1.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
2.The Growing Burden of Fall-Related Injuries among Older Adults: A Seven-Year Study from a Tertiary Medical Center in Taiwan
Yu-Chieh TSAI ; Shey-Ying CHEN ; Ya-Mei CHEN ; Edward Pei-Chuan HUANG ; Feng-Ping LU
Annals of Geriatric Medicine and Research 2026;30(1):70-76
Background:
As Taiwan’s population ages, falls among older adults have become a critical public health concern. However, limited data exist regarding temporal trends and injury patterns in fall-related emergency department (ED) visits. This study aimed to examine trends in fall-related ED visits and hospitalizations among older adults in Taiwan and to explore injury distributions by age group.
Methods:
We conducted a retrospective cohort study using data from the National Taiwan University Hospital between 2011 and 2017. Patients aged ≥65 years were compared with those aged 20–64 years. Fall-related visits were identified using chief complaints and the International Classification of Diseases 9th/10th revision (ICD-9/ICD-10) codes. Outcomes included hospitalization rates, length of stay, and 30-day mortality.
Results:
A total of 22,471 fall-related ED visits were analyzed. While visits among younger adults declined (annual growth rate, -1.34%), visits among older adults increased (2.37% annually), with the steepest rise in those aged ≥85 years. Hospitalization occurred in 27.1% of older adults, nearly double that of younger adults (14.4%). Older adults also had longer hospital stays and higher 30-day mortality rates, findings consistent even when restricted to lower limb fractures.
Conclusion
Fall-related ED visits and hospitalizations are rising disproportionately among Taiwan’s older population. Targeted prevention strategies and transitional care interventions are urgently needed to address the growing clinical and economic burden of falls in aging societies.
3.Engineered Bacteriophages for The Treatment of Multidrug-resistant Bacterial Infections
Yu-Ying CHEN ; Chun-Mei HUANG ; Jin-Zhi PAN ; De-Liang LIU ; Yang ZHOU ; Gui-Qin DAI ; Peng-Fei ZHAO ; Hong-Zhou LU ; Ming-Bin ZHENG
Progress in Biochemistry and Biophysics 2026;53(6):1581-1596
Multidrug-resistant (MDR) bacterial infections have emerged as a serious challenge of global public health crisis. The overuse and misuse of conventional antibiotics have dramatically accelerated the emergence, evolution and worldwide spread of drug-resistant bacterial strains, necessitating urgent exploration of novel antibacterial strategies. Bacteriophages serve as natural bacterial predators offering distinct advantages including high host specificity, autonomous self-replication capabilities and cost-effective large-scale production. However, wild-type phages present significant clinical limitations due to their narrow host ranges, susceptibility to rapid immune clearance and poor penetration of bacterial biofilms, which severely restrict their therapeutic applications. The convergence of synthetic biology, nanotechnology and advanced gene editing technologies has accelerated the development of engineered bacteriophage platforms, providing programmable, scalable and clinically translatable pathways to overcome these inherent biological constraints. Here, we systematically delineate four fundamental strategies for engineered bacteriophage development. Chemical modification utilizes reactive functional groups such as amino, carboxyl and thiol moieties on capsid proteins through esterification, amidation or click chemistry reactions to achieve precise drug conjugation and surface functionalization. In vivo editing encompasses ultraviolet or chemical mutagenesis for random mutation induction, homologous recombination for targeted genetic alterations, recombineering methodologies including electroporation-mediated bacteriophage recombination engineering, and CRISPR-Cas systems for precise genome editing to enable exact genetic reconstruction and host range reprogramming. In vitro synthesis leverages genome engineering platforms where intact phage genomes are transferred into yeast or host bacteria to facilitate highly efficient homologous recombination, enabling large DNA fragment assembly and cross-gene host range expansion without bacterial toxicity constraints. Directed evolution combines artificial selection through mutation library screening with rational design approaches involving chimeric receptor binding protein construction or site-specific mutagenesis, effectively balancing the discovery of unknown adaptive pathways with targeted host specificity modification. Moreover, we comprehensively discuss therapeutic applications across diverse clinical scenarios. Engineered bacteriophage effectively disrupt bacterial biofilms through sophisticated functionalized delivery platforms including nanozyme-conjugated phages, phage-liposome nanoconjugates and bio-responsive hydrogels, demonstrating significantly enhanced bactericidal efficiency compared to unmodified free phages. These bioengineered vectors attenuate bacterial virulence and resensitize pathogens to antibiotics by delivering CRISPR-Cas systems or base editors to disrupt critical virulence factors such as pili, capsule synthesis machineries and quorum sensing systems, or by inactivating antibiotic resistance determinants including beta-lactamase genes. As an intelligent nanomedicine delivery platform, engineered bacteriophage enable precise pathogen elimination an through photocatalytic reactive oxygen species generation, immunomodulatory interventions, or controlled release of antibacterial drugs. Furthermore, oral administration of engineered bacteriophage facilitates microbiota modulation, which selectively eliminate intestinal pathogens while preserve beneficial commensal microbiota, thereby restoring microbial community balance and preventing complications associated with dysbiosis. Finally, we critically analyze persistent challenges including host strain matching complexity, evolution of bacterial resistance mechanisms, pharmacokinetic optimization requirements, optimal administration route selection, large-scale production quality control standards and clinical dosing determination protocols. Through multidisciplinary integration of synthetic biology, infectious disease medicine and immunology, future translational medicine studies of bacteriophage should establish comprehensive technical platforms encompassing rapid phage screening, intelligent rational design, rigorous in vivo evaluation and standardized clinical validation processes, ultimately advancing engineered bacteriophage from laboratory innovations to clinically approved therapeutics for effectively combating MDR bacterial infections.
4.Current status and influencing factors of work readiness in patients returning to work after lung cancer surgery
Yuanyuan YIN ; Xingxia LONG ; Jie ZHANG ; Yanli, JI ; Ying ZHU ; Lijun HE ; Mei YANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):1079-1084
Objective To investigate the current status of work readiness and its influencing factors among patients returning to work after lung cancer surgery. Methods A retrospective study was conducted on young and middle-aged postoperative lung cancer patients who were treated at the Department of Thoracic Surgery, West China Hospital, Sichuan University from March to September 2023 and returned to their jobs. Data were collected through a general information questionnaire, readiness for return-to-work scale (RRTW), general self-efficacy scale (GSES), and simplified coping style questionnaire (SCSQ). Univariate and multivariate logistic regression analyses were used to explore the factors affecting the work readiness of patients returning to work. Results A total of 219 patients were included, with 59 males and 160 females aged 18-60 years. Among the postoperative lung cancer patients returning to work, 73.1% were in the active maintenance stage of return-to-work readiness with a RRTW score of (17.59±1.48) points, and 26.9% were in the uncertain maintenance stage with a RRTW score of (16.22±1.50) points. Multivariate logistic regression analysis showed that patients aged≤30 years (OR=52.381), employees of enterprises and institutions (OR=7.682), agricultural, pastoral, fishery, forestry laborers (OR=15.665), positive coping (OR=5.043), those with higher self-efficacy (OR=1.157) and engaged in physically demanding work (OR=2.449) had higher return-to-work readiness, while patients with≥2 children (OR=0.055), self-payment (OR=0.044), and those working more than 40 hours per week (OR=0.122) had lower return-to-work readiness. Conclusion The return-to-work readiness of young and middle-aged postoperative lung cancer patients needs to be improved, and occupation, job nature, main coping styles, general self-efficacy and other factors are associated with return-to-work readiness.
5.Identification and infection rate of densovirus in Culex pipiens pallens in Beijing in 2023
Xiu-yan XU ; Ting YAN ; Si-jie ZHU ; Jing LI ; Mei-de LIU ; Hong-jiang ZHANG ; Ting LIU ; Qiu-hong LI ; Xiao-jie ZHOU ; Ying TONG ; Yong ZHANG
Acta Parasitologica et Medica Entomologica Sinica 2026;33(1):25-30
Objective This study conducted molecular biological identification of the viruses carried by Culex pipiens pallens specimens collected in Shunyi District, Beijing in 2023, and observed the changes in the infection rate of the viruses carried by Cx. pipiens pallens at different collection times. Methods Cx. pipiens pallens were collected using carbon dioxide mosquito traps. The mosquito samples were ground in batches and analyzed by molecular biology technologies. The virus infection rate at different collection times was analyzed statistically. Results 17 strains of Culex pipiens pallens densovirus(CppDNV)were identified from Cx. pipiens pallens samples collected in Shunyi District, Beijing, in 2023. The nucleotide sequence analysis of the virus genome coding region showed that CppDNV was a single-stranded DNA virus with a total length of 3 335 nt, encoding 2 non-structural proteins(NS1, NS2)and 1 capsid protein(VP). The nucleotide(amino acid)sequence lengths of the three proteins were 2 376 nt(791 aa),1 092 nt(363 aa)and 1 071 nt(356 aa), respectively. Phylogenetic analysis showed that CppDNV was located in genus Brevihamaparvovirus. Statistical analysis showed no significant difference in infection rates across collection times(χ2=4.429, P=0.194). Conclusions CppDNV was identified in Cx. pipiens pallens in Beijing, and it was stably maintained in this natural population.
6.The pathological diagnostic efficacy of endoscopic ultrasound-guided fine-needle biopsy using a fork-tip needle
Bahetinuer JIASHAER ; Mei YING ; Baohui SONG ; Tianyin CHEN ; Yiqun ZHANG ; Yunshi ZHONG ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Clinical Medicine 2026;33(4):689-693
Objective To compare the pathological diagnosis rate, number of punctures, and applicability to different lesion locations between a fork-tip biopsy needle and a conventional needle. Methods A retrospective collection of data was conducted on 137 patients who underwent endoscopic ultrasound (EUS)-guided fine needle biopsy (novel needle group, n=12) or aspiration (conventional needle group, n=125) at Zhongshan Hospital, Fudan University from January to August 2023. After propensity score matching at a ratio of 1∶5, there were 12 patients in the novel needle group and 60 patients in the conventional needle group. The pathological diagnosis rate and number of punctures were compared between the two groups. The stratified analyses on the size and location of lesions were performed. Results After matching, the pathological diagnosis rate was 91.7% (11/12) in the novel needle group, with a median of 2 punctures; the rate was 61.7% (37/60) in the conventional needle group, with a median of 3 punctures. No statistically significant differences in pathological diagnosis rate and number of punctures were observed between the two groups. Subgroup analysis showed that for lesions ≥20 mm, there was no significant difference in the number of punctures between the novel and conventional needles. The novel needle achieved a significantly higher pathological diagnosis rate for subepithelial tumors compared with the conventional needle (100.0% vs 30.4%, P=0.019), whereas no significant differences were found for pancreatic masses or lymph node lesions. Conclusions Compared with EUS-guided aspiration using the conventional needle, EUS-guided biopsy using the novel fork-tip needle shows a trend toward a higher pathological diagnosis rate, with particular advantages in subepithelial tumors.
7.Mechanisms of Babaodan in Attenuating Acetaminophen-induced Acute Liver Injury via Metabolic Reprogramming and Inflammatory Pathways
Ying ZHANG ; Yuchang AN ; Xiang ZHU ; Mei ZHONG ; Yanfang ZHENG ; Mingqing HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):122-130
ObjectiveTo investigate the effects and potential mechanisms of Babaodan (BBD) against acetaminophen (APAP)-induced acute liver injury (ALI) based on transcriptomics. MethodsA total of 36 male C57BL/6 mice were randomly divided into 6 groups (n=6 per group): normal group, model group, N-acetylcysteine group (NAC, 120 mg·kg-1), and BBD low-, medium-, and high-dose groups (BBD-L, BBD-M, BBD-H groups, 75, 150, 300 mg·kg-1, respectively). Except for the normal group, all other groups were subjected to APAP-induced ALI. The serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were measured in each group. Hepatic levels or activities of malondialdehyde (MDA) and glutathione peroxidase (GSH-Px) were detected using commercial kits. Hematoxylin-eosin (HE) staining was performed to evaluate the degree of liver histopathological damage. Transcriptomic analysis was employed to screen differentially expressed genes (DEGs), and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify differential pathways involved in BBD intervention against ALI. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were applied to validate the expression of differential genes and related pathway proteins. Additionally, glucose (GLU) consumption, as well as lactate (LD) and adenosine triphosphate (ATP) content were assessed across all mouse groups. ResultsPharmacodynamic evaluation showed that, compared with the normal group, the model group exhibited significantly elevated serum levels of ALT, AST, TC, TG, and LDL-C (P<0.01), significantly increased MDA level (P<0.01), and significantly decreased GSH-Px level (P<0.05). Compared with the model group, BBD intervention at different doses significantly reduced the serum levels of ALT, AST, TC, TG, and LDL-C (P<0.05, P<0.01), increased GSH-Px level (P<0.05, P<0.01), significantly decreased MDA level (P<0.01), and ameliorated hepatic histopathological injury. Liver transcriptomic analysis revealed that, following high-dose BBD intervention, the core genes were mainly enriched in pathways related to inflammatory responses and energy metabolic reprogramming, including the interleukin-17 (IL-17) signaling pathway, the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, fructose and mannose metabolism, and glycolysis. Real-time PCR validation demonstrated that, compared with the normal group, the mRNA expression levels of glycolysis-related genes [hexokinase 1 (HK1), hexokinase 2 (HK2), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 4 (PFKFB4), pyruvate kinase M (PKM), and lactate dehydrogenase A (LDHA)], as well as inflammatory cytokines [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β)] were significantly upregulated in the model group (P<0.05, P<0.01). Compared with the model group, the BBD-H group showed significantly decreased mRNA expression of HK1, HK2, PFKFB3, PFKFB4, PKM, LDHA, TNF-α, IL-6, and IL-1β (P<0.05, P<0.01). Western blot results indicated that, compared with the normal group, the model group had significantly increased expression of glycolysis-related proteins [glucose transporter 1 (GLUT1), HK1, PFKFB3, and PKM], inflammatory proteins [interleukin-18 (IL-18), TNF-α, and IL-1β], and phosphorylated (p)-PI3K and p-Akt proteins (P<0.05, P<0.01). Compared with the model group, the BBD-H group exhibited significantly decreased expression of GLUT1, HK1, PFKFB3, PKM, IL-18, TNF-α, IL-1β, p-PI3K, and p-Akt (P<0.05, P<0.01). Metabolic indicator measurements showed that, compared with the model group, the BBD-H group showed significantly reduced GLU consumption, LD and ATP content (P<0.05, P<0.01). ConclusionBBD may alleviate APAP-induced ALI through dual regulation of metabolic reprogramming and inflammatory responses, potentially via inhibition of the PI3K/Akt signaling pathway.
8.Mechanisms of Babaodan in Attenuating Acetaminophen-induced Acute Liver Injury via Metabolic Reprogramming and Inflammatory Pathways
Ying ZHANG ; Yuchang AN ; Xiang ZHU ; Mei ZHONG ; Yanfang ZHENG ; Mingqing HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(20):122-130
ObjectiveTo investigate the effects and potential mechanisms of Babaodan (BBD) against acetaminophen (APAP)-induced acute liver injury (ALI) based on transcriptomics. MethodsA total of 36 male C57BL/6 mice were randomly divided into 6 groups (n=6 per group): normal group, model group, N-acetylcysteine group (NAC, 120 mg·kg-1), and BBD low-, medium-, and high-dose groups (BBD-L, BBD-M, BBD-H groups, 75, 150, 300 mg·kg-1, respectively). Except for the normal group, all other groups were subjected to APAP-induced ALI. The serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglyceride (TG), and low-density lipoprotein cholesterol (LDL-C) were measured in each group. Hepatic levels or activities of malondialdehyde (MDA) and glutathione peroxidase (GSH-Px) were detected using commercial kits. Hematoxylin-eosin (HE) staining was performed to evaluate the degree of liver histopathological damage. Transcriptomic analysis was employed to screen differentially expressed genes (DEGs), and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify differential pathways involved in BBD intervention against ALI. Real-time quantitative polymerase chain reaction (Real-time PCR) and Western blot were applied to validate the expression of differential genes and related pathway proteins. Additionally, glucose (GLU) consumption, as well as lactate (LD) and adenosine triphosphate (ATP) content were assessed across all mouse groups. ResultsPharmacodynamic evaluation showed that, compared with the normal group, the model group exhibited significantly elevated serum levels of ALT, AST, TC, TG, and LDL-C (P<0.01), significantly increased MDA level (P<0.01), and significantly decreased GSH-Px level (P<0.05). Compared with the model group, BBD intervention at different doses significantly reduced the serum levels of ALT, AST, TC, TG, and LDL-C (P<0.05, P<0.01), increased GSH-Px level (P<0.05, P<0.01), significantly decreased MDA level (P<0.01), and ameliorated hepatic histopathological injury. Liver transcriptomic analysis revealed that, following high-dose BBD intervention, the core genes were mainly enriched in pathways related to inflammatory responses and energy metabolic reprogramming, including the interleukin-17 (IL-17) signaling pathway, the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, fructose and mannose metabolism, and glycolysis. Real-time PCR validation demonstrated that, compared with the normal group, the mRNA expression levels of glycolysis-related genes [hexokinase 1 (HK1), hexokinase 2 (HK2), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 3 (PFKFB3), 6-phosphofructo-2-kinase/fructose-2,6-bisphosphatase 4 (PFKFB4), pyruvate kinase M (PKM), and lactate dehydrogenase A (LDHA)], as well as inflammatory cytokines [tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β)] were significantly upregulated in the model group (P<0.05, P<0.01). Compared with the model group, the BBD-H group showed significantly decreased mRNA expression of HK1, HK2, PFKFB3, PFKFB4, PKM, LDHA, TNF-α, IL-6, and IL-1β (P<0.05, P<0.01). Western blot results indicated that, compared with the normal group, the model group had significantly increased expression of glycolysis-related proteins [glucose transporter 1 (GLUT1), HK1, PFKFB3, and PKM], inflammatory proteins [interleukin-18 (IL-18), TNF-α, and IL-1β], and phosphorylated (p)-PI3K and p-Akt proteins (P<0.05, P<0.01). Compared with the model group, the BBD-H group exhibited significantly decreased expression of GLUT1, HK1, PFKFB3, PKM, IL-18, TNF-α, IL-1β, p-PI3K, and p-Akt (P<0.05, P<0.01). Metabolic indicator measurements showed that, compared with the model group, the BBD-H group showed significantly reduced GLU consumption, LD and ATP content (P<0.05, P<0.01). ConclusionBBD may alleviate APAP-induced ALI through dual regulation of metabolic reprogramming and inflammatory responses, potentially via inhibition of the PI3K/Akt signaling pathway.
9.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Atopic Dermatitis
Junfeng LIU ; Xiumei MO ; Mei MO ; Hongyi LI ; Ying LIN ; Xiaoxiao ZHANG ; Dacan CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):244-252
Atopic dermatitis (AD) is a common pruritic and chronic inflammatory dermatosis in clinical practice and is one of the diseases responding specifically to traditional Chinese medicine (TCM). With the launch of biological agents and small molecule drugs and the development and implementation of guidelines of diagnosis and treatment, clinical pathways of treatment of moderate to severe AD, and consensus on the whole-process management of AD, the clinical efficacy of moderate to severe AD has been significantly improved. However, there are still many unmet clinical needs that require more effective methods to meet. In response to the Opinions of the CPC Central Committee and the State Council on Facilitating the Inheritance, Innovation, and Development of Traditional Chinese Medicine and the spirit of the National Conference on TCM, the China Association of Chinese Medicine organized more than 20 experts in TCM dermatology, Western medicine dermatology, interdisciplinary fields, and industries to discuss the difficulties and advantages of TCM in the treatment of AD. TCM treatment for AD can not only improve rash and relieve itching but also solve many concomitant syndromes. The abundant external treatment methods of TCM have advantages for different special populations and rash characteristics. The concept of treating disease before its onset in TCM is in line with the chronic disease management mode of prevention and treatment of atopic march and prevention of recurrence. In addition, TCM therapy can reduce the use of topical glucocorticoids and has good safety. Regarding the comorbidity of AD, equal emphasis on TCM and Western medicine and multidisciplinary joint treatment should be advocated to achieve maximum benefit for patients. The exchange of TCM and Western medicine has clarified the positioning and advantages of TCM intervention in AD, providing guidance for clinical and scientific research.
10.Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.
Fan WANG ; Hai-Qing GAO ; Zhe LYU ; Xiao-Ming WANG ; Hui HAN ; Yong-Xia WANG ; Feng LU ; Bo DONG ; Jun PU ; Feng LIU ; Xiu-Guang ZU ; Hong-Bin LIU ; Li YANG ; Shao-Ying ZHANG ; Yong-Mei YAN ; Xiao-Li WANG ; Jin-Han CHEN ; Min LIU ; Yun-Mei YANG ; Xiao-Ying LI
Chinese journal of integrative medicine 2025;31(3):195-205
OBJECTIVE:
To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:
This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:
A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS
Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans
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Amlodipine/adverse effects*
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Drugs, Chinese Herbal/adverse effects*
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Male
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Female
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Hypertension/complications*
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Middle Aged
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Treatment Outcome
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Drug Therapy, Combination
;
Adult
;
Blood Pressure/drug effects*
;
Double-Blind Method
;
Aged
;
Antihypertensive Agents/adverse effects*


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