1.Research Tackling Paradigm and Technological Layout Strategies Based on Erectile Dysfunction, A Clinical Dominant Disease of Traditional Chinese Medicine
Qi ZHAO ; Yun CHEN ; Baoxing LIU ; Xuejun SHANG ; Fei SUN ; Xiaozhi ZHAO ; Zhigang WU ; Chao SUN ; Peihai ZHANG ; Wanjun CHENG ; Xing ZHOU ; Zhan QIN ; Yufeng PAN ; Weiwei TAO ; Jianhuai CHEN ; Mei MO ; Xiaoxiao ZHANG ; Xing ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):291-299
To thoroughly implement the strategic deployment outlined in the Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance and Innovative Development of Traditional Chinese Medicine regarding research on dominant diseases of traditional Chinese medicine and to uphold the development philosophy of equal emphasis on traditional Chinese medicine and western medicine,the China Association of Chinese Medicine has fully played a leading academic role by systematically organizing and conducting a series of academic youth salons on clinical dominant diseases of traditional Chinese medicine. On September 13,2024,the 36th Youth Salon on Clinical Dominant Diseases was successfully held in Nanjing,focusing on the advantages of traditional Chinese medicine and the integrative traditional Chinese medicine and western medicine in the diagnosis and treatment of erectile dysfunction (ED). The conference brought together leading experts from traditional Chinese medicine,western medicine,and interdisciplinary fields,facilitating in-depth multidisciplinary discussions that led to key consensus on optimizing traditional Chinese medicine treatment protocols for ED,researching and developing new drugs of traditional Chinese medicine,and advancing interdisciplinary development in traditional Chinese medicine. This salon systematically sorted out the clinical strengths and distinctive features of traditional Chinese medicine in the diagnosis and treatment of ED. Based on current research foundations and clinical needs,it identified key directions for future scientific layout and scientific research tackling: (1) Standardization of syndrome differentiation system of traditional Chinese medicine for ED. (2) Optimization and standardization of intervention methods of integrated traditional Chinese medicine and western medicine. (3) High-quality clinical research guided by evidence-based medicine. (4) In-depth analysis of the pharmacological mechanisms of traditional Chinese medicine in the treatment of ED. (5) Clinical translation and application promotion of new drugs of traditional Chinese medicine. (6) Interdisciplinary integration and innovation in traditional Chinese medicine. For each research direction,key focus areas,expected objectives,and clinical value were further refined,along with the establishment of a scientifically sound priority funding level evaluation system. Therefore,building on the series of salons on the ED-focused dominant diseases of traditional Chinese medicine,this paper provides standardized guidance for clinical practice of traditional Chinese medicine in ED management,effectively contributing to the high-quality development of traditional Chinese medicine. It serves as a valuable reference for national scientific and technological strategic layout, research and development decision-making in new drugs of traditional Chinese medicine,research topic planning,and clinical guideline formulation.
2.Morphological differences in the psoas major muscle and influencing factors for pain severity in patients with different types of lumbar disc herniation: an analysis based on quantitative computed tomography
Hongjie WANG ; Zhigang CHEN ; Pengfei GUO ; Qinghua ZHAO
Chinese Journal of Radiological Health 2026;35(2):235-239
Objective To analyze the difference of psoas major muscle morphology and pain degree in patients with different types of lumbar disc herniation ( LDH ) by quantitative CT, and to further explore the relationship between psoas major muscle morphology and pain degree. Methods A total of 120 patients with LDH admitted to our hospital from January to December 2025 were enrolled as study subjects. Based on clinical symptoms and lesion location, they were divided into a simple lower extremity pain group and a lumbar and leg pain group. All patients underwent lumbar CT examination. The psoas major muscle index was used as a CT quantitative parameter, which was calculated as the mean of the maximum cross-sectional areas of both psoas major muscles divided by the cross-sectional area of the L5 vertebral body. This index was measured to reflect psoas major muscle morphology. Pain severity was assessed using the visual analogue scale (VAS). Differences in psoas major muscle morphology and pain severity between the two groups were compared. A Pearson correlation analysis was used to examine the relationship between the psoas major muscle index and pain severity. A linear regression model was used to analyze the independent risk factors affecting pain severity. Results There were no statistically significant differences in sex, age, or body mass index between the two groups (P>0.05). The disease duration was longer and the incidence of anxiety and depression was higher in the lumbar and leg pain group than those in the simple lower extremity pain group (P<0.05). Compared with the simple lower extremity pain group, the lumbar and leg pain group showed lower psoas major muscle index [(0.53 ± 0.05) vs. (0.61 ± 0.07)] and higher VAS score [(4.67 ± 1.10) vs. (3.02 ± 0.89)], and the differences were statistically significant (P<0.05). Pearson correlation analysis revealed a negative correlation between the psoas major muscle index and the VAS score (r=−0.288, P<0.05). Linear regression model analysis indicated that the independent risk factors affecting the VAS score were age, disease duration, LDH type, and the psoas major muscle index. Conclusion Compared with LDH patients with simple lower extremity pain, those with lumbar and leg pain demonstrate a longer disease duration, a higher incidence of anxiety and depression, and a higher severity of psoas major muscle atrophy and pain. The severity of pain is associated with not only advanced age and prolonged disease duration but also the LDH type and psoas major muscle atrophy.
3.Morphological differences in the psoas major muscle and influencing factors for pain severity in patients with different types of lumbar disc herniation: an analysis based on quantitative computed tomography
Hongjie WANG ; Zhigang CHEN ; Pengfei GUO ; Qinghua ZHAO
Chinese Journal of Radiological Health 2026;35(2):235-239
Objective To analyze the difference of psoas major muscle morphology and pain degree in patients with different types of lumbar disc herniation ( LDH ) by quantitative CT, and to further explore the relationship between psoas major muscle morphology and pain degree. Methods A total of 120 patients with LDH admitted to our hospital from January to December 2025 were enrolled as study subjects. Based on clinical symptoms and lesion location, they were divided into a simple lower extremity pain group and a lumbar and leg pain group. All patients underwent lumbar CT examination. The psoas major muscle index was used as a CT quantitative parameter, which was calculated as the mean of the maximum cross-sectional areas of both psoas major muscles divided by the cross-sectional area of the L5 vertebral body. This index was measured to reflect psoas major muscle morphology. Pain severity was assessed using the visual analogue scale (VAS). Differences in psoas major muscle morphology and pain severity between the two groups were compared. A Pearson correlation analysis was used to examine the relationship between the psoas major muscle index and pain severity. A linear regression model was used to analyze the independent risk factors affecting pain severity. Results There were no statistically significant differences in sex, age, or body mass index between the two groups (P>0.05). The disease duration was longer and the incidence of anxiety and depression was higher in the lumbar and leg pain group than those in the simple lower extremity pain group (P<0.05). Compared with the simple lower extremity pain group, the lumbar and leg pain group showed lower psoas major muscle index [(0.53 ± 0.05) vs. (0.61 ± 0.07)] and higher VAS score [(4.67 ± 1.10) vs. (3.02 ± 0.89)], and the differences were statistically significant (P<0.05). Pearson correlation analysis revealed a negative correlation between the psoas major muscle index and the VAS score (r=−0.288, P<0.05). Linear regression model analysis indicated that the independent risk factors affecting the VAS score were age, disease duration, LDH type, and the psoas major muscle index. Conclusion Compared with LDH patients with simple lower extremity pain, those with lumbar and leg pain demonstrate a longer disease duration, a higher incidence of anxiety and depression, and a higher severity of psoas major muscle atrophy and pain. The severity of pain is associated with not only advanced age and prolonged disease duration but also the LDH type and psoas major muscle atrophy.
4.Morphological differences in the psoas major muscle and influencing factors for pain severity in patients with different types of lumbar disc herniation: an analysis based on quantitative computed tomography
Hongjie WANG ; Zhigang CHEN ; Pengfei GUO ; Qinghua ZHAO
Chinese Journal of Radiological Health 2026;35(2):235-239
Objective To analyze the difference of psoas major muscle morphology and pain degree in patients with different types of lumbar disc herniation ( LDH ) by quantitative CT, and to further explore the relationship between psoas major muscle morphology and pain degree. Methods A total of 120 patients with LDH admitted to our hospital from January to December 2025 were enrolled as study subjects. Based on clinical symptoms and lesion location, they were divided into a simple lower extremity pain group and a lumbar and leg pain group. All patients underwent lumbar CT examination. The psoas major muscle index was used as a CT quantitative parameter, which was calculated as the mean of the maximum cross-sectional areas of both psoas major muscles divided by the cross-sectional area of the L5 vertebral body. This index was measured to reflect psoas major muscle morphology. Pain severity was assessed using the visual analogue scale (VAS). Differences in psoas major muscle morphology and pain severity between the two groups were compared. A Pearson correlation analysis was used to examine the relationship between the psoas major muscle index and pain severity. A linear regression model was used to analyze the independent risk factors affecting pain severity. Results There were no statistically significant differences in sex, age, or body mass index between the two groups (P>0.05). The disease duration was longer and the incidence of anxiety and depression was higher in the lumbar and leg pain group than those in the simple lower extremity pain group (P<0.05). Compared with the simple lower extremity pain group, the lumbar and leg pain group showed lower psoas major muscle index [(0.53 ± 0.05) vs. (0.61 ± 0.07)] and higher VAS score [(4.67 ± 1.10) vs. (3.02 ± 0.89)], and the differences were statistically significant (P<0.05). Pearson correlation analysis revealed a negative correlation between the psoas major muscle index and the VAS score (r=−0.288, P<0.05). Linear regression model analysis indicated that the independent risk factors affecting the VAS score were age, disease duration, LDH type, and the psoas major muscle index. Conclusion Compared with LDH patients with simple lower extremity pain, those with lumbar and leg pain demonstrate a longer disease duration, a higher incidence of anxiety and depression, and a higher severity of psoas major muscle atrophy and pain. The severity of pain is associated with not only advanced age and prolonged disease duration but also the LDH type and psoas major muscle atrophy.
5.Preliminary exploration of differentiating and treating multiple system atrophy from the perspective of the eight extraordinary meridians
Di ZHAO ; Zhigang CHEN ; Nannan LI ; Lu CHEN ; Yao WANG ; Jing XUE ; Xinning ZHANG ; Chengru JIA ; Xuan XU ; Kaige ZHANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(3):392-397
Multiple system atrophy (MSA) is a rare neurodegenerative disease with complex clinical manifestations, presenting substantial challenges in clinical diagnosis and treatment. Its symptoms and the eight extraordinary meridians are potentially correlated; therefore, this article explores the association between MSA symptom clusters and the eight extraordinary meridians based on their circulation and physiological functions, as well as their treatment strategies. The progression from deficiency to damage in the eight extraordinary meridians aligns with the core pathogenesis of MSA, which is characterized by "the continuous accumulation of impacts from the vital qi deficiency leading to eventual damage". Liver and kidney deficiency and the emptiness of the eight extraordinary meridians are required for the onset of MSA; the stagnation of qi deficiency and the gradual damage to the eight extraordinary meridians are the key stages in the prolonged progression of MSA. The disease often begins with the involvement of the yin and yang qiao mai, governor vessel, thoroughfare vessel, and conception vessel before progressing to multiple meridian involvements, ultimately affecting all eight extraordinary meridians simultaneously. The treatment approach emphasizes that "the direct method may be used for joining battle, but indirect method will be needed in order to secure victory" and focuses on "eliminate pathogenic factors and reinforce healthy qi". Distinguishing the extraordinary meridians and focusing on the primary symptoms are pivotal to improving efficacy. Clinical treatment is aimed at the target, and tailored treatment based on careful clinical observation ensures precision in targeting the disease using the eight extraordinary meridians as the framework and core symptoms as the specific focus. Additionally, combining acupuncture, daoyin therapy, and other method may help prolong survival. This article classifies clinical manifestations based on the theory of the eight extraordinary meridians and explores treatment.
6.Cost-effectiveness of vitamin D analogue for postmenopausal osteoporosis in women
Haijing GUAN ; Yanan XU ; Zhigang ZHAO ; Changsheng FAN
China Pharmacy 2025;36(10):1209-1215
OBJECTIVE To evaluate the cost-effectiveness of vitamin D analogue for postmenopausal osteoporotic women in China. METHODS A Markov microsimulation model was developed to analyze the clinical and economic outcomes of eldecalcitol, alfacalcidol and calcitriol for postmenopausal osteoporosis from the healthcare system perspective in China. The clinical parameters required for the model were derived from network meta-analysis, while cost and utility data were primarily obtained from the literature. The cycle length was 1 year , the time horizon was life time, and the willingness-to-pay threshold was 0.5 times the gross domestic product per capita in China in 2023(44 679 yuan/QALY). Model uncertainty was tested with one-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis. RESULTS The quality-adjusted life years (QALYs) for eldecalcitol were calculated to be 12.03 QALYs, which were higher than those for alfacalcidol (11.94 QALYs) and calcitriol (11.92 QALYs). Meanwhile, the direct medical cost associated with eldecalcitol treatment amounted to 38 805 yuan, which was lower than that of alfacalcidol (45 173 yuan) and calcitriol (45 821 yuan). The results of the one-way sensitivity analysis showed that the risk ratio of hip fracture and vertebral fracture had a significant impact on the result. The probabilistic sensitivity analysis and scenario analysis showed the robustness of the findings from the base-case analysis. CONCLUSIONS Compared with alfacalcidol and calcitriol, eldecalcitol is likely to be a cost-effective treatment for postmenopausal osteoporotic women in China.
7.Adverse events in mavacamten treatment for hypertrophic cardiomyopathy: a study based on the US FDA Adverse Event Reporting System database
Yilong YAN ; Yi'nan ZHANG ; Zhigang ZHAO
Adverse Drug Reactions Journal 2025;27(4):207-211
Objective:To mine the risk signals of adverse events (AEs) in mavacamten treatment for hypertrophic cardiomyopathy, and provide reference for safe use of the drug in clinic.Methods:AE reports on mavacamten from June 2022 to June 2024 were collected by searching US Food and Drug Administration Adverse Event Reporting System (FAERS) database. AEs were classified and standardized according to the system organ class (SOC) and preferred term (PT) of Medical Dictionary for Regulatory Activities version 26.1. Reporting odds ratio (ROR) method and comprehensive standard method of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were used to mine the AE risk signals. An AE that simultaneously met the criteria of ≥3 reports, lower limit of the 95% confidence interval ( CI) of ROR>1, PRR ≥2, and χ2 ≥4 was defined as a risk signal. Descriptive statistical analysis on signals was performed. Results:A total of 1 041 AE reports were collected, involving 47 PTs and 12 SOCs. The top 10 risk signals based on the number of AE reports were dyspnea, dizziness, fatigue, atrial fibrillation, cardiac failure, palpitation, nasopharyngitis, chest pain, COVID-19, and weight increased. Except dizziness and heart failure, above AEs were not recorded in the label. The top 10 risks in signal intensity were acquired left ventricle outflow tract obstruction, transvalvular pressure gradient increased, cardiovascular symptom, echocardiogram abnormal, hypervolaemia, left ventricular failure, ejection fraction decreased, coronavirus infection, brain fog, and atrial fibrillation. Except cardiovascular symptom, left ventricular failure, and ejection fraction decreased, above AEs were not recorded in the label.Conclusions:The AE risk signals of mavacamten in the treatment for hypertrophic cardiomyopathy recorded in the label are mainly heart failure and ejection fraction decreased. Clinicians and pharmacists should also be vigilant against risk signals not recorded in the lakel, such as atrial fibrillation, fatigue, nasopharyngitis, coronavirus infection, and brain fog, etc.
8.Comprehensive Evaluation of Original Research Sodium-glucose Transporters 2 Inhibitors Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition)
Cheng JI ; Bing ZHOU ; Pengli ZHU ; Chao WANG ; Xunlong ZHONG ; Aizong SHEN ; Yi ZHANG ; Ruolun WANG ; Weihong GE ; Zhanjun DONG ; Zhigang ZHAO
Herald of Medicine 2025;44(2):251-258
Objective In order to provide a better reference and basis for the selection of reasonable hypoglycemic drugs for clinical treatment,the study conducted a comprehensive clinical evaluation of the innovator sodium-glucose transporters 2(SGLT-2)inhibitors,based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition).Methods The real-world studies,randomized controlled trials,Meta-analysis/systematic review,drug clinical use guidelines,expert consensus and drug description evaluation evidence were collected,and the included drugs were assigned and evaluated from five dimensions:pharmaceutical characteristics,efficacy,safety,economy and other attributes.Results All SGLT-2 inhibitors had evaluation scores above 75,with dagaglifloztin tablets having the highest score of 84.6,and canaglifloztin having the lowest score of 75.1.Conclusions All five original SGLT-2 inhibitors showed good clinical utility,the difference is that the participating original drugs have different advantageous intervals in clinical use.The results show that dagliflozin has the most ideal clinical utility,and its clinical use should be safer and more effective.Due to the short time on the market and insufficient evidence-based reasons,the advantages of clinical use of proline hemegliflozin are not obvious compared with other evaluated drugs.
9.Analysis of differences on contraindication information for children in domestic and foreign drug instructions
Pengxiang ZHOU ; Xinwen XU ; Xiaoling WANG ; Ruiling ZHAO ; Zhigang ZHAO
Adverse Drug Reactions Journal 2025;27(6):339-347
Objective:To explore the differences on contraindication information for children in domestic and foreign drug instructions, and provide reference for improving the relevant information in Chinese drug insert sheets.Methods:Chinese drug insert sheets of chemicals and biological products contained in the China Pharmacopoeia 2020 and those of the western medicines in the 2023 China′s Basic Medical Insurance, Work-related Injury Insurance and Childbirth Insurance Drug Catalog were collected; drugs that were marked as contraindication for children were selected and relevant contraindication information in the Chinese drug insert sheets was collected. Instructions of the above-mentioned drugs approved by the U.S. Food and Drug Administration (English labels) were also collected, and the information on pediatric medication was reviewed and compared with the Chinese drug insert sheets. Results:A total of 222 drugs were labeled as contraindication for children in the Chinese drug insert sheets, of which 149 were available for their English labels; 123 drugs (17.5%) were not labeled as contraindication for children in English labels, and 26 (82.5%) were labeled. The 123 drugs that were not labeled as contraindication for children in the English labels included the following conditions: 58 were labeled as contraindication for children of some age in the Chinese drug insert sheets but not in the English labels, and relevant medication information was provided; 40 were labeled as contraindication for children of some age group in the Chinese drug insert sheets but was described as the effectiveness and safety of the use for children have not yet been determined for this age group in the English labels; 13 were labeled as contraindication for children in the Chinese drug insert sheets, but the medication information on children in the English labels was not clear or missing; 12 were labeled as contraindicated for children in Chinese drug insert sheets but not in the English labels, only expressed as not yet determined or not recommended for use, etc., with inconsistent age group. Among the 26 drugs labeled as contraindication for children in both Chinese and English instructions, the contraindication age group were the same in above 2 instructions for 20 drugs, and were inconsistent for the other 6 drugs; reasons for contraindication were described in both the 2 instructions for 17 drugs (13 were consistent, 4 were inconsistent), only in English labels for 8 drugs, and only in Chinese drug insert sheets for 1 drug.Conclusions:Many drugs are labeled as contraindication for children in Chinese drug insert sheets, but reasons for contraindication are rarely explained. Differences in children′s age in contraindications exist for some drugs between the Chinese drug insert sheets and English labels. The information on contraindications for children in Chinese drug insert sheets still needs to be further improved.
10.Implementation of US FDA boxed warning in drug labels from 2019 to 2024 and comparison with relevant situations in China
Yinan ZHANG ; Wenshuo JIANG ; Xiao ZHANG ; Yilong YAN ; Zhigang ZHAO
Adverse Drug Reactions Journal 2025;27(10):621-628
Objective:To investigate the implementation of boxed warning of drug labels in US Food and Drug Administration (FDA) from 2019 to 2024, and compared it with the relevant situations in China, in order to provide reference for the revision of drug labels and safe drug use.Methods:Data on boxed warning revisions in the US FDA "Drugs Safety Related Labeling Changes" Database from January 1, 2019 to December 31, 2024 were retrieved, and the revised contents were classified. The drug labels for newly marketed drugs in the United States during the same period were collected, the boxed warnings were recorded and summarized, and compared with the warning statements in drug labels of relevant drugs approved in China.Results:From 2019 to 2024, FDA revised boxed warnings in 209 drug labels. Among them, 22 items (10.53%) were newly added, 63 items (30.14%) were major updates, 115 items (55.02%) were minor updates, and 9 items (4.31%) were removed. A total of 293 new drugs were approved in the United States from 2019 to 2024, of which 69 (23.55%) had boxed warnings when they were approved, and 4 (1.37%) were added boxed warnings when they were revised in the labels. Up to December 31, 2024, 92 of the 293 new drugs had been approved in China. Compared with the labeling in the United States, some drugs lacked warning statements section in China, including zolpidem tartrate, dexzopiclone, zaleplon, montelukast sodium, denosumab, terlipressin, etc.Conclusions:The warning statements in some Chinese drug labels are inconsistent with the boxed warnings in the American drug labels. It is suggested that the revision of the boxed warning by US FDA should be regarded as one of the new sources of safety information to assess the risks of related drugs and determine whether it is necessary to revise the relevant drug labels in China.


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