1.Quality standard for Jinqiaomai Tablets
Meishan HE ; Binghui QIAN ; Zhaolong WANG ; Zhiyong WANG ; Yumei YAN
Chinese Traditional Patent Medicine 1992;0(05):-
AIM: To establish the quality standard for Jinqiaomai Tablets ( Fagopyri Dibotryis Rhizoma). METHODS: Fagopyri Dibotryis Rhizoma was identified by TLC. The contents of (-)-epicatechin and procyanidin B2 were determined simultaneously by HPLC,the Symmetry C18 column (5 ?m,3. 9 mm id ? 150 mm) was used. The water (adjust pH value to 3. 00 ? 0. 02 with phosphoric acid)-acetonitrile (92 ∶ 8) was used as a mobile phase,the detecting wavelength was at 280 nm. The column temperature was at 35 ℃. RESULTS: Fagopyri Dibotryis Rhizoma could be identified. The calibration curve of (-)-epicatechin was linear in the range of 0. 113 6-2. 272 ?g with the correlation of 0. 999 968 (n = 8). The average recovery of (-)-epicatechin was 97. 12% ,RSD = 0. 92% (n = 6). The calibration curve of procyanidin B2 was linear in the range of 0. 166 4-1. 664 ?g with the correlation of 0. 999 702(n = 8). The average recovery of procyanidin B2 was 98. 26% ,RSD = 0. 61% (n = 6). CONCLUSION: The method is specific,reliable and accurate,so it can be used for the quality control of Jinqiaomai Tablets.
3.Prognostic value of the preoperative systemic immune-inflammation index in patients with non-small cell lung cancer: A systematic review and meta-analysis
Mengqi CHEN ; Kemeng LIU ; Huaqin ZHAO ; Xia HE
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2023;30(03):440-446
Objective To explore the association between the preoperative systemic immune-inflammation index (SII) and prognosis in non-small cell lung cancer (NSCLC) patients. Methods A comprehensive literature survey was performed on PubMed, Web of Science, EMbase, The Cochrane Library, Wanfang, and CNKI databases to search the related studies from inception to December 2021. The hazard ratio (HR) and 95% confidence interval (CI) were combined to evaluate the correlation of the preoperative SII with overall survival (OS), disease-free survival (DFS), and recurrence-free survival (RFS) in NSCLC patients. Results A total of 11 studies involving 9 180 patients were eventually included. The combined analysis showed that high SII levels were significantly associated with worse OS (HR=1.61, 95%CI 1.36-1.90, P<0.001), DFS (HR=1.50, 95%CI 1.34-1.68, P<0.001), and RFS (HR=1.17, 95%CI 1.04-1.33, P<0.001). Subgroup analyses also further verified the above results. Conclusion Preoperative SII is a powerful prognostic biomarker for predicting outcome in patients with operable NSCLC and contribute to prognosis evaluation and treatment strategy formulation. However, more well-designed and prospective studies are warranted to verify our findings.
4.Open, multicenter, phase Ⅳ clinical trial of Shenbei Guchang capsules in treatment of diarrhea type irritable bowel syndrome.
Chun-Hua QIU ; Liang-Ping LI ; Chu-Min ZHANG ; Chun-Sheng LIU ; Tao LIANG ; Yi JIAN ; Hong-Bin WANG ; Yang ZHANG ; Guang-Shang WANG ; Xin-Xi XIE ; Shu-An CHEN ; Wei-Ming HE ; Xu ZHANG ; Yong-Su JIANG ; Jing LIAO ; Dong CHEN ; Bi LIU ; Wen-Bin PAN
China Journal of Chinese Materia Medica 2016;41(10):1947-1951
To evaluate the safety and effectiveness of Shenbei Guchang capsules in treatment of diarrhea type irritable bowel syndrome (yang deficiency of spleen and kidney) under widely used conditions, an open, multicenter, controlled, phase Ⅳ clinical trial was conducted in the drug clinical trial centers of 16 domestic hospitals. 2 123 patients from June 10, 2011 to November 29, 2012 were enrolled in the trial. Drug clinical trial was approved by Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital Ethics Committee before implementation. Before the start of trial, subjects were selected according to the research scheme and inclusion criteria, then they would step into the 14 d study after signing Informed Consent Form. All subjects were treated according to the research scheme, evaluated the conditions and filled in CFR sheet, to provide the evaluation data and information on safety and efficacy of Shenbei Guchang capsules. Shenbei Guchang capsules were used to treat diarrhea type irritable bowel syndrome in widely used conditions (2 123 cases), and 2 029 cases of them entered FAS set, cure+markedly effective in 1 921 cases, with a comprehensive curative effect rate of 94.68%; 2 010 cases of them entered PPS set, cure+markedly effective in 1 906 cases, with a comprehensive curative effect rate of 94.83%. The primary symptoms of IBS were abdominal pain and diarrhea. After treatment, both abdominal pain and diarrhea were improved, with significant differences (P<0.000 1). There were significant differences in traditional Chinese medicine symptom scores on both post-treatment day 7 and day 14 as compared with the conditions before treatment (P<0.000 1). 35 cases of adverse events occurred during the trial with an incidence of 1.65%, including 12 cases of drug-related adverse events (adverse reaction) with an incidence of 0.57%, mainly manifested as nausea, abdominal distension and dry mouth, most of which would be spontaneously relieved without any measures. No serious adverse events occurred. The commercially available Shenbei Guchang capsules are proved safe and effective for the treatment of diarrhea type irritable bowel syndrome (yang deficiency of spleen and kidney) under widely used conditions (2 123 cases), and can be continued for clinical promotion and application.
5.Application of regional citrate anticoagulation in patients at high risk of bleeding during intermittent hemodialysis: a prospective multicenter randomized controlled trial.
Xiaoyan TANG ; Dezheng CHEN ; Ling ZHANG ; Ping FU ; Yanxia CHEN ; Zhou XIAO ; Xiangcheng XIAO ; Weisheng PENG ; Li CHENG ; Yanmin ZHANG ; Hongbo LI ; Kehui LI ; Bizhen GOU ; Xin WU ; Qian YU ; Lijun JIAN ; Zaizhi ZHU ; Yu WEN ; Cheng LIU ; Hen XUE ; Hongyu ZHANG ; Xin HE ; Bin YAN ; Liping ZHONG ; Bin HUANG ; Mingying MAO
Journal of Zhejiang University. Science. B 2022;23(11):931-942
OBJECTIVES:
Safe and effective anticoagulation is essential for hemodialysis patients who are at high risk of bleeding. The purpose of this trial is to evaluate the effectiveness and safety of two-stage regional citrate anticoagulation (RCA) combined with sequential anticoagulation and standard calcium-containing dialysate in intermittent hemodialysis (IHD) treatment.
METHODS:
Patients at high risk of bleeding who underwent IHD from September 2019 to May 2021 were prospectively enrolled in 13 blood purification centers of nephrology departments, and were randomly divided into RCA group and saline flushing group. In the RCA group, 0.04 g/mL sodium citrate was infused from the start of the dialysis line during blood draining and at the venous expansion chamber. The sodium citrate was stopped after 3 h of dialysis, which was changed to sequential dialysis without anticoagulant. The hazard ratios for coagulation were according to baseline.
RESULTS:
A total of 159 patients and 208 sessions were enrolled, including RCA group (80 patients, 110 sessions) and saline flushing group (79 patients, 98 sessions). The incidence of severe coagulation events of extracorporeal circulation in the RCA group was significantly lower than that in the saline flushing group (3.64% vs. 20.41%, P<0.001). The survival time of the filter pipeline in the RCA group was significantly longer than that in the saline flushing group ((238.34±9.33) min vs. (221.73±34.10) min, P<0.001). The urea clearance index (Kt/V) in the RCA group was similar to that in the saline flushing group with no statistically significant difference (1.12±0.34 vs. 1.08±0.34, P=0.41).
CONCLUSIONS
Compared with saline flushing, the two-stage RCA combined with a sequential anticoagulation strategy significantly reduced extracorporeal circulation clotting events and prolonged the dialysis time without serious adverse events.
Humans
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Citric Acid/adverse effects*
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Prospective Studies
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Sodium Citrate
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Hemorrhage/chemically induced*
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Citrates/adverse effects*
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Anticoagulants/adverse effects*
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Renal Dialysis/adverse effects*