1.Multi-center clinical study on the efficacy and safety of combined lienal polypeptide injection therapy in children with Mycoplasma pneumoniae pneumonia
Qi CHENG ; Yunxiao SHANG ; Han ZHANG ; Jiujun LI ; Ning CHEN ; Lishen SHAN ; Nan YANG ; Lihua NING ; Xuemei BAI ; Jianhua LIU ; Yuling HAN ; Jichun WANG ; Jing LI ; Yong FENG ; Liyun LIU ; Li CHEN ; Si LIU ; Qinzhen ZHANG ; Jia ZHENG ; Fengchao LI ; Sukun LU ; Yun ZHANG ; Xiaoyi CHAI
International Journal of Pediatrics 2025;52(3):204-210
Objective:To observe the efficacy and safety of combined lienal polypeptide injection therapy in the treatment of Mycoplasma pneumoniae pneumonia(MPP)in children aged 3 to 14 years old in multiple clinical centers.Methods:A randomized,controlled,multi-center clinical study design was adopted.A total of 240 hospitalized children aged 3 to 14 years old with MPP from 7 hospitals from September 1,2023 to January 31,2024 were included.According to the severity of pneumonia,they were divided into the mild MPP group with 80 cases and the severe MPP/refractory MPP(SMPP/RMPP)group with 160 cases,and then randomly divided into the control group and the experimental group at a ratio of 1 ∶1,using the random number table method.After screening,subjects entered a treatment period of 5 to 7 days.The control group was treated with azithromycin,while the experimental group was treated with azithromycin plus lienal polypeptide injection .The recovery of lung CT,length of hospital stay,duration of fever,cough score,whether mild cases developed into severe or refractory cases,duration of hormone use,use of intravenous immunoglobulin(IVIG),bronchoscopy treatment,and immune function were observed between the two groups to evaluate the efficacy of lienal polypeptide injection.Adverse events after medication,vital signs,blood routine,urine routine,liver function,myocardial enzymes,renal function,and electrocardiogram were observed to evaluate the safety. Results:A total of 231 subjects have completed the trial in the 7 hospitals,including 118 cases in the experimental group and 113 cases in the control group.Main observation index:the rate of lung CT aggravation in the experimental group was lower than that in the control group(2.6% vs 15.3%, P<0.01),and the difference was statistically significant.Secondary indexes:there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).However,the rate of cases of plastic bronchitis(PB)found under bronchoscopy in the experimental group was lower than that in the control group(0 vs 18.8%, P=0.03),and the difference was statistically significant.Among the mild MPP(72 cases),there were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and the improvement rate of lung CT between the two groups(all P>0.05).However,compared with the control group,the rate of cases developing into SMPP/RMPP in the experimental group was less(24.3% vs 48.6%, P=0.03),and the difference in IgG before and after treatment was small[0.53(-0.04,1.18)g/L vs 1.33(0.48,2.25)g/L, P=0.01].Among the SMPP/RMPP cases(159 cases),the rate of cases of PB found under bronchoscopy in the experimental group was less than that in the control group(0 vs 20%, P=0.04),and the rate of cases with aggravated lung CT in the experimental group was less than that in the control group(1.3% vs 19.5%, P<0.01),and the improvement rate of lung CT in the experimental group was higher than that in the control group(88.8% vs 75.3%, P=0.03),with statistically significant differences.There were no statistically significant differences in the length of hospital stay,duration of fever,cough score,duration of hormone use,whether IVIG treatment was used,the number of bronchoscopy treatment cases,and immunoglobulin between the two groups(all P>0.05).Two cases in the experimental group developed rashes,which improved after the drug was discontinued.There were no serious adverse reactions such as abnormal vital signs like dyspnea and cyanosis due to the use of lienal polypeptide injection.There were no obvious changes in blood routine,liver function,myocardial enzymes,renal function,electrocardiogram,and urine routine values before and after medication compared with the baseline. Conclusion:The combined use of lienal polypeptide injection in the treatment of MPP in children can reduce the probability of the transformation from mild cases to SMPP/RMPP,reduce the rate of aggravation of the image findings,promote the absorption of lung inflammation,reduce the rate of PB found under bronchoscopy,and has good safety.
2.The safety and anti-adhesive effect of acellular dermal matrix application after thyroid surgery: a multicenter randomized controlled trial
Kwangsoon KIM ; Young Jun CHAI ; Mira HAN ; Sang-Wook KANG ; Ji-Sup YUN
Annals of Surgical Treatment and Research 2025;108(2):71-78
Purpose:
Postoperative adhesions following thyroid surgery can lead to multiple complications that significantly impact quality of life. The use of an acellular dermal matrix (ADM) adhesion barrier device has been proposed as a potential solution to reduce the risk of such adhesions. This study aimed to evaluate the safety and anti-adhesive effect of an ADM in patients undergoing thyroid surgery.
Methods:
In this multicenter randomized controlled trial, patients undergoing thyroid surgery were randomly assigned to receive either ADM (n = 42) or no ADM (n = 39) during surgery. The primary outcome was the Swallowing Impairment Score (SIS-6), measured 6 weeks after surgery and compared between groups. Secondary outcomes included intergroup comparisons of the SIS-6, the Voice Handicap Index (VHI)-10, and the Glasgow-Edinburgh Throat Scale (GETS) at baseline, and 2, 6, and 18 weeks after surgery.
Results:
At week 6, the mean SIS-6 scores were 4.0 ± 4.1 and 3.3 ± 4.2 in the ADM and control groups, respectively, which was not significantly different. Both groups showed similar postoperative improvements in SIS-6, VHI-10, and GETS scores over time, without significant differences between groups at any time point, indicating that the ADM did not reduce the incidence of postoperative adhesions or alter the course of recovery compared to the control group.
Conclusion
Although application of the ADM is safe for use in patients undergoing thyroid surgery, it did not produce a clinically significant advantage in preventing postoperative adhesions. Future research should focus on identifying specific patient populations or surgical scenarios where the use of the ADM may be beneficial.
3.Chemical and pharmacological research progress on Mongolian folk medicine Syringa pinnatifolia.
Kun GAO ; Chang-Xin LIU ; Jia-Qi CHEN ; Jing-Jing SUN ; Xiao-Juan LI ; Zhi-Qiang HUANG ; Ye ZHANG ; Pei-Feng XUE ; Su-Yi-le CHEN ; Xin DONG ; Xing-Yun CHAI
China Journal of Chinese Materia Medica 2025;50(8):2080-2089
Syringa pinnatifolia, belonging to the family Oleaceae, is a species endemic to China. It is predominantly distributed in the Helan Mountains region of Inner Mongolia and Ningxia of China. The peeled roots, stems, and thick branches have been used as a distinctive Mongolian medicinal material known as "Shan-chen-xiang", which has effects such as suppressing "khii", clearing heat, and relieving pain and is employed for the treatment of cardiovascular and pulmonary diseases and joint pain. Over the past five years, significant increase was achieved in research on chemical constituents and pharmacological effects. There were a total of 130 new constituents reported, covering sesquiterpenoids, lignans, and alkaloids. Its effects of anti-myocardial ischemia, anti-cerebral ischemia/reperfusion, sedation, and analgesia were revealed, and the mechanisms of agarwood formation were also investigated. To better understand its medical value and potential of clinical application, this review updates the research progress in recent five years focusing on the chemical constituents and pharmacological effects of S. pinnatifolia, providing reference for subsequent research on active ingredient and support for its innovative application in modern medicine system.
Medicine, Mongolian Traditional
;
Humans
;
Drugs, Chinese Herbal/pharmacology*
;
Animals
;
Syringa/chemistry*
4.Advance on clinical and pharmacological research of Bawei Chenxiang Powder and related formulae.
Lu-Lu KANG ; Jia-Tong WANG ; Feng ZHOU ; Guo-Dong YANG ; Xiao-Juan LI ; Xiao-Li GAO ; Luobu GESANG ; Xing-Yun CHAI
China Journal of Chinese Materia Medica 2025;50(10):2875-2882
Bawei Chenxiang Powder(BCP), first documented in the Tibetan medical work Four Medical Classics, has been widely applied in clinical practices in Tibetan and Mongolian medicines since its development. It has the effect of clearing the heart heat, calming the mind, and inducing resuscitation. On the basis of BCP, multiple types of formulae have been developed, such as Bawei Yiheyi Chenxiang Powder, Bawei Rang Chenxiang Powder, and Bawei Pingchuan Chenxiang Powder, which are widely used for treating cardiovascular and respiratory diseases. Current pharmacological research has revealed the pharmacological effects of BCP and its related formulae against myocardial ischemia, cerebral ischemia, renal ischemia, and anti-hypoxia. BCP and its related formulae introduced more treatment options for related clinical diseases and provided insights for fully comprehending the essence and pharmacological components of the formulae. This paper systematically reviewed the clinical and pharmacological research on BCP and its related formulae, analyzing the formulation principles and potential key flavors and active ingredients. This lays a fundamental scientific basis for the clinical use, quality evaluation, and subsequent development and application of BCP and its related formulae, providing references for studying traditional Chinese medicine formulae in a thorough and systematic manner.
Drugs, Chinese Herbal/chemistry*
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Humans
;
Powders/chemistry*
;
Animals
;
Medicine, Chinese Traditional
5.Studies on pharmacological effects and chemical components of different extracts from Bawei Chenxiang Pills.
Jia-Tong WANG ; Lu-Lu KANG ; Feng ZHOU ; Luo-Bu GESANG ; Ya-Na LIANG ; Guo-Dong YANG ; Xiao-Li GAO ; Hui-Chao WU ; Xing-Yun CHAI
China Journal of Chinese Materia Medica 2025;50(11):3035-3042
The medicinal materials of Bawei Chenxiang Pills(BCPs) were extracted via three methods: reflux extraction by water, reflux extraction by 70% ethanol, and extraction by pure water following reflux extraction by 70% ethanol, yielding three extracts of ST, CT, and CST. The efficacy of ST(760 mg·kg~(-1)), CT(620 mg·kg~(-1)), and CST(1 040 mg·kg~(-1)) were evaluated by acute myocardial ischemia(AMI) and p-chlorophenylalanine(PCPA)-induced insomnia in mice, respectively. Western blot was further utilized to investigate their hypnosis mechanisms. The main chemical components of different extracts were identified by the UPLC-Q-Exactive-MS technique. The results showed that CT and CST significantly increased the ejection fraction(EF) and fractional shortening(FS) of myocardial infarction mice, reduced left ventricular internal dimension at end-diastole(LVIDd) and left ventricular internal dimension at end-systole(LVIDs). In contrast, ST did not exhibit significant effects on these parameters. In the insomnia model, CT significantly reduced sleep latency and prolonged sleep duration, whereas ST only prolonged sleep duration without shortening sleep latency. CST showed no significant effects on either sleep latency or sleep duration. Additionally, both CT and ST upregulated glutamic acid decarboxylase 67(GAD67) protein expression in brain tissue. A total of 15 main chemical components were identified from CT, including 2-(2-phenylethyl) chromone and 6-methoxy-2-(2-phenylethyl) chromone. Six chemical components including chebulidic acid were identified from ST. The results suggested that chromones and terpenes were potential anti-myocardial ischemia drugs of BCPs, and tannin and phenolic acids were potential hypnosis drugs. This study enriches the pharmacological and chemical research of BCPs, providing a basis and reference for their secondary development, quality standard improvement, and clinical application.
Animals
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Drugs, Chinese Herbal/isolation & purification*
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Mice
;
Male
;
Sleep Initiation and Maintenance Disorders/physiopathology*
;
Humans
;
Myocardial Infarction/drug therapy*
;
Myocardial Ischemia/drug therapy*
6.Synthetic data production for biomedical research
Yun Gyeong LEE ; Mi-Sook KWAK ; Jeong Eun KIM ; Min Sun KIM ; Dong Un NO ; Hee Youl CHAI
Osong Public Health and Research Perspectives 2025;16(2):94-99
Synthetic data, generated using advanced artificial intelligence (AI) techniques, replicates the statistical properties of real-world datasets while excluding identifiable information.Although synthetic data does not consist of actual data points, it is derived from original datasets, thereby enabling analyses that yield results comparable to those obtained with real data. Synthetic datasets are evaluated based on their utility—a measure of how effectively they mirror real data for analytical purposes. This paper presents the generation of synthetic datasets through the Healthcare Big Data Showcase Project (2019–2023). The original dataset comprises comprehensive multi-omics data from 400 individuals, including cancer survivors, chronic disease patients, and healthy participants. Synthetic data facilitates efficient access and robust analyses, serving as a practical tool for research and education. It addresses privacy concerns, supports AI research, and provides a foundation for innovative applications across diverse fields, such as public health and precision medicine.
7.Lentivirus-modified hematopoietic stem cell gene therapy for advanced symptomatic juvenile metachromatic leukodystrophy: a long-term follow-up pilot study.
Zhao ZHANG ; Hua JIANG ; Li HUANG ; Sixi LIU ; Xiaoya ZHOU ; Yun CAI ; Ming LI ; Fei GAO ; Xiaoting LIANG ; Kam-Sze TSANG ; Guangfu CHEN ; Chui-Yan MA ; Yuet-Hung CHAI ; Hongsheng LIU ; Chen YANG ; Mo YANG ; Xiaoling ZHANG ; Shuo HAN ; Xin DU ; Ling CHEN ; Wuh-Liang HWU ; Jiacai ZHUO ; Qizhou LIAN
Protein & Cell 2025;16(1):16-27
Metachromatic leukodystrophy (MLD) is an inherited disease caused by a deficiency of the enzyme arylsulfatase A (ARSA). Lentivirus-modified autologous hematopoietic stem cell gene therapy (HSCGT) has recently been approved for clinical use in pre and early symptomatic children with MLD to increase ARSA activity. Unfortunately, this advanced therapy is not available for most patients with MLD who have progressed to more advanced symptomatic stages at diagnosis. Patients with late-onset juvenile MLD typically present with a slower neurological progression of symptoms and represent a significant burden to the economy and healthcare system, whereas those with early onset infantile MLD die within a few years of symptom onset. We conducted a pilot study to determine the safety and benefit of HSCGT in patients with postsymptomatic juvenile MLD and report preliminary results. The safety profile of HSCGT was favorable in this long-term follow-up over 9 years. The most common adverse events (AEs) within 2 months of HSCGT were related to busulfan conditioning, and all AEs resolved. No HSCGT-related AEs and no evidence of distorted hematopoietic differentiation during long-term follow-up for up to 9.6 years. Importantly, to date, patients have maintained remarkably improved ARSA activity with a stable disease state, including increased Functional Independence Measure (FIM) score and decreased magnetic resonance imaging (MRI) lesion score. This long-term follow-up pilot study suggests that HSCGT is safe and provides clinical benefit to patients with postsymptomatic juvenile MLD.
Humans
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Leukodystrophy, Metachromatic/genetics*
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Pilot Projects
;
Genetic Therapy/methods*
;
Hematopoietic Stem Cell Transplantation
;
Male
;
Follow-Up Studies
;
Female
;
Lentivirus/genetics*
;
Child
;
Child, Preschool
;
Hematopoietic Stem Cells/metabolism*
;
Cerebroside-Sulfatase/metabolism*
;
Adolescent
8.Synthetic data production for biomedical research
Yun Gyeong LEE ; Mi-Sook KWAK ; Jeong Eun KIM ; Min Sun KIM ; Dong Un NO ; Hee Youl CHAI
Osong Public Health and Research Perspectives 2025;16(2):94-99
Synthetic data, generated using advanced artificial intelligence (AI) techniques, replicates the statistical properties of real-world datasets while excluding identifiable information.Although synthetic data does not consist of actual data points, it is derived from original datasets, thereby enabling analyses that yield results comparable to those obtained with real data. Synthetic datasets are evaluated based on their utility—a measure of how effectively they mirror real data for analytical purposes. This paper presents the generation of synthetic datasets through the Healthcare Big Data Showcase Project (2019–2023). The original dataset comprises comprehensive multi-omics data from 400 individuals, including cancer survivors, chronic disease patients, and healthy participants. Synthetic data facilitates efficient access and robust analyses, serving as a practical tool for research and education. It addresses privacy concerns, supports AI research, and provides a foundation for innovative applications across diverse fields, such as public health and precision medicine.
9.Synthetic data production for biomedical research
Yun Gyeong LEE ; Mi-Sook KWAK ; Jeong Eun KIM ; Min Sun KIM ; Dong Un NO ; Hee Youl CHAI
Osong Public Health and Research Perspectives 2025;16(2):94-99
Synthetic data, generated using advanced artificial intelligence (AI) techniques, replicates the statistical properties of real-world datasets while excluding identifiable information.Although synthetic data does not consist of actual data points, it is derived from original datasets, thereby enabling analyses that yield results comparable to those obtained with real data. Synthetic datasets are evaluated based on their utility—a measure of how effectively they mirror real data for analytical purposes. This paper presents the generation of synthetic datasets through the Healthcare Big Data Showcase Project (2019–2023). The original dataset comprises comprehensive multi-omics data from 400 individuals, including cancer survivors, chronic disease patients, and healthy participants. Synthetic data facilitates efficient access and robust analyses, serving as a practical tool for research and education. It addresses privacy concerns, supports AI research, and provides a foundation for innovative applications across diverse fields, such as public health and precision medicine.
10.The safety and anti-adhesive effect of acellular dermal matrix application after thyroid surgery: a multicenter randomized controlled trial
Kwangsoon KIM ; Young Jun CHAI ; Mira HAN ; Sang-Wook KANG ; Ji-Sup YUN
Annals of Surgical Treatment and Research 2025;108(2):71-78
Purpose:
Postoperative adhesions following thyroid surgery can lead to multiple complications that significantly impact quality of life. The use of an acellular dermal matrix (ADM) adhesion barrier device has been proposed as a potential solution to reduce the risk of such adhesions. This study aimed to evaluate the safety and anti-adhesive effect of an ADM in patients undergoing thyroid surgery.
Methods:
In this multicenter randomized controlled trial, patients undergoing thyroid surgery were randomly assigned to receive either ADM (n = 42) or no ADM (n = 39) during surgery. The primary outcome was the Swallowing Impairment Score (SIS-6), measured 6 weeks after surgery and compared between groups. Secondary outcomes included intergroup comparisons of the SIS-6, the Voice Handicap Index (VHI)-10, and the Glasgow-Edinburgh Throat Scale (GETS) at baseline, and 2, 6, and 18 weeks after surgery.
Results:
At week 6, the mean SIS-6 scores were 4.0 ± 4.1 and 3.3 ± 4.2 in the ADM and control groups, respectively, which was not significantly different. Both groups showed similar postoperative improvements in SIS-6, VHI-10, and GETS scores over time, without significant differences between groups at any time point, indicating that the ADM did not reduce the incidence of postoperative adhesions or alter the course of recovery compared to the control group.
Conclusion
Although application of the ADM is safe for use in patients undergoing thyroid surgery, it did not produce a clinically significant advantage in preventing postoperative adhesions. Future research should focus on identifying specific patient populations or surgical scenarios where the use of the ADM may be beneficial.

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