1.Clinical Effectiveness and Safety of Bairui Granules (百蕊颗粒) in Treating Patients with Acute Pharyngitis with Wind-Heat Syndrome: A Multi-Center, Double-Blind, Double-Simulation, Randomized Controlled Trial
Siming LIU ; Hui ZHOU ; Qiang LI ; Min ZHOU ; Qixiang WU ; Shanjun YANG ; Jun WANG ; Jingjing YUAN ; Ying ZHANG ; Ziqi ZHU ; Jingyi HU ; Shuang WU ; Mengting LI ; Zhanfeng YAN
Journal of Traditional Chinese Medicine 2024;65(11):1139-1145
ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules (百蕊颗粒) in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter, double-blind, double-simulation, randomised controlled trial was conducted, in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited, and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group, 108 cases were orally administered with Bairui Granules plus Reyanning Granules (热炎宁颗粒) simulant, and in the control group, 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days, with a follow-up visit on the 6th day. Full analysis set (FAS) analysis and per protocol set (PPS) were used for analysis, respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment; the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment, as well as the visual analogue score (VAS) of sore throat before treatment, every day during the treatment, and follow-up on day 6, and the traditional Chinese medicine (TCM) syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6, and the changes of vital signs, blood routine, urine routine, liver functions, kidney function, the adverse events before and after the treatment were recorded, and safety analysis set (SS) was analysed. Results162 patients entered the FAS and SS analyses, and 158 cases (105 cases in the trial group and 53 cases in the control group) entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% (87/108) in the trial group and 64.81% (35/54) in the control group, and the difference between groups was statistically significant (χ2 = 5.10, P = 0.0239). PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% (84/105) in the trial group and 64.15% (34/53) in the control group, and the difference between groups was statistically significant (χ2 =4.85, P = 0.0277). FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant (P>0.05). Compared with those before treatment, the VAS scores of sore throat were lower in both groups during treatment on day 2, 3, 4, 5, and follow-up on day 6 (P<0.01), but the difference between groups at each time point was not statistically significant (P>0.05). TCM syndrome scores of both groups at the follow-up were lower than that before treatment, and those of the trial group were lower than those of the control group (P<0.01). The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group (P<0.01). There was no significant difference in blood routine, urine routine, liver function, kidney function between groups before and after treatment (P>0.05), and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome, and it could significantly improve the clinical symptoms, accelerate the disappearance time of sore throat with good safety.
2.A review on application of Global Leadership Initiative on Malnutrition criteria at home and abroad
Shanjun TAN ; Mingyue YAN ; Junjie WANG ; Guohao WU
Chinese Journal of Clinical Nutrition 2022;30(1):53-60
Malnutrition is closely related to clinical outcomes and accurate evaluation of nutritional status is the cornerstone of nutritional therapy. However, consistent diagnostic criteria for malnutrition have been absent for quite a long period. The Global Leadership Initiative on Malnutrition (GLIM) criteria were introduced in September 2018 and served as a consensus-based evaluation tool. As per GLIM criteria, evaluation of malnutrition should follow a two-step approach with nutritional screening as the first step and then malnutrition diagnosis assessment and severity grading based on etiologic as well as phenotypic metrics. Since debut, GLIM criteria have been applied in different countries, healthcare settings and populations, showing good accuracy and prognostic value for outcomes such as complications and survival. However, most of the studies are retrospective in nature and high-quality prospective studies are needed to better validate GLIM criteria. The way to steer nutritional interventions based on GLIM criteria is also worth future investigation.
3.Predictive factors for prepatellar subfascial gas in patients with closed patellar fracture and their impacts on early infection following internal fixation
Xiaolong LIN ; Liming WANG ; Fei YAN ; Jianfei GE ; Shanjun NI ; Weiping SHA ; Shoujin TIAN
Chinese Journal of Orthopaedic Trauma 2022;24(7):610-616
Objective:To explore the predictive factors for prepatellar subfascial gas in patients with closed patellar fracture and their impacts on the early infection following internal fixation.Methods:A retrospective analysis was performed in the 148 patients with closed patellar fracture who had been treated at Department of Orthopaedic Surgery, Zhangjiagang Hospital Affiliated to Soochow University from January 2018 through December 2021. All patients underwent preoperative three-dimensional CT examination of the knee joint and was treated by open reduction and internal fixation of patellar fractures. According to the presence or absence of gas in the prepatellar fascia, the patients were divided into 2 groups. In the gas group of 18 patients, there were 12 males and 6 females with an age of (58.3±14.5) years; in the gas-free group of 130 patients, there were 57 males and 73 females with an age of (60.5±14.6) years. The risk factors for prepatellar subfascial gas were screened out by comparing the gender, age, body mass index, injury mechanism, AO/OTA classification, diabetes, primary hypertension, neutrophil percentage, lymphocyte percentage, white blood cell count, neutrophil count, lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, procalcitonin, and albumin before operation between the 2 groups. A receiver operating characteristic (ROC) curve for risk factors were made to identify the best screening points. The impacts of prepatellar subfascial gas were analyzed on early infection after internal fixation.Results:The preoperative neutrophil percentage was the risk factor for prepatellar subfascial gas ( P<0.05). The area under the ROC curve of preoperative neutrophil percentage for prediction of prepatellar subfascial gas was 0.700 (95% CI: 0.554 to 0.847), the optimal critical value was 78.45%, and the sensitivity and specificity were 0.556 and 0.831, respectively ( P=0.006). In the gas group, the incidence of early postoperative infection was insignificantly higher ( P=0.058) , but the time for postoperative antibiotic use was significantly longer and the dressing changes were significantly more frequent than those in the gas-free group ( P<0.05). Conclusions:In patients with closed patellar fracture, preoperative neutrophil percentage >78.45% can be used as an effective non-imaging indicator for prepatellar subfascial gas. A patient with prepatellar subfascial gas could be more prone to early postoperative infection.
4.Correlation between corneal neuropathy and ocular surface flora in type 2 diabetes
Tian CHANG ; Limin WANG ; Shanjun GAO ; Pingping WANG ; Huijuan YUAN
Chinese Journal of Endocrinology and Metabolism 2021;37(6):534-541
Objective:To explore the changes of corneal neuropathy and ocular surface flora in patients with type 2 diabetes, and the correlation between corneal neuropathy and ocular surface flora changes.Methods:According to the results of fundus fluorescein angiography, 65 patients with type 2 diabetes (130 eyes in total) who were treated with insulin alone and without comorbid retinopathy in the Department of Endocrinology, Henan People′s Hospital from March to June 2019 were selected. Sixty-five age-matched normal glucose tolerance subjects (130 eyes in total) were also enrolled. Confocal microscopy was performed and conjunctival sac secretions were collected. Through 16S rRNA analysis and sequencing and PICRUSt bacterial gene function prediction, the relationship between patients with type 2 diabetes and the difference in the degree of corneal neuropathy and the composition of ocular surface flora and function prediction in healthy people were explored, and the correlation between corneal neuropathy and ocular surface flora was analyzed as well.Results:Compared with healthy people, patients with type 2 diabetes have more severe corneal neuropathy, and it was related to the changes in ocular surface flora. Brevibacillus and paenibacillus were significantly positively correlated with the degree of corneal neuropathy ( P<0.05), and enhydrobacter and proteobacteria were significantly negatively correlated with the degree of corneal neuropathy ( P<0.05). PICRUSt analysis showed that the degree of enrichment of metabolism-related genes in the ocular surface flora of patients with type 2 diabetes was significantly changed compared with healthy people. Conclusion:Patients with type 2 diabetes present with more severe corneal neuropathy. The diversity of ocular surface flora and metabolic function have significant changes. The degree of severity corneal neuropathy is related to brevibacillus, paenibacillus, enhydrobacter, and proteobacteria.
5.Highlights of the European Society for Clinical Nutrition and Metabolism 2021 virtual congress
Yanni ZHANG ; Junjie WANG ; Hao LIU ; Shanjun TAN ; Guohao WU
Chinese Journal of Digestive Surgery 2021;20(11):1167-1172
The European Society for Clinical Nutrition and Metabolism held the 43 rd annual academic conference online from September 9 to 14,2021. Based on reports from the con-ference, the authors launched a review on the current hot topics in clinical nutrition.
6.Study on the composition of ocular surface bacteria in patients with type 2 diabetes mellitus
Limin WANG ; Tian CHANG ; Shanjun GAO ; Hongcai SHI ; Huijuan YUAN
Chinese Journal of Endocrinology and Metabolism 2020;36(7):572-578
Objective:To analyze the differences of ocular surface bacteria between patients with type 2 diabetes and healthy subjects, and to explore the relationship between ocular surface bacteria and type 2 diabetic keratopathy.Methods:Fifty subjects were selected and divided into type 2 diabetes group and healthy control group. Bacterial culture of conjunctival sac secretion was conducted and 16S rRNA sequencing was performed to analyze the difference in the composition of ocular surface bacteria between patients with type 2 diabetes and healthy subjects.Results:There were significant differences in the diversity of ocular surface bacteria between patients with type 2 diabetes and healthy subjects. The species of bacillus brevis and paenibacillus in type 2 diabetes group were significantly higher than those of the healthy control group, while the species of aquatic bacteria were lower.Conclusion:The differences in the composition of ocular surface bacteria may be related to type 2 diabetes mellitus.
7.Influence of ticagrelor on levels of serum high sensitive C reactive protein and plasma homocysteine in patients with acute coronary syndrome/
Dayu WANG ; Shanjun ZHAO ; Jiayong LIANG ; Jianhao LI ; Wenzhu ZHANG ; Jun CHEN
Chinese Journal of cardiovascular Rehabilitation Medicine 2019;28(1):72-75
Objective :To explore influence of ticagrelor on levels of serum high sensitive C reactive protein (hsCRP) and plasma homocysteine (Hcy) in patients with acute coronary syndrome (ACS).Methods :A total of 135 ACS pa‐ tients hospitalized in our department from Jan 2016 to Feb 2017 were selected .Based on routine treatment ,Patients were randomly and equally divided into routine group ,clopidogrel group and ticagrelor group (based on routine treatment respectively received clopidogrel or ticagrelor ) for four weeks .Levels of serum hsCRP and plasma Hcy were measured and compared among all groups before and after treatment .Results :Compared with before treat‐ment ,after four‐week treatment , there were significant reductions in levels of serum hsCRP and plasma Hcy in three groups (P<0. 05 or <0.01).Compared with routine group and clopidogrel group after four‐week treatment , there were significant reductions in levels of serum hsCRP [ (12.95 ± 1.99) mg/L , (8. 56 ± 1. 24) mg/L vs.(4. 47 ± 1. 92) mg/L] and plasma Hcy [ (13.48 ± 2.12) μmol/L , (9.55 ± 0. 94) μmol/L vs.(6. 61 ± 1. 15) μmol/L] in ticagrelor group ( P<0.05 or <0.01).Conclusion :Ticagrelor can significantly reduce levels of serum hsCRP and plasma Hcy while effective antiplatelet therapy ,then significantly inhibit inflammatory response ,improve vascular endothelial function ,contribute to stabilizing atherosclerotic plaques ,improve prognosis in ACS patients .
8.Lymph node metastasis and prognostic analysis of early gastric cancer patients
Yingchao WU ; Miao XIE ; Yunlong CAI ; Tao WU ; Shanjun HUANG ; Xin WANG
Chinese Journal of General Surgery 2019;34(7):561-564
Objective To investigate the correlation between clinicopathological features and lymph node metastasis in early gastric cancer (EGC) and evaluate the influence of lymph node metastasis on the overall survival.Methods The clinicopathological data of 178 EGC patients undergoing radical gastrectomy with lymphadenectomy in Peking University First Hospital between Jan 2006 and Dec 2015 were retrospectively reviewed.The impact of lymph node metastasis on the overall survival was analyzed.Results Lymph node metastasis was detected in 19 (10.7%) of 178 patients.Univariate analysis showed a positive relationship between tumor size (x2 =4.804,P =0.028),depth of invasion (x2 =8.176,P =0.003),histological type (x2 =4.333,P =0.037),vascular tumor thrombus (x2 =9.992,P =0.002) and lymph node metastasis in EGC.Multivariate analysis revealed that depth of invasion (Wald =4.954,P =0.026)and intra-vascular tumor thrombus (Wald =3.966,P =0.046) were independent relative factors of lymph node metastasis in EGC patients.The 5-year survival rates of EGC patients with lymph node metastasis were 78.9%,much lower than that without lymph node metastasis (94.3%,x2 =8.310,P=0.004).Conclusions Lymph node metastasis in EGC is mainly correlated with depth of invasion and intra-vascular tumor thrombus.The prognosis of patients with lymph node metastasis is significantly poorer than those without lymph node metastasis.
9.Efficacy analysis of neoadjuvant chemoradiotherapy combined with total pelvic exenteration in the treatment of primary T4b rectal cancer.
Tao WU ; Long WEN ; Jixin ZHANG ; Yingchao WU ; Yong JIANG ; Guowei CHEN ; Xin WANG ; Shanjun HUANG ; Yuanlian WAN
Chinese Journal of Gastrointestinal Surgery 2019;22(1):59-65
OBJECTIVE:
To investigate the value of neoadjuvant chemoradiotherapy (nCRT) combined with total pelvic exenteration (TPE) in the treatment of primary T4b rectal cancer.
METHODS:
A retrospective cohort study was conducted to analyze the clinicopathological data of 31 patients with primary T4b rectal cancer who underwent TPE from January 2008 to December 2015 at Peking University First Hospital.
INCLUSION CRITERIA:
preoperative clinical stage (cTNM) was defined as cT4b primary rectal cancer with only front wall Invasion; the lower edge of tumor was within 10 cm from the anal margin; TPE was performed; R0 resection was confirmed by pathology. Patients with recurrent rectal cancer, distant metastasis, and undergoing TPE for non-rectal tumors were excluded. Patients were divided into nCRT group and non-nCRT group according to whether receiving nCRT before surgery. The nCRT group received long course radiotherapy (total dose 50 Gy in 25 daily fractions) with concomitant chemotherapy (Capecitabine), and the surgery was performed 6-8 weeks after the neoadjuvant chemoradiation, while the non-nCRT group received surgery directly. The intraoperative, postoperative and pathological conditions and local recurrence were compared between the two groups. The survival curves were drawn by Kaplan-Meier method and the survival of two groups were compared.
RESULTS:
A total of 31 patients were enrolled, including 13 patients in the nCRT group and 18 patients in the non-nCRT group. The baseline data, such as age, duration of disease, preoperative basic disease, body mass index, smoking rate, and tumor distance from the anal margin, were not significantly different between the two groups (all P>0.05). In the nCRT group and non-nCRT group respectively, the ratio of anal preservation was 30.8%(4/13) and 38.9%(7/18) (P=0.468), the median intraoperative blood loss was 1 000 ml and 800 ml (P=0.644), the operation time was (531.7±137.2) minutes and (498.0±90.1) minutes (P=0.703), the median hospital stay was 18 days and 14 days (P=0.400), the morbidity of complications within 30 days after surgery was 23.1%(3/13) and 38.9%(7/18)(P=0.452), the incidence of postoperative abdominal abscess was 15.4%(2/13) and 0 (P=0.168), the proportion of secondary surgery was 7.7%(1/13) and 11.1%(2/18)(P=1.000), whose differences were not significantly different. The proportion of postoperative pathological pT4b in whole group was 58.1%(18/31), including 53.8%(7/13) in nCRT group and 61.1%(11/18) in non-nCRT group, which was not significantly different between the two groups (P=0.691). The number of harvested lymph node in nCRT group was 13.5±5.9, which was significantly less than 23.0±11.8 in non-nCRT group (P=0.013). There was no pathological complete remission (ypCR) case in nCRT group, and among 13 patients, tumor regression grade (TRG) of 2, 3, 4, and 5 was in 1 case (7.7%), 6 cases (46.2%), 5 cases(38.5%), and 1 case (7.7%), respectively. The median follow-up time was 33 (2 to 115) months, and the follow-up rate was 93.5%(29/31). One case was lost in both the nCRT group and non-nCRT group. The 3-year disease-free survival rate was 43.5% in pooled data, and was 43.6% and 43.3% in nCRT group and non-CRT group respectively without significant difference (P=0.833). The 3-year overall survival rate was 51.1% in pooled data, and was 45.7% and 54.7% in nCRT group and non-nCRT group respectively without significant difference (P=0.653).The local recurrence rate of nCRT and non-nCRT groups was 8.3%(1/12) and 5.9%(1/17) respectively, and the distant metastasis rate was 50.0%(6/12) and 41.2%(7/17) respectively, whose differences were not statistically significant as well (P=1.000 and P=0.865, respectively).
CONCLUSION
For primary T4b rectal cancer which can achieve R0 resection through total pelvic exenteration, neoadjuvant chemoradiotherapy has not been demonstrated any advantage in tumor regression, reducing local recurrence, or improving survival, and may increase postoperative complications.
Adenocarcinoma
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pathology
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therapy
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Antineoplastic Agents
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administration & dosage
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Chemoradiotherapy
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Combined Modality Therapy
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Humans
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Neoadjuvant Therapy
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Neoplasm Staging
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Pelvic Exenteration
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Rectal Neoplasms
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pathology
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therapy
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Retrospective Studies
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Treatment Outcome
10.Expression and mechanism of UCA1 in gastrointestinal tumors
Yi ZHAO ; Shanjun YAN ; Qizhi WANG
Journal of International Oncology 2017;44(2):142-144
Urothelial carcinoma associated 1 (UCA1) is a kind of long non-coding RNA (lncRNA),which has no capacities for coding proteins.UCA1 over-expresses in diverse tumors,and plays a pivotal role in initiation and progression of tumors.Researches indicate that UCA1 may function as an oncogene in gastrointestinal tumors,such as gastric cancer,colorectal cancer and hepatocellular cancer,and participate in regulating cell proliferation,metastasis and chemo-resistance.

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