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 clinical effectiveness and safety of Jiu Wei Lv Ping particle in the treatment of generalized anxiety disorder (GAD). Methods The multi-center, randomized double-blind method was used to observe 227 GAD patients who were divided into the treatment group (n=114, treated with Jiu Wei Lv Ping particle 6 g, three times a day) and the control group (n=113, treated with buspirone 10 mg, three times a day). HAMD score, and CGI-GI score were used to evaluate the clinical efficacy. TESS score and the list of symptom-recording were used to observe the safety. All the outcomes for evaluation before and after treatment at week 1, week 2, week 3 and week 4. Results According to intention-to-treat analysis (ITT), the level of decrease of HAMA score from baseline at each observational point of the treatment group was similar to that of the control group (t test, Pgt;0.05). At the end point, the effective rate of treatment group was 87.72％, and the effective rate of the control group was 87.61%. There was no significant difference between the two groups (CMH test, Pgt;0.05). According to the score of CGI-GI at each observational point, there was no difference of the effective rate between the treatment group and the control group (student test, Pgt;0.05). The side effect rate of the treatment group was 16.67%, The frequent symptoms were thirst (8.77%), dizziness (7.02%), nausea (2.63%), constipation (2.63%) and diarrhea (1.75%). The side effect rate of the control group was 30.97%, The frequent symptoms were thirst (15.04%), constipation (6.19%), nausea (4.42%), diarrhea (4.42%), dizziness (3.45%) and tachycardia (1.77%). The side effect of the treatment group was lower than that of the control group. But there was no significant difference between the two groups according to the score of TESS (F test, Pgt;0.05). Conclusions The therapeutic action of Jiu Wei Lv Ping particle in the treatment of GAD is affirmed with less side effects. It is valuable to use clinically.