1.Preventive Effect and Safety Evaluation of Xiaozhen Formula (消疹方) on Skin Toxicity Induced by Epidermal Growth Factor Receptor Inhibitors in the Treatment of Non-small Cell Lung Cancer:A Multicenter,Randomized,Double-Blind,Placebo-Controlled Trial
Ling LUO ; Xintian WANG ; Cheng CHENG ; Zitong HAN ; Chunru WANG ; Guoli WEI ; Jianyue LI ; Li WANG ; Jirong WANG ; Peng SHU ; Liang LI ; Fenglin LIU ; Ran SONG ; Jing BAI ; Haiyan XING
Journal of Traditional Chinese Medicine 2026;67(18):1987-1994
ObjectiveTo evaluate the clinical efficacy and safety of Xiaozhen Formula (消疹方) in preventing skin toxicity induced by epidermal growth factor receptor inhibitors (EGFRIs) in patients with EGFR-mutant non-small cell lung cancer (NSCLC). MethodsA randomized, double-blind, placebo-controlled, multicenter clinical study was conducted. A total of 120 patients with EGFR-mutant NSCLC from seven centers were enrolled and randomly assigned to a treatment group (60 cases) or a control group (60 cases). On the basis of EGFRI-targeted therapy, patients in the treatment group received Xiaozhen Formula granules, whereas those in the control group received Xiaozhen Formula placebo granules, both at 10 g twice daily for 4 consecutive weeks. The primary outcomes were the grading of skin toxicity evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 and the incidence of rash. Secondary outcomes included the time to onset and time to resolution of the highest-grade rash, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scores, the Hospital Anxiety and Depression Scale (HADS) scores, and disease control rate, together with safety assessments. ResultsBased on the full analysis set (FAS), the incidence of skin toxicity in the treatment group was 18.33% (11/60), significantly lower than 45.00% (27/60) in the control group (P<0.01), with the highest severity of skin toxicity in both groups was grade 2. Among patients who developed rash, the resolution rate in the treatment group was 90.91% (10/11), higher than that 33.33% (9/27) in the control group. The median time to resolution was 15 days (95%CI: 8-17 days) in the treatment group and it was not reached in the control group; the distribution of time to resolution differed significantly between groups (P<0.001). After treatment, the treatment group had higher EORTC QLQ-C30 functional scale and global health status/quality-of-life scores, and lower symptom scale, single-item scores, as well as HADS-A, and HADS-D scores than the control group (P<0.05). In the FAS analysis, the disease control rate (DCR) was 85.0% (51/60) in the treatment group, lower than 100.0% (60/60) in the control group (P=0.003), whereas no significant between-group difference was observed in the per-protocol set (PPS) analysis (P=0.464). The incidence of adverse events did not differ significantly between the two groups (P>0.05), and no definite safety signals related to the investigational drug were observed. ConclusionXiaozhen Formula can reduce the incidence of EGFRI-induced skin toxicity, and improve the outcome of rash regression, the patients' quality of life and psychological status in EGFR-mutant NSCLC patients.
2.Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Ying-Qiang ZHAO ; Yong-Fa XING ; Ke-Yong ZOU ; Wei-Dong JIANG ; Ting-Hai DU ; Bo CHEN ; Bao-Ping YANG ; Bai-Ming QU ; Li-Yue WANG ; Gui-Hong GONG ; Yan-Ling SUN ; Li-Qi WANG ; Gao-Feng ZHOU ; Yu-Gang DONG ; Min CHEN ; Xue-Juan ZHANG ; Tian-Lun YANG ; Min-Zhou ZHANG ; Ming-Jun ZHAO ; Yue DENG ; Chang-Jiang XIAO ; Lin WANG ; Bao-He WANG
Chinese journal of integrative medicine 2025;31(8):685-693
OBJECTIVE:
To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS:
This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS:
This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION
STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans
;
Double-Blind Method
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Angina, Stable/physiopathology*
;
Aged
;
Syndrome
;
Treatment Outcome
;
Placebos
;
Tablets
3.Concordance and pathogenicity of copy number variants detected by non-invasive prenatal screening in 38,611 pregnant women without fetal structural abnormalities.
Yunyun LIU ; Jing WANG ; Ling WANG ; Lin CHEN ; Dan XIE ; Li WANG ; Sha LIU ; Jianlong LIU ; Ting BAI ; Xiaosha JING ; Cechuan DENG ; Tianyu XIA ; Jing CHENG ; Lingling XING ; Xiang WEI ; Yuan LUO ; Quanfang ZHOU ; Ling LIU ; Qian ZHU ; Hongqian LIU
Chinese Medical Journal 2025;138(4):499-501
4.The neurophysiological mechanisms of exercise-induced improvements in cognitive function.
Jian-Xiu LIU ; Bai-Le WU ; Di-Zhi WANG ; Xing-Tian LI ; Yan-Wei YOU ; Lei-Zi MIN ; Xin-Dong MA
Acta Physiologica Sinica 2025;77(3):504-522
The neurophysiological mechanisms by which exercise improves cognitive function have not been fully elucidated. A comprehensive and systematic review of current domestic and international neurophysiological evidence on exercise improving cognitive function was conducted from multiple perspectives. At the molecular level, exercise promotes nerve cell regeneration and synaptogenesis and maintains cellular development and homeostasis through the modulation of a variety of neurotrophic factors, receptor activity, neuropeptides, and monoamine neurotransmitters, and by decreasing the levels of inflammatory factors and other modulators of neuroplasticity. At the cellular level, exercise enhances neural activation and control and improves brain structure through nerve regeneration, synaptogenesis, improved glial cell function and angiogenesis. At the structural level of the brain, exercise promotes cognitive function by affecting white and gray matter volumes, neural activation and brain region connectivity, as well as increasing cerebral blood flow. This review elucidates how exercise improves the internal environment at the molecular level, promotes cell regeneration and functional differentiation, and enhances the brain structure and neural efficiency. It provides a comprehensive, multi-dimensional explanation of the neurophysiological mechanisms through which exercise promotes cognitive function.
Animals
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Humans
;
Brain/physiology*
;
Cognition/physiology*
;
Exercise/physiology*
;
Nerve Regeneration/physiology*
;
Neuronal Plasticity/physiology*
5.Zhu-Tokita-Takenouchi-Kim syndrome in a neonate.
Wei-Na LIU ; Ya-Lei PI ; Xing-Yu BAI ; Hui-Fen CHEN
Chinese Journal of Contemporary Pediatrics 2025;27(3):373-376
The patient is a male neonate born at term. He was admitted 16 minutes after birth due to stridor and inspiratory respiratory distress. Physical examination revealed a cleft palate, and a grade II systolic ejection murmur was audible at the left sternal border. Whole exome sequencing identified a heterozygous variant in the SON gene, c.5753-5756del (p.Val1918GlufsTer87), which was absent in either parent, indicating a de novo mutation. According to the guidelines of the American College of Medical Genetics and Genomics, this was classified as a "pathogenic variant" leading to a diagnosis of Zhu-Tokita-Takenouchi-Kim (ZTTK) syndrome. Upon admission, symptomatic supportive treatment was provided. Follow-up at the age of 8 months revealed persistent stridor; the infant could only consume small amounts of milk and was unable to sit steadily. This patient represents the youngest reported case to date, and his symptoms expand the clinical spectrum of the disease, providing valuable insights for clinical diagnosis and treatment.
Humans
;
Infant, Newborn
;
Male
;
Minor Histocompatibility Antigens/genetics*
;
DNA-Binding Proteins/genetics*
;
Rare Diseases/genetics*
;
Neurodevelopmental Disorders/genetics*
6.Progress of research on biological surveillance sampling and culture methods for flexible endoscopes
Xiaochao SONG ; Meijuan JIN ; Wei DING ; Yubin XING ; Mingmei DU ; Hongwu YAO ; Yanling BAI ; Yunxi LIU
Chinese Journal of Nosocomiology 2025;35(17):2702-2706
In recent years,the microorganisms residues in endoscopes have frequently resulted in cross transmis-sion or even the outbreak of hospital-associated infections.It is of great importance to carry out standardized bio-logical surveillance of endoscopes,find out the high-risk links of cleaning and disinfection,and take targeted inter-vention measures to reduce the incidence of endoscopy-related infection.Based on the related guidelines in China and abroad as well as the latest clinical practice researches,the biological surveillance sampling and culture for en-doscopes were summarized in the article so as to enhance the surveillance quality,ensure the reprocessing effect and guarantee the endoscopy-related quality and safety.
7.Clinical efficacy of laparoscopic left hemi-fundoplication for gastroesophageal reflux disease
Weixue ZHANG ; Guolei LI ; Hao FENG ; Yuan LIU ; Lihui JIA ; Haiyan BAI ; Wei XING ; Zhao XU
Chinese Journal of Digestive Surgery 2025;24(10):1333-1337
Objective:To explore the clinical efficacy of laparoscopic left hemi-fundoplica-tion for gastroesophageal reflux disease (GERD).Method:The retrospective and descriptive study was conducted. The clinical data of 45 patients with GERD who were admitted to Hebei Provincial Hospital of Traditional Chinese Medicine from July 2019 to July 2022 were collected. There were 26 males and 19 females, aged (46±12) years. All patients underwent laparoscopic left hemi-fundoplication. Observation indicators: (1) intraoperative and postoperative conditions; (2) follow-up. Measurement data with normal distribution were expressed as Mean± SD. Count data were expressed as absolute numbers. The paired samples t-test was used for comparison of indicators before and after surgery. Result:(1) Intraoperative and postoperative conditions. All 45 patients successfully underwent the operation, with no conversion to open surgery or intraoperative complications. The operation time was (86±8)minutes, volume of intraoperative blood loss was (12±3)mL, and time to postoperative first flatus was (2.2±0.8)days. Among the 45 patients after surgery, 4 cases had fever, 3 cases had retrosternal dull pain and discomfort, 4 cases had dysphagia, 3 cases had abdominal distension, and 5 cases had constipation. All these symptoms were cured or relieved spontaneously after sympto-matic treatment. The duration of postoperative hospital stay was (3.5±0.5)days. There was no patient with infection, delayed bleeding or perforation.(2) Follow-up. All 45 patients were followed up for 1 year after surgery, with no recurrence of GERD. Gastroscopy showed no esophageal mucosal damage such as erosion or ulcer, and no hiatal hernia occurred. Before surgery, the reflux symptom index score, GERD questionnaire score, reflux disease questionnaire score, lower esophageal sphincter resting pressure, and DeMeester score of 24-hour esophageal pH monitoring were 24.3±1.9, 12.5±2.1,20.1±4.5, (7.1±1.1)mmHg (1 mmHg=0.133 kPa), and 31.4±6.4, respectively. At 1 year after surgery, the above indicators were 2.2±0.7, 6.5±0.5, 4.0±2.6, (23.2±2.9)mmHg, and 6.0±1.4, respectively. There were significant differences before and after surgery ( t=80.75, 18.70,20.09, -33.45, 26.15, P<0.05). Conclusion:Laparoscopic left hemi-fundoplication is safe and feasible for GERD, which can improve the clinical symptoms of patients.
8.Progress of research on biological surveillance sampling and culture methods for flexible endoscopes
Xiaochao SONG ; Meijuan JIN ; Wei DING ; Yubin XING ; Mingmei DU ; Hongwu YAO ; Yanling BAI ; Yunxi LIU
Chinese Journal of Nosocomiology 2025;35(17):2702-2706
In recent years,the microorganisms residues in endoscopes have frequently resulted in cross transmis-sion or even the outbreak of hospital-associated infections.It is of great importance to carry out standardized bio-logical surveillance of endoscopes,find out the high-risk links of cleaning and disinfection,and take targeted inter-vention measures to reduce the incidence of endoscopy-related infection.Based on the related guidelines in China and abroad as well as the latest clinical practice researches,the biological surveillance sampling and culture for en-doscopes were summarized in the article so as to enhance the surveillance quality,ensure the reprocessing effect and guarantee the endoscopy-related quality and safety.
9.Clinical efficacy of laparoscopic left hemi-fundoplication for gastroesophageal reflux disease
Weixue ZHANG ; Guolei LI ; Hao FENG ; Yuan LIU ; Lihui JIA ; Haiyan BAI ; Wei XING ; Zhao XU
Chinese Journal of Digestive Surgery 2025;24(10):1333-1337
Objective:To explore the clinical efficacy of laparoscopic left hemi-fundoplica-tion for gastroesophageal reflux disease (GERD).Method:The retrospective and descriptive study was conducted. The clinical data of 45 patients with GERD who were admitted to Hebei Provincial Hospital of Traditional Chinese Medicine from July 2019 to July 2022 were collected. There were 26 males and 19 females, aged (46±12) years. All patients underwent laparoscopic left hemi-fundoplication. Observation indicators: (1) intraoperative and postoperative conditions; (2) follow-up. Measurement data with normal distribution were expressed as Mean± SD. Count data were expressed as absolute numbers. The paired samples t-test was used for comparison of indicators before and after surgery. Result:(1) Intraoperative and postoperative conditions. All 45 patients successfully underwent the operation, with no conversion to open surgery or intraoperative complications. The operation time was (86±8)minutes, volume of intraoperative blood loss was (12±3)mL, and time to postoperative first flatus was (2.2±0.8)days. Among the 45 patients after surgery, 4 cases had fever, 3 cases had retrosternal dull pain and discomfort, 4 cases had dysphagia, 3 cases had abdominal distension, and 5 cases had constipation. All these symptoms were cured or relieved spontaneously after sympto-matic treatment. The duration of postoperative hospital stay was (3.5±0.5)days. There was no patient with infection, delayed bleeding or perforation.(2) Follow-up. All 45 patients were followed up for 1 year after surgery, with no recurrence of GERD. Gastroscopy showed no esophageal mucosal damage such as erosion or ulcer, and no hiatal hernia occurred. Before surgery, the reflux symptom index score, GERD questionnaire score, reflux disease questionnaire score, lower esophageal sphincter resting pressure, and DeMeester score of 24-hour esophageal pH monitoring were 24.3±1.9, 12.5±2.1,20.1±4.5, (7.1±1.1)mmHg (1 mmHg=0.133 kPa), and 31.4±6.4, respectively. At 1 year after surgery, the above indicators were 2.2±0.7, 6.5±0.5, 4.0±2.6, (23.2±2.9)mmHg, and 6.0±1.4, respectively. There were significant differences before and after surgery ( t=80.75, 18.70,20.09, -33.45, 26.15, P<0.05). Conclusion:Laparoscopic left hemi-fundoplication is safe and feasible for GERD, which can improve the clinical symptoms of patients.
10.Minimally invasive treatment and surgical injury control strategies for elderly patients with acute incarcerated ingui-nal hernias
Zhou-Wei XU ; Bai-Cheng DING ; Kai-Qiang WANG ; Tian-Le ZHAO ; Xing-Han LI ; Xing-Yu WANG
Chinese Journal of Current Advances in General Surgery 2024;27(8):622-626
Objective:To explore the application value and damage control of minimally inva-sive techniques in the treatment of acute incarcerated inguinal hernias in the elderly.Methods:In this study,62 elderly patients with acute incarcerated inguinal hernias admitted to the department of emergency surgery at the First Affiliated Hospital of Anhui Medical University from June 2018 to June 2023 were selected as the research subjects.After obtaining informed consent from the pa-tient's family for both treatment modalities,they were randomly divided into open surgery group and laparoscopic surgery group.Differences in clinical efficacy,perioperative indicators,post-operative complications,and prognostic follow-up of the two groups of patients were observed.Seven cases of elderly patients aged above 80 had many underlying diseases and poor tolerance during surgery.After treatment of lesions in the hernia contents,only damage control surgery for hernia sac high ligation was performed.Results:In comparison to patients treated with laparo-scopic surgery,there were statistically significant differences(P<0.05)in the open surgery group in clinical efficacy(efficacy,ineffectiveness,and overall effectiveness),perioperative indicators(length of stay,recovery time of digestive tract function,and VAS pain score),post-operative complica-tions,and prognostic follow-up(local mass,chronic pain,and ratio of second-stage hernia sur-gery).Seven patients treated according to injury control strategies all recovered and discharged from hospital after surgery.Conclusion:Emergency laparoscopic surgery for detecting incarcer-ated inguinal hernias in the elderly is safe and feasible.At the same time,it is essential to correctly assess the patient's vital signs during surgery.If necessary,surgery should be simplified to provide opportunities for follow-up treatment.

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