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目的评价健康志愿者对口服七竭止痛片的耐受性。方法 48例健康志愿受试者随机分为单次给药组4组(剂量分别为3,6,9,12片,每个试验组设安慰剂对照组2例)和多次给药组2组(剂量分别为6,9片,连续7 d),观察用药前后受试者生命体征、心电图和血生化指标的变化,并观察和记录药物不良事件。结果单次给药后24 h内,有6例受试者出现口干(4例,均为第4组)或头晕头痛(4例,其中第2组、第3组各1例,第4组2例),症状较轻微,未给予特殊处理,均于数小时内自行缓解,判定与试验药物可能有关;2例受试者(第2组、第3组各1例)出现血压降低,2例受试者(第1组、第4组各1例)出现心电图改变,均轻微,判定可能与试验药物无关。多次给药试验中,7例受试者出现异常,其中3例(第2组)体温升高(37.1~37.4℃),1例(第2组)头痛,2例(第2组)视物模糊,4例(第1组3例,第2组1例)心电图改变,均轻微,未行干预自行缓解,判定可能与试验药物有关。结论七竭止痛片不良事件主要有头晕、头痛、口干、视物模糊、发热、心电图异常,主要发生于单次给药12片组和多次给药9片组,建议Ⅱ期临床试验中,应严格选择中医证候和适宜疗程,最大日给药量不超过9片,并在试验期间密切观察神经系统、循环系统、消化系统的不良反应。
Objective To evaluate the resistance of healthy volunteers to oral Qidan painkillers. Methods Forty-eight healthy volunteers were randomly divided into 4 groups (3,6,9,12 tablets, 2 placebo control group) (6,9 tablets for 7 consecutive days). The changes of vital signs, electrocardiogram and blood biochemistry before and after treatment were observed and the adverse drug events were observed and recorded. Results Within 24 hours after the single administration, there were 6 cases with dry mouth (4 cases, group 4) or dizziness and headache (4 cases, group 1, group 2, group 3, group 4, Group 2), mild symptoms, no special treatment were relieved within a few hours, the determination and the test drug may be related; 2 subjects (group 2, group 3, 1 case) decreased blood pressure, Two subjects (group 1, group 4, each one) had ECG changes that were mild and may not be related to the test drug. In multiple administrations, seven patients developed abnormalities, including 3 subjects (Group 2) with elevated body temperature (37.1-37.4 ° C), 1 patient (Group 2) headache, and 2 patients (Group 2) Obscure, 4 cases (group 1 in 3 cases, group 1 in 2 cases) ECG changes were mild, without intervention to ease, the determination may be related to experimental drugs. Conclusion The main adverse events of Qidan painkillers were dizziness, headache, dry mouth, blurred vision, fever and abnormal electrocardiogram. It mainly occurred in 12 single-dose groups and 9 multiple-dose groups. It is suggested that in Phase II clinical trials , Should be strictly selected TCM syndromes and appropriate treatment, the maximum daily dose of not more than 9, and closely observe the nervous system during the test, circulatory system, digestive system adverse reactions.