1.Effectiveness of anatomical major nail implant guide in the treatment of senile intertrochanteric fracture with proximal femoral nail antirotation.
Yu-Xin YANG ; Shun-Li XU ; Xin WANG ; Cheng-Qi ZHANG ; Kai GUAN
China Journal of Orthopaedics and Traumatology 2025;38(7):668-675
OBJECTIVE:
To explore the application effect of self-developed anatomical main nail insertion guide in proximal femoral nail antirotation (PFNA) internal fixation for the treatment of intertrochanteric fractures (IFF) in elderly patients.
METHODS:
A retrospective analysis was performed on 62 patients with AO31-A2 intertrochanteric fractures who underwent PFNA surgery and met the inclusion criteria from January 2022 to December 2024. They were divided into the conventional PFNA insertion group (conventional operation group) and the anatomical main nail insertion guide-assisted PFNA insertion group(guide group). The conventional operation group (PFNA) included 31 patients, 14 males and 17 females, the age ranged from 64 to 90 with an average of (75.2±11.6) years old;the guide group (PFNA) included 31 patients, 10 males and 21 females, the age ranged fron 67 to 97 with an average of (78.6±13.4) years old. The incision length of the main nail entry, the number of fluoroscopies from satisfactory reduction to before main nail insertion, operation time, intraoperative blood loss, 3-day postoperative VAS score, postoperative hip function Harris score, complications, etc. were observed and compared between the two groups.
RESULTS:
All patients were followed up for a period ranging from 4 to 12 months, with an average follow-up duration of (6.8±1.6) months. Compared with the guide group, the conventional operation group showed significant differences in the following parameters:the entrance length of the main screw was (6.74±3.77) cm vs. (5.13±1.31) cm, the number of fluoroscopies before the insertion of the main screw was (10.32±3.08) times vs. (7.71±2.41) times, the operation time was (150.45±53.47) minutes vs. (127.48±30.37) minutes, and the intraoperative blood loss was (196.77±121.06) ml vs. (140.97±86.00) ml, with P<0.05 indicating statistical significance.There was no statistically significant difference in 3-day postoperative VAS between the two groups (P>0.05). There was a statistically significant difference in the Harris scores between the conventional operation group and the guided operation group one month post-surgery (60.61±6.60) vs. (65.48±5.19) points (P<0.05). and there was no statistically significant difference in hip Harris scores between the two groups at 3 months after operation (P>0.05). During the 3-month follow-up after operation, neither group had incision infection, screw loosening, cutting, pressure sores, deep vein thrombosis, etc., and there was no statistically significant difference in the complication rate between the two groups.
CONCLUSION
It is quickly and accurately to implant PFNA assisted by the anatomical major nail implant guide in treatment of osteoporotic intertrochanteric fracture in the elderly.Compared with the traditional operation, it can shorten the operation time and reduce the surgical and X-ray trauma, and beneficial to the rapid rehabilitation of patients.
Humans
;
Male
;
Female
;
Aged
;
Hip Fractures/surgery*
;
Bone Nails
;
Retrospective Studies
;
Aged, 80 and over
;
Middle Aged
;
Fracture Fixation, Intramedullary/instrumentation*
;
Fracture Fixation, Internal/instrumentation*
2.The Preclinical Models of Glioma Dependent on Alternative Lenthening of Telomeres (ALT) and Current Applications
Jin-Kai TONG ; Si-Xiang YAN ; Yan-Duo ZHANG ; Kai-Long HOU ; Ke ZHANG ; Hao-Nan ZHANG ; Shun CHANG ; Shu-Ting JIA
Progress in Biochemistry and Biophysics 2024;51(2):269-275
Glioma is the most common malignancy of the central nervous system, originating mainly from glial cells. Because of its highly aggressive nature, glioma has one of the highest rates of death among all types of cancer. Therefore, it is very important to develop new therapeutic approaches and drugs for glioma treatment. Instead of activate the telomerase, approximately 30% of glioma use alternative lenthening of telomere (ALT) to maintain telomere length. The mechanism of ALT development is poorly understood, however, some genetic mutations have been reported to induce the development of ALT glioma, such as ATRX, IDH1, p53, etc. The lack of ALT glioma cell lines and preclinical ALT glioma models has limited the mechanistic studies of ALT glioma. Therefore, this review listed ALT glioma cell lines that derived from primary culture or gene editing in the last decade, as well as the xenografted animal models established by ALT glioma cell lines, and discussed the role and significance these cell and animal models play in preclinical studies.
3.Study on quality evaluation of Gegen Qinlian decoction based on UHPLC fingerprint and multi-component quantification
Juan XIE ; Qi TANG ; Pan ZHANG ; Xin LI ; Kai-shun BI ; Qing LI
Acta Pharmaceutica Sinica 2024;59(8):2365-2371
Gegen Qinlian decoction has a wide range of clinical applications. However, there is a lack of systematic quality evaluation methods to ensure the safety and effectiveness of Gegen Qinlian decoction in clinical use. The UHPLC fingerprint and multi-component determination method of Gegen Qinlian decoction were established to provide scientific basis for the quality control and evaluation of Gegen Qinlian decoction. The chromatography was performed on a ZORBAX Eclipse Plus-C18 column (150 mm × 4.6 mm, 3.5 μm) with mobile phase consisted of acetonitrile (A) - 20 mmol·L-1 ammonium acetate (containing 0.8% acetic acid and 0.5% triethylamine) (B) and gradient elution at a flow rate of 1.0 mL·min-1. The column temperature was 25 ℃, the detection wavelength was 260 nm, the fingerprint of 10 batches of Gegen Qinlian decoction was determined, and the similarity evaluation system of TCM chromatographic fingerprint was used for comprehensive analysis, and 9 components were quantitatively analyzed. In the fingerprint study of Gegen Qinlian decoction, a total of 18 peaks were obtained, 12 of which were identified by reference substances. Moreover, the similarity of 10 batches of Gegen Qinlian decoction was good, and all of them were greater than 0.99. In the multi-component quantitative analysis, the linear relationship between the nine components and the peak area was good (
4.Effects of Compound Danshen Dripping Pills on Ventricular Remodeling and Cardiac Function after Acute Anterior Wall ST-Segment Elevation Myocardial Infarction (CODE-AAMI): Protocol for a Randomized Placebo-Controlled Trial.
Yu-Jie WU ; Bo DENG ; Si-Bo WANG ; Rui QIAO ; Xi-Wen ZHANG ; Yuan LU ; Li WANG ; Shun-Zhong GU ; Yu-Qing ZHANG ; Kai-Qiao LI ; Zong-Liang YU ; Li-Xing WU ; Sheng-Biao ZHAO ; Shuang-Lin ZHOU ; Yang YANG ; Lian-Sheng WANG
Chinese journal of integrative medicine 2023;29(12):1059-1065
BACKGROUND:
Ventricular remodeling after acute anterior wall ST-segment elevation myocardial infarction (AAMI) is an important factor in occurrence of heart failure which additionally results in poor prognosis. Therefore, the treatment of ventricular remodeling needs to be further optimized. Compound Danshen Dripping Pills (CDDP), a traditional Chinese medicine, exerts a protective effect on microcirculatory disturbance caused by ischemia-reperfusion injury and attenuates ventricular remodeling after myocardial infarction.
OBJECTIVE:
This study is designed to evaluate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function after AAMI on a larger scale.
METHODS:
This study is a multi-center, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The total of 268 patients with AAMI after primary percutaneous coronary intervention (pPCI) will be randomly assigned 1:1 to the CDDP group (n=134) and control group (n=134) with a follow-up of 48 weeks. Both groups will be treated with standard therapy of ST-segment elevation myocardial infarction (STEMI), with the CDDP group administrating 20 tablets of CDDP before pPCI and 10 tablets 3 times daily after pPCI, and the control group treated with a placebo simultaneously. The primary endpoint is 48-week echocardiographic outcomes including left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume index (LVEDVI), and left ventricular end-systolic volume index (LVESVI). The secondary endpoint includes the change in N terminal pro-B-type natriuretic peptide (NT-proBNP) level, arrhythmias, and cardiovascular events (death, cardiac arrest, or cardiopulmonary resuscitation, rehospitalization due to heart failure or angina pectoris, deterioration of cardiac function, and stroke). Investigators and patients are both blinded to the allocated treatment.
DISCUSSION
This prospective study will investigate the efficacy and safety of CDDP in improving ventricular remodeling and cardiac function in patients undergoing pPCI for a first AAMI. Patients in the CDDP group will be compared with those in the control group. If certified to be effective, CDDP treatment in AAMI will probably be advised on a larger scale. (Trial registration No. NCT05000411).
Humans
;
ST Elevation Myocardial Infarction/therapy*
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Stroke Volume
;
Ventricular Remodeling
;
Prospective Studies
;
Microcirculation
;
Ventricular Function, Left
;
Myocardial Infarction/etiology*
;
Treatment Outcome
;
Percutaneous Coronary Intervention/adverse effects*
;
Heart Failure/drug therapy*
;
Drugs, Chinese Herbal/therapeutic use*
;
Randomized Controlled Trials as Topic
;
Multicenter Studies as Topic
5.Methodology and application of process analytical technology (PAT) for traditional Chinese medicine manufacturing:a review.
Hao-Shu XIONG ; Qiang ZHANG ; Shun-Nan ZHANG ; Jin-Yong CAI ; Jing SU ; Yong-Hong ZHU ; Kai-Jing YAN
China Journal of Chinese Materia Medica 2023;48(1):22-29
Owing to the advancement in pharmaceutical technology, traditional Chinese medicine industry has seen rapid development. Preferring conventional manufacturing mode, pharmaceutical enterprises of traditional Chinese medicine have no effective process detection tools and process control methods. As a result, the quality of the final products mainly depends on testing and the quality is inconsistent in the same batch. Process analytical technology(PAT) for traditional Chinese medicine manufacturing, as one of the key advanced manufacturing techniques, can break through the bottleneck in quality control of medicine manufacturing, thus improving the production efficiency and product quality and reducing the material and energy consumption. It is applicable to the process control and real-time release of advanced manufacturing modes such as intelligent manufacturing and continuous manufacturing. This paper summarized the general idea of PAT for traditional Chinese medicine manufacturing. Through the analysis of the characteristics and status quo of the technology, we summed up the methodology for the continuous application and improvement of PAT during the whole life-cycle of traditional Chinese medicine. The five key procedures(process understanding, process detection, process modeling, process control, and continuous improvement) were summarized, and the application was reviewed. Finally, we proposed suggestions for the technical and regulatory challenges in implementing PAT in traditional Chinese medicine industry. This paper aims to provide a reference for development and application of PAT in advanced manufacturing, intelligent manufacturing, and continuous manufacturing of traditional Chinese medicine industry.
Medicine, Chinese Traditional
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Drugs, Chinese Herbal
;
Technology, Pharmaceutical
;
Drug Industry
;
Quality Control
6.Research on batch-to-batch quality control of compound Danshen extract based on physical characterization and multivariate statistical analysis.
Hao-Shu XIONG ; Yao-Yao LI ; Kai-Xuan ZHANG ; Wan-Shun ZHAO ; Chen-Ming LI ; Jin-Yong CAI ; Jing SU ; Yong-Hong ZHU ; Kai-Jing YAN
China Journal of Chinese Materia Medica 2022;47(9):2465-2473
Physical attributes of Chinese herbal extracts are determined by their chemical components, and the physical and chemical attributes jointly affect the preparation process performance and the final product quality. Therefore, in order to improve the quality control of Chinese herbal extracts, we should comprehensively study the batch-to-batch consistency of physical and chemical attributes as well as the correlations between them. This paper first explored the physical attributes affecting the preparation process performance of the compound Danshen extract and developed a method for characterizing the texture attributes. With such main chemical components as water, phenolic acids, saponins, and saccharides and texture, rheology, and other physical attributes taken into consideration, the batch-to-batch quality fluctuation of products from different production lines and time was analyzed by principal components analysis(PCA). Finally, the correlation and partial least squares(PLS) analysis was conducted, and the regression equation was established. The fitting result of the PLS model for dynamic viscosity was satisfying(R~2Y=0.857, Q~2=0.793), suggesting that the chemical components could be adjusted by the component transfer rate in the extraction process, the impurity removal rate in the alcohol precipitation process, and the water retention rate of the concentration process to meet the control of the extract dynamic viscosity. This study clarified the correlations between physical and chemical attributes of the compound Danshen extract and established a method for controlling its physical attributes based on process regulation, which would provide reference for improving the quality control of Chinese herbal extracts.
Drugs, Chinese Herbal/chemistry*
;
Quality Control
;
Salvia miltiorrhiza/chemistry*
;
Water
7.Research progress on chemical constituents and pharmacological activities of seabuckthorn and prediction of its Q-markers.
Ning-Ning WANG ; Wen-Hui ZHENG ; Kai-Xue ZHANG ; Xiu-Feng WEN ; Shun-Guang LU ; Zhi-Gang YANG
China Journal of Chinese Materia Medica 2021;46(21):5522-5532
Seabuckthorn contains flavonoids, tannins, terpenoids, polysaccharides, and vitamins, which have anti-inflammation,anti-oxidation, liver protection, anti-cardiovascular disease, anti-aging, immune enhancing, anti-tumor, and anti-bacterial activities.We reviewed the papers focusing on the chemical constituents, pharmacological activities, and utilization of seabuckthorn. The quality markers(Q-markers) of seabuckthorn were predicted and analyzed based on original plant phylogeny, chemical composition correlation, traditional medicinal properties, pharmacodynamic correlation, traditional and extended efficacy, pharmacokinetics, metabolic processes, and measurable components. With this review, we aim to provide theoretical reference for the quality control and quality standard establishment of seabuckthorn, so as to promote the rational exploitation and utilization of seabuckthorn resources, and improve the healthy and sustainable development of seabuckthorn industry.
Anti-Inflammatory Agents
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Biomarkers
;
Drugs, Chinese Herbal
;
Flavonoids
;
Hippophae
8.Research on feedforward control method of mixing process for compound Danshen Dripping Pills based on quality by design(QbD).
Yao-Yao LI ; Kai-Xuan ZHANG ; Hao-Shu XIONG ; Wan-Shun ZHAO ; Ming-Yue HAN ; Kai-Jing YAN ; Shun-Nan ZHANG
China Journal of Chinese Materia Medica 2021;46(11):2816-2823
The mixing process is one of the key operation units for solid preparation of traditional Chinese medicine. The physical properties such as particle size, density and viscosity of the mixture are key factors that need to be controlled, which will directly affect the performance of the preparation molding process and product quality. Subsequent dripping process performance and appearance qua-lity of dripping pills will be affected by dynamic viscosity of materials in the mixing process. Based on this, with mixing process of compound Danshen dripping pills as the object, a feedforward control method for the dripping pill mixing process was established based on the concept of quality by design(QbD). Firstly, critical quality attribute(CQA)-dynamic viscosity, critical material attributes(CMAs)-the moisture content of compound Danshen extract, average molecular weight of polyethylene glycol 6000 and critical process parameter(CPP)-mixing temperature were identified through the analysis of properties for multiple batches of the raw materials and excipients as well as technological mechanism. Then the Box-Behnken experimental design was used to establish the regression model among CMA, CPP and CMA(R■=0.972 0, RMSE =16.24) to obtain the design space. Finally, through the verification of three batches within the design space, the mixing process temperature was adjusted according to the properties of the raw materials and exci-pients to achieve accurate control of the dynamic viscosity attribute. The relative deviation between the actual dynamic viscosity value and the target value was less than 3.0 %. The feedforward control of the mixing process of compound Danshen dripping pills was rea-lized in this study, which can contribute to improving quality consistency of the mixing process intermediates, simultaneously provide a reference for the research on the process quality control of other Chinese medicine dripping pills.
Drugs, Chinese Herbal
;
Medicine, Chinese Traditional
;
Quality Control
;
Research Design
9. Resveratrol inhibits advanced glycation end products induced PC12 cell apoptosis through ROS-JNK pathway
Lei JIANG ; Guo-Jun ZHANG ; Lei JIANG ; Guo-Jun ZHANG ; Lei JIANG ; Rui ZHANG ; Shun-Jiang XU ; Yan-Chao LU ; Jia-Kai ZHANG ; Guo-Jun ZHANG
Chinese Pharmacological Bulletin 2021;37(8):1104-1109
Aim To investigate the effect of resveratrol (RSV)on apoptosis of PC 12 cells induced by advanced glycation end products(AGEs) and its possible molecular mechanism. Methods MTS assay was used to detect the effects of AGEs (0, 50, 100, 200, 400 g • L"1) and RSV (0, 5, 10, 20, 40 jxmol • L"1) on cell viability. PC12 cells were treated with AGEs (400 g • L-1) and RSV (10 |xmol • L"1). TUNEL staining was used to detect apoptosis; flow cytometry was used to detect apoptosis and reactive oxygen species (ROS) ; Western blot was used to detect protein expression of p-JNK, JNK, PUMA, Bcl-2, Bax and Caspase-3. Apoptosis was observed by flow cytometry after pretreat- ment with JNK specific phosphorylation inhibitor (sp600125). Results Compared with normal control group, the cell viability of AGEs group decreased, the apoptotic rate and ROS levels increased, the expressions of p-JNK, PUMA, Bax and Caspase-3 protein in-creased, the expression of Bcl-2 protein decreased; Compared with AGEs group, the cell viability of the AGEs + RSV group increased, the levels of apoptotic rate and ROS were reduced, the expressions of p-JNK, PUMA, Bax and caspase-3 protein decreased, the expression of Bcl-2 protein increased. Sp600125 could partially reverse the effect of AGEs on PC)2 cell apopto-sis. Conclusions RSV can significantly inhibit the apoptosis of PC 12 cells induced by AGEs, which may be related to the activation of ROS-JNK pathway.
10.Application Progress of Texture Analyzer in Pharmaceutical Preparation Research
Yao-yao LI ; Kai-xuan ZHANG ; Hao-shu XIONG ; Shun-nan ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2020;26(21):226-234
Texture analyzer is a multifunctional physical property analyzer. Through a variety of test modes such as compression, puncture, shearing and stretching, hardness, adhesion, elasticity, cohesiveness and other physical property parameters are characterized. The results are objective, sensitive, and accurate, which can provide theoretical basis and reference for interpretation of basic theoretical, optimization of prescription technology and quality control research of pharmaceutical preparations. Firstly, the principles, test modes, measurement indexes and measurement data analysis methods of texture analyzer were summarized in this paper. Secondly, the application progress of texture analyzer in solid preparations, semi-solid preparations, liquid preparations, traditional Chinese medicine decoction pieces and their intermediates was described in detail, and compared with the commonly used measurement methods of physical property indicators. Finally, the application prospects of texture analyzer and its research contents to be improved were reviewed, so as to facilitate the use of texture analyzer by pharmaceutical researchers to promote the development of related fields of pharmaceutics, and to provide new ideas and methods for the research and development of pharmaceutical preparations.

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