Clinical trail

临床线索
  • 文章类型: Journal Article
    背景:全球面膜市场以每年8.5%的速度稳步增长。然而,长期使用可能导致皮肤炎症。
    目的:研究不同类型的面罩和佩戴时间如何影响健康受试者的皮肤生理学和水通道蛋白3(AQP3)表达。
    方法:我们使用随机对照设计来研究三种类型的面膜(纯净水,透明质酸,和双裂发酵裂解物)和四种不同的持续时间(5、15、25和40分钟)对志愿者的各种皮肤参数,评估水分含量,经皮水分流失(TEWL),皮脂,角质细胞大小,和AQP3表达之前和之后的掩模应用,在评估不良反应的同时,不适,和不遵守。
    结果:首先水化和TEWL增加,然后减少。所有类型的口罩都会增加皮脂,特别是在40分钟后。血管舒张和AQP3表达与掩蔽持续时间相关。角膜细胞大小保持恒定。主要不良反应为红肿(10.71%,n=28)和干燥度(57.14%,n=28),尤其是使用超过25分钟的纯净水口罩。
    结论:短期使用面膜(<25分钟)可改善皮肤的水合作用,减少发红,和AQP3激活,而长时间使用会导致干燥和发红增加。
    BACKGROUND: The global facial mask market grows steadily at 8.5 % annually. However, prolonged use may lead to skin inflammation.
    OBJECTIVE: To investigate how various mask types and wearing durations impact skin physiology and aquaporins3 (AQP3) expression in healthy subjects.
    METHODS: We used a randomized controlled design to investigate the effects of three types of facial masks (pure water, hyaluronan, and bifida ferment lysate) and four different duration(5, 15, 25, and 40 min) on various skin parameters in volunteers, assessing moisture content, transepidermal water loss (TEWL), sebum, corneocyte size, and AQP3 expression before and after mask application, while also evaluating adverse reactions, discomfort, and noncompliance.
    RESULTS: Hydration and TEWL increased at first, then decreased. Sebum increased with all types of masks, particularly after 40 min. Vasodilation and AQP3 expression were linked to mask duration. Corneocyte sizes remained constant. The main adverse reactions were redness (10.71 %, n = 28) and dryness (57.14 %, n = 28), especially with pure water masks lasting over 25 min.
    CONCLUSIONS: Short-term use of facial sheet masks (<25 min) benefits skin with improved hydration, reduced redness, and AQP3 activation, while prolonged use can lead to increased dryness and redness.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    尽管抗逆转录病毒疗法(ART)取得了进展,但严重免疫抑制的AIDS患者的复发性机会性感染(OI)仍然是一个尚未解决的医学挑战。为了解决这个差距,我们开发了一种HLA错配的同种异体过继免疫疗法(AAIT),专门针对该患者人群.这种新型治疗方法的安全性和有效性在我们的1期试验中得到了初步证实。随后,一个多中心,开放标签,控制,我们进行了2a期试验,以评估AAIT联合ART与常规ART方案相比的疗效.在96周的随访中,两组之间的不良事件(AE)发生率没有差异。与对照组相比,AAIT治疗在第72周(P=0.048)和第96周(P=0.024)改善了CD4T细胞的恢复。此外,AAIT组患者的分层分析显示,供体/受体性别不匹配与患者获得免疫应答的可能性显著相关(OR=8.667;95%CI,2.010-37.377;P=0.004).这些发现表明,AAIT可作为改善严重免疫抑制AIDS患者预后的有希望的辅助疗法。需要进一步的研究来阐明AAIT的免疫机制,并确定对这种治疗方法反应最佳的亚群。该试验已在www上注册。clinicaltrials.gov(NCT04098770)。试用注册:ClinicalTrials.gov标识符:NCT04098770。试用注册:ClinicalTrials.gov标识符:NCT02651376。
    Recurrent opportunistic infections (OIs) in patients with severely immunosuppressed AIDS remain an unresolved medical challenge despite advancements in antiretroviral therapy (ART). To address this gap, we developed an HLA-mismatched allogeneic adoptive immune therapy (AAIT) specifically targeting this patient population. The safety and efficacy of this novel therapeutic approach were preliminarily confirmed in our phase 1 trial. Subsequently, a multicenter, open-label, controlled, phase 2a trial was conducted to evaluate the efficacy of AAIT in combination with ART compared with the conventional ART-only regimen. No difference in the incidence of adverse events (AEs) was observed between the two groups at the 96-week follow-up. AAIT treatment improved CD4+ T cell recovery at weeks 72 (P = 0.048) and 96 (P = 0.024) compared to the Control Group. Additionally, stratified analysis of patients in the AAIT Group showed that donor/recipient sex mismatch was significantly associated with the likelihood of patients achieving an immunological response (OR = 8.667; 95% CI, 2.010-37.377; P = 0.004). These findings suggest that AAIT serves as a promising adjunct therapy for improving the outcomes of patients with severely immunosuppressed AIDS. Further studies are needed to elucidate the immunological mechanisms underlying AAIT and identify the subpopulations that respond optimally to this therapeutic approach. This trial is registered at www.clinicaltrials.gov (NCT04098770).Trial registration: ClinicalTrials.gov identifier: NCT04098770.Trial registration: ClinicalTrials.gov identifier: NCT02651376.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    在过去的十年里,肠道类器官技术为体外复制肠道生理过程中的组织或器官形态发生以及研究各种肠道疾病的发病机理铺平了道路。肠道类器官在药物筛选中受到青睐,因为它们具有高通量体外培养的能力,并且与患者的遗传特征更相似。此外,作为疾病模型,肠道类器官在筛选诊断标志物方面有广泛的应用,确定治疗目标,探索疾病的表观遗传机制。此外,作为一个可移植的细胞系统,在溃疡性结肠炎和短肠综合征等疾病中,类器官在受损上皮的重建中发挥了重要作用,以及肠道物质交换和代谢功能恢复。跨学科方法的兴起,包括类器官芯片技术,基因组编辑技术,和微流体,大大加速了类器官的发展。在这次审查中,首先使用VOSviewer软件可视化肠道类器官的热合被引期刊和关键词趋势。随后,我们总结了目前肠道类器官技术在疾病建模中的应用,药物筛选,和再生医学。这将加深我们对肠道类器官的理解,并进一步探索肠道的生理机制和肠道疾病的药物开发。
    In the past decade, intestinal organoid technology has paved the way for reproducing tissue or organ morphogenesis during intestinal physiological processes in vitro and studying the pathogenesis of various intestinal diseases. Intestinal organoids are favored in drug screening due to their ability for high-throughput in vitro cultivation and their closer resemblance to patient genetic characteristics. Furthermore, as disease models, intestinal organoids find wide applications in screening diagnostic markers, identifying therapeutic targets, and exploring epigenetic mechanisms of diseases. Additionally, as a transplantable cellular system, organoids have played a significant role in the reconstruction of damaged epithelium in conditions such as ulcerative colitis and short bowel syndrome, as well as in intestinal material exchange and metabolic function restoration. The rise of interdisciplinary approaches, including organoid-on-chip technology, genome editing techniques, and microfluidics, has greatly accelerated the development of organoids. In this review, VOSviewer software is used to visualize hot co-cited journal and keywords trends of intestinal organoid firstly. Subsequently, we have summarized the current applications of intestinal organoid technology in disease modeling, drug screening, and regenerative medicine. This will deepen our understanding of intestinal organoids and further explore the physiological mechanisms of the intestine and drug development for intestinal diseases.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Systematic Review
    背景:基因组不稳定性是指细胞分裂过程中基因组改变的增加,在大多数癌细胞中很常见。基因组不稳定性增加了初始致癌转化的风险,产生新的肿瘤细胞克隆,增加肿瘤异质性。尽管基因组不稳定会导致恶性肿瘤,它也是一个“致命弱点”,构成了治疗上可利用的弱点-当足够先进时,它可以通过产生DNA损伤和突变事件来降低肿瘤细胞的存活率,从而压倒癌细胞修复这些病变的能力。此外,它可以通过产生编码能够被免疫系统识别的新免疫原性抗原的突变来促成外在的降低生存的事件。特别是当免疫治疗药物增强抗肿瘤免疫力时。这里,我们描述了基因组失稳如何诱导癌症患者的免疫激活,并系统地回顾了临床上利用的基因组不稳定性的诱导,结合免疫检查点阻断。方法:我们对利用联合方法成功治疗癌症患者的临床试验进行了系统评价。我们系统地搜索了PubMed,Cochrane中央控制试验登记册,Clinicaltrials.gov,并从相关文章的参考列表中发表。最相关的纳入标准是以英文发表的同行评审临床试验。结果:我们确定了1,490项研究,其中164项是临床试验.共有37项临床试验符合纳入标准,纳入研究。主要结果测量为总生存期和无进展生存期。大多数临床试验(37个中的30个)显示患者预后显着改善。结论:大多数纳入的临床试验报道了靶向DNA修复途径概念的有效性,结合免疫检查点抑制剂,创造一个“协同作用环”,用合理的组合来治疗癌症。
    Background: Genomic instability is increased alterations in the genome during cell division and is common among most cancer cells. Genome instability enhances the risk of initial carcinogenic transformation, generating new clones of tumor cells, and increases tumor heterogeneity. Although genome instability contributes to malignancy, it is also an \"Achilles\' heel\" that constitutes a therapeutically-exploitable weakness-when sufficiently advanced, it can intrinsically reduce tumor cell survival by creating DNA damage and mutation events that overwhelm the capacity of cancer cells to repair those lesions. Furthermore, it can contribute to extrinsic survival-reducing events by generating mutations that encode new immunogenic antigens capable of being recognized by the immune system, particularly when anti-tumor immunity is boosted by immunotherapy drugs. Here, we describe how genome-destabilization can induce immune activation in cancer patients and systematically review the induction of genome instability exploited clinically, in combination with immune checkpoint blockade. Methods: We performed a systematic review of clinical trials that exploited the combination approach to successfully treat cancers patients. We systematically searched PubMed, Cochrane Central Register of Controlled Trials, Clinicaltrials.gov, and publication from the reference list of related articles. The most relevant inclusion criteria were peer-reviewed clinical trials published in English. Results: We identified 1,490 studies, among those 164 were clinical trials. A total of 37 clinical trials satisfied the inclusion criteria and were included in the study. The main outcome measurements were overall survival and progression-free survival. The majority of the clinical trials (30 out of 37) showed a significant improvement in patient outcome. Conclusion: The majority of the included clinical trials reported the efficacy of the concept of targeting DNA repair pathway, in combination with immune checkpoint inhibitors, to create a \"ring of synergy\" to treat cancer with rational combinations.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    目的本研究旨在评估沙特阿拉伯东部省成年人对临床试验(CT)参与的知识和态度。材料和方法这项横断面研究是在沙特阿拉伯东部省的人口中进行的。使用在线调查在普通人群中分发了一份自我管理的问卷。结果共有334名参与者完成问卷。参与者的年龄从18岁到65岁不等,平均年龄为31.2±13.9岁,其中56.6%是男性,42.2%被雇用,29.6%是学生,23.1%的人失业。令人惊讶的是,只有一小部分受访者(7.5%)被要求参加随机对照试验(RCT),其中大多数人都参与了。此外,25.4%的参与者认为CT用于评估新药;其他人认为CT用于了解疾病和人类行为。数据显示,大多数参与者认为CT可以改善患者护理,福利,和社会。此外,如果参与者知道研究的目的和发现,并且有更多的时间考虑他们的选择,他们更有可能参加。结论参与者认为最大的障碍是缺乏CT知识。对患者进行更多关于CT的教育是至关重要的。多模式策略,例如改善患者与提供者的交流和用于试验信息共享的在线信息,可能会有效地提高知识和CT招募。
    Objective This study aims to assess the knowledge and attitudes toward clinical trial (CT) participation among the adult population in the Eastern Province of Saudi Arabia. Material and methods This cross-sectional study was conducted among the population of the Eastern Province of Saudi Arabia. A self-administered questionnaire was distributed among the general population using an online survey. Results A total of 334 participants completed the questionnaire. Participants\' ages ranged from 18 to 65 years, with a mean age of 31.2 ± 13.9 years, 56.6% of whom were males, 42.2% were employed, 29.6% were students, and 23.1% were unemployed. Surprisingly, only a small percentage of respondents (7.5%) were requested to participate in a randomized controlled trial (RCT), of which the majority did partake. Additionally, 25.4% of participants believe CTs are used to evaluate new drugs; others believe that CTs are used to understand diseases and human behavior. The data show that most participants believe that CTs improve patient care, welfare, and society. Also, participants were more likely to take part if they were aware of the study\'s purpose and findings and were given more time to consider their options. Conclusion Participants believed that the biggest obstacle was a lack of knowledge of CTs. It is crucial to educate patients more about CTs. Multimodal strategies such as improved patient-provider communication and online information for trial information sharing may be effective in boosting knowledge and CT recruitment.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    中枢神经系统(CNS)肿瘤是一系列肿瘤,范围从良性病变到高度恶性和侵袭性病变。尽管采取了积极的多模式治疗方法,这些恶性肿瘤的发病率和死亡率都很高,生存结果令人沮丧.此外,常规治疗的非特异性证实了选择性靶向脑内浸润性肿瘤细胞的精确治疗策略的基本原理,并尽量减少系统和附带损害。随着用于生物材料应用的纳米平台的最新进展,基于脂质的纳米颗粒系统对中枢神经系统肿瘤管理具有吸引力和突破性的影响。以脂质纳米颗粒为中心的免疫治疗剂治疗恶性中枢神经系统肿瘤可以引起对精确治疗策略的明确需求。免疫治疗剂可以通过脑内局部部位的主动或先天性免疫应答选择性地诱导特异性免疫应答。在这次审查中,我们讨论了基于脂质的纳米平台在中枢神经系统肿瘤中的治疗应用,重点是脑靶向的革命性方法,成像,以及通过免疫疗法进行药物和基因递送。基于脂质的纳米颗粒平台代表了用于化疗的最有前途的胶体载体之一。和免疫治疗药物。他们目前在肿瘤学,特别是脑肿瘤中的应用,通过改善几种可用于选择性靶向脑肿瘤的药物的抗肿瘤活性,带来了癌症治疗的范式转变。随后,解决了在CNS肿瘤管理背景下,基于脂质的纳米平台用于药物和基因/免疫疗法递送的实验室到临床转化和翻译可行性方面的挑战.
    Tumors of the Central nervous System (CNS) are a spectrum of neoplasms that range from benign lesions to highly malignant and aggressive lesions. Despite aggressive multimodal treatment approaches, the morbidity and mortality are high with dismal survival outcomes in these malignant tumors. Moreover, the non-specificity of conventional treatments substantiates the rationale for precise therapeutic strategies that selectively target infiltrating tumor cells within the brain, and minimize systemic and collateral damage. With the recent advancement of nanoplatforms for biomaterials applications, lipid-based nanoparticulate systems present an attractive and breakthrough impact on CNS tumor management. Lipid nanoparticles centered immunotherapeutic agents treating malignant CNS tumors could convene the clear need for precise treatment strategies. Immunotherapeutic agents can selectively induce specific immune responses by active or innate immune responses at the local site within the brain. In this review, we discuss the therapeutic applications of lipid-based nanoplatforms for CNS tumors with an emphasis on revolutionary approaches in brain targeting, imaging, and drug and gene delivery with immunotherapy. Lipid-based nanoparticle platforms represent one of the most promising colloidal carriers for chemotherapeutic, and immunotherapeutic drugs. Their current application in oncology especially in brain tumors has brought about a paradigm shift in cancer treatment by improving the antitumor activity of several agents that could be used to selectively target brain tumors. Subsequently, the lab-to-clinic transformation and challenges towards translational feasibility of lipid-based nanoplatforms for drug and gene/immunotherapy delivery in the context of CNS tumor management is addressed.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    由于各种解剖和生理障碍,眼部药物递送一直挑战眼科医生和药物递送科学家。静态和动态眼屏障可防止外源性物质进入并阻碍治疗剂的主动吸收。这篇综述详细阐述了眼睛的解剖结构和相关的约束。接下来是一些常见的眼部疾病的插图,包括青光眼和他们目前的临床治疗,强调药物治疗在治疗眼部疾病中的意义。随后,眼部给药方式的进展,特别是基于纳米技术的眼部药物递送系统,被推荐,并重点介绍了一些典型的研究。在相关研究的基础上,总结了纳米载体的系统和全面的表征,希望对未来的研究有所帮助。此外,我们总结了目前市场上或仍在临床试验中的基于纳米技术的眼科药物以及纳米载体的最新专利。最后,受到当前趋势和治疗概念的启发,我们为新型眼部给药系统所面临的挑战提供了见解,并进一步提出了未来的研究方向。我们希望这篇综述可以为更好地设计和开发新型眼科制剂提供启发和动力。
    Ocular drug delivery has constantly challenged ophthalmologists and drug delivery scientists due to various anatomical and physiological barriers. Static and dynamic ocular barriers prevent the entry of exogenous substances and impede therapeutic agents\' active absorption. This review elaborates on the anatomy of the eye and the associated constraints. Followed by an illustration of some common ocular diseases, including glaucoma and their current clinical therapies, emphasizing the significance of drug therapy in treating ocular diseases. Subsequently, advances in ocular drug delivery modalities, especially nanotechnology-based ocular drug delivery systems, are recommended, and some typical research is highlighted. Based on the related research, systematic and comprehensive characterizations of the nanocarriers are summarized, hoping to assist with future research. Besides, we summarize the nanotechnology-based ophthalmic drugs currently on the market or still in clinical trials and the recent patents of nanocarriers. Finally, inspired by current trends and therapeutic concepts, we provide an insight into the challenges faced by novel ocular drug delivery systems and further put forward directions for future research. We hope this review can provide inspiration and motivation for better design and development of novel ophthalmic formulations.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Systematic Review
    糖尿病(DM)是一种广泛的代谢紊乱,全球每年有670万人死亡。有几种治疗选择,但有常见的副作用,如体重增加,心血管疾病,神经毒性,肝毒性,和肾毒性。因此,民族医学正在引起研究人员对DM治疗的兴趣。民族医学通过防止肠道吸收和肝脏产生葡萄糖以及增强肌肉和脂肪组织中的葡萄糖摄取和增加胰岛素分泌来发挥作用。多种植物已经进入临床试验,但很少有植物获得批准使用。本研究提供了对此类临床试验的评估。为此,使用“民族医学糖尿病临床试验”等关键词从数据库中进行了广泛的文献综述,“临床试验”,“糖尿病临床试验”,\"糖尿病\",“糖尿病中的天然产物”,“天然产物与糖尿病的药理学相关性”,等。根据合格标准评估了20种植物和天然产物的临床试验。与这些临床试验相关的主要限制是缺乏患者依从性,剂量-反应关系,以及小样本量和治疗持续时间的生物标志物评估。可以考虑在严格的法规方面采取措施,以实现临床试验的质量。本系统综述的一个具体目标是根据过去7年的最新临床试验,通过种族医学讨论DM治疗。
    Diabetes mellitus (DM) is a widespread metabolic disorder with a yearly 6.7 million deaths worldwide. Several treatment options are available but with common side effects like weight gain, cardiovascular diseases, neurotoxicity, hepatotoxicity, and nephrotoxicity. Therefore, ethnomedicine is gaining the interest of researchers in the treatment of DM. Ethnomedicine works by preventing intestinal absorption and hepatic production of glucose as well as enhancing glucose uptake in muscles and fatty tissues and increasing insulin secretion. A variety of plants have entered clinical trials but very few have gained approval for use. This current study provides an evaluation of such clinical trials. For this purpose, an extensive literature review was performed from a database using keywords like \"ethnomedicine diabetes clinical trial\", \"clinical trials\", \"clinical trial in diabetes\", \"diabetes\", \"natural products in diabetes\", \"ethno-pharmacological relevance of natural products in diabetes\", etc. Clinical trials of 20 plants and natural products were evaluated based on eligibility criteria. Major limitations associated with these clinical trials were a lack of patient compliance, dose-response relationship, and an evaluation of biomarkers with a small sample size and treatment duration. Measures in terms of strict regulations can be considered to achieve quality clinical trials. A specific goal of this systematic review is to discuss DM treatment through ethnomedicine based on recent clinical trials of the past 7 years.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

  • 文章类型: Journal Article
    背景:手术是早期肺癌最有效的治疗方法。本研究将为早期肺腺癌纵隔淋巴结清扫提出个性化方案,以降低手术风险,提高生活质量。
    方法:本研究回顾性分析胸外科行肺叶切除和淋巴结清扫术的患者,中山医院,复旦大学。包括实体成分比(CTR)在0.5和1之间的临床I期肺腺癌患者。患者分为系统(S-MLND)和肺叶特异性(L-MLND)纵隔淋巴结清扫组。住院的日子,是否存在并发症,无复发生存率,并计算总生存率以评估患者的术后质量和手术风险。
    结果:包括210例患者(138例L-MLND和72例S-MLND)。S-MLND组出现2例淋巴结转移,L-MLND组无淋巴结转移(P=0.049)。年龄没有差异,肿瘤部位,尺寸,固体成分,肿瘤浸润程度,和舞台。L-MLND组术后严重咳嗽的患者比例和住院时间均下降。整个队列的5年OS为98.1%,L-MLND中的98.6%,S-MLND为97.2%;RFS为94.8%,L-MLND中的95.7%,与S-MLND中的93.0%相比。
    结论:对于cIA肺腺癌,根据手术前1个月内的薄层CT,如果主要病变小于3厘米且CTR超过0.5,则L-MLND与S-MLND一样有效。
    Surgery is the most effective treatment for early-stage lung cancer. This study will propose a personalized plan for mediastinal lymph node dissection in early-stage lung adenocarcinoma to reduce the risk of surgery and improve the quality of life.
    This study retrospectively analyzed the patients underwent lobectomy and lymph node dissection in the Department of Thoracic Surgery, Zhongshan Hospital, Fudan University. Clinical stage I lung adenocarcinoma patients with solid component ratio (CTR) between 0.5 and 1 were included. Patients were divided into systematic (S-MLND) and lobe-specific (L-MLND) mediastinal lymph node dissection groups. The days of hospitalization, the presence or absence of complications, the recurrence-free survival rate, and the overall survival rate were calculated to evaluate the postoperative quality and operation risk of the patients.
    210 patients (138 L-MLND and 72 S-MLND) were included. 2 lymph node metastases appeared in the S-MLND group while none in the L-MLND group (P = .049). No differences were shown in age, tumor site, size, solid component, degree of tumor invasion, and stage. The proportion of patients with severe postoperative cough and the length of hospital stay in the L-MLND group decreased. The 5-year OS of the entire cohort was 98.1%, 98.6% in L-MLND, compared with 97.2% in S-MLND; RFS was 94.8%, 95.7% in L-MLND, compared with 93.0% in S-MLND.
    For cIA lung adenocarcinoma, according to the Thin-slice CT within 1 month before the operation, if the main lesion was less than 3 cm and CTR over 0.5, L-MLND is as effective as S-MLND.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

    求助全文

  • 文章类型: Journal Article
    为了研究重复经颅磁刺激(rTMS)对截肢者幻肢痛(PLP)的影响,并与镜像疗法(MT)的治疗效果进行比较。
    该研究设计为随机对照试验。评估人员失明了,而受试者和治疗师是不失明的。使用计算机生成的随机数表将受试者随机分配到rTMS组或MT组。从2018年6月到2020年12月,从45名接受研究筛查的截肢患者中,招募30名符合纳入标准的人进行研究。所有患者均来自康复医学中心,华西医院,四川大学。最后,4名患者退出研究,26名患者(rTMS组12名,MT组14名)完成了规定的治疗和评估。rTMS组给予rTMS(1Hz,15分钟,5d/周)除常规康复治疗外,为期2周,而MT组接受MT(相应的四肢运动,15分钟,5d/周),除常规康复治疗外,为期2周。通过视觉模拟评分(VAS)和DouleurNeuropathique4问题(DN-4)评估PLP。受试者在治疗前进行评估(t0),治疗完成后立即(t1)和治疗完成后3个月(t2)。
    26例患者的平均年龄为39.73±12.64。有15名男性和11名女性。根据患者对PLP特征的报告描述,发病率最高的特征是刺痛,刺伤,麻木,电击和燃烧降序。两组PLP特点发生率比较差异无统计学意义(P>0.05)。两组具有可比性的基线数据,两组在t0时的VAS和DN-4差异无统计学意义(P>0.05)。在t1和t2时,VAS和DN-4评分均较t0降低,两组比较差异均有统计学意义(P<0.01)。在rTMS组中,在t1和t2时,VAS和DN-4评分之间没有显着差异(P>0.05)。在MT组中,t2时的VAS和DN-4评分明显低于t1(P<0.05)。rTMS组与MT组疼痛测量值的变化无统计学意义,即,VAS和DN-4评分,干预前后(P>0.05)。完成实验的26名患者没有出现头晕,头痛,或研究期间的其他异常。
    这项研究的结果表明,重复经颅磁刺激可以改善截肢者的PLP,改善效果与镜像疗法相当。
    UNASSIGNED: To investigate the effect of repetitive transcranial magnetic stimulation (rTMS) on phantom limb pain (PLP) in amputees, and to compare the therapeutic effect with that of mirror therapy (MT).
    UNASSIGNED: The study was designed as a randomized controlled trial. The evaluators were blinded, while the subjects and the therapists were unblinded. Subjects were randomly assigned to either the rTMS group or the MT group with a computer-generated random number table. From June 2018 to December 2020, from out of 45 amputee patients screened for the study, 30 who met the inclusion criteria were recruited for the study. All patients were recruited from the Rehabilitation Medicine Center, West China Hospital, Sichuan University. In the end, 4 patients withdrew from the study and 26 patients (12 in the rTMS group and 14 in the MT group) completed the prescribed treatment and evaluation. The rTMS group was given rTMS (1 Hz, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy, while the MT group received MT (corresponding movements of limbs, 15 min, 5 d/week) for 2 weeks in addition to conventional rehabilitation therapy. PLP was evaluated by the Visual Analogue Scale (VAS) and Douleur Neuropathique 4 Questions (DN-4). Subjects were assessed before treatment ( t 0), immediately after the completion of the treatment ( t 1) and 3 months after the completion of the treatment ( t 2).
    UNASSIGNED: The mean age of the 26 patients was 39.73±12.64. There were 15 males and 11 females. According to the reported description of the characteristics of the PLP by the patients, the characteristics with the highest incidence were tingling, stabbing, numbing, electric shocks and burning in descending order. There was no significant difference in the incidence of PLP characteristics between the two groups ( P>0.05). The two groups had comparable baseline data, showing no significant difference in VAS and DN-4 between the two groups at t 0 ( P>0.05). At t 1 and t 2, the VAS and DN-4 scores were decreased from those of t 0, showing statistically significant difference in both groups ( P<0.01 for both scores). In the rTMS group, there was no significant difference between VAS and DN-4 scores at t 1 and those at t 2 ( P>0.05). In the MT group, the VAS and DN-4 scores at t 2 were significantly lower than those of t 1 ( P<0.05). There was no statistically significant difference between the rTMS group and MT group in the changes in pain measurements, i.e., VAS and DN-4 scores, before and after the intervention ( P>0.05). The 26 patients who completed the experiment showed no dizziness, headache, or other abnormalities during the study.
    UNASSIGNED: The results of this study indicate that repetitive transcranial magnetic stimulation could improve PLP in amputees, and the improvement effect was comparable to that of mirror therapy.
    导出

    更多引用

    收藏

    翻译标题摘要

    我要上传

       PDF(Pubmed)

公众号