Randomized, double-blind, placebo-controlled phase I dose escalation study of Dan Qi Tong Mai tablet in healthy volunteers.

BACKGROUND: This study aims to assess the tolerability and safety of DQTM tablet, which contains a complex mixture of Salvia miltiorrhiza salvianolic acids and Panax notoginseng saponins. METHODS: A double-blind, randomized, placebo-controlled phase I dose escalation study was conducted in 84 healthy volunteers. In a single ascending dose study, active ingredients were administered in various doses (90, 270, 540, 1080, 1800, 2880, 4320 or 5760 mg) to 60 subjects in cohorts 1-8. In a multiple ascending dose study, active ingredients were administered at doses of 360, 720 or 2160 mg twice daily to 24 subjects in cohorts 9-11 for 14 consecutive days. Safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiography, laboratory tests and adverse events. RESULTS: No serious adverse events or clinically significant changes in vital signs or electrocardiography were observed. One subject experienced mildly elevated levels of alanine aminotransferase and aspartate transaminase but recovered spontaneously. Five subjects experienced a small increase in the number of daily stools. CONCLUSIONS: DQTM tablet was well tolerated at single doses of up to 5760 mg and twice-daily doses of up to 2160 mg for 14 consecutive days. The most frequent adverse event was an increase in the number of daily stools.

[Diagnosis Values of Back Propagation Neural Network Integrating Age, Transrectal Ultrasound Characteristics and Serum PSA for Prostate Cancer].

OBJECTIVE: To explore the diagnosis value of back propagation (BP) neural network integrating age, transrectal ultrasound characteristics and serum prostate specific antigen (PSA) for prostate cancer. METHODS: The data of age, PSA, and transrectal ultrasound characteristics were collected from 941 patients who received color doppler transrectal ultrasound scan and systemic biopsies of prostates. A prostate cancer diagnosis system of BP neural network with age, transrectal ultrasound characteristics and serum PSA was developed in MATLAB software, and its diagnostic value for prostate cancer was analyzed based on the pathological results of prostatic biopsy. RESULTS: The biopsy results confirmed 358 cases of prostate cancer (38.04%) and 583 cases noncancerous prostate diseases (61.96%). The sensitivity, specificity, accuracy, positive value and negative predictive value of BP neural networks for prostate cancer diagnosis were 78.57%, 92.94%, 87.23%, 88.00% and 86.81% respectively. CONCLUSION: Back propagation neural network with age, transrectal ultrasound characteristics and PSA shows good diagnosis value for prostate cancer.

[Predicting prostate cancers using a logistic regression model with transrectal ultrasound characteristics, age and serum PSA].

OBJECTIVE: To determine the value of transrectal ultrasound characteristics in combination with age and prostate specific antigen (PSA) for predicting prostate cancers. METHODS: 579 patients with prostate diseases were examined with color doppler, followed by biopsies of prostates. A logistic regression model was developed to determine the relationship between prostate cancers and transrectal ultrasound characteristics, age and PSA levels. RESULTS: The biopsy confirmed 194 (33. 5%) prostate cancer cases and 385 (66. 5%) noncancerous patients with prostate diseases. The prostate cancer patients showed hypoechoic nodule, uneven echo, abnormal blood flow, abnormal prostate shape, unclear boundary of internal and external glands, unclear dividing line of prostate and seminal vesicle glands, unclear dividing line of prostate and rectal, and lymph node metastasis. Our prediction model had a 83.59% accuracy, 64.95% sensitivity, 92.99% specificity, 82.35% positive predictive value, and 84.04% negative predictive value. CONCLUSION: Transrectal ultrasound characteristics in combination with patients age and serum PSA is a good predictor of prostate cancer.