OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

OBJECTIVEThe influence of anti-tuberculosis (TB) treatment history on tuberculous lymphadenitis (TBLN) diagnosis is unclear. Therefore, this study aims to evaluate the diagnostic methods, including histology, microbiology, and molecular tests, used for TBLN.

METHODSIn this study, suspected patients with TBLN and having different anti-TB treatment background were enrolled. All the samples were tested simultaneously by histology, Ziehl-Neelsen (ZN) staining, mycobacterial culture (culture), Xpert MTB/RIF (xpert), real-time PCR, and high-resolution melting curve PCR (HRM). Thereafter, the performance of these methods on samples with different anti-TB treatment background was assessed.

RESULTSIn our study, 89 patients were prospectively included 82 patients with TBLN and 7 with other diseases. The overall sensitivities of Xpert, real-time PCR, histology, ZN staining, and culture were 86.6%, 69.5%, 58.5%, 43.9%, and 22.0%, respectively. The anti-TB treatment history revealed dramatic influences on the sensitivity of culture (P < 0.0001). In fact, the treatment that lasted over 3 months also influenced the sensitivity of Xpert (P < 0.05). However, the treatment history did not affect the performance of remaining tests (P > 0.05). For rifampicin drug susceptibility test (DST), the anti-TB treatment showed only significant influence on the success rate of culture DST (P = 0.001), but not on those of Xpert and HRM tests (P > 0.05).

CONCLUSIONOther tests as well as culture should be considered for patients with TBLN having retreatment history or over 1-month treatment to avoid false negative results.

Adolescent ; Adult ; Aged ; Antitubercular Agents ; therapeutic use ; Bacteriological Techniques ; Drug Resistance, Bacterial ; Female ; Humans ; Male ; Middle Aged ; Tuberculosis, Lymph Node ; diagnosis ; drug therapy ; microbiology ; Young Adult

Objective:To analyze the effectiveness and safety of the treatment strategies for vascular restenosis after stent implantation in atherosclerosis obliterans (ASO) .Methods:The clinical data of 5 cases who had received drug‐perfused balloon from January to July in 2016 and 15 cases who had received femoral artery retrograde endarterectomy from June 2012 to July 2016 after presenting reocclusion or restenosis atherosclerosis lesions were reviewed retrospectively .The effects of surgery and complications in follow‐up period were analyzed .The effectiveness ,availability and safety of the above two methods were assessed .Results:The 20 patients had acquired an adequate blood perfusion in their distal limbs and got warmer on their feet after underwent drug‐perfused balloon and stent implantation or femoral artery retrograde endarterectomy .In addition ,they could have good palpitation in dorsal artery of feet and have better feelings on account of relieving pain .In the follow‐up ,no restenosis case had been found among them .Conclusions:The application of the stent angioplasty after using drug‐perfused balloon and femoral artery retrograde endarterectomy on vascular restenosis after stent implantation in atherosclerosis lesions proved to be effective and safe ,greatly reducing the restenosis or reocclusion frequency .

BACKGROUNDSrc homology 2 domain-containing protein tyrosine phosphatase-2 (SHP-2) is a kind of intracellular protein tyrosine phosphatase. Studies have revealed its roles in various disease, however, whether SHP-2 involves in renal fibrosis remains unclear. The aim of this study was to explore the roles of myeloid cells SHP-2 in renal interstitial fibrosis.

METHODSMyeloid cells SHP-2 gene was conditionally knocked-out (CKO) in mice using loxP-Cre system, and renal interstitial fibrosis was induced by unilateral ureter obstruction (UUO). The total collagen deposition in the renal interstitium was assessed using picrosirius red stain. F4/80 immunostaing was used to evaluate macrophage infiltration in renal tubular interstitium. Quantitative real-time polymerase chain reaction and enzyme linked immunosorbent assay were used to analyze the production of cytokines in the kidney. Transferase-mediated dUTP nick-end labeling stain was used to assess the apoptotic renal tubular epithelial cells.

RESULTSSrc homology 2 domain-containing protein tyrosine phosphatase-2 gene CKO in myeloid cells significantly reduced collagen deposition in the renal interstitium after UUO. Macrophage infiltration was evidently decreased in renal tubular interstitium of SHP-2 CKO mice. Meanwhile, the production of pro-inflammatory cytokines was significantly suppressed in SHP-2 CKO mice. However, no significant difference was observed in the number of apoptotic renal tubular epithelial cells between wild-type and SHP-2 CKO mice.

CONCLUSIONSOur observations suggested that SHP-2 in myeloid cells plays a pivotal role in the pathogenesis of renal fibrosis, and that silencing of SHP-2 gene in myeloid cells may protect renal from inflammatory damage and prevent renal fibrosis after renal injury.

Animals ; Enzyme-Linked Immunosorbent Assay ; Female ; Fibrosis ; enzymology ; pathology ; Immunohistochemistry ; Kidney Diseases ; enzymology ; pathology ; Male ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Myeloid Cells ; metabolism ; Protein Tyrosine Phosphatase, Non-Receptor Type 11 ; genetics ; metabolism ; Ureteral Obstruction ; enzymology ; pathology

Aged ; Humans ; Male ; Urinary Diversion ; adverse effects ; Urinary Fistula ; diagnosis ; etiology

OBJECTIVETo evaluate the efficacy of laparoscopic total mesorectal excision (laparoscopic TME) versus open total mesorectal excision (open TME) in the treatment of middle and low rectal cancer using meta-analysis.

METHODFrom 1991 to 2012, the Chinese and English articles of randomized controlled trails (RTCs) about laparoscopic TME versus open TME in the treatment of middle and low rectal cancer were collected, and a meta-analysis was performed with RevMan 5.1 software.

RESULTSEight RCTs including 863 patients with middle and low rectal cancer (428 cases in laparoscopic TME group, 435 cases in open TME group) were enrolled in the meta-analysis. Laparoscopic TME was associated with significantly less intraoperative blood loss (P<0.01), earlier to pass first flatus (P<0.01), shorter hospital stay (P<0.05), less postoperative incision infections (P<0.01) and postoperative bleeding (P<0.05) compared to open TME. There were no significant differences between laparoscopic TME and open TME groups in operative time, number of resected lymph nodes, anastomotic leak, ileus and pelvic abscess (all P>0.05).

CONCLUSIONSAs compared to open TME, laparoscopic TME has similar efficacy in terms of lymph nodes harvest, and it can promote postoperative recovery, and reduce incision infection and postoperative bleeding.

Humans ; Laparoscopy ; methods ; Mesentery ; surgery ; Randomized Controlled Trials as Topic ; Rectal Neoplasms ; surgery ; Rectum ; surgery ; Treatment Outcome

BACKGROUNDTransurethral resection of the bladder tumor (TURBT) remains the gold standard for non-muscle-invasive bladder cancer (NMIBC). Laser techniques have been widely used in urology. This analysis aimed to assess the safety and efficacy of holmium resection of the bladder tumor (HoLRBT) vs. TURBT.

METHODSA systemic search of MEDLINE, Embase, Web of Science, and The Cochrane Library as well as manual bibliography searches were performed to identify the relevant studies. The pooled estimates of operation time, obturator nerve reflex rate, bladder perforation rate, bladder irrigation rate, catheterization time, hospital stay, and one- and two-year recurrence free survivals were calculated.

RESULTSFive studies were enrolled into our meta-analysis. No significant difference was observed in the operation time between groups (weighted mean difference (WMD) 1.01, 95% confidential interval (95% CI) -3.52 - 5.54, P = 0.66). The significant difference in the obturator nerve reflex (OR 0.05, 95% CI 0.01 - 0.04, P = 0.004), bladder perforation (OR 0.14, 95% CI 0.03 - 0.61, P = 0.009), bladder irrigation (OR 0.13, 95% CI 0.04 - 0.45, P = 0.001), catheterization time (WMD -0.96, 95% CI -1.11 to -0.82, P < 0.00001), and hospital stay (WMD -1.46, 95% CI -1.65 to -1.27, P < 0.00001) showed advantages of HoLRBT over TURBT. The 2-year recurrence free survival rate favors the HoLRBT group (OR 1.46, 95% CI 1.02 - 2.11, P = 0.04).

CONCLUSIONSAs a promising technique, HoLRBT is safe and efficient, and showed several advantages over TURBT. HoLRBT can be used as an alternative procedure for TURBT in terms of low-grade papillary urothelial carcinoma or low-grade early TNM-stage urothelial carcinoma.

Aged ; Female ; Follow-Up Studies ; Humans ; Lasers, Solid-State ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Urethra ; Urinary Bladder Neoplasms ; surgery

BACKGROUNDAlthough many midterm oncologic data have been reported for extraperitoneal laparoscopic radical prostatectomy (ELRP) in western countries, few oncologic data of the extraperitoneal procedure was published in China. The aim of the study was to evaluate the oncologic outcomes of patients treated with ELRP in China.

METHODSFrom January 2005 to March 2010, a total of 152 consecutive patients diagnosed with clinically localized prostate cancer were included in this study and treated with ELRP. The patients were staged according to the TNM (tumor, nodes, metastases) system. Median and mean postoperative follow-up were 28.1 months and 27.0 months, respectively. The patients were retrospectively analyzed for progression-free survival.

RESULTSOne hundred and twelve cases (73.7%) were postoperatively diagnosed as pT2 in, and 40 cases (26.3%) as pT3. Positive lymph nodes were shown in 5 patients (3.3%). Gleason score was < 7 in 49 men (32.2%), 7 in 69 men (45.4%), and > 7 in 34 men (22.4%). Positive surgical margins (PSM) were observed in 15 patients (9.9%), which included 32.0% of all pT3a cases and 46.7% of all pT3b cases, respectively. The overall prostate-specific antigen recurrence-free survival rate was 86% in all patients. The recurrence-free survival rates were 91.8% and 62.2% in pT2N0 patients and pT3N0 patients, respectively. Preoperative prostate-specific antigen, surgical margins, tumor stage, and lymph nodal status were identified as independent predictors of biochemical recurrence-free survival using multivariate Cox proportional hazard model.

CONCLUSIONSELRP is a precise, safe and effective procedure at this particular Chinese institution. The prognostic power of prostate-specific antigen relapse after ELRP is not identical to that described previously with transperitoneal or open retropubic approaches.

Aged ; Humans ; Laparoscopy ; methods ; Male ; Middle Aged ; Prostate ; surgery ; Prostatectomy ; methods ; Prostatic Neoplasms ; surgery ; Treatment Outcome

OBJECTIVETo evaluate the clinical efficacy and the toxicity of neoadjuvant chemotherapy with paclitaxel and FOLFOX4 (5-fluorouracil/leucovorin combined and oxaliplatin) regimen for advanced gastric cancer.

METHODSSeventy-eight patients with cTNM stage III or IV (M0) gastric cancer were enrolled and 39 were randomized into the treatment arm (n=39, paclitaxel combined with FOLFOX4 regimen neoadjuvant chemotherapy every two weeks in each cycle) and control group (n=39). Clinical response was evaluated with RECIST criteria after 3 cycles. Patients in experimental group received surgery after 2-4 weeks and postoperative chemotherapy of 3 cycles of the original regimen. When disease progressed, postoperative chemotherapy regimen was changed into ECF regimen. The control group of 39 patients received surgery within 2 weeks and postoperative chemotherapy of 6 cycles of paclitaxel combined with FOLFOX4 regimen.

RESULTSThe clinical response rate was 66.7% in the treatment arm. The R0 resection rate (59.0%) was significantly higher than that in the control group (P=0.025) and the number of lymph node metastasis in the treatment arm(3.23±2.80) was significantly lower than that in the control group (5.79±2.69, P=0.001). There were no significant differences in postoperative complication rate (5.1% vs. 2.6%) and the number of lymph node dissection (19.69±2.95 vs. 20.59±3.22) between the two groups (P>0.05). The median survival time and 2-year survival rate in the treatment arm [(27.10±2.32) months and 59.0%] was significantly higher than that in the control group[(18.20±1.30) months and 28.2%] (P=0.001, P=0.006). Cox regression multivariable analysis showed that tumor differentiation, R0 resection, lymph node metastasis were independent prognostic factors. Adverse reaction of chemotherapy, mainly hematological adverse reactions, and peripheral nerve toxicity, were tolerable. No significant differences were noted between the two groups in adverse reactions (P>0.05).

CONCLUSIONSThe efficacy of paclitaxel combined with FOLFOX4 as neoadjuvant chemotherapy is high. Patients tolerance and compliance are satisfactory. It can improve in patients with advanced gastric cancer the R0 resection rate, reduce lymph node metastasis and improve survival.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Female ; Fluorouracil ; administration & dosage ; Humans ; Leucovorin ; administration & dosage ; Male ; Middle Aged ; Neoadjuvant Therapy ; Neoplasm Staging ; Organoplatinum Compounds ; administration & dosage ; Paclitaxel ; administration & dosage ; Stomach Neoplasms ; drug therapy ; pathology