研究疾病:
|
血管性痴呆
|
研究疾病代码:
|
F01.9
|
Target disease:
|
Vascular dementia
|
Target disease code:
|
研究类型:
Study type:
|
观察性研究
Observational study
|
研究设计:
Study design:
|
单臂
Single arm
|
研究所处阶段:
Study phase:
|
上市后药物
Post-marketing clinical trial
|
研究目的:
|
(1)评价广泛人群中使用复方苁蓉益智胶囊治疗血管性痴呆的安全性,监测患者可能发生的不良反应特征,获得不良反应的发生频率、严重程度及相关特点,探索不良反应可能的影响因素;
(2)评估药物间相互作用评估药物间相互作用,本疾病多为老年人,合并用药多,监测与其他药物相互作用背景下的不良反应情况并探索其可能影响因素;
(3)为该药未来修订药品说明书和指导临床用药提供证据,为制定和实施风险管理计划提供参考;
(4)收集使用复方苁蓉益智胶囊后临床症状改善情况,为进一步有效性研究设计提供参考依据。
|
Objectives of Study:
|
(1) The characteristics of adverse reactions, the possible adverse reactions, and the characteristics of adverse reactions were evaluated;
(2) Objective to evaluate the interaction between drugs and evaluate the interaction between drugs. The disease is mostly the elderly, and the combination of drugs is more. The adverse reactions under the background of interaction with other drugs are monitored and the possible influencing factors are explored;
(3) To provide evidence for the future revision of drug instructions and guidance of clinical medication, and to provide reference for the formulation and implementation of risk management plan;
(4) Objective to collect the improvement of clinical symptoms after the use of compound Cistanche yizhi capsule, and to provide reference for further effectiveness research design.
|
药物成份或治疗方案详述:
|
药物成分:制何首乌、肉苁蓉、荷叶、地龙、漏芦。方案详述:此研究为前瞻性、多中心、大样本的注册登记研究式医院集中监测单臂观察性研究,嵌套巢式病例对照研究。2021年1月1日-2022年4月30日期间,从患者使用复方苁蓉益智胶囊开始至停止使用复方苁蓉益智胶囊结束,对患者在医院用药期间进行全程监测,用药停止后随访观察2周,以观察药物的延迟不良反应。自实验开始,收满3000例患者为止。以发生不良反应为实验组、与之匹配的未发生不良反应者为对照组,按照1:4的比例,作巢式病例对照研究。
|
Description for medicine or protocol of treatment in detail:
|
Drug ingredients: Radix Polygoni Multiflori, Cistanche, lotus leaf, earthworm, rhaponticum. Protocol details: This study is a prospective, multi center, large sample registered research hospital centralized monitoring, single arm observational study, nested nested case-control study. During the period from January 1, 2021 to April 30, 2022, patients were monitored from the beginning of using compound Cistanche yizhi capsule to the end of stopping using compound Cistanche yizhi capsule. The patients were followed up for 2 weeks after drug withdrawal to observe the delayed adverse reactions. Since the beginning of the experiment, 3000 patients have been enrolled. A nested case-control study was conducted in the proportion of 1:4.
|
纳入标准:
|
(1)所有使用了复方苁蓉益智胶囊的全部住院患者和/或门诊患者,至少使用了1次,无论用药时间长短,全部作为监测人群;
(2)符合血管性痴呆诊断的门诊患者和住院患者(可有合并病);
(3)患者其本人或合法代理人在清醒、正常的精神状态下详细明确的告知研究目的、方式和可能存在的风险,不干涉患者或其合法代理人的决定,同意参加本研究,并签署知情同意书。
|
Inclusion criteria
|
(1) All the inpatients and / or outpatients who used compound Cistanche yizhi capsule at least once, regardless of the duration of medication, were regarded as the monitoring population;
(2) Outpatients and inpatients with vascular dementia (may have comorbidities);
(3) The patient or his / her legal representative informed the research purpose, method and possible risks in a clear and normal mental state, did not interfere with the decision of the patient or his / her legal agent, agreed to participate in the study, and signed the informed consent.
|
排除标准:
|
(1)大便稀溏者;
(2)合并有心、脑、肝、肾或造血系统等严重疾病者;
(3)肝、肾功能异常、有临床意义的异常心电图;
(4)已知对复方苁蓉益智胶囊组成成分过敏者;
(5)患者正在参加其他临床试验。
|
Exclusion criteria:
|
(1) Loose stool;
(2) Patients with serious diseases such as heart, brain, liver, kidney or hematopoietic system;
(3) Abnormal liver and kidney function, abnormal ECG with clinical significance;
(4) Known to be allergic to the components of compound Congrong yizhi capsule;
(5) Patients are participating in other clinical trials.
|
研究实施时间:
Study execute time:
|
从From
2021-01-01
至To
2022-04-30
|
征募观察对象时间:
Recruiting time:
|
从From
2021-01-01
至To
2022-04-30
|