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 reveal the diurnal variation characteristics of the exercise adaptability of cardiac function in healthy men of different ages by the analysis of echocardiographic parameter changes before and after exercise intervention using the left ventricular pressure-strain loop techniques.Methods:A prospective control design was used to collect 193 healthy male volunteers from October 2022 to July 2023 in Tangdu Hospital, 101 in the young group [(26±5) years old], and 92 in the middle-aged group [(50±4) years old]. The heart rate, blood pressure and routine echocardiographic parameters were collected at rest and after exercise stress (3-minute step test) at 7∶00 a.m.and 10∶00 p.m., respectively. The heart rate, blood pressure cardiac output, and echocardiographic parameters [anteroposterior diameter of left atrium (LAD), ratio of peak early diastolic flow velocity to late diastolic peak flow velocity of mitral valve (E/A), left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter (LVEDD), left ventricular end systolic diameter (LVEDS)] were then determined. The parameters of myocardial work including left ventricular longitudinal strain (GLS), global work index (GWI), global work efficiency (GWE), global constructive work (GCW) and global wasted work (GWW) were obtained by left ventricular pressure-strain loop technique. The differences of the parameters above between before and after step test, morning and night, young group and middle-aged group were compared.Results:The heart rate, blood pressure and cardiac output of young and middle-aged healthy men increased significantly in the morning and night step test (all P<0.05), GLS, GWI, GCW and GWW were significantly higher than those in resting state (all P<0.05), and GWE was significantly lower than that in resting state ( P<0.05). The change rates of heart rate, cardiac output, GLS, GWI and GCW in the early morning were significantly higher than those at night (all P<0.05), while the change rates of blood pressure and GWE in each group were significantly lower than those at night ( P<0.05). The change rates of heart rate, systolic blood pressure, GLS and GWI in the middle-aged group were significantly higher than those in the young group in the morning and night (all P<0.05), while the change rate of diastolic blood pressure at night was significantly higher than that in the young group ( P<0.05), but there was no significant difference in the morning ( P>0.05). Conclusions:The cardiac adaptability of healthy men has obvious circadian rhythm, characterized by being of low in the morning and high in the evening. Age mainly affects the cardiac adaptability in the morning. The response to low-intensity load stimulation increases with aging, indicating the decrease of morning cardiac adaptability.

Objective:To evaluate the performance of the self-developed transcranial ultrasound patch probe as well as its stability and safety in clinical applications.Methods:This study was a cross-sectional study. Fifty healthy subjects in Tangdu Hospital from October to December 2023 were randomly and equally divided into two groups using a simple randomization method. The transcranial Doppler ultrasound (TCD) examinations were performed using the self-developed transcranial ultrasound patch probe and normal TCD probe alternatively in each group from squatting to sitting and then to standing posture. Two experienced sonographers (A, B) each completed one test for the same subject using the above two different probes. The differences of the ultrasound parameters of middle cerebral artery (MCA) blood flow measured by the self-developed transcranial ultrasound patch probe and the normal TCD probe in different postures (squatting, sitting, standing) were compared. At the same time, operator satisfaction with the use of the two probes was assessed in terms of time taken to obtain satisfactory images, operational comfort, and ease of handling. In addition, the subject's comfort during the examination was examined, and the signal acquisition stability of the two probes was comprehensively evaluated.Results:There was no significant difference in detection of various ultrasound parameters of MCA between using the transcranial patch probe and the normal TCD probe (all P>0.05). The overall satisfaction of transcranial ultrasound patch probe and normal TCD probe was quite similar. The transcranial ultrasound patch probe acquired favorable and stable signals. No subjects experienced adverse events/accidents during the examination of the subjects using the transcranial ultrasound patch probe as well as the normal TCD probe.Both probes had good and stable signal acquisition. Conclusions:TCD examinations could be well performed using the transcranial ultrasound patch probe, which might provide a potential new method for real-time monitoring and evaluating of cerebral blood flow of a moving subject.

Objective: This study’s objective is to assess the efficacy and safety of Pulsed Magnetic Therapy System (PMTS) in improving insomnia disorder. Methods: Participants with insomnia disorder were randomly assigned to receive either PMTS or sham treatment for four weeks (n= 153; PMTS: 76, sham: 77). Primary outcomes are the Insomnia Severity Index (ISI) scores at week 0 (baseline), 1, 2, 3, 4 (treatment), and 5 (follow-up). Secondary outcomes are the Pittsburgh Sleep Quality Index at baseline and week 4, and weekly sleep diary-derived values for sleep latency, sleep efficiency, real sleep time, waking after sleep onset, and sleep duration. Results: The ISI scores of the PMTS group and the sham group were 7.13±0.50, 11.07±0.51 at week 4, respectively. There was a significant group×time interaction for ISI (F3.214, 485.271=24.25, p<0.001, ηp 2=0.138). Only the PMTS group experienced continuous improvement throughout the study; in contrast, the sham group only experienced a modest improvement after the first week of therapy. At the end of the treatment and one week after it, the response of the PMTS group were 69.7% (95% confidence interval [CI]: 58.6%–79.0%), 75.0% (95% CI: 64.1%–83.4%), respectively, which were higher than the response of the sham group (p<0.001). For each of the secondary outcomes, similar group×time interactions were discovered. The effects of the treatment persisted for at least a week. Conclusion PMTS is safe and effective in improving insomnia disorders.

Objective:To evaluate the effect of gender factor on efficacy of remimazolam combined with alfentanil in the patients undergoing gastrointestinal endoscopy.Methods:Two hundred patients, aged 18-64 yr, with body mass index of 18-30 kg/m 2, of American Society of Anesthesiologists Physical Status classificationⅠor Ⅱ, scheduled for elective gastrointestinal endoscopy, were divided into 2 groups ( n=100 each) according to gender: male group (group M) and female group (group F). Remimazolam 0.2-0.3 mg/kg and alfentanil 5-7 μg/kg were intravenously injected, remimazolam 0.5-0.7 mg·kg -1·h -1 was continuously infused during operation to maintain the modified observer′s assessment of alert/sedation score<3 points, and alfentanil 2 μg/kg was administered when necessary. The consumption of remimazolam and alfentanil, examination time, recovery time and time of post-anesthesia care unit stay were recorded. The satisfaction scores of examination physicians and patients were recorded. The occurrence of adverse reactions such as injection pain, intraoperative body movement, respiratory depression, hypotension, bradycardia and hiccups and postoperative dizziness, nausea, vomiting, fatigue, abdominal pain and abdominal distension were recorded. Results:There was no significant difference in the consumption of remimazolam and alfentanil, examination time, recovery time, satisfaction scores of examination physicians and patients between the two groups ( P>0.05). There was no significant difference in the incidence of respiratory depression, hypotension, bradycardia, injection pain, body movement, hiccups, abdominal pain, abdominal distension, and fatigue between the two groups ( P>0.05). Compared with group M, the time of post-anesthesia care unit stay was significantly prolonged, and the incidence of postoperative dizziness, nausea and vomiting was increased in group F ( P<0.05). Conclusions:Remimazolam combined with alfentanil provides better efficacy in male patients than in female patients undergoing gastrointestinal endoscopy.

Objective:To explore the preventive value of "integrated prevention strategy" for nipple and areola ischemia after single-port endoscopic subcutaneous mastectomy.Methods:The clinical data of 72 patients with breast cancer who received single-port endoscopic subcutaneous mastectomy in Beijing Friendship Hospital, Capital Medical University from July 2019 to July 2021 were retrospectively analyzed, they were all female. The follow-up period was up to July 2022. According to the perioperative treatment methods, the patients were divided into observation group ( n=40) and control group ( n=32). The patients in the observation group who adopted the "integrated prevention strategy" scheme, and patients in the control group who adopted the conventional treatment scheme. The incidence of postoperative nipple and areola ischemic was compared between the two groups, and the postoperative cosmetic effect, quality of life and satisfaction of patients were evaluated. Measurement data were expressed as mean ± standard deviation ( ± s), and t-test was used for comparison between groups; the Chi-square test was used to compare the data groups. Results:The postoperative drainage volume in the observation group was significantly lower than that in the control group [(632.40±226.37) mL vs (774.91±239.85) mL], and the difference was statistically significant ( P=0.013). Two weeks after operation, there was 1 case of nipple and areola ischemia in the observation group, and 7 cases in the control group, the difference was statistically significant between the two groups ( P=0.019). Twelve months after operation, the score of breast satisfaction (83.93±11.64 vs 67.28±11.52), chest satisfaction (89.63±8.06 vs 83.03±9.49) and psychosocial well-being (89.43±12.42 vs 78.88±10.40) in the observation group were better than those in the control group, the differences were statistically significant ( P<0.05). Conclusion:"Integrated prevention strategy" can effectively prevent the occurrence of nipple and areola ischemic after single-port endoscopic subcutaneous mastectomy and improve patient satisfaction, which has certain promotion value.

OBJECTIVE: To investigate whether Omicron BA.1 breakthrough infection after receiving the SARS-CoV-2 vaccine could create a strong immunity barrier. METHODS: Blood samples were collected at two different time points from 124 Omicron BA.1 breakthrough infected patients and 124 controls matched for age, gender, and vaccination profile. Live virus-neutralizing antibodies against five SARS-CoV-2 variants, including WT, Gamma, Beta, Delta, and Omicron BA.1, and T-lymphocyte lymphocyte counts in both groups were measured and statistically analyzed. RESULTS: The neutralizing antibody titers against five different variants of SARS-CoV-2 were significantly increased in the vaccinated population infected with the Omicron BA.1 variant at 3 months after infection, but mainly increased the antibody level against the WT strain, and the antibody against the Omicron strain was the lowest. The neutralizing antibody level decreased rapidly 6 months after infection. The T-lymphocyte cell counts of patients with mild and moderate disease recovered at 3 months and completely returned to the normal state at 6 months. CONCLUSION Omicron BA.1 breakthrough infection mainly evoked humoral immune memory in the original strain after vaccination and hardly produced neutralizing antibodies specific to Omicron BA.1. Neutralizing antibodies against the different strains declined rapidly and showed features similar to those of influenza. Thus, T-lymphocytes may play an important role in recovery.
Humans ; Antibodies, Neutralizing ; Prospective Studies ; SARS-CoV-2 ; Breakthrough Infections ; COVID-19 Vaccines ; COVID-19 ; T-Lymphocytes ; China/epidemiology* ; Antibodies, Viral

BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Proanthocyanidins (PCs) are a class of polyphenols that are composed of flavanate monomers and their polymers, which have antibacterial and anti-inflammatory properties with very few side effects. This article reviews the mechanism by which PCs differentially regulate microbiota, reshape microflora diversity and play a role in suppressing inflammation, providing a reference for the basic research of PCs in improving female vaginal health, and is expected to provide a new idea and breakthrough for the combined use of PCs with other antibacterial drugs in the treatment of vaginitis.
Humans ; Female ; Microbiota ; Inflammation ; Proanthocyanidins/therapeutic use* ; Anti-Bacterial Agents/therapeutic use*

Proanthocyanidins (PCs) are a class of polyphenols that are composed of flavanate monomers and their polymers, which have antibacterial and anti-inflammatory properties with very few side effects. This article reviews the mechanism by which PCs differentially regulate microbiota, reshape microflora diversity and play a role in suppressing inflammation, providing a reference for the basic research of PCs in improving female vaginal health, and is expected to provide a new idea and breakthrough for the combined use of PCs with other antibacterial drugs in the treatment of vaginitis.
Humans ; Female ; Microbiota ; Inflammation ; Proanthocyanidins/therapeutic use* ; Anti-Bacterial Agents/therapeutic use*