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

Objective: To explore the effect of perioperative chemotherapy on the prognosis of gastric cancer patients under real-world condition. Methods: A retrospective cohort study was carried out. Real world data of gastric cancer patients receiving perioperative chemotherapy and surgery + adjuvant chemotherapy in 33 domestic hospitals from January 1, 2014 to January 31, 2016 were collected. Inclusion criteria: (1) gastric adenocarcinoma was confirmed by histopathology, and clinical stage was cT2-4aN0-3M0 (AJCC 8th edition); (2) D2 radical gastric cancer surgery was performed; (3) at least one cycle of neoadjuvant chemotherapy (NAC) was completed; (4) at least 4 cycles of adjuvant chemotherapy (AC) [SOX (S-1+oxaliplatin) or CapeOX (capecitabine + oxaliplatin)] were completed. Exclusion criteria: (1) complicated with other malignant tumors; (2) radiotherapy received; (3) patients with incomplete data. The enrolled patients who received neoadjuvant chemotherapy and adjuvant chemotherapy were included in the perioperative chemotherapy group, and those who received only postoperative adjuvant chemotherapy were included in the surgery + adjuvant chemotherapy group. Propensity score matching (PSM) method was used to control selection bias. The primary outcome were overall survival (OS) and progression-free survival (PFS) after PSM. OS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the last effective follow-up or death. PFS was defined as the time from the first neoadjuvant chemotherapy (operation + adjuvant chemotherapy group: from the date of operation) to the first imaging diagnosis of tumor progression or death. The Kaplan-Meier method was used to estimate the survival rate, and the Cox proportional hazards model was used to evaluate the independent effect of perioperative chemo therapy on OS and PFS. Results: 2 045 cases were included, including 1 293 cases in the surgery+adjuvant chemotherapy group and 752 cases in the perioperative chemotherapy group. After PSM, 492 pairs were included in the analysis. There were no statistically significant differences in gender, age, body mass index, tumor stage before treatment, and tumor location between the two groups (all P>0.05). Compared with the surgery + adjuvant chemotherapy group, patients in the perioperative chemotherapy group had higher proportion of total gastrectomy (χ(2)=40.526, P<0.001), smaller maximum tumor diameter (t=3.969, P<0.001), less number of metastatic lymph nodes (t=1.343, P<0.001), lower ratio of vessel invasion (χ(2)=11.897, P=0.001) and nerve invasion (χ(2)=12.338, P<0.001). In the perioperative chemotherapy group and surgery + adjuvant chemotherapy group, 24 cases (4.9%) and 17 cases (3.4%) developed postoperative complications, respectively, and no significant difference was found between two groups (χ(2)=0.815, P=0.367). The median OS of the perioperative chemotherapy group was longer than that of the surgery + adjuvant chemotherapy group (65 months vs. 45 months, HR: 0.74, 95% CI: 0.62-0.89, P=0.001); the median PFS of the perioperative chemotherapy group was also longer than that of the surgery+adjuvant chemotherapy group (56 months vs. 36 months, HR=0.72, 95% CI:0.61-0.85, P<0.001). The forest plot results of subgroup analysis showed that both men and women could benefit from perioperative chemotherapy (all P<0.05); patients over 45 years of age (P<0.05) and with normal body mass (P<0.01) could benefit significantly; patients with cTNM stage II and III presented a trend of benefit or could benefit significantly (P<0.05); patients with signet ring cell carcinoma benefited little (P>0.05); tumors in the gastric body and gastric antrum benefited more significantly (P<0.05). Conclusion: Perioperative chemotherapy can improve the prognosis of gastric cancer patients.
Chemotherapy, Adjuvant ; Female ; Gastrectomy ; Humans ; Male ; Neoadjuvant Therapy ; Neoplasm Staging ; Prognosis ; Retrospective Studies ; Stomach Neoplasms/surgery*

AIM:To investigate the effects of ethyl acetate(EtOAc)extract of Pleione bulbocodioides (Franch.)Rolfe on proliferation and apoptosis of human leukemia K 562 and HL-60 cells and the possible apoptosis path-way.METHODS:Human leukemia cell lines were treated with EtOAc extract of Pleione bulbocodioides at different con-centrations.XTT method was used to evaluate the viability of K 562 cells and HL-60 cells.The cell growth inhibition was calculated by Trypan blue exclusion test.The percentage of apoptotic cells was determined by flow cytometry,and 4,,6-dia-midino-2-phenylindole(DAPI)was used to observe morphological changes of the cells.The cell cycle was observed by pro-pidium iodide(PI)staining.The protein expression of Bcl-2, Bax, cleaved poly(ADP-ribose)polymerase(PARP), cleaved caspase-3,cytochrome C and apoptosis-inducing factor(AIF)wase determined by Western blot.RESULTS:The cell viability and proliferation were inhibited by EtOAc extract of Pleione bulbocodioides with IC50of(42.14 ±2.54)mg/L for HL-60 cells and(51.28 ±3.12)mg/L for K562 cells at 24 h.The results of Annexin V-FITC/PI and DAPI staining showed that EtOAc extract of Pleione bulbocodioides induced cell apoptosis in a dose-dependent manner.The apoptotic rate was increased compared with control group(P<0.05).The G2phase increased with typical cell apoptosis-induced mor-phological changes.The levels of pro-apoptotic proteins Bax,cleaved PARP and cleaved caspase-3 were increased, while Bcl-2 was down-regulated(P<0.05).Cytochrome C and AIF in cytosol,characteristic proteins of intrinsic mitochondrial apoptosis pathway,also increased with the concentration of EtOAc extract of Pleione bulbocodioides increasing(P<0.05). CONCLUSION:EtOAc extract of Pleione bulbocodioides significantly inhibits cell proliferation and induces cell apoptosis in human leukemia cell lines HL-60 and K562 through intrinsic mitochondrial apoptosis pathway.

Objective To explore the treatment effect of group cognitive behavioral therapy (GCBT) for patients with insomnia.Methods Two hundred and forty-one cases of insomnia were collected in the department of Sleep and Neurology Psychological in D aping Hospital and Field Surgery Research Institute of Army Medical University from March 2016 to June 2017.They were randomly divided into GCBT group (n=128) and pharmacotherapy group (n=113),and the treatment last for 8 weeks for each group.Then the differences of the sleep parameters,Insomnia Severity Index (ISI) scores,Hamilton Depression Scale (HAMD)scores and Hamilton Anxiety Scale (HAMA) scores were compared in two groups at per-treatment,four-week treatment time point and eight-week treatment time point.Results At the four week treatment time point,the differences of sleep onset latency (SOL),total sleep time (TST),time in bed (TIB),number of awakenings (NOA) and insomnia severity index (ISI) in GCBT group compared to pharmacotherapy group were statistically significant (P＜0.05).While the differences of sleep efficiency (SE),HAMA and HAMD were of no statistically significant difference (P＞0.05).At the eight week treatment time point,the differences of SOL,SE,NOA,HAMA,HAMD and ISI in GCBT group compared to pharmacotherapy group were statistically significant (P＜0.05),and there is no significant difference in TST and TIB (P＞0.05).Conclusion GCBT and pharmacotherapy can improve insomnia symptoms,reduce the level of anxiety and insomnia severity.GCBT can also reduce the level of depression,although GCBT improve insomnia symptoms were slower than pharmacotherapy,but curative cffect is superior to pharmacotherapy,and it should be popularized in clinic.

The clinical value of whole body positron emission tomography/computed tomography (PET/CT) as an imaging tool in diagnosis of ophthalmic tumors was investigated.The retrospective observational case series were performed on the patients with suspected ophthalmic tumors who underwent whole body PET/CT.The golden standard of diagnosis was the final pathological diagnosis or the results of long-term follow-up for patients without surgery/ biopsy.PET/CT findings were compared with the golden standard.The sensitivity,specificity,accuracy and positive likelihood ratio of PET/CT in the detection of ophthalmic tumors were calculated.The clinical application of PET/CT in different types of ophthalmic tumors was evaluated.The results showed that 30 patients (18 males and 12 females) with a mean age of 43.0 years (range 4-63 years) were collected.The mean sizes of orbital tumors and intraocular tumors were 26.8 mm×17.8 mm and 11.2 mm×6.1 mm,respectively.The overall sensitivity,specificity,accuracy and positive likelihood ratio of whole body PET/CT in ophthalmic tumors were 76.5％,71.4％,75.0％ and 2.67,and were 62.5％,100％ and 70.0％ in intraocular tumors,and those were 100％,60.0％ and 84.6％ in orbital tumors,respectively.PET/CT findings were applied to help make appropriate treatment options in 27 out of 30 patients (90.0％),and 12 (40.0％) patients changed the treatment strategy.False negative results in 4 cases and false positive results in 2 cases were observed in this series.It was suggested that PET/CT was an effective imaging modality in detecting,diagnosing and developing therapeutic schedule for patients with ophthalmic tumors.It was more sensitive and accurate for detecting orbital tumors than for detecting intraocular tumors.

OBJECTIVETo evaluate the clinical efficacy and safety of treatment of chronic primary glomerulopathy (CPG) patients of Shen deficiency and dampness heat syndrome (SDDHS) by Yishen Qingli Granule (YQG) combined with low-dose Tripterygium Wilfordii multiglycoside Tablet (TWT).

METHODSTotally 231 CPG patients of SDDHS were enrolled in this study (including 60 patients from First Affiliated Hospital of Nanjing University of Chinese Medicine, 58 from First Affiliated Hospital of Nanjing Medical University, 46 from Xinqiao Hospital of Third Military Medical University, 35 from First Affiliated Hospital of Guangzhou University of Chinese Medicine, 14 from First Affiliated Hospital of Soochow University, and 18 from Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine). They were randomly assigned to the control group (116 cases) and the trial group (115 cases) according to block group method. There were 217 cases in the safety analysis set (109 cases in the trial group vs 108 cases in the control group), and 203 cases in the full analysis set (99 cases in the trial group vs 104 cases in the control group). All patients received basic treatment such as ACEI/ARB. Furthermore, YQG (consisting of raw astragalus 10 g, prepared Polygonum Multiflorum 10 g, Pyrrosia 10 g, 1.5 g each package, containing 10 g of crude drugs) was additionally given to patients in the trial group, each package, twice daily. The TWT (10 mg) was given, twice a day. The TWT dose was adjusted according to 24 h urinary total protein (UTP). The placebos of YQG and TWT were administered to those in the control group. The treatment course consisted of 24 weeks and the follow-up visit lasted for 24 weeks. The biochemical indices were observed before and after treatment including 24 h UTP, urine red cell count (U(RBC)), renal functions (BUN, SCr), blood routine test (WBC), and liver functions (SGPT, SGOT). Reverse reactions such as gastrointestinal discomfort, skin rash, and irregular menstruation were also observed.

RESULTSCompared with the control group, the total effective rate was better in the trial group (82.83% vs 61.54%, P < 0.01). Results of stratified comparison of UTP showed better efficacy in the trial group (0.8-3.0 g/24 h, P < 0.01). The UTP decline occurred in the trial group after 8 weeks of treatment, with stable action, showing statistical difference when compared with the control group (P < 0.01). In the trial group, U(RBC) level decreased after treatment but changed more significantly. But there was no statistical difference in the changes when compared with the control group (P > 0.05). After treatment, there were no statistical difference in safety indicators such as WBC, SGPT, and SGOT between the two groups after treatment (P > 0.05).

CONCLUSIONOn the basis of basic treatment such as ACEI/ARB, application of YQG combined with low-dose TWT had better effect in controlling proteinuria of CPG patients, and could help stabilizing their conditions with less adverse reactions.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Kidney Diseases ; diagnosis ; drug therapy ; Kidney Glomerulus ; pathology ; Male ; Medicine, Chinese Traditional ; Middle Aged ; Phytotherapy ; methods ; Treatment Outcome ; Tripterygium

OBJECTIVETo investigate the expression of the Eag1 K( +) channel in the prostate cancer (PCa) tissue, its correlation with the development and progression of PCa, and whether it could be a target for the diagnosis and treatment of PCa.

METHODSWe used RT-PCR and immunohistochemistry to determine the mRNA and protein expressions of the Eag1 K(+) channel in the normal peritumoral tissue of androgen-dependent PCa (ADPCa) (group A) and androgen-independent PCa (AIPCa) (group B) as well as in the tumorous tissue of ADPCa (group C) and AIPCa (group D).

RESULTSThe relative coefficients of the mRNA expression of the Eag1 K(+) channel were 0.265 +/- 0.413, 0.167 +/- 0.511, 2.673 +/- 2.988 and 2.815 +/- 2.901 in groups A, B, C and D, respectively, increased significantly in the latter two groups (P < 0.05). The positive rates of the protein expression of the Eag1 K (+) channel were significantly higher in groups C (88.9%) and D (86.7%) than in A (7.4%) and B (6.7%) (P < 0.05).

CONCLUSIONThe Eag1 K(+) channel might be involved in the pathophysiological processes of PCa, and is expected to be a valuable target for the diagnosis and treatment of PCa.

Ether-A-Go-Go Potassium Channels ; metabolism ; Humans ; Immunohistochemistry ; Male ; Prostate ; metabolism ; pathology ; Prostatic Neoplasms ; metabolism ; pathology ; RNA, Messenger ; genetics ; Reverse Transcriptase Polymerase Chain Reaction

Objective To study the time between the onset and diagnosis of Dengue fever and its influencing factors in China.Methods Data were obtained from the Infectious Disease Surveillance System (IDSS).Descriptive analysis was performed for the time interval while nonparametric tests and logistic regression analysis were used to study the related influencing factors.Results Time interval appeared positively skewed with distribution at median of 6 days,quartile range as 4 days,while 57.8％ of them were longer than five days.Data showed that patients with longer intervals among the imported cases,being elderly,cases in non-endemic season and provinces as Fujian,Yunnan and Zhejiang appeared to have had greater influences on the disease.Median of those imported cases was six days,one day longer than locally generated cases,while median of the nonepidemic month was one day more than that of the epidemic month.In Fujian and Yunnan provinces,the medians were 7 days,one day more than that from Guangdong province.The median among young people was 5 days,one day less than that of the patients older than 20 years of age.Conclusion Most Dengue patients did not get diagnosed early enough so it was of urgent need to enhance the sensitivity of the monitoring system,especially in epidemic regions and during non-epidemic season.

Objective To investigate the effects of transient axonal glycoprotein-1 (TAG-1) on activity of U251 cells and expressions of AICD, p53 and EGFR genes in the cells. Methods The viability of U251 cells was tested by MTT assay at 48 h following the addition of various concentrations of TAG-1 (0, 5, 10 and 20 μg/mL). The expression ofamyloid precursor protein (ALP) was detected by immunofluorescent staining. The apoptotic cells were examined by TUNEL. Real-time PCR was employed to detect the influence of TAG-1 on the expressions of AICD, p53 and EGFR genes in U251 cells. Results TAG-1 did not play an inhibitory effect on the proliferation of the U251 cells. APP was abundantly expressed on membrane of the U251 cells. U251 cells did not show apoptotic cells but increased expressions of AICD, p53 and EGFR genes were noted when U251 cells were exposed at 10 μg/mL of TAG-1. Conclusion TAG-1 plays an important role in regulating the proliferation of glioma and may not induce the apoptosis of U251 cells through the signal pathway of TAG-1/APP/AICD/p53 or TAG- 1/APP/AICD/EGFR.

Objective To map the vision cortex of rats by dynamic manganese-enhanced functional magnetic resonance imaging and provide a method for researching the nervous function. Methods Six adult male Wistar rats were chosen and the process was divided into 4 continuous phases. No agent was injected into the rats in the first phase (5 min). Disrupting the BBB with marmitol and injecting manganese chloride were performed in the fight internal carotid artery (ICA) in the second phase (10 min). In the third phase (15 min), manganese chloride was administrated into theright ICA and vision stimulation was performed before the imaging process. The mixed liquor of manganese chloride and glutamate was injected into the rats in the forth phase (5 min). MRI was performed instantly after the handles in each phase. SPM and Matlab software were employed to help analyze the imaging data. Region-of-interest (ROI) was recorded to observe the stimulated regions and compare the signal intensity in the visual cortex. Results No specific enhanced region was found in the rat brain in the first and second phases. The right visual cortex was enhanced specifically on T1WI in the third phase. Many brain regions of the right hemisphere, the sites that agents was injected, were obviously enhanced in the forth 2008A1-E4011)phase. ROI analysis showed that the signal intensity in the third phrase (1.897±0.172) was significantly stronger as compared with that in the second phrase(1.549±0.163)(P<0.05). Conclusion The dynamic manganese-enhanced functional magnetic resonance imaging can analyze the functional activities of the vision cortex in rats and provide a new method for researching the function of the nervous system.