1.Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement drug list access application
Qingwen WANG ; Qin AN ; Xiaoyan YUAN ; Yuzhi HAN ; Xi CHEN ; Hongyan WU
China Pharmacy 2026;37(8):985-990
OBJECTIVE To analyze the selection and rationales of comparators for pharmaceutical enterprises in their medical insurance access application, so as to provide a reference for promoting communication and consensus between enterprises and medical insurance authorities in this process. METHODS The application materials for drugs outside the catalogue that passed formal review published by the National Healthcare Security Administration from 2021 to 2025 were extracted, and then content analysis was used to systematically sort out relevant information of the declared drugs and comparators; the specific situations and rationales of pharmaceutical enterprises’ selection of comparators were analyzed. RESULTS A total of 1 341 declared drug documents were collected. Data analysis showed that 1 035 (77.18%) were submitted with positive comparators and 306 (22.82%) used blank comparators; 58 drugs (4.33%) took combination therapy as the reference, and 5 drugs (0.37%) referred to non-pharmacological (or non-single pharmacological) treatment regimens. Among competitive drugs declared by multiple enterprises, 50.00% of the enterprises submitted different comparators. A total of 4 basic conditions and 39 additional conditions were extracted as the rationales for selecting positive comparators. For blank comparators, 12 drug-related factors, 2 administrative factors, and 1 other factor were identified. More than 10% of the drugs did not state the rationale for comparator selection, and over 44% of drugs using blank comparators provided only one justification. CONCLUSIONS Pharmaceutical enterprises mainly select comparators based on their own interests in the medical insurance access application, and there are deficiencies in the adequacy and standardization of their selection basis and reasoning. It is recommended that enterprises follow the principled requirements of medical insurance authorities, and fully and normatively explain the reasons for selecting comparators in combination with the characteristics of their own products. Meanwhile, it is advisable to change the current open-ended statement form of selection reasons into a closed-ended answering mode, so as to highlight the priority of selection, standardize the declaration behavior of enterprises, and reduce communication divergences between the two parties.
2.Genetic Association Between Attention-Deficit/Hyperactivity Disorder and Sarcopenia: A Bidirectional Two-Sample, Two-Step Mendelian Randomized Study
Xiaoyan ZHAO ; Yueqin JIN ; Leping MA ; Xiaole ZHAO ; Xiaoqing FANG ; Fenfang YUAN
Psychiatry Investigation 2025;22(3):304-310
Objective:
Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders in children and adolescents, often accompanied by motor function disorders. Sarcopenia not only has skeletal muscle dysfunction but also has neurocognitive dysfunction. At present, there is no research to explore the relationship between ADHD and skeletal muscle function. The purpose of this study is to explore whether there is a causal effect between ADHD and sarcopenia.
Methods:
In this study, genome-wide association study data of ADHD, appendicular lean mass (ALM), hand grip strength, and walking pace (WP) were extracted from public databases. The bidirectional two-sample Mendelian randomization (MR) method was employed to investigate the correlation between ADHD and sarcopenia-related indicators, and the inverse-variance weighted analysis as the primary analysis method.
Results:
Based on the forward MR analysis, a potential causal relationship exists between ADHD and ALM (odds ratio [OR]=1.020, 95% confidence interval [CI]: 1.012–1.029, p<0.001). The reverse MR analysis indicates a link between WP and the risk of ADHD (OR=2.712, 95% CI: 1.609–4.571, p<0.001), with an accelerated WP increasing the likelihood of ADHD. Nevertheless, other MR analysis results did not show significant differences.
Conclusion
The findings of this study indicate an intricate causal relationship between ADHD and sarcopenia, suggesting the absence of a clear link. WP may be used as one of the indicators to evaluate the risk of ADHD. At the same time, we should pay more attention to the ALM of ADHD patients.
3.Longitudinal changes of symptoms and nursing strategies of patients under daytime lung cancer surgery after discharge
Nafei HAN ; Hong HE ; Huadi YUAN ; Meijuan LAN ; Xiaoyan WU ; Junhua CAO ; Liyan GAO ; Dingjie XIN
Chinese Journal of Nursing 2025;60(4):432-438
Objective To explore the longitudinal changes of symptoms after discharge in patients with daytime lung cancer surgery by factor analysis,in order to strengthen nursing countermeasures and improve the quality of life of patients.Methods Patients who underwent day surgery in the thoracic surgery department of a tertiary general hospital in Zhejiang Province from October 2023 to January 2024 were selected using convenience sampling.On the 1st,3rd,14th and 30th day after discharge,the general information questionnaire and the postoperative symptom inventory for patients with lung cancer were used for investigation.Exploratory factor analysis was performed to extract the symptom clusters.Results A total of 227 patients were followed up in this study,including 19 shed cases and 2 excluded cases,and 206 patients were finally included.The percentage of the 9 major symptoms of patients with daytime lung cancer surgery after discharge showed dynamic changes.The highest percentage symptom on the 1st day after discharge was pain in 197 cases(95.63%).The highest percentage on the 30th day after discharge was cough in 129 cases(62.62%).The results of exploratory factor analysis were P<0.001 and KMO>0.500 for Bartlett's test of sphericity on days 1,3,and 14 after discharge,except for P=0.874 and KMO=0.495 on day 30,with digestive and respiratory symptom clusters on day 1;respiratory,digestive,and fatigue symptom clusters on day 3;fatigue and respiratory symptom clusters on day 14.Conclusion The single symptom and symptom clusters of patients with daytime lung cancer surgery after discharge showed dynamic changes at different time points.Therefore,in clinical work,targeted intervention strategies should be adopted,and precise symptom management should be implemented according to the characteristics of symptom clusters in different periods of discharge of patients undergoing daytime lung cancer surgery,so as to reduce the symptom burden of patients.
4.Current status and reflections on the prevention and treatment of metabolic associated fatty liver disease through different fasting patterns
Huaxin CHEN ; Wenxia ZHAO ; Jiachen YUAN ; Yuzhu ZHENG ; Yaokun HAO ; Xiaoyan LIU
Journal of Clinical Hepatology 2025;41(8):1643-1648
The incidence rate of metabolic associated fatty liver disease(MAFLD)is gradually increasing,and it has become a common chronic liver disease globally.MAFLD is closely associated with metabolic dysfunction,with dietary and exercise interventions as the primary treatment method,among which dietary control is of particular importance.This article summarizes related articles on the prevention and treatment of MAFLD through different fasting patterns in recent years,and the analysis showed that by restricting food intake and controlling calorie consumption,fasting therapy can help to reduce body weight and improve metabolic disorders.Further studies and clinical practice are needed to explore and validate the value of different fasting patterns in the prevention and treatment of MAFLD.
5.The value of amide proton transfer imaging combined with diffusion weighted imaging in neurovascular invasion of stage T3/T4 rectal cancer
Peiqi MA ; Xiaoyan ZHANG ; Xu LI ; Bin PENG ; Shubao SUN ; Yushan YUAN ; Xingwang WU
Journal of Practical Radiology 2025;41(8):1324-1328
Objective To explore the value of amide proton transfer(APT)imaging combined with diffusion weighted imaging(DWI)in the assessment of neurovascular invasion(NVI)of stage T3/T4 rectal cancer.Methods The clinical and MR imaging data of 46 patients with rectal cancer were analyzed retrospectively and divided into NVI positive group and NVI negative group according to the pathological results of NVI.The differences of APT values[maximum APT(APTmax)value,minimum APT(APTmin)value,mean APT(APTmean)value]and apparent diffusion coefficient(ADC)value between the two groups were compared,and the diagnostic efficiency was analyzed by receiver operating characteristic(ROC)curve.Results The APTmax and APTmean values in the NVI positive group were significantly higher than those in the NVI negative group,while the ADC value in the NVI positive group was significantly lower than that in the NVI negative group(P<0.05).The area under the curve(AUC)of APTmax,APTmean and ADC values for NVI identification were 0.717,0.722 and 0.751,respectively.The AUC of the three indexes combined to identify NVI was 0.858.The combined AUC of the three indexes was larger than that of APTmax,APTmean and ADC alone(P<0.05).Conclusion APT imaging combined with DWI has a high value in the evaluation of NVI of stage T3/T4 rectal cancer,which can provide guidance for clinical treatment.
6.The decolorization efficiency and influencing factors of low-temperature plasma on crystal violet wastewater
Xiaoyan LI ; Jinren LIU ; Jiajia LU ; Xingmin SHI ; Wang YUAN
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(1):12-19
Objective To investigate the decolorization performance and key influencing factors of a novel low temperature plasma(LTP)on crystal violet(CV)simulated wastewater.Methods In this experiment,CV was used as the target pollutant and treated with LTP generated by argon atmospheric pressure plasma jet;the absorbance(A590)and chemical oxygen demand(COD)of CV solution were systematically evaluated before and after LTP treatment by adjusting the treatment volume,initial pH value,NaCl concentration,addition of Fe 2+and other parameters.The dynamic changes of active particles in the liquid were monitored.Results Compared with those of the control group,the A590 and COD values of LTP treatment groups were significantly reduced(P<0.05).At the treatment time of 180 s,the decolorization rate and COD removal rate of CV solution reached 62.34%and 50.22%,respectively.Under the same treatment time(>90 s),the A590 values in the 0.1 mol/L NaCl group,pH=9 or 11 group,and Fe2+group were lower than those in LTP-only treatment group,but the A590 values in the n-butanol group were higher(P<0.05).The A590 values in 2 mL or 3 mL group were higher than those in 1 mL group(P<0.05).Compared with CV solution treated with LTP,the H2O2 content in the activated water was higher while the NO3content was significantly lower than those in CV solutions(P<0.05).Conclusion LTP has an efficient decolorization ability for CV solution.The decolorization of CV solution could be promoted by NaCl addition,Fe2+inclusion or high pH values,but was inhibited by the increase in treatment volume or the addition of n-butanol.The?OH and H2O2 generated by LTP played a key role in the decolorization process.
7.Complication of transoral robotic surgery: single institution study
Haitao XIAO ; Yabing ZHANG ; Xiaoyan YUAN ; Bin ZHANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2025;60(3):300-304
Objective:To investigate the complications of transoral robotic surgery (TORS) and to identify the risk factors for the complications.Methods:This was a retrospective study of 134 cases of head and neck tumors underwent TORS at the Department of Surgery of Beijing United Family Hospital from September 2017 to June 2024. There were 9 cases of benign tumors and 125 cases of malignant tumors, including 119 squamous cell carcinomas, 3 adenocarcinomas, 2 lymphomas, and 1 sarcoma. There were 37 cases of pure TORS and 96 cases of TORS combined with neck dissection. Postoperative complications within 90 days were collected and graded with the Clavien-Dindo system. χ2 test was used for statistical analysis. Results:A total of 25 (18.7%) cases experienced surgical complications, including 9 cases with Clavien-Dindo grade≥Ⅲ complications. Postoperative complications included 2 cases of death, 3 cases of massive hemorrhage, 3 cases of pharyngeal fistula, 2 cases of aspiration pneumonia, 2 cases of minor bleeding, 1 case of tooth injury, 1 case of arytenoid dislocation, 2 cases of tongue laceration, and 10 cases of long-term (>3 months) tracheostomy open. Postoperative pharyngeal fistula was significantly correlated with the scope of neck dissection ( χ2=9.86, P<0.05), and Clavien-Dindo grade≥Ⅲ complications were significantly correlated with the scope of neck dissection ( χ2=13.91, P<0.05) and tumor N stage ( χ2=14.33, P<0.05). Conclusion:The high N-stage and neck dissection involving more than three regions are risk factors for the complications of TORS for head and neck tumors.
8.Therapeutic effects of adeno-associated virus-mediated hepatic lipoprotein lipase expression on hypertriglyceridemic acute pancreatitis mice
Yao XU ; Chenchen YUAN ; Guotao LU ; Xiaoyan DONG ; Xiaobing WU ; Guoqing LIU ; Baiqiang LI ; Weiqin LI
Chinese Journal of Pancreatology 2025;25(1):50-56
Objective:To investigate the therapeutic effects of adeno-associated virus vector 5 (AAV5)-mediated hepatic lipoprotein lipase (LPL) expression on serum triglyceride (TG) metabolism and hypertriglyceridemic acute pancreatitis (HTG-AP) in mice.Methods:Ten male C57BL/6 Lpl+/- mice were randomly divided into two groups by a random number table: the Lpl+/- control group and the Lpl+/- gene therapy group, with five mice in each group. The Lpl+/- control group received a tail vein injection of AAV5 vector carrying the enhanced green fluorescent protein (EGFP) gene (AAV5-EGFP), while the Lpl+/- gene therapy group received a tail vein injection of AAV5 vector carrying the human LPLS447X gene (AAV5-LPLS447X). Oral fat tolerance tests were performed at 14, 28, and 56 days post-injection. Twenty wild-type ICR mice were randomly divided into a control group and a gene therapy group, with ten mice in each group. The ICR control group was injected with AAV5-EGFP, and the ICR gene therapy group was injected with AAV5-LPLS447X. Fourteen days after injection, the mice underwent intraperitoneal injection of P407 solution (0.5 g/kg) and caerulein (200 μg/kg) to induce HTG-AP. Serum TG, total cholesterol (TC), amylase, lipase levels, and plasma LPL activity after heparin injection were measured by microplate reader. Plasma LPL concentration was measured using an enzyme-linked immunosorbent assay (ELISA). LPL mRNA expression levels in the liver, heart, and adipose tissue of Lpl+/- mice were determined by quantitative reverse-transcription polymerase chain reaction (qRT-PCR). LPL protein expression in the liver tissue of ICR mice was detected by immunohistochemistry at 28 days after gene therapy. Histopathological changes in the pancreas were observed using hematoxylin-eosin staining. Results:Compared to the Lpl+/- control group, the Lpl+/- gene therapy group showed a significant decrease in serum TG levels starting from day 21. After oral administration of olive oil, the increase and peak of serum TG levels were significantly lower than those in the control group. Furthermore, hepatic LPL mRNA expression levels were significantly higher (1.96±0.11 vs 1.02±0.12) with statistical significance ( P<0.05). Compared to the ICR control group, the ICR gene therapy group showed a significant decrease in serum TG and TC levels, and plasma LPL activity (0.17±0.05 mEq/L·h -1vs 0.06±0.02 mEq/L·h -1) was significantly higher at 28 days after heparin injection with statistical significance (all P value <0.05). Immunohistochemical results showed high expression of LPL protein on the hepatocyte membrane in the liver of ICR gene therapy group mice. Moreover, pancreatic edema, inflammatory infiltration, and acinar cell necrosis were significantly alleviated compared to the control group. Conclusions:LPLS447X treatment can promote LPL expression in the liver of mice, significantly reduce TG levels, and alleviate the severity of HTG-AP.
9.Comparison of efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children: a multicenter, randomized, controlled clinical trial
Xing XIAO ; Shan WANG ; Huan YANG ; Hong SHU ; Yanping GUO ; Jinping CHEN ; Yao LU ; Qinfeng LI ; Yuan LIANG ; Mutong ZHAO ; Xiaoyan LUO ; Limin MIAO ; Rui XU ; Xuemei LI ; Sha LAI ; Jianhong LI ; Zhen LUO ; Lu YU ; Lu XING ; Meitan WANG ; Xiaoli LI ; Haitao XU ; Ping LI ; Hua WANG ; Lin MA
Chinese Journal of Dermatology 2025;58(5):425-430
Objective:To compare the efficacy and safety of crisaborole ointment 2% versus pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged 2 years or older.Methods:A multicenter, randomized, open-label, controlled clinical trial was conducted. A total of 120 pediatric patients aged 2 - 17 years with mild to moderate atopic dermatitis were enrolled from departments of dermatology of 8 hospitals in China between March 2022 and February 2023. The participants were randomly assigned in a 1∶1 ratio to the crisaborole group and the pimecrolimus group, and received the treatment with crisaborole ointment 2% and pimecrolimus cream 1% respectively, twice a day for 4 weeks. Visits were scheduled at baseline/on day 1, as well as on days 8, 15, and 29. The primary efficacy outcome was the percentage of patients achieving the Investigator's Static Global Assessment (ISGA) success (defined as clear [0] or almost clear [1] on the ISGA scale, combined with ≥ 2‐grade improvement from baseline) on day 29. The secondary efficacy outcomes included changes in the Eczema Area and Severity Index (EASI) total scores from baseline to day 29, percentages of patients achieving ISGA improvement (defined as clear [0] or almost clear [1] on the ISGA scale), as well as changes in the Peak Pruritus Numerical Rating Scale (NRS) scores, Dermatology Life Quality Index (DLQI) /Infants' Dermatology Life Quality Index (IDLQI) /Children's Dermatology Life Quality Index (CDLQI) scores, and in the Dermatitis Family Impact (DFI) scores. Drug safety was evaluated according to the incidence of adverse events. Categorical data were compared using the chi-square test. Since measurement data did not follow a normal distribution, the rank sum test was used for comparisons of measurement data between groups.Results:A total of 106 children with mild to moderate atopic dermatitis were included in the per-protocol analysis set, with 52 in the crisaborole group (26 males and 26 females) and 54 in the pimecrolimus group (27 males and 27 females). There were no significant differences in age, disease duration, ISGA and EASI scores at baseline between the two groups (all P > 0.05). On day 29, 22 patients (42.31%) in the crisaborole group and 25 (46.30%) in the pimecrolimus group achieved ISGA success, with no significant difference between the two groups ( χ2 = 0.17, P = 0.68) ; 35 patients (67.31%) in the crisaborole group and 45 (83.33%) in the pimecrolimus group achieved ISGA improvement, also with no significant difference between the two groups ( χ2 = 3.68, P = 0.06) ; additionally, there were no significant differences in the EASI, pruritus NRS, DLQI/IDLQI/CDLQI, or DFI scores between the two groups (all P > 0.05). Adverse reactions to the two topical agents were mainly local reactions such as mild to moderate pain, itching, or worsening of itching, and no obvious systemic adverse reactions occurred. The incidence of drug-related adverse reactions was 46.15% (24 cases) in the crisaborole group and 37.04% (20 cases) in the pimecrolimus group, with no significant difference between the two groups ( χ2 = 0.91, P = 0.34) . Conclusion:The efficacy of crisaborole ointment 2% was comparable to that of pimecrolimus cream 1% in the treatment of mild to moderate atopic dermatitis in children aged ≥ 2 years, and it yielded early and rapid improvement in the quality of life of patients and their families, with good safety and tolerability profiles.
10.Current status and reflections on the prevention and treatment of metabolic associated fatty liver disease through different fasting patterns
Huaxin CHEN ; Wenxia ZHAO ; Jiachen YUAN ; Yuzhu ZHENG ; Yaokun HAO ; Xiaoyan LIU
Journal of Clinical Hepatology 2025;41(8):1643-1648
The incidence rate of metabolic associated fatty liver disease(MAFLD)is gradually increasing,and it has become a common chronic liver disease globally.MAFLD is closely associated with metabolic dysfunction,with dietary and exercise interventions as the primary treatment method,among which dietary control is of particular importance.This article summarizes related articles on the prevention and treatment of MAFLD through different fasting patterns in recent years,and the analysis showed that by restricting food intake and controlling calorie consumption,fasting therapy can help to reduce body weight and improve metabolic disorders.Further studies and clinical practice are needed to explore and validate the value of different fasting patterns in the prevention and treatment of MAFLD.

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