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

Humans ; Mycobacterium tuberculosis/genetics* ; Microspheres ; Antitubercular Agents/pharmacology* ; Mutation ; Microbial Sensitivity Tests ; Fluoroquinolones ; Drug Resistance, Bacterial/genetics* ; Tuberculosis, Multidrug-Resistant/microbiology*

Objective To explore the protective effects and mechanisms of cysteinyl leukotriene 2(CysLT2)receptor antagonist HAMI3379 on cerebral ischemia injury in rats.Methods 30 male SD rats were randomly divided into sham operation group,model group,and HAMI3379 group,with 10 rats in each group.The rats of model group were subjected to middle cerebral artery occlusion(MCAO)to construct the cerebral ischemia injury model,while HAMI3379 group received intraperitoneal injection of HAMI3379(0.2 mg/kg)before and after MCAO 30 min.The rats after cerebral ischemia injury were scored for neurological symptoms.The infarction volume of rats was observed by TTC staining,the activation marker Iba1 of microglia was detected by immunofluorescence staining,the mRNA level of M1/M2 polarized phenotype molecules of microglia was detected by Real-time PCR,the number of neurons was observed by NeuN staining,and neuronal degeneration was observed by Fluoro-Jade B staining.Western blotting assay was used to detect the expression of CysLT2 protein and nuclear factors κB-related protein Cα(PKCα),IκBα,p65 and p50 proteins in brain tissue.Results Compared with sham operation group,the neurological symptom score and cerebral infarction volume of model group were significantly increased(P<0.05).Compared with model group,the neurological symptom score and cerebral infarction volume of HAMI3379 group were significantly decreased(P<0.05).The results of immunofluorescence staining showed that the expression of microglia activation marker Iba1 was increased in brain tissue of rats after cerebral ischemia injury(P<0.05).Compared with sham operation group,mRNA expression of M1 polarized molecules(CD86,IL-1β,TNF-α)and M2 polarized molecules(CD206,TGF-β,IL-10)were significantly increased in the ischemic central brain tissue of model group(P<0.05).Compared with model group,the expression of M1 polarized molecules in HAMI3379 group was significantly downregulated(P<0.05),while the expression of M2 polarized molecules was significantly upregulated(P<0.05).Compared with sham operation group,the expressions of PKCα,IκBα,p65 and p50 in brain tissue of model group were significantly up-regulated(P<0.05);compared with model group,the expressions of PKCα,IκBα,p65,and p50 in HAMI3379 group were significantly down-regulated(P<0.05).The NeuN staining results showed that the number of neurons in the brain tissue of model group was decreased when compared with sham operation group(P<0.05),while the number of degenerated neurons was increased(P<0.05).Compared with model group,the number of neurons in HAMI3379 group was increased(P<0.05),while the number of degenerated neurons was decreased(P<0.05).Conclusions CysLT2 receptor antagonist HAMI3379 may regulate PKCα/IκBα/NF-κB signaling pathway,inhibits M1 polarization activation of microglia and promotes its transition to M2 polarization,inhibits neuronal degeneration,and plays a neuroprotective role.

OBJECTIVE: To introduce an arthroscopic "inlay" Bristow procedure based on the Mortise-Tenon joint structure concept using suture button fixation, and to evaluate its clinical and radiology results postoperatively with a minimal 3-year follow-up. METHODS: A total of 56 patients who received arthroscopic "inlay" Bristow procedure with suture button fixation between June 2015 to June 2016 were eventually enrolled in this study. Radiological assessment on the 3D CT scan was performed preoperatively, immediately after operation, and postoperatively at the end of 3 months, 6 months and the final follow-up. Complications postoperatively were also recorded. RESULTS: A total of 56 patients were finally included in this study. The mean follow-up time was (36.1±3.7) months. Coracoid grafts (middle point) were positioned at about 4 o'clock (123.8°±12.3°) in the En-face view. In the axial view, 95% (53/56) of the grafts positioning were measured as flush, 5% (3/56) as medial. Bone union rate was 96.4% at the final follow-up. At the end of 3 months, 6 months, and the final follow-up, the length of the coracoid graft was 96.9%±4.9%, 91.9%±6.2%, and 91.6%±6.6% of the immediate postoperative length, respectively. Compared with the immediate postoperative length, the length measured at the end of 3 months shortened not significantly (t=2.12, P > 0.05). The coracoid graft shortened more pronouncedly 6 months postoperatively (t=4.98, P < 0.05) and then remained almost constant over time (t=-0.75, P > 0.05), with all grafted coracoid graft retaining more than 90% of their initial length by the 3-year follow-up. And new bone formation at the junction between the coracoid graft and glenoid neck in the axial view were obviously noted in 25 cases. The quantitative evaluation showed that the glenoid area in En-face view was significantly increased at the final follow-up than that immediately after surgery [(9.72±1.22) cm² vs. (9.42±1.11) cm²]. No degenerative changes were noted on CT images in all the patients at the final follow-up. CONCLUSION This study reported a series of "inlay" Bristow procedure with suture button fixation for recurrent shoulder dislocation, providing satisfactory union rate and excellent graft positioning. And using suture button fixation instead of screw can reduce osteolysis and complications related to hardware implantation. Moreover, the bone remodeling between the coracoid process and glenoid could be beneficial to restoring the anterior stability of shoulder joint in a long term follow-up.
Arthroscopy ; Humans ; Joint Instability ; Radiology ; Shoulder Dislocation ; Shoulder Joint ; Sutures

OBJECTIVE: To explore the clinical features and therapeutic efficacy in adult ALL patients with t (1; 19) (E2A-PBX1). METHODS: The clinic data of 19 adult ALL patients with t (1; 19) (E2A-PBX1) in our hospital from Nov. 22, 2010 to Apr. 4, 2018 were collected. The clinical features,complete remission (CR) rate, overall survival (OS) rate and relapse-free survival (RFS) rate of patients received chemotherapy and chemotherapy+HSCT were analyzed. RESULTS: In all the 19 patients, the median age was 24 (14-66), median WBC count was 16.47×109 (1.8-170.34)/L, median Hb level was 98 (65-176) g/L, median Plt count was 50 (15-254)×109/L. Pre B-ALL were 17 cases (89.5%), and common B-ALL were 2 cases (10.5%). Patients received the induction therapy, the overall CR rate was 94.7%, one course CR rate was 94.7%, 4 year OS rate was 47.1% and RFS rate was 43.3%. The OS rate and RFS rate of patients received transplantation were slightly higher than those of patients not received transplantation (OS: 62.5% vs 36.7%) (P=0.188)；RFS (62.5% vs 38.9%) (P=0.166). CONCLUSION Most adult ALL patients with t (1; 19) (E2A-PBX1) is Pre B-ALL by Immunophenotyping, as compared with the pediatric patients, the therapeutic efficacy for adult patients with t (1; 19) (E2A-PBX1) is worsen, therefore, stem cell transplantation is still acquired for better long term survival.
Adult ; Chromosomes, Human, Pair 1 ; Chromosomes, Human, Pair 19 ; Homeodomain Proteins ; genetics ; Humans ; Immunophenotyping ; Oncogene Proteins, Fusion ; genetics ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; genetics ; therapy ; Recurrence ; Remission Induction

Objective: To compare the time of the recovery of neutrophils or leukocytes by pegylated recombinant human granulocyte stimulating factor (PEG-rhG-CSF) or common recombinant human granulocyte stimulating factor (rhG-CSF) in the myelosuppressive phase after induction chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients. At the same time, the incidences of infection and hospitalization were compared. Methods: A prospective randomized controlled trial was conducted in patients with newly diagnosed AML who met the enrollment criteria from August 2014 to December 2017. The patients were randomly divided into two groups according to a 1:1 ratio: PEG-rhG-CSF group and rhG-CSF group. The time of neutrophil or leukocyte recovery, infection rate and hospitalization interval were compared between the two groups. Results: 60 patients with newly diagnosed AML were enrolled: 30 patients in the PEG-rhG-CSF group and 30 patients in the rhG-CSF group. There were no significant differences in age, chemotherapy regimen, pre-chemotherapy ANC, WBC, and induction efficacy between the two groups (P>0.05) . The median time (range) of ANC or WBC recovery in patients with PEG-rhG-CSF and rhG-CSF were 19 (14-35) d and 19 (15-26) d, respectively, with no statistical difference (P=0.566) . The incidences of infection in the PEG-rhG-CSF group and the rhG-CSF group were 90.0%and 93.3%, respectively, and there was no statistical difference (P=1.000) . The median days of hospitalization (range) was 20.5 (17-49) days and 21 (19-43) days, respectively, with no statistical difference (P=0.530) . Conclusions: In AML patients after induction therapy, there was no significant difference between the application of PEG-rhG-CSF and daily rhG-CSF in ANC or WBC recovery time, infection incidence and hospitalization time.
Granulocyte Colony-Stimulating Factor/therapeutic use* ; Humans ; Induction Chemotherapy/adverse effects* ; Leukemia, Myeloid, Acute/drug therapy* ; Neutropenia ; Neutrophils ; Prospective Studies ; Recombinant Proteins

Trastuzumab is a humanized monoclonal antibody that targets at human epidermal growth factor receptor 2(Her2)proto-oncogenes,which can act on Her2 over-expression of tumor cells,inhibits tumor cells proliferation, differentiation,migration and other physiological activities,reduces the risk of tumor metastasis and extend the sur-vival time of patients.

OBJECTIVETo evaluate the efficacy of primary prophylaxis of voriconazole against invasive infection of pulmonary aspergillosis (IPA) during remission-induction chemotherapy (RIC) of patients with acute myeloid leukemia (AML).

METHODSClinical data of 102 de novo AML patients who received primary anti-IPA prophylaxis during the first induction chemotherapy were analyzed retrospectively. All the cases were divided into voriconazole-treated group and posaconazole-treated group according to the prophylactic agent. The incidences of IPA and systemic antifungal treatment during induction chemotherapy were analyzed for both groups.

RESULTSAmong 102 enrolled cases, 42 cases received voriconazole and other 60 received posaconazole as primary prophylaxis. IPA occurred in 3 cases of voriconazole group (1 probable, 2 possible); IPA occurred in 4 cases of posaconazose group, and all were possible cases. The incidence of IPA during remission-induction chemotherapy in variconazole group equaled to posaconazose group (7.1% vs. 6.7%) (P=0.925). Beside IPA cases, 2 cases in voriconazole group and 4 cases in posaconazole group received intravenous anti aspergillosis drugs preemptive treatment, and no significant difference of prophylactic success rate was observed between two groups (88.1% vs. 86.7%) (P=0.831). Visual disturbance was the most common adverse event occurred in voriconazole group, but no significant differences of incidences of other adverse effects were observed when compared with posaconazole group.

CONCLUSIONAccording to similar prophylactic effect with posaconazole, voriconazole appears to be a good alternative for primary prophylaxis of IPA during remission-induction chemotherapy in AML patients.

With the growth of number of Chinese patent medicines and clinical use, the rational use of Chinese medicine is becoming more and more serious. Due to the complexity of Chinese medicine theory and the uncertainty of clinical application, the prescription review of Chinese patent medicine always relied on experience in their respective, leading to the uncontrolled of clinical rational use. According to the traditional Chinese medicine (TCM) theory and characteristics of the unique clinical therapeutics, based on the practice experience and expertise comments, our paper formed the expert consensus on the prescription review of Chinese traditional patent medicine for promoting the rational use of drugs in Beijing. The objective, methods and key points of prescription review of Chinese patent medicine, were included in this expert consensus, in order to regulate the behavior of prescription and promote rational drug use.

Objective To analyze the status of quality indicators(QI) on specimen acceptability and establish preliminary qual ity specification.Methods Web based External Quality Assessment system was used to collect data of laboratories partici pated in "Medical quality control indicators in clinical laboratory" from 2015 to 2017,including once in 2015 and 2017 and twice in 2016.Rate and sigma scales were used to evaluate incorrect sample type,incorrect sample container,incorrect fill level and anticoagulant sample clotted.The 25th percentile (P25) and 75th percentile (P75) of the distribution of each QI were employed to establish the high,medium and low specification.Results 5 346,7 593,5 950 and 6 874 laboratories sub mitted the survey results respectively.The P50 of biochemistry (except incorrect fill level),immunology and microbiology reach to 6σ.The P50 of clinical laboratory is 4 to 6σ except for incorrect sample container.There is no significant change of the continuous survey results.Based on results in 2017 to establish the quality specification,the P25 and P75 of the four QIs is 0 and 0.084 4 ％,0 and 0.047 6 ％,0 and 0.114 2 ％,0 and 0.078 4 ％,respectively.Conclusion According to the results of the survey,most laboratories had a faire performance in biochemistry,immunology and microbiology,and clinical laboratory needs to be strengthened.Laboratories should strengthen the laboratory information system construction to ensure the actual and reliable data collection,and make a long time monitoring to achieve a better quality.