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To evaluate the efficacy and safety of different dose combinations of levamlodipine besilate tablets and bisoprolol fumarate tablets compared with placebo and control.
A multicenter, randomized, double-blind, double-dummy, placebo-positive drug-controlled dose-finding study in which patients with grade 1-2 essential hypertension were randomly divided into 5 groups after 14 days of placebo, namely: group A (placebo group), group B (levamlodipine besilate 2.5 mg/placebo), group C (bisoprolol 5 mg/placebo), group D (levamlodipine besilate 2.5 mg/bisoprolol fumarate 2.5 mg group) and E group (levamlodipine besilate 2.5 mg/bisoprolol fumarate 5 mg group), treated for 56 days. 14 days, 28 days, and 56 days after treatment, the main indicators-diastolic blood pressure, and the secondary indicators-systolic blood pressure, were analyzed, and the efficacy and safety were analyzed.
After 56 days of treatment, the decrease in diastolic blood pressure was 3.26±8.09 mmHg in group A, 8.89±6.97 mmHg in group B, 7.89±6.48 mmHg in group C, 12.64±6.49 mmHg in group D, and 13.46±7.80 mmHg in group E. Compared with group A, groups B, C, D, and E, P<0.001; the reduction of blood pressure between groups D and E (combination treatment group) and group B and C (monotherapy group) was significantly lower than that of group A P<0.01, and P>0.05 between combination treatment groups (D and E) and monotherapy groups (B and C groups). In terms of reducing systolic blood pressure, group B (decrease of 13.39±11.48 mmHg), group D (decrease of 17.55±10.31 mmHg) and group E (decrease of 20.60±13.06 mmHg) and group A (decrease of 5.55±13.19 mmHg) were P<0.001; group E compared with group B and C, P<0.001; compared between group D and C, P<0.01; and P>0.05 between groups D and E of the two combination treatment groups.
The 2.5 mg levamlodipine besilatee tablets combined with 2.5 mg bisoprolol fumarate tablets and 2.5 mg levamlodipine besilate tablets combined with 5 mg bisoprolol fumarate tablets have good efficacy and are better than the single agent levamlodipine besilate or bisoprolol fumarate in reducing diastolic blood pressure, and are well tolerated.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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