1.Overview of the British pharmaceutical standard-setting system
Chinese Journal of Health Policy 2014;(9):48-53
The paper presents a detailed review of British pharmaceutical standards including British Pharma-copoeia, European Pharmacopoeia, British Approved Names, Reference Standards and Non-Statutory Pharmaceutical Standards. British pharmaceutical standards are established by the British Pharmacopoeia Commission, Expert Advi-sory Groups, Panels of Experts and Working Parties, British Pharmacopoeia Commission Secretariat, British Pharma-copoeia Laboratory, and standard-setting procedures are clear and definite. British Pharmacopoeia standards are le-gally binding, and pharmaceutical products sold in the United Kingdom must comply with pharmacopoeia require-ments. British pharmaceutical standards can serve as an important reference for reforms to China’s pharmaceutical standards, including the scientific management of pharmaceutical standards, the improvement of organizational frame-works in the establishment pharmaceutical standards, the promptness of amendments to pharmacopoeia, and the uni-versality of international exchanges.
2.Clinical and pathological analysis of urothelial carcinoma with clear cell variant
Gang LI ; Hualin SONG ; Yuming YANG ; Shumin ZHANG ; Yuanjie NIU
Chinese Journal of Urology 2015;36(8):628-631
Objective To investigate the clinical and pathological features of urothelial carcinoma with clear cell variant.Methods The pathological and clinical data of 7 cases pathological diagnosed urothelial carcinoma with clear cell variant between March 2005 and May 2014 were retrospectively reviewed.There were 6 males and 1 female,aged 46-75 years (mean,61 years).Clinical manifestations included gross hematuria in 5 cases,hematuria and backache in another 2 cases.The mean tumor size was 3.5 cm (ranged 2.0-6.0 cm).One case was multiple tumor and 6 cases were single tumor.Five cases were positive in urine cytology.All the 7 cases accepted surgical treatment,including radical nephroureterectomy in 2 cases,transurethral resection of bladder tumor plus pharmorubicin regular intravesicalinstillationin 1 case,and radical cystectomy in 4 patients.Results Pathological findings revealed that all the tumors were high-grade urothelial carcinoma with clear cell variant in different proportion.Among them,clear cell tumor was predominant in 1 case and focal in other 6 cases.Meanwhile,tumorsaccompanied by glandular differentiation were found in 2 cases,squamous differentiation was found in 1 case,and micropapillary variant was found in 1 case.Vascular tumor embolus was found in 4 cases.Pathological stage was pT2a (n =1),pT2b (n =3),and pT3a (n =3).Immunohistochemicalstaining revealed cytokeratin 7 (+),cytokeratin 20 (+),epithelial membrane antigen (+)and prostate specific antigen (-).Six cases were followed up.The bladder preservation case was followed up for 8 months without recurrence.In 3 radical cystectomy cases,1 died of cancer 25 months after surgery and another 2 case were followed up for 10 and 12 months after surgery without recurrence and metastasis.In 2 nephroureterectomy cases,1 died of tumor metastasis 18 months after surgery and the other case was followed up for 6 months without recurrence or metastasis.Conclusions Urothelialcarcinoma with clear cell variant is a malignancy often with advanced stage and poor prognosis.Radical surgery is recommended for the treatment.
3.On the Development and Edification of Canadian Guidelines for the Pharmacoeconomic Evaluation
Ni ZHANG ; Jinxin CHEN ; Hualin SONG ; Li SHENG
China Pharmacy 2001;12(3):138-140
AIM:To put forward the suggestions for standardizing the pharmacoeconomic research.METHODS:The background of formulation and main points of Canadian Guidelines for the Pharmacoeconomic Evaluation were introduced and its recent development was described.At the same time,we put forward our tentative plan about establishing Chinese guidelines for the pharmacoeconomic evaluation.RESULTS & CONCLUSION:A series of guidelines for the pharmacoeconomic evaluation should be established,which is approved by departments of social safeguard,drug supervision and public health administration,to standardize the pharmacoeconomic research.The goverment should make corresponding policy publicized and make pharmacoeconomic evaluation connect with drug price,clinically rational drug use,catalog of classified management of drugs and catalog of drugs in medical insurance.A pharmacoeconomic framework,which conforms China's national conditions and is controlled by goverment,will established.
4.Analysis of pathological character of 4 200 bladder tumor cases
Gang LI ; Xiuzhen WU ; Hualin SONG ; Yuming YANG ; Jiwu CHANG ; Shumin ZHANG ; Yuanjie NIU
Chinese Journal of Urology 2016;37(4):268-271
Objective To investigate the histopathologic characteristics of bladder tumor and provide theoretical basis for the reasonable selection of treatment modality.Methods This retrospective study collected the pathological data of 4 200 bladder tumor from May 2001 to October 2014.There were 3 443 male and 757 female, and the average diameter of these tumors was (1.8 ± 0.6) cm (ranged 0.2 to 6.5 cm).Among all cases, 3 214 (76.5%) cases were solitary tumor while 986 (23.5%) were multiple tumors.The histologic subtype, pathological grade and stage, the existence of vascular and lymphovascular invasion, tumor in situ, abnormal variants and rare subtypes were recorded and analyzed.Results 162 cases (3.9%)were benign tumors and 4 038 cases (96.1%)were malignant tumors including 4 008 cases of urothelial cancer (UC), 18 cases of primary adenocarcinoma and 12 cases of primary bladder squamous carcinoma.Furthermore, 2 460 (61.4%)cases were high grade UC while 1 548(38.6%)cases were low grade.320 cases were found intravascular tumor embolus or lymphovascular tumor thrombus and 391 (9.3%)cases were found metaplasia of squamous epithelium.Moreover, there were 230 cases of squamous differentiation, 120 cases of glandular differentiation, 110 cases of both squamous and glandular differentiation, and 39 cases (0.9%)of other rare subtypes or variations.On pathological stage, 112 (2.8 %) cases were carcinoma in situ, 548 (13.7%)cases were Ta, 2 599(65.1%)cases were T1, 480(12%)cases were T2, 92 cases(2.3%)were T3 and 23 cases(0.6%)were T4 stage, with the rest cases being unable to be accurate staging.Multiple Logistic regression analysis revealed that lymphovascular invasion was related to tumor grade , pathological stage and abnormal differentiation (P < 0.02).Moreover, UC with squamous and glandular differentiation were related with tumor recurrence and progression (P =0.02).Conclusions Most bladder tumors were high grade and low stage urothelial cancer with various forms of differentiation.Squamous and glandular differentiation were most common variation which should be avoided to diagnosed as hybrid carcinoma.Lymphovascular tumor thrombus and abnormal differentiation were correlated with tumor stage and grade.
5.Pathological characteristics of small renal carcinoma and its clinical value
Gang LI ; Hualin SONG ; Chao WANG ; Shumin ZHANG ; Yuming YANG ; Jiwu CHANG ; Yuanjie NIU
Chinese Journal of Urology 2015;36(5):325-328
Objective To study the clinical and histopathologic features of small renal carcinoma (diameter≤4 cm)and provide theoretical basis for evaluating the safety,efficacy and prognosis of nephron sparing surgery.Methods This retrospective study collected the pathological data of 490 patients with small renal cell carcinoma,who were treated in our hospital,from May 2000 to October 2014.We recorded and analyzed the tumor size,histological subtype,Fuhrman grading,pathological stage,the existence of mulifocality,vascular invasion,tumor psuedocapsule,hemorrhage or necrosis and distant metastasis.Results The median diameter of tumor was (3.2 ± 0.6) cm,ranged 0.6 to 4.0 cm.Of all the subjects,422 (86.1%) were clear cell carcinoma,32 (6.5%) were chromophobe cell carcinoma,23 (4.7%) were papillary carcinoma and 13 (2.7%) were other rare types.Among the 422 clear cell carcinoma cases,27 were Fuhrman grade Ⅰ,157 were Ⅰ-Ⅱ grade,210 were grade Ⅱ,21 were Ⅱ-Ⅲ grade,7 were grade Ⅲ and no one was grade Ⅳ.Multifocal tumors were found in 18 cases (3.7%) and tumor embolus of renal vein was found in 6 cases (1.2%).Intact psuedocapsule were found in 326 (66.5%) tumors with the thickness ranged from 0.2 to 1.0 mm.Tumor infiltration without the psuedocapsule penetration were found in 82 cases (16.7%),penetrated into the psuedocapsule were found in 11 cases (2.2%),infringement of perirenal fat were found in 9 cases (1.8%).Hemorrhage and necrosis were found in 240 cases (48.9%),synchronous lung metastases occurred in 3 patients (0.6%).Logistic regression analysis revealed that tumor invasion and pseudocapsule penetration were related to Fuhrman Ⅱ-Ⅲ,Ⅲ and tumor diameter (P =0.04).Moreover,tumor size was related with histological grade and renal capsule invasion (P =0.02).Nevertheless,there was no relationship among tumor size,renal vein embolus or mulifocality (P =0.35).Conclusions Although most small renal tumors are high differentiation and low grade,but rare cases are aggressive with infringement of perirenal fat or early distant metastasis,suggesting heterogeneity in its biological behavior.Most small renal tumors have obvious psuedocapsule.When the tumor size is greater than 3.0 cm and its Fuhrman classification was high,the psuedocapsule and perirenal fat are more likely to be infiltrated.Nephron sparing surgery should remove the tumor and its surface adipose tissue entirely.
6.Reoperative laparoscopic surgery in children with failed pyeloplasty
Hualin CAO ; Huixia ZHOU ; Rui WANG ; Lifei MA ; Dehong LIU ; Xiaoguang ZHOU ; Tian TAO ; Xiaolong LUO ; Yan ZHANG ; Baile SONG
Chinese Journal of Urology 2017;38(5):362-366
Objective To investigate the etilolgy of failed pyeloplasty in children and to study the feasibility of redo laparoscopic surgery for recurrent nreterupelvic junction obstruction.Methods The clinical data of 39 patients with recurrent ureteropelvic junction obstruction after the primary pyeloplasty underwent redo laparoscopic surgery were analyzed retrospectively between September 2009 and June 2016 in our institution.There were 31 males and 8 females with a mean age of 66 months,ranged from 4 to 204 months.28 patients had left obstructions and 11 had fight obstructions,who were diagnosed by ultrasonography,MRU,and MAG3 renal scan et a1.Under general anesthesia,we identified that two patients (5.1%) had renal calices strictures,four patients (10.3%) had unsolved disease ureter and anastomotic strictures,two patients (5.1%) had adhesion band and anastomotic strictures,one patient had adhesion band,high ureteropelvic anastomosis and ureter torsion,and 30 (76.9%) patients had anastomotic strictures.Thirty-three patients underwent cdismembered pyeloplasty,five patients underwent onlay appendiculoureteroplasty and one patient underwent ureterocalicostomy.Results All surgeries were successfully completed without conversion.No intraoperative complication was encountered.One patient had persistent,frequent and intolerable flank pain with severe hydronephrosis after surgery,he subsequently underwent nephrectomy.One patient had persistent severe hydronephrosis which was repaired with on-lay appendiculoureteroplasty.One patient had anastomotic adhesion and balloon dilatation was performed with no further obstruction in follow up imaging.The rest of the patients got complete clinical or radiologic resolution.The successive rate was 36 of 39 (92.3%) at a mean follow up of 25 months (ranging 3-60 months).Conclusions Unsolved ureteric pathologies,anastomotic stricture,renal calices stricture,adhesion band,torsion of ureter and high ureteropelvic anastomosis all contribute to recurrent obstruction after the primary pyeloplasty.Laparoscopic redo pyeloplasty is safe and feasible for skilled surgeons.