Phase III clinical trial of Diterpene Ginkgolides Meglumine Injection for syndrome of stagnant phlegm blocking collaterals in convalescence of atherosclerotic thrombotic cerebral infarction / 中草药

ABSTRACT

Objective: To evaluate the efficacy and safety of Diterpene Ginkgolides Meglumine Injection (DGMI) in the treatment of recovered stroke with syndrome of stagnant phlegm blocking collaterals, especially the clinical efficacy in improving the function of language and movements. Methods: The clinical trial was carried out by the methods of stratification and r andomization (416 cases of patients with atherosclerotic thrombotic cerebral infarction (ATCI) were r andomly divided into experimental and control groups by the ratio of 31), blindness, and positive parallel control of Shuxuening Injection (SI), and multi-center clinical study. DGMI (25 mg, 5 mL/amp) or SI (5 mL/amp) was diluted into 250 mL physiological saline, iv drip, once daily for 14 d. The dropping speed must be controlled as 10-15 drops/min for the first infusion. Results: There was statistical difference (P=0.000 1) for the variations of inducing rate of the defect extent of nervous functions before and after the treatment in the experimental and control groups. The experimental group was superior to the control group. There was no statistical difference for the variation of scales of the patient living ability in the two groups (P>0.05). For the comprehensive efficacy of cerebral infarction, the total effective rates were 85.39% and 73.27% in the experimental and control groups, respectively, with statistical difference (P=0.0001). For the efficacy of syndrome of traditional Chinese medicine (TCM), the total effective rates were 62.99% and 40.59% in the experimental and control groups, respectively, with the statistical difference (P=0.0001). For the single indicator of nervous functions, such as arm movements, h and movements, extremity movements, walking, as well as the syndromes of TCM, such as upper limb disable, lower limb disable, deviated tongue, aphasia, abate or deficiency of feeling, dizziness, more and turbid phlegm, abnormal tongue and pulse manifestation, the experimental group was superior to the control group with statistified difference. Conclusion: It is safe and effective for DGMI in the treatment of the syndrome of stagnant phlegm blocking collaterals in convalescence of ATCI. Meanwhile, it is also manifested that DGMI has the certain superiorities in the fields, such as improving the total score of nervous function deficiency for the patients with stroke, the nervous function, the total score of TCM syndromes, including upper limb disable, deviated tongue, dizziness, more and turbid phlegm, white coat of tongue, abnormal pulse, etc.