OBJECTIVE: To compare the pharmacokinetic parameters between matrine tablets and matrine capsules in healthy volunteers and evaluate the bioequivalence of the two formulations.METHODS: 18 healthy volunteers were assigned to receive matrine tablets(test formulation,600mg) and matrine capsule(reference formulation) respectively q.d on empty stomach.The plasma concentrations of oxymatrine before and after medication were determined by HPLC and the pharmacokinetic parameters(calculated by oxymatrine) were calculated.RESULTS:The pharmacokinetic parameters of matrine tablets vs.matrine capsules in healthy volunteers were as follows:t1/2:(1.51?0.62)h vs.(1.53?0.54)h;Tmax:(1.35?0.13) hvs.(1.29?0.13)h;Cmax:(730.86?101.13)ng?mL-1 vs.(729.58?74.35)ng?mL-1;AUC0～8:(2 579.1?244.4)ng?h? mL-1 vs.(2 505.7?223.5)ng?h?mL-1;AUC0～∞:(2 754.1?331.8)ng?h?mL-1 vs.(2 659.4?253.5)ng?h?mL-1.The relative bioavailability of matrine tablets(calculated by oxymatrine) was(103.7?13.3)%.CONCLUSION: There are no significant differences between matrine tablets and matrine capsule in main pharmacokinetic parameters,which were in conformity with the presumption of bioequivalence between different individuals,different periods or different dosage forms.The two formulations are bioequivalent.

Objective To investigate the features of renal lesions in von Hippel-Lindau (VHL) disease and the surgical intervention. Methods The clinical and pathological data from 6 patients with renal lesions in a large Chinese VHL disease kindred were reviewed individually.One patient had multifocal renal cysts,and 5 patients had bilateral renal cell carcinomas and multifocal renal cysts. Results Among 10 kidneys in the 5 cases of bilateral renal cell carcinomas, nephron-sparing surgery (NSS) was performed in 5,radical nephrectomy (RN) in 3 and observation in 2.After operation,the pathological findings indicated that all solid lesions were renal clear cell carcinoma, with one malignant cyst being detected.The Fuhrman's nuclear grade of the RCC was grade Ⅰ in 14 tumors,grade Ⅱ in 6 tumors.The TNM stage was T 1N 0M 0 in 4 cases and T 2N 0M 0 in 1 case.During a mean follow-up of 47 months (range,9 to 113 months),all patients were alive without evidence of RCC recurrence and metastasis.Five patients had normal renal function and 1 patient experienced an increase in serum creatinine but without dialysis. Conclusions The renal lesions in VHL disease include both cysts and carcinomas,which are often multifocal and bilateral.Almost all the tumors are of clear cell type with a low stage and grade.Nephron-sparing surgery may be justified and effective in the management of VHL patients.

Objective To study the effects of community-based rehabilitation on cerebral apoplexy patients with cognitive disorders.Methods 30 cases of cerebral apoplexy patients were enrolled according to relevant standards,who were given standard rehabihtation care in Community Health Service Center(training group) ,while another 30 similar cases from subordinate health service stations (control group) given only rehabilitation guidance once a week.Two groups were not do professional cognitive training.All patients were assessed with Mini Mental State Examination( MMSE), Fugl-Meyer Assessment(FMA) and modified Bathel index rating scale(MBI) to evaluate their cognition ,movement function and activity of daily living(ADL) before training as well as after 4-week and 8-week training.Results There was no signficant difference in cognition,movement functions and ADL between training group and control group before treatment(P>0.05).The differences in the assessment of Brounnstrom scale and MBI between two groups after 4-week training were not significant( P > 0.05 ).The scores of Fugl-Meyer scale, MMSE and Barthel index of the training group after 8-week training were significantly higher than those of control group( all P < 0.05 ).Conclusion Community-based rehabilitation training could improve the movement functions and ADL,and cognitive functions of cerebral apoplexy patients.

Background: Hypoalbuminemia adversely affects the clinical outcomes of various cancers. The purpose of this study was to estimate the prognostic value of hypoalbuminemia 3–5 weeks after treatment in patients with metastatic renal cell carcinoma (mRCC) who received sorafenib or sunitinib as first-line treatment. Methods: In this single-center, retrospective study, we assessed the progression-free survival (PFS) and overall sur-vival (OS) of 184 mRCC patients who received first-line sorafenib or sunitinib treatment. PFS and OS were compared between patients with post-treatment hypoalbuminemia (post-treatment albumin level <36.4 g/L) and those with normal post-treatment albumin level (albumin level ≥36.4 g/L). The Memorial Sloan Kettering Cancer Center (MSKCC)risk model stratified mRCC patients into three risk categories. Prognostic values of all patient characteristics including MSKCC risk category were determined by using univariate and multivariate Cox regression models. Prognostic value was further determined using the Harrell concordance index and receiver operating characteristic curve analysis. Results: The median PFS and OS of the 184 patients were 11 months (95% confidence interval [CI] 9–12 months) and 23 months (95% CI 19–33 months), respectively. Patients with post-treatment hypoalbuminemia had significantly shorter median PFS (6 months [95% CI 5–7 months]) and OS (11 months [95% CI 9–15 months]) than patients who had normal post-treatment albumin levels (PFS: 12 months [95% CI 11–16 months], P < 0.001; OS: 31 months [95% CI 24–42 months], P < 0.001), respectively. Multivariate analysis showed that post-treatment hypoalbuminemia was an independent predictor of PFS (hazard ratio [HR], 2.113; 95% CI 1.390–3.212; P < 0.001) and OS (HR, 2.388; 95% CI 1.591–3.585; P < 0.001). Post-treatment hypoalbuminemia could also be combined with the MSKCC risk category for better prediction about OS. The model that included post-treatment hypoalbuminemia and MSKCC risk category improved the predictive accuracy for PFS and OS (c-index: 0.68 and 0.73, respectively) compared with the basic MSKCC risk model (c-index: 0.67 and 0.70, respectively). The prognostic values for PFS and OS of the integrated MSKCC risk model involving post-treatment hypoalbuminemia were significantly more accurate than the basic MSKCC risk model using likelihood ratio analysis (both P < 0.001). Conclusions: Post-treatment hypoalbuminemia can be considered an independent prognostic factor for patients with mRCC who undergo first-line treatment with tyrosine kinase inhibitors. Additionally, integrating post-treatment serum albumin level into the basic MSKCC risk model can improve the accuracy of this model in predicting patient overall survival and progression-free survival.

Objective To study the natural history of renal cell carcinomas associated with von Hippel-Lindau disease (VHL). Methods An active surveillance strategy was carried out on 11 VHL cases(5 males and 6 females with average age of 45 years)with 32 renal masses. The mean maximum diameter of these masses at initial diagnosis was 2. 5 cm ranging from 0. 5 to 6.2 cm. Clinical materials, radiographic, and pathologic records were reviewed to determine tumor growth rate, subsequent interventions and outcome of follow-up. Results During a median follow-up of 70 months (range 32 to 258 months), bilateral solid renal tumors developed in 6 patients;13 surgical interventions were performed in 8 cases;tumor local recurrence occurred in 4 cases;3 cases died (2 of metastasis diseases and 1 of an unrelated disease) ;8 cases survived with 1 case taking regular hemodialysis.The median follow-up duration for 32 renal masses was 51 months (range 19 to 106 months). The mean tumor growth rate observed were 0. 55 cm/year (range 0. 04 to 1.75 em/year). Three tumors grew faster (1.13-1.75 cm/year), and the other 29 tumors grew slower (0. 17-0.88 cm/year).Among the 3 tumors, 1 was found to be grade Ⅱ at pathologic examination and another developed metastasis. Progression to metastatic disease was found in 2 patients. At the last follow-up, 27 (84 %)tumors were larger than 3 cm and no metastasis disease developed among tumors less than 4 cm.Conclusions The majority of enhanced renal masses with VHL disease may still be indolent and do not metastasize during long period of follow-up even in tumors larger than 3 cm. Active surveillance appears to be a reasonable option for VHL patients with enhanced renal masses less than 4 cm.

Objective To discuss the management of renal cell carcinoma(RCC) associated with von Hippel-Lindau(VHL) disease. Methods Clinical data were analyzed retrospectively from 28 ca-ses ( 16 males and 12 females, with a mean age of 45 years), of whom 15 had bilateral RCC and 13 had unilateral RCC. VHL germline mutation was analyzed in 25 cases. Nephron sparing surgery (NSS) or radical nephrectomy was performed in 24 cases. Results VHL germline mutations were detected in 25 cases including 14 asymptomatic patients. Among 29 solid renal tumors in 9 cases observed for a mean time of 44 months (range 12 to 86), the mean increase in tumor size was 0. 531 cm/year. There were 19(65.5%) tumors>3 cm at the end of follow-up but only 1 developed retroperitoneum lymph nodes metastasis. A total of 87 solid tumors were removed and 62 (71.3%) solid tumors were man-aged by NSS. Pathological results showed 86 clear cell carcinomas (73 Fuhrman Ⅰ and 12 Fuhrman Ⅱ ) and 1 calcified lesion. During mean follow-up of 50(5-237) months, local recurrence occurred in 4 cases treated with NSS; 26 patients were alive at the end of follow-up. Conclusions DNA testing might be helpful in the earlier detection of asymptomatic VHL patients. Most solid renal tumors in VHL disease grow slowly. The majority of the tumors >3 cm may still be indolent and do not metas-tasize during longer follow-up and can be observed. NSS is effective and safe for RCC in VHL disease.

Objective To discuss the necessity of closing the peritoneum during the operation of ileal conduit after the radical cystectomy.Methods We retrospectively analyzed the clinical data of 395 patients with bladder cancer who received radical cystectomy from Jan.2014 to Sep.2016.The amount of male was 327,female was 68.The mean age was (65.8 ± 9.7) years old.Patients were divided into four groups according to the surgical method of cystectomy and urinary diversion.In group A,patients,including 78 males and 9 females,were received open radical cysectomy (ORC) with extraperitoneal ileal conduit.The mean age was (67.8 ± 9.2) years old.In the preoperative clinical staging,66 cases were less than T2 and 21 cases were more than T2.Preoperative pathological grade in 83 cases and low grade in 4 cases.In group B,patients,including 31 males and 2 females,were accepted ORC with ileal conduit without peritoneum closure.The mean age was (67.3 ± 8.7) years old.Preoperative clinical staging showed less than T2 in 25 cases,more than T2 in 8 cases,The preoperative pathological grade showed high grade in 33 cases.In group C,patients,including 112 males and 27 females,were accpeted LRC with ileal conduit without peritoneum closure.The mean age was (64.3 ± 10.5)years old.The preoperative clinical staging showed less than T2 in 107 cases and more than T2 in 32 cases.The preoperative pathological grade showed high grade in 135 cases and low grade in 4 cases.In group D,patients,including 106 males and 30 females,were accepted RARC with ileal conduit without peritoneum closure.The mean age was (65.9 ±10.0)years old.Preoperative clinical staging showed less than T2 in 103 cases and more than T2 in 33 cases.The preoperative pathological grade showed high grade in 132 cases and low grade in 4 cases.Ileal conduit without peritoneum closure means completely open the peritoneum after anastomosis of the ureter and intestine in the urinary diversion surgery without shutting down the peritoneum,which is different from the extraperitoneal ileal conduit.The operating time,blood loss,blood transfusion rate,recovery time of intestinal function and perioperative complications and rate of hydronephrosis were analyzed.Results The 395 cases completed operation successfully,no LRC or RARC had been converted to ORC.The operative time was (280.1 ± 92.3) min,(233.6 ± 99.4) min,(304.8 ± 108.9) min,(364.6 ± 86.4) min in four groups,respectively (P ＜ 0.05).The blood loss in four groups were (489.1 ± 285.6) ml,(431.8 ± 233.1) ml,(373.0 ±213.7) ml,(205.6 ± 137.8) ml,respectively (P ＜0.05).The transfusion rate in four groups were 18 (20.7％),16 (48.0％),15 (10.8％),14 (10.3％),respectively (P ＜ 0.05).The mean time to flatus in four groups were (3.7 ±1.8)d,(3.6±1.0)d,(3.5±1.2)d,(2.2±1.7)d,respectively (P ＜ 0.05).While ileal obstruction rate had no statistical difference in four groups [group A 17 cases(19.5％),group B 6 cases(18.2％),group C 27 cases(19.4％),group D 19 cases(14.0％),P =0.678].Urine leakage,intestinal leakage,lymphocyst were only occurred in group A [7 cases (8.0％),2 cases (2.3％),2 cases (2.3％)].Pyelonephritis was noticed in each group,including 14 cases(16.1％)in group A,2 cases(6.1％)in group B,9 cases (6.5％)in group C,6 cases(4.4％)in group D (P ＜ 0.05).Hydronephrosis 6 months after surgery was observed in four groups,including 15 cases(17.2％)in group A,3 cases(9.1％)in group B,7 cases(5.0％)in group C,5 cases(3.7％)in group D (P ＜ 0.05).Conclusions Ileal conduit without peritoneum closure would not increase the incidence of complications,on the contrary,it would relieve the tension of anastomosis,and reduce the occurrence of complications such as urine leakage.

Background: Sorafenib and sunitinib are widely used as first-line targeted therapy for metastatic renal cell carcinoma (mRCC) in China. This study aimed to compare the efficacy, safety, and quality of life (QoL) in Chinese mRCC patients treated with sorafenib and sunitinib as first-line therapy. Methods: Clinical data of patients with mRCC who received sorafenib (400 mg twice daily; 4 weeks) or sunitinib (50 mg twice daily; on a schedule of 4 weeks on treatment followed by 2 weeks off) were retrieved. Primary outcomes were overall survival (OS), progression-free survival (PFS), adverse events (AEs), and QoL (SF-36 scores), and secondary outcomes were associations of clinical characteristics with QoL. Results: Medical records of 184 patients (110 in the sorafenib group and 74 in the sunitinib group) were reviewed. PFS and OS were comparable between the sorafenib and sunitinib groups (bothP > 0.05). The occurrence rates of leukocytopenia, thrombocytopenia, and hypothyroidism were higher in the sunitinib group (36.5％ vs. 10.9％, P < 0.001; 40.5％ vs. 10.9％,P < 0.001; 17.6％ vs. 3.6％,P= 0.001), and that of diarrhea was higher in the sorafenib group (62.7％ vs. 35.2％,P < 0.001). There was no significant difference in SF-36 scores between the two groups. Multivariate analysis indicated that role-physical and bodily pain scores were associated with the occurrence rate of grade 3 or 4 AEs (P= 0.017 and 0.005). Conclusions: Sorafenib has comparable efficacy and lower toxicity profile than sunitinib as first-line therapy for mRCC. Both agents showed no significant impact on QoL of patients.

Objective: To investigate the therapeutic effects of surgical management for local retroperitoneal recurrence of renal cell carcinoma after radical nephrectomy. Methods: Clinical and follow-up data of 33 cases of local recurrence after radical nephrectomy in Renji Hospital from January 2010 to April 2018 were retrospectively analyzed. Results: In these 33 patients, 25 was male and 8 was female; The median age was 54 years old. The pathological stage of radical nephrectomy included 14 cases of pT1-2N0M0 stage, 16 cases of pT3-4 N0M0 stage, and 3 cases of pN1 stage. Only 4 relapsing patients had symptoms, the others were all found to have recurrence by imaging examination during follow up period of postoperation.The median recurrence time for all patients was 30 months, and the median diameter of recurrent tumors was 4.5 cm.Twenty-nine patients underwent complete resection of local recurrent lesions, and 4 patients whose recurrent lesions could not be completely resected converted receive palliative surgery. The median intraoperative blood loss was 500 ml and the median hospital stay after surgery was 4 days. Clavien grade Ⅰ-Ⅱ complications occurred in 5 patients after surgery, and no serious complications of Clavien grade Ⅲ-Ⅴ complications occurred. Six patients received postoperative adjuvant target therapy and distant metastasis occurred in one patient.In the 27 patients without adjuvant target therapy, postoperative distant metastases occurred in 12 patients. The median survival time for all patients after local recurrence surgery was 31 months. The 1-year and 3-year survival rates were 86.8% and 36.9%, respectively. Conclusions The rigorous imaging examination after radical nephrectomy can detect local recurrent lesions as early as possible in most relapsing patients and imaging examination can predict the integrity of surgical resection of local recurrence.Although intraoperative bleeding of resection of local recurrence is relatively high, the operation is safe and the postoperative complications are controllable. Postoperative adjuvant therapy may also provide better survival benefit for patients with local recurrence.

Background and Objectives: Preimplantation QRS-T morphology screening (TMS) is a composite tool for selecting subcutaneous implantable cardioverter defibrillator (S-ICD) candidates. However, its role in predicting the patient's response to cardiac resynchronization therapy (CRT) is uncertain. Methods: A total of 55 consecutive de novo CRT candidates were enrolled between January 2016 and March 2017. Electrocardiogram (ECG) and TMS were performed before and soon after implantation. The ECG parameters were recorded, including QRS duration and morphology (such as ΔQRS_Index, QTc during biventricular pacing mode [BiV pacing QTc], and QRS/T ratio during biventricular pacing mode [BiV pacing QRS/T ratio]). TMS monitored three sensory vectors of the S-ICD. Six months after implantation, the responses to CRT were evaluated. Results: Thirty-nine patients (70.9%) passed the TMS during biventricular pacing mode. At the six-month follow-up, the number of responders and super-responders was significantly higher in the passing group than in the non-passing group (responders: 31/39 [79.5%] vs.5/16 [31.3%], p<0.001; super-responders: 9/39 [23.1%] vs. 1/16 [6.3%], p=0.020). The superresponse rate was higher among patients who passed all three vectors than among those who passed 1 or 2 vectors (3 vs. 2 vectors, p=0.018; 3 vs. 1 vector, p=0.003). A smaller left atrial diameter, vectors that passed TMS during biventricular pacing mode, and larger ΔQRS_Index values were independently associated with good CRT response. Conclusions Our study demonstrated that patients on CRT who pass the TMS during biventricular pacing mode are more likely to respond and super-respond to CRT.