1.Phase Ⅱ clinical trial of Shixinyatong buccal tablets in the treatment of gastropyretic toothache(pericoronitis)
Junzheng WU ; Yuancong LI ; Kaijin HU ; Xianchun BO ; Desheng WEN ; Sumin GUAN
Journal of Practical Stomatology 2009;25(6):865-871
Objective: To study the effects and safety of Shixinyatong buccal tablets in the treatment of gastropyretic toothache (perico-ronitis). Methods: Randemized, double-blinded, double-imitated, parallel-controlled and multi-center clinical study was employed. 120 cases of gastropyretic toothache (pericoronitis) was enrolled in the experimental group( SBT group) and another 120 in control group(CBD group). Pericoronal pocket rinsing was performed for each case at the first visit, then the patients in SBT group were treated by Shixin buccal tablets(SBT) , 0. 6 g×2, 4/d and oral adiministration of the vehicle of cow-bezoare detoxicating tablets,0.3 g×3, 3/ d. The patients in CBD group were treated by oral adiministration of cow-bezoare detoxicating tablets ( SBD), 0. 3 g×3, 3/d and the vehicle of SBT, 0.6 g ×2, 4/d respectively. Pain, gingiva contagious tumefaction, pyorrhea of periocoronal pocket and limitation of mouth opening were scored by 0, 2, 4 and 6 as the major physical signs and symptoms(MAS); periocoronal flap and pocket, facial swelling, hot and foul breath, costipation, lymphadenectasis, thirsty and desire of cold drinks, fever by 0, 1,2 and 3 as the minor (MIS). Treatment was continued for 5 days and data were statistically analysed with SAS6. 12 software. Significant effectiveness was i-dentified by the decrease of total score of all the physical signs and symptoms(TS) ≥70% .effectiveness 30%~69% and ineffectiveness ≤29%. Routine examinations of blood, urine and stool, function of liver and kidney and electrocardiogram were conducted before and after treatment. Adverse events(AE) were observed. Results: 3 cases divorced from SBT group and 2 from CBD group. The demographic data and all the scores before treatment were not statistically different between groups (P>0.05). 3 and 5 days after treatment theTS, TSMA and TSMI were decreased(P= 0.000) in both groups, in SBT group decreased more than in CBD(P<0.001). Significant effectiveness ratio of SBT group was higher than that of CBD (P=0. 000). 5 days after treatment TS of MASs and the scores of each MAS in SBT group decreased more than in CBD( P<0.05). Vital signs were in normal range and not statisticaly different between groups(P>0.05). The clinical lab examinations showed no abnormal changes. Drug-related AE were observed in 3 cases, 1 with moderate AE in SBT group recovered after drug withdrawal, 2 with mild AE in CBD group recovered without aditional treatment. Conclusion; Shixinyatong buccal tablet is more effective in the treatment of gastropyretic toothache (pericoronitis) than cow-bezoare detoxicating tablets and with similar safety.
2.Comparison of 3D conformal radiotherapy with conventional radiotherapy in gliomas on dosimetry and prognosis
Yun SHU ; Hongyun WANG ; Minfa YE ; Yanling WU ; Liming TAO ; Xianchun HU ; Cailiang ZOU
Chongqing Medicine 2013;(23):2710-2711,2714
Objective In contrast to conventional radiotherapy ,analyze the dosimetry and prognosis of 3D conformal radiothera-py in the treatment of gliomas with different pathological stages .Methods 97 patients with gliomas were selected ,and divided into two groups as conventional radiotherapy group (CR group) and 3D conformal radiotherapy group(3D group) .analyzed the influence of different radiotherapy to the gliomas in the same pathological stage .Compared the dosimetry differences between these two radio-therapies .Results There was no obvious differences in 3 year survival rate between CR group and 3D group at low grade gliomas . But 3D group had better 3 year survival rate than CR group at high grade gliomas .And 3D group had lower rate of relevant sequel after radiotherapy .3D group had higher conformal index (CI) and average dosage of radiation than CR group .Conclusion 3D radio-therapy has better dosimetry and conformal index than conventional radiotherapy ,especially has better prognosis in high grade glio-mas and lower rate of relevant sequel after radiotherapy .
3.Multi-center clinical trial of Rongxin Pills in treating viral myocarditis in children with deficiency of both qi and yin and heart meridian stasis syndrome
Shuai FAN ; Hong CUI ; Siyuan HU ; Hong LIU ; Jie SHEN ; Xianchun DING ; Honghua KUANG ; Shunyi SONG ; Wei ZHANG
Drug Evaluation Research 2017;40(1):68-74
Objective To observe Rongxin Pills in the treatment of viral myocarditis in children (deficiency of both qi and yin and heart meridian stasis syndrome) and the effectiveness and clinical application of safety.Methods Viral myocarditis patients (280 cases,deficiency of both qi and yin and heart meridian stasis syndrome),according to 3:1 ratio as the test group (n =21 0) and control group (n =70).The test group took orally Rongxin pills each time 4.5~9 g,3 times daily;the control group oral coenzyme Q10 capsule each time 10 ~ 20 mg,twice daily.The course of treatment was 28 d.The experiment was carried out with the random and double blind method.The symptoms of myocarditis,integrated and electrocardiogram,echocardiography,myocardial enzymes,as well as the efficacy of traditional Chinese medicine and improvement of the effect of the disease were observed.Results The results of FAS (PPS) analysis showed that 28 d after treatment,the symptom score and mean of experimental group and control group were 5.975 (6.000) and 4.721 (4.788).The syndromes of the total effective rates were 91.62% (90.59%) and 70.59% (71.21%),curative effect the total effective rates were 90.14% (92.08%) and 72.06% (72.73%).The total effective rate of experimental group was higher than that of the control group,the difference was statistically significant.In this experiment,three cases of clinical adverse events were reported,which were not related to the experimental drug.It also not belongs to adverse drug reactions.Conclusion Rongxin Pill in the treatment of viral myocarditis in children (deficiency of both qi and yin and heart meridian stasis syndrome) is more effective than coenzyme Q 10 capsule,and there was no indication of higher risk of clinical application.
4.Lipid-lowering efficacy and safety of varying doses of Simvastatin in patients with early stage acute coronary syndromes: one-year follow-up study.
Yangchun ZOU ; Dayi HU ; Xianchun YANG ; Zhimin XU ; Liang CUI ; Xiaohui LIU ; Yu WEI ; Mingming GAO
Chinese Medical Journal 2003;116(6):853-856
OBJECTIVETo investigate whether patients, who are at risk of major acute coronary events, are safe to undergo and benefit from early intervention after using simvastatin.
METHODSThe study was a randomized, open, two-dosage-controlled trial to evaluate the safety and benefits of simvastatin administered to 197 patients (10 mg group, n = 98 and 20 mg group, n = 99), within 48 hours of hospitalization for a diagnosis of unstable angina or acute myocardial infarction (MI), with total cholesterol (TC) >/= 180 mg/dL or low-density lipoprotein cholesterol (LDL-C) >/= 100 mg/dL. Lipid levels were measured immediately, followed by the 3rd, 6th and 12th month after admission and all adverse events were recorded during follow-up.
RESULTSTC levels fell by 10.15% and 14.52% in the 10 mg and 20 mg groups (P < 0.05), and LDL-C levels fell 13.87% and 19.38% in the 10 mg and 20 mg groups, respectively (P < 0.01), 12 months after using simvastatin. The rates of achieving target TC reached 26.3% and 36.5% in the 10 mg and 20 mg groups (P < 0.01), and that of LDL-C reached 28.2% and 40.3% in the 10 mg and 20 mg groups, respectively (P < 0.01). There were higher rates of MI and re-hospitalization resulting from angina pectoris and revascularization in the 10 mg group compared with the 20 mg group.
CONCLUSIONSThe results suggest that early intervention with the HMG-CoA reductase inhibitor, simvastatin, in acute coronary syndromes is possible and safe. It also indicates that the clinical dosage of simvastatin are relatively smaller than that for satisfactory lipid control in patients with acute coronary syndromes.
Acute Disease ; Aged ; Cholesterol ; blood ; Cholesterol, LDL ; blood ; Coronary Disease ; blood ; drug therapy ; Female ; Follow-Up Studies ; Humans ; Hypolipidemic Agents ; therapeutic use ; Male ; Middle Aged ; Simvastatin ; therapeutic use
5.Clinical value of peripheral regulatory cells in patients with non-small cell lung cancer undergoing radiotherapy
Jun YI ; Liming TAO ; Fan WANG ; Xianchun HU ; Li LIU
Chinese Journal of Clinical Oncology 2019;46(2):77-82
Objective: To investigate the predictive value of peripheral regulatory T cells, NK cells, and T lymphocyte subsets in patients with non-small cell lung cancer (NSCLC) receiving radiotherapy. Methods: From January 2016 to December 2017, 105 patients with NSCLC and 45 healthy volunteers were enrolled in the study. Sixty-two patients were newly diagnosed, and 43 patients had relapsed. The lymphocyte subsets of patients with NSCLC were examined in fasting peripheral venous blood samples, and the influencing factors of progression-free survival were analyzed through univariate and multivariate analyses. Results: Compared with the healthy control group, the proportion of CD4+CD25+Foxp3+regulatory T cells in NSCLC patients was significantly higher (P<0.05); the high expression of CD4+CD25+Foxp3+regulatory T cells in recurrent NSCLC patients was further confirmed compared with the newly diagnosed patients. CD19+B cells, CD4+cells and the ratio of CD4/CD8 was significantly decreased and CD8+T cells as well as CD8+CD28-T cells were signifi-cantly increased in NSCLC patients (P<0.05). There was no significant difference in NK, NKT, γδT, CD3+, and CD8+CD28+T cells between patients and controls (P>0.05). In 40 patients with recurrence, the number of regulatory T cells increased compared with that in pa-tients with relapse, and the proportion of CD4+T cells and ratio of CD4/CD8 decreased. The difference was statistically significant (P<0.05). The high proportion of regulatory T cells was associated with progression-free survival [hazard ratio (HR)=2.55, 95% confidence interval (CI): 1.07 to 6.11, P=0.019]. There was no significant association between other lymphocyte subsets and progression-free sur-vival. In addition to lymphocyte subsets, the neutrophil/lymphocyte ratio was negatively correlated with progression-free survival (HR=2.66, 95%CI: 1.01 to 7.05, P=0.033). There was a positive correlation between lymphocyte and progression-free survival (HR=0.42, 95% CI: 0.17 to 1.03, P=0.042). According to clinicopathological features, the degree of tumor differentiation, T stage, and N stage in NSCLC patients were related to clinical prognosis (P<0.05). Multivariate analysis showed that the independent factors affecting progression-free survival were CD4+CD25+Foxp3+regulatory T cells and N stage (P<0.05). The proportion of regulatory T cells in patients with dis-ease progression was significantly higher than that in patients with stable disease, partial remission, and complete remission (P<0.05). The diagnostic efficacy of peripheral CD4+CD25+Foxp3+regulatory T cells in predicting progression-free survival in patients with NSCLC was analyzed using a receiver-operating characteristic curve (ROC) with an area under the curve of 0.915. When the optimal threshold was 2.85, the predictive sensitivity of peripheral CD4+CD25+Foxp3+regulatory T cells for progression-free survival in NSCLC patients was 87.7% and the specificity was 71.4%. Conclusions: CD4+CD25+Foxp3+regulatory T cells in crease in the peripheral blood of patients with NSCLC receiving radiotherapy and play as an independent factor in the progression of NSCLC. CD4+CD25+Foxp3+regulatory T cells can predict the prognosis of patients with NSCLC.
6.Three-dimensional finite element study of mandibular first molar distalization with clear aligner.
Fujia KANG ; Lei YU ; Qi ZHANG ; Xinpeng LI ; Zhiqiang HU ; Xianchun ZHU
West China Journal of Stomatology 2023;41(4):405-413
OBJECTIVES:
This study aimed to construct the finite element model of the mandibular first molar with the invisible appliance and explore the dentition movement characteristics of the mandibular first molar when using micro-implant anchorage and different initial positions of the first molar.
METHODS:
Models of the mandible, tooth, periodontal membrane, and invisible appliance were constructed using cone beam computed tomography (CBCT) data. The two groups were divided into the non-anchorage group and the micro-implant group (between the roots of the first molar and the second molar) based on whether the elastic traction of the micro-implant was assisted or not. The two groups were divided into the following conditions based on the starting position of the first molar: Working condition 1: the distance between the first molar and the second premolar was 0 mm; working condition 2: the distance between the first molar and the second premolar was 1 mm; working condition 3: the distance between the first molar and the second premolar was 2 mm; working condition 4: the distance between the first molar and the second premolar was 3 mm. The data characte-ristics of total displacement and displacement in each direction of dentition were analyzed.
RESULTS:
In the non-ancho-rage group, all the other teeth showed reverse movement except for the first molar which was moved distally. Meanwhile, in the micro-implant group, except for a small amount of mesial movement of the second molar in wor-king condition 1, the whole dentition in other working conditions presented distal movement and anterior teeth showed lingual movement, among which the distal displacement of the first molar in working condition 4 was the largest. With the change of the initial position of the first molar to the distal, the movement of the first molar to the distal, the premolar to the mesial, and the anterior to the lip increased, while the movement of the second molar to the mesial decreased.
CONCLUSIONS
The micro-implant can effectively protect the anterior anchorage, increase the expression rate of molar distancing, and avoid the round-trip movement of the second molar. The initial position of the first molar movement is related to the amount of distancing and the remaining tooth movement.
Finite Element Analysis
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Molar
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Bicuspid
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Periodontal Ligament
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Tooth Movement Techniques/methods*
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Orthodontic Appliances, Removable
7.The construction of nasal cavity-mimic M-cell model, design of M cell-targeting nanoparticles and evaluation of mucosal vaccination by nasal administration.
Xiaotong YANG ; Xianchun CHEN ; Ting LEI ; Lin QIN ; Yang ZHOU ; Chuan HU ; Qingfeng LIU ; Huile GAO
Acta Pharmaceutica Sinica B 2020;10(6):1094-1105
In order to better evaluate the transport effect of nanoparticles through the nasal mucosa, an nasal cavity-mimic model was designed based on M cells. The differentiation of M cells was induced by co-culture of Calu-3 and Raji cells in invert model. The ZO-1 protein staining and the transport of fluorescein sodium and dexamethasone showed that the inverted co-culture model formed a dense monolayer and possessed the transport ability. The differentiation of M cells was observed by up-regulated expression of Sialyl Lewis A antigen (SLAA) and integrin 1, and down-regulated activity of alkaline phosphatase. After targeting M cells with iRGD peptide (cRGDKGPDC), the transport of nanoparticles increased. , the co-administration of iRGD could result in the increase of nanoparticles transported to the brain through the nasal cavity after intranasal administration. In the evaluation of immune effect , the nasal administration of OVA-PLGA/iRGD led to more release of IgG, IFN-, IL-2 and secretory IgA (sIgA) compared with OVA@PLGA group. Collectively, the study constructed M cell model, and proved the enhanced effect of targeting towards M cell with iRGD on improving nasal immunity.