preventive treatment

预防性治疗
  • 文章类型: Case Reports
    牙囊囊肿,如果不及时治疗,可以显着生长并削弱下颌骨,造成病理性或医源性骨折的风险。治疗方案可能包括减压,有袋化,和摘除,可用的,选择是多因素的,适合每个案例。本文介绍了两个有骨折风险的复杂牙质囊肿的治疗方法,一个是84岁的女人,第二个是41岁的男人。囊肿和相关牙齿被手术切除,同时放置定制的钛接骨板以防止每次和术后的骨折风险。这种方法似乎适用于无法进行有袋化或减压以及医源性骨折风险较高的情况。
    Dentigerous cysts, if left untreated, can grow significantly and weaken the mandible, posing risks of pathological or iatrogenic fracture. Treatment options may include decompression, marsupialization, and enucleation, which are available, with the choice being multifactorial and tailored to each case. This article describes the management of two complex dentigerous cysts at risk of fracture, one about an 84-year-old woman and the second about a 41-year-old man. The cysts and associated teeth were surgically removed, and simultaneously custom-made titanium osteosynthesis plates were placed to prevent per- and postoperative fracture risks. This approach appears to be indicated in cases where marsupialization or decompression is impossible and when there is a high risk of iatrogenic fracture.
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  • 文章类型: Journal Article
    结核病(TB)预防性治疗(TPT)有效地防止了从TB感染到TB疾病的进展。本研究使用从结核病管理信息系统(TB-MIS)检索的6年计划数据(2018-2023年),探讨了与柬埔寨TPT未完成相关的因素。在14,262例潜伏性结核感染(LTBI)患者中,299(2.1%)未完成治疗。与年龄<5岁的人相比,年龄在15-24岁至25-34岁之间的人更有可能无法完成治疗。分别为aOR=1.7,p=0.034和aOR=2.1,p=0.003。与每周3个月的异烟肼和利福喷丁(3HP)相比,每天服用3个月的利福平和异烟肼(3RH)或每天服用6个月的异烟肼(6H)的个体更有可能无法完成治疗。分别为aOR=2.6,p<0.001和aOR=7,p<0.001。在转诊医院开始TPT的患者与在医疗中心开始治疗的患者相比,未完成治疗的可能性几乎是后者的两倍(aOR=1.95,p=0.003)。为了提高TPT完成,应优先加强年龄在15至34岁之间的患者的治疗随访,并在转诊医院开始TPT。国家结核病计划应将3HP视为首选治疗方法。
    Tuberculosis (TB) preventive treatment (TPT) effectively prevents the progression from TB infection to TB disease. This study explores factors associated with TPT non-completion in Cambodia using 6-years programmatic data (2018-2023) retrieved from the TB Management Information System (TB-MIS). Out of 14,262 individuals with latent TB infection (LTBI) initiated with TPT, 299 (2.1%) did not complete the treatment. Individuals aged between 15-24 and 25-34 years old were more likely to not complete the treatment compared to those aged < 5 years old, with aOR = 1.7, p = 0.034 and aOR = 2.1, p = 0.003, respectively. Individuals initiated with 3-month daily Rifampicin and Isoniazid (3RH) or with 6-month daily Isoniazid (6H) were more likely to not complete the treatment compared to those initiated with 3-month weekly Isoniazid and Rifapentine (3HP), with aOR = 2.6, p < 0.001 and aOR = 7, p < 0.001, respectively. Those who began TPT at referral hospitals were nearly twice as likely to not complete the treatment compared to those who started the treatment at health centers (aOR = 1.95, p = 0.003). To improve TPT completion, strengthen the treatment follow-up among those aged between 15 and 34 years old and initiated TPT at referral hospitals should be prioritized. The national TB program should consider 3HP the first choice of treatment.
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  • 文章类型: Journal Article
    这项研究确定了在深度镇静下接受牙科手术的患者的牙科治疗方式,并检查了治疗类型之间的潜在关系。年龄,性别和牙齿类型。这项研究方案包括502名患者的数据,包括总共5141颗牙齿,他们在2022年10月至2023年10月期间在深度镇静下接受了牙科手术。根据主要类型和亚型对牙科治疗进行分类。随后,这项研究检查了治疗类型和年龄之间的关系,性别和牙齿类型。数据分析采用卡方检验,显著性水平设置为5%。大多数患者(76.9%)年龄在0-6岁之间,93.4%的治疗牙齿是乳牙。以恢复性治疗为主(61.6%),其次是提取(27.2%),牙髓治疗(6.1%),和预防性治疗(5.1%)。在修复材料中,复合体是最常用的(49.8%)。在年龄组和牙齿类型方面观察到治疗类型之间的显着差异(两者均p<0.001),但性别方面没有差异(p=0.920)。根据我们的发现,修复治疗和拔牙是最常见的手术,而在深度镇静下进行牙髓治疗的频率较低。
    This study identified the dental treatment modalities administered to patients undergoing dental procedures under deep sedation and examined potential relations among treatment types, age, gender and tooth types. This study protocol included data from 502 patients, including a total of 5141 teeth, who underwent dental procedures under deep sedation between October 2022 and October 2023. The dental treatments were categorized based on primary types and subtypes. Subsequently, this study examined the associations between treatment types and age, gender and tooth type. Data were analyzed using the Chi-Square test, with the significance level set at 5%. Most patients (76.9%) were aged 0-6 years, and 93.4% of the treated teeth were primary teeth. The predominant treatment was restorative therapy (61.6%), followed by extraction (27.2%), endodontic treatment (6.1%), and preventive treatment (5.1%). Among restorative materials, compomer was the most frequently applied (49.8%). Significant differences between the treatment types were observed in terms of age group and tooth type (p < 0.001 for both) but not gender (p = 0.920). Based on our findings, restorative treatments and tooth extraction are the most frequently performed procedures, whereas endodontic treatments are performed less frequently under deep sedation.
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  • 文章类型: Journal Article
    偏头痛是全球残疾的主要原因,然而它仍然被低估和对待,尤其是在儿童和青少年人群中。慢性偏头痛大约发生在需要预防性治疗的儿童和青少年的1%。托吡酯是FDA批准的唯一用于12岁以上儿童的预防性治疗药物。但是关于它的功效有相互矛盾的证据。OnabotulinumtoxinA是一种已知且批准的治疗18岁以上人群的慢性偏头痛的治疗方法。一些研究以积极的结果检验了其在儿科人群中的作用;然而,明确的好处还不清楚。OnabotulinumtoxinA似乎不仅可以提高残疾评分(PedMIDAS),而且还可以提高质量,特点,以及上述人群中偏头痛的频率。本系统综述旨在总结疗效的证据,给药,administration,长期结果,以及小儿和青少年偏头痛中单纯碱毒素A的安全性。18项研究符合资格标准,并被纳入本综述。平均每月偏头痛天数(MMD),从每月21.2天减少到治疗后的10.7天。报告的治疗相关不良反应是轻度的,主要是注射部位相关的,范围为0%至47.0%。因此,本综述提供了令人信服的证据,表明OnabotulinumtoxinA可能是小儿偏头痛安全有效的预防性治疗选择.
    Migraine is a leading cause of disability worldwide, yet it remains underrecognized and undertreated, especially in the pediatric and adolescent population. Chronic migraine occurs approximately in 1% of children and adolescents requiring preventive treatment. Topiramate is the only FDA-approved preventative treatment for children older than 12 years of age, but there is conflicting evidence regarding its efficacy. OnabotulinumtoxinA is a known and approved treatment for the management of chronic migraine in people older than 18 years. Several studies examine its role in the pediatric population with positive results; however, the clear-cut benefit is still unclear. OnabotulinumtoxinA seems not only to improve disability scores (PedMIDAS) but also to improve the quality, characteristics, and frequency of migraines in the said population. This systematic review aims to summarize the evidence on the efficacy, dosing, administration, long-term outcomes, and safety of onabotulinumtoxinA in pediatric and adolescent migraine. Eighteen studies met the eligibility criteria and were included in this review. The mean monthly migraine days (MMDs), decreased from of 21.2 days per month to 10.7 after treatment. The reported treatment-related adverse effects were mild and primarily injection site related and ranged from 0% to 47.0%. Thus, this review provides compelling evidence suggesting that OnabotulinumtoxinA may represent a safe and effective preventive treatment option for pediatric migraine.
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  • 文章类型: Journal Article
    目的:描述美国偏头痛患者开始治疗急性和预防性治疗药物标准后3年的治疗模式和直接医疗费用。
    背景:关于长期(>1年)偏头痛治疗模式和相关结局的数据有限。
    方法:这是一个回顾性研究,使用IBM®MarketScan®研究数据库(2010年1月至2017年12月)的美国索赔数据进行的观察性队列研究.如果成年人在指数期(2011年1月至2014年12月)有急性偏头痛治疗(AMT)或预防性偏头痛治疗(PMT)的处方要求,则包括在内。AMT队列被归类为持久性,骑自行车,或附加亚组;PMT队列被归类为PMT-持久性,无间隙切换,或与间隙循环。AMT和PMT队列亚组的偏头痛特异性年度直接费用(2017美元)在基线至3年(随访)进行了总结。
    结果:在索引期间,20,778和42,259名患者开始了AMT和PMT,分别。在3年的随访中,在两个AMT中,相对于非持续性亚组,持续性亚组的偏头痛特异性直接成本较低(平均值[SD]:$789[$1741]vs.附加子组中为$2847[$8149],循环子组中为$862[$5426])和PMT队列(持久性子组中的平均值[SD]:$1817[$5892]与无间隙子组中的$4257[$11,392]和带间隙子组中的$3269[$18,540])。急性药物过度使用在持续性亚组(1025/6504[27.2%])和非持久性亚组(11,236/58,863[32.2%]在有间隙的循环亚组和1431/6504[39.4%]在无间隙的切换亚组)。大多数患者在治疗开始后3年内使用多种急性(19,717/20,778[94.9%])或预防性(38,494/42,259[91.1%])药物治疗。预防性治疗的差距很常见;平均差距为85至211天(〜3-7个月)。
    结论:在AMT和PMT持续治疗的患者中,偏头痛特异性年度医疗费用和急性偏头痛药物过度使用仍然最低。研究结果仅限于美国人口。未来的研究应该比较偏头痛患者的新型预防性偏头痛药物的成本和相关结果。
    OBJECTIVE: To describe treatment patterns and direct healthcare costs over 3 years following initiation of standard of care acute and preventive migraine medications in patients with migraine in the United States.
    BACKGROUND: There are limited data on long-term (>1 year) migraine treatments patterns and associated outcomes.
    METHODS: This was a retrospective, observational cohort study using US claims data from the IBM® MarketScan® Research Database (January 2010-December 2017). Adults were included if they had a prescription claim for acute migraine treatments (AMT) or preventive migraine treatments (PMT) in the index period (January 2011-December 2014). The AMT cohort was categorized as persistent, cycled, or added-on subgroups; the PMT cohort was categorized PMT-persistent, switched without gaps, or cycled with gaps. Migraine-specific annual direct costs (2017 US$) across AMT and PMT cohort subgroups were summarized at baseline through 3 years from index (follow-up).
    RESULTS: During the index period, 20,778 and 42,259 patients initiated an AMT and a PMT, respectively. At the 3-year follow-up, migraine-specific direct costs were lower in the persistent subgroup relative to the non-persistent subgroups in both AMT (mean [SD]: $789 [$1741] vs. $2847 [$8149] in the added-on subgroup and $862 [$5426] for the cycled subgroup) and PMT cohorts (mean [SD]: $1817 [$5892] in the persistent subgroup vs. $4257 [$11,392] in the switched without gaps subgroup and $3269 [$18,540] in the cycled with gaps subgroup). Acute medication overuse was lower in the persistent subgroup (1025/6504 [27.2%]) vs. non-persistent subgroups (11,236/58,863 [32.2%] in cycled with gaps subgroup and 1431/6504 [39.4%] in the switched without gaps subgroup). Most patients used multiple acute (19,717/20,778 [94.9%]) or preventive (38,494/42,259 [91.1%]) pharmacological therapies over 3 years following treatment initiation. Gaps in preventive therapy were common; an average gap ranged from 85 to 211 days (~3-7 months).
    CONCLUSIONS: Migraine-specific annual healthcare costs and acute migraine medication overuse remained lowest among patients with persistent AMT and PMT versus non-persistent treatment. Study findings are limited to the US population. Future studies should compare costs and associated outcomes between newer preventive migraine medications in patients with migraine.
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  • 文章类型: Journal Article
    确定偏头痛患者对急性和预防性治疗方案的偏好和看法,并调查哪些治疗结果是最重要的。
    作者在一组来自希腊和塞浦路斯的偏头痛患者中进行了选择格式调查。使用了与希腊偏头痛患者协会合作开发的自我管理问卷。
    对617名偏头痛患者进行问卷调查。作为唯一最重要的参数,疗效优于安全性。无论是在急性和预防性治疗。在分析单一结果时,患者优先考虑急性治疗给药后1小时疼痛完全缓解.关于偏头痛的预防,频率减少75%,疼痛的强度,伴随症状和急性药物摄入被认为是最重要的。相反,临床试验中常规使用的结果,即急性治疗给药后2小时完全或部分疼痛缓解,预防偏头痛频率减少50%或30%,被认为不是特别相关。片剂配方是最优选的,无论是在急性和预防性治疗。结论:倾听患者的需求可能会增加临床实践中普遍缺失的难题,并经常解释急性和预防性抗偏头痛治疗缺乏依从性。
    UNASSIGNED: To identify the preferences and perceptions of migraine patients for acute and preventive treatment options and to investigate which treatment outcomes are the most important.
    UNASSIGNED: The authors performed a choice-format survey in a cohort of migraine patients from Greece and Cyprus. A self-administered questionnaire developed in collaboration with the Greek Society of Migraine Patients was used.
    UNASSIGNED: Questionnaires were collected from 617 migraine patients. Efficacy was preferred over safety as the single most important parameter, both in acute and preventive treatment. When analyzing single outcomes, patients prioritized a complete pain remission at 1-hour post-dose for acute therapies. Regarding migraine prevention, a 75% reduction in frequency, intensity of pain, accompanying symptoms and acute medication intake were considered as most important. Conversely, outcomes routinely used in clinical trials, namely complete or partial pain remission at 2-hours post-dose for acute treatment and 50% or 30% reduction in migraine frequency for prevention, were not deemed particularly relevant. Tablet formulation was mostly preferred, both in acute and preventive treatment. Conclusion: Listening to patients\' needs may add a piece of the puzzle that is generally missing in clinical practice and often explains the lack of adherence in both acute and preventative anti-migraine therapies.
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  • 文章类型: Journal Article
    希腊偏头痛和头痛患者协会在2023年进行了第三次在线人群网络调查,以确定疾病负担和患者对传统和新型偏头痛疗法的满意度是否正在发生变化。方法:抽样过程基于对参与者的随机呼吁,以回答特定的偏头痛为重点的自我管理问卷,包括83个希腊语问题,通过在线研究软件SurveyMonkey在全国范围内分发。结果:我们最终招募了2565名患者,其中大多数是女性。我们的发现清楚地表明,偏头痛仍然是一种繁重的疾病。其对生产力各个方面的影响程度取决于偏头痛的每月频率以及对急性和预防性治疗的反应率。共有1029例(42.4%)的患者因对急性治疗或先兆相关症状无反应而去急诊室。Triptans作为急性疗法似乎部分有效。对于几乎一半的慢性偏头痛患者(43.9%)来说,对这种治疗有足够的满意度(27.8%的人“相当满意”,10.6%的人“非常高兴”,5.5%的人“非常高兴”)。由于它们的高预防效力,大多数接受抗CGRPMab治疗的受访者对偏头痛的未来表示乐观(88.25%),以及进一步提高他们的生活质量(82.8%),主要是Fremanezumab.结论:患者认识到抗CGRPMab在偏头痛预防中的有用性,因此似乎比以前对偏头痛的生活更加乐观。考虑到使用gepants和ditans预期的市场变化,有必要进行更大规模的基于人群的纵向研究,以进一步探讨偏头痛治疗的新时代是否可以进一步减轻疾病负担.
    Objective: The Greek Society of Migraine and Headache Patients conducted its third in-line population web-based survey in 2023 to ascertain if the burden of the disease and the patients\' satisfaction with conventional and novel migraine therapies are changing compared to our previous findings from 2018 and 2020. Methods: The sampling process was based on a random call to participants to reply to a specific migraine-focused self-administered questionnaire, including 83 questions in Greek, which was distributed nationwide through the online research software SurveyMonkey. Results: We eventually enrolled 2565 patients, the majority of which were females. Our findings clearly demonstrate that migraine is still a burdensome condition. The degree of its impact on all aspects of productivity depends on the monthly frequency of migraine and the response rates to acute and prophylactic treatments. A total of 1029 (42.4%) of the patients had visited the emergency room mainly for unresponsiveness to acute treatments or aura-related symptoms. Triptans seem to be partly effective as acute therapies. OnabotulinumtoxinA seems to be effective for almost half of chronic migraine patients (43.9%) to report adequate satisfaction with this treatment (27.8% were \"fairly happy\", 10.6% were \"very happy\", and 5.5% were \"extremely happy\"). Due to their high rates of preventative effectiveness, most respondents treated with anti-CGRP Mabs expressed their optimism concerning their future while living with their migraine (88.25%), as well as towards further improvements in their quality of life (82.8%) status, mostly with fremanezumab. Conclusions: The patients recognize the usefulness of anti-CGRP Mabs in migraine prevention and consequently seem to be more optimistic than before about living with migraine. Considering the market change that is anticipated with the use of gepants and ditans, larger longitudinal population-based studies are warranted to further explore if the new era of migraine therapeutics might further lessen the burden of the disease.
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  • 文章类型: Journal Article
    目的:比较降钙素基因相关肽单克隆抗体(CGRPmAb)与非特异性口服偏头痛预防药物(NOEP)。
    背景:保险公司在批准CGRPmAb之前,必须使用NOEP进行阶梯治疗。
    方法:在数据库中搜索I类或II类随机对照试验(RCTs),比较CGRPmAb或NOEP与安慰剂预防成人偏头痛的作用。主要结果指标是每月偏头痛天数(MMD)或中度至重度头痛天数。
    结果:CGRP单克隆抗体的12个RCT,5托吡酯的随机对照试验,和3个双丙戊酸钠的RCT纳入荟萃分析。有很高的确定性,CGRP单克隆抗体比安慰剂更有效,加权平均差(WMD;95%置信区间)为-1.64(-1.99至-1.28)MMD,这与小效应大小(科恩的d-0.25[-0.34至-0.16])兼容。托吡酯或双丙戊酸钠比安慰剂更有效的证据的确定性非常低,(WMD分别为-1.45[-1.52至-1.38]和-1.65[-2.30至-1.00],分别;科恩的d-1.25[-2.47至-0.03]和-0.48[-0.67至-0.29],分别)。试验序贯分析表明,信息大小足够,CGRPmAb与安慰剂相比具有明显的益处。网络荟萃分析显示CGRPmAb与托吡酯(WMD-0.19[-0.56,0.17])或二丙戊酸钠(0.01[-0.73,0.75])之间无统计学差异。托吡酯或双丙戊酸钠之间没有显著差异(0.21[-0.45至0.86])。
    结论:有很高的确定性,CGRP单克隆抗体比安慰剂更有效,但效果大小小。在可行的情况下,CGRP单克隆抗体可作为一线预防药物;托吡酯或双丙戊酸钠可能同样有效,但耐受性较差。这项研究的结果支持了美国头痛协会最近发表的2024年关于使用CGRPmAb作为一线治疗的立场。
    OBJECTIVE: To compare calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) versus nonspecific oral migraine preventives (NOEPs).
    BACKGROUND: Insurers mandate step therapy with NOEPs before approving CGRP mAbs.
    METHODS: Databases were searched for class I or II randomized controlled trials (RCTs) comparing CGRP mAbs or NOEPs versus placebo for migraine prevention in adults. The primary outcome measure was monthly migraine days (MMD) or moderate to severe headache days.
    RESULTS: Twelve RCTs for CGRP mAbs, 5 RCTs for topiramate, and 3 RCTs for divalproex were included in the meta-analysis. There was high certainty that CGRP mAbs are more effective than placebo, with weighted mean difference (WMD; 95% confidence interval) of -1.64 (-1.99 to -1.28) MMD, which is compatible with small effect size (Cohen\'s d -0.25 [-0.34 to -0.16]). Certainty of evidence that topiramate or divalproex is more effective than placebo was very low and low, respectively (WMD -1.45 [-1.52 to -1.38] and -1.65 [-2.30 to -1.00], respectively; Cohen\'s d -1.25 [-2.47 to -0.03] and -0.48 [-0.67 to -0.29], respectively). Trial sequential analysis showed that information size was adequate and that CGRP mAbs had clear benefit versus placebo. Network meta-analysis showed no statistically significant difference between CGRP mAbs and topiramate (WMD -0.19 [-0.56 to 0.17]) or divalproex (0.01 [-0.73 to 0.75]). No significant difference was seen between topiramate or divalproex (0.21 [-0.45 to 0.86]).
    CONCLUSIONS: There is high certainty that CGRP mAbs are more effective than placebo, but the effect size is small. When feasible, CGRP mAbs may be prescribed as first-line preventives; topiramate or divalproex could be as effective but are less well tolerated. The findings of this study support the recently published 2024 position of the American Headache Society on the use of CGRP mAbs as the first-line treatment.
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  • 文章类型: Journal Article
    背景:幼儿龋齿(ECC)是一种普遍存在的牙科问题,影响六岁以下的儿童。传统的修复治疗,如填充物,对幼儿来说往往是具有挑战性和侵入性的。氟化银二胺(SDF)为管理ECC提供了一种微创且经济高效的替代方案。然而,的影响,接受,父母对这种治疗的理解对于其成功实施仍然至关重要。
    目的:评估在ECC中接受SDF治疗的影响和水平。
    方法:选择了来自Anganwadi中心的32名儿童,年龄在2至5岁之间患有ECC。在确定的龋齿病变上施加38%的SDF3分钟,在三周三个月的召回期后,对逮捕率进行了检查。Likert量表用于有关父母对申请程序的简易性反馈的问卷,牙齿变色,可能与手术相关的疼痛,和SDF的味道。
    结果:在本研究中,总共75个表面经受SDF的应用。三个星期后,据观察,这些表面中有64个成功地经历了龋齿阻止的过程。这一发现被认为具有统计学意义,P值为0.021。此外,其余未达到龋齿阻止的表面随后在三个月后得到治疗。这项后续治疗的结果也被发现具有统计学意义,P值为0.027。这些发现强调了龋齿治疗和龋齿阻止与使用SDF有关的功效。
    结论:发现SDF是微创的,易于管理,便宜,高效,以及有效的治疗方法来阻止幼儿的原发性牙列龋齿,特别是缺乏合作的患者。
    BACKGROUND:  Early childhood caries (ECC) is a widespread dental problem that impacts children below the age of six years. Traditional restorative treatments like fillings are often challenging and invasive for young children. Silver diamine fluoride (SDF) offers a minimally invasive and cost-effective alternative for managing ECC. However, the effects, acceptance, and understanding of this treatment by parents remain crucial for its successful implementation.
    OBJECTIVE: To evaluate the impact and level of acceptance of SDF treatment in ECC.
    METHODS: Thirty-two children from an Anganwadi center aged between two to five years suffering from ECC were selected. A 38% SDF was applied for 3 minutes on the identified carious lesion, and the arrest percentage was checked after a recall period of three weeks and three months. The Likert scale was used for the questionnaire regarding parental feedback about the ease of application procedure, tooth discoloration, possible pain associated with the procedure, and the taste of SDF.
    RESULTS: In the present study, a total of 75 surfaces were subjected to the application of SDF. After a period of three weeks, it was observed that 64 of these surfaces had successfully undergone the process of caries arrest. This finding was deemed to be statistically significant, with a P value of 0.021. Furthermore, the remaining surfaces that had not achieved caries arrest were subsequently treated at three months. The results of this subsequent treatment were also found to be statistically significant, with a P value of 0.027. These findings highlight the efficacy of both caries treatment and caries arrest in relation to the utilization of SDF.
    CONCLUSIONS: SDF was found to be minimally invasive, easy to administer, inexpensive, highly efficient, and effective treatment in arresting caries in the primary dentition of young children, particularly in patients lacking cooperation.
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  • 文章类型: Journal Article
    背景:在最近的一项随机研究中,双盲,安慰剂对照研究,我们观察到脉冲给药后,丛集性头痛的发作频率没有显着降低(10mg/70kg,3剂,每个间隔5天)。我们进行了盲延伸阶段,以考虑重复脉冲方案的安全性和有效性。
    方法:符合条件的参与者在第一轮研究参与后至少6个月返回接受psilocybin脉冲。参与者在第一次服药前两周开始记录头痛日记,并在第一次服药后持续八周。十名参与者完成了扩展阶段,所有十名都包括在最终分析中。
    结果:在脉搏开始后的三周内,集群攻击频率较基线显著降低(18.4[95%置信区间8.4~28.4]至9.8[4.3~15.2]次攻击/周;p=0.013,d'=0.97).观察到约50%的减少,无论在第一轮中个体对裸盖素的反应如何。Psilocybin耐受性良好,没有任何意外或严重的不良事件。
    结论:本研究显示,在反复循环脉冲裸盖素给药过程中,集群攻击频率显著降低,并提示先前的反应可能无法预测反复治疗的效果。为了评估psilocybin作为丛集性头痛的可行药物的全部潜力,未来的工作应该研究更大的安全性和治疗效果,在更长的时间内更有代表性的样本,包括重复治疗。
    背景:NCT02981173。
    BACKGROUND: In a recent randomized, double-blind, placebo-controlled study, we observed a nonsignificant reduction of attack frequency in cluster headache after pulse administration of psilocybin (10 mg/70 kg, 3 doses, 5 days apart each). We carried out a blinded extension phase to consider the safety and efficacy of repeating the pulse regimen.
    METHODS: Eligible participants returned to receive a psilocybin pulse at least 6 months after their first round of study participation. Participants kept headache diaries starting two weeks before and continuing through eight weeks after the first drug session. Ten participants completed the extension phase and all ten were included in the final analysis.
    RESULTS: In the three weeks after the start of the pulse, cluster attack frequency was significantly reduced from baseline (18.4 [95% confidence interval 8.4 to 28.4] to 9.8 [4.3 to 15.2] attacks/week; p = 0.013, d\' = 0.97). A reduction of approximately 50% was seen regardless of individual response to psilocybin in the first round. Psilocybin was well-tolerated without any unexpected or serious adverse events.
    CONCLUSIONS: This study shows a significant reduction in cluster attack frequency in a repeat round of pulse psilocybin administration and suggests that prior response may not predict the effect of repeated treatment. To gauge the full potential of psilocybin as a viable medicine in cluster headache, future work should investigate the safety and therapeutic efficacy in larger, more representative samples over a longer time period, including repeating the treatment.
    BACKGROUND: NCT02981173.
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