1.Clinical Efficacy of Qi-regulating and Phlegm-removing Method(Liu Junzitang Combined with Linggang Wuwei Jiangxintang) in Treating AECOPD with Increased EOS
Renjie HUANG ; Wangqin YU ; Wuyinuo TANG ; Hong SONG ; Lyuyuan HE ; Wenbo LIN ; Guanyi WU ; Hang HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):149-156
ObjectiveTo assess the efficacy and safety of the Qi-regulating and phlegm-removing method(Liu Junzitang Combined with Linggang Wuwei Jiangxintang) for treating acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with increased eosinophils (EOS). MethodsSixty-eight AECOPD patients with increased EOS who were hospitalized in the Department of Pulmonary Diseases of Jinhua Traditional Chinese Medicine Hospital from April 2023 to April 2024 were recruited and randomly assigned to an experimental group (EG) or a control group (CG). Both groups received conventional Western medicine, with the EG additionally receiving Liujunzitang and Linggan Wuwei Jiangxintang. The therapeutic efficacy indicators were measured after the treatment. The main therapeutic efficacy indicators included partial pressure of oxygen (PaO2) and partial pressure of carbon dioxide (PaCO2). The secondary efficacy indicators included the TCM symptom scores, the COPD Assessment Test (CAT) score, the Modified Medical Research Council (mMRC) Dyspnea Scale score, and the length of hospital stay. The indicators were measured at baseline and on days 3 and 7 of intervention. The safety was evaluated based on the adverse events. ResultsBaseline characteristics were not statistically different between the two groups. Compared with CG, EG showed no significant difference in PaO2 (P=0.773), PaCO2 (P=0.632) and or CAT score (P=0.336) at on day 3 but better PaO2 (P=0.004), PaCO2 (P=0.008), and CAT score (P=0.013) were significantly better at on day 7. Compared with CGAfter treatment, EG had lower TCM syndrome scores of than CG EG on day 3 (P=0.005) and day 7 were significantly decreased (P0.001). There was no significant difference in mMRC score between the two groups on day 3 (P=0.514) and day 7 (P=0.176) as wasor the length of hospital stay (P=0.915). The generalized linear mixed model (GLMM) showed that compared with CG, EG had significant improvements over time in PaO2, PaCO2, TCM syndrome symptom scores, CAT score, and mMRC score. ConclusionRegulating qi Qi and removing phlegm combined with conventional Western medicine can significantly alleviateimprove the clinical symptoms and improve the lung function of AECOPD patients with increased EOS increased AECOPDwhich has and demonstrates good safety.
2.Clinical Efficacy of Qi-regulating and Phlegm-removing Method(Liu Junzitang Combined with Linggang Wuwei Jiangxintang) in Treating AECOPD with Increased EOS
Renjie HUANG ; Wangqin YU ; Wuyinuo TANG ; Hong SONG ; Lyuyuan HE ; Wenbo LIN ; Guanyi WU ; Hang HUANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(3):149-156
ObjectiveTo assess the efficacy and safety of the Qi-regulating and phlegm-removing method(Liu Junzitang Combined with Linggang Wuwei Jiangxintang) for treating acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with increased eosinophils (EOS). MethodsSixty-eight AECOPD patients with increased EOS who were hospitalized in the Department of Pulmonary Diseases of Jinhua Traditional Chinese Medicine Hospital from April 2023 to April 2024 were recruited and randomly assigned to an experimental group (EG) or a control group (CG). Both groups received conventional Western medicine, with the EG additionally receiving Liujunzitang and Linggan Wuwei Jiangxintang. The therapeutic efficacy indicators were measured after the treatment. The main therapeutic efficacy indicators included partial pressure of oxygen (PaO2) and partial pressure of carbon dioxide (PaCO2). The secondary efficacy indicators included the TCM symptom scores, the COPD Assessment Test (CAT) score, the Modified Medical Research Council (mMRC) Dyspnea Scale score, and the length of hospital stay. The indicators were measured at baseline and on days 3 and 7 of intervention. The safety was evaluated based on the adverse events. ResultsBaseline characteristics were not statistically different between the two groups. Compared with CG, EG showed no significant difference in PaO2 (P=0.773), PaCO2 (P=0.632) and or CAT score (P=0.336) at on day 3 but better PaO2 (P=0.004), PaCO2 (P=0.008), and CAT score (P=0.013) were significantly better at on day 7. Compared with CGAfter treatment, EG had lower TCM syndrome scores of than CG EG on day 3 (P=0.005) and day 7 were significantly decreased (P0.001). There was no significant difference in mMRC score between the two groups on day 3 (P=0.514) and day 7 (P=0.176) as wasor the length of hospital stay (P=0.915). The generalized linear mixed model (GLMM) showed that compared with CG, EG had significant improvements over time in PaO2, PaCO2, TCM syndrome symptom scores, CAT score, and mMRC score. ConclusionRegulating qi Qi and removing phlegm combined with conventional Western medicine can significantly alleviateimprove the clinical symptoms and improve the lung function of AECOPD patients with increased EOS increased AECOPDwhich has and demonstrates good safety.
3.Construction of glucose oxidase–loaded nanogels and its inhibition effect on the Warburg effect in glioma cells
Wenbo ZHOU ; Weilin LI ; Wuting DAI ; Ruiyao LIU ; Yuan YU
Journal of Pharmaceutical Practice and Service 2026;44(3):132-136
Objective To construct glucose oxidase(GOx)–loaded nanogels (GONGs), optimize their formulation, and evaluate their capacity to inhibit the Warburg effect in glioma cells. Methods A responsive polymer (HAM) was synthesized and used to self-assemble GONGs, which were then characterized. Encapsulation efficiency and drug loading were determined using fluorescence spectrophotometry. Biocompatibility was tested by measuring cytotoxicity and hemolytic activity. Western blotting was used to evaluate the effects of GONGs on the expression of proteins associated with the Warburg phenotype and oxidative damage in glioma cells. Results GONGs prepared at a drug–to–polymer ratio of 1∶10 exhibited a particle size of 140.3 nm and a zeta potential of −27.2 mV. Compared with free GOx, GONGs markedly reduced cytotoxicity, increased the IC50 in hUVEC cells from 2.150 nmol/L to 74.86 nmol/L, and significantly decreased hemolysis. At a GOx concentration of 2 nmol/L, GONGs effectively downregulated glycolysis-related proteins, such as HK2 and LDHA, and inhibited glutamine metabolism in glioma cells. Conclusion GONGs exhibited high GOx loading capacity, significantly reduced GOx-induced cytotoxicity, inhibited the Warburg effect in glioma cells and induced oxidative damage.
4.Clinical study on noninfectious fever of endovascular aortic repair
Zhengyue QIAN ; Yao FU ; Wenbo ZHOU ; Bingbing MA
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(02):275-280
Objective To analyze the clinical characteristics and risk factors of noninfectious fever after endovascular repair of aortic dilatation diseases, and to explore management strategies. Methods A retrospective analysis was conducted on the clinical data of patients who underwent endovascular aortic repair for aortic dilatation diseases from January 2021 to October 2023. Based on inclusion and exclusion criteria, the enrolled patients were divided into a febrile group and an afebrile group according to the presence of postoperative fever. Clinical data, including demographics and surgical details, were compared between the two groups. Multivariate logistic regression analysis was performed on indicators with P≤0.05 in the univariate analysis, and receiver operating characteristic (ROC) curves were generated to analyze the predictive value of risk factors for postoperative noninfectious fever. Results A total of 305 patients were included in the final analysis. Postoperative noninfectious fever occurred in 75.08% (229/305) of the patients, with 98.25% of cases occurring within the first two postoperative days. The febrile group (n=229) had a median age of 65.0 (IQR: 53.0, 73.0) years with 83.4% males, while the afebrile group (n=76) had a median age of 71.0 (IQR: 65.0, 76.7) years with 84.2% males. Univariate analysis showed that the age, prevalence of coronary heart disease, preoperative statin use, and prevalence of aortic aneurysm were significantly lower in the febrile group compared to the afebrile group. Logistic regression analysis indicated that age, surgical site, disease type, preoperative elevated body temperature, and stent type were significantly associated with noninfectious fever, while preoperative statin use was negatively correlated. ROC curve analysis demonstrated that age, surgical site, preoperative elevated body temperature, and stent type had significant predictive value for postoperative noninfectious fever (P<0.01). Conclusion Noninfectious fever is highly prevalent following aortic repair. The relationship between fever and infection should be comprehensively evaluated based on risk factors and changes in the patient's condition to promote the rational use of antibiotics.
5.Peyton's Four-Step Teaching Method for Intestinal Ultrasound Training: Efficacy and Practical Implications
Zihan NIU ; Xiaoyan ZHANG ; Zhaojue WANG ; Qingli ZHU ; Mengsu XIAO ; Li MA ; Yudi HE ; Wenbo LI
Medical Journal of Peking Union Medical College Hospital 2026;17(2):591-596
To evaluate the application value of the Peyton four-step teaching method in the standardized training of intestinal ultrasound and compare it with traditional teaching methods, so as to provide an optimized approach for clinical ultrasound training. Participants from the Department of Ultrasound at Peking Union Medical College Hospital between September 2024 and March 2025 were randomly assigned to either the traditional group or Peyton group. The traditional group followed the conventional "lecture- demonstration-practice" model, while the Peyton group implemented the standardized "demonstration-deconstruction-comprehension-execution" four-step approach. All training focused on standard intestinal ultrasound scanning techniques. After the training, the operational skills were independently evaluated by the instructors. To verify the reproducibility of the teaching method, the participants in traditional teaching group received additional Peyton method training after the initial assessment and underwent a second evaluation. A total of 18 participants were included in this study, with 9 in the traditional teaching group and 9 in the Peyton teaching group. Participants in the Peyton group demonstrated significantly higher scores than those in the traditional group at every anatomical site assessed (all The Peyton four-step method is significantly more effective than traditional teaching in improving residents' intestinal ultrasound skills, demonstrating its suitability as the preferred approach for standardized training programs.
6.DING Ying's Experience in Treating Children with IgA Nephropathy from the Perspective of "Wind-Induced Water Turbidity"
Yudi LI ; Yan XU ; Xiaodan REN ; Wenbo LIU
Journal of Traditional Chinese Medicine 2025;66(3):228-232
To summarize Professor DING Ying's clinical experience in treating children's IgA nephropathy from the perspective of "wind-induced water turbidity". It is believed that the core pathogenesis of IgA nephropathy in children is the wind stimμlating water to become turbidity, and the basic treatment principles are to eliminate wind and settle viscera, and to remove turbidity and drain water. For those with the syndrome of wind-heat invading the lungs and injury to blood collaterals, modified Yinqiao Powder (银翘散) combined with Xiaoji Decoction (小蓟饮子) could be used; for those with dampness-heat in Sanjiao, heavy dampness and light heat pattern, modified Sanren Decoction (三仁汤) combined with Bazheng Powder (八正散) could be used; for those with lung-spleen qi deficiency and kidney essence depletion pattern, modified Buzhong Yiqi Decoction (补中益气汤) combined with Wuzi Yanzong Pill (五子衍宗丸) could be used; for those with deficiency of both qi and yin, kidney deficiency with stasis pattern, self-prescribed Yishen Huazhuo Formula (益肾化浊方) could be used. Meanwhile on the basis of pattern identification and treatment, rattan-type herbs could be combined in use in order to unblock the meridians and collaterals.
7.Syndrome and Pathogenesis Treated by Mahuang Shengmatang
Xinyu WAN ; Yin CHENG ; Wenbo GAO ; Zhiguo ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):253-258
The prescription Mahuang Shengmatang in the Treatise on Cold Damage (《伤寒论》) has sparked considerable debate among medical practitioners throughout history, with varying opinions on its indications, pathogenesis described in the text, principle of compatibility, and clinical applications. Both ancient and modern interpreters of Mahuang Shengmatang often focus on herbal compatibility as a primary approach to deduce the pathogenesis and treatment methods. Building upon this foundation, this paper utilizes herbal dosage as a clue to discern the primary and secondary herbs in the prescription. It further analyzes the principle of compatibility based on herbal indications, summarizing the indications and therapeutic principles of this prescription. Ultimately, it reveals the underlying pathogenesis reflected in the text. The internal closure of heat and toxin leads to the stagnation of Qi, preventing Yang Qi from reaching the extremities and causing cold hands and feet. When the pathogenic Qi finds no outlet, it floods both the upper and lower regions of the body, attacking the throat and causing cough with expectoration of pus and blood, and descending to the large intestine to consume Yin fluids, resulting in persistent diarrhea. Based on this pathogenesis, the paper expands the scope of symptoms and signs associated with the prescription, providing a more detailed portrayal of the applicable patient population and enhancing the basis for clinical prescription references. Additionally, the paper presents considerations on several controversial topics, suggesting that the "lower pulse" described in the text refers to the lower limb arterial pulsation, and the symptoms and signs resemble those of septic shock in modern medicine. Therefore, Mahuang Shengmatang should be categorized as a prescription for treating warm diseases and it is not developed by ZHANG Zhongjing. By employing a detailed discussion on the syndrome, pathogenesis, and clinical application in the texts of Mahuang Shengmatang from the dosage, principle of compatibility, and herbal indications, this paper not only enriches the theoretical foundation of Mahuang Shengmatang but also provides a comprehensive perspective and fresh ideas for understanding its clinical application.
8.CMC considerations of manufacturing site changes for marketed therapeutic recombinant protein drugs from regulatory review
Chinese Journal of Biologicals 2025;38(02):252-256
With the continuous improvement of China's drug regulatory laws and regulations, Life-cycle regulatory management has become a key means and an inevitable development trend to ensure the safety of public drug use. The management of post-approval changes to biological products is gradually shifting towards the risk-based model from the item-based model.In recent years, there has been a significant increase in supplementary applications for manufacturing site changes of marketed therapeutic recombinant protein drugs. However, the risks associated with manufacturing site changes vary under different circumstances. Therefore, the research that needs to be carried out is also different. This paper provides an in-depth discussion on three key aspects: risk assessment and grading, general requirements and special considerations for pharmaceutical research, and common application issues. It outlines general requirements for manufacturing site change, aiming to offer valuable insights for industry needs. Through the collaborative efforts between regulatory authorities and the industry, patient rights and interests can be effectively protected, and high-quality drugs can be made available to the public.
9.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.
10.Optimization of Processing Technology of Calcined Pyritum Based on QbD Concept and Its XRD Fingerprint Analysis
Xin CHEN ; Jingwei ZHOU ; Haiying GOU ; Lei ZHONG ; Tianxing HE ; Wenbo FEI ; Jialiang ZOU ; Yue YANG ; Dewen ZENG ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):197-205
ObjectiveBased on the concept of quality by design(QbD), the processing process of calcined Pyritum was optimized, and its X-ray diffraction(XRD) fingerprint was established. MethodsThe safety, effectiveness and quality controllability of calcined Pyritum were taken as the quality profile(QTPP), the color, hardness, metallic luster, phase composition, the contents of heavy metals and hazardous elements were taken as the critical quality attributes(CQAs), and the calcination temperature, calcination time, paving thickness and particle size were determined as the critical process parameters(CPPs). Differential thermal analysis, X-ray diffraction(XRD) and inductively coupled plasma mass spectrometry(ICP-MS) were used to analyze the correlation between the calcination temperature and CQAs of calcined Pyritum. Then, based on the criteria importance through intercriteria correlation(CRITIC)-entropy weight method, the optimal processing process of calcined Pyritum was optimized by orthogonal test. Powder XRD was used to analyze the phase of calcined Pyritum samples processed according to the best process, and the mean and median maps of calcined Pyritum were established by the superposition of geometric topological figures, and similarity evaluation and cluster analysis were carried out. ResultsThe results of single factor experiments showed that the physical phase of Pyritum changed from FeS2 to Fe7S8 during the process of temperature increase, the color gradually deepened from dark yellow, and the contents of heavy metals and harmful elements decreased. The optimized processing process of calcined Pyritum was as follows:calcination temperature at 750 ℃, calcination time of 2.5 h, paving thickness of 3 cm, particle size of 0.8-1.2 cm, vinegar quenching 1 time[Pyritum-vinegar(10∶3)]. After calcination, the internal structure of Pyritum was honeycomb-shaped, which was conducive to the dissolution of active ingredients. XRD fingerprints of 13 batches of calcined Pyritum characterized by 10 common peaks were established. The similarities of the relative peak intensities of the XRD fingerprints of the analyzed samples were>0.96, and it could effectively distinguish the raw products and unqualified products. ConclusionTemperature is the main factor affecting the quality of calcined Pyritum. After processing, the dissolution of the effective components in Pyritum increases, and the contents of heavy metals and harmful substances decrease, reflecting the function of processing to increase efficiency and reduce toxicity. The optimized processing process is stable and feasible, and the established XRD fingerprint can be used as one of the quality control standards of calcined Pyritum.


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