Keep in mind sex differences when prescribing psychotropic drugs

Women represent the majority of patients with psychiatric diagnoses and also the largest users of psychotropic drugs.There are inevitable differences in efficacy,side effects and long-term treatment response between men and women.Psychopharmacological research needs to develop adequately powered animal and human trials aimed to consider pharmacokinetics and pharmacodynamics of central nervous system drugs in both male and female subjects.Healthcare professionals have the responsibility to prescribe sex-specific psychopharmacotherapies with a priority to differentiate between men and women in order to minimize adverse drugs reactions,to maximize therapeutic effectiveness and to provide personalized management of care.

Psychotropic drugs and liver disease:A critical review of pharmacokinetics and liver toxicity

The liver is the organ by which the majority of sub-stances are metabolized, including psychotropic drugs. There are several pharmacokinetic changes in end-stage liver disease that can interfere with the metabolization of psychotropic drugs. This fact is particularly true in drugs with extensive first--pass metabolism, highly protein bound drugs and drugs depending on phase I hepatic metabolic reactions. Psychopharmacological agents are also associated with a risk of hepatotoxicity. The evidence is insufficient for definite conclusions regarding the prevalence and severity of psychiatric drug-induced liver injury. High-risk psychotropics are not advised when there is pre-existing liver disease, and after starting a psychotropic agent in a patient with hepatic impairment, frequent liver function/lesion monitoring is advised. The authors carefully review the pharmacokinetic disturbances induced by end-stage liver disease and the potential of psychopharmacological agents for liver toxicity.

Effects of Pilocarpine Hydrochloride on the Hyposalivation Induced by Psychotropic Drugs

The aim was to study the secretagogue action of pilocarpine on the murine parotid glands submitted to chronic treatment with psychotropic drugs by salivary flow rate determinations and histological alterations. Fifty four male Wistar rats were equally divided in three groups： C group （control） received saline solution for 30 days; AD group （n = 18） received AmitriptylineR and DiazepamR for 30 days, and ADP group （n = 18） received Amitriptyline R and DiazepamR for 30 days and AmitriptylineR, DiazepamR and pilocarpine for further 30 days, resulting in 60 days of treatment. Saliva samples were collected 30 h after the end of treatment. Parotids were removed and processed for hematoxylin-eosin histological analysis. Dedicated software for image processing allowed the determination of cell number and volume. Significant differences between paired-groups C-AD （P 〈 0.01） and AD-ADP （P 〈 0.01） were observed for glands size and weight. The volume of serous cells was greater in AD, suggesting a hypertrophy of the salivary glands. For salivary flow rate, C group showed the highest average. The number of serous cells was similar between groups ADP and C, with the lowest average being found in AD group （P 〈 0.05）.

Psychotropic drug abuse in pregnancy and its impact on child neurodevelopment:A review

Substance abuse by women of child-bearing age and fetal in utero drug exposure has increased in the number of infants born with health issues.Prenatal exposure to psychoactive substances can lead to neurological and neurodevelopmental deficits later in life.Useful data concerning the effects of psychoactive drugs on fetal neurodevelopmental status are sparse.Understanding the neurodevelopmental consequences of prenatally drug-exposed children has become a pressing global concern.The aim of this review is to gather current evidence and information on neurodevelopmental outcomes of in utero drug exposure.A literature search was performed on the PubMed,Scopus,and Google Scholar databases using the terms“psychotropic drugs”,“neurodevelopmental consequences”,“prenatal drug exposure”,and“pregnancy”.Available studies on in utero drug exposure were reviewed and found to support the idea that some degree of health issues are present in fetuses and children.Different psychoactive substances have profound neurodevelopmental consequences,such as structural brain changes,poor attention span,Down syndrome,attention deficit hyperactivity disorder,autism spectrum disorder,imbalances in neurotransmitter levels,and many structural deficits.The pervasive use of psychoactive drugs in women of child-bearing age is an important health concern.Further scientific efforts are needed to investigate the effect of prenatal exposure to psychoactive drugs on children.

Six psychotropics for pre-symptomatic ＆ early Alzheimer＇s (MCI), Parkinson＇s, and Huntington＇s disease modification

The quest for neuroprotective drugs to slow the progression of neurodegenerative diseases （NDDs）, including Alzheimer＇s disease （AD）, Parkinson＇s disease （PD）, and Huntington＇s disease （HD）, has been largely unrewarding. Preclinical evidence suggests that repurposing quetiapine, lithium, valproate, fluoxetine, donepezil, and memantine for early and pre-symptomatic disease-modification in NDDs may be promising and can spare regulatory barriers. The literature of these psychotropics in early stage and pre-symptomatic AD, PD, and HD is reviewed and propitious findings follow. Mild cognitive impairment （MCI） phase of AD： salutary human randomized controlled trial findings for low-dose lithium and, in selected patients, donepezil await replication. Pre-symptomatic AD： human epidemiological data indicate that lithium reduc- es AD risk. Animal model studies （AMS） reveal encouraging results for quetiapine, lithium, donepezil, and memantine. Early PD： valproate AMS findings show promise. Pre-symptomatic PD： lithium and valproate AMS findings are encouraging. Early HD： uncontrolled clinical data indicate non-progression with lithium, fluoxetine, donepezil, and memantine. Pre-symptomatic HD： lithium and valproate are auspicious in AMS. Many other promising findings awaiting replication （valproate in MCI; lithium, valproate, fluoxetine in pre-symptomatic AD; lithium in early PD; lithium, valproate, fluoxetine in pre-symptomatic PD; donepezil in early HD; lithium, fluoxetine, memantine in pre-symptomatic HD） are reviewed. Dose- and stage-dependent effects are considered. Suggestions for signal-enhancement in human trials are provided for each NDD stage.

Aging effects on QT interval： Implications for cardiac safety of antipsychotic drugs

Objectives To explore the effect of aging on cardiac toxicity specifically the interaction of age and antipsychotic drugs to alter the QT interval. Methods The Medline databases were searched using the OvidSP platforms with the search strategy： ＂QT interval＂ or ＂QT＂ and ＂age＂ or ＂aging＂. The entry criteria were： over 10,000 apparently healthy individuals with data on both sexes; QT interval corrected for heart rate （QTc） and an expression of its variance for multiple age decades extending into the older ages. Results QTc increased in duration with increasing age. Considering a modest one SD increment in QTc in the normal population, the addition of Chlorpromazine produced a QTc on average greater than 450 ms for ages 70 years and older. Risperidone, that did not on average alter QTc, would be expected to produce a QTc of 450 ms in persons in their mid 70 years under some circumstances. QTc prolongation 〉 500 ms with antipsychotic drugs is more likely for persons with QTc initially at the 99th percentile. It may occur with Haloperidol which does not on average alter QTc. Conclusions The range of values for the QT interval in apparently normal older men or women, when combined with the range of expected QT interval changes induced by antipsychotic drugs, can readily be associated with prolonged QTc. Individuals with QTc at the 99th percentile may have serious QTc prolongation with antipsychotic drugs even those that are not usually associated with QTc prolongation.

Drug-induced stuttering:A comprehensive literature review

Drug-induced stuttering(DIS)is a type of neurogenic stuttering(NS).Although DIS has not been reported as frequently as other cases of NS in the literature,it is not a negligible adverse drug reaction(ADR)which can significantly affect the quality of life if not treated.This literature review aims to evaluate the epidemiological and clinical characteristics of DIS and suggests some pathophysiological mechanisms for this ADR.Relevant English-language reports in Google Scholar,PubMed,Web of Science,and Scopus were identified and assessed without time restriction.Finally,a total of 62 reports were included.Twenty-seven drugs caused 86 episodes of stuttering in 82 cases.The most episodes of DIS were related to antipsychotic drugs(57%),mostly including clozapine,followed by central nervous system agents(11.6%)and anticonvulsant drugs(9.3%).The majority of the cases were male and between the ages of 31 and 40 years.Repetitions were the most frequent core manifestations of DIS.In 55.8%of the episodes of DIS,the offending drug was withdrawn to manage stuttering,which resulted in significant improvement or complete relief of stuttering in all cases.Based on the suggested pathophysiological mechanisms for developmental stuttering and neurotransmitters dysfunctions involved in speech dysfluency,it seems that the abnormalities of several neurotransmitters,especially dopamine and glutamate,in different circuits and areas of the brain,including cortico-basal ganglia-thalamocortical loop and white matter fiber tracts,may be engaged in the pathogenesis of DIS.

HPTLC-MS as a Neoteric Hyphenated Technique for Separation and Forensic Identification of Drugs

Drugs are traditionally been identified on basis of chromatographic-spectroscopic hyphenated techniques in instrumental analysis. Gas chromatography (GC) and Liquid chromatography (LC) hyphenated with mass spectroscopy (MS) i.e. GC-MS and LC-MS give reliable and confirmatory results in drugs identification. In the present work the novel hyphenated technique High Performance Thin Layer Chromatography-Mass Spectroscopy (HPTLC-MS) has been used. This technique provides efficient, quick and simple method for identification and separation of Narcotic drugs and psychotropic substances. The drugs under study are Papaverine, Methadone, Cocaine, Ketamine, Caffeine, Codeine, Diazepam, Thebaine, Heroin, Methamphetamine, Carbamazepine, Morphine, Narcotine and Ephedrine. The present study comprising of sixteen drugs has been carried out on CAMAG HPTLC instrument with automatic sampling. Thin layer chromatography (TLC) plates were developed in various solvent systems, scanned under TLC scanner and the results in terms of Retention Factor (Rf value) and UV spectrum (λmax) are presented in the manuscript. Using hyphenated technique of HPTLC-MS (MS 2020 SHIMADZU) spots of these drugs from TLC plate was lifted with CAMAG TLC-MS interface and confirmed by the mass spectrum of the individual drugs by their m/z values thus delivering fast and accurate confirmatory result on the TLC plate.

医疗机构麻醉、第一类精神药品信息化管理模式探讨

麻醉、第一类精神药品是我国依法依规实行特殊管理的药品,是医疗机构药事管理工作的重点内容。由于其特殊性,我国医疗机构内麻醉、第一类精神药品管理主要以人工操作为主,智能化程度不高。随着医疗信息化的发展,传统管理模式已不足以满足现在医疗机构对麻醉、第一类精神药品的管理需求。本文通过分析传统管理模式中医疗机构内麻醉、第一类精神药品的管理难点及风险,探讨在医院信息系统下,结合智能化设备,构建麻醉、第一类精神药品智能化信息管理模式的方法及可达到的应用效果,为临床应用提供思路。

Comparative Study of Solubility of Tranquilizers(Alternative Date Rape Drugs)in Stomach Acid

Date Rape Drugs are the members of tranquilizers and sedative class of drugs.These are the substances that make it easier for someone to rape or assault sexually.The person who is administrated by these drugs can cause sleepiness,slow breathing,slow heartbeat rate,trouble in muscle coordination,loss of consciousness.GHB(gamma-hydroxybutyric acid),Rohypnol(flunitrazepam),Ketamine are generally considered as date rape drugs.As Food and Drug Administration Department of Central Government of India considered this issue and placed these drugs under the schedule of Narcotic Drugs and Psychotropic Substances Act.Thereafter it is nearly impossible to get these drugs easily.But criminals have been searched new way through it.Normal tranquilizers and sedatives are also being used for committing such crimes.These drugs are also scheduled,but one can get them with prescription from a registered medical practitioner.So we carried out a comparative study of 3 tranquilizers from the benzodiazepine class that are Diazepam,Alprazolam,and Librium to check their dissolving rate in stomach acid.Estimation of action time of drug can help an investigator to identify the class of drug and time of drug injected(early phase).In our study,we found that the dissolving period of Diazepam and Alprazolam is more than conventional drugs.

液相色谱串联质谱法检测10种精神药物的实验室间比对

目的通过实验室间比对,了解液相色谱串联质谱法检测10种精神药物(氯氮平、奥氮平、利培酮、喹硫平、阿立哌唑、舍曲林、艾司西酞普兰、文拉法辛、度洛西汀、丙戊酸)及5种代谢物(去甲氯氮平、9-羟利培酮、N-脱烷基喹硫平、脱氢阿立哌唑、O-去甲文拉法辛)血清浓度的技术能力、质量管理现状及存在的问题,推进治疗药物监测工作的健康发展。方法选择8家已使用液相色谱串联质谱法开展了精神药物治疗药物监测的实验室,进行问卷调查,并进行质控血清及患者血清检测的实验室间比对试验。结果8家实验室使用的液相色谱串联质谱仪包括Waters、AB SCIEX、Agilent、岛津、德米特等,检测方法均为实验室自建,采用的样本前处理方法包括蛋白沉淀法和液液萃取法,液相和质谱等相关参数存在差异,方法学确证的批内和批间精密度均小于11%。8家实验室均开展了检测项目的室内质控,参加了室间质量评价活动。除去甲氯氮平外,其他被分析物质的质控血清检测结果的实验室间变异系数(CV)均小于25%。除去甲氯氮平低浓度水平、舍曲林低浓度水平外,其他被分析物质的质控血清检测结果的稳健变异系数(RCV)均小于15%。除去甲氯氮平、脱氢阿立哌唑外,在临床样本的检测范围内,各药物或代谢物超90%患者血清样品检测结果的实验室间CV小于15%。脱氢阿立哌唑患者血清样品检测结果的实验室间CV偏大,但也小于25%。对于去甲氯氮平,实验室E无论检测的质控血清还是患者血清,均存在大于50%的系统误差,剔除该实验室检测结果后,去甲氯氮平在其他实验室间检测结果的CV小于25%。结论液相色谱串联质谱法检测本研究所涉及药物或代谢物血清浓度的实验室间一致性尚可,检测结果具有可比性。部分实验室在标准曲线范围的设定、允许总误差的设定及应用、量值溯源等方面存在问题,需要进一步研究解决。

五灵胶囊防治精神类药物致肝损伤的作用及对患者睡眠质量的影响

目的 探讨五灵胶囊防治精神类药物致肝损伤的作用及对患者睡眠质量的影响。方法 将2021年1月—2023年12月收治的使用精神类药物的抑郁症患者240例作为研究对象,用随机数字表法分为对照组和观察组,每组120例。对照组用盐酸度洛西汀肠溶胶囊治疗,观察组在对照组治疗的基础上加用五灵胶囊治疗。治疗12周后,比较2组主要肝功能指标[丙氨酸氨基转移酶(alanine aminotransferase,ALT)、天冬氨酸氨基转移酶(aspartate aminotransferase,AST)、谷氨酰转肽酶(glutamyl transpeptidase,GGT)、总胆红素(total bilirubin,TBiL)],匹兹堡睡眠质量指数量表(Pittsburgh sleep quality index,PSQI)评分及不良反应发生率。结果 治疗后,观察组的AST[(33.45±8.32) U·L^(-1)]、ALT[(35.45±5.35) U·L^(-1)]、GGT[(31.12±5.15) U·L^(-1)]、TBiL[(6.44±2.53)μmol·L^(-1)]均低于对照组,组间比较差异均有统计学意义(P<0.05);治疗后,观察组的PSQI评分优于对照组(P<0.05);观察组的不良反应发生率(8.33%)低于对照组(26.67%),P<0.05。结论 五灵胶囊可有效防治由精神类药物造成的肝损伤,且有助于改善患者的情志抑郁、焦虑和失眠的症状,患者的生活质量明显改善,且安全性较好。

北京市二级及以上医院麻醉科麻精药品管理现状及分析

目的调查北京市二级及以上医院麻醉科麻醉药品、精神药品管理情况,为不同级别医院麻醉科对于麻精药品管理提供依据。方法通过北京市临床麻醉质量控制和改进中心平台由专人一对一对有麻醉科建制的二级以上医院发放问卷星链接,调查问卷包括医院基本信息,目前麻醉科内麻精药品管理制度、使用现状以及建议等内容。结果本次调查共发放问卷159份,共回收有效问卷139份,其中二级医院及其他专科医院50家,三级综合医院89家,有效回收率为87.4%。调查结果显示北京市二级及以上医院麻醉科主要使用的麻精药品种类:枸橼酸舒芬太尼注射液、注射用盐酸瑞芬太尼、盐酸麻黄碱注射液、枸橼酸芬太尼注射液等。参与药品管理的人员包括麻醉科医生(63.3%)、麻醉科护士(45.3%)、手术室护士(45.3%)、临床药师(11.5%),存在交叉共管现象。在管理和使用麻精药品过程中存在的主要问题包括药品积压过期浪费(36.4%)、麻精药品无处方或处方错误(31.8%),不同药品存放问题、管理人员数量有限但身兼多职等问题。结论北京市不同级别医院麻醉科在法律规范基础上应结合自身特点建立麻精药品管理制度,明确岗位职责、规范临床人员资质,建议可引入智能化药车、设立麻醉科护士岗位,提升麻精药品管理效率。

刑法中毒品概念的再审视

为进一步加强对毒品犯罪的打击,前置性规范中麻醉药品和精神药品列管品种不断增加、范围不断扩张,这与刑法中的毒品概念应具备相对明确性、确定性之间存有内在冲突。应当重新审视刑法中的毒品概念,明晰麻醉药品、精神药品与毒品概念的关系。刑法中的毒品概念应当具备国家管制性、致瘾癖性、麻精药品和非法用途等四个基本要素。区别于前置法中麻精药品的概念,建议在刑事立法中进一步明确毒品的非法用途要素,即在毒品概念层面通过考察麻精药品的用途,将医疗、教学、科研用途的麻精药品排除出毒品的范围。

贩卖麻醉药品、精神药品行为刑法规制的困境与出路——以《昆明会议纪要》为视角

麻醉药品和精神药品具有药品、毒品和化学的多元属性,贩卖此类物品在司法认定及法律适用上需要坚持更高的要求和标准,紧扣认定罪名的构成要件。贩卖毒品罪的适用条件模糊、“代购型”贩卖等特殊贩卖行为所产生的认定争议,以及妨害药品管理罪与非法经营罪适用混乱导致的定罪偏差,是刑法规制过程中亟待解决的问题。为破解前述现实困境,应以主观目的之认定为重要依据,明确贩卖毒品罪中“明知”在先、“治疗疾病”在后的主观判断顺序,并综合考量具体行为的违法程度,坚持法律效果与社会效果协调统一理念的指引,提出相对应的路径优化建议。在具体优化路径方面,从药品性质、销售对象和方式等角度出发,为主观目的之认定提供客观参考标准;整理“代购型”贩卖、网络销售两种特殊贩卖行为的刑法规制思路,厘清所涉及的走私、贩卖毒品罪和非毒品犯罪之间的认定逻辑;妨害药品管理罪与非法经营罪中关于“许可”的具体指向不同,应以此为基点辨析两罪的适用界限,并深化构成要件的理解,为该类案件的办理提供参考。

An overview of management of narcotics and psychotropic drugs in China

Narcotics and psychotropic drugs are known as controlled drugs with special management and super vision due to their psychic and physiological dependence. Based on the literature review, experts interview and policy comparative analysis, our study summarized and reviewed the status of related legislation and regulations since the enactment of the Narcotics and Psychotropic Drugs Regulations in 2005. We found the problems of legal loopholes, the complexity of supervision system and the irrational use of narcotics in the treatment of chronic non-cancer. Our analysis suggested that China should reinforce legislation, strengthen the cooperation among departments, establish the information network and improve the guideline of narcotics and psychotropic drugs for clinical treatment as quickly as possible.

精神类药品集中带量采购的执行现状与政策优化

目的:分析精神类药品集中带量采购执行情况和存在问题,为政策完善提供参考建议。方法:采用文献分析法综述精神类药品的特殊性以及采购、使用风险,描述性分析草酸艾司西酞普兰片、帕罗西汀片在医院端和零售端的销售量和销售结构。结果:前八批国家集中带量采购共纳入25种精神类药品,基本覆盖常用药品,中选产品销售量上升,未中选仿制药市场份额逐渐被替代,未中选原研药份额变化不大;仿制药替换管理尚不完善,国家层面尚未出台针对精神类药品集中带量采购的特殊管理政策。结论:国家药品集中带量采购在政策设计层面要慎重纳入高风险精神类药品,采购量约定实行特殊药品特殊设置,并建立全链条质量管理闭环;在政策执行层面要设置过渡期,鼓励地方探索并完善配套政策;在临床使用层面要遵循患者个体化用药原则,谨慎使用替换,加强药物浓度和不良反应监测,并强化医患沟通。

柏拉图及鱼骨图分析法在规范麻醉药品和精神药品管理中的应用

目的分析麻醉药品和精神药品的使用情况,为麻醉药品和精神药品的规范管理和合理使用提供科学参考和依据。方法利用医院审方系统随机抽取娄底市中心医院2022年1—12月的麻醉药品和精神药品处方,利用柏拉图和鱼骨图进行统计分析,并提出有针对性的整改措施和改进方案;再将整改前(2022年7—12月)与整改后(2023年7—12月)的处方合格率进行比较,从而确定整改措施的科学合理性。结果通过对448例麻醉药品和精神药品不合理处方(医嘱)进行柏拉图分析,发现不合理处方类型主要有3种,不合理处方产生科室主要有7个;再运用鱼骨图进行根因分析,找到4个方面的主要原因,提出一系列对应整改措施;最后对整改前后处方进行对比,发现合格率从87.56%提升至98.56%,主要和次要的不合理处方类型数量皆有明显减少,差异有统计学意义(P<0.05)。结论应用柏拉图及鱼骨图对麻醉药品和精神药品处方进行分析,可有效改进医院监管措施、规范处方行为、促进合理用药,具有一定的临床价值。

5-HT_(2A)受体拮抗剂治疗神经精神疾病幻觉症状研究进展

帕金森病、阿尔茨海默病和精神分裂症等神经精神疾病在发展过程中会出现幻觉、妄想等精神病症状,这些症状发病率高、治愈难,严重影响患者生活质量。尽管经典抗精神病药物氯丙嗪、舒必利和奋乃静等通过拮抗多巴胺2型(D_(2))受体可治疗相关症状,但也会引发不可控的锥体外系反应和高泌乳素症等不良反应。近年来研究发现,奥氮平、氯氮平、利培酮和匹莫范色林等非经典抗精神病药物通过拮抗5-羟色胺2A(5-HT_(2A))受体或同时拮抗5-HT_(2A)受体(强)和D_(2)受体(弱)治疗神经精神疾病的幻觉症状。非临床研究结果表明,在多种因素诱导的幻觉模型上,非经典抗精神病药物均表现出良好的治疗作用;临床研究进一步证实,该类药物显著改善精神病症状(以幻觉和妄想为主),尤其是匹莫范色林,其对氯氮平、利培酮不敏感或耐受的患者仍能表现出良好的治疗效果。同时,非经典抗精神病药物不良反应的发生率和严重程度较低,总体耐受性较好。本文综述了5-HT_(2A)受体拮抗剂改善神经精神疾病伴随的幻觉症状的研究进展,为设计开发新型神经精神疾病治疗药物提供参考。

PDCA循环法在麻精药品规范化管理中的应用效果分析

目的评价麻醉剂、精神类(麻精)药品规范化管理中应用PDCA(计划、执行、检查、处理)循环法的有效性。方法选择85例麻精药品使用患者,根据随机数字表法分为对照组(40例)和观察组(45例)。对照组采用常规管理,观察组采用PDCA循环法管理。对比两组管理效果和麻醉药品调剂管理情况。结果观察组处方书写不规范、用药后空安瓿未收回、处方剂量含糊不清管理问题总发生率2.22%低于对照组的20.00%,存在统计学意义(P<0.05)。观察组的处方审核率、药品用法用量规范率、处方专册登记率分别为100.00%、95.56%、97.78%,均高于对照组的72.50%、75.00%、70.00%,存在统计学意义(P<0.05)。结论麻精药品规范化管理中,采用PDCA循环法的效果显著,可以减少麻精药品处方开具、使用和管理过程中的问题,值得予以推广和使用。