研究疾病:
|
抗精神病药物所致勃起功能障碍
|
研究疾病代码:
|
|
Target disease:
|
Erectile dysfunction due to antipsychotics
|
Target disease code:
|
研究类型:
Study type:
|
干预性研究
Interventional study
|
研究设计:
Study design:
|
随机平行对照
randomized controlled trial(parallel group design)
|
研究所处阶段:
Study phase:
|
III期临床试验
Phase III clinical trial
|
研究目的:
|
男性阴茎勃起功能障碍是常见的抗精神病药物副作用。服用抗精神病药物的患者中,高达48%~75%的患者出现性功能障碍。药物相关的勃起功能障碍中,大约有50%与抗精神病药物的使用相关。其中非典型抗精神病药物利培酮可能产生患者性欲降低或勃起功能障碍。ED的发生伴随着患者焦虑情绪的产生,容易影响服药依从性,降低患者生活质量,增加家庭与社会负担。
在本课题预实验结果中显示,催产素参与影响服用抗精神病患者的勃起功能。催产素参与多种大脑活动,参与男性勃起功能。NO是重要的阴茎勃起能神经递质,目前研究表明cAMP、cGMP对NO信号影响明显,而催产素通路可能与NO调节勃起功能相关。中医药对于ED的治疗由来已久。“疏肝气、温肾阳”的治疗理念符合APDs所致ED肝郁肾虚型患者,并且临床中取得一定的疗效。基于此,本研究以APDs所致肝郁肾虚型ED患者为研究对象,利用“解郁兴阳汤”作为治疗手段,通过临床观察比较采用“疏肝气、温肾阳”的解郁兴阳汤治疗前后患者临床疗效与NPT、IIEF-5、CALM以及NO等指标。探讨“疏肝气、温肾阳”的解郁兴阳汤与下丘脑催产素通路的关联性,以及催产素通路调节CALM的相关机制,为抗精神病药物所致肝郁肾虚型阳痿机制提供新的治疗方向。
|
Objectives of Study:
|
Erectile dysfunction in men is a common antipsychotic side effect. Sexual dysfunction occurs in 48% to 75% of patients taking antipsychotics. About 50% of drug-related erectile dysfunction is related to the use of antipsychotic drugs. Among them, the atypical antipsychotic risperidone may produce decreased libido or erectile dysfunction in patients. The occurrence of ED is accompanied by the generation of anxiety in patients, which can easily affect medication compliance, reduce the quality of life of patients, and increase the burden on families and society.
In the preliminary experimental results of this subject, it is shown that oxytocin is involved in affecting the erectile function of patients taking antipsychotics. Oxytocin is involved in a variety of brain activities and is involved in male erectile function. NO is an important penile erectile neurotransmitter. Current studies have shown that cAMP and cGMP have a significant effect on NO signaling, and the oxytocin pathway may be related to NO regulation of erectile function. Traditional Chinese medicine has a long history in the treatment of ED. The treatment concept of "soothing liver qi and warming kidney yang" is in line with the ED patients with liver stagnation and kidney deficiency caused by APDs, and has achieved certain curative effects in clinical practice. Based on this, this study took APDs-induced ED patients with liver stagnation and kidney deficiency as the research object, using "Jieyu Xingyang Decoction" as a treatment method, and through clinical observation to compare the clinical symptoms of patients before and after treatment with "Jieyu Xingyang Decoction" of "soothing liver qi and warming kidney yang". Efficacy and NPT, IIEF-5, CALM and NO indicators. To explore the relationship between Jieyu Xingyang Decoction "soothing liver qi and warming kidney yang" and hypothalamic oxytocin pathway, as well as the related mechanism of oxytocin pathway regulating CALM, so as to provide a new treatment direction for the mechanism of liver stagnation and kidney deficiency type impotence caused by antipsychotic drugs .
|
药物成份或治疗方案详述:
|
解郁兴阳汤方剂组成:柴胡15g、白芍15g、枳实15g、炙甘草15g、淫羊藿10g、巴戟天10g、生龙骨30g、生牡蛎30g。两组在接受原有抗精神病药物利培酮系统治疗的基础上,中药组给予“解郁兴阳汤”中药配方颗粒治疗;对照组予安慰剂干预(“解郁兴阳汤”中药配方颗粒及安慰剂均由广东一方制药有限公司制成包装相同,口感、气味、重量相近的中药颗粒),用法:早晚各1次,每次1盒,连续干预 4 周。
|
Description for medicine or protocol of treatment in detail:
|
|
纳入标准:
|
纳入标准
(1)男性,年龄在22至50周岁,且有固定性伴侣和规律性生活;
(2)符合精神障碍诊断与统计手册(第五版)DSM-V中的精神分裂症诊断标准;
且满足DSM-V临床定式访谈(SCID)精神分裂症的结果。
(3)IIEF-5评分得分≤21分;
(4)近2周内连续服用利培酮;且近一周内未使用过治疗勃起功能障碍的药物,或使用过此类药物,已停药7天以上者;
(5)符合《勃起功能障碍中西医结合诊疗指南(试行版)》中关于阳痿证型为肝郁肾虚的诊断标准;
(6)无语言及听力障碍;
(7)愿意接受为期28天中药治疗者,受试者知情,并自愿签署知情同意书;
如以上任何一个答案为“否”,此受试者不能参加。
|
Inclusion criteria
|
Inclusion criteria
(1) Male, aged 22 to 50 years old, with a regular sexual partner and regular sexual life;
(2) Meet the diagnostic criteria for schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) DSM-V;
And meet the DSM-V clinical stereotyped interview (SCID) results of schizophrenia.
(3) IIEF-5 score ≤ 21 points;
(4) Those who have taken risperidone continuously within the past 2 weeks; and have not used drugs for erectile dysfunction in the past week, or have used such drugs and have been discontinued for more than 7 days;
(5) Meet the diagnostic criteria for erectile dysfunction syndrome of liver stagnation and kidney deficiency in the Guidelines for the Diagnosis and Treatment of Erectile Dysfunction (Trial Version);
(6) No language and hearing impairment;
(7) Those who are willing to accept traditional Chinese medicine treatment for 28 days, the subjects are informed, and voluntarily sign the informed consent;
If the answer to any of the above is "No", the subject cannot participate.
|
排除标准:
|
排除标准
(1)既往精神病史:
①不能除外其它器质性或药物引起的继发性精神疾病;
②有严重自伤、自杀倾向神障碍病史;
③有酒精或其它物质依赖或滥用证据者;
④有精神发育迟滞或智力障碍患者。
⑤因兴奋、冲动伤人、言行紊乱等不配合的患者。
(2)外生殖器畸形及外伤者;
(3)其它躯体疾病史:
①手术后一年康复期内;②一年内有过严重躯体疾病者,如胃溃疡、慢性腹泻等胃肠道疾病,严重心、肺、
肝胆、肾等疾病的患者;
③有如癫痫等严重神经系统疾病患者;
④有脑外伤史或器质性疾病等。
(4)不能坚持配合治疗和随访者。
如以上任何一个答案为“是”,此受试者不能参加。
|
Exclusion criteria:
|
Exclusion criteria
(1) Past history of mental illness:
① Other organic or drug-induced secondary mental illnesses cannot be excluded;
② There is a history of severe self-injury, suicidal tendencies and mental disorder;
③ Those who have evidence of alcohol or other substance dependence or abuse;
④ Patients with mental retardation or intellectual disability.
⑤ Patients who do not cooperate due to excitement, impulsive injury, disorder of words and deeds, etc.
(2) External genital deformity and trauma;
(3) History of other physical diseases:
① One-year recovery period after the operation; ② Those who have had serious physical diseases within one year, such as gastric ulcer, chronic diarrhea and other gastrointestinal diseases, severe heart, lung,
Patients with liver and gallbladder, kidney and other diseases;
③ Patients with severe neurological diseases such as epilepsy;
④ There is a history of traumatic brain injury or organic diseases.
(4) Those who cannot insist on cooperating with treatment and follow-up.
If the answer to any of the above is "yes", the subject cannot participate.
|
研究实施时间:
Study execute time:
|
从From
2020-11-01
至To
2023-12-31
|
征募观察对象时间:
Recruiting time:
|
从From
2022-05-30
至To
2023-12-31
|