1.Clinical study of lateral cervical approach surgery in the treatment of primary hyperparathyroidism
Feng ZHU ; Yijun WU ; Yibin SHEN ; Xueyu ZHOU ; Jun PAN ; Linghui CHEN ; Lixian ZHU ; Qiwen HE
Journal of Xi'an Jiaotong University(Medical Sciences) 2024;45(1):69-73
Objective To explore the feasibility and clinical outcome of lateral cervical incision via sternocleidomastoid intermuscular approach(SMIA)in the treatment of primary hyperparathyroidism.Methods The clinical data of 64 patients with primary hyperparathyroidism who underwent unilateral parathyroid surgery in the First Affiliated Hospital,School of Medicine of Zhejiang University from January 2019 to June 2022 were retrospectively analyzed.They were divided into lateral cervical incision via sternocleidomastoid intermuscular approach group(SMIA group)and linea alba cervicalis approach group(LACA group)based on the surgical incision and access route.The differences in clinical features,surgery-related outcomes and postoperative functions of the anterior cervical region were compared between the two groups.The EQ-5D-5L scale was used to assess the subjective feeling of postoperative neck discomfort,while the Hollander Wound Assessment Scale was used to assess the clinical outcome of incision healing.Results There were no statistical differences between the two groups of patients in terms of age,gender,intraoperative bleeding,parathyroid hormone or blood calcium levels before and after surgery(P>0.05).The duration of surgery was significantly shorter in the SMIA group than in the LACA group[(39.77±5.69)min vs.(54.41±4.66)min].There was a statistical difference between the two groups in functional protection of the anterior cervical region at 1 month and 12 months after surgery(1 month,84.67±3.74 vs.79.47±5.38,P<0.001;12 months,93.80±2.52 vs.89.94±2.39,P<0.001),and the SMIA group was better than the LACA group.The Hollander Incision Assessment Scale scores of the SMIA group were better than those of the LACA group at 6 months and 12 months after surgery,and the difference was statistically significant(6 months,1.93±0.58 vs.2.41±0.66,P=0.003;12 months,1.03±0.67 vs.1.74±0.62,P<0.001).Conclusion Parathyroidectomy via sternocleidomastoid intermuscular approach through lateral cervical incision is a simple,safe and effective surgical procedure,which makes it easier to search for parathyroid lesions and shortens the surgical time compared with the traditional incision,and has obvious advantages in the protection of anterior cervical region function.
2.Effect of intensive blood pressure control after successful endovascular therapy on outcomes in patients with anterior circulation stroke: a multicentre, open-label, blinded-endpoint, randomized controlled trial
Chengfang LIU ; Qiwen DENG ; Hongchao SHI ; Feng ZHOU ; Yukai LIU ; Meng WANG ; Qiaoyu ZHANG ; Bingqi ZHANG ; Min LI ; Lei PING ; Tao WANG ; Haicun SHI ; Wei WANG ; Jiankang HOU ; Shi HUANG ; Jinfeng LYU ; Rui SHEN ; Yingdong ZHANG ; Junshan ZHOU
International Journal of Cerebrovascular Diseases 2023;31(6):401-408
Objective:To compare the effects of intensive and standard blood pressure control on the outcomes of patients with acute ischemic stroke in the anterior circulation who have successfully recanalized after endovascular therapy (EVT).Methods:A multicenter, open-label, blinded-endpoint, randomized controlled design was used. Patients with anterior circulation stroke received EVT and successfully recanalized in Nanjing First Hospital, Nanjing Medical University and several branch hospitals from July 2020 to October 2022 were prospectively included. They were randomly divided into the intensive blood pressure control group (target systolic blood pressure [SBP] 100-120 mmHg) or the standard blood pressure control group (target SBP 121-140 mmHg). The blood pressure of both groups needs to achieve the target within 1 h and maintain for 72 h. The primary outcome endpoint was outcome at 90 d, and the good outcome was defined as a score of 0-2 on the modified Rankin Scale. Secondary outcome endpoints included early neurological improvement, symptomatic intracranial hemorrhage (sICH) within 24 h, and death and serious adverse events within 90 d.Results:A total of 120 patients were included, including 63 in the intensive blood pressure control group and 57 in the standard blood pressure control group. There was no statistically significant difference in baseline characteristics between the two groups. The SBP at 72 h after procedure was 122.7±8.1 mmHg in the intensive blood pressure control group and 130.2±7.4 mmHg in the standard blood pressure control group, respectively. There were no significantly differences in the good outcome rate (54.0% vs. 54.4%; χ2=0.002, P=0.963), the early neurological improvement rate (45.2% vs. 34.5%; χ2=1.367, P=0.242), the incidence of sICH (6.3% vs. 3.5%; P=0.682), mortality (7.9% vs. 14.0%; χ2=1.152, P=0.283) and the incidence of serious adverse events (12.7% vs. 15.8%; χ2=0.235, P=0.628) at 90 d between the intensive blood pressure control group and the standard blood pressure control group. Conclusion:In patients with anterior circulation stroke and successful revascularization of EVT, early intensive blood pressure control don’t improve clinical outcomes and reduce the incidence of sICH.
3.Prognostic factors of salvage radiotherapy after radical prostatectomy
Yang LIU ; Feng WEN ; Yali SHEN ; Qiwen PAN ; Jinxia HE ; Lixin MAI ; Hao ZENG ; Jianming GAO ; Xiang LI ; Zhiping LI ; Yonghong LI ; Xin WANG ; Liru HE ; Qiang WEI ; Fangjian ZHOU
Chinese Journal of Urology 2021;42(9):650-655
Objective:To investigate the prognosis after salvage radiotherapy with or without hormone therapy for prostate cancer.Methods:From May 2014 to December 2020, 248 patients undergoing salvage radiotherapy due to prostate-specific antigen (PSA)persistence or biochemical progression after radical prostatectomy at Sun Yat-sen University Cancer Center (n=157) and West China Hospital, Sichuan University (n=91) were analyzed. Median age was 66 (45-78) years old. Median PSA was 23.50 (0.18-845.00) ng/ml. The number of PSA persistence and biochemical progression were 143 (59%) and 105 (42%). The number of pT 2, pT 3a, pT 3b, pT 4, and unknown T stage was 99, 49, 78, 15 and 7 cases.The number of N 0, N 1 and unknown N stage was 153, 44 and 51 cases. 165 cases had positive surgical margin. Gleason score of 6, 7, 8, >8 score and unknown was in 12, 104, 34, 90 and 8 patients. Early and late salvage radiotherapy was performed in 117 and 131 patients, and 70 patients (28%) were CRPC. Hormone therapy was used combined with radiotherapy in 182 patients (73%). PSA decline after radiotherapy was compared with Chi-squre test. Kaplan-Meier method and log-rank test were used to compare progression free-survival (PFS)after radiotherapy. Univariate and multivariate analyses of PFS were performed using Cox proportional hazards model. Early salvage radiotherapy was defined as PSA≤0.5 ng/ml before radiotherapy, and late salvage radiotherapy was defined as PSA>0.5ng/ml. Results:PSA response (PSA decline ≥50%) rate was 94% (233/248), and 82% (203/248) patients had PSA decline ≥ 90%. Twelve (5%) patients had rising PSA after completing radiotherapy, but only 4 (2%) had real progression. The median PFS was 69 months (95% CI 68-70), and 3-year and 5-year PFS rate were 80% and 67%. PFS of PSA persistence and biochemical progression were similar ( HR =0.71, 95% CI 0.37-1.37, P=0.311). Compared with late salvage radiotherapy, early salvage radiotherapy had better PFS [69 (95% CI 68-70) vs. 59 (95% CI 44-74) months, P<0.001]. Compared with hormone sensitive, castration-resistant was associated with worse PFS (5-year PFS rate 74% vs. 51%, P<0.001). In multivariate analysis, Gleason score>8, castration-resistant and late salvage radiotherapy were unfavorable prognostic factors. Conclusions:In patients receiving salvage radiotherapy with or without hormone therapy for PSA persistence and biochemical progression after radical prostatectomy, high PSA level before radiotherapy and castration resistant is associated with poor prognosis.
4.Synthesis and cell biological properties of polyaspartic acid drug/gene vector
Jie SHEN ; Qiwen WANG ; Dongruo GAO ; Yuanyuan LYU ; Guping TANG
Journal of Zhejiang University. Medical sciences 2019;48(6):657-667
OBJECTIVE: Taking polysuccinimide as the main chain, amine side chain and alkyl side chain were grafted to prepare the drug/gene co-delivery vector. The property of the polymers with various side links were investigated to select an optimal vector. METHODS: Poly-D, L-polysuccinimide was synthesized by polymerization reaction of D, L-aspartic acid as monomer. Therefore, N, N-dimethylenedipropyl-triamine and 3, 3'-diaminodipropylamine were grafted with dodecylamine/adecylamine/octadecylamine at different proportions by ring-opening reaction to obtain amphiphilic PEECs. The structure of the material was confirmed by 1H NMR; the particle size and surface potential of the micelles were measured by dynamic light scattering; the critical micelle concentration (CMC) was determined by pyrene fluorescent probe; the RNA blocking ability was characterized by agarose gel electrophoresis; the release behavior of the PEECs was examined and the cytotoxicity, cellular uptake and gene silencing efficiency of the PEECs were studied at the cellular level. RESULTS A series of PEECs with different grafting rates was successfully synthesized. The particle sizes and surface potential of the PEEC derived micelles were between 250 nm and 350 nm and 27 mV and 45 mV, respectively, with a small CMC value. The RNA binding ratio of PEECs was at a mass ratio of about 0.8:1. MTT assay demonstrated that PEEC micelles had certain cytotoxicity. PEECs had excellent micelle formation, drug-loading and gene binding abilities, particularly, PEEC16-2 showed high gene silencing efficiency at the cellular level. CONCLUSIONS PEECs are able to co-delivery drug and gene, and PEEC16-2 micelles have the best ability of drug encapsulation and gene delivery.
5.Predictive factors for postoperative hypocalcemia after reoperation of thyroid cancer
Liang CHEN ; Fuqiang LI ; Xiaojun XIE ; Yibin SHEN ; Feng ZHU ; Liang HU ; Qiwen HE ; Yijun WU
Chinese Journal of Endocrine Surgery 2019;13(4):273-277
Objective Hypothyroidism(HypoPT) is one of the most common complications of thyroid reoperation,and hypocalcemia caused by HypoPT is a difficult problem in clinical practice.This study aims to investigate the risk factors for hypoealcemia after reoperation of thyroid cancer.Methods Data of 106 patients who underwent reoperation for thyroid cancer from 2013 to 2018 were retrospectively analyzed.According to the parathyroid area involved in the reoperation,the reoperation was graded:low-risk group,intermediate-risk group and high-risk group.Parathyroid hormone(PTH) and total calcium(Ca) levels were monitored at 12 to 24 hours after surgery.The follow-up period was at least 6 months.The PTH cut-off values of postoperative hypocalcemia were analyzed by ROC curve.The chi-square test and logistic regression analysis were used to analyze the risk factors of postoperative hypocalcemia.Results The incidence of transient HypoPT after reoperation was 35%,and the permanent HypoPT was 1.9%.The grade of reoperation was positively correlated with postoperative HypoPT.The ROC curve showed that the PTH cut-off values of postoperative hypocalcemia was 15 pg/ml and area under curve(AUC) was 0.636(95% CI:0.530-0.742,P<0.017).Univariate and multivariate analysis showed that reoperation grade and postoperative PTH<15 pg/ml were independent risk factors for postoperative hypocalcemia.Conclusion The grade of reoperation and postoperative PTH value <15 pg/ml can predict postoperative hypocalcemia.
6.Application of Control Chart in Quality Trend Analysis and Abnormal Location Management of Pharma-ceutical Production
Yi LIANG ; Huangying SUN ; Qiwen SHEN
China Pharmacy 2016;27(10):1297-1301
OBJECTIVE:To introduce the application of control chart in quality trend analysis and abnormal location manage-ment of pharmaceutical production,thus encourage pharmaceutical manufacturing enterprises to more frequently use control chart as a statistical analysis tool in quality control process. METHODS:Taking a pharmaceutical manufacturing enterprise as examples,the way for selection of different kinds of control charts in different conditions(such as stability study,product quality review)was il-lustrated. Based on the given data of quality characteristic analysis and stability study of a certain product in this company,analysis process was demonstrated using control chart. RESULTS & CONCLUSIONS:When the sample capacity for analysis is not less than 25,meeting the minimum requirement for steady state estimation,Hugh Hart control chart (conventional control chart)alone can accurately locate the abnormal data;while under the adverse circumstance of small sample capacity,the modified control chart (such as the regression control chart)is still able to equally reflect the overall trend and out of trend(OOT)ones. As a statistical analysis tool,control chart introduced into quality management activities is an effective technic way for control.
7.Application Evaluation of Hazard Analysis and Critical Control Point System in Wet Granulation and Tableting Technology
Yong YU ; Jiahui GU ; Wenbo CUI ; Fang FANG ; Qiwen SHEN
China Pharmacy 2015;(25):3460-3463
OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.
8.Disucussion on the Training Mode of Medical Management Graduates Based on the Combination of School and Enterprise
Yi LIANG ; Yuxia JIA ; Lang XIONG ; Qiwen SHEN
China Pharmacy 2015;26(33):4748-4750
OBJECTIVE:To explore the training method for the postgraduates majoring in medicine management,and provide reference for the teaching effect of medical management. METHODS:Based on the existing problems in the training mode of post-graduates majoring in medical management,the foundation,feasibility implementation process of the coalition of college and enter-prise were analyzed. RESULTS & CONCLUSIONS:The training mode of coalition of college and enterprise can really make teach-ers,students and enterprises to achieve a win-win situation;at the same time,through the feasibility analysis of the training mode, the performance evaluation method of multi-level evaluation system and fuzzy comprehensive evaluation are put forward to finally achieve the exploration of training management mode of undergraduates from the perspective of operational level. But in the owner-ship of intellectual property rights,technology security,personal safety of graduate and other aspects still exist some problems and need further improvement.
9.Surveillance of antimicrobial resistance of clinical bacterial isolates in a hospital during 2013
Rongfeng YAO ; Guoxiang XU ; Long XUE ; Juying SHEN ; Zhi LI ; Rong XIA ; Qiwen XIAO
Chinese Journal of Infection and Chemotherapy 2015;(3):244-248
Objective To investigate the antibiotic resistance of clinical isolates from hospital for the guidance of rational use of antibiotics .Methods Automatic VITEK‐2 system was used to identify bacterial strains and analyze the antimicrobial resistance . WHONET 5 .6 was applied for data analysis according to the breakpoints of Clinical and Laboratory Standards Institute 2013 . Results A total of 3 880 nonduplicate strains were collected in 2013 ,35 .2% (1 366/3 880) of which were gram positive organisms ,64 .8% (2 514/3 880) were gram negative bacteria .The top 6 most frequently isolated microorganisms were E . coli (20 .2% ) , K . pneumoniae (12 .0% ) , P . aeruginosa (11 .1% ) , coagulase negative Staphylococcus (9 .8% ) , A . baumannii (9 .8% ) ,E .f aecalis (8 .1% ) .The bacteria were mainly isolated from respiratory tract (51 .0% ) ,urine (26 .2% ) , and blood (9 .4% ) .The prevalence of both meticillin‐resistant Staphylococcus was higher than 72 .0% .No staphylococcal strainwasfoundresistanttolinezolid,vancomycinortigecycline.Amongthe509Enterococcusisolates,E.faecalisandE. f aecium accounted for 61 .5% and 32 .8% ,respectively .No enterococcal strain was resistant to vancomycin or tigecycline . Enterococcal isolates also showed low resistance (<2 .0% ) to teicoplanin and linezolid .About 67 .4% of the E .coli strains and 32 .0% of the K lebsiella isolates produced extended spectrumbeta‐lactamases.Thestrainsof E.coli,Klebsiella spp.,Enterobacterspp.,and Proteusspp.wererelatively susceptible to beta‐lactam/beta‐lactamase inhibitor combinations such as cefoperazone‐sulbactam and piperacillin‐tazobactam , carbapenems such as meropenem ,imipenem and ertapenem ,and amikacin (< 15 .0% of the strains were resistant) . K . pneumoniae isolates were more resistant than other gram‐negative bacilli .P .aeruginosa was relatively susceptible to amikacin , tobramycin ,cefepime ,gentamicin ,piperacillin‐tazobactam ,but more than 20% of these strains were resistant to meropenem and imipenem .More than 35 .0% of the A . baumannii isolates were resistant to any of the antimicrobial agents tested . Conclusions Antimicrobial resistance is still a serious threat in clinical antimicrobial therapy .It is important to promote the rational use of antimicrobial agents so that resistance is minimized . It is necessary to conduct epidemiological survey and proactively implement effective interventions in the clinical setting with relatively heavy burden of antimicrobial resistance .
10.Research on the Classification of Deviations in Drug Production
Yong YU ; Xin MEI ; Fang FANG ; Wenbo CUI ; Qiwen SHEN
China Pharmacy 2015;(19):2601-2603,2604
OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

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