Objective To evaluate the efficacy and safety of safflower yellow pigment lyophilized power amp; dripping solution in the treatment of patients with angina, by using parenteral solution of Dan-shen root extraction as control, we designed the nonferiority clinical trial phase Ⅲ. Method 784 patients with stable angina pectoris Ⅰ, Ⅱ, Ⅲ degree and occurred more than twice per week were selected. They were randomly, stratified and blindly assigned into 5 parallel groups including one control. They were treated by using safflower yellow pigment lyophilized power (SYPLP) 80 mg + 0.9% NS 250ml, intravenously guttae, daily (trial group 1); SYPLP 160 mg + 0.9% NS 250 ml, intravenously guttae, daily (trial group 2); safflower yellow pigment lyophilized dripping solution (SYPLDS) 200 ml (160 mg), intravenously guttae, daily (trial group 3); SYPLDS 100 ml (80 mg), intravenously guttae, daily (trial group 4) and parenteral solution of Dan-shen root extraction 20 ml + 0.9% NS 250 ml, intravenously guttae, daily (control group) respectively. Efficacy and safety were evaluated after 14 days of continuous treatment. Results The angina efficacy (per-protocol population, PP): The notable effective rates of trial groups 1 to 4 and control group were 53.27%，69.44%，70.09%，55.09% and 26.00% respectively, and the effective rates were 88.79%，92.59%，93.46%，89.81% and 73.00% respectively。There was significant differences between trial group 1 and 2, trial group 3 and 4. All trial groups showed significant different effect when compared with control (P＜0.05). The effect of trial group 2 was better than those of trial group 1, and trial group 3 better than trial group 4, the four trial groups better than control group. The intention-to-treat (ITT) analysis result was almost the same to PP analysis, but trial group 3 showed no significant difference to trial group 4. In trial group 2, 3 and 4, each occurred one adverse effect, while the number was 10 in control group.Conclusion SYPLP amp; SYPLDS have certain effect on angina. They are more effective than parenteral solution of Dan-shen root extraction. No toxic side effect has been found in clinic tests.
Objective To evaluate the efficacy and safety of Niuhuangjiangya tablets (NT) on mild to moderate primary hypertension (overabundant liver-fire) in comparison with Niuhuangjiangya pills (NP). Method The double-dummy and randomized controlled method was adapted to assess 240 patients (overabundant liver-fire) who were divided into the treatment group (n =120, treated with NT 2 tablets, twice a day) and the control group (n =120, treated with NP 1 pill, twice a day).The duration of treatment for both groups was 4 weeks. Results Blood pressure began to decline in the first week of treatment. After 4 weeks, the mean diastolic and systolic blood pressure dropped 7.51 and 12.16 mmHg, respectively, in the treatment group; 7.53 and 12.45 mmHg dropped respectively in the control group. For diastolic blood pressure, the total efficacy rates of the two groups were 50.8% and 54.9% (Pgt;0.05), respectively. For TCM syndromes, the total efficacy rates of the two groups were 45.6% and 42.34% (Pgt;0.05), respectively. The two drugs were equivalent by the equivalent test (Plt;0.05). No adverse effect was found in the study. Conclusions Niuhuangjiangya tablets have confirmed that the effects on mild to moderate hypertension has few side effects. The efficacy of the two drugs is equivalent by the equivalence test. placebo=controlled trials are required.