single dose

单剂量
  • 文章类型: Comparative Study
    背景:阴道念珠菌病(VC)通常影响孕妇。传统上,克霉唑阴道片(CLO)一直是管理的基石。然而,舍他康唑胚珠(SER)提供了一种新颖的局部抗真菌剂选择。这个双盲,随机试验评估了单剂量SER和CLO治疗妊娠期急性VC的疗效.
    方法:从2020年6月至2021年5月,这项试验招募了年龄≥18岁的孕妇,这些孕妇具有经显微镜检查证实的VC症状(阴道分泌物异常和/或外阴/阴道瘙痒)。前一年有≥4次VC发作的参与者,免疫受损状态,或咪唑禁忌症和在2周随访时缺席的患者被排除.参与者随机接受300mgSER或500mgCLO。初始用药后2周的评估包括临床治愈(所有症状的自我报告解决),显微治疗(假菌丝缺失),患者满意度,副作用,和临床治愈的时间。持续性VC的参与者每周接受SER剂量直至分娩。对复发和妊娠结局进行评估。
    结果:分析包括96名参与者(每组48名,平均年龄27.4±7.4岁,诊断时的胎龄22.9±6.4周)。没有统计学意义,SER取得了较高的临床治愈率(62.5%vs50%,p=0.217;平均差为12.5%,95CI:-17.5%至42.5%;比率为1.25,95CI:0.71至2.23)和较低的微观固化(47.9%与62.5%,p=0.151;平均差为-14.6%,95CI:-44.3%至15.1%;比率为0.77,95CI:0.43至1.37)。两组的临床治愈时间相当(SER:3.1±1.8天,CLO:3.4±2.7天;p=0.848)和实质性满意率(SER:66.7%,CLO:60.4%;p=0.753)。没有副作用的报道。在Siriraj医院分娩的60名参与者中,妊娠结局无显著差异.反复SER给药根除症状并提高显微治愈率。在1-2个月内,四名SER和两名CLO参与者观察到复发。
    结论:在妊娠期急性VC的治疗中,300mgSER和500mgCLO在临床和微观治愈率方面表现出可比的疗效,满意,副作用,临床治愈的时间,复发率,和妊娠结局。
    背景:TCTR20190308004(注册日期2019年3月8日)。
    BACKGROUND: Vaginal candidiasis (VC) commonly affects pregnant women. Traditionally, clotrimazole vaginal tablets (CLO) have been the cornerstone of management. However, sertaconazole ovules (SER) offer a novel topical antimycotic option. This double-blinded, randomized trial evaluated the efficacy of single-dose SER and CLO in treating acute VC during pregnancy.
    METHODS: From June 2020 to May 2021, this trial recruited pregnant women aged ≥ 18 years with VC symptoms (abnormal vaginal discharge and/or vulvar/vaginal itching) confirmed by microscopy. Participants with ≥ 4 VC episodes in the prior year, immunocompromised status, or imidazole contraindications and those who were absent at the 2-week follow-up were excluded. Participants were randomized to receive either 300 mg SER or 500 mg CLO. Evaluations 2 weeks after the initial medication administration included clinical cure (self-reported resolution of all symptoms), microscopic cure (pseudohyphal absence), patient satisfaction, side effects, and time to clinical cure. Participants with persistent VC received weekly SER doses until delivery. Assessments of recurrence and pregnancy outcomes were done.
    RESULTS: The analysis included 96 participants (48 per group, mean age 27.4 ± 7.4 years, gestational age at diagnosis 22.9 ± 6.4 weeks). Without statistical significance, SER achieved a higher clinical cure rate (62.5% vs 50%, p = 0.217; a mean difference of 12.5%, 95%CI: -17.5% to 42.5%; and a rate ratio of 1.25, 95%CI: 0.71 to 2.23) and a lower microscopic cure (47.9% vs. 62.5%, p = 0.151; a mean difference of -14.6%, 95%CI: -44.3% to 15.1%; and a rate ratio of 0.77, 95%CI: 0.43 to 1.37). The two groups had comparable times to clinical cure (SER: 3.1 ± 1.8 days, CLO: 3.4 ± 2.7 days; p = 0.848) and substantial satisfaction rates (SER: 66.7%, CLO: 60.4%; p = 0.753). No side effects were reported. Of 60 participants who gave birth at Siriraj Hospital, there were no significant differences in pregnancy outcomes. Repeated SER dosing eradicated symptoms and enhanced the microscopic cure rate. Recurrence was observed in four SER and two CLO participants within 1-2 months.
    CONCLUSIONS: In the treatment of acute VC during pregnancy, 300 mg SER and 500 mg CLO exhibited comparable efficacy in terms of clinical and microscopic cure rates, satisfaction, side effects, time to clinical cure, recurrence rates, and pregnancy outcomes.
    BACKGROUND: TCTR20190308004 (registration date March 8, 2019).
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  • 文章类型: Journal Article
    目的:本研究的目的是确定术后单剂量抗凝治疗在预防THA修订后静脉血栓栓塞(VTE)中的疗效和安全性,与多剂量化学预防方案相比。
    方法:我们回顾性比较了295例接受修正THA的患者,这些患者接受多剂量化学预防方案(一次40mg低分子量肝素和10天口服利伐沙班)或单剂量化学预防方案(一次40mg低分子量肝素)治疗VTE。两组患者均进行积极的下肢锻炼。根据翻修的病因,将每组进一步分为亚组。VTE的发病率,三个月内伤口并发症,隐性失血(HBL),输血率,记录手术引流时间。
    结果:两种预防方案之间的VTE发生率(P=0.870)没有差异。然而,3个月内伤口并发症差异显著(P=0.002),HBL(P=0.015),输血率(P=0.028)。单剂量化学预防组的手术引流时间也较短(P=0.0023)。在亚组分析中,使用单剂量化学预防方案不能显著降低脓毒症修正THA后的HBL和输血率.采用多剂量化疗方案(OR=2.89,P=0.002)和高BMI(OR=1.09,P=0.037)是切口并发症的独立危险因素。
    结论:与多剂量化学预防方案相比,单剂量化学预防方案可有效且安全地预防修订THA后的VTE。在脓毒症翻修中,降低HBL和术后输血率的作用有限。
    The purpose of the study is to determine the efficacy and safety of postoperative single-dose anticoagulant treatment in preventing venous thromboembolism (VTE) after revision THA, in comparison with a multiple-dose chemoprophylaxis protocol.
    We retrospectively compared 295 patients undergoing revision THA who received multiple-dose chemoprophylaxis protocol (40 mg low-molecular-weight heparin once and oral rivaroxaban for 10 days) or single-dose chemoprophylaxis protocol (40 mg low-molecular-weight heparin once) for VTE. The patients in both groups performed active lower limb exercises. Each group was further stratified into subgroups based on the aetiology of revision. The incidence of VTE, wound complications within three months, hidden blood loss (HBL), transfusion rate, and surgical drainage duration were recorded.
    The incidence rates of VTE (P = 0.870) did not differ between the two prophylaxis protocols. However, significant differences were observed in wound complications within three months (P = 0.002), HBL (P = 0.015), transfusion rate (P = 0.028). Surgical drainage duration was also shorter in the single-dose chemoprophylaxis group (P = 0.0023). In the subgroup analysis, the use of single-dose chemoprophylaxis protocol cannot significantly reduce HBL and transfusion rate after septic revision THA. The use of multiple-dose chemoprophylaxis protocol (OR = 2.89, P = 0.002) and high BMI (OR = 1.09, P = 0.037) were independent risk factors of wound complications.
    Single-dose chemoprophylaxis protocol effectively and safely prevented VTE after revision THA compared with multiple-dose chemoprophylaxis protocol. The effect in reducing HBL and postoperative transfusion rate was limited in septic revision.
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  • 文章类型: Journal Article
    在2008/9年,斐济为30,000名9-12岁的女孩接种了至少一剂四价人乳头瘤病毒(4vHPV)疫苗,覆盖率>60%(一剂仅为14%,两次剂量仅为13%,三次剂量为35%)。我们计算了一种疫苗的有效性(VE),接种疫苗八年后,两剂和三剂4vHPV对抗致癌HPV基因型16/18。
    在≤23岁的孕妇中进行了一项回顾性队列研究(2015-2019年),2008/9年度有资格接受4vHPV,并已确认疫苗接种状态。由于询问斐济性行为的文化敏感性,该研究仅限于孕妇。临床医生为每个参与者收集了一份问卷,阴道拭子和生殖器疣检查,接种疫苗后8年(6-11年)的中位数。通过分子方法检测HPVDNA。针对疫苗HPV基因型检测的调整VE(AVE)(16/18),非疫苗基因型的对照组(31/33/35/39/45/51/52/56/58/59/66/68),并计算了生殖器疣。调整后模型中包含的协变量为:年龄,种族和吸烟,根据与任何HPV检测的单变量关联。
    在822名参与者中,未接种疫苗的人中HPV16/18的患病率,一,两个和三个剂量组为13.3%(50/376),2.5%(4/158),0%(0/99)和1.6%(3/189),分别;对于非疫苗高风险基因型,各剂量组的检出率相似(33.2%-40.4%,p=0.321)。针对HPV16/18的AVE之一,两剂和三剂为81%(95%CI;48-93%),100%(95%CI;100-100%),和89%(95%CI;64-96%),分别。在接种疫苗时间较长的女性中,HPV16/18的患病率较低。
    单剂量4vHPV疫苗在接种8年后对HPV基因型16和18非常有效。我们的结果为西太平洋区域的低收入或中等收入国家的减量4vHPV计划提供了最长的保护持续时间。
    这项研究得到了比尔和梅琳达·盖茨基金会以及澳大利亚政府外交和贸易部和斐济卫生部门支持计划(FHSSP)的支持。FHSSP由AbtJTA代表澳大利亚政府实施。
    UNASSIGNED: In 2008/9, Fiji vaccinated >30,000 girls aged 9-12 years with the quadrivalent human papillomavirus (4vHPV) vaccine coverage for at least one dose was >60% (one dose only was 14%, two dose only was 13%, three doses was 35%). We calculated vaccine effectiveness (VE) of one, two and three doses of 4vHPV against oncogenic HPV genotypes 16/18, eight years following vaccination.
    UNASSIGNED: A retrospective cohort study was undertaken (2015-2019) in pregnant women ≤23 years old, eligible to receive 4vHPV in 2008/9, with confirmed vaccination status. The study was restricted to pregnant women due to the cultural sensitivity of asking about sexual behavior in Fiji. For each participant a clinician collected a questionnaire, vaginal swab and genital warts examination, a median eight (range 6-11) years post vaccination. HPV DNA was detected by molecular methods. Adjusted VE (aVE) against the detection of vaccine HPV genotypes (16/18), the comparison group of non-vaccine genotypes (31/33/35/39/45/51/52/56/58/59/66/68), and genital warts were calculated. Covariates included in the adjusted model were: age, ethnicity and smoking, according to univariate association with any HPV detection.
    UNASSIGNED: Among 822 participants the prevalence of HPV 16/18 in the unvaccinated, one, two and three-dose groups were 13.3% (50/376), 2.5% (4/158), 0% (0/99) and 1.6% (3/189), respectively; and for the non-vaccine high-risk genotypes, the detection rate was similar across dosage groups (33.2%-40.4%, p = 0.321). The aVE against HPV 16/18 for one, two and three doses were 81% (95% CI; 48-93%), 100% (95% CI; 100-100%), and 89% (95% CI; 64-96%), respectively. Prevalence of HPV 16/18 was lower among women with longer time since vaccination.
    UNASSIGNED: A single dose 4vHPV vaccine is highly effective against HPV genotypes 16 and 18 eight years following vaccination. Our results provide the longest duration of protection for reduced dose 4vHPV schedule in a low- or middle-income country in the Western Pacific region.
    UNASSIGNED: This study was supported by the Bill & Melinda Gates Foundation and the Department of Foreign Affairs and Trade of the Australian Government and Fiji Health Sector Support Program (FHSSP). FHSSP is implemented by Abt JTA on behalf of the Australian Government.
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  • 文章类型: Journal Article
    这个随机的,平行组研究评估了沙芬酰胺在24名健康中国男性和女性中的血浆药代动力学特征,随机分配接受50或100毫克的沙芬酰胺作为单剂量,跟着,经过7天的清洗,多剂量,每日一次,持续7天。在第一次单剂量(第1天)和最后一次多剂量(第14天)后的96小时内测定血浆沙芬酰胺,并在第一次多次给药后24小时(第8天)。单剂量和多剂量给药后,在1.5-2小时的中值时间达到峰值浓度。血浆暴露以剂量成比例的方式增加。单剂量后,平均半衰期为23-24小时。从时间零外推至无穷大的浓度-时间曲线下面积(AUC)仅略高于从时间零到最后可量化浓度的AUC,对应于2个参数,分别,对于50mg剂量为12,380和11,560ng•h/mL,对于100mg剂量为22,030和20,790ng•h/mL。对于50和100mg的safinamide,在稳态的给药间隔中的AUC为13,150和23,100ng·h/mL。6天达到稳定状态,积累大约是两倍,药代动力学与时间无关。在这项研究中观察到的血浆沙芬酰胺药代动力学特征与在中国和非亚洲人群中发表的结果一致。
    This randomized, parallel-group study evaluated the plasma pharmacokinetic profile of safinamide in 24 healthy Chinese men and women, randomly assigned to receive 50 or 100 mg of safinamide as a single dose, followed, after a 7-day washout, by multiple doses once daily for 7 days. Plasma safinamide was determined up to 96 h after the first single dose (day 1) and the last multiple dose (day 14), and up to 24 h after the first multiple dose (day 8). Following single- and multiple-dose administration, peak concentrations were achieved at a median time of 1.5-2 h. Plasma exposure increased in a dose-proportional manner. After single dose, mean half-life was 23-24 h. Area under the concentration-time curve (AUC) from time zero extrapolated to infinity was only slightly higher than AUC from time zero to the last quantifiable concentration, corresponding for the 2 parameters, respectively, to 12,380 and 11,560 ng • h/mL for the 50 mg and to 22,030 and 20,790 ng • h/mL for the 100-mg dose. AUC in the dosing interval at steady state was 13,150 and 23,100 ng • h/mL for 50 and 100 mg of safinamide. Steady state was reached in 6 days, accumulation was approximately twofold, and the pharmacokinetics were time independent. The plasma safinamide pharmacokinetic profile observed in this study is in line with the published results in both Chinese and non-Asian populations.
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  • 文章类型: Randomized Controlled Trial
    Rimegepant是一种小分子降钙素基因相关肽受体拮抗剂(gepant),在偏头痛的急性和预防性治疗中具有良好的疗效和安全性。这里,我们报告了单次75mg口服剂量的Rimegepant在患有严重,中度,或轻度肝功能损害和来自开放标签的匹配健康受试者,单剂量,4组1期研究。纳入36名年龄在41-71岁的受试者,包括严重的6个,中度,或轻度肝功能损害和18名健康受试者。所有受试者完成研究。与匹配的健康对照相比,在轻度肝功能损害的受试者中观察到总的和未结合的药代动力学增加<20%,中度肝功能损害的受试者增加≤65%。在严重肝功能损害组中,总的和未结合的全身暴露增加了2.0倍和3.9倍。在患有严重肝功能损害的受试者中,从时间0到最后一个可量化浓度的血浆浓度-时间曲线下面积的几何平均比率(严重损伤/对照)为202.2%,从时间0到无穷大的血浆浓度-时间曲线下面积为202.2%,观察到的最大血浆浓度为189.1%。使用未结合浓度的相应几何平均比率为388.8%和388.7%,分别。三名(8.3%)受试者报告了4起治疗引起的不良事件。Rimegepant不推荐用于患有严重肝功能损害的成人。
    Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral dose of rimegepant in subjects with severe, moderate, or mild hepatic impairment and matched healthy subjects from an open-label, single-dose, 4-group phase 1 study. Thirty-six subjects aged 41-71 years were enrolled, including 6 each with severe, moderate, or mild hepatic impairment and 18 healthy subjects. All subjects completed the study. A <20% increase in total and unbound pharmacokinetics was observed in subjects with mild hepatic impairment and ≤65% increase with moderate hepatic impairment versus matched healthy controls. Total and unbound systemic exposure increased 2.0- and 3.9-fold in the severe hepatic impairment group. In subjects with severe hepatic impairment, geometric mean ratios (severe impairment/controls) for total concentrations were 202.2% for area under the plasma concentration-time curve from time 0 to the last quantifiable concentration, 202.2% for area under the plasma concentration-time curve from time 0 to infinity, and 189.1% for maximum observed plasma concentration. Corresponding geometric mean ratios using unbound concentrations were 388.8% and 388.7%, respectively. Three (8.3%) subjects reported 4 treatment-emergent adverse events. Rimegepant is not recommended for use in adults with severe hepatic impairment.
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  • 文章类型: Journal Article
    (1)背景:本文调查了单剂量研究中的哪些PK指标(姿势间隔结束时的浓度,Cτ,曲线下的部分区域,pAUCs,或半值持续时间,HVD)对于预测长期释放产品在稳态下的失效更敏感且变量更小,这是Cmax的生物等效性,AUC0-t和AUC0-inf,在单剂量研究中;(2)方法:在接受去文拉法辛100mg缓释片的36名受试者中进行了一项交叉研究。常规(Cmax,AUC0-t和AUC0-inf)和附加(Cτ,单剂量条件后考虑pAUC和HVD)PK指标。稳态下的预测PK指标(AUC0-τ,Cmax,ss,和Cτ,ss)是使用种群PK模型方法得出的;(3)结果:浓度-时间曲线形状的现有差异排除了对Cτ的等效性,SS在稳态下的模拟研究中。Cτ预测了在稳态下未能显示等效性,单剂量研究中的pAUCs和HVD。Cτ是检测不同形状的最敏感指标,受试者内变异性低于HVD;(4)结论:单剂量研究的常规PK指标(Cmax,AUC0-t和AUC0-inf)不足以保证长期释放产品在稳态下的生物等效性。
    (1) Background: this article investigates which PK metrics in a single-dose study (concentration at the end of posology interval, Cτ, partial areas under the curve, pAUCs, or half-value duration, HVD) are more sensitive and less variable for predicting the failure of a prolonged-release product at steady-state that was the bioequivalent for Cmax, AUC0-t and AUC0-inf, in the single-dose study; (2) Methods: a cross-over study was performed in 36 subjects receiving desvenlafaxine 100 mg prolonged-release tablets. Conventional (Cmax, AUC0-t and AUC0-inf) and additional (Cτ, pAUCs and HVD) PK metrics were considered after single-dose conditions. Predicted PK metrics at steady state (AUC0-τ, Cmax,ss, and Cτ,ss) were derived using a population PK model approach; (3) Results: the existing differences in the shape of the concentration-time curves precluded to show equivalence for Cτ,ss in the simulated study at steady state. This failure to show equivalence at steady state was predicted by Cτ, pAUCs and HVD in the single-dose study. Cτ was the most sensitive metric for detecting the different shape, with a lower intra-subject variability than HVD; (4) Conclusions: conventional PK metrics for single-dose studies (Cmax, AUC0-t and AUC0-inf) are not enough to guarantee bioequivalence at steady state for prolonged-release products.
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  • 文章类型: Letter
    暂无摘要。
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  • 文章类型: Journal Article
    BACKGROUND: Control of hookworm and other soil-transmitted helminth infections primarily relies on preventive chemotherapy using a single dose of albendazole/mebendazole drugs on high-risk groups. Herein, the efficacy of a single dose (400 mg) of albendazole (ALB) was investigated both in vivo and in vitro model in northwest Ethiopia.
    METHODS: An open-label, single-arm clinical trial was conducted to assess anti-hookworm effect of albendazole. Stool samples were collected and examined using McMaster and Harada-Mori filter paper culture. Eligible hookworm-infected patients were treated with a single dose of ALB. After 14-21 days post-treatment, stool samples were also taken again and re-examined using the abovementioned technique. Egg reduction rate (ERR) and larval motility were used as a therapeutic outcome measure. An independent t test was used to compare the mean difference in egg counts, and probit analysis was performed for calculating the lethal concentration dose of albendazole. P value < 0.05 at 95% CI was considered statistically significant.
    RESULTS: A total of 70 participants had completed the drug efficacy study. The efficacy of ALB against hookworm in terms of CR and ERR was 87% and 93%, respectively. Participants who had not eaten one or more hours prior to treatment had higher CR than those who had eaten within 1 h before treatment (97.4% vs 74.2%), while individuals with heavy infection intensity had a lower post-treatment ova clearing rate than those who were with light infection intensity (43% vs 94.6%). The in vitro larvicidal effect of ALB was 63-93% after applying 50-250 μg/ml concentration of ALB solution. The LC50 and LC99 were 152 μg/ml and 573 μg/ml, respectively.
    CONCLUSIONS: A single dose of albendazole was found to be effective for treating hookworm infections according to WHO anthelminthic evaluation standard in the study area. Preventive chemotherapy might therefore be extended to risk groups, with proper continuous monitoring of its efficacy to strengthen and keep the ongoing control and prevention measures one step ahead.
    BACKGROUND: This trial is retrospectively registered with www.pactr.org , number PACTR202010511829332 on October 26, 2020.
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  • 文章类型: Clinical Trial Protocol
    OBJECTIVE: The aim of this trial is to investigate the safety and clinical efficacy of passive immunization therapy through Hyperimmune anti-COVID-19 Intravenous Immunoglobulin (C-IVIG: 5% liquid formulation), on severe and critically ill patients with COVID-19.
    METHODS: This is a phase I/II single centre, randomised controlled, single-blinded, superiority trial, through parallel-group design with sequential assignment. Participants will be randomised either to receive both C-IVIG and standard care or only standard care (4:1).
    METHODS: The study is mono-centric with the participants including COVID19 infected individuals (positive SARS-CoV-2 PCR on nasopharyngeal and/or oropharyngeal swabs) admitted in institute affiliated with Dow University Hospital, Dow University of Health Sciences, Karachi, Pakistan. Consenting patients above 18 years that are classified by the treating physician as severely ill i.e. showing symptoms of COVID-19 pneumonia; dyspnea, respiratory rate ≥30/min, blood oxygen saturation ≤93%, PaO2/FiO2 <300, and lung infiltrates >50% on CXR; or critically ill i.e. respiratory failure, septic shock, and multiple organ dysfunction or failure. Patients with reported IgA deficiency, autoimmune disorder, thromboembolic disorder, and allergic reaction to immunoglobulin treatment were excluded from study. Similarly, pregnant females, patients requiring two or more inotropic agents to maintain blood pressure and patients with acute or chronic kidney injury/failure, were also excluded from the study.
    UNASSIGNED: The study consists of four interventions and one comparator arm. All participants receive standard hospital care which includes airway support, anti-viral medication, antibiotics, fluid resuscitation, hemodynamic support, steroids, painkillers, and anti-pyretics. Randomised test patients will receive single dose of C-IVIG in following four dosage groups: Group 1: 0.15g/Kg with standard hospital care Group 2: 0.2g/Kg with standard hospital care Group 3: 0.25g/Kg with standard hospital care Group 4: 0.3g/Kg with standard hospital care Group 5 (comparator) will receive standard hospital care only MAIN OUTCOMES: The primary outcomes are assessment and follow-up of participants to observe 28-day mortality and, • the level and duration of assisted ventilation during hospital stay, • number of days to step down (shifting from ICU to isolation ward), • number of days to hospital discharge, • adverse events (Kidney failure, hypersensitivity with cutaneous or hemodynamic manifestations, aseptic meningitis, hemolytic anemia, leuko-neutropenia, transfusion related acute lung injury (TRALI)) during hospital stay, • change in C-Reactive Protein (CRP) levels, • change in neutrophil lymphocyte ratio to monitor inflammation.
    UNASSIGNED: Consenting participants who fulfill the criteria are allocated to either intervention or comparator arm with a ratio of 4:1, using sequentially numbered opaque sealed envelope simple randomization method. The participant allocated for intervention will be sequentially assigned dosage group 1-4 in ascending order. Participants will not be recruited in the next dosage group before a set number of participants in one group (10) are achieved.
    UNASSIGNED: Single blinded study, with participants blinded to allocation.
    UNASSIGNED: Total 50 patients are randomised. The intervention arms consist of 40 participants divided in four groups of 10 participants while the comparator group consists of 10 patients.
    UNASSIGNED: Current version of the protocol is \"Version 2\" dated 29th September, 2020. Participants are being recruited. Recruitment started on June, 2020 and is estimated to primarily end on January, 2021.
    BACKGROUND: This trial was registered at ClinicalTrials.gov, NCT04521309 on 20 August 2020 and is retrospectively registered.
    UNASSIGNED: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1).
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  • 文章类型: Journal Article
    目的:评估三种术前漱口水对唾液细菌水平的影响,并在不同牙周状态的受试者之间进行比较。
    方法:根据牙周参数,牙周健康个体(n=60)和牙龈炎(n=60)和牙周炎(n=60)被随机分配到单剂量的术前氯己定(CHX),精油(EO),氯化十六烷基吡啶(CPC)或阴性对照漱口水。在上午8:00到11:00之间收集唾液样本,在用各自的漱口水单剂量冲洗之前和之后。牙龈卟啉单胞菌的总细菌载量和水平,连翘坦菌,通过qPCR测定了树突状螺旋体和口腔链球菌。使用配对t检验和Studentt检验(p<0.05)对数据进行统计学分析。
    结果:CHX,EO和CPC显示出比阴性对照更大的抗微生物效力。与CPC[106302.96]和阴性对照[37852.46]相比,CHX[1226445.53]和EO[1743639.38]提供更大的减少)。CHX提供了更大的同时Pg水平降低[106326.00],健康组的Td[3335841]和Tf[61557.47],EO在患病组中也是如此。CPC在牙周炎组中提供了最大的减少[3775319.36]。
    结论:牙周状态影响术前漱口水的抗菌效果。因此,临床医生应考虑牙周状况。所测试的试剂之间的抗微生物功效不同。CHX和EO显示出最大的功效。临床医生必须识别牙周状况,以选择最有效的术前漱口水。
    OBJECTIVE: The effects of three preoperative mouthwashes on salivary bacterial levels were evaluated and compared between subjects with differing periodontal status.
    METHODS: Based on periodontal parameters, periodontally healthy individuals (n = 60) and those with gingivitis (n = 60) and periodontitis (n = 60) were randomly assigned to a single preoperative dose of chlorhexidine (CHX), essential oils (EO), cetylpyridinium chloride (CPC) or negative control mouthwashes. Saliva samples were collected between 8:00 and 11:00 a.m., before and after a single-dose rinse with the respective mouthwash. Total bacterial load and levels of Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola and Streptococcus oralis were determined by qPCR. Data were statistically analysed using paired t- and Student\'s t-tests (p < 0.05).
    RESULTS: CHX, EO and CPC showed greater antimicrobial efficacy than did the negative control. CHX [1226445.53] and EO [1743639.38] provided greater reductions in comparison to both CPC [106302.96] and negative control [37852.46]). CHX provided greater reductions of simultaneous levels of Pg [106326.00], Td [3335841] and Tf [61557.47] in the healthy group, as did EO in the diseased groups. CPC provided the greatest reduction [3775319.36] in the periodontitis group.
    CONCLUSIONS: Periodontal status influenced the antimicrobial efficacy of preoperative mouthwashes. Therefore, periodontal status should be taken into consideration by clinicians. The antimicrobial efficacy differed among the agents tested. CHX and EO showed the greatest efficacy. The recognition of periodontal condition by clinicians is mandatory to select the most effective preoperative mouthwash.
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