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 reform the management mode for medical consumables.Methods The problems and countermeasures in medical consumables management were explored from the aspects of variety introduction,consumables naming,secondary warehouse management,charging management,qualification management,logistics delivery,supervision and professional level.Results Medical consumables management had to emphasize on demonstration management,warehouse management,information management,safety management and personnel management.Conclusion Standardization of medical consumables management can be promoted by optimizing the management methods and strengthening the quality control management strategy.

Objective To establish a method for simultaneously determining the concentration of clozapine and amisulpride in human plasma by HPLC.Methods The drugs from plasma was analyzed in a reverse phase HPLC system ZE Month Crest DDS-L column (4.6 mm × 250 mm,5 μm); mobile phase consisted of 30 mmol? L-1 postassium dihydeogen phosphate ( pH 7.5) -methanol (35∶65);the flow rate was 1.0 mL? min-1 and the column temperature was 35 ℃; the detection wavelength was at 270 nm.Ether was used as extracting solvent.And then the specificity, lower limit of quantitation and standard curve, precision and recovery rate and stability of the method were investigated. Results The calibration curves were linear in the range of 10 -1000 ng? mL-1 for clozapine, the regression equation of clozapine was Y=4.20 ×10 -3 C -3.13 ×10 -2 (r=0.999 4).The relative recovery rate ranged from 91.89% to 95.18% and the absolute recovery rate ranged from 93.78%to 107.70%.The calibration curves were linear in the range of 10-1000 ng? mL-1 for amisulpride, the regression equa-tion of amisulpride was Y=3.60 ×10 -3 C-3.12 ×10 -2 ( r=0.999 2 ) . The relative recovery rate ranged from 92.98%to 95.51%and the abso-lute recovery rate ranged from 91.50%to 96.54%.The intra-day and inter-day variation ( RSD) were both lower than 15%.Conclusion The method is sensitive, accurate, simple and quick, it can be used for clinical drug monitoring and pharmacokinetics studies of clozapine and amisulpride.