1.Clinical study on high-dose ilaprazole combined with amoxicillin for newly diagnosed elderly patients with Helicobacter pylori infection
Chen LI ; Yujing WANG ; Jianna MAO ; Hao GUO ; Yuhou SHEN ; Zhichao DONG ; Binbin YAN
China Pharmacy 2025;36(14):1792-1796
OBJECTIVE To evaluate the efficacy and safety of high-dose ilaprazole combined with amoxicillin for newly diagnosed elderly patients with Helicobacter pylori (Hp) infection, and analyze independent risk factors for failure of Hp infection eradication treatment. METHODS Totally 200 cases of newly diagnosed elderly patients with Hp infection in Xinxiang Central Hospital from August 1, 2021 to December 1, 2024 were selected and randomly divided into control group and study group, with 100 cases in each group. The control group was treated with classic quadruple therapy regimen (Amoxicillin capsules+ Clarithromycin tablets+Bismuth potassium citrate tablets+Ilaprazole enteric-coated tablets). The study group was treated with high- dose Ilaprazole enteric-coated tablets+Amoxicillin capsules. All patients were administered medication for 2 weeks. Hp eradication rates in the two groups were compared using intention-to-treat (ITT) and per-protocol (PP) analyses. The incidence of adverse reactions in both groups was also recorded. The multiple-factor Logistic regression analysis was used to identify independent risk factors for failure of Hp infection eradication treatment. RESULTS In ITT and PP analyses, there was no significant difference of Hp eradication rates between the two groups (P>0.05). There was no significant difference in incidence of mild to moderate adverse reactions between the two groups (P>0.05). BMI ≤18.5 kg/m2, BMI >23.9 kg/m2, rural residence, concomitant diabetes and concomitant heart disease were identified as independent risk factors influencing the failure of Hp infection eradication treatment (P<0.05). CONCLUSIONS The efficacy and safety of high-dose ilaprazole combined with amoxicillin are comparable to classic quadruple therapy regimen in treating newly diagnosed elderly patients with Hp infection. Independent risk factors influencing the failure of Hp infection eradication treatment include BMI ≤18.5 kg/m2, BMI >23.9 kg/m2, rural residence, concomitant diabetes and concomitant heart disease.
2.Oxidative stress in diabetes mellitus and its complications: From pathophysiology to therapeutic strategies.
Xingyu CHEN ; Na XIE ; Lixiang FENG ; Yujing HUANG ; Yuyao WU ; Huili ZHU ; Jing TANG ; Yuanyuan ZHANG
Chinese Medical Journal 2025;138(1):15-27
Oxidative stress due to aberrant metabolism is considered as a crucial contributor to diabetes and its complications. Hyperglycemia and hyperlipemia boost excessive reactive oxygen species generation by elevated mitochondrial respiration, increased nicotinamide adenine dinucleotide phosphate oxidase activity, and enhanced pro-oxidative processes, including protein kinase C pathways, hexosamine, polyol, and advanced glycation endproducts, which exacerbate oxidative stress. Oxidative stress plays a significant role in the onset of diabetes and its associated complications by impairing insulin production, increasing insulin resistance, maintaining hyperglycemic memory, and inducing systemic inflammation. A more profound comprehension of the molecular processes that link oxidative stress to diabetes is crucial to new preventive and therapeutic strategies. Therefore, this review discusses the mechanisms underlying how oxidative stress contributes to diabetes mellitus and its complications. We also summarize the current approaches for prevention and treatment by targeting the oxidative stress pathways in diabetes.
Oxidative Stress/physiology*
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Humans
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Diabetes Mellitus/physiopathology*
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Diabetes Complications/metabolism*
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Reactive Oxygen Species/metabolism*
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Glycation End Products, Advanced/metabolism*
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Animals
3.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 1):Concept and Current Practice
Lijiao YAN ; Ning LIANG ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Xiaoling LI ; Wenjie CAO ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):269-274
Rapid and living guidelines are those developed in response to public health emergencies in a short period of time using a scientific and standardized approach. Subsequently, they provide timely and credible recommendations for decision makers through regular and frequent updates of clinical evidence and recommendations. In this paper, we introduced the definition of rapid and living guideline as well as analyzed the basic characteristics of eight rapid and living guidelines in the field of traditional Chinese medicine (TCM) published till 2023 June, summarizing three core methodological issues in relation to how to rapidly develop guidelines, how to formulate recommendations when there is lack of evidence, and how to ensure the timeliness of guidelines. Based on the analysis of current rapid and living guidelines, it is implicated that there is necessity to carry out rapid and living guideline in the field of TCM, and the methodology of rapid integration of multivariate evidence in the field of TCM needs to be further explored; furthermore, it is necessary to further explore the obstacles of implementation of guidelines and promote timely updating, all of which provide certain theoretical references for relevant guideline developers and researchers.
4.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 2): Development Process and Key Steps during Preparation Stage
Yujing ZHANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Qianzi CHE ; Jingya WANG ; An LI ; Nannan SHI ; Yanping WANG ; Ning LIANG
Journal of Traditional Chinese Medicine 2024;65(3):275-280
It is necessary to develop rapid and living guidelines in order to improve the evidence translation and guidance for clinical practice in emergency situations, and to enhance the participation of traditional Chinese medicine (TCM) in management of emergencies. This paper introduced the process of developing rapid and living guidelines of TCM and divided it into three stages, that is preparation, rapid development and dynamic updating, which highlights the features of rapid development, high quality, and dynamic updating and the integration with the predominance of TCM. By comparing with general guidelines on composition, personnel number, timing to formulate and communication patterns of the guideline working groups, as well as the content and number of clinical questions, this paper mainly gave suggestions on how to formulate a concise but authoritative team during the preparation stage, how to efficiently manage the guideline team and promote the development process from conflict of interest management, working and communication mode adjustment, and how to formulate and update the important and prioritized clinical questions, all of which may provide reference for the development of TCM rapid and living guidelines.
5.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 3): Rapid Evidence Collection, Integration and Recommendation Formation
Ziteng HU ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Xiaoling LI ; Haili ZHANG ; Huizhen LI ; Jingya WANG ; An LI ; Zhao CHEN ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):281-286
The lack of direct evidence is an important problem faced in the formation of recommendations in rapid living guidelines of traditional Chinese medicine under public health emergencies, and the supplementation of indirect evidence can be a key method to solve this problem. For the collection of evidence, the type of evidence required, including direct and indirect evidence, should be clarified, and ‘direct first’ principle for selecting evidence can be set to standardize and accelerate the guideline development. When integrating evidence, recommendations can be formed directly if there is sufficient direct evidence, while regarding insufficient direct evidence, recommendations need to be supplemented and improved by integrating indirect evidence. In addition, when the body of evidence contains evidence from multiple sources, it is suggested to rate the evidence according to “higher rather than lower” principle. Finally, when forming recommendations, the level of evidence, safety and economic efficiency should be taken into consideration to determine the strength of the recommendation.
6.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 4): Evidence Monitoring and Dynamic Updates
Lijiao YAN ; Ning LIANG ; Yujing ZHANG ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Wenjie CAO ; Huizhen LI ; Xingyu ZONG ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):287-291
In developing rapid and living guidelines of traditional Chinese medicine (TCM) in response to public health emergencies, it is important that evidence continue to be reviewed, and clinical questions and recommendations updated if necessary, due to the rapid changes in disease progression and the continuous generation of relevant research evidence. This paper proposed that the updating scope in dynamic mode should first be identified; then evidence monitoring should be carried out in four aspects, including clinical research, related guidelines or laws and regulations, disease progression, as well as clinical use of recommendations and clinical needs; finally, based on the results of the evidence monitoring, different options should be made, including revising the clinical questions, updating the evidence and recommendations, and withdrawing the guideline.
7.Methodology for Developing Patient Guideline (3):Reporting Frameworks and Presentation
Lijiao YAN ; Ning LIANG ; Haili ZHANG ; Nannan SHI ; Ziyu TIAN ; Ruixiang WANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Yingfeng ZHOU ; Dan YANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(22):2304-2309
Standardized reporting is a crucial factor affecting the use of patient guidelines (PGs), particularly in the reporting and presentation of recommendations. This paper introduced the current status of PG reporting, including the research on PG content and presentation formats, and provided comprehensive recommendations for PG reporting from aspects such as overall framework, recommendations, presentation format, and readability. First, the presentation of PG recommendations should include clearly defined clinical questions, recommendations and their rationale, and guidance on how patients should implement the interventions; for specific content in the PG, such as level of evidence, level of recommendation, it is recommended to explain in text the reasons for giving different levels of recommendation, i.e., to present the logic behind giving the level of recommendation to the patient; additional information needed in the recommendation framework should be supplemented by tracing references or authoritative textbooks and literature that support the recommendations. Subsequently, the PG text should be written based on the Reporting Checklist for Public Versions of Guidelines (RIGHT-PVG) reporting framework. Finally, to enhance readability and comprehension, it is recommended to refer to the Patient Education Materials Assessment Tool (PEMAT) for translating PG content. To enhance the readability of PGs, it is suggested to present the PG content in a persona-lized and layered manner.
8.Methodology for Developing Patient Guideline(1):The Concept of Patient Guideline
Lijiao YAN ; Ning LIANG ; Ziyu TIAN ; Nannan SHI ; Sihong YANG ; Yufang HAO ; Wei CHEN ; Xiaojia NI ; Yingfeng ZHOU ; Ruixiang WANG ; Zeyu YU ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(20):2086-2091
Since the concept of patient versions of guidelines (PVGs) was introduced into China, several PVGs have been published in China, but we found that there is a big difference between the concept of PVG at home and abroad, and the reason for this difference has not been reasonably explained, which has led to ambiguity and even misapplication of the PVG concept by guideline developers. By analyzing the background and purpose of PVGs, and the understanding of the PVG concept by domestic scholars, we proposed the term patient guidelines (PGs). This refers to guidelines developed under the principles of evidence-based medicine, centered on health issues that concern patients, and based on the best available evidence, intended for patient use. Except for the general attribute of providing information or education, which is typical of common health education materials, PGs also provide recommendations and assist in decision-making, so PGs include both the patient versions of guidelines (PVG) as defined by the Guidelines International Network (GIN) and "patient-directed guidelines", i.e. clinical practice guidelines resulting from the adaptation or reformulation of recommendations through clinical practice guidelines.
9.Methodology for Developing Patient Guideline (2):Process and Methodology
Lijiao YAN ; Ning LIANG ; Nannan SHI ; Sihong YANG ; Ziyu TIAN ; Dan YANG ; Xiaojia NI ; Yufang HAO ; Wei CHEN ; Ruixiang WANG ; Yingfeng ZHOU ; Shibing LIANG ; Shuyu YANG ; Yujing ZHANG ; Ziteng HU ; Jianping LIU
Journal of Traditional Chinese Medicine 2024;65(21):2194-2198
At present, the process and methodology of patient guidelines (PGs) development varies greatly and lacks systematic and standardised guidance. In addition to the interviews with PG developers, we have sorted out the relevant methodology for the adaptation and development of existing clinical practice guideline recommendations and facilitated expert deliberations to achieve a consensus, so as to finally put forward a proposal for guidance on the process and methodology for the development of PGs. The development of PGs can be divided into the preparation stage, the construction stage, and the completion stage in general, but the specific steps vary according to the different modes of development of PGs. The development process of Model 1 is basically the same as the patient version of the guideline development process provided by the International Guidelines Network, i.e., team formation, screening of recommendations, guideline drafing, user testing and feedback, approval and dissemination. The developer should also first determine the need for and scope of translating the clinical practice guideline into a patient version during the preparation phase. Model 2 adds user experience and feedback to the conventional clinical practice guideline development process (forming a team, determining the scope of the PG, searching, evaluating and integrating evidence, forming recommendations, writing the guideline, and expert review). Based on the different models, we sort out the process and methods of PG development and introduce the specific methods of PG development, including how to identify the clinical problem and how to form recommendations based on the existing clinical practice guidelines, with a view to providing reference for guideline developers and related researchers.
10.Mechanism of Yantiao Fang regulating the Rho/ROCK signaling pathway in apoptosis of intestinal epithelial cells in mice with acute gastrointestinal injury caused by sepsis
Qian CHEN ; Di WANG ; Dingyi ZHANG ; Sailei JIA ; Lihui WANG ; Yujing CAO ; Xian LI ; Yanhong LI
Chinese Journal of Comparative Medicine 2024;34(2):16-24
Objective To investigate the effect of Yantiao Fang on apoptosis of intestinal epithelial cells in mice with acute gastrointestinal injury caused by sepsis by regulating the Rho/ROCK signaling pathway.Methods Seventy BALB/c mice were randomly divided into normal,sham,and model groups.Except for normal and sham groups,mice were subjected to cecal ligation and perforation to establish a mouse model of acute gastrointestinal injury caused by sepsis.The mouse models were randomly divided into model,Low,Medium,and High dose of Yantiao Fang,and ROCK inhibitor groups.Histopathological changes of the ileum were observed by HE staining.Serum levels of IL-1β,IL-6,TNF-α,and IL-10 were measured by ELISA.PCNA and Ki-67 expression was detected by immunohistochemistry.Cleaved caspase3 and Bax expression was detected by Western blot.ROCK and MLC mRNA expression in the ileum was measured by RT-qPCR.Results Compared with normal and sham groups,Chiu's pathological score,proinflammatory factor(IL-1β,IL-6,and TNF-α)levels,cleaved caspase3 and Bax protein expression,and ROCK and MLC mRNA levels were increased in the model group(P<0.05).Moreover,anti-inflammatory mediator IL-10 and expression of PCNA and Ki-67 in the ileum were decreased in the model group(P<0.05).Compared with the model group,histopathological changes of the ileum in all Yantiao Fang groups were improved by various degrees with the increase in dose.Chiu's pathological score,IL-1β,IL-6,and TNF-α serum levels,cleaved caspase3 and Bax protein expression,and ROCK and MLC mRNA levels were decreased in Yantian Fang groups(P<0.05).The IL-10 level and expression of PCNA and Ki-67 in the ileum were increased in Yantian Fang groups(P<0.05).Conclusions Yantiao Fang may inhibit apoptosis of intestinal epithelial cells in mice with acute gastrointestinal injury due to sepsis by regulating the Rho/ROCK signaling pathway,thereby alleviating intestinal tissue inflammation and ultimately preventing intestinal mucosal tissue injury.

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