Objective:To assess the efficacy and safety of compound Salvia pellet (CSP) in treating hypertensive cerebral hemorrhage (HCH). Methods: Control group (n=116) was given HCH conventional therapy, and the treated group ...Objective:To assess the efficacy and safety of compound Salvia pellet (CSP) in treating hypertensive cerebral hemorrhage (HCH). Methods: Control group (n=116) was given HCH conventional therapy, and the treated group (n=118) given the same conventional therapy plus CSP 10 pills through sublingual sucking/6 hrs, the efficacy was compared. Results: (1) The 3rd day after admission CT monitoring showed both the volume of hematoma and hematoma plus edema in the treated group were smaller than those in the control group, the difference was significant (P<0.05); comparison between 14th day and 28th day after admission showed that the difference was significant (P<0.01). (2) The 14th day, 28th day and 3 months after admission, regarding the Chinese stroke scale (CSS), activity of daily living (ADD and modified Barthol index (Bl), the treated group was better than that of control group, the difference was significant (P<0.01). (3) The incidence of brain-heart syndrome reduced as time went by in both groups, but that of the treated group lowered more than that of control group, the difference being significant (P<0.05, or P< 0.01). Conclusion: CSP in treating HCH patients could cease the expansion of cerebral hematoma in the early phase, and accelerate the absorption of cerebral hematoma, improve the cerebral blood flow, alleviate cerebral edema, lower the disability, and elevate the quality of life. Besides, CSP also could prevent and treat brain-heart syndrome. CSP is cheap, convenient in administration, effective and safe.展开更多
Atrial fibrillation (AF) is a kind of common arrhythmia, which, besides affecting cardiac function, has another serious outcome, that is, it is easy to form atrial thrombosis and induce thrombus/embolus, especially ce...Atrial fibrillation (AF) is a kind of common arrhythmia, which, besides affecting cardiac function, has another serious outcome, that is, it is easy to form atrial thrombosis and induce thrombus/embolus, especially cerebral embolus. The incidence of left atrial thrombosis ( LAT) could reach 25% - 30%(1) , the incidence of embol-展开更多
Background: Compound Salvia Pellet (T89), consisting of Danshen (salvia miltiorrhiza), Sanqi (panax notoginseng), and Borneol (Cinnamomum camphora), has been used worldwide for 14 years for chronic angina treatment. P...Background: Compound Salvia Pellet (T89), consisting of Danshen (salvia miltiorrhiza), Sanqi (panax notoginseng), and Borneol (Cinnamomum camphora), has been used worldwide for 14 years for chronic angina treatment. Purpose: A dose escalation study to determine the maximum tolerance dose (MTD) in Chinese population to support a proposed dose regimen change. Methods: Forty-six participants (age 18 to 45 yrs, male to female ratio = 1:1) were divided into a series of 6 patients cohorts, and sequentially assigned into one of the escalating dose groups, starting from 540 mg, the clinical doses, until 4 out of 6 subjects experience clinical Adverse Events (AEs) or when the pre-defined 3510 mg dose level is reached and completed. All doses were given orally as a single dose 2 hours after breakfast. Adverse events, vital signs, 12-lead ECG, clinical and laboratory parameters and medical evaluation were conducted as outcome measures. Results: Study completed at the highest pre-defined dose level of 3510 mg dose as never had 4/6 of subject experience AEs in any dose levels studied. All participants completed the study and data were included in the safety analysis. The only moderate AE observation (muscle damage) was observed at 2970 mg dose and was recovered without any medical treatment, and all other AEs (ECG, dizziness, muscle damage) were mild and may (5 cases) or may not (9 cases) be related to testing drug and were all self-resolved within 30 min after dose. Conclusion: Given as single oral dose, Compound Salvia Pellet is safe and well-tolerated up to the 3510 mg studied. The MTD value of Compound Salvia Pellet is unknown from this trial and must be higher than 3510 mg, 13 times higher than its current clinical dose.展开更多
文摘Objective:To assess the efficacy and safety of compound Salvia pellet (CSP) in treating hypertensive cerebral hemorrhage (HCH). Methods: Control group (n=116) was given HCH conventional therapy, and the treated group (n=118) given the same conventional therapy plus CSP 10 pills through sublingual sucking/6 hrs, the efficacy was compared. Results: (1) The 3rd day after admission CT monitoring showed both the volume of hematoma and hematoma plus edema in the treated group were smaller than those in the control group, the difference was significant (P<0.05); comparison between 14th day and 28th day after admission showed that the difference was significant (P<0.01). (2) The 14th day, 28th day and 3 months after admission, regarding the Chinese stroke scale (CSS), activity of daily living (ADD and modified Barthol index (Bl), the treated group was better than that of control group, the difference was significant (P<0.01). (3) The incidence of brain-heart syndrome reduced as time went by in both groups, but that of the treated group lowered more than that of control group, the difference being significant (P<0.05, or P< 0.01). Conclusion: CSP in treating HCH patients could cease the expansion of cerebral hematoma in the early phase, and accelerate the absorption of cerebral hematoma, improve the cerebral blood flow, alleviate cerebral edema, lower the disability, and elevate the quality of life. Besides, CSP also could prevent and treat brain-heart syndrome. CSP is cheap, convenient in administration, effective and safe.
基金This project is supported by Guangdong Provincial Ad-ministration of TCM(No.99592)
文摘Atrial fibrillation (AF) is a kind of common arrhythmia, which, besides affecting cardiac function, has another serious outcome, that is, it is easy to form atrial thrombosis and induce thrombus/embolus, especially cerebral embolus. The incidence of left atrial thrombosis ( LAT) could reach 25% - 30%(1) , the incidence of embol-
文摘Background: Compound Salvia Pellet (T89), consisting of Danshen (salvia miltiorrhiza), Sanqi (panax notoginseng), and Borneol (Cinnamomum camphora), has been used worldwide for 14 years for chronic angina treatment. Purpose: A dose escalation study to determine the maximum tolerance dose (MTD) in Chinese population to support a proposed dose regimen change. Methods: Forty-six participants (age 18 to 45 yrs, male to female ratio = 1:1) were divided into a series of 6 patients cohorts, and sequentially assigned into one of the escalating dose groups, starting from 540 mg, the clinical doses, until 4 out of 6 subjects experience clinical Adverse Events (AEs) or when the pre-defined 3510 mg dose level is reached and completed. All doses were given orally as a single dose 2 hours after breakfast. Adverse events, vital signs, 12-lead ECG, clinical and laboratory parameters and medical evaluation were conducted as outcome measures. Results: Study completed at the highest pre-defined dose level of 3510 mg dose as never had 4/6 of subject experience AEs in any dose levels studied. All participants completed the study and data were included in the safety analysis. The only moderate AE observation (muscle damage) was observed at 2970 mg dose and was recovered without any medical treatment, and all other AEs (ECG, dizziness, muscle damage) were mild and may (5 cases) or may not (9 cases) be related to testing drug and were all self-resolved within 30 min after dose. Conclusion: Given as single oral dose, Compound Salvia Pellet is safe and well-tolerated up to the 3510 mg studied. The MTD value of Compound Salvia Pellet is unknown from this trial and must be higher than 3510 mg, 13 times higher than its current clinical dose.
