1.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
2.Methodological Issues in the Design,Evaluation,and Reporting of Randomized Controlled Trials with "Pattern Dominating Disease"
Lu WANG ; Jiajia WANG ; Yingying ZHANG ; Xufei LUO ; Yaolong CHEN ; Jiansheng LI
Journal of Traditional Chinese Medicine 2026;67(14):1497-1502
This study explores methodological issues in the design, evaluation, and reporting of randomized controlled trials (RCTs) under the concept of "syndrome dominating disease". The discussion focuses on key aspects including the adaptability of trial design, the screening of research participants, the standardization of syndrome differentiation, the balance between intervention individualization and standardization, the integration of multi-dimensional outcome measures, and the limitations of existing evaluation and reporting tools when applied to this type of research, along with corresponding recommendations and future perspectives. Regarding research design, it is recommended to select or draw upon innovative design concepts such as basket trials and subgroup-based dynamic/static parallel-group designs, in order to innovate the design format of RCTs. Meanwhile, criteria for participant screening, TCM syndrome differentiation, and disease classification should be standardized. The balance should be appropriately achieved between intervention individualization and standardization, and a multidimensional assessment system encompassing TCM syndromes, disease-specific outcomes, and patient-reported outcomes should be established. For risk of bias assessment and research reporting, it is recommended,to develop specialized assessment and reporting tools based on existing instruments, in order to standardize the assessment and reporting of study findings. Future research may further explore the potential applications of artificial intelligence in the study design, risk-of-bias assessment, and reporting quality assessment of RCTs based on the "syndrome dominating disease" model, with a particular focus on methodological optimization, data integration, and enhancement of research quality.
3.Application of Omics Technologies in the Study of Traditional Chinese Medicine's Anti-infective Properties
Huaiyuan SUN ; Wenyue LI ; Jiajia FENG ; Weihua KONG ; Kun JIANG ; Likai LIN
Herald of Medicine 2025;44(6):917-923
Traditional Chinese medicine(TCM)has been used for the control and prevention of infectious diseases for thousands of years.Due to its characteristics of multiple components and multiple targets,it shows promising therapeutic prospects in the field of anti-infection.Here,we provide a detailed introduction to the current application of various omics technologies,such as metabolomics,proteomics,genomics,and transcriptomics in the study of TCM's anti-infective properties.The application of omics technologies can help explore the active components and their targets in TCM that contribute to its anti-infective effects;elucidate the biosynthetic pathways of active components,aiding in the discovery of new active ingredients;and investigate the mechanisms by which TCM affects pathogenic microorganisms,as well as interpret the mechanisms of TCM's synergy with antibiotics.As more research findings are produced and validated,the role of TCM in addressing the global challenge of antimicrobial resistance will become increasingly prominent through the integration of multi-omics and multidisciplinary research methods in the future.
4.Application of Omics Technologies in the Study of Traditional Chinese Medicine's Anti-infective Properties
Huaiyuan SUN ; Wenyue LI ; Jiajia FENG ; Weihua KONG ; Kun JIANG ; Likai LIN
Herald of Medicine 2025;44(6):917-923
Traditional Chinese medicine(TCM)has been used for the control and prevention of infectious diseases for thousands of years.Due to its characteristics of multiple components and multiple targets,it shows promising therapeutic prospects in the field of anti-infection.Here,we provide a detailed introduction to the current application of various omics technologies,such as metabolomics,proteomics,genomics,and transcriptomics in the study of TCM's anti-infective properties.The application of omics technologies can help explore the active components and their targets in TCM that contribute to its anti-infective effects;elucidate the biosynthetic pathways of active components,aiding in the discovery of new active ingredients;and investigate the mechanisms by which TCM affects pathogenic microorganisms,as well as interpret the mechanisms of TCM's synergy with antibiotics.As more research findings are produced and validated,the role of TCM in addressing the global challenge of antimicrobial resistance will become increasingly prominent through the integration of multi-omics and multidisciplinary research methods in the future.
5.Analysis and clinical application of preimplantation genetic testing for monogenic disorders in a case with Spinal muscular atrophy "2+ 0" genotype
Shaoying LI ; Jianchun HE ; Wenzhi HE ; Jiajia XIAN ; Lingling HUANG ; Gengye ZHAO ; Xin ZHANG ; Renqian DU ; Liming CHU ; Yueqiang WANG ; Lingyin KONG ; Bo LIANG ; Qing LI
Chinese Journal of Medical Genetics 2024;41(3):294-299
Objective:To explore the clinical application of preimplantation genetic testing for monogenic disorders (PGT-M) in an unique case with Spinal muscular atrophy (SMA) type 2+ 0.Methods:A special SMA family presented at the Third Affiliated Hospital of Guangzhou Medical University on October 19, 2020 was selected as the study subject. Multiple ligation-dependent probe amplification (MLPA) and molecular tagging linkage analysis were carried out to identify the SMN1 genotype of the couple and their fetus. Subsequently, next-generation sequencing (NGS), molecular tagging linkage analysis, and chromosomal microarray analysis were employed to determine the haplotypes and validate the result of PGT-M on the 11 embryos derived for the couple. Results:The female partner was identified as a carrier of the rare SMN1[2+ 0] variant, and prenatal diagnosis confirmed the fetus to be affected by SMA. Ultimately, PGT-M has successfully selected four embryos free from the pathogenic SMN1 variants and X chromosome deletion. Conclusion:PGT-M can effectively prevent the transmission of rare genetic variants such as the SMA 2+ 0 subtype in the families. Above finding has provided guidance for genetic counseling and family planning for the couple.
6.Interpretation of China′s fungal infection management policy
Jiajia FENG ; Weihua KONG ; Likai LIN
Chinese Journal of Applied Clinical Pediatrics 2024;39(1):7-9
Fungal infections are a growing public health threat, especially as the at-risk population for invasive fungal disease expanding and antifungal resistance emerging.In 2022, the World Health Organization released the first fungal priority pathogens list, aiming to encourage countries to strengthen the response to fungal infections.As one of the first countries to issue and implement the National Action Plan to Contain Antimicrobial Resistance in the world, China has attached great importance to the management of fungal infections.A series of actions and efforts have been made, including improving the legal and regulatory system related to the prevention and treatment of fungal infections, strengthening the management of clinical application of antifungal drugs, improving the diagnosis and treatment ability of fungal infections and the standardization of diagnosis and treatment, establishing a monitoring and evaluation system for fungal infections and drug resistance.Initial results have been achieved.In the future, under the guidance of the new national action plan to contain antimicrobial resistance, the level of diagnosis and treatment of fungal infections will be further improved to reduce the occurrence of fungal infections and the spread of antifungal resistance.
7.Clinical features and risk factors for invasive fungal sinusitis after allogeneic hematopoietic stem cell transplantation
Haixia FU ; Jiajia LI ; Yuanyuan ZHANG ; Yuqian SUN ; Xiaodong MO ; Tingting HAN ; Jun KONG ; Meng LYU ; Wei HAN ; Huan CHEN ; Yuhong CHEN ; Fengrong WANG ; Chenhua YAN ; Yao CHEN ; Jingzhi WANG ; Yu WANG ; Lanping XU ; Xiaojun HUANG ; Xiaohui ZHANG
Chinese Journal of Hematology 2024;45(1):22-27
Objective:To analyze the clinical characteristics and outcomes of patients with invasive fungal sinusitis (invasive fungal rhinosinusitis, IFR) after allogeneic hematopoietic stem cell transplantation (allo-HSCT) and explored the risk factors for IFR after allo-HSCT.Methods:Nineteen patients with IFR after allo-HSCT at Peking University People’s Hospital from January 2012 to December 2021 were selected as the study group, and 95 patients without IFR after allo-HSCT during this period were randomly selected as the control group (1:5 ratio) .Results:Nineteen patients, including 10 males and 9 females, had IFR after allo-HSCT. The median age was 36 (10–59) years. The median IFR onset time was 68 (9–880) days after allo-HSCT. There were seven patients with acute myeloid leukemia, five with acute lymphoblastic leukemia, two with myelodysplastic syndrome, two with chronic myeloid leukemia, one with acute mixed-cell leukemia, one with multiple myeloma, and one with T-lymphoblastic lymph node tumor. There were 13 confirmed cases and 6 clinically diagnosed cases. The responsible fungus was Mucor in two cases, Rhizopus in four, Aspergillus in four, and Candida in three. Five patients received combined treatment comprising amphotericin B and posaconazole, one patient received combined treatment comprising voriconazole and posaconazole, nine patients received voriconazole, and four patients received amphotericin B. In addition to antifungal treatment, 10 patients underwent surgery. After antifungal treatment and surgery, 15 patients achieved a response, including 13 patients with a complete response and 2 patients with a partial response. Multivariate analysis revealed that neutropenia before transplantation ( P=0.021) , hemorrhagic cystitis after transplantation ( P=0.012) , delayed platelet engraftment ( P=0.008) , and lower transplant mononuclear cell count ( P=0.012) were independent risk factors for IFR after allo-HSCT. The 5-year overall survival rates in the IFR and control groups after transplantation were 29.00%±0.12% and 91.00%±0.03%, respectively ( P<0.01) . Conclusion:Although IFR is rare, it is associated with poor outcomes in patients undergoing allo-HSCT. The combination of antifungal treatment and surgery might be effective.
8.Problems and suggestions in the implementation of drug centralized volume-based procurement policies in the hospitals
Weihua KONG ; Qi QIAO ; Guoqiang LIU ; Nan CHEN ; Chengwu SHEN ; Qi CHEN ; Feng QIU ; Jianhua WANG ; Ling JIANG ; Qinghong LU ; Junyan WU ; Yafeng WANG ; Likai LIN ; Jiajia FENG ; Hong CHENG
Chinese Journal of Hospital Administration 2024;40(7):535-540
Objective:To explore the challenges in the implementation of drug centralized volume-based procurement policies in hospitals and propose corresponding optimization suggestions.Methods:From August to December 2023, a purposive sampling was conducted to select 11 pharmaceutical experts from tertiary hospitals in China for Delphi method. The survey content included " policy recommendations for promoting the acceleration and expansion of national drug centralized procurement and retaining surplus medical insurance funds for centralized procurement" .Results:Survey participants gave feedback on a set of existing problems found in the implementation of drug centralized procurement policies and proposed corresponding optimization methods. Kendall′s W coefficient of the specialist consultation was 0.332( P<0.05), demonstrating good consistency and concentration of the expert opinions. Among the problems, the score of drug supply guarantee was the highest(mean value of importance was 4.45). At the same time, the recommendation of strengthening monitoring and early warning, coordination and dispatch, and effectively ensuring the supply of centralized drug procurement had the highest score and concentration(mean value of importance was 4.91, coefficient of variation was 0.06). Conclusions:Through Delphi method, this study revealed issues and optimization methods in the implementation of drug centralized procurement policies in hospitals. The findings could provide valuable insights for improvements in the pharmaceutical sector and future policy adjustments.
9.A scoping review of assessment tools for care complexity of patients at home and abroad
Kexin JI ; Jie CHENG ; Wenrui LI ; Jiajia KONG ; Ruiyuan YIN ; Rui WANG ; Li ZENG ; Zhigang ZHANG
Chinese Journal of Modern Nursing 2023;29(1):110-116
Objective:To systematically retrieve the assessment tools for patient care complexity at home and abroad, and compare their release institutions, formation process, applicable population, assessment methods and main contents.Methods:Articles on patient care complexity assessment tools was retrieved through computers in PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, WanFang Data, China Biomedical Database, and VIP Database. The retrieval time limit was from the establishment of the database to July 2, 2022. Excel 2019 was used to extract the name, release institution, evaluation method, main content and other information of the assessment tools and compare the content characteristics of the assessment tools.Results:A total of 26 assessment tools for patient care complexity were included in this study, involving 37 articles, mainly observational studies. The 26 tools were mainly issued by institutions of higher learning, and most of them were applicable to ordinary inpatients. The assessment contents included the general situation of the patient, severity of the disease, treatment items, mental cognitive function, mental health, socio-economic support and compliance.Conclusions:At home and abroad, the patient care complexity evaluation tools are mainly used to evaluate ordinary adult inpatients. There are few tools to evaluate children, the elderly, Intensive Care Unit (ICU) and other special types of patients, and there is a lack of relevant intervention research. In China, there are few tools for evaluating patient care complexity involving indicators related to mental cognitive function, which suggests that nurses can consider the mental cognitive function of patients when building relevant assessment tools in the future. In addition, the application effect of such tools in patient risk identification and safety management, nursing human resource allocation and other fields should be verified.
10.Meta-analysis of effects of neuromuscular electrical stimulation of lower limbs on patients with mechanical ventilation in intensive care unit
Jie CHENG ; Jiajia KONG ; Rui WANG ; Kexin JI ; Huiya GAO ; Li YAO ; Nannan DING ; Zhigang ZHANG
Chinese Critical Care Medicine 2021;33(10):1243-1248
Objective:To evaluate the effect of lower limb neuromuscular electrical stimulation (NMES) on mechanical ventilation patients in intensive care unit (ICU).Methods:Databases including the Cochrane Library, PubMed, Web of Science, Embase, SinoMed, CNKI, VIP and Wanfang database were searched from inception to May 2021. Randomized controlled trails (RCT) about the influence of NMES of lower limbs in patients with mechanical ventilation in ICU were collected. Routine rehabilitation measures were implemented in the control group, while the combination of routine rehabilitation and NMES on the lower limbs was implemented in the observation group. The literature screening, data extracting, and bias risk assessment of included studies were conducted independently by two reviewers. RevMan 5.3 software was used to perform Meta-analysis. Funnel plot was used to test publication bias.Results:A total of 8 RCT were eventually enrolled. The literature quality evaluation results showed that 1 study was grade A and 7 studies were grade B, suggesting that the quality of the included literature was relatively high. The Meta-analysis results showed that NMES in the lower extremities could effectively shorten the duration of mechanical ventilation in ICU patients [standardized mean difference ( SMD) = -0.51, 95% confidence interval (95% CI) was -0.72 to -0.31, P < 0.000 01], increase the maximum inspiratory pressure [MIP; mean difference ( MD) = 14.19, 95% CI was 9.30 to 19.09, P < 0.000 01], and improve the functional status of critically ill patients [functional status score for ICU (FSS-ICU); MD = 10.44, 95% CI was 3.12 to 17.77, P = 0.005] with statistically significances. However, there were no significant advantages in increasing the Medical Research Council (MRC) score ( MD = 2.13, 95% CI was -1.38 to 5.63, P = 0.23), reducing ICU mortality [relative risk ( RR) = 0.80, 95% CI was 0.51 to 1.24, P = 0.31], shortening length of ICU stay ( MD = -0.54, 95% CI was -3.67 to 2.59, P = 0.74), and the combined effect was not statistically significant. Funnel plot based on the duration of mechanical ventilation showed that the distribution of included articles was basically symmetrical, and no publication bias was detected. Conclusions:NMES of the lower limbs can not only shorten the ventilation duration effectively, but also improve the MIP and functional status of mechanically ventilated patients in ICU. However, it has no significant effect on the MRC score, ICU mortality and length of ICU stay of patients with mechanical ventilation. In the future, high-quality, large sample size and multi-center RCT are needed to verify the effects of NMES.

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