OBJECTIVETo evaluate the clinical efficacy of syndrome differentiation-based treatment with traditional Chinese medicine (TCM) versus losartan therapy in addition to basic treatment for management of proteinuria in patients with chronic kidney disease.

METHODSThis multicenter, randomized, and case-controlled clinical trial was conducted among 81 consecutive patients meeting the inclusion criteria. The patients were randomized consecutively to receive TCM treatments according to the syndrome patterns in TCM (spleen and kidney Qi and Yin deficiency, and spleen and kidney Qi and Yang deficiency, n=60) or oral losartan therapy (50 mg/day, n=21) in addition to the basic treatments. All the patients were followed up for 24 weeks to observe the clinical effects.

RESULTSThe patients in TCM group showed a significantly higher overall response rate (93.33%) than those in losartan group (76.20%, P<0.05). The TCM score in the two groups were all decreased at week 24 as compared with baseline (P<0.01 or P<0.05). The TCM scores in both groups decreased significantly after the treatments as compared with the baseline scores (P<0.05). After a 8-week-long treatment, Scr, eGFR and Cys-C, U-Pro/24 h, and MA/Cr all decreased significantly in TCM group (P<0.05) but showed no significant changes in losartan group (P>0.05).

CONCLUSIONSyndrome differentiation-based TCM treatment in addition to basic treatments can produce satisfactory therapeutic effects on proteinuria in patients with chronic kidney disease by improving the clinical symptoms, reducing TCM symptom scores and proteinuria, and protecting the renal functions.

Adult ; Aged ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Losartan ; therapeutic use ; Male ; Medicine, Chinese Traditional ; methods ; Middle Aged ; Phytotherapy ; Prospective Studies ; Proteinuria ; drug therapy ; etiology ; Renal Insufficiency, Chronic ; complications ; drug therapy

Objective:To investigate the predictive value of systemic immune inflammation index (SII) for the overall survival of patients with pancreatic cancer by propensity score matching analysis.Methods:The clinical data of 457 patients with pancreatic cancer admitted to the Affiliated Hospital of Qingdao University from August 2000 to December 2019 were retrospectively analyzed. The age, gender, presence of jaundice, pancreatitis and diabetes, serum CA19-9, total bilirubin level, neutrophil count, platelet count, lymphocyte count in blood, presence of radical surgery, tumor TNM stage, tumor location and the like were recorded. The cut-off value of SII was determined by Youden index. The patients were divided into high and low SII groups accroding to the cut-off value. The propensity score matching was applied to reduce the selection bias of patients. Patients were 1∶2 matched and the caliper value was 0.1. The difference on overall survival between the two groups was compared. The prognostic factors were analyzed by univariate and multivariate Cox regression analysis. Kaplan-Meier was used to draw the overall survival curve to calculate the cumulative survival rate, and the differences between the curves were analyzed by Log-Rank test.Results:The cut-off value of SII was 765. There were statistically significant differences between the high SII group ( n=125) and the low SII group ( n=332) on the presence or absence of pancreatitis, the level of total bilirubin in blood, radical surgery, and TNM stage before the propensity score matching (all P value <0.05). After propensity score matching, there was no statistically significant difference between the high SII group ( n=113) and the low SII group ( n=182) on all the clinical parameters mentioned above except for CA19-9, indicating that the two groups were comparable. Univariate analysis showed that the level of CA19-9, SII, radical surgery and different TNM stage were all related to the overall survival of pancreatic cancer patients. Multivariate analysis showed that high CA19-9 level, high SII, no radical surgery, and worse TNM stage were independent risk factors for short overall survival, and high SII ( HR=1.882, 95% CI 1.446-2.450, P<0.001) was significantly associated with poor prognosis. The overall survival of patients with high SII was obviously shorter than the low SII group ( P<0.001), and the average survival time of patients with high and low SII were 8.86 and 11.38 months, respectively. Conclusions:SII is of great value in evaluating the overall survival of pancreatic cancer patients. Higher SII is associated with shorter overall survival.

Purpose: Reduced quality of life after cystectomy has made bladder preservation a popular research topic for muscle-invasive bladder cancer (MIBC). Previous research has indicated significant tumor downstaging after neoadjuvant chemotherapy (NAC). However, maximal transurethral resection of bladder tumor (TURBT) was performed before NAC to define the pathology, impacting the real evaluation of NAC. This research aimed to assess real NAC efficacy without interference from TURBT and apply combined modality therapies guided by NAC efficacy. Materials and Methods: Patients with cT2-4aN0M0 MIBC were confirmed by cystoscopic biopsy and imaging. NAC efficacy was assessed by imaging, urine cytology, and cystoscopy with multidisciplinary team discussion. Definite responders (≤ T1) underwent TURBT plus concurrent chemoradiotherapy. Incomplete responders underwent radical cystectomy or partial cystectomy if feasible. The primary endpoint was the bladder preservation rate. Results: Fifty-nine patients were enrolled, and the median age was 63 years. Patients with cT3-4 accounted for 75%. The median number of NAC cycles was three. Definite responders were 52.5%. The complete response (CR) was 10.2%, and 59.3% of patients received bladder-sparing treatments. With a median follow-up of 44.6 months, the 3-year overall survival (OS) was 72.8%. Three-year OS and relapse-free survival were 88.4% and 60.0% in the bladder-sparing group but only 74.3% and 37.5% in the cystectomy group. The evaluations of preserved bladder function were satisfactory. Conclusion After stratifying MIBC patients by NAC efficacy, definite responders achieved a satisfactory bladder-sparing rate, prognosis, and bladder function. The CR rate reflected the real NAC efficacy for MIBC. This therapy is worth verifying through multicenter research.

Objective:To investigate the long-term survival and safety in patients with muscle-invasive bladder cancer (MIBC) who experienced a noninvasive down-staging (≤pT 1)after transurethral resection of bladder tumor (TURBT) plus systemic chemotherapy and received bladder-sparing treatment. Methods:The records of patients with MIBC who underwent maximal TURBT plus systemic chemotherapy-guided bladder-sparing treatment were reviewed retrospectively from Dec 2013 to Dec 2020. Eventually, 22 patients who achieved noninvasive down-staging underwent conservative management. The total patient cohort contained 10 males and 12 females. A majority of patients had single lesion and stage T2 disease. The median age of the patients was 66 years and the median tumor size was 3.0 cm. All patients underwent maximal TURBT to resect all visible diseases and followed by 3-4 cycles platinum-based systemic chemotherapy. After achieving noninvasive down-staging, 14 patients received concurrent chemoradiotherapy, and the other 8 patients underwent surveillance. Overactive bladder symptom score (OABSS) was used to assess the bladder function after treatment.Results:Twelve patients achieved pT 0 and 10 patients were down-staged to cT a-T 1. At a median follow-up of 36.7 months, 90.9%(20/22) patients retained their bladder function successfully. Among the 14 patients who received concurrent chemoradiotherapy, 4 had grade 3 or 4 adverse events. Among the 8 patients who underwent surveillance, 3 had grade 3 or 4 adverse events after systemic chemotherapy.Nine patients experienced tumor recurrence in the bladder, and 2 patients died of bladder cancer. Seven (31.8%) patients experienced Ⅲ/Ⅳ grade complications. The 5-year recurrence-free survival (RFS) and overall survival (OS) in patients achieved pT0 were 66.7% and 100.0%, respectively. The 5-year RFS and OS in patients achieved cTa-T1 were 40% and 72%, respectively. The OABSS score of 20 patients who retained their bladder successfully was (1.00±1.03). Conclusions:MIBC patients who achieved noninvasive down-staging might be candidates for the bladder-sparing treatment with maximum TURBT followed by systemic chemotherapy.The patients who achieved pT 0 might have better prognosis with functional bladder.