论著
Yan Benyong;Zhang Feng;Sun Li;Liang Juncheng;Fan Huaying;Shi Jie;Xu Guozhu;Deng Yanping
2011, 13(3): 137-5.
Objective: To study the tolerance of Yanshen oral solution and to determine its safe dosage. Methods: A total of 38 healthy volunteers (aged 18-32 years) entered the tolerance study and received a single-dose regimen or a multi-dose regimen in clinical trials. The single-dose regimen was an open study, 26 subjects were divided into 5 groups: the 5 ml dose group (n=4), the 10 ml dose group (n=4), the 20 ml dose group (nn=6), the 30 ml dose group (n=6), and the 40 ml dose group (n=6). The multiple-dose regimen was a randomized, double-blinded, and placebo-controlled study, 12 subjects were divided into 2 groups: the Yanshen group (n=6) and the placebo group (n=6). The ratio of male to female in each group was 1 to 1. During the study period,the subjects’vital signs and adverse events were observed and recorded; routine blood, urine, and stool tests, blood biochemical tests (including the levels of K+, Na+, Ca2+, Cl-, glutamic-pyruvic transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, urea nitrogen, creatinine, etc.) , and electrocardiogram (ECG) were performed and all the results were statistically analyzed. Results: There were no differences in the age, gender, body weight and height among the 4 single-dose groups (the 40 ml dose group was canceled because of intolerance) and between the 2 multiple-dose groups. The maximum tolerance dose was 30 ml in the single-dose regimen and 20 subjects completed the study. A dose of 20 ml thrice daily for 7 consecutive days was selected for the multiple-dose regimen study. There were no statistically significant changes in vital signs, the routine blood, urine, and stool tests, and blood biochemical tests in all subjects after receiving the single-dose or multiple dose regimens. In the single-dose regimen study, sinus bradycardia occurred in 1 subject each in the 20 ml dose and 30 ml dose groups. All subjects receiving the multi-dose regimen had normal ECG. The main adverse reactions after drug administration were mild nausea and vomiting. In the single-dose regimen study, nausea occurred in 1 subject in the 5 ml dose group and 3 subjects in the 20 ml dose group, vomiting occurred in 1 subject in the 5 ml dose group and 2 subjects in the 20 ml dose group; in addition, all 6 subjects in the 30 ml dose group developed nausea and vomiting. In the multiple-dose regimen study, mild nausea and vomiting occurred in 2 subjects in the Yanshen group; however, the symptoms improved 30 min after developing adverse reactions. Conclusion: Yanshen oral solution could be well tolerated in a dose of 20 ml thrice daily with no severe adverse reactions.