1.Clinical analysis of 68 cases of small intestine bleeding
Kejie LIU ; Shilun TONG ; Yongbin ZHENG ; Hongfa GAN ; Fengyu CAO ; Xiaobo HE ; Yu DING
Clinical Medicine of China 2012;28(3):307-309
Objective To investigate the causes,diagnosis and treatment of small intestine bleeding.Methods Sixty-eight cases of small intestine bleeding from January 2000 to June 2010 were retrospectively analyzed.Among all cases,4 underwent routine hemostatic treatment under colonoscopy,40treated with open surgery and 24 patients with laparoscopic therapy.Among them,57 cases underwent part resection for some small intestine,completely laparoscopic resection of diverticula was performed in 7patients.Results Neoplasms was the leading cause of small intestine bleeding,accounting for 48.5% (33/68)in these patients,followed by small intestine diverticulum accounted for 29.4% ( 20/68 ),intestinal infective diseases accounted for 14.7% ( 10/68 ) and vascular disease accounted for 7.4% ( 5/68 ).Conclusion The clinical manifestations of small intestinal bleeding showed no specific signs.Neoplasm,intestine diverticulum and intestinal infective diseases are the most common causes of small intestinal bleeding.Small intestinal bleeding can be diagnosed in intraoperative colonoscopy.Surgery is the most effective treatment for small intestinal bleeding.
2.Value of normalization window of tumor vasculature in neoadjuvant chemotherapy for patients with unresectable gastric cancer.
Yong-bin ZHENG ; Feng-yu CAO ; Ke-jie LIU ; Hong-fa GAN ; Xiao-bo HE ; Shi-lun TONG
Chinese Journal of Gastrointestinal Surgery 2012;15(1):55-58
OBJECTIVETo evaluate the value of normalization window of tumor vasculature (NWTV) in patients with unresectable gastric cancer undergoing neoadjuvant chemotherapy.
METHODSFrom October 2010 to March 2011, 93 patients with unresectable advanced or locally advanced gastric carcinoma were prospectively collected and randomly divided to Group A(n=30), Group B(n=29), and Group C(n=34). Group A received FOLFOX4 as conventional neoadjuvant chemotherapy. Group B received FOLFOX4 plus bevacizumab. The treatment was adjusted in Group C according to the hypothesis of NWTV with neoadjuvant chemotherapy delivered 5 days after bevacizumab treatment. The efficacy, drug toxicity and clinical outcome were assessed and compared between the three groups.
RESULTSThere were no significant differences among the 3 groups in demographics(P>0.05). All the patients completed the neoadjuvant chemotherapy. Efficacy and toxicity between the three groups were comparable(P>0.05). The rates of tumor downstaging in the three groups were 56.7%(17/30), 72.4%(21/29), 85.3%(29/34), respectively, with a significantly lower downstaging rate in Group C as compared to Group A(P<0.05). R0 resection rates were 23.3%(7/30), 27.6%(8/29), 52.9% (18/34), respectively, with significantly higher R0 resection rate in Group C as compared to Group A and Group B(All P<0.05). There was no perioperative death in this cohort. Postoperative complications were comparable among the 3 groups(P>0.05).
CONCLUSIONSAnti-angiogenesis agent can improve the efficacy of neoadjuvant chemotherapy in unresectable gastric cancer. Furthermore, administration according to NWTV may achieve better outcomes.
Adolescent ; Adult ; Aged ; Antibodies, Monoclonal, Humanized ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bevacizumab ; Female ; Fluorouracil ; therapeutic use ; Humans ; Leucovorin ; therapeutic use ; Male ; Middle Aged ; Neoadjuvant Therapy ; Neovascularization, Pathologic ; drug therapy ; Organoplatinum Compounds ; therapeutic use ; Prospective Studies ; Stomach Neoplasms ; blood supply ; drug therapy ; Treatment Outcome ; Young Adult
3.Pharmacokinetic/pharmacodynamic study of sparfloxacin
Tong YU ; Gan-Bin WU ; Xiao-Tian LI ; Yan-Le CHU ; Ling-Xi WANG
The Chinese Journal of Clinical Pharmacology 2014;(8):681-684
Objective To optimize clinical dosage regimen of sparfloxa-cin through series of pharmacokinetic/pharmacodynamic ( PK/PD ) val-ues.Methods The minimum inhibitory concentration ( MIC ) of spar-floxacin to 479 isolated bacteria were measured by two -fold agar dilution method.To perform pharmacokinetic test after those healthy volunteers were given a single oral dose of 0.1 , 0.2 , 0.3 g of Sparfloxacin , respec-tively.Based on PK/PD theory, calculation of AUC0-24 h/MIC values af-ter three dosages were done.Estimated value of AUC 0-24 h/MIC≥125 was expected to be the target value ( for streptococcus pneumoniae AUC0-24 h/MIC≥50).The Monte Carlo simulation was repeated 1 ×104 times, and the cumulative fraction of response ( CFR) value was calculat-ed according to the respective probability distributions and different AUC0-24 h/MIC and MIC values.The dosage achieving a CFR above 90 percent was recognized as the optimal dosage regimen.Results Given dose of 0.1 g, the pharmacodynamics value CFR was above 90%only to salmonella genera.Given dose of 0.2 g, the pharmacodynamics value CFR was above 90%to Nitrate negative bacillus, Streptococcus pneumoni-ae, Acinetobacter and Methicillin -sensitive Staphylococcus aureus (MSSA).For other strains, oral dose of 0.3 g was needed to not only achieve satisfactory clinical curative effect but also effectively prevent the drug resistance.And for infections caused by Methicillin -resistant Staphylococcus aureus (MRSA), enhanced drug dose should be considered to achieve satisfactory clinical efficacy.Conclusion For infection caused by salmonella genera, oral dose of 0.1 g was a appropriate dosage regimen.For infection caused by Nitrate negative bacillus, Strepto-coccus pneumoniae, Acinetobacter and MSSA, oral dose of 0.2 g was a proper dosage regimen.For infection caused by others, oral dosage regimen of 0.3 g could achieve the expected satisfactory clinical efficacy.And for infections caused by MRSA, an increasing dosage , such as 0.4 mg, could achieve satisfactory clinical curative effect.
4.Modified laparoscopic transabdominal preperitoneal repair of groin hernias.
Gan YAO ; Qing-tang YANG ; Qing-feng ZHANG ; Jian-sheng LIANG ; Yu-zhou LI ; Jian-tong GUO
Journal of Southern Medical University 2008;28(12):2272-2273
OBJECTIVETo assess the clinical value of modified transabdominal preperitoneal (TAPP) repair of groin hernias in adult patients.
METHODFrom May 2006 to April 2008, modified TAPP repair for hernia was performed in 403 adult patients with groin hernia and 22 with femoral hernia. Indirect hernia sac was treated by high ligation of the hernia sac in similar fashion with the management in children, while direct or femoral hernia was treated by dissecting the hernia sac. An incision was made on the lateral umbilical ligament, and the mesh was stapled and covered completely by the peritoneum of the lateral umbilical ligament, followed by fixation of the mesh with stapling and absorbable sutures.
RESULTSAll the operations were accomplished successfully with the operating time from 20 to 30 min for unilateral hemioplasty and the blood loss volume was 4-5 ml. Two patients developed scrotal edema and three showed scrotal seroma. No hernia recurrence was found in follow-up for 2-22 months. The patients complained of no intestinal obstruction symptoms including traction pain, abdominal pain, or nausea or urinary bladder stimulation symptoms.
CONCLUSIONSModified TAPP repair of groin hernias requires simple operation and produces reliable effect, and is therefore of clinical values for wide application.
Adult ; Aged ; Aged, 80 and over ; Female ; Hernia, Inguinal ; surgery ; Humans ; Laparoscopy ; methods ; Male ; Middle Aged ; Peritoneum ; surgery ; Surgical Mesh ; Surgical Procedures, Operative ; methods ; Treatment Outcome ; Young Adult
5.Reliability and validity assessment of Chinese version of nursing home survey on patient safety culture
Yan XIE ; Xiuli YU ; Pei GAN ; Lifang TONG ; Haiyan HE
Chinese Journal of Modern Nursing 2016;22(10):1337-1340
Objective To translate the English version of nursing home survey on patient safety culture (NHSPSC) into Chinese one, and to test the reliability and validity of Chinese version of NHSPSC. Methods The items of NHSPSC were translated into Chinese version using a standard procedure of double-back translation and cross-culture adapted. A total of 237 staff members of nursing home were recruited to examine the reliability and validity of Chinese version of NHSPSC. Results The Chinese version of NHSPSC consisted of 36 items. The Cronbach′s α coefficient was 0. 847 for the total scale and Cronbach′s α of each factors ranged from 0. 632 to 0. 832. The test-retest reliability was 0. 822. The correlation coefficient between each dimension score ranged from 0. 151 to 0. 728 and the correlation coefficient between each dimension and the total score ranged from 0. 294 to 0. 779. The content validity index was 0. 873. Twelve factors were extracted by factor analysis which could explain 63. 156% of the total variance. Conclusions The Chinese version of NHSPSC is reliable and valid, which can be used to evaluate the patient safety culture in nursing homes.
6.The Role and Positioning of Clinical Trial Ethics Review under Pharmaceutical Innovation Strategy
Zhonglin CHEN ; Gan HE ; Yu FENG ; Huihui HAN ; Yao YAO ; Ning ZHENG
Chinese Medical Ethics 2023;36(2):180-185
Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.
7.High volume practice proved the safety of off-pump coronary artery bypass surgery in left main coronary artery lesions: a two-year single center experience.
Tong LIU ; Jia-Kai LU ; Hui-Li GAN ; Jian-Qun ZHANG ; Fang-Jong HUANG ; Cheng-Xiong GU ; Qing-Yu KONG ; Xiang-Rong CAO ; Ping BO ; Chun-Shan LU
Chinese Medical Journal 2012;125(21):3861-3867
BACKGROUNDLeft main coronary artery (LMCA) stenosis has been recognized as a risk factor for early death among patients undergoing coronary artery bypass grafting (CABG). This study aimed to assess if LMCA lesions pose an additional risk of early or mid-term mortality and/or a major adverse cardiac and cerebrovascular event (MACCE) after off-pump coronary artery bypass grafting (OPCABG), compared with non-left main coronary artery stenosis (non-mainstem disease).
METHODSFrom January 1, 2009 to December 31, 2010, 4869 patients had a primary isolated OPCABG procedure at Beijing Anzhen Hospital. According to the pathology of LMCA lesions, they were retrospectively classified as a non-mainstem disease group (n = 3933) or a LMCA group (n = 936). Propensity scores were used to match the two groups, patients from the non-mainstem disease group (n = 831) were also randomly selected to match patients from the LMCA group (n = 831). Freedom from MACCE in the two groups was calculated using the Kaplan-Meier method.
RESULTSThe difference in the mortality and the rate of MACCE during the first 30 days between the non-mainstem disease group and the LMCA group did not reach statistical significance (P = 0.429, P = 0.127 respectively). With a mean follow-up of (12.8 ± 7.5) months and a cumulative follow-up of 1769.6 patient-years, the difference in the freedom from MACCEs between the two groups, calculated through Kaplan-Meier method, did not reach statistical significance (P = 0.831).
CONCLUSIONAnalysis of a high volume of OPCABG procedures proved that LMCA lesions do not pose additional early and mid-term risk to OPCABG. Therefore, a LMCA lesion is as safe as non-mainstem disease lesion during the OPCABG procedure.
Adult ; Aged ; Coronary Artery Bypass, Off-Pump ; adverse effects ; mortality ; statistics & numerical data ; Coronary Artery Disease ; surgery ; Female ; Follow-Up Studies ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Retrospective Studies
8.Related factors of negative conversion time of nucleic acid in children with COVID-19.
Yu Feng LI ; Jian Hua ZHANG ; Han GAN ; Kai Chuang ZHANG ; Kang CAI ; Wei LIU ; Sheng Nan LUO ; Hong Li JIANG ; Biao JIN ; Li Bin ZHAO ; Kun SUN
Chinese Journal of Pediatrics 2023;61(3):256-260
Objective: To explore the related factors of negative conversion time (NCT) of nucleic acid in children with COVID-19. Methods: A retrospective cohort study was conducted. A total of 225 children who were diagnosed with COVID-19 and admitted to Changxing Branch of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from April 3rd to May 31st 2022 were enrolled in the study. The infection age, gender, viral load, basic disease, clinical symptoms and information of accompanying caregivers were retrospectively analyzed. According to age, the children were divided into<3 years of age group and 3-<18 years of age group. According to the viral nucleic acid test results, the children were divided into positive accompanying caregiver group and negative accompanying caregiver group. Comparisons between groups were performed using Mann-Whitney U test or Chi-square test. Multivariate Logistic regression analysis was used to analyze the related factors of NCT of nucleic acid in children with COVID-19. Results: Among the 225 patients (120 boys and 105 girls) of age 2.8 (1.3, 6.2) years, 119 children <3 years and 106 children 3-<18 years of age, 19 cases were diagnosed with moderate COVID-19, and the other 206 cases were diagnosed with mild COVID-19. There were 141 patients in the positive accompanying caregiver group and 84 patients in the negative accompanying caregiver group.Patients 3-<18 years of age had a shorter NCT (5 (3, 7) vs.7 (4, 9) d, Z=-4.17, P<0.001) compared with patients <3 years of age. Patients in the negative accompanying caregiver group had a shorter NCT (5 (3, 7) vs.6 (4, 9) d,Z=-2.89,P=0.004) compared with patients in the positive accompanying caregiver group. Multivariate Logistic regression analysis showed that anorexia was associated with NCT of nucleic acid (OR=3.74,95%CI 1.69-8.31, P=0.001). Conclusion: Accompanying caregiver with positive nucleic acid test may prolong NCT of nucleic acid, and decreased appetite may be associated with prolonged NCT of nucleic acid in children with COVID-19.
Adolescent
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Child
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Child, Preschool
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Female
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Humans
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Male
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Young Adult
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China/epidemiology*
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COVID-19/genetics*
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Nucleic Acids
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Retrospective Studies
9.Analysis and Discussion on the Ethical Pre-review Model of Clinical Trials under the Pharmaceutical Innovation Strategy
Zhonglin CHEN ; Gan HE ; Yu FENG ; Huihui HAN ; Yao YAO ; Ning ZHENG
Chinese Medical Ethics 2022;35(11):1214-1217
With the implementation of the national biomedical innovation strategy, new requirements for ethical review of clinical trials have been put forward, and more attention has been paid to the ethical pre-review. Based on the current situation of clinical trials and ethical review of new drugs in China, this paper discussed the concept, advantages and necessity of ethical pre-review, sorted out the problems and challenges in the implementation of ethical pre-review at this stage, and put forward the following suggestions on how to better implement ethical pre-review in clinical trials under the pharmaceutical innovation strategy: the complete definition of "ethical pre-review" should be made clearly; ethical review should be carried out on the basis of necessary reference; the scope of application of ethical pre-review should be clarified; after the ethical pre-review, the statement of the approval document should be standardized and accurate.
10.Asthma treatment adherence and related factors in Shanghai, China.
Juan DU ; Yu-Heng SHI ; Yu-Xiang DUAN ; Xiao-Ru WANG ; Min ZHOU ; Wen-Chao GU ; Chi-Jun WEN ; Yi GONG ; Chun-Ling DU ; Bo PENG ; Lin SUN ; Wei TANG
Chinese Medical Journal 2021;134(20):2506-2508