1.Study design and rationale of the TXL-CAP trial: a randomized, double-blind, placebo-controlled, multicenter clinical trial assessing the effect of Tongxinluo capsules on the stability of coronary atherosclerotic plaques.
Mei NI ; Yun TI ; Yan QI ; Meng ZHANG ; Dayue Darrel DUAN ; Chen YAO ; Zhen-Hua JIA ; Yun ZHANG ; Pei-Li BU
Journal of Geriatric Cardiology 2025;22(7):615-624
Recent clinical trials have demonstrated a protective effect in using traditional Chinese medicine Tongxinluo (TXL) capsule to treat atherosclerosis. However, clinical evidence of the effects of TXL treatment on coronary plaque vulnerability is unavailable. In response, we developed this study to investigate the hypothesis that on the basis of statin therapy, treatment with TXL capsule may stabilize coronary lesions in patients with acute coronary syndrome (ACS). The TXL-CAP study was an investigator-initiated, randomized, double-blind clinical trial conducted across 18 medical centers in China. Patients with ACS aging from 18 to 80 years old who had a non-intervened coronary target lesion with a fibrous cap thickness (FCT) < 100 μm and lipid arc > 90° as defined by optical coherence tomography (OCT) were recruited. A total of 220 patients who met the selection criteria but did not meet the exclusion criteria will be finally recruited and randomized to receive treatment with TXL (n = 110) or placebo (n = 110) for a duration of 12 months. The primary endpoint was the difference in the minimum FCT of the coronary target lesion between TXL and placebo groups at the end of the 12-month follow-up. Secondary endpoints included: (1) changes of the maximum lipid arc and length of the target plaque, and the percentage of lipid, fibrous, and calcified plaques at the end of the 12-month period; (2) the incidence of composite cardiovascular events and coronary revascularization within the 12 months; (3) changes in the grade and scores of the angina pectoris as assessed using the Canadian Cardiovascular Society (CCS) grading system and Seattle angina questionnaire (SAQ) score, respectively; and (4) changes in hs-CRP serum levels. The results of the TXL-CAP trial will provide additional clinical data for revealing whether TXL capsules stabilizes coronary vulnerable plaques in Chinese ACS patients.
2.Design and application of intelligent monitoring platform for adverse drug reactions
Guang-hua CHEN ; Jin XU ; Xi-long FENG ; Yong GAO ; Pei-yun NI ; Hua ZHU
Chinese Medical Equipment Journal 2025;46(9):33-38
Objective To design an intelligent monitoring platform for adverse drug reactions(ADRs)to solve the problems of the traditional ADR monitoring mode.Methods The ADR intelligent monitoring platform was designed based on artificial intelligence and big data technologies,which was developed with Browser/Server(B/S)architecture,C#programming language and.NET development tool.There were five functional modules involved in the platform for ADR knowledge base,monitoring rule setting,intelligent monitoring,report management and statistical analysis.Results The platform realized the full-process management of ADR intelligent monitoring,reporting,review and statistical analysis,which enhanced the ADR report in quantity,quality and timeliness.Conclusion The platform contributes to improving the monitoring of ADR and patient medication safety.[Chinese Medical Equipment Journal,2025,46(9):33-38]
3.Clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinnal Dampness-heat Pattern
Tian CHEN ; Ze-hui WANG ; Yun-hua PENG ; Qing-yuan WANG ; Yan-ni PEI ; Qi-qi YANG ; Wei YANG
Chinese Traditional Patent Medicine 2025;47(2):453-457
AIM To investigate the clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases)for 1-month administration of Pefikang Capsules and Mesalazine Sustained Release Granules,and observation group(60 cases)for 1-month administration of Supplemented Gegen Qinlian Decoction,acupuncture,Pefikang Capsules and Mesalazine Sustained Release Granules.The changes in clinical effects,symptom remission time,TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors(IL-6,IL-8,TNF-α),immune function indices(IgA,IgG,IgM),IBDQ score and recurrence rate were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05),along with shorter symptom remission time(P<0.05)and lower recurrence rate(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors,IgG,IgM(P<0.05),and increased IBDQ score(P<0.05),especially for the observation group(P<0.05).CONCLUSION For the patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern,Gegen Qinlian Decoction combined with acupuncture can improve clinical symptoms,promote disease recovery,enhance immune functions and life quality,and reduce recurrence rate.
4.Design and application of intelligent monitoring platform for adverse drug reactions
Guang-hua CHEN ; Jin XU ; Xi-long FENG ; Yong GAO ; Pei-yun NI ; Hua ZHU
Chinese Medical Equipment Journal 2025;46(9):33-38
Objective To design an intelligent monitoring platform for adverse drug reactions(ADRs)to solve the problems of the traditional ADR monitoring mode.Methods The ADR intelligent monitoring platform was designed based on artificial intelligence and big data technologies,which was developed with Browser/Server(B/S)architecture,C#programming language and.NET development tool.There were five functional modules involved in the platform for ADR knowledge base,monitoring rule setting,intelligent monitoring,report management and statistical analysis.Results The platform realized the full-process management of ADR intelligent monitoring,reporting,review and statistical analysis,which enhanced the ADR report in quantity,quality and timeliness.Conclusion The platform contributes to improving the monitoring of ADR and patient medication safety.[Chinese Medical Equipment Journal,2025,46(9):33-38]
5.Clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinnal Dampness-heat Pattern
Tian CHEN ; Ze-hui WANG ; Yun-hua PENG ; Qing-yuan WANG ; Yan-ni PEI ; Qi-qi YANG ; Wei YANG
Chinese Traditional Patent Medicine 2025;47(2):453-457
AIM To investigate the clinical effects of Supplemented Gegen Qinlian Decoction combined with acupuncture on patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern.METHODS One hundred and twenty patients were randomly assigned into control group(60 cases)for 1-month administration of Pefikang Capsules and Mesalazine Sustained Release Granules,and observation group(60 cases)for 1-month administration of Supplemented Gegen Qinlian Decoction,acupuncture,Pefikang Capsules and Mesalazine Sustained Release Granules.The changes in clinical effects,symptom remission time,TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors(IL-6,IL-8,TNF-α),immune function indices(IgA,IgG,IgM),IBDQ score and recurrence rate were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05),along with shorter symptom remission time(P<0.05)and lower recurrence rate(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,Geboes index,lesion activity index,Baron score,inflammatory factors,IgG,IgM(P<0.05),and increased IBDQ score(P<0.05),especially for the observation group(P<0.05).CONCLUSION For the patients with ulcerative colitis of Large Intestinal Dampness-heat Pattern,Gegen Qinlian Decoction combined with acupuncture can improve clinical symptoms,promote disease recovery,enhance immune functions and life quality,and reduce recurrence rate.
6.Clinical effects of Shiyan Prescription on patients with ulcerative colitis due to Bowel Dampness-Heat Stagnation
Li HUANG ; Wei YANG ; Yun-Hua PENG ; Tian CHEN ; Yan-Ni PEI ; Hong LU
Chinese Traditional Patent Medicine 2024;46(8):2591-2595
AIM To explore the clinical effects of Shiyan Prescription on patients with ulcerative colitis due to Bowel Dampness-Heat Stagnation.METHODS Eighty-two patients were randomly assigned into control group(41 cases)for 8-week administration of Mesalazin Enteric-coated Tablets,and observation group(41 cases)for 8-week administration of both Shiyan Prescription and Enteric-coated Tablets.The changes in clinical effects,TCM syndrome scores,serum inflammatory factors(interleukin-6,interleukin-22,interleukin-33),intestinal mucosal barrier function indices(diamine oxidase,D-lactic acid,endotoxin),intestinal flora(Escherichia coli,Enterococcus,Bifidobacterium,Lactobacillus)and GQOLI-74 scores were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05).After the treatment,the two groups displayed decreased TCM syndrome scores,serum inflammatory factors,intestinal mucosal barrier function indices(P<0.05),increased GQOLI-74 scores(P<0.05),reduced Enterococcus(P<0.05),and enhanced Bifidobacterium,Lactobacillus(P<0.05),especially for the observation group(P<0.05).CONCLUSION For the patients with ulcerative colitis due to Bowel Dampness-Heat Stagnation,Shiyan Prescription can enhance life quality with obvious clinical effects.
7.Effect of acupuncture on HIF-1α/NLRP3 inflammatory signaling pathway in the rats with cerebral ischemia-reperfusion injury.
Zheng-Yun CAI ; Xin-Chang ZHANG ; Fu-Rong LIU ; Zheng HUANG ; Meng-Ning YANG ; Pei-Yan HUANG ; Zhi-Hui ZHANG ; Guang-Xia NI
Chinese Acupuncture & Moxibustion 2023;43(9):1056-1061
OBJECTIVE:
To observe the effects of Xingnao Kaiqiao (regaining consciousness and opening orifices) acupuncture therapy on the expression of hypoxia-inducible factor 1α (HIF-1α) and Nod-like receptor protein 3 (NLRP3) in cerebral ischemia-reperfusion rats, and to explore the mechanism of acupuncture against cerebral ischemia-reperfusion injury.
METHODS:
Seventy-two male SD rats were randomly divided into a sham-operation group, a model group, an acupuncture group and a non-point acupuncture group, with 18 rats in each one. Using modified Longa thread embolization method, the rat model of acute focal cerebral ischemia was prepared; and after 2 h ischemia, the reperfusion was performed to prepared the model of cerebral ischemia-reperfusion. Immediately after reperfusion, Xingnao Kaiqiao acupuncture method was applied to bilateral "Neiguan" (PC 6) and "Shuigou" (GV 26) in the acupuncture group, while in the non-point acupuncture group, acupuncture was delivered at non-points and all of the needles were retained for 30 min in these two groups. The samples were collected 24 h after reperfusion in the rats of each group. Zea-Longa neurological deficit score was used to evaluate the degree of cerebral neurological impairment, TTC staining was adopted to observe the volume percentage of cerebral infarction, HE staining was provided to observe the morphological changes of brain, and Western blot was applied for detecting the expression of HIF-1α and NLRP3 proteins in the cerebral cortex on the right side.
RESULTS:
Compared with the sham-operation group, neurological deficit score and volume percentage of cerebral infarction were increased in the model group (P<0.01), and HIF-1α and NLRP3 protein expression was elevated (P<0.01). Compared with the model group, neurological deficit score and volume percentage of cerebral infarction were decreased (P<0.01), and HIF-1α and NLRP3 protein expression was lower (P<0.01) in the acupuncture group. There was no significant difference in above indexes in the non-point acupuncture group compared with the model group (P>0.05). Compared with the sham-operation group, the brain tissue of the rats in the model group and the non-point acupuncture group was loose and edema, and the nuclei were shriveled. The brain tissue morphology in the acupuncture group was similar to that of the sham-operation group.
CONCLUSION
Acupuncture can alleviate cerebral ischemia-reperfusion injury, and its mechanism may be related to the regulation of HIF-1α/NLRP3 signaling pathway to attenuate inflammatory response.
Male
;
Animals
;
Rats
;
Rats, Sprague-Dawley
;
NLR Family, Pyrin Domain-Containing 3 Protein/genetics*
;
Acupuncture Therapy
;
Reperfusion Injury/therapy*
;
Brain Ischemia/therapy*
;
Cerebral Infarction/therapy*
;
NLR Proteins
8.Pathophysiological Mechanisms Underlying Unilateral Vocal Fold Paralysis in Female Patients: An Ultrasonographic Study
Yi-An LU ; Yun-Chen TSAI ; Wan-Ni LIN ; Yu-Cheng PEI ; Tuan-Jen FANG
Clinical and Experimental Otorhinolaryngology 2023;16(4):395-402
Objectives:
. Laryngeal ultrasonography (LUS) has been suggested as an alternative diagnostic tool for unilateral vocal fold paralysis (UVFP). The present study applied LUS and quantitative laryngeal electromyography (LEMG) in female UVFP patients to investigate the pathophysiologic mechanisms of UVFP.
Methods:
. In this cross-sectional study, vocal fold (VF) length parameters included resting and phonating VF length measured using B-mode LUS, and color Doppler vibrating length (CDVL) measured using the color Doppler mode.
Results:
. Forty female patients with UVFP were enrolled, among whom 11 and 29 were assigned to the thyroarytenoid (TA) muscle+cricothyroid (CT) muscle group (with CT involvement) and the TA (without CT involvement) group, respectively. In the TA group, the turn frequency in thyroarytenoid-lateral cricoarytenoid (TA-LCA) on the paralyzed side, as observed through LEMG, correlated with the VF length during the resting phase (R=0.368, P=0.050) and CDVL values (R=0.627, P=0.000) on the paralyzed side. In the TA+CT group, the turn ratio in the CT muscle correlated with the normalized phonatory vocal length change (nPLC; R=0.621, P=0.041) on the paralyzed side.
Conclusion
. CDVL and nPLC are two parameters that can be utilized to predict the turn frequencies of TA-LCA in UVFP cases without CT involvement, and the turn ratio of CT in cases of UVFP with CT involvement, respectively. The findings suggest that LUS, as a noninvasive tool, can serve as an alternative method for assessing the severity of laryngeal nerve injury and offer valuable insights into the pathophysiology of UVFP.
9.1,8-cineol based influenza vaccine can improve vaccine efficacy on mice infected influenza virus
Hui Shang LIAO ; Yun LI ; Lin Yu XU ; Ni Yan LAI ; Ping Pei XU
Chinese Journal of Immunology 2017;33(11):1606-1610
Objective:To evaluate 1,8-cineol as vaccine adjuvants to enhance influenza vaccine immune efficacy.Methods:80 BALB/c mice were divided into blank control group,1,8-cineol group,HA group and HA+ 1,8-cineol group,each group of 20.Blank control group normal breeding,HA group accepted HA protein 0.2 μg,the HA+1,8-cineol group was given 0.2 μg HA+ 100 mg/kg 1,8-cineol,1,8-cineol group was given 100 mg/kg 1,8-cineol.Except the blank group,other groups of mice intranasal immunized for three times interval of one week.At the fourth weeks each mice was infected with 10LD50 influenza virus FM1.On the 6 days after the infected,10 mice in each group were collected serum,using enzyme-linked immunoassay(ELISA)to detect serum IgG,IgG1b,IgG2a, IgG2b in 450 nm absorbance values(OD).Removed the lung tissue and measured the lung index and pathological.Remaining mice continue to observe 15 days and record the deaths,calculating the infected mice survival rate.Results:Compared with the HA group, HA + 1,8-cineol group can reduce the lung index,alleviate the pulmonary lesions,improve the serum IgG,IgG1b,IgG2a,and increases the survival rate of infected mice.Conclusion:1,8-cineol as vaccine adjuvants,can strengthen the immune effect of influenza vaccine.
10.Rapid detection and identification of infectious pathogens based on high-throughput sequencing.
Pei-Xiang NI ; Xin DING ; Yin-Xin ZHANG ; Xue YAO ; Rui-Xue SUN ; Peng WANG ; Yan-Ping GONG ; Jia-Li ZHOU ; Dong-Fang LI ; Hong-Long WU ; Xin YI ; Ling YANG ; Yun LONG
Chinese Medical Journal 2015;128(7):877-883
BACKGROUNDThe dilemma of pathogens identification in patients with unidentified clinical symptoms such as fever of unknown origin exists, which not only poses a challenge to both the diagnostic and therapeutic process by itself, but also to expert physicians.
METHODSIn this report, we have attempted to increase the awareness of unidentified pathogens by developing a method to investigate hitherto unidentified infectious pathogens based on unbiased high-throughput sequencing.
RESULTSOur observations show that this method supplements current diagnostic technology that predominantly relies on information derived five cases from the intensive care unit. This methodological approach detects viruses and corrects the incidence of false positive detection rates of pathogens in a much shorter period. Through our method is followed by polymerase chain reaction validation, we could identify infection with Epstein-Barr virus, and in another case, we could identify infection with Streptococcus viridians based on the culture, which was false positive.
CONCLUSIONSThis technology is a promising approach to revolutionize rapid diagnosis of infectious pathogens and to guide therapy that might result in the improvement of personalized medicine.
Female ; Herpesvirus 4, Human ; genetics ; isolation & purification ; High-Throughput Nucleotide Sequencing ; methods ; Humans ; Male ; Viridans Streptococci ; genetics ; isolation & purification

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