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

Risks of food safety induced by small molecule drug residues in animal food and environment have become an increasing public concern,so it is necessary to develop highly sensitive and easy-to-operate techniques to detect small molecules.Herein,a metasurface plasma resonance(MetaSPR)sensor chip coupled with gold nanoparticles(AuNPs)was developed for detection of enrofloxacin(ENR)based on competitive immunoassay.The detection range of the sensor for ENR was 0.025-3.2 ng/mL,and the detection limit(3σ)was 20 pg/mL.The biosensor showed excellent performance including high selectivity,good stability,ease to operate and high throughput,etc.The developed method was applied to detection of ENR residues in real samples,with recoveies of 96.0% -105.0%.The proposed sensing strategy provided new technique reference for detection of other small molecules in the field of residue analysis in food safety and environment monitoring.

Objective:To summarize the experience and effect of extracorporeal cardiopulmonary resuscitation (ECPR) in acute myocardial infarction (AMI) with in-hospital cardiac arrest (IHCA).Methods:The data of 70 patients with AMI-IHCA-ECPR in extracorporeal life support center of the first affiliated hospital of Nanjing medical university from January 2017 to December 2024 were retrospectively analyzed. The patients were grouped by Survival/death at 90 days, with/without combined intra-aortic balloon pump (IABP). Age, sex, Charlson comorbidity index, initial rhythm, Gensini score, ECPR initial blood gas pH and lactate value, no-flow time, time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) initiation (CA-Pump On time), ECMO treatment time, 90-day survival rate were analyzed.Results:Among the 70 patients with AMI-IHCA-ECPR, 22 (31.4%) patients survived at 90 days, of whom 19 (86.4%) patients had good neurological outcomes. About 50% of AMI-IHCA-ECPR patients had severe multi-vessel coronary artery lesions, and there was no significant difference in survival outcomes among different vascular lesions. In the IABP group, the success rate of ECMO withdrawal was low, the duration of ECMO treatment was long, and the combination of IABP did not reduce the mortality. Compared with the death group, the 90-day survival group had a lower Gensini score, a higher ECPR initial blood gas pH and a lower lactic acid value.Conclusions:AMI-IHCA-ECPR combined with IABP did not show significant survival benefits, and about 50% of patients had severe lesions of multiple coronary arteries. It is difficult to evaluate the prognosis based on a single offender vessel. It is recommended to evaluate the outcome of patients by quantification of the severity of coronary artery lesions by Gensini score.

Objective:To summarize the experience and effect of extracorporeal cardiopulmonary resuscitation (ECPR) on the treatment of sudden cardiac death (SCD).Methods:The data of 120 adults with SCD-ECPR in emergency department of the first affiliated hospital of Nanjing Medical University from April 2015 to April 2023 were retrospectively analyzed. The patients were grouped by Survival/death at 90 days, OHCA/IHCA (out-of-hospital/in-hospital cardiac arrest), with/without acute myocardial infarction (AMI) and divided according to 60 min of the time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) initiation (CA-Pump On time). Age, sex, Charlson comorbidity index, IHCA/OHCA, initial rhythm, no-flow time, CA-Pump On time, ECMO evacuation success rate, 90-day survival rate, ECMO treatment time were analyzed.Results:①Total of 114 adult patients with SCD-ECPR were enrolled, and 45 (39.5%) patients survived at 90 days, of whom 40 (88.9%) patients had good neurological outcomes.②Age and no-flow time were significantly lower in the 90-day survival group than that in death group, and the proportion of IHCA and shockable initial rhythm was higher. ③The no flow time in IHCA group was significantly lower than that in OHCA group, and the 90-day survival rate was higher. ④OHCA and regional interhospital transport prolonged CA-Pump On time and reduced the 90-day survival rate. ⑤The AMI group was older with a higher Charlson comorbidity index, and the 90-day survival rate was significantly lower than that in non-AMI group.Conclusions:ECPR improves the prognosis of patients with SCD, there are high benefits in patients with long healthy life expectancy, IHCA, shockable initial rhythm, and short no flow time. The smooth life-saving chain of SCD-ECPR improves survival rate, by screening high benefit candidates in patients with OHCA, delayed initiation of ECPR or requiring interhospital transport, despite CA-Pump On time > 60 min, there is still survival potential.

Objective:To investigate the major adverse kidney events (MAKE) in acute myocardial infarction (AMI) with extracorporeal cardiopulmonary resuscitation (ECPR).Methods:The data of 75 patients with AMI-ECPR in Emergency Medicine Department of the First Affiliated Hospital of Nanjing Medical University from April 2015 to April 2023 were retrospectively analyzed. The patients were grouped by survival/death at 90 days, with/without renal replacement therapy (RRT), and whether to initiate RRT because of acute kidney injury (AKI). age, sex, Charlson comorbidity index, OHCA/IHCA (out-of-hospital/in-hospital cardiac arrest), initial rhythm, Gensini score, ECPR initial blood gas pH and lactate value, no-flow time, time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) initiation (CA-Pump On time), ECMO and RRT treatment time, 90-day survival rate were analyzed. Moreover, the renal function of the survivors was followed up.Results:① Total of 68 AMI-ECPR patients were enrolled, 22 (32.4%) patients survived at 90 days, 54 (79.4%) combined with RRT, and 48 (70.6%) MAKE within 90 days. ②Compared with the death group, the 90-day survival group had a higher proportion of initial shockable heart rhythm, a lower Gensini score, a higher ECPR initial blood gas pH and a lower lactic acid value. ③The severity of coronary artery disease, ECPR initial acidosis and hyperlactacemia in the RRT group was significantly higher than that in the non-RRT group, and all the non-RRT group patients survived. ④ There was no difference between the AKI-RRT group and the non-AKI-RRT group. Of 21 patients with stage 1 AKI initiating RRT, 5 survived, one of them still needs RRT for 90 days, and 7 patients with stage 2 to 3 AKI initiating RRT died.Conclusions:The 90-day MAKE rate in AMI-ECPR patients was as high as 70.6%, and the 90-day renal insufficiency rate in AMI-ECPR survivors with AKI was as high as 20.0%. Active initiation of RRT to avoid AKI or early initiation of RRT may improve the prognosis of AMI-ECPR patients.

To establish a method for determining 26 inorganic elements in earthworm polypeptide and determine the elemental content in different batches of earthworm polypeptide, microwave digestion method was used to pre-treat the samples, and ICP-MS method was used to determine the content of 26 elements in different batches of earthworm polypeptide. The linear relationships of 26 elements were good in the range of 0-1 000 μg·L^-1, with R² greater than 0.999, precision RSD 0.21%-2.71%, repeatability RSD 0.19%-4.69%, stability RSD 0.11%-4.24%, and recovery rates of 82.41%-116.16%. The data was plotted using Origin 2022 software to characterize the distribution of elements content. SPSS 27.0 was used for principal component analysis, and SIMCA 14.1 software was used for OPLS-DA analysis. The results showed that among the 26 elements, the higher content of earthworm polypeptide was K, Na, and Ca, followed by Zn, Fe, Al, B and other trace elements, In, Sc, Co, Pb, Bi and other elements had little or no detectable content, and there were differences in the content of polypeptide in different batches. This study provides a theoretical basis for the production quality control, quality evaluation and drug efficacy application of earthworm polypeptide through the determination and analysis of the elements and content of earthworm polypeptide.

Objective:To investigate the time characteristics from extracorporeal cardiopulmonary resuscitation (ECPR) initiation to termination.Methods:The data of ECPR patients in extracorporeal life support center of the First Affiliated Hospital of Nanjing Medical University from April 2015 to October 2023 were retrospectively analyzed. The patients were grouped by survival/death at 90 days, in-hospital/out-of-hospital cardiac arrest (IHCA/OHCA), daytime/evening initiation, and procedural/non-procedural termination. Data on age, sex, Charlson comorbidity index, interhospital transport, initial rhythm, ECPR initial blood gas pH and lactate value, no-flow time, time from cardiac arrest to extracorporeal membrane oxygenation (ECMO) initiation (CA-Pump On time), ECPR initiation/termination and ECMO treatment time, 90-day survival rate and so on were analyzed.Results:200 ECPR patients were enrolled, the cardiogenic etiologies were accounted for 70.5%, more men than women, 68 (34.0%) patients survived at 90 days, of whom 61 (89.7%) patients had good neurological outcomes. The 90-day survival group had a significantly lower of no-flow time, a higher proportion of IHCA and initial shockable heart rhythm, with a higher ECPR initial blood gas pH and a lower lactic acid value than those in the death group. 3. The no flow time in OHCA group was significantly longer than that in IHCA group, with a lower ECPR initial blood gas pH and a higher lactic acid value, 77.4% were non-procedural termination and the 90-day survival rate was 16.1%. ECPR were initiated in all time periods, IHCA-ECPR initiated at random, OHCA-ECPR were rare in the early morning, and the initiation time had no significant effect on ECPR outcomes. There were 75.5% of ECPR terminated at the daytime, 56.8% death cases were occurred within 3 days after ECPR, and 19.0% of patients in the procedural termination group died due to a combination of factors.Conclusions:ECPR had a potentially high benefit for patients with IHCA, initial shockable rhythm, and a short no-flow time. The ECPR initiation time were irregular and had no effect on ECPR outcomes. Death events tend to occur in the early days after ECPR, and ECPR terminated is mostly during the daytime working hours. The construction of full-time ECPR team should be strengthened.

Objective:To evaluate the prognostic value of coagulofibrinolytic changes in survivors of adult extracorporeal cardiopulmonary resuscitation (ECPR) in Chinese.Methods:133 cardiac arrest (CA) patients whose blood samples were collected after establishment of extracorporeal membrane oxygenation between January 2018 and April 2023 in Emergency Department of the First Affiliated Hospital of Nangjing Medical University were enrolled in this single-center study. The following were examined: platelet counts (PLT), prothrombin time (PT), activated partial thrombin time (APTT), thrombin time (TT), fibrinogen (Fib), and D-dimer (D-D). The prognostic values of these coagulation-related indicators in predicting poor outcomes (Cerebral Performance Category 3-5) were analyzed.Results:Among the 133 patients involved, 96 (72.2%) had poor outcomes after ECPR treatment. In the poor-outcome group, PLT and Fib were significantly decreased, while PT and APTT were significantly prolonged (all P < 0.05). ECPR survivors had a significantly higher risk of poor neurological outcomes in the high-level group than those in the low-level group for PT ( HR=1.87, 95% CI:1.17-2.99, P=0.009), APTT ( HR=1.95, 95% CI:1.26-3.00, P=0.003), and D-D levels ( HR=5.18, 95% CI:2.06-13.03, P<0.001). The risk of poor neurological outcomes was significantly lower in the high-level group for PLT ( HR=0.55, 95%CI:0.35-0.84, P=0.007). Conclusion:Coagulofibrinolytic changes can be promising tools to assess poor neurological outcomes in adult ECPR survivors.

Objective To investigate the clinical characteristics and prognosis of pneumococcal meningitis(PM),and drug sensitivity of Streptococcus pneumoniae(SP)isolates in Chinese children.Methods A retrospective analysis was conducted on clinical information,laboratory data,and microbiological data of 160 hospitalized children under 15 years old with PM from January 2019 to December 2020 in 33 tertiary hospitals across the country.Results Among the 160 children with PM,there were 103 males and 57 females.The age ranged from 15 days to 15 years,with 109 cases(68.1% )aged 3 months to under 3 years.SP strains were isolated from 95 cases(59.4% )in cerebrospinal fluid cultures and from 57 cases(35.6% )in blood cultures.The positive rates of SP detection by cerebrospinal fluid metagenomic next-generation sequencing and cerebrospinal fluid SP antigen testing were 40% (35/87)and 27% (21/78),respectively.Fifty-five cases(34.4% )had one or more risk factors for purulent meningitis,113 cases(70.6% )had one or more extra-cranial infectious foci,and 18 cases(11.3% )had underlying diseases.The most common clinical symptoms were fever(147 cases,91.9% ),followed by lethargy(98 cases,61.3% )and vomiting(61 cases,38.1% ).Sixty-nine cases(43.1% )experienced intracranial complications during hospitalization,with subdural effusion and/or empyema being the most common complication[43 cases(26.9% )],followed by hydrocephalus in 24 cases(15.0% ),brain abscess in 23 cases(14.4% ),and cerebral hemorrhage in 8 cases(5.0% ).Subdural effusion and/or empyema and hydrocephalus mainly occurred in children under 1 year old,with rates of 91% (39/43)and 83% (20/24),respectively.SP strains exhibited complete sensitivity to vancomycin(100% ,75/75),linezolid(100% ,56/56),and meropenem(100% ,6/6).High sensitivity rates were also observed for levofloxacin(81% ,22/27),moxifloxacin(82% ,14/17),rifampicin(96% ,25/26),and chloramphenicol(91% ,21/23).However,low sensitivity rates were found for penicillin(16% ,11/68)and clindamycin(6% ,1/17),and SP strains were completely resistant to erythromycin(100% ,31/31).The rates of discharge with cure and improvement were 22.5% (36/160)and 66.2% (106/160),respectively,while 18 cases(11.3% )had adverse outcomes.Conclusions Pediatric PM is more common in children aged 3 months to under 3 years.Intracranial complications are more frequently observed in children under 1 year old.Fever is the most common clinical manifestation of PM,and subdural effusion/emphysema and hydrocephalus are the most frequent complications.Non-culture detection methods for cerebrospinal fluid can improve pathogen detection rates.Adverse outcomes can be noted in more than 10% of PM cases.SP strains are high sensitivity to vancomycin,linezolid,meropenem,levofloxacin,moxifloxacin,rifampicin,and chloramphenicol.[Chinese Journal of Contemporary Pediatrics,2024,26(2):131-138]