Institute of Clinical Trials, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, People's Republic of China.
Cheng Fei Hospital, Chengdu, Sichuan, 610041, People's Republic of China.
BMC Complement Altern Med. 2019 Nov 27;19(1):336. doi: 10.1186/s12906-019-2751-x.
This study aims to assess the tolerability and safety of DQTM tablet, which contains a complex mixture of Salvia miltiorrhiza salvianolic acids and Panax notoginseng saponins.
A double-blind, randomized, placebo-controlled phase I dose escalation study was conducted in 84 healthy volunteers. In a single ascending dose study, active ingredients were administered in various doses (90, 270, 540, 1080, 1800, 2880, 4320 or 5760 mg) to 60 subjects in cohorts 1-8. In a multiple ascending dose study, active ingredients were administered at doses of 360, 720 or 2160 mg twice daily to 24 subjects in cohorts 9-11 for 14 consecutive days. Safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiography, laboratory tests and adverse events.
No serious adverse events or clinically significant changes in vital signs or electrocardiography were observed. One subject experienced mildly elevated levels of alanine aminotransferase and aspartate transaminase but recovered spontaneously. Five subjects experienced a small increase in the number of daily stools.
DQTM tablet was well tolerated at single doses of up to 5760 mg and twice-daily doses of up to 2160 mg for 14 consecutive days. The most frequent adverse event was an increase in the number of daily stools.
本研究旨在评估 DQTM 片的耐受性和安全性，该片剂含有丹参酸和三七总皂苷的复杂混合物。
在 84 名健康志愿者中进行了一项双盲、随机、安慰剂对照的 I 期剂量递增研究。在单次递增剂量研究中，将有效成分以 90、270、540、1080、1800、2880、4320 或 5760mg 的不同剂量（1-8 队列中的 60 名受试者）给药。在多次递增剂量研究中，将有效成分以 360、720 或 2160mg 每日两次的剂量（9-11 队列中的 24 名受试者）给药，连续给药 14 天。安全性基于临床症状、生命体征、体格检查、心电图、实验室检查和不良事件进行评估。
未观察到严重不良事件或生命体征或心电图的临床显著变化。1 名受试者丙氨酸氨基转移酶和天门冬氨酸氨基转移酶水平轻度升高，但自行恢复。5 名受试者每日排便次数略有增加。
DQTM 片在单次剂量高达 5760mg 和连续 14 天每日两次剂量高达 2160mg 时具有良好的耐受性。最常见的不良事件是每日排便次数增加。
