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.Guidelines for the perioperative diagnosis and treatment of oncogene-driven non-small cell lung cancer (2026)
Weidong WANG ; Yongbin LIN ; Hui TIAN ; Gaofeng LI ; Shun XU ; Yongde LIAO ; Haitao MA ; Junfeng LIU ; Chundong GU ; Xiaolong YAN ; Shumin WANG ; Daqiang SUN ; Jianyang LIU ; Tao XUE ; Shaohua MA ; Zhigang LI ; Shuanghu YUAN ; Gen LIN ; Ling CAI ; Jianping ZHOU ; Wenzhao ZHONG ; Naixin LIANG ; Yi HAN ; Junfeng WANG ; Weidong ZHANG ; Xin WANG ; Lianjuan CHEN ; Lunxu LIU ; Xiuyi ZHI ; Lanjun ZHANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(09):1337-1353
Lung cancer constitutes the most prevalent and lethal malignant tumor in China. Approximately 85% of lung cancer diagnoses correspond to the non-small cell histological subtype [non-small cell lung cancer (NSCLC)]. Despite surgery being the mainstay for early-stage disease, postoperative recurrence remains high and adjuvant chemotherapy offers limited benefit. In recent years, targeted therapy has demonstrated substantial advantages in driver mutation-positive NSCLC. To this end, the Lung Cancer Medical Education Committee of the Chinese Medical Education Association developed guidelines based on a systematic review of evidence through November 2025, using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach and a modified Delphi method. Focusing on epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK), and addressing ROS proto-oncogene 1 (ROS1), B-Raf proto-oncogene serine/threonine kinase (BRAF) V600E mutation, and mesenchymal-epithelial transition factor (MET) exon 14 (METex14) skipping, the guideline covers molecular testing, neoadjuvant/adjuvant therapy, perioperative strategies, minimal residual disease monitoring, and postoperative surveillance. It defines testing requirements, specifies stage-directed and subtype-specific treatments, and standardizes minimal residual disease monitoring. These recommendations emphasize precision and feasibility to improve survival and quality of life.
3.Differentiation and Treatment of Coronary Heart Disease from the Perspective of "Guarding the Channel Passages" Based on Circadian Rhythm
Jingjing ZHAO ; Yuanyuan CHEN ; Lanlan LI ; Xiaoqing ZHANG ; Ran ZHAO ; Shujuan XU ; Han PENG ; Lingmei LI ; Hao GUO ; Jianhua FU
Journal of Traditional Chinese Medicine 2026;67(18):1977-1981
Coronary heart disease (CHD) has a distinct circadian rhythmicity in its onset, which is closely related to the waxing and waning of qi and blood in the channel passages of the human body. Grounded in the circadian rhythm theory of "correspondence between heaven and humankind", this paper explores the pathogenic evolution rules of qi-blood disharmony, channel obstruction, interacting as cause and effect with circadian rhythm disorders in CHD. Clinically, CHD can be observed to attack in the early morning, at night, in the afternoon, and at fixed or unfixed circadian intervals. The pathogenesis rhythms at different time nodes can correspondingly reflect the susceptibility tendencies and pathological stress responses of the human body to core pathogeneses such as yang deficiency with cold congelation, yin deficiency with yang floating, qi and yin deficiency, and liver constraint with qi stagnation under specific temporal states. Treatment should be adapted to the season and time, regulating yin and yang in accordance with biological rhythms. It is recommended to regulate qi during the daytime by promoting ascending and dispersing to unblock the channel passages, and select the appropriate timing for administration to harness natural timing. At the Mao (卯) hour, yang ascends while yin descends, and taking medication at this time conforms to the ascending of yang qi. At the Wu (午) hour, the heart meridian is active, and taking medication at this time warms the channel passages and assists heart yang, which can be treated with modified Buzhong Yiqi Decoction (补中益气汤) or Shengyang Yiwei Decoction (升阳益胃汤). At night, blood should be harmonized, when the channel passages are unblocked through nourishing, restraining, and searching, with Lianmei Decoction (连梅汤) combined with Dahuang Zhechong Pill (大黄䗪虫丸). Following the temporal rhythm, the focus is put on the transitional time of day and night and the four seasons to treat disease before it arises, resonating and corresponding with the natural rhythm.
4.Association Between the Triglyceride High-density Cholesterol-glucose Body Index and Gestational Giabetes Mellitus
Qingqing WANG ; Yuan ZHANG ; Peiling GUO ; Xiaodan CHEN ; Zhenyan HAN
Journal of Sun Yat-sen University(Medical Sciences) 2026;47(4):699-708
ObjectiveTo explore the relationship between triglyceride high-density cholesterol-glucose body index (TyHGB) and gestational diabetes mellitus (GDM). MethodsThis single-center retrospective cohort study was conducted. A total of 723 singleton pregnant women who received prenatal care and delivered at Lingnan Hospital, the Third Affiliated Hospital of Sun Yat-sen University, from May 2024 to July 2024 were enrolled. Clinical baseline data and laboratory test results in the first trimester (before 13+6 weeks of gestation) were collected. Based on the tertiles of the TyHGB index were equally divided into 3 groups. Clinical baseline data, and GDM risk were compared among the three groups. ResultsCompared with the control group, the GDM group had older maternal age, higher Pre-pregnancy BMI, FPG, TG, and higher values of 75 g OGTT fasting plasma glucose, 1 h plasma glucose, and 2 h plasma glucose. The early-pregnancy TyHGB index, andincidence of macrosomiawere all higher in the GDM group than in the control group ( all P<0.05), whereas gestational weight gain (GWG) was lower than that of the control group (P<0.05). The individuals were divided into three groups according to the tertiles of the TyHGB index. Significantly differences were identified among TyHGB index tertiles in maternal age, parity, Pre-BMI, FPG, TC, TG, HDL-C, LDLL-C, Ur, 75 g OGTT fasting plasma glucose, 1 h plasma glucose, 2 h plasma glucose, GWG, neonatal birth weight, GDM, GH, macrosomia incidence, and cesarean section rate(all P<0.05). Further trend test analysis found that matenal age, parity, Pre-BMI, FPG, TC, TG, LDL-C, 75 g OGTT_FPG, 75 g OGTT_1 h PG and 75 g OGTT_2 h PG level, neonatal birth weight, GDM, GH, incidence of macrosomia and cesarean section rate all showed an upward trend. The multivariate Logistic regression models revealed that there was an independent positive correlation between TyHGB index and the risk of GDM. Curve fitting by restricted cubic splines (RCS) were used to assess linearity between TyHGB and GDM, and there was a linear dose-response relationship between TyHGB and GDM (P nonlinear test = 0.597). The threshold value for early pregnancy TyHGB index to predict GDM was 6.449 , with an area under the curve (AUC) of 0.644 (95% CI: 0.597-0.691), sensitivity of 0.480 , and specificity of 0.779. After adjusting for maternal age, Pre-BMI, family history of diabetes, and history of GDM, the AUC for the early pregnancy TyHGB index to predict GDM was 0.672 (95% CI: 0.626-0.718). ConclusionThe early-pregnancy TyHGB index is independently associated with GDM risk, and exhibits a linear dose-response relationship with GDM. It may serve as an early screening and monitoring tool for pregnant women at high risk of GDM. However, its predictive value for GDM requires further validation.
5.Clinical application of hemostatic drugs in special populations:an expert consensus
Lizhu HAN ; Yuan BIAN ; Qinan YIN ; Siying CHEN ; Feifei YU ; Jing CHEN ; Xingxing CUI ; Yiding TANG ; Xin YAO ; Hongxi LIU ; Shuhong LIANG ; Nan LIU
China Pharmacy 2026;37(20):2628-2639
OBJECTIVE To develop evidence-based clinical practice recommendations for the use of hemostatic drugs in special populations, so as to improve the efficacy and safety of medication.METHODS Led by the Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, a working group of 79 experts covering clinical pharmacy, obstetrics and gynecology, pediatrics and other fields was established. Clinical questions regarding the efficacy and safety of hemostatic drugs in special populations were screened through literature review and two rounds of Delphi questionnaire surveys. Intervention questions were structured using the population, intervention, comparison, and outcome framework, while management questions were additionally described using the population, clinical setting, management measure, and outcome framework. Databases including Medline, Embase, Cochrane Library, CNKI, Wanfang Data, and VIP were systematically searched to collect and screen relevant evidence. Recommendations were formulated through recommendation questionnaire surveys and expert consensus meetings, and the quality of evidence and strength of recommendations were graded according to the Grading of Recommendations Assessment, Development and Evaluation system. RESULTS &CONCLUSIONS A total of 8 clinical questions were finally determined, the consensus rates of all clinical questions and recommendations were more than 90%, and 8 recommendations on the use of hemostatic drugs in special populations were formulated. These recommendations cover special populations including children, women during pregnancy/puerperium/lactation, the elderly, patients with hepatic impairment, patients in the perioperative period of liver transplantation, patients with renal impairment/on dialysis/in the perioperative period of kidney transplantation, immunocompromised patients, and patients with hematological diseases. The recommendations specify the applicable scenarios, dose adjustment principles, monitoring indicators, and safety management strategies of hemostatic drugs in different special populations, which can provide a reference for the clinical application of hemostatic drugs in special populations and help clinicians and pharmacists develop individualized medication plans.
6.Discriminating Tumor Deposits From Metastatic Lymph Nodes in Rectal Cancer: A Pilot Study Utilizing Dynamic Contrast-Enhanced MRI
Xue-han WU ; Yu-tao QUE ; Xin-yue YANG ; Zi-qiang WEN ; Yu-ru MA ; Zhi-wen ZHANG ; Quan-meng LIU ; Wen-jie FAN ; Li DING ; Yue-jiao LANG ; Yun-zhu WU ; Jian-peng YUAN ; Shen-ping YU ; Yi-yan LIU ; Yan CHEN
Korean Journal of Radiology 2025;26(5):400-410
Objective:
To evaluate the feasibility of dynamic contrast-enhanced MRI (DCE-MRI) in differentiating tumor deposits (TDs) from metastatic lymph nodes (MLNs) in rectal cancer.
Materials and Methods:
A retrospective analysis was conducted on 70 patients with rectal cancer, including 168 lesions (70 TDs and 98 MLNs confirmed by histopathology), who underwent pretreatment MRI and subsequent surgery between March 2019 and December 2022. The morphological characteristics of TDs and MLNs, along with quantitative parameters derived from DCE-MRI (K trans , kep, and v e) and DWI (ADCmin, ADCmax, and ADCmean), were analyzed and compared between the two groups.Multivariable binary logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the diagnostic performance of significant individual quantitative parameters and combined parameters in distinguishing TDs from MLNs.
Results:
All morphological features, including size, shape, border, and signal intensity, as well as all DCE-MRI parameters showed significant differences between TDs and MLNs (all P < 0.05). However, ADC values did not demonstrate significant differences (all P > 0.05). Among the single quantitative parameters, v e had the highest diagnostic accuracy, with an area under the ROC curve (AUC) of 0.772 for distinguishing TDs from MLNs. A multivariable logistic regression model incorporating short axis, border, v e, and ADC mean improved diagnostic performance, achieving an AUC of 0.833 (P = 0.027).
Conclusion
The combination of morphological features, DCE-MRI parameters, and ADC values can effectively aid in the preoperative differentiation of TDs from MLNs in rectal cancer.
7.Effect of Anti-reflux Mucosal Ablation on Esophageal Motility in Patients With Gastroesophageal Reflux Disease: A Study Based on High-resolution Impedance Manometry
Chien-Chuan CHEN ; Chu-Kuang CHOU ; Ming-Ching YUAN ; Kun-Feng TSAI ; Jia-Feng WU ; Wei-Chi LIAO ; Han-Mo CHIU ; Hsiu-Po WANG ; Ming-Shiang WU ; Ping-Huei TSENG
Journal of Neurogastroenterology and Motility 2025;31(1):75-85
Background/Aims:
Anti-reflux mucosal ablation (ARMA) is a promising endoscopic intervention for proton pump inhibitor (PPI)-dependent gastroesophageal reflux disease (GERD). However, the effect of ARMA on esophageal motility remains unclear.
Methods:
Twenty patients with PPI-dependent GERD receiving ARMA were prospectively enrolled. Comprehensive self-report symptom questionnaires, endoscopy, 24-hour impedance-pH monitoring, and high-resolution impedance manometry were performed and analyzed before and 3 months after ARMA.
Results:
All ARMA procedures were performed successfully. Symptom scores, including GerdQ (11.16 ± 2.67 to 9.11 ± 2.64, P = 0.026) and reflux symptom index (11.63 ± 5.62 to 6.11 ± 3.86, P = 0.001), improved significantly, while 13 patients (65%) reported discontinuation of PPI. Total acid exposure time (5.84 ± 4.63% to 2.83 ± 3.41%, P = 0.024) and number of reflux episodes (73.05 ± 19.34 to 37.55 ± 22.71, P < 0.001) decreased significantly after ARMA. Improved esophagogastric junction (EGJ) barrier function, including increased lower esophageal sphincter resting pressure (13.89 ± 10.78 mmHg to 21.68 ± 11.5 mmHg, P = 0.034), 4-second integrated relaxation pressure (5.75 ± 6.42 mmHg to 9.99 ± 5.89 mmHg, P = 0.020), and EGJ-contractile integral(16.42 ± 16.93 mmHg · cm to 31.95 ± 21.25 mmHg · cm, P = 0.016), were observed. Esophageal body contractility also increased significantly (distal contractile integral, 966.85 ± 845.84 mmHg · s · cm to 1198.8 ± 811.74 mmHg · s · cm, P = 0.023). Patients with symptom improvement had better pre-AMRA esophageal body contractility.
Conclusions
ARMA effectively improves symptoms and reflux burden, EGJ barrier function, and esophageal body contractility in patients with PPIdependent GERD during short-term evaluation. Longer follow-up to clarify the sustainability of ARMA is needed.
8.Discriminating Tumor Deposits From Metastatic Lymph Nodes in Rectal Cancer: A Pilot Study Utilizing Dynamic Contrast-Enhanced MRI
Xue-han WU ; Yu-tao QUE ; Xin-yue YANG ; Zi-qiang WEN ; Yu-ru MA ; Zhi-wen ZHANG ; Quan-meng LIU ; Wen-jie FAN ; Li DING ; Yue-jiao LANG ; Yun-zhu WU ; Jian-peng YUAN ; Shen-ping YU ; Yi-yan LIU ; Yan CHEN
Korean Journal of Radiology 2025;26(5):400-410
Objective:
To evaluate the feasibility of dynamic contrast-enhanced MRI (DCE-MRI) in differentiating tumor deposits (TDs) from metastatic lymph nodes (MLNs) in rectal cancer.
Materials and Methods:
A retrospective analysis was conducted on 70 patients with rectal cancer, including 168 lesions (70 TDs and 98 MLNs confirmed by histopathology), who underwent pretreatment MRI and subsequent surgery between March 2019 and December 2022. The morphological characteristics of TDs and MLNs, along with quantitative parameters derived from DCE-MRI (K trans , kep, and v e) and DWI (ADCmin, ADCmax, and ADCmean), were analyzed and compared between the two groups.Multivariable binary logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the diagnostic performance of significant individual quantitative parameters and combined parameters in distinguishing TDs from MLNs.
Results:
All morphological features, including size, shape, border, and signal intensity, as well as all DCE-MRI parameters showed significant differences between TDs and MLNs (all P < 0.05). However, ADC values did not demonstrate significant differences (all P > 0.05). Among the single quantitative parameters, v e had the highest diagnostic accuracy, with an area under the ROC curve (AUC) of 0.772 for distinguishing TDs from MLNs. A multivariable logistic regression model incorporating short axis, border, v e, and ADC mean improved diagnostic performance, achieving an AUC of 0.833 (P = 0.027).
Conclusion
The combination of morphological features, DCE-MRI parameters, and ADC values can effectively aid in the preoperative differentiation of TDs from MLNs in rectal cancer.
9.Discriminating Tumor Deposits From Metastatic Lymph Nodes in Rectal Cancer: A Pilot Study Utilizing Dynamic Contrast-Enhanced MRI
Xue-han WU ; Yu-tao QUE ; Xin-yue YANG ; Zi-qiang WEN ; Yu-ru MA ; Zhi-wen ZHANG ; Quan-meng LIU ; Wen-jie FAN ; Li DING ; Yue-jiao LANG ; Yun-zhu WU ; Jian-peng YUAN ; Shen-ping YU ; Yi-yan LIU ; Yan CHEN
Korean Journal of Radiology 2025;26(5):400-410
Objective:
To evaluate the feasibility of dynamic contrast-enhanced MRI (DCE-MRI) in differentiating tumor deposits (TDs) from metastatic lymph nodes (MLNs) in rectal cancer.
Materials and Methods:
A retrospective analysis was conducted on 70 patients with rectal cancer, including 168 lesions (70 TDs and 98 MLNs confirmed by histopathology), who underwent pretreatment MRI and subsequent surgery between March 2019 and December 2022. The morphological characteristics of TDs and MLNs, along with quantitative parameters derived from DCE-MRI (K trans , kep, and v e) and DWI (ADCmin, ADCmax, and ADCmean), were analyzed and compared between the two groups.Multivariable binary logistic regression and receiver operating characteristic (ROC) curve analyses were performed to assess the diagnostic performance of significant individual quantitative parameters and combined parameters in distinguishing TDs from MLNs.
Results:
All morphological features, including size, shape, border, and signal intensity, as well as all DCE-MRI parameters showed significant differences between TDs and MLNs (all P < 0.05). However, ADC values did not demonstrate significant differences (all P > 0.05). Among the single quantitative parameters, v e had the highest diagnostic accuracy, with an area under the ROC curve (AUC) of 0.772 for distinguishing TDs from MLNs. A multivariable logistic regression model incorporating short axis, border, v e, and ADC mean improved diagnostic performance, achieving an AUC of 0.833 (P = 0.027).
Conclusion
The combination of morphological features, DCE-MRI parameters, and ADC values can effectively aid in the preoperative differentiation of TDs from MLNs in rectal cancer.
10.Effect of Anti-reflux Mucosal Ablation on Esophageal Motility in Patients With Gastroesophageal Reflux Disease: A Study Based on High-resolution Impedance Manometry
Chien-Chuan CHEN ; Chu-Kuang CHOU ; Ming-Ching YUAN ; Kun-Feng TSAI ; Jia-Feng WU ; Wei-Chi LIAO ; Han-Mo CHIU ; Hsiu-Po WANG ; Ming-Shiang WU ; Ping-Huei TSENG
Journal of Neurogastroenterology and Motility 2025;31(1):75-85
Background/Aims:
Anti-reflux mucosal ablation (ARMA) is a promising endoscopic intervention for proton pump inhibitor (PPI)-dependent gastroesophageal reflux disease (GERD). However, the effect of ARMA on esophageal motility remains unclear.
Methods:
Twenty patients with PPI-dependent GERD receiving ARMA were prospectively enrolled. Comprehensive self-report symptom questionnaires, endoscopy, 24-hour impedance-pH monitoring, and high-resolution impedance manometry were performed and analyzed before and 3 months after ARMA.
Results:
All ARMA procedures were performed successfully. Symptom scores, including GerdQ (11.16 ± 2.67 to 9.11 ± 2.64, P = 0.026) and reflux symptom index (11.63 ± 5.62 to 6.11 ± 3.86, P = 0.001), improved significantly, while 13 patients (65%) reported discontinuation of PPI. Total acid exposure time (5.84 ± 4.63% to 2.83 ± 3.41%, P = 0.024) and number of reflux episodes (73.05 ± 19.34 to 37.55 ± 22.71, P < 0.001) decreased significantly after ARMA. Improved esophagogastric junction (EGJ) barrier function, including increased lower esophageal sphincter resting pressure (13.89 ± 10.78 mmHg to 21.68 ± 11.5 mmHg, P = 0.034), 4-second integrated relaxation pressure (5.75 ± 6.42 mmHg to 9.99 ± 5.89 mmHg, P = 0.020), and EGJ-contractile integral(16.42 ± 16.93 mmHg · cm to 31.95 ± 21.25 mmHg · cm, P = 0.016), were observed. Esophageal body contractility also increased significantly (distal contractile integral, 966.85 ± 845.84 mmHg · s · cm to 1198.8 ± 811.74 mmHg · s · cm, P = 0.023). Patients with symptom improvement had better pre-AMRA esophageal body contractility.
Conclusions
ARMA effectively improves symptoms and reflux burden, EGJ barrier function, and esophageal body contractility in patients with PPIdependent GERD during short-term evaluation. Longer follow-up to clarify the sustainability of ARMA is needed.

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