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20-Week Study of Clinical Outcomes of Over-the-Counter COVID-19 Prophylaxis and Treatment. 非处方COVID-19预防和治疗20周临床结果研究
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211026193
Leon Margolin, Jeremy Luchins, Daniel Margolin, Michelle Margolin, Sanford Lefkowitz

Objectives and setting.: As the lethal COVID-19 pandemic enters its second year, the need for effective modalities of alleviation remains urgent. This includes modalities that can readily be used by the public to reduce disease spread and severity. Such preventive measures and early-stage treatments may temper the immediacy of demand for advanced anti-COVID measures (drugs, antibodies, vaccines) and help relieve strain also on other health system resources.

Design and participants.: We present results of a clinical study with a multi-component OTC "core formulation" regimen used in a multiply exposed adult population. Analysis of clinical outcome data from our sample of over 100 subjects - comprised of roughly equal sized regimen-compliant (test) and non-compliant (control) groups meeting equivalent inclusion criteria - demonstrates a strong statistical significance in favor of use of the core formulations.

Results.: While both groups were moderate in size, the difference between them in outcomes over the 20-week study period was large and stark: Just under 4% of the compliant test group presented flu-like symptoms, but none of the test group was COVID-positive; whereas 20% of the non-compliant control group presented flu-like symptoms, three-quarters of whom (15% overall of the control group) were COVID-positive.

Conclusions.: Offering a low cost, readily implemented anti-viral approach, the study regimen may serve, at the least, as a stopgap modality and, perhaps, as a useful tool in combatting the pandemic.

目标和设定。随着致命的COVID-19大流行进入第二年,仍然迫切需要有效的缓解方式。这包括公众可以轻易使用的方式,以减少疾病传播和严重程度。此类预防措施和早期治疗可能会缓和对先进抗疫措施(药物、抗体、疫苗)的迫切需求,并有助于缓解其他卫生系统资源的压力。设计和参与者。我们介绍了一项临床研究的结果,该研究使用了一种多组分OTC“核心配方”方案,用于多次暴露的成人人群。我们对100多名受试者样本的临床结果数据进行了分析,这些受试者包括规模大致相等的符合相同纳入标准的方案依从组(测试组)和不依从组(对照组),结果表明,支持使用核心配方的统计意义很强。结果:虽然两组的规模都不大,但在20周的研究期间,两组之间的结果差异很大。只有不到4%的依从测试组出现流感样症状,但测试组都没有covid - 19阳性;而不遵守规定的对照组中有20%出现流感样症状,其中四分之三(占对照组总数的15%)呈新冠病毒阳性。该研究方案提供了一种成本低、易于实施的抗病毒方法,至少可以作为一种权宜之计,或许还可以作为防治大流行病的一种有用工具。
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引用次数: 16
Benefit of OTC Formula Against COVID-19-Statistical Analysis Explained. 非处方配方抗新冠肺炎效果统计分析
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211058421
Leon Margolin, Jeremy Luchins, Daniel Margolin, Michelle Margolin, Sanford Lefkowitz
“Our adoption of conservative exposure-and-symptom-presentation values in data analysis may compensate for lacunae in study design and execution. The study emerged from our efforts to protect our patients and staff members from COVID-19 [in the time-frame March-July 2020, when no or very limited effective guidelines or treatments were available]...it is our hope that the study will serve as a basis for future larger-scale studies of enhanced design...While we believe that the stark difference in clinical outcomes between the test and control groups demonstrates the utility of the study formulations, we certainly welcome future extensive prospective studies.”
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引用次数: 0
Effects of Triphala on Lipid and Glucose Profiles and Anthropometric Parameters: A Systematic Review. Triphala对血脂、血糖和人体测量参数的影响:系统综述。
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211011038
Wiraphol Phimarn, Bunleu Sungthong, Hiroyuki Itabe

Aim: The efficacy of triphala on lipid profile, blood glucose and anthropometric parameters and its safety were assessed.

Methods: Databases such as PubMed, ScienceDirect, Web of Science, and Thai Library Integrated System (ThaiLIS) were systematically searched to review current evidence of randomized controlled trials (RCT) on triphala. RCTs investigating the safety and efficacy of triphala on lipid profile, blood glucose and anthropometric parameters were included. Study selection, data extraction, and quality assessment were performed independently by 2 authors.

Results: Twelve studies on a total of 749 patients were included. The triphala-treated groups showed significantly reduced low-density lipoprotein-cholesterol, total cholesterol and triglyceride in 6 studies. Five RCTs demonstrated triphala-treated groups led to statistically significant decrease in body weight, body mass index and waist circumference of obese patients. Moreover, triphala significantly decreased fasting blood glucose level in diabetic patients but not in people without diabetes. No serious adverse event associated with triphala was reported during treatment.

Conclusions: This review summarized a current evidence to show triphala might improve the lipid profile, blood glucose, the body weight, body mass index and waist circumference under certain conditions. However, large well-designed RCTs are required to confirm this conclusion.

目的:评价triphala对血脂、血糖、人体测量指标的影响及其安全性。方法:系统检索PubMed、ScienceDirect、Web of Science和Thai Library Integrated System (thailand)等数据库,回顾有关triphala的随机对照试验(RCT)的现有证据。本研究纳入了调查triphala对血脂、血糖和人体测量参数的安全性和有效性的随机对照试验。研究选择、数据提取和质量评估由2位作者独立完成。结果:12项研究共纳入749例患者。在6项研究中,triphala治疗组显示低密度脂蛋白胆固醇、总胆固醇和甘油三酯显著降低。五项随机对照试验显示,服用三氟组肥胖患者的体重、体重指数和腰围均有统计学意义的下降。此外,triphala显著降低了糖尿病患者的空腹血糖水平,而非糖尿病患者则没有。治疗期间未见与triphala相关的严重不良事件。结论:本文综述了目前有证据表明,在一定条件下,三联麻可能改善血脂、血糖、体重、体重指数和腰围。然而,需要大量设计良好的随机对照试验来证实这一结论。
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引用次数: 9
Can the Multi-Theory Model (MTM) of Health Behavior Change Explain the Intent for People to Practice Meditation? 健康行为改变的多理论模型(MTM)能否解释人们练习冥想的意图?
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211064582
Manoj Sharma, Matthew Asare, Ram Lakhan, Amar Kanekar, Vinayak K Nahar, Sheniz Moonie

Meditation is gaining popularity as adjuvant therapy for many chronic ailments, mental well-being, and spiritual growth. Behavioral theories have been underutilized in understanding meditation behavior. This study aimed to test if a fourth-generation multi-theory model (MTM) could explain the intent for starting and maintaining meditation behavior in a sample of US adults. A face and content valid 48-item instrument based on MTM was administered in a cross-sectional design through an online survey (n = 330). Internal consistency (Cronbach's alpha > 0.70) and construct validation using structural equation modeling of the subscales were all acceptable. Hierarchical multiple regression revealed that, after controlling for demographic covariates, the MTM constructs of participatory dialogue (β  =  0.153; P  =  .002) and behavioral confidence (β  =  0.479; P < .001) were statistically significant in predicting intent for starting meditation behavior and accounted for 32.9% of the variance. Furthermore, after controlling for demographic covariates, the MTM constructs of emotional transformation (β  =  0.390; P < .001) and changes in the social environment (β  =  0.395; P < .001) were statistically significant and accounted for 52.9% of the variance in the intent for maintaining meditation behavior. Based on this study, it can be concluded that MTM offers a pragmatic framework to design, implement, and evaluate evidence-based (theory-based) meditation behavior change interventions.

冥想作为许多慢性疾病、心理健康和精神成长的辅助疗法越来越受欢迎。行为理论在理解冥想行为方面一直没有得到充分的利用。这项研究旨在测试第四代多理论模型(MTM)是否可以解释美国成年人开始和保持冥想行为的意图。采用横断面设计,通过在线调查(n = 330),使用基于MTM的48项面部和内容有效量表。内部一致性(Cronbach’s alpha > 0.70)和使用结构方程模型对子量表进行结构验证均可接受。层次多元回归显示,在控制人口统计协变量后,MTM构建了参与式对话(β = 0.153;P = .002)和行为的信心(β= 0.479;p p p
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引用次数: 1
Artemisia lactiflora Extracts Prevent Inflammatory Responses of Human Macrophages Stimulated with Charcoal Pyrolysis Smoke. 青蒿提取物对木炭热解烟雾刺激人巨噬细胞炎症反应的抑制作用。
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211068837
Nateelak Kooltheat, Kamonrat Chujit, Kanjana Nuangnong, Nuttikarn Nokkaew, Kingkan Bunluepuech, Kenshi Yamasaki, Moragot Chatatikun

Artemisia lactiflora, a Chinese-origin plant, has been reported to have unique phytochemicals responsible for its medicinal properties. The growth of the agricultural industry emits air pollution, which has adverse effects on health. There are limited scientific reports on the biological activities of A. lactiflora. Studies on its activities and mechanisms may provide insight into its use in medicinal purposes to treat those health problems and conditions. In this study, leaves of A. lactiflora were extracted and fractioned with solvents of different polarities. Total phenolics, total flavonoids DPPH scavenging, ABTS•+ scavenging, and cytotoxicity of A. lactiflora were assessed. Anti-inflammatory activities were evaluated by pre-treating macrophages with extract or fractions then induced inflammatory response by coconut shell pyrolysis smoke. Inflammatory responses were assessed by measuring pro-inflammatory genes expression and pro-inflammatory cytokines secretion. Among all extract and fractions of A. lactiflora, butanol fraction has the highest phenolic, flavonoid, and DPPH scavenging activity. All extract and fractions significantly down-regulated pro-inflammatory genes expression (RelA, TNF, IL6) and decreased pro-inflammatory cytokines secretion (TNF-α, IL-6), p < 0.0001, compared with pyrolysis smoke-induced macrophages. The ethyl acetate fraction showed the highest anti-inflammatory activity in decreasing pro-inflammatory cytokines secretion. These results may prove the anti-inflammatory activities of A. lactiflora through the inhibition of the NF-κB-dependent pathway. Taken together, this study first reported the anti-inflammatory activities of A. lactiflora. Thus, the plant can be used to prevent and treat inflammatory responses caused by highly oxidative pyrolysis smoke released from the re-utilization of agro-industrial leftovers.

据报道,乳香蒿(Artemisia lactiflora)是一种原产于中国的植物,具有独特的植物化学物质,具有药用价值。农业的发展排放空气污染,这对健康有不利影响。目前关于乳酸菌生物活性的科学报道有限。对其活性和机制的研究,可能有助于深入了解其在医疗上的用途,以治疗这些健康问题和状况。本研究以乳香叶为研究对象,采用不同极性的溶剂对其进行提取和分馏。研究了乳香草总酚类、总黄酮对DPPH•清除能力、ABTS•+清除能力和细胞毒性。采用椰壳热解烟诱导巨噬细胞产生炎症反应,并对巨噬细胞进行预处理,观察其抗炎活性。通过测量促炎基因表达和促炎细胞因子分泌来评估炎症反应。在乳香提取物和馏分中,丁醇馏分的酚类、类黄酮和DPPH•清除活性最高。与热解烟雾诱导的巨噬细胞相比,各提取物和馏分均显著下调促炎基因(RelA、TNF、IL-6)表达,降低促炎细胞因子(TNF-α、IL-6)分泌,p < 0.0001。乙酸乙酯部位在降低促炎细胞因子分泌方面表现出最高的抗炎活性。这些结果可能证明乳香草通过抑制NF-κ b依赖通路而具有抗炎作用。综上所述,本研究首次报道了乳酸菌的抗炎活性。因此,该植物可用于预防和治疗由农工剩余物再利用释放的高氧化热解烟雾引起的炎症反应。
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引用次数: 4
Effect of Structured Yoga Program on Stress and Professional Quality of Life Among Nursing Staff in a Tertiary Care Hospital of Delhi-A Small Scale Phase-II Trial. 结构化瑜伽计划对德里一家三级医院护理人员压力和职业生活质量的影响--一项小规模第二阶段试验。
IF 3.3 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2021-01-01 DOI: 10.1177/2515690X21991998
Suprakash Mandal, Puneet Misra, Gautam Sharma, Rajesh Sagar, Shashi Kant, S N Dwivedi, R Lakshmy, Kiran Goswami

Background: Nursing staff suffer from various level of stress and burnout. We aimed to assess the effect of 12 weeks of structured yoga on stress and the professional quality of life among nursing staff.

Design and method: An open-label, phase-II randomized clinical trial was undertaken considering a sample size of convenience was done. In service nursing staff were randomized (1:1) to intervention group and wait-list control group. Primary outcome was perceived stress which was measured by Perceived Stress Scale (PSS). Secondary measures were professional quality measured by Professional Quality of Life (ProQOL) scale, blood pressure, serum cortisol, and high-sensitive C-reactive protein. Both the per-protocol and intention to treat analysis was done.

Results: Total 113 participants were allocated to intervention group (n = 58, mean = 35 years, SD = 7.9 years) and wait-list control group (n = 55, mean = 32.5 years, SD = 6.8 years). After 12 weeks, 19 participants of intervention group and 32 participants of wait-list control group were included in the per-protocol analysis. Follow-up mean PSS score was 15.4 (95% CI 12.6-18.2, SD 5.8) in intervention group, 20.7 (95% CI 19.7-21.7, SD 2.8) in wait-list control group (p-value < 0.0001). The other parameters didn't differ between the groups and from baseline to end line too.

Conclusions and relevance: The finding showed supervised structured yoga may be efficacious to reduce stress. Studies with larger sample size are needed to confirm the findings.

Trial registration: It was approved by the Institute Ethics Committee (Reference no: IECPG-543/20.12.2017, RT-57/31.01.2018) and was registered prospectively in the Clinical Trial Registry of India prospectively (No. CTRI/2018/02/012206).

背景:护理人员承受着不同程度的压力和职业倦怠。我们旨在评估为期 12 周的结构化瑜伽对护理人员压力和职业生活质量的影响:考虑到样本量的便利性,我们开展了一项开放标签的第二阶段随机临床试验。在职护理人员被随机(1:1)分为干预组和等待对照组。主要结果是感知压力,通过感知压力量表(PSS)进行测量。次要测量指标包括职业生活质量(ProQOL)量表、血压、血清皮质醇和高敏 C 反应蛋白。结果显示,共有 113 名参与者被分配到干预组:共有 113 名参与者被分配到干预组(n = 58,平均年龄 = 35 岁,SD = 7.9 岁)和候补对照组(n = 55,平均年龄 = 32.5 岁,SD = 6.8 岁)。12 周后,干预组的 19 名参与者和候补对照组的 32 名参与者被纳入方案分析。干预组的随访平均 PSS 评分为 15.4(95% CI 12.6-18.2,SD 5.8),等待对照组为 20.7(95% CI 19.7-21.7,SD 2.8)(P 值<0.0001)。其他参数在各组之间以及从基线到终点线之间没有差异:研究结果表明,有督导的结构化瑜伽可有效减轻压力。试验登记:该试验已获得研究所伦理委员会批准(参考号:IECPG-543/20.12.2017,RT-57/31.01.2018),并在印度临床试验登记处进行了前瞻性登记(编号:CTRI/2018/02/012206)。
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引用次数: 0
Is There an Association Between Social Support and Pain Among Individuals Living With Multiple Sclerosis? 社会支持与多发性硬化症患者的疼痛有关联吗?
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X21991995
Khrisha B Alphonsus, Carl D'Arcy

Context: Pain is one of the most common symptoms reported by patients living with Multiple Sclerosis (MS). Risk factors associated with pain may include individual's cognitive thinking process, emotional and behavioural response to pain and amount of social support. There is a lack of research on the influence on the amount of social support and its association to pain outcomes.

Objective: The primary objective of this study was to determine the association between amount and of social support and its association with odds of pain among individuals with MS.

Methods: The Survey on Living with Neurological Conditions in Canada (SLNCC) 2011-2012 linked to the Canadian Community Health Survey (CCHS) 2010-2011 was used to carry out a logistic regression model for this analysis (N = 78,623).

Main outcome measures: The factors that were assessed were psychological factors, problems with sleeping, self-perceived general health, self-perceived level of stress, number of years living with MS, as well as social factors. The outcome variable was pain.

Results: The amount of social support was found to be significant in that individuals who had 3 or fewer types of social support were 3.02 times more likely (95% CI 1.06 to 8.59) to report being in pain as opposed to individuals who had 4 types of support. The results indicate the importance of self efficacy in overcoming symptoms of MS and the need for more home care services.

背景:疼痛是多发性硬化症(MS)患者最常见的症状之一。与疼痛相关的风险因素可能包括个人的认知思维过程、对疼痛的情绪和行为反应以及社会支持的数量。关于社会支持的数量及其对疼痛结果的影响还缺乏研究:本研究的主要目的是确定社会支持的数量及其与多发性硬化症患者疼痛几率之间的关系:方法:使用与2010-2011年加拿大社区健康调查(CCHS)相关联的2011-2012年加拿大神经系统疾病患者生活调查(SLNCC)进行逻辑回归模型分析(N=78623):评估的因素包括心理因素、睡眠问题、自我感觉的总体健康状况、自我感觉的压力水平、与多发性硬化症共同生活的年数以及社会因素。结果变量为疼痛:结果发现:社会支持的数量具有重要意义,与拥有 4 种社会支持的人相比,拥有 3 种或更少的社会支持的人报告疼痛的可能性是后者的 3.02 倍(95% CI 1.06 至 8.59)。研究结果表明,自我效能对于克服多发性硬化症症状非常重要,因此需要更多的家庭护理服务。
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引用次数: 0
Parent-Child Mindfulness-Based Training: A Feasibility and Acceptability Study. 基于正念的亲子训练:可行性和可接受性研究。
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211002145
Courtney H Guenther, Rebecca L Stephens, Macy L Ratliff, Sarah J Short

Stress in young children can interfere with academic achievement. To help address stress and aid in developing beneficial lifelong coping skills, educational systems are more widely incorporating programs that teach social and emotional regulation, such as mindfulness-based programs. The effects of these programs may be strengthened through parental support in the home environment. This study examined the feasibility and acceptability of a new Parent-Child Mindfulness-Based Training (PC-MBT) program, which delivered mindfulness-based training to parents and children simultaneously in the home environment. This study also implemented a working memory training after PC-MBT to assess the feasibility of completing two trainings sequentially. Healthy children, ages 8-10 (n = 14), and their parents participated in the PC-MBT program. They met with an instructor at home and online each week for 6 weeks and were provided resources including books, worksheets, audio recordings, and daily practices to reinforce mindfulness skills. A control group (n = 8) participated in the working memory training only. All PC-MBT and control children, except one, participated in the working memory training. All PC-MBT assigned families completed the PC-MBT program, and a majority utilized all types of the mindfulness training materials. A majority of participants also reported high levels of enjoyment and understanding of the PC-MBT program. This study establishes the feasibility and acceptability of the PC-MBT program and lays the foundation for future studies to assess program efficacy in healthy and clinical populations as well as the utility of PC-MBT to improve engagement and outcomes of other cognitive training programs.

幼儿的压力会影响学业成绩。为了帮助解决压力问题,并帮助培养有益的终生应对技能,教育系统正在更广泛地纳入教授社交和情绪调节的课程,例如正念课程。这些计划的效果可以通过家长在家庭环境中的支持得到加强。本研究考察了新的亲子正念训练(PC-MBT)项目的可行性和可接受性,该项目在家庭环境中同时为父母和孩子提供正念训练。本研究还在 PC-MBT 之后实施了工作记忆训练,以评估依次完成两项训练的可行性。8-10 岁的健康儿童(14 人)及其父母参加了 PC-MBT 项目。在为期 6 周的时间里,他们每周都会在家或通过网络与导师见面,并获得包括书籍、工作表、录音和日常练习在内的资源,以强化正念技能。对照组(n = 8)只参加工作记忆训练。除一名儿童外,所有 PC-MBT 儿童和对照组儿童都参加了工作记忆训练。所有被分配到 PC-MBT 的家庭都完成了 PC-MBT 计划,而且大多数家庭都使用了所有类型的正念训练材料。大多数参与者还表示非常喜欢和理解 PC-MBT 项目。这项研究确定了 PC-MBT 项目的可行性和可接受性,并为今后的研究奠定了基础,以便评估该项目在健康和临床人群中的有效性,以及 PC-MBT 在提高其他认知训练项目的参与度和成果方面的实用性。
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引用次数: 0
A Recent Achievement in the Discovery and Development of Vaccines and Therapeutic Agents in the Race for COVID-19 Protection and Treatment. 在COVID-19保护和治疗竞赛中发现和开发疫苗和治疗剂的最新成就。
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211003727
Zemene Demelash Kifle, Engidaw Fentahun Enyew, Abebe Basazn Mekuria

Currently, the coronavirus disease 2019 (COVID-19) is a big challenge to the healthcare systems in the world. Several researchers in the world have immediately carried out clinical investigations for the discovery of vaccines and drugs. Different studies have shown that antiviral measures including small bioactive compounds targeting multifaceted molecular communications take in COVID-19 infection. The drug development archived in this review emphasizes mainly on drugs that are effective for the Management of MERS-CoV, SARS-CoV, and other RNA viruses. The investigation of therapeutic agents for COVID-19 includes anti-inflammatory agents, antibodies, and nucleic acid-based treatments targeting virus gene expression as well as different sorts of vaccines. Numerous patents revealed techniques of these biologics with the potential for treating and preventing coronavirus infections, which may apply to COVID-19. Phase 3 clinical trials such as Sputnik V, AZD1222, mRNA-1273, BNT162b2, Ad5-nCoV, Anti-COVID antibodies, Kevzara; Actemra, Jakafi; Baricitinib, and some others were undergoing in the race for Covid-19 treatment. However, there's still a lack of a review on vaccines and drugs for COVID-19 management. Therefore, this review summarizes different studies that are ongoing in the race for Covid-19 protection and treatment.

目前,2019冠状病毒病(COVID-19)对世界卫生系统构成了巨大挑战。世界上有几位研究人员立即开展了临床研究,以发现疫苗和药物。不同的研究表明,包括靶向多面分子通信的小生物活性化合物在内的抗病毒措施在COVID-19感染中起作用。本文综述的药物开发主要集中在MERS-CoV、SARS-CoV和其他RNA病毒的有效治疗药物。新冠肺炎治疗剂的研究包括抗炎药、抗体、针对病毒基因表达的核酸治疗以及不同类型的疫苗。许多专利揭示了这些生物制剂的技术,这些技术具有治疗和预防冠状病毒感染的潜力,可能适用于COVID-19。Sputnik V、AZD1222、mRNA-1273、BNT162b2、Ad5-nCoV、Anti-COVID抗体、Kevzara等三期临床试验;Actemra Jakafi;巴西替尼和其他一些药物正在接受Covid-19治疗。然而,目前仍缺乏对COVID-19管理疫苗和药物的审查。因此,本综述总结了在Covid-19保护和治疗竞赛中正在进行的不同研究。
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引用次数: 2
Meta-Analysis of Aidi Injection and First-Generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor Therapy in Treating Advanced Non-Small Cell Lung Cancer. 爱地注射液与第一代表皮生长因子受体-酪氨酸激酶抑制剂治疗晚期非小细胞肺癌的meta分析。
IF 3.5 Q1 Medicine Pub Date : 2021-01-01 DOI: 10.1177/2515690X211010733
Na Xiao, Hailang He, Jing Wang, Li Zhang, Brandon Chow, Fanchao Feng, Yong Xu, Jingyi Huang, Xianmei Zhou, Rui Dong

The combination of Aidi injection (ADI) and epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) in treating non-small cell lung cancer (NSCLC) has been reported, but the effects of this therapy have not been systematically assessed. Randomized controlled trials (RCTs) published before June 2020 were searched from 6 databases. Two reviewers independently assessed the methodological quality of 8 RCTs involving 667 patients diagnosed with stage III-IV NSCLC. We found that ADI combined with EGFR-TKI increased the objective response rate (ORR) significantly (relative risk [RR]: 1.60; 95% confidence interval [CI]: 1.28-1.99, P < 0.0001). There was also improvement in the disease control rate (DCR) (RR: 1.25; 95% CI: 1.11-1.40, P = 0.0002) as compared with EGFR-TKI alone. This therapy also increased the percentage of CD3+ cells (weighted mean difference [WMD]: 9.86; 95% CI: 4.62-15.10), CD4+ cells (WMD: 6.10; 95% CI: 1.67-10.53), and the CD4+/CD8+ (WMD: 0.35; 95% CI: 0.28-0.43). With regard to drug toxicity, the occurrence of rash was significantly reduced by ADI combined with EGFR-TKI (RR: 0.78, 95% CI: 0.63-0.97, P = 0.03); however, we did not find a significant reduction in the occurrence of dry skin, nausea and vomiting, as well as diarrhea between the 2 therapies. ADI combined with first-generation EGFR-TKIs may be more effective in improving tumor response, reducing the occurrence of rash, and enhancing immune function in NSCLC than EGFR-TKI alone.

爱地注射液(ADI)联合表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKI)治疗非小细胞肺癌(NSCLC)已有报道,但该疗法的效果尚未得到系统评估。从6个数据库中检索2020年6月之前发表的随机对照试验(RCTs)。两名评论者独立评估了8项随机对照试验的方法学质量,涉及667名诊断为III-IV期NSCLC的患者。我们发现,ADI联合EGFR-TKI显著提高了客观缓解率(ORR)(相对危险度[RR]: 1.60;95%置信区间[CI]: 1.28-1.99, P < 0.0001)。疾病控制率(DCR)也有改善(RR: 1.25;95% CI: 1.11-1.40, P = 0.0002)。该疗法还增加了CD3+细胞的百分比(加权平均差[WMD]: 9.86;95% CI: 4.62-15.10), CD4+细胞(WMD: 6.10;95% CI: 1.67-10.53), CD4+/CD8+ (WMD: 0.35;95% ci: 0.28-0.43)。在药物毒性方面,ADI联合EGFR-TKI可显著降低皮疹的发生(RR: 0.78, 95% CI: 0.63-0.97, P = 0.03);然而,我们没有发现两种治疗方法在皮肤干燥、恶心和呕吐以及腹泻的发生率上有显著减少。ADI联合第一代EGFR-TKI可能比单独EGFR-TKI更有效地改善NSCLC的肿瘤反应、减少皮疹的发生和增强免疫功能。
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引用次数: 1
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Journal of Evidence-based Integrative Medicine
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