[Element relationship and extension path of clinical evidence knowledge map with Chinese patent medicine].

This study aims to construct the element relationship and extension path of clinical evidence knowledge map with Chinese patent medicine, providing basic technical support for the formation and transformation of the evidence chain of Chinese patent medicine and providing collection, induction, and summary schemes for massive and disorganized clinical data. Based on the elements of evidence-based PICOS, the conventional construction methods of knowledge graph were collected and summarized. Firstly, the data entities related to Chinese patent medicine were classified, and entity linking was performed(disambiguation). Secondly, the study associated and classified the attribute information of the data entity. Finally, the logical relationship between entities was constructed, and then the element relationship and extension path of the knowledge map conforming to the characteristics of clinical evidence of Chinese patent medicine were summarized. The construction of the clinical evidence knowledge map of Chinese patent medicine was mainly based on process design and logical structure, and the element relationship of the knowledge map was expressed according to the PICOS principle and evidence level. The extension path crossed three levels(model layer, data layer application, and new evidence application), and the study gradually explored the path from disease, core evaluation indicators, Chinese patent medicine, core prescriptions, syndrome and treatment rules, and medical case comparison(evolution law) to new drug research and development. In this study, the top-level design of the construction of the clinical evidence knowledge map of Chinese patent medicine has been clarified, but it still needs the joint efforts of interdisciplinary disciplines. With the continuous improvement of the map construction technology in line with the characteristics of TCM, the study can provide necessary basic technical support and reference for the development of the TCM discipline.

[Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines].

Due to the lack of specialized guidance, the post-marketing research on clinical effectiveness of Chinese patent medicines demonstrates varied quality and lacks high-quality evidence, failing to meet the demands of policy-making, clinical decision-making, and industrial decision-making. To address this issue, this project gathered experts in clinical medicine, clinical pharmacy, evidence-based medicine, drug epidemiology, medical ethics, and policy and regulation in China. They referred to the model of international post-marketing research on medicines and developed Guidelines for post-marketing research on clinical effectiveness of Chinese patent medicines under the framework of relevant laws and regulations and technical guidance documents in China. The guidelines were developed with consideration to the characteristics of Chinese patent medicines, China's national conditions, and all the stakeholders including marketing authorization holders, clinical researchers, drug administration, and users. The development of the guidelines followed the requirements for developing group standards set by the China Association of Chinese Medicine. The guidelines fully implement the concept of full life-cycle research, emphasizing the combination of traditional Chinese medicine(TCM) theory, human use experience, and clinical trials and pay attention to the compliance, scientificity, and ethics of research. The guidelines clarify the topic selection and decision-making path of the post-marketing research on effectiveness of Chinese patent medicines through six steps: determining research purpose, analyzing drug characteristics, evaluating research basis, proposing clinical orientation, clarifying research purpose, and implementing classified research. The general principles of research design and implementation were clarified from eight aspects: research type, research objects, sample size, efficacy indicators, bias, missing data, evidence level, and practicality. It focuses on the research on the TCM syndrome-based efficacy evaluation, clinical value-oriented mechanism of action, and the effectiveness of Chinese patent medicines with different routes of administration. The guidelines provide a universal methodological basis for the post-marketing research on clinical effectiveness of Chinese patent medicines.

Traditional Chinese medicine diagnostic prediction model for holistic syndrome differentiation based on deep learning.

Background: With the development of traditional Chinese medicine (TCM) syndrome knowledge accumulation and artificial intelligence (AI), this study proposes a holistic TCM syndrome differentiation model for the classification prediction of multiple TCM syndromes based on deep learning and accelerates the construction of modern foundational TCM equipment. Methods: We searched publicly available TCM guidelines and textbooks for expert knowledge and validated these sources using ten-fold cross-validation. Based on the BERT and CNN models, with the classification constraints from TCM holistic syndrome differentiation, the TCM-BERT-CNN model was constructed, which completes the end-to-end TCM holistic syndrome text classification task through symptom input and syndrome output. We assessed the performance of the model using precision, recall, and F1 scores as evaluation metrics. Results: The TCM-BERT-CNN model had a higher precision (0.926), recall (0.9238), and F1 score (0.9247) than the BERT, TextCNN, LSTM RNN, and LSTM ATTENTION models and achieved superior results in model performance and predictive classification of most TCM syndromes. Symptom feature visualization demonstrated that the TCM-BERT-CNN model can effectively identify the correlation and characteristics of symptoms in different syndromes with a strong correlation, which conforms to the diagnostic characteristics of TCM syndromes. Conclusions: The TCM-BERT-CNN model proposed in this study is in accordance with the TCM diagnostic characteristics of holistic syndrome differentiation and can effectively complete diagnostic prediction tasks for various TCM syndromes. The results of this study provide new insights into the development of deep learning models for holistic syndrome differentiation in TCM.

[Effect of moxibustion at "Mingmen" (GV 4) and "Guanyuan" (CV 4) on immune function in healthy rats based on intestinal flora].

OBJECTIVE: To observe the effects of moxibustion at "Mingmen" (GV 4) and "Guanyuan" (CV 4) on immune function and intestinal flora in healthy rats, thereby investigating the underlying mechanism of moxibustion on immune function. METHODS: Twenty 8-week-old SD rats were randomly divided into a young blank group and a young moxibustion group, with 10 rats in each group. Similarly, twenty 8-month-old SD rats were randomly divided into a middle-aged blank group and a middle-aged moxibustion group, with 10 rats in each group. The rats in the two moxibustion groups received moxibustion at "Mingmen" (GV 4) and "Guanyuan" (CV 4), 15 min per session, once daily, five times a week, for a total of four months. The rats in the two blank groups were fed under normal conditions. After the intervention, thymus and spleen indexes were calculated; the morphology of thymus and spleen tissues was observed using HE staining; the flow cytometry was used to detect the expression of CD and CD T lymphocytes and the CD/CD ratio was calculated; ELISA was used to measure the serum levels of tumor necrosis factor-alpha (TNF-α), interferon-gamma (IFN-γ), interleukin-6 (IL-6), interleukin-10 (IL-10), and interleukin-17 (IL-17); 16S rRNA high-throughput sequencing was used to analyze the intestinal flora. Additionally, the correlation between the relative abundance of intestinal flora and serum levels of TNF-α, IFN-γ, IL-6, IL-10 and IL-17 was analyzed. RESULTS: Compared with the young blank group, the young moxibustion group exhibited an increase in the cortical area of thymus tissue with tighter lymphocyte arrangement; compared with the middle-aged blank group, the middle-aged moxibustion group showed an increase in thymus index (P<0.05) and an increase in the cortical area of thymus tissue. There were no significant differences in spleen index between the 2 moxibustion groups and the 2 blank groups (P>0.05). There were no significant differences in the expression of CD, CD, and CD/CD ratio between the 2 moxibustion groups and the corresponding blank groups (P>0.05). Compared with the young blank group, the young moxibustion group had elevated IL-6 level (P<0.05); compared with the middle-aged blank group, the middle-aged moxibustion group had decreased IL-10 and IL-17 levels (P<0.05). Compared with the young blank group, the young moxibustion group exhibited increased Sobs index, Ace index, and Chao index (P<0.01, P<0.05), as well as increased relative abundance of Spirochaetota, Treponema, Turicibacter, Rikenellaceae_RC9_gut_group (P<0.05), and decreased relative abundance of Dubosiella (P<0.05). Compared with the middle-aged blank group, the middle-aged moxibustion group had increased relative abundance of Spirochaetota, Treponema, norank_f_Peptococcaceae (P<0.05), and decreased relative abundance of Proteobacteria, Allobaculum, and Faecalibaculum (P<0.05). Correlation analysis revealed that relative abundance of Eubacterium_xylanophilum_group and unclassified _f_Lachnospiraceae was negatively correlated with serum TNF-α level (r=-0.39, P=0.03; r=-0.24, P=0.04), while relative abundance of norank_f_norank_o_Clostridia_UCG-014 and Lactobacillus was positively correlated with serum TNF-α level (r=0.37, P=0.04; r=0.43, P=0.02). The relative abundance of Roseburia and Monoglobus was negatively correlated with serum IFN-γ level (r=-0.40, P=0.02; r=-0.44, P=0.01), while relative abundance of Lactobacillus was positively correlated with serum IL-10 level (r=0.43, P=0.02). CONCLUSION: Moxibustion could improve immune function in healthy rats, and its mechanism may be related to the regulation of relative abundance of intestinal flora.

Expert consensus on the use of traditional Chinese medicine for the treatment of common symptoms of post-COVID-19 short-term condition.

A proportion of patients who recovered from COVID-19 have ongoing, recurrent, or new symptoms with negative nucleic acid/antigen test results, which has become a new public health problem that needs to be concerned. Traditional Chinese medicine (TCM) has shown its unique advantages in preventing, treating, and rehabilitating COVID-19. To further standardize clinician's clinical diagnosis and use of TCM for the treatment of common symptoms associated with COVID-19 infection following negative nucleic acid/antigen results, the front-line clinical experts were invited for discussion on the concepts, etiology, clinical manifestations of post-COVID-19 condition, and on treatment with TCM to form the consensus. Clinicians of TCM, Western medicine, or integration of both can use this consensus document for clinical practice and research purposes.

The role and advantage of traditional Chinese medicine in the prevention and treatment of COVID-19.

The global coronavirus disease 2019 (COVID-19) pandemic has had a massive impact on global social and economic development and human health. By combining traditional Chinese medicine (TCM) with modern medicine, the Chinese government has protected public health by supporting all phases of COVID-19 prevention and treatment, including community prevention, clinical treatment, control of disease progression, and promotion of recovery. Modern medicine focuses on viruses, while TCM focuses on differential diagnosis of patterns associated with viral infection of the body and recommends the use of TCM decoctions for differential treatment. This differential diagnosis and treatment approach, with its profoundly empirical nature and holistic view, endows TCM with an accessibility advantage and high application value for dealing with COVID-19. Here, we summarize the advantage of and evidence for TCM use in COVID-19 prevention and treatment to draw attention to the scientific value and accessibility advantage of TCM and to promote the use of TCM in response to public health emergencies. Please cite this article as: Huang M, Liu YY, Xiong K, Yang FW, Jin XY, Wang ZQ, Zhang JH, Zhang BL. The role and advantage of traditional Chinese medicine in the prevention and treatment of COVID-19. J Integr Med. 2023; 21(5): 407-412.

Discovery and evaluation of active compounds from Xuanfei Baidu formula against COVID-19 via SARS-CoV-2 Mpro.

BACKGROUND: The coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2) is still a widespread concern. As one of the effective traditional Chinese medicine (TCM) formulae, Xuanfei Baidu formula (XFBD) shows significant efficacy for treatment of COVID-19 patients. However, its antiviral active compounds and mechanism are still unclear. PURPOSE: In this study, we explored the bioactive compounds of XFBD and its antiviral mechanism by integrating computational analysis and experimental testing. METHODS: Focusing on the SARS-CoV-2 main protease (Mpro), as a key target in virus transcription and replication, the fluorescence resonance energy transfer (FRET) assay was built to screen out satisfactory natural inhibitors in XFBD. The surface plasmon resonance (SPR) and isothermal titration calorimetry (ITC) were undertaken to verify the binding affinity of ligand-Mpro. Omicron BA.1.1 and BA.2.3 variants were used to evaluate the antiviral activity of the focused compounds in non-cytotoxicity concentrations. For introducing the molecular mechanism, computational modeling and NMR spectra were employed to characterize the ligand-binding modes and identify the ligand-binding site on Mpro. RESULTS: From a library of 83 natural compounds, acteoside, licochalcone B, licochalcone D, linoleic acid, and physcion showed the satisfactory inhibition effects on Mpro with IC50 ranging from 1.93 to 42.96 µM, which were further verified by SPR. Showing the excellent binding affinity, acteoside was witnessed to gain valuable insights into the thermodynamic signatures by ITC and presented antiviral activity on Omicron BA.1.1 and BA.2.3 variants in vitro. The results revealed that acteoside inhibited Mpro via forming the hydrogen bond between 7-H of acteoside and Mpro. CONCLUSION: Acteoside is regarded as a representative active natural compound in XFBD to inhibit replication of SARS-CoV-2, which provides the antiviral evidence and some insights into the identification of SARS-CoV-2 Mpro natural inhibitors.

Efficacy and safety of acupuncture on sleep quality for post-stroke insomnia: a systematic review and meta-analysis.

Background: Stroke is the second leading cause of death worldwide, and improving sleep quality in post-stroke insomnia is beneficial to the recovery of stroke. Acupuncture is widely used for the treatment of post-stroke insomnia in China. Therefore, this systematic review and meta-analysis were performed to explore the efficacy and safety of acupuncture for post-stroke insomnia. Methods: Eight databases were searched from their inception to 12 September 2022. Two reviewers independently performed the study screening and data extraction. The outcomes include Pittsburgh Sleep Quality Index (PSQI), objective sleep data measured by polysomnography (PSG), long-term efficacy and adverse events. The quality of the trials was assessed by the Cochrane risk of bias tool 2.0. The RevMan 5.4 and Stata 15.1 were used for data synthesis. Results: Among 3,233 participants from 41 studies were included. Pooled results indicated that acupuncture was superior to control group (CG) in improving PSQI total score (standardized mean difference (SMD) = -1.03, 95% confidence interval (CI): -1.32, -0.74, P < 0.00001), increasing sleep efficiency (SMD = 0.65, 95% CI: 0.37 to 0.92) and total sleep time (SMD = 0.54, 95% CI: 0.22 to 0.86). The favorable results in improving PSQI total score (SMD = 0.65, 95% CI: 0.37 to 0.92), reduced sleep latency (SMD = 1.84, 95% CI: 0.31 to 3.38) and increased total sleep time (SMD = -0.73, 95% CI: -1.15 to -0.31) were also observed in comparisons of acupuncture plus CG vs. CG. As of long-term efficacy and safety, the effects of acupuncture were long-term and robustness, however, due to limited safety information, reliable safety conclusions cannot be drawn. Subgroup analysis showed that acupuncture plus CG was superior to CG for post-infarction patients, but the efficacy of acupuncture alone compared to non-BZDs or other hypnotics needs further research. The GRADE assessment demonstrated that the level of evidence was mostly low or very low given the flaws in the study design and considerable heterogeneity among the included studies. Conclusion: Acupuncture could improve sleep quality, has long-term efficacy and without serious adverse events. However, the findings should be treated with caution owing to the existence of methodological quality issues. More studies with rigorous designs are warranted for validation and explored the safety of acupuncture.

[Overview of systematic reviews of Chinese herbal injections for sepsis].

In this study, an overview of systematic reviews/Meta-analysis(SR/MA) of Chinese herbal injections for sepsis was performed to provide references for clinical practice and promote the quality improvement of clinical evidence. Eight Chinese and English databases such as CNKI, Medline, and EMbase were electronically searched for SR/MA of Chinese herbal injections for sepsis from database inception to June 2022. AMSTAR 2, PRISMA 2020, and GRADE system, combined with Recommendations for Clinical Evidence Grading on Traditional Chinese Medicine Based on Evidence Body, were applied to evaluate the methodological quality, reporting quality, and evidence quality of the included articles. Twenty-seven articles of SR/MA were included, containing four Chinese herbal injections(Xuebijing Injection, Shenfu Injection, Shenmai Injection, and Shengmai Injection). AMSTAR 2 checklist showed that the methodological quality of the SR/MA ranged from moderate to very low. Item 2(prior study design) was the critical item with poor scores, and the non-critical items with poor scores were items 3(explain the selection of the study designs), items 10(report on the sources of funding), and items 16(conflicts of interest stated). In terms of PRISMA 2020, items in eight topics with complete reporting of missing>50%, including search strategy, certainty assessment, results of syntheses, certainty of evidence, registration and protocol, support, competing interests, availability of data, code and other materials. The included SR/MA involved 30 outcome indicators. Evidence quality of mortality, APACHE Ⅱ, and safety, the top three outcome indicators, was evaluated, and all of them were graded as the medium level. The lack of random allocation sequence, allocation concealment mechanism, blinding, and trial sample size was the main reason for the reduction of the evidence level. The available evidence shows that Chinese herbal injections can serve as an effective and safe adjunctive treatment for sepsis, which can reduce mortality, inhibit inflammation, improve coagulation function, and regulate immune function, tissue perfusion, and oxygenation in patients with sepsis. However, the quality of SR/MA was suboptimal, and more high-quality SR/MA is needed to provide evidence to support the efficacy and safety of Chinese herbal injections in the treatment of sepsis.

Perspectives of international multi-center clinical trials on traditional Chinese herbal medicine.

With the introduction of various subjects, such as clinical epidemiology and evidence-based medicine, the qualities and levels of Traditional Chinese Herbal Medicine (TCHM) in China improved substantially, and the processes of internationalization of Traditional Chinese Medicine (TCM) are further accelerated. Since, a variety of drug products in China have been approved for marketing in other countries, and approximately 10 products have submitted the IND application to FDA of United States, of which various Chinese herbal preparations such as compound Danshen dripping pills, Xingling granules, and HMPL-004 have been approved to be investigated in phase III clinical trials. In general, multi-center studies of TCHM are increasing with years, but most of the studies are performed in some certain country, and the actual international multi-center clinical trials are very rare. Number of SCI literatures on multi-center clinical trials of TCHM that published in the recent decade also showed increasing tendency with years, despite the evident reduction in the past 2 years due to the influence of COVID-19 pandemic. Of the multi-center clinical trials of TCHM that performed by mainland China and other oversees regions, except for Taiwan, China, nearly 70% were focused on classic Chinese medicinal formulae and Chinese patent medicine, while the other 30% were on dietary supplements and plant extracts. Facing the future, the "human experience" has attracted close attentions from researchers throughout the world. Effectively utilizing the historic "human experience" is an important method to vitalize potential of original scientific and technological resources of TCHM. Performing multi-center clinical trials with high qualities is still an essential method for TCHM in accessing the mainstream medicine market. In addition, it is also required to further improve the evaluation techniques and methods that not only meet the international standards but also meet the characteristics of TCHM. Furthermore, we should also focus on the TCHM specific clinical values and scientific reports.

IL5RA as an immunogenic cell death-related predictor in progression and therapeutic response of multiple myeloma.

Previous studies have shown the potential of immunogenic cell death-related modalities in myeloma. The significance of IL5RA in myeloma and immunogenic cell death remains unknown. We analyzed IL5RA expression, the gene expression profile, and secretory protein genes related to IL5RA level using GEO data. Immunogenic cell death subgroup classification was performed using the ConsensusClusterPlus and pheatmap R package. Enrichment analyses were based on GO/KEGG analysis. After IL5RA-shRNA transfection in myeloma cells, cell proliferation, apoptosis, and drug sensitivity were detected. P < 0.05 was considered statistically significant. IL5RA was upregulated in myeloma and progressed smoldering myeloma. We observed enrichment in pathways such as the PI3K-Akt signaling pathway, and Natural killer cell mediated cytotoxicity in the high-IL5RA group. IL5RA was also closely associated with secretory protein genes such as CST6. We observed the enrichment of cellular apoptosis and hippo signaling pathway on differential genes in the immunogenic cell death cluster. Furthermore, IL5RA was associated with immune infiltration, immunogenic cell death-related genes, immune-checkpoint-related genes, and m6A in myeloma. In vitro and in vivo experiments showed the involvement of IL5RA in apoptosis, proliferation, and drug resistance of myeloma cells. IL5RA shows the potential to be an immunogenic cell death-related predictor for myeloma.

Characteristics and result reporting of registered COVID-19 clinical trials of Chinese and Indian traditional medicine: A comparative analysis.

Objective: To assess the main characteristics and result reporting of registered COVID-19 interventional trials of traditional Chinese medicine and traditional Indian medicine. Materials and methods: We assessed design quality and result reporting of COVID-19 trials of traditional Chinese medicine (TCM) and traditional Indian medicine (TIM) registered before 10 February 2021, respectively, on Chinese Clinical Trial Registry (ChiCTR) and Clinical Trial Registry-India (CTRI). Comparison groups included registered COVID-19 trials of conventional medicine conducted in China (WMC), India (WMI), and in other countries (WMO). Cox regression analysis was used to assess the association between time from trial onset to result reporting and trial characteristics. Results: The proportion of COVID-19 trials investigating traditional medicine was 33.7% (130/386) among trials registered on ChiCTR, and 58.6% (266/454) on CTRI. Planned sample sizes were mostly small in all COVID-19 trials (median 100, IQR: 50-200). The proportion of trials that were randomized was 75.4 and 64.8%, respectively, for the TCM and TIM trials. Blinding measures were used in 6.2% of the TCM trials, and 23.6% of the TIM trials. Cox regression analysis revealed that planned COVID-19 clinical trials of traditional medicine were less likely to have results reported than trials of conventional medicine (hazard ratio 0.713, 95% confidence interval: 0.541-0.939; p = 0.0162). Conclusion: There were considerable between-country and within-country differences in design quality, target sample size, trial participants, and reporting of trial results. Registered COVID-19 clinical trials of traditional medicine were less likely to report results than trials of conventional medicine.

[Inheritance, innovation and development of traditional Chinese medicine in new era call for scientific supervision].

Pharmaceutical products need to ensure the effectiveness, safety and quality controllability through scientific supervision, and as the broad masses of the people are full of new expectations for the supply of high-quality traditional Chinese medicine products, the reform and innovation of traditional Chinese medicine regulatory policies are also facing new opportunities and new challenges. National Medical Products Administration, National Administration of Traditional Chinese Medicine and other relevant departments have implemented the requirements of the Party Central Committee and the State Council, vigorously promoted the reform of the regulatory system in line with the characteristics of traditional Chinese medicine, introduced a series of innovative policies, and achieved phased results. Including the new registration classification standards in line with the characteristics of traditional Chinese medicine, encouraging the development of classical formulas and hospital preparations, encouraging the research and development of symptomatic Chinese medicines, and gra-dually improving the "three-combined " evidence system. However, in the face of the development problems of traditional Chinese medicine in the new era, it is still necessary to improve the scientific supervision system, further optimize the management measures for the registration of traditional Chinese medicines based on classical formulas, accelerate the improvement of the standard system for traditional Chinese medicine formula granules, and form management measures to encourage and support the secondary development of traditional Chinese medicines. In terms of scientific supervision of traditional Chinese medicine, it is necessary to follow the characteristics and development laws of traditional Chinese medicine itself, comprehensively consider the characteristics of epochal, scientific and systematic in regulatory policies, and serve the inheritance and innovative development of traditional Chinese medicine with scientific supervision.

[Guideline for clinical comprehensive evaluation of Chinese patent medicine (2022 version)].

Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.

Xuanfei Baidu Decoction suppresses complement overactivation and ameliorates IgG immune complex-induced acute lung injury by inhibiting JAK2/STAT3/SOCS3 and NF-κB signaling pathway.

BACKGROUND: The significant clinical efficacy of Xuanfei Baidu Decoction (XFBD) is proven in the treatment of patients with coronavirus disease 2019 (COVID-19) in China. However, the mechanisms of XFBD against acute lung injury (ALI) are still poorly understood. METHODS: In vivo, the mouse model of ALI was induced by IgG immune complexes (IgG-IC), and then XFBD (4g/kg, 8g/kg) were administered by gavage respectively. 24 h after inducing ALI, the lungs were collected for histological and molecular analysis. In vitro, alveolar macrophages inflammation models induced by IgG-IC were performed and treated with different dosage of XFBD-containing serum to investigate the protective role and molecular mechanisms of XFBD. RESULTS: The results revealed that XFBD mitigated lung injury and significantly downregulated the production of pro-inflammatory mediators in lung tissues and macrophages upon IgG-IC stimulation. Notably, XFBD attenuated C3a and C5a generation, inhibited the expression of C3aR and C5aR and suppressed the activation of JAK2/STAT3/SOCS3 and NF-κB signaling pathway in lung tissues and macrophages induced by IgG-IC. Moreover, in vitro experiments, we verified that Colivelin TFA (CAF, STAT3 activator) and C5a treatment markedly elevated the IgG-IC-triggered inflammatory responses in macrophages and XFBD weakened the effects of CAF or C5a. CONCLUSION: XFBD suppressed complement overactivation and ameliorated IgG immune complex-induced acute lung injury by inhibiting JAK2/STAT3/SOCS3 and NF-κB signaling pathway. These data contribute to understanding the mechanisms of XFBD in COVID-19 treatment.

Comparison of Alkaline Sulfite Pretreatment and Acid Sulfite Pretreatment with Low Chemical Loading in Saccharification of Poplar.

Sulfite pretreatment is a productive process for lignin dissolution in lignocelluloses and to reduce the hydrophobicity of lignin by sulfonation, thus promoting the hydrolyzability of the substrate. Previously, sulfite pretreatment needs high dosages of chemicals and thus results in the high cost of the pretreatment and the great pressure of environmental pollution. To overcome these problems, it was crucial to research whether alkaline sulfite pretreatment (ALS) and acid sulfite pretreatment (ACS) with low chemical loading could enhance the saccharification of poplar. In this work, the results indicated that with low loading of chemicals in sulfite pretreatment, ALS pretreatment (1.6% Na2SO3 and 0.5% NaOH) at 180 °C removed more lignin, resulted in lower hydrophobicity and higher cellulase adsorption capacity of poplar than ACS pretreatment (1.6% Na2SO3 and 0.5% H2SO4) at 180 °C. A satisfying glucose yield of 84.9% and a xylose yield of 76.0% were obtained from poplar after ALS pretreatment with 1.6% Na2SO3 and 0.5% NaOH at 180 °C for 1 h using 10 FPU cellulase/g dry matter, saving sodium sulfite by 60.0% compared to the loading of sulfite in traditional sulfite pretreatment. The strategy developed in this work reduced chemical loading and cellulase loading in alkali sulfite pretreatment for the saccharification of poplar.

The add-on effect of Shufeng Jiedu capsule for treating COVID-19: A systematic review and meta-analysis.

Introduction: Shufeng Jiedu capsule (SFJD) is a commonly used Chinese patent medicine in China. Some studies have reported that SFJD has therapeutic effects in patients diagnosed with COVID-19. This systematic review aimed to critically evaluate the efficacy and safety of SFJD combined with western medicine (WM) for treating COVID-19. Methods: A literature search by using WHO COVID-19 database, PubMed, Embase, Cochrane Library, the Web of Science, CKNI, Wanfang, VIP, SinoMed, and clinical trial registries was conducted, up to 1 August 2022. Randomized controlled trials (RCTs), non-RCTs, cohort studies and case series of SFJD combined with WM for COVID-19 were included. Literature screening, data extraction, and quality assessment were performed independently by two reviewers in line with the same criteria. We used the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the certainty of evidence. Meta-analyses were performed with Revman 5.3 if possible. The descriptive analysis was conducted when the studies could not be meta-analyzed. Results: Totally 10 studies with 1,083 patients were included. Their methodological quality were moderate. The results demonstrated that compared to WM group, SFJD + WM group remarkably increased the nucleic acid negative conversion rate (RR = 1.40, 95%CI: 1.07-1.84), total effective rate (RR = 1.18, 95%CI: 1.07-1.31), cure rate (RR = 4.06, 95%CI: 2.19-7.53), and the chest CT improvement rate (RR = 1.19, 95%CI: 1.08-1.31), shorten nucleic acid negative conversion time (MD = -0.70, 95%CI: -1.14 to -0.26), reduced the clinical symptom disappearance time (fever, diarrhea, cough, fatigue, pharyngalgia, nasal congestion, and rhinorrhea), as well as improved the levels of laboratory outcomes (CRP, IL-6, Lym, and Neu). Additionally, the incidence of adverse reactions did not exhibit any statistically significant difference between SFJD + WM group and WM group. Conclusion: SFJD combined with WM seems more effective than WM alone for the treatment of COVID-19. However, more well-designed RCTs still are warranted. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022306307].

Development of a core outcome set on Traditional Chinese Medicine and Western Medicine for rheumatic heart disease: a study protocol.

INTRODUCTION: Globally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine are gradually increasing in China. However, because the outcomes of clinical trials are subject to heterogeneity and selective reporting, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, and diminishing the value of clinical trials. Therefore, there is an urgent need to design a TCM or integrated medicine core outcome set (COS) for RHD. METHODS AND ANALYSIS: The development of this study will take place in four stages under the direction of a multidisciplinary advisory board. (1) Establishing a comprehensive outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centres, patient's semistructured interviews, and clinician's questionnaire surveys; (2) Screen stakeholder groups from various fields to participate in the Delphi survey; (3) Two e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4) Hold a face-to-face consensus meeting to develop the COS-TCM-RHD. ETHICS AND DISSEMINATION: The ethical approval for this study has been obtained from the Tianjin University of Traditional Chinese Medicine Ethics Committee (TJUTCM-EC20210008). The findings will be disseminated in peer-reviewed journals and meetings. TRIAL REGISTRATION NUMBER: This study has been registered at the Core Outcome Measures in Effectiveness Trials (COMET) database (Registration #1743).

Efficacy and safety of zhibitai in the treatment of hyperlipidemia: A systematic review and meta-analysis.

Objective: To evaluate the efficacy and safety of Zhibitai (ZBT) in the treatment of patients with hyperlipidemia (HLP). Methods: A search of 8 electronic databases was conducted to find randomized controlled trials (RCTs), to evaluate the efficacy and safety of ZBT for the treatment of HLP. The risk of bias in randomized controlled trials was assessed by using the Cochrane Collaboration Risk of Bias tool for randomized controlled trials 2.0 (RoB 2.0). The primary outcomes were the levels of triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C). The total effective rate served as the secondary outcome. The incidence of adverse events was considered the safety outcome. Review Manager 5.4 was used to conduct meta-analyses. Data were pooled by random-effects or fixed-effects model to obtain the mean difference (MD), risk ratio (RR), odds ratio (OR), and 95% confidence interval (CI). Results: There were 28 eligible RCTs with a total of 2,952 participants. Overall, we verified that ZBT plus conventional therapy (CT) was superior to CT for the treatment of HLP [TC: MD = -0.50, 95% CI (-0.80, -0.19); TG: MD = -0.38, 95% CI (-0.49, -0.27); LDL-C: MD = -0.50, 95% CI (-0.69, -0.31); HDL-C: MD = 0.17, 95% CI (0.11, 0.24); total effective rate: OR = 4.26, 95% CI (2.28, 7.95)]. There were no significant differences in the primary outcomes between ZBT alone vs. CT (p > 0.05). For safety, the ZBT group (with CT or alone) outperformed the CT group [ZBT alone: RR = 0.51, 95% CI (0.32, 0.81); ZBT plus CT: RR = 0.51, 95% CI (0.30, 0.89)]. For each outcome, the subgroups and the sensitivity analysis matched the overall results. Conclusion: ZBT may be safe and beneficial to HLP patients, especially for serum lipid management. ZBT can be used along with CT for the treatment of HLP. However, it is necessary to conduct more rigorous RCTs to confirm these findings. Systematic Review Registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022316251].

Development of a reporting guideline for systematic reviews of animal experiments in the field of traditional Chinese medicine.

OBJECTIVE: In recent years, there are several systematic reviews published on animal experiments of Traditional Chinese medicine (TCM). PRISMA (preferred reporting items for systematic reviews and meta-analysis) guidelines provide a guarantee for significantly improving the reporting quality of systematic reviews (SRs) and meta-analysis (MAs) to a certain extent; however, there are still certain defects found in the quality of SRs/MAs of animal experiments of TCM. It has been found that especially, the descriptions of the rationale and animal characteristics of TCM interventions are inadequate. As a result, we have developed a novel reporting guideline for SRs/MAs of animal experimental in the field of TCM (PRISMA-ATCM) to overcome these problems. METHODS: PRISMA-ATCM reporting guidelines were formed by analyzing both the status and quality of published SRs/MAs of animal experiments and consulting experts in the related fields, and then by Delphi consultation, consensus meeting and revision. RESULTS: Among the 27 items on the PRISMA checklist, Title (1), Structured summary (2), Rationale (3), Objectives (4), Protocol and registration (5), Eligibility criteria (6), Data items (11), Planned methods of analysis (14), Study characteristics (18), Summary of evidence (24), Limitations (25), and Funding (27) have been extensively revised and expanded, to specifically include the details about TCM intervention and animal characteristics. In addition, illustrative examples and explanations have been provided for each item. CONCLUSION: PRISMA-ATCM could markedly improve the quality SRs/MAs of animal experiments in the field of TCM.