1.Research progress of non-insulin hypoglycemic drugs in the treatment of type 1 diabetes mellitus
Zejie XU ; Jiaoni ZHENG ; Jing LUO ; Liangyu WANG ; Wei YAN ; Qiang HE ; Xuefeng SHAN
China Pharmacy 2026;37(2):263-267
Traditional treatment for type 1 diabetes mellitus (T1DM) primarily involves insulin replacement, yet some patients encounter issues such as significant blood glucose fluctuations, high risk of hypoglycemia, and weight gain. In recent years, the adjuvant therapeutic role of non-insulin hypoglycemic drugs in T1DM has gradually gained attention. This article reviews the mechanisms of action and clinical research progress of five types of non-insulin hypoglycemic drugs in the treatment of T1DM: amylin analogues (pramlintide), biguanides (metformin), sodium-glucose co-transporter 2 inhibitor, dipeptidyl peptidase-4 inhibitor, and glucagon-like peptide-1 receptor agonist. It is found that these drugs can enhance clinical benefits for T1DM patients by improving insulin sensitivity, delaying gastric emptying, promoting urinary glucose excretion, and regulating incretin levels, thereby reducing glycated hemoglobin levels, decreasing insulin dosage, and managing body weight. Simultaneously, these drugs also present limitations such as low patient compliance due to complex dosing regimens, increased risk of diabetic ketoacidosis, and heterogeneity in glycemic control. Future research could focus on developing individualized treatment strategies, combining pharmacogenomics with novel biomarkers to precisely identify subpopulations of patients who may benefit, and delving into the potential value of these drugs in delaying diabetic vascular complications and improving patients’ quality of life.
2.Clinical Efficacy of Yiqi Yangyin Huoxue Prescription in Treatment of Cathartic Colon and Analysis of Influencing Factors of Disease Severity
Youcheng HE ; Jingyi SHAN ; Fengru JIANG ; Yue WU ; Chunyu ZHOU ; Lu HANG ; Yan ZHOU ; Lian MO ; Shuyu CAI ; Keyi PAN ; Lifeng WEI ; Jianye YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):173-184
ObjectiveTo observe the clinical efficacy of the Yiqi Yangyin Huoxue prescription (YYHP) in the treatment of cathartic colon (CC) and its effects on fecal short-chain fatty acids (SCFAs), and to explore the correlations among CC severity indicators and between these indicators and patient history. MethodsAccording to the inclusion and exclusion criteria, 98 patients meeting the diagnostic criteria of both traditional Chinese and Western medicine for CC with the syndrome of Qi-Yin deficiency complicated by blood stasis were randomly assigned to an observation group and a control group. The observation group received YYHP granules, while the control group received lactulose. Both medications were administered twice daily, one sachet each time, half an hour after breakfast and dinner, with a treatment course of 8 weeks. The primary constipation symptom score, Patient Assessment of Constipation Quality of Life (PAC-QOL) score, and TCM syndrome score were assessed before and after treatment and at the 8th week after the end of treatment. The overall clinical effective rate, as well as the efficacy attenuation index and degree, were evaluated. Fecal SCFA levels were measured using gas chromatography-mass spectrometry (GC-MS). Spearman correlation analysis was performed to explore the correlations among CC severity indicators and between these indicators and patient history. ResultsThe overall clinical effective rate in the observation group (95.83%) was higher than that in the control group (78.72%) (P<0.05). After treatment, the total scores for primary constipation symptoms, PAC-QOL, and TCM syndromes decreased in both groups (P<0.05), with more significant reductions in the observation group (P<0.05). The severity of all primary constipation symptoms was alleviated in both groups (P<0.05). In terms of "excessive straining and difficult defecation", "anal heaviness, incomplete evacuation, and bloating sensation", "abdominal distension", and "defecation frequency", the observation group showed better efficacy than the control group (P<0.05). Scores of the four PAC-QOL dimensions and the scores and severity of primary and secondary TCM symptoms were reduced in both groups (P<0.05), with more significant reductions in the observation group (P<0.05). After treatment, acetic acid, propionic acid, butyric acid, and total SCFAs in the observation group increased significantly (P<0.05). The efficacy attenuation index and degree in the observation group were lower than those in the control group (P<0.05). No severe adverse reactions occurred in either group, and there was no statistically significant difference in the incidence of adverse reactions between the two groups. Positive correlations of varying degrees were observed among the total scores of primary constipation symptoms, PAC-QOL, and TCM syndromes, as well as between these scores and the history of stimulant laxative use, disease duration, and age. ConclusionYYHP can effectively alleviate the primary constipation symptoms in CC patients, improve quality of life, and ameliorate TCM syndromes, with good safety. It also has the advantage of a lower rebound degree after drug withdrawal, and its mechanism may be related to increasing fecal SCFA levels. Long-term abuse of stimulant laxatives may aggravate the severity of CC and prolong the disease course.
3.Impact of infusion of red blood cell suspension at different perioperative periods in patients with valvular heart disease: A propensity score matching study
Shan XU ; Bo FU ; Ao WEI ; Qian ZHANG ; Yaqing CAO ; Nan JIANG ; Zhigang GUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(05):772-777
Objective To investigate the impact of red blood cell suspension infusion across various perioperative periods on patients with valvular heart disease. Methods The patients with valvular heart disease admitted to Tianjin Chest Hospital from 2018 to 2020 were selected. Based on the timing of perioperative red cell suspension infusion, patients were categorized into three groups: a group 1 receiving intraoperative red cell suspension infusion, a group 2 receiving red cell suspension infusion within 24 hours after entering the ICU, and a group 3 receiving red cell suspension infusion at both time points. The laboratory results, perioperative blood component infusion volume, and other relevant parameters were retrospectively analyzed. After propensity score matching, the differences in different variables among the three groups were compared. Results After propensity score matching, 102 patients were enrolled, including 52 males and 50 females, with an average age of (61.74±10.58) years. There were 34 patients in each group. The preoperative hemoglobin (Hb) value of the group 2 was significantly higher than that of the group 1 and the group 3, and the amount of red cell suspension and autoblood transfusion was the lowest (P<0.05). Group 1 had the highest postoperative Hb, as well as the highest Hb and hematocrit (HCT) levels within 24 hours post-surgery (P<0.05). The group 1 had the lowest plasma, platelet and cryoprecipitate infusion volumes, and the shortest cardiopulmonary bypass time, aortic occlusion time, postoperative ICU stay and hospital stay, and the least blood loss and total drainage volume (P<0.05). The difference between postoperative and preoperative Hb (△Hb1) was highest in group 1 (P<0.05). Conclusion For patients with valvular heart disease, intraoperative-only infusion of red blood cell suspension is associated with a better prognosis at discharge and during follow-up.
4.A panel study on association of short-term air pollution exposure and peripheral blood microparticles in healthy adults
Bin ZHANG ; Xinghou HE ; Jiahui LIU ; Xuyang SHAN ; Yan FANG ; Huiying XU ; Erlu ZHAO ; Shengcong LIU ; Hongbing XU ; Jianping LI ; Wei HUANG
Journal of Environmental and Occupational Medicine 2026;43(1):1-7
Background Microparticles (MPs) are one of the main medium of inflammatory reaction with an important role in atherosclerotic progression. Studies on association of air pollution exposure and levels of peripheral blood MPs are limited among human. Objective To evaluate the effects of short-term exposure to air pollution on levels of peripheral blood MPs. Method A panel of 73 healthy adults was followed with 4 repeated follow-ups in Beijing, China, from November 2014 to January 2016. During each visit, we collected questionnaire information, fasting venous blood, urine, and exposures to fine particulate matter (PM2.5), black carbon, nitric oxide, nitrogen dioxide, nitrogen oxide, sulfur dioxide, carbon monoxide, and ozone. We used linear mixed-effect models to analyze associations of air pollution exposure with levels of total MPs (TMPs) and MPs derived from various cells. Stratified analysis was conducted by levels of C-reactive protein (CRP) and malondialdehyde (MDA). Results The results showed significant associations between air pollution exposure and peripheral blood TMPs at 2 h-6 d prior to the follow-ups (P<0.05), while no statistical associations were found for MPs derived from different cell types. Significant increases in TMPs of 7.8% (95%CI: 0.7%, 15.3%) and 14.3% (95%CI: 2.8%, 27.2%) were observed with each interquartile range (IQR) increase in PM2.5 (IQR=64.9 μg·m−3) at prior 18 h and NO (IQR=40.5 μg·m−3) at prior 48 h. Among participants with low levels of CRP and MDA, significantly positive associations were observed between air pollution exposure and levels of TMPs (P<0.05). Conclusion Short-term exposure to air pollution is significantly associated with increased levels of circulating MPs in healthy adults, and in people with lower systemic inflammation, peripheral blood MPs levels are more easily affected after exposure to air pollutants.
5.Early assessment of responsive neurostimulation for drug-resistant epilepsy in China: A multicenter, self-controlled study.
Yanfeng YANG ; Penghu WEI ; Jianwei SHI ; Ying MAO ; Jianmin ZHANG ; Ding LEI ; Zhiquan YANG ; Shiwei SONG ; Ruobing QIAN ; Wenling LI ; Yongzhi SHAN ; Guoguang ZHAO
Chinese Medical Journal 2025;138(4):430-440
BACKGROUND:
To evaluate the efficacy and safety of the first cohort of people in China treated with a responsive neurostimulation system (Epilcure TM , GenLight MedTech, Hangzhou, China) for focal drug-resistant epilepsy in this study.
METHODS:
This multicenter, before-and-after self-controlled study was conducted across 8 centers from March 2022 to June 2023, involving patients with drug-resistant epilepsy who were undergoing responsive neurostimulation (RNS). The study was based on an ongoing multi-center, single-blind, randomized controlled study. Efficacy was assessed through metrics including median seizure count, seizure frequency reduction (SFR), and response rate. Multivariable linear regression analysis was conducted to explore the relationships of basic clinical factors and intracranial electrophysiological characteristics with SFR. The postoperative quality of life, cognitive function, depression, and anxiety were evaluated as well.
RESULTS:
The follow-up period for the 19 participants was 10.7 ± 3.4 months. Seizure counts decreased significantly 6 months after device activation, with median SFR of 48% at the 6th month (M6) and 58% at M12 ( P <0.05). The average response rate after 13 months of treatment was 42%, with 21% ( n = 4) of the participants achieving seizure freedom. Patients who have previously undergone resective surgery appear to achieve better therapeutic outcomes at M11, M12 and M13 ( β <0, P <0.05). No statistically significant differences were observed in patients' scores of quality of life, cognition, depression and anxiety following stimulation when compared to baseline measurements. No serious adverse events related to the devices were observed.
CONCLUSIONS:
The preliminary findings suggest that Epilcure TM exhibits promising therapeutic potential in reducing the frequency of epileptic seizures. However, to further validate its efficacy, larger-scale randomized controlled trials are required.
REGISTRATION
Chinese Clinical Trial Registry (No. ChiCTR2200055247).
Humans
;
Female
;
Male
;
Drug Resistant Epilepsy/therapy*
;
Adult
;
Young Adult
;
Middle Aged
;
China
;
Adolescent
;
Treatment Outcome
;
Quality of Life
;
Single-Blind Method
;
Seizures
;
Electric Stimulation Therapy/methods*
6.Identification of GSK3 family and regulatory effects of brassinolide on growth and development of Nardostachys jatamansi.
Yu-Yan LEI ; Zheng MA ; Jing WEI ; Wen-Bing LI ; Ying LI ; Zheng-Ming YANG ; Shao-Shan ZHANG ; Jing-Qiu FENG ; Hua-Chun SHENG ; Yuan LIU
China Journal of Chinese Materia Medica 2025;50(2):395-403
This study identified 8 members including NjBIN2 of the GSK3 family in Nardostachys jatamansi by bioinformatics analysis. Moreover, the phylogenetic tree revealed that the GKS3 family members of N. jatamansi had a close relationship with those of Arabidopsis. RT-qPCR results showed that NjBIN2 presented a tissue-specific expression pattern with the highest expression in roots, suggesting that NjBIN2 played a role in root growth and development. In addition, the application of epibrassinolide or the brassinosteroid(BR) synthesis inhibitor(brassinazole) altered the expression pattern of NjBIN2 and influenced the photomorphogenesis(cotyledon opening) and root development of N. jatamansi, which provided direct evidence about the functions of NjBIN2. In conclusion, this study highlights the roles of BIN2 in regulating the growth and development of N. jatamansi by analyzing the expression pattern and biological function of NjBIN2. It not only enriches the understanding about the regulatory mechanism of the growth and development of N. jatamansi but also provides a theoretical basis and potential gene targets for molecular breeding of N. jatamansi with improved quality in the future.
Brassinosteroids/metabolism*
;
Steroids, Heterocyclic/metabolism*
;
Gene Expression Regulation, Plant/drug effects*
;
Plant Proteins/metabolism*
;
Phylogeny
;
Nardostachys/metabolism*
;
Plant Growth Regulators/pharmacology*
;
Plant Roots/drug effects*
7.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
;
Child
;
Child, Preschool
;
Female
;
Humans
;
Male
;
Double-Blind Method
;
Drugs, Chinese Herbal/therapeutic use*
;
Tic Disorders/drug therapy*
;
Treatment Outcome
8.Qualitative and quantitative analysis of chemical components of different processed products of Corni Fructus by UPLC-Q-TOF-MS and UPLC-QqQ-MS/MS.
Li-Qiang ZHANG ; Guo-Shun SHAN ; Yi-Dan HONG ; Si-Han LIU ; Guo-Wei XU ; Hui GAO ; Wei WANG ; Cheng-Guo JU
China Journal of Chinese Materia Medica 2025;50(8):2145-2158
Qualitative and quantitative analysis methods for chemical components of different processed products of Corni Fructus were established to systematically characterize and identify these components, and the content of the main differential components was determined. The chemical components of different processed products of Corni Fructus were collected using ultra-high performance liquid chromatography-quadrupole time-of-flight tandem mass spectrometry(UPLC-Q-TOF-MS). Through analysis of self-built databases, literature, and reference standards, a total of 93 components were obtained, including 19 iridoids, 15 flavonoids, 16 organic acids, eight triterpenoids, eight tannins, four amino acids, two polysaccharides, five olefins, and 16 other compounds. Additionally, by using multivariate statistical methods, the differential components between different processed products of Corni Fructus were screened under the conditions of VIP>1.0 and FC<0.5 or FC>2.0 and P<0.05. The PCA and OPLS-DA results showed differences in the chemical components between different processed products of Corni Fructus. A total of 21 differential components were screened, including tartaric acid, morroniside, and rutin. On this basis, ultra-high performance liquid chromatography-triple quadrupole tandem mass spectrometry(UPLC-QqQ-MS/MS) was used to determine the content of 10 main common differential components, including gallic acid, morroniside, ursolic acid, loganin, swertiamarin, rutin, 5-hydroxymethylfurfural, cornuside Ⅰ, quercetin, and oleanolic acid. The above 10 components showed a good linear relationship within the determined concentration range, with the precision, stability, repeatability, and sample recovery rate all meeting the requirements. Compared with that in Corni Fructus, the content of iridoid glycosides in wine-prepared Corni Fructus and wine-and honey-prepared Corni Fructus decreased, while the content of gallic acid, rutin, quercetin, 5-hydroxymethylfurfural, ursolic acid, and oleanolic acid increased. Compared with wine-prepared Corni Fructus, wine-and honey-prepared Corni Fructus showed varying degrees of increase in all other components, except for a slight decrease in gallic acid content. In summary, this study clarified the influence of different processing methods on the chemical components of Corni Fructus, providing a theoretical basis for the scientific connotation, overall quality evaluation, and clinically rational application of Corni Fructus processing in the future.
Tandem Mass Spectrometry/methods*
;
Chromatography, High Pressure Liquid/methods*
;
Cornus/chemistry*
;
Drugs, Chinese Herbal/chemistry*
;
Fruit/chemistry*
9.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
;
Humans
;
Consensus
;
Drugs, Chinese Herbal/therapeutic use*
;
Surveys and Questionnaires
10.Evidence analysis of clinical research on traditional Chinese medicine treatment of adenomyosis in recent ten years.
Zhi-Ran LI ; Xiao-Jun BU ; Shan HUANG ; Xing LIAO ; Rui-Hua ZHAO ; Wei-Wei SUN
China Journal of Chinese Materia Medica 2025;50(10):2853-2864
This study aims to systematically review and evaluate the quality of clinical research on the treatment of adenomyosis(AM) with traditional Chinese medicine(TCM) in recent ten years, using evidence graphs. Computer searches were conducted on eight Chinese and English databases, commonly used guideline databases, and guideline-related websites, covering the period from January 1, 2014, to October 1, 2024. Two researchers independently screened, extracted information, and evaluated the quality of the evidence. The distribution and quality of the clinical research evidence were presented using both text and charts. A total of 565 articles were included in the study, comprising 523 intervention studies, 23 observational studies, 18 systematic reviews/Meta-analysis, and 1 guideline. The overall publication volume has shown a downward trend in past two years. The sample sizes of the intervention and observational studies primarily focused on 60 to 120 cases. The intervention schemes mainly involved multi-therapy combinations, including 33 classic prescriptions and 25 Chinese patent medicines. Among these, 48 studies related to 17 classic prescriptions and 45 studies related to 10 types of Chinese patent medicines involved TCM syndrome types. Randomized controlled trial(RCT) tended to focus on overall clinical efficacy and the degree of dysmenorrhea as key outcome measures. Methodological quality issues were found in 97 RCTs related to TCM decoctions and 131 RCTs related to Chinese patent medicines, primarily involving unclear explanations of some information. The AMSTAR scores for the 18 systematic reviews/Meta-analysis ranged from 1 to 8 points, with 16 studies suggesting "evidence of potential therapeutic efficacy". The recommended level for the one included guideline was B-level. TCM shows significant advantages in treating AM. Future clinical research should further standardize study designs, reference relevant reporting guidelines, improve the quality of clinical research, generate higher-level evidence-based results, and promote the high-quality development of clinical research on TCM for treating AM.
Humans
;
Adenomyosis/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
;
Female
;
Medicine, Chinese Traditional
;
Randomized Controlled Trials as Topic

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