational signature, indicating a relatively low overall AAI exposure rate. In animal models, long-term administration of AAI barely increased liver tumorigenesis in adult mice, opposite from its tumor-inducing role when subjected to infant mice. Furthermore, AAI induced dose-dependent accumulation of AA-DNA adduct in target organs in adult mice, with the most detected in kidney instead of liver. Taken together, our data indicate that AA exposure was not the major threat of liver cancer in adulthood.
4.Clinical observation of combined oral contraceptives drospirenone and ethinylestradiol tablets (Ⅱ) in the treatment of dysmenorrhea in Chinese women
Xiaoyu LI ; Fangbo QIAN ; Yaojuan HE ; Xuesong ZHANG ; Yishan ZHANG ; Chengzhen HOU ; Wen DI ; Xiangying GU
Chinese Journal of Obstetrics and Gynecology 2021;56(10):684-690
Objective:To evaluate the efficacy and safety of drospirenone and ethinylestradiol tablets (Ⅱ) in Chinese women with dysmenorrhea.Methods:This was a single-arm, open-label, interventional, multicenter, post-authorization safety/effectiveness study of drospirenone and ethinylestradiol tablets (Ⅱ) across 6 treatment cycles, a total of 526 patients were included in the dysmenorrhea subgroup. Visual analog scale (VAS) was used to assess the severity of menstrual pain. Secondary outcomes included unintended pregnancies, bleeding pattern, cycle control and safety.Results:After treated with drospirenone and ethinylestradiol tablets (Ⅱ), VAS of pain had decreased significantly compared with baselines [(49.5±23.7) vs (32.3±24.9) vs (20.7±19.4) vs (18.4±18.7) mm, P<0.01]. From the second cycle to the fifth cycle, the incidence of scheduled bleeding increased from 93.9% (450/479) to 96.4% (431/447). The duration of scheduled bleeding decreased from (5.7±2.7) to (5.4±1.8) days. The incidence of intermenstrual bleeding decreased from 9.0% (43/479) to 5.6% (25/447). 17.5% (92/526) patients reported adverse drug reactions, most frequently reported adverse events were breast pain, nausea, breast swelling, headache, and uterine bleeding. No death occurred during the study. Conclusion:Drospirenone and ethinylestradiol tablets (Ⅱ) is effective for the treatment of dysmenorrhea and has good safety.
5. Overview of hot issues in breast cancer surgery
International Journal of Surgery 2020;47(1):45-48
Surgical treatment is still an important treatment method for comprehensive breast cancer treatment. The surgical method of breast cancer has also changed from traditional radical surgery to breast-conserving radical surgery. In recent years, the safety and effectiveness of breast-conserving radical mastectomy for breast cancer have been widely recognized; plastic surgery after breast-conserving radical mastectomy can help patients reshape their appearance and return to normal life with confidence. With the renewal of the treatment concept and the progress of life, breast cancer surgical treatment has entered the era of individualized plastic surgery. This article discusses the hot issues of breast cancer surgery in recent years.
6. Specifications for diagnosis and treatment of non-neonatal tetanus
Chuanlin WANG ; Si LIU ; Qingjun CHEN ; Zhujun SHAO ; Jifeng WU ; Zhao FAN ; Peige WANG ; Zhenggang ZHU ; Pin LAN ; Jianguo LI ; Yishan ZHENG ; Wubing HE ; Zhe XU ; Weidong TANG ; Jinman PANG ; Zhihong BAN ; Shuqing YANG ; Wentao DING ; Xifu ZHENG ; Qilong ZHANG
Chinese Journal of Trauma 2020;36(1):18-23
Tetanus consists of neonatal tetanus and non-neonatal tetanus. Non-neonatal tetanus remains a serious public health problem, although neonatal tetanus has been eliminated in China since 2012. Non-neonatal tetanus is a potential fatal disease. In the absence of medical intervention, the mortality rate of severe cases is almost 100%. Even with vigorous treatment, the mortality rate remains 30%-50% globally. These specifications aim to regulate non-neonatal tetanus diagnosis and treatment in China, in order to improve medical quality and safety. These specifications introduce the etiology, epidemiology, pathogenesis, clinical manifestations and laboratory tests, diagnosis, differential diagnosis, grading and treatment of non-neonatal tetanus.
7.Specifications for diagnosis and treatment of non-neonatal tetanus
Chuanlin WANG ; Si LIU ; Qingjun CHEN ; Zhujun SHAO ; Jifeng WU ; Zhao FAN ; Peige WANG ; Zhenggang ZHU ; Pin LAN ; Jianguo LI ; Yishan ZHENG ; Wubing HE ; Zhe XU ; Weidong TANG ; Jinman PANG ; Zhihong BAN ; Shuqing YANG ; Wentao DING ; Xifu ZHENG ; Qilong ZHANG
Chinese Journal of Epidemiology 2020;41(2):162-166
Tetanus consists of neonatal tetanus and non-neonatal tetanus.Non-neonatal tetanus remains a serious public health problem,although neonatal tetanus has been eliminated in China since 2012.Non-neonatal tetanus is a potential fatal disease.In the absence of medical intervention,the mortality rate of severe cases is almost 100%.Even with vigorous treatment,the mortality rate is still 30%-50% globally.These specifications aim to regulate non-neonatal tetanus diagnosis and treatment in China,in order to improve medical quality and safety.These specifications introduce the etiology,epidemiology,pathogenesis,clinical manifestations and laboratory tests,diagnosis,differential diagnosis,grading and treatment of non-neonatal tetanus.
8. Specifications for diagnosis and treatment of non-neonatal tetanus
Chuanlin WANG ; Si LIU ; Qingjun CHEN ; Zhujun SHAO ; Jifeng WU ; Zhao FAN ; Peige WANG ; Zhenggang ZHU ; Pin LAN ; Jianguo LI ; Yishan ZHENG ; Wubing HE ; Zhe XU ; Weidong TANG ; Jinman PANG ; Zhihong BAN ; Shuqing YANG ; Wentao DING ; Xifu ZHENG ; Qilong ZHANG
Chinese Journal of Preventive Medicine 2019;53(12):1206-1211
Tetanus consists of neonatal tetanus and non-neonatal tetanus. Although neonatal tetanus in China has been eliminated since 2012, non-neonatal tetanus remains a serious public health problem. Non-neonatal tetanus is a potential fatal disease, and the mortality rate of severe cases is almost 100% in the absence of medical intervention. Even with vigorous treatment, the mortality rate is still 30~50% globally. In order to standardize the diagnosis and treatment of non-neonatal tetanus in China, this specification is hereby formulated. This standard includes etiology, epidemiology, pathogenesis, clinical manifestations, laboratory tests, diagnosis, differential diagnosis, classification, grading and treatment of non-neonatal tetanus.
9.Establishment and Application of DUE Criteria for Tigecycline in a Hospital
Guifeng WANG ; Xueqin LI ; Ruifeng LIU ; Yunjing LI ; Yishan LI ; Huiqing HE
China Pharmacy 2017;28(14):1892-1895
OBJECTIVE:To establish drug use evaluation(DUE)criteria for tigecycline,and to provide reference for rational use of tigecycline. METHODS:Based on tigecycline instructions,referring to related specifications and literatures,DUE criteria for tigecycline was established. And on a basis of it,referring to DUE criteria,in retrospective study,the utilization of tigecycline in 179 inpatients of some one hospital during Nov. 2012-Oct. 2016 was evaluated and analyzed in respects of management indexes, medication indication,medication duration,medication results,etc. RESULTS:The results for DUE of tigecycline in this hospital was that the proportion of patients with consultation records was 83.2%(aiming at 100%);microbial inspection rate was 90.5%(aiming at 80%);the coincidence rate of medication indication was 98.9%(aiming at 90%);the rates of solvent selection,ad-ministration route,drug interaction,incompatibility,drug use in special populations meeting the criteria were all 100%(aiming at 100%);the rate of prescribing authority was 20.1%(aiming at 100%);the rate of drug dosage and medication interval meeting the criteria were 7.3%(aiming at 100%);response rate was 54.7%(aiming at 80%). CONCLUSIONS:Established DUE criteria of tigecycline can standardize the clinical utilization of tigecycline.
10.Effect of palonosetron in preventing chemotherapy-induced vomiting
Zhongsheng TONG ; Shufen LI ; Rongsheng ZHENG ; Zhiyong HE ; Lili ZHANG ; Xuenong OUYANG ; Jinfei CHEN ; Hao YU ; Yehui SHI ; Xu WANG ; Xiaoxin LI ; Yishan ZHANG
Chinese Journal of Clinical Oncology 2014;(20):1323-1327
Objective:To evaluate the efficacy and safety of palonosetron in preventing chemotherapy-induced vomiting. Meth-ods:A multi-center, randomized, double-blind, and self-cross-over positively controlled clinical trial design was used. All patients were randomized into two groups, as follows:Regiment A (61 cases) and Regiment B (64 cases). Regimen A with palonosetron hydrochlo-ride injection (test agent) was used in the treatment cycle A, whereas granisetron hydrochloride injection (control drug) was used in the cycle B. Treatments were randomly administered on the patients of the two groups. Regimen B was on the contrary, the control drug was used in the cycle A, and the test agent was used in the treatment cycle B. All patients treated with the test agent were classified as the test group, whereas those treated with the control drug were classified as the control group. Complete control rate and adverse reac-tion of acute and delayed vomiting in the two groups during the two cycles of chemotherapy regimen were compared. Results: In Group One, the complete control rate of delayed vomiting was significantly higher in the palonosetron administration cycles than in the granisetron cycles (76.92%vs. 55.38%, P=0.0110). In the same group, the frequency of vomiting was significantly less in palonosetron cycles than in the granisetron cycles during day 1 to day 5 (1.32±3.42 vs. 1.94±3.03, P=0.0096). The incidences of adverse effects were low in both groups. No grades 3 and 4 adverse effects were observed. Conclusion: Palonosetron showed efficacy in preventing the acute and delayed chemotherapy-induced vomiting. The drug is superior to granisetron, specifically in delaying vomiting in Group One. Palonosetron hydrochloride showed slight adverse effects. Hence, this drug can be used in clinic.

Result Analysis
Print
Save
E-mail