1.Management of complications in endovascular treatment for arteriosclerotic occlusive disease of lower extremities
Zhonghua WANG ; Lei TIAN ; Xuedong CHEN ; Baixi ZHUANG ; Xiaodong YANG ; Shihua WANG ; Futing JIANG ; Yuhong WANG
Chinese Journal of Interventional Imaging and Therapy 2011;08(5):363-366
ObjectiveTo discuss the prevention and treatment of the perioperative complications in endovascular treatment for arteriosclerosis obliterans (ASO) of lower extremities.MethodsEndovascular treatment was performed for 210 patients (248 limbs) with ASO of lower extremities,including 28 iliac lesions,76 femoral-popliteal lesions,56 inferior genicular lesions and 88 multiple segment lesions.The clinical data and complications were reviewed and analyzed.Results The technical success was achieved in 92.74% (230/248).Perioperative complications occurred in 21 patients (21/210,10.00 %),including hematoma (n= 6),pseudoaneurysm (n= 1),heart failure (n= 2),constrast-induced nephropathy (n = 1),artery perforation (n= 3),artery section (n = 3) and restenosis (n= 5).All the complications were relieved after corresponding treatment.ConclusionEndovascular treatment is a safe and effective method for ASO of lower extremities because of its high success rate and few complications.Effective control of systemic diseases,careful operation and regular treatment after operation are all the effective measures to prevent and reduce the occurrenceof complications.
2.Problem Analysis and Regu latory Countermeasures of Unannounced Inspection and Tracking Inspection of 28 Pharmaceutical Manufacturers
Shihua LU ; Yingying WEI ; Shan LI ; Guanghui WEI
China Pharmacy 2019;30(20):2741-2745
OBJECTIVE: To provide reference for pharmaceutical manufacturers improving the quality system of GMP and drug regulatory departments improving their supervision level. METHODS: Through analyzing and summarizing the problems existing in the 28 pharmaceutical enterprises which had been published on the website in the National Medical Products Administration from February 6th, 2018 to January 25th, 2019, the common problems were found and their causes were analyzed, then the regulatory countermeasures were put forward. RESULTS & CONCLUSIONS: Pharmaceutical enterprises have some problems of inadequate implementation of GMP, such as the inadequate performance of personnel in key positions and the unsatisfactory training effect of relevant personnel, the inconsistency between actual production technology and approved legal technology, the non-standard management of enterprise materials, the incomplete batch production records and the inability to effectively monitor the production cycle. However, there are also some problems in the supervision department, such as the large difference in the scale of inspectors’ on-site inspection, the need to strengthen the inspectors’ inspection ability and level, and the lack of innovation in the means of supervision. It is suggested that pharmaceutical manufacturers should improve the construction of GMP quality management system and strengthen the training of relevant personnel; the regulatory authorities should continue to promote the reform of “release, control and service”, strictly enforce the access conditions of inspectors, strengthen the training of inspectors and ideological construction of the inspector team,further strengthen the construction of supervision system and enhance the innovation of supervision means, so as to jointly maintain the safety, effectiveness and quality controllability of medicines.
3.Value of cystic fluid carcinoembryonic antigen combined with glucose detection in the diagnosis of mucinous cystadenoma of pancreas
Ying ZHUANG ; Jiayun CHEN ; Yan QIU ; Rong ZUO ; Dandan WANG ; Shihua LIU
Modern Interventional Diagnosis and Treatment in Gastroenterology 2024;29(7):794-798
Background and Objective Accurate diagnosis of mucous cystic lesion(PCL)remains a clinical difficult.Both Carcinoembryonic antigen(CEA)and glucose(GLU)are reported to have ability to distinguish mucinous PCL from non-mucinous PCL,but the accuracy was limited.The objective of this study was to evaluate the value of cystic CEA combined with GLU in the diagnosis of mucinous PCL.Methods PCL patients who underwent pancreatic surgery and endoscopic ultrasonography guided fine-needle aspiration(EUS-FNA)were retrospectively collected from the First Affiliated Hospital of Naval Medical University.Clinical data and cystic fluid analysis of included PCLs patients were analyzed using receiver operator(ROC)curves.ROC analysis,sensitivity and specificity analyses were used to evaluate the value of CEA combined with GLU in the diagnosis of mucinous PCL.Results From January 2015 to December 2021,a total of 84 patients underwent cyst fluid CEA and GLU analysis,of whom 44(52.4%)had mucinous PCL and 40(47.6%)had non-mucinous PCL.The AUC for distinguishing mucinous from non-mucinous PCL by CEA was 0.82[(95%confidence interval(CI):0.72-0.92)].When 192 ng/mL was used as the cutoff level,the diagnostic sensitivity and specificity were 50%and 93%,respectively.Using 20 ng/mL as cutoff level,the diagnostic sensitivity increased to 80%and the specificity decreased to 68%.The AUC for the cystic GLU to distinguish mucinous from non-mucinous PCL was 0.73(95%CI:0.99-0.87),and the diagnostic sensitivity and specificity were 100%and 60%,respectively.When the cutoff level of CEA was 192 ng/mL,the AUC of CEA combined with GLU in the diagnosis of mucinous PCLs was 0.94(95%Cl:0.86-0.99),while when the cutoff level of CEA was 20 ng/mL,the AUC of CEA combined with Glu in the diagnosis of mucinous PCLs was 0.94(95%CI:0.85-0.99).The AUCs were significantly higher than the AUC with single diagnostic indicators.Conclusion When using the cutoff level of 192 ng/mL,cyst fluid CEA combined with GLU has high sensitivity and specificity in differentiating mucinous PCL from non-mucinous PCL,so it can be considered for clinical application.Lower CEA cutoff level(20 ng/mL)can improve the sensitivity of diagnosis.
4.Establishment of MRI classification for traumatic osteonecrosis of the femoral head and its correlation with femoral head collapse
Zhikun ZHUANG ; Ziqi LI ; Shihua GAO ; Hanglin QIU ; Zhiqing XU ; Zhibing GONG ; Qingwen ZHANG ; Zhaoke WU ; Wei HE
Chinese Journal of Orthopaedics 2024;44(13):881-888
Objective:To establish a classification system for the repair band in the subchondral bone origination point in MRI for traumatic osteonecrosis of the femoral head (ONFH) and preliminarily explore the correlation between this classification and the progression of femoral head collapse.Methods:A retrospective analysis was conducted on 73 cases of traumatic ON-FH treated at the Quanzhou Orthopedic-traumatological hospital from January 2000 to December 2019. Among them, there were 46 males and 27 females with an average age of 34.9±8.3 years (range 19-55 years). Clinical and radiological data such as age, gender, side, fracture classification, reduction quality, JIC classification, and bone repair band (BRB) classification were recorded. The progression of traumatic ONFH was assessed using the ARCO staging system, with stages IIIA and IIIB defined as mild collapse and progressive collapse, respectively. The BRB classification was established based on MRI findings, and the inter- and intra-observer consistency of the BRB classification was analyzed using Kappa test. The correlation between the BRB classification and progressive femoral head collapse was analyzed using the Kaplan-Meier survival curve and binary variable Cox regression analysis.Results:According to the BRB classification, 73 cases were divided into type 1 with superficial lesion in 38.4%, type 2 with uncertain lesion in 21.9%, and type 3 with extensive lesion in 39.7%. The inter-observer consistency Kappa value for the BRB classification was 0.798, and the intra-observer consistency Kappa value was 0.896, indicating a high level of consistency. A follow-up of 73 cases (54.8±34.9 months, range 24-165 months) showed a significant correlation between the BRB classification and ARCO staging at the last follow-up (χ 2=37.556, P<0.001), with progression to stages IIIA and IIIB as follows: type 1 had 3 and 1 cases, type 2 had 4 and 1 cases, and type 3 had 14 and 12 cases, respectively. Using the occurrence of progressive collapse (stage IIIB) as the endpoint, the risk of progression to stage IIIB for type 2 was not statistically different from type 1 [ HR=1.766, 95% CI (0.465, 6.702), P=0.403]; the risk of progression to stage IIIB for type 3 was significantly higher than for type 1 [ HR=15.126, 95% CI (4.708, 48.592), P<0.001]. Conclusion:The BRB classification is closely related to the progression of traumatic ONFH and is an independent risk factor for predicting the occurrence of progressive collapse; this classification is helpful for early diagnosis and predicting the progression of collapse and treatment plan decision-making.
5.Clinical analysis of 134 case of gallbladder stones complicated with gallbladder carcinoma
Hui JIAO ; Yan LU ; Zhigang ZHANG ; Zuo WANG ; Jing WANG ; Ruibin MA ; Jian LI ; Haiqin LU ; Heyan RU ; Shihua ZHUANG
Chinese Journal of Primary Medicine and Pharmacy 2020;27(13):1555-1558
Objective:To investigate the relationship between gallbladder carcinoma and gallbladder stones, and provide theoretical basis for the prevention and treatment of gallbladder carcinoma.Methods:A case-control study was used to retrospectively analyze the clinical data of 134 patients(study group) with gallbladder stones and gallbladder carcinoma treated in the Xinjiang Uygur Autonomous Region Corps Hospital of Chinese People′s Armed Police Forces from January 2010 to December 2012.Another 134 patients with gallbladder stones were selected as control group, and the clinical characteristics of the two groups were compared.Results:The average age of patients in the study group was (60.5±11.7)years, which was significantly older than that in the control group [(49.6±10.3)years], the difference was statistically significant ( t=7.916, P<0.05). The history of gallbladder stones in the study group and control group were (9.3±4.1)years and (4.6±2.5)years, respectively, and the difference between the two groups was statistically significant( t=11.682, P<0.01). The multiple stones, maximum stone diameter and maximum gallbladder wall thickness in the study group were 75 cases, (2.4±0.6)cm and (0.59±0.16)cm, respectively, which in the control group were 46 cases, (1.3±0.5)cm and (0.87±0.23)cm, respectively, the differences between the two groups were statistically significant(χ 2=3.978, t=6.217, 5.110, all P<0.05). The incidences of cholecystitis and jaundice in the study group were higher than those in the control group, and the differences were statistically significant(all P<0.05). Conclusion:Gallbladder stones are one of the causative factors of gallbladder carcinoma.Early diagnosis of gallbladder carcinoma is difficult.Patients with high-risk gallbladder stones who are old, have a long history of gallbladder stones, multiple stones, large stone diameters, and thick gallbladder walls should actively undergo surgical intervention.
6. Clinical efficacy of percutaneous nephroscopy in the treatment of retroperitioneal abscess after common bile duct exploration
Zhigang ZHANG ; Hui JIAO ; Shihua ZHUANG ; Jian LI ; Haiqin LU ; Zuo WANG ; Jing WANG ; Suxi HUANG
Chinese Journal of Digestive Surgery 2019;18(12):1158-1162
Objective:
To investigate the clinical efficacy of percutaneous nephroscopy in the treatment of retroperitioneal abscess after common bile duct exploration.
Methods:
The retrospective and descriptive study was conducted. The clinical data of 13 patients with retroperitioneal abscess after common bile duct exploration who were admitted to Xinjiang Autonomous Region Hospital of Chinese People′s Armed Forces between January 2004 and December 2018 were collected.There were 5 males and 8 females, aged from 34 to 81 years, with an average age of 57 years. All the 13 patients underwent debridement and drainage for retroperitioneal abscess under percutaneous nephroscope. Observation indicators: (1) surgical and postoperative situations; (2) follow-up. Follow-up was performed using outpatient examination and telephone interview to detect postoperative choledocholithiasis recurrence up to September 2019. Measurement data with skewed distribution were represented as