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Facts about standardization of herbal medicine: a review. 关于草药标准化的事实:综述。
Pub Date : 2012-10-01 DOI: 10.3736/jcim20121002
Vandana Garg, Vir Ji Dhar, Anupam Sharma, Rohit Dutt

Natural products, either as pure compounds or as standardized plant extracts, provide extensive opportunities for new drug leads because of the unmatched availability of chemical diversity. In contrast to modern medicines, herbal medicines are frequently used to treat chronic diseases. Standardization guarantees the content of one or more active constituents and marker compounds. The plant environment and genetic factors could significantly affect the biochemical components of the plant extract, in which plants are still the most abundant and cost-effective resource for drug innovation. Production of botanical drugs requires genetically uniform monocultures of the source plant in fully standardized conditions, to assure the biochemical consistency and to optimize the safety and efficacy of every crop. The present review article illustrates about the methods for standardization of herbal medicine and how the goal of preparing herbal medicines of consistent quality and effects can be achieved.

天然产物,无论是作为纯化合物还是作为标准化的植物提取物,由于化学多样性无与伦比的可用性,为新药先导提供了广泛的机会。与现代药物相比,草药经常用于治疗慢性疾病。标准化保证了一种或多种有效成分和标记化合物的含量。植物环境和遗传因素可以显著影响植物提取物的生化成分,其中植物仍然是最丰富和最具成本效益的药物创新资源。植物性药物的生产需要源植物在完全标准化的条件下进行基因统一的单一栽培,以确保生物化学的一致性,并优化每种作物的安全性和有效性。本文阐述了中药标准化的方法,以及如何制备质量一致、效果一致的中药。
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引用次数: 74
[Practice and exploration on clinical evaluations of hospital-made Chinese herbal formulas in the Pudong new area of Shanghai]. 上海浦东新区医院自制中药方剂临床评价的实践与探索
Pub Date : 2012-10-01 DOI: 10.3736/JCIM20121003
Jie-ning Wang, Sheng Ye, Dong Yu, Hui Zhao, L. Du
Chinese herbal formulas can well present the characteristics of traditional Chinese medicine (TCM) with their simple, convenient, inexpensive and effective uses. However, due to the high cost of production, manufacturing pharmacies inside the hospital closed down one after another, which rendered the difficult situation of developing preparation of Chinese herbal formulas. The Pudong New Area of Shanghai, as a pilot region for comprehensive reforms on national development of TCM, vigorously explores the standardized research on and application of hospital-made Chinese herbal formulas. The Health Bureau of the Pudong New Area, based on the Shuguang Hospital, has established a clinical evaluation center for hospital-made Chinese herbal formulas. Through screening, manufacturing, quality control, unified allocation, and standardized clinical evaluation, the clinical evaluation center has summarized its experience on these processes.
中草药配方具有简单、方便、廉价、有效的特点,能很好地体现中药的特点。但由于生产成本高,院内生产药房陆续倒闭,导致中药配方制剂开发困难。上海浦东新区作为国家中医药发展综合改革试验区,积极探索医院制方规范化研究和应用。浦东新区卫生局以曙光医院为依托,建立了医院自制中药配方临床评价中心。临床评价中心通过筛选、制造、质量控制、统一配置、临床评价标准化等流程,总结了经验。
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引用次数: 0
[Analysis of syndrome discipline of generalized anxiety disorder using data mining techniques]. [应用数据挖掘技术分析广泛性焦虑障碍的证候学科]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120905
Qi-sheng Tang, Wen-jun Sun, Miao Qu, Dong-fang Guo

Objective: To study the use of data mining techniques in analyzing the syndrome discipline of generalized anxiety disorder (GAD).

Methods: From August 1, 2009 to July 31, 2010, 705 patients with GAD in 10 hospitals of Beijing were investigated over one year. Data mining techniques, such as Bayes net and cluster analysis, were used to analyze the syndrome discipline of GAD.

Results: A total of 61 symptoms of GAD were screened out. By using Bayes net, nine syndromes of GAD were abstracted based on the symptoms. Eight syndromes were abstracted by cluster analysis. After screening for duplicate syndromes and combining the experts' experience and traditional Chinese medicine theory, six syndromes of GAD were defined. These included depressed liver qi transforming into fire, phlegm-heat harassing the heart, liver depression and spleen deficiency, heart-kidney non-interaction, dual deficiency of the heart and spleen, and kidney deficiency and liver yang hyperactivity. Based on the results, the draft of Syndrome Diagnostic Criteria for Generalized Anxiety Disorder was developed.

Conclusion: Data mining techniques such as Bayes net and cluster analysis have certain future potential for establishing syndrome models and analyzing syndrome discipline, thus they are suitable for the research of syndrome differentiation.

目的:研究数据挖掘技术在广泛性焦虑障碍(GAD)证候学科分析中的应用。方法:2009年8月1日至2010年7月31日,对北京市10家医院705例广泛性焦虑症患者进行1年多的调查。采用贝叶斯网络和聚类分析等数据挖掘技术对广泛性焦虑症的证候规律进行分析。结果:共筛选出61种广泛性焦虑症的症状。利用贝叶斯网络,根据症状提取出GAD的9个证候。采用聚类分析方法提取8个证候。经过重复的证候筛选,结合专家经验和中医理论,确定了广泛性焦虑症的6个证候。包括肝气降火、痰热缠扰心、肝郁脾虚、心肾互不作用、心脾双虚、肾虚肝阳亢。在此基础上,编制了《广泛性焦虑障碍证候诊断标准》。结论:贝叶斯网络、聚类分析等数据挖掘技术在建立证候模型、分析证候学科方面具有一定的发展潜力,适合于辨证研究。
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引用次数: 2
[Effects of extracts of Radix Scrophulariae on blood pressure in spontaneously hypertensive rats and the underlying mechanisms]. [玄参提取物对自发性高血压大鼠血压的影响及其机制]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120910
Chan Chen, Chang-xun Chen, Xi-min Wu, Rui Wang, Yi-ming Li

Objective: To explore the effects of extracts of Radix Scrophulariae (ERS) on blood pressure, vasoconstrictors and morphology of artery in spontaneously hypertensive rats (SHRs).

Methods: Fifty SHRs were randomly divided into SHR, SHR plus 40 mg/kg of captopril, SHR plus 70 mg/kg of ERS, SHR plus 140 mg/kg of ERS and SHR plus 280 mg/kg of ERS groups. Wistar-Kyoto (WKY) rats were randomly divided into two groups, namely, WKY and WKY plus 140 mg/kg of ERS groups. The rats were orally administered with the corresponding drugs or drinking water once a day for 20 weeks. The blood pressure was determined every three weeks. At the 21st week, the concentrations of noradrenaline (NA), angiotensin II (Ang II), thromboxane B(2) (TXB(2)) and 6-keto-prostaglandin F(1α) in serum and endothelin-1 (ET-1) were detected by enzyme-linked immunosorbent assay. The morphological changes in abdominal aorta were observed under an optical microscope with hematoxylin and eosin staining. The ratio of intima-media thickness/lumen radius of abdominal aorta was calculated.

Results: ERS significantly lowered the blood pressure of SHRs from the 3rd to the 21st week; ERS also reduced the levels of NA, Ang II, ET-1 and TXB(2), decreased the intima-media thickness of abdominal aortal wall and improved the morphological changes in abdominal aorta in SHRs. In addition, ERS did not significantly change blood pressure and vasoactive substances in WKY rats.

Conclusion: ERS possesses beneficial effects in inhibiting hypertension and attenuating arteriosclerosis. The underlying mechanism may be associated with restraining the release of vasoconstrictors, such as NA, Ang II, ET-1 and TXB(2).

目的:探讨玄参提取物(ERS)对自发性高血压大鼠(SHRs)血压、血管收缩剂及动脉形态的影响。方法:50例SHR随机分为SHR组、SHR加卡托普利40 mg/kg组、SHR加ERS 70 mg/kg组、SHR加ERS 140 mg/kg组和SHR加ERS 280 mg/kg组。Wistar-Kyoto (WKY)大鼠随机分为两组,分别为WKY组和WKY加140 mg/kg ERS组。大鼠口服相应药物或饮水,每天1次,连续20周。每三周测量一次血压。第21周采用酶联免疫吸附法检测大鼠血清去甲肾上腺素(NA)、血管紧张素II (Ang II)、血栓素B(2)、TXB(2)、6-酮-前列腺素F(1α)及内皮素-1 (ET-1)的浓度。光学显微镜下苏木精、伊红染色观察大鼠腹主动脉形态变化。计算腹主动脉内膜-中膜厚度/管腔半径之比。结果:ERS在第3 ~ 21周显著降低SHRs血压;ERS还能降低NA、Ang II、ET-1和TXB水平(2),降低腹主动脉壁内膜-中膜厚度,改善SHRs腹主动脉形态学改变。此外,ERS对WKY大鼠血压和血管活性物质无显著影响。结论:ERS具有抑制高血压、减轻动脉硬化的作用。其潜在机制可能与抑制血管收缩剂的释放有关,如NA、Ang II、ET-1和TXB(2)。
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引用次数: 8
[Investigation on response of the patient-reported outcome scale of the main-symptoms of chronic obstructive pulmonary disease complicated with pulmonary heart disease]. [慢性阻塞性肺疾病合并肺源性心脏病主要症状患者报告结局量表的反应调查]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120904
Lu-ming Chen, Hui Yu, Da-rong Wu, Xun Hu, Lan Zheng

Objective: To select appropriate descriptors for response of the patient-reported outcome (PRO) scale for the main symptoms of patients with chronic obstructive pulmonary disease (COPD) complicated with pulmonary heart disease.

Methods: A cross-sectional investigation was carried out. Five equidistant ordinal descriptive words in the PRO scale of main symptoms for COPD complicated with pulmonary heart disease were selected. There were 32 alternative words in the questionnaire. Thirty respondents were required to place each descriptive word on a 10-centimeter line according to where they considered each descriptive word should be placed. Then, the line was measured by ruler; average, standard deviation and median were calculated by excel software; the authors finally chose the five equidistant words which accurately reflect the degree of main symptoms.

Results: The five most appropriate descriptive words were selected; they were "never", "seldom", "half-partly sometimes", "very often" and "always".

Conclusion: These selected decorated words are suitable for the PRO scale for patients with COPD complicated with pulmonary heart disease.

目的:为慢性阻塞性肺疾病(COPD)合并肺源性心脏病患者主要症状的患者报告预后(PRO)量表选择合适的描述符。方法:采用横断面调查。选取COPD合并肺源性心脏病主要症状PRO量表中5个等距顺序描述性词汇。问卷中有32个备选词。30名被调查者被要求根据他们认为每个描述性词语应该放置的位置,将每个描述性词语放在10厘米的线上。然后,用尺子量线;采用excel软件计算平均值、标准差和中位数;作者最终选择了准确反映主要症状程度的五个等距词。结果:选出5个最合适的描述性词语;它们是“从不”、“很少”、“有时一半”、“经常”和“总是”。结论:所选修饰词适用于COPD合并肺源性心脏病患者的PRO量表。
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引用次数: 0
[Study on the correlation between traditional Chinese medicine syndrome and short-term prognosis of ischemic stroke using logistic regression model and repeated-measures analysis of variance]. [运用logistic回归模型和重复测量方差分析研究中医证候与缺血性脑卒中短期预后的相关性]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120906
Lu Liu, Ying Gao

Objective: To investigate the correlation between traditional Chinese medicine (TCM) syndrome and short-term prognosis of ischemic stroke.

Methods: TCM syndrome factors and the neurological deficit degree of 464 patients with ischemic stroke were assessed using the Ischemic Stroke TCM Syndrome Factor Diagnostic Scale (ISTSFDS) and National Institutes of Health Stroke Scale (NIHSS) on the 1st, 7th and 14th day from the onset of ischemic stroke. Patients were assigned to the favorable short-term prognosis group and the unfavorable short-term prognosis group, depending on the NIHSS score on the 14th day after onset of stroke. The correlation between TCM syndrome factors and the short-term prognosis of ischemic stroke was studied using the logistic regression model. Then, the receiver operating characteristic (ROC) curves were used to evaluate the predicting capacity of logistic regression mode. Lastly, according to the results of the logistic regression model, the authors investigated the correlation between blood stasis syndrome and the neurological deficit degree of stroke with application of repeated-measures analysis of variance.

Results: Blood stasis syndrome (odds ratio=2.924, 95% confidence interval from 1.231 to 6.946, P=0.015) on the 14th day and NISSS score (odds ratio=1.956, 95% confidence interval from 1.701 to 2.250, P=0.000) on the 1st day after onset of stroke were risk factors that could predict short-term prognosis of ischemic stroke. The area under the ROC curves of the logistic regression model was 0.95. There was a tendency for stroke patients with blood stasis syndrome to have higher NIHSS scores than patients without blood stasis syndrome, and there was a decreased NIHSS score with time points delay.

Conclusion: Blood stasis syndrome is a risk whose diagnosis could predict short-term prognosis of ischemic stroke. Clinically, the application of treatment focusing on activating blood and resolving stasis can improve the short-term prognosis of stroke patients. This study provides an evidence base for dynamic intervention of a comprehensive integrative medical treatment program based on syndrome differentiation for ischemic stroke.

目的:探讨中医证候与缺血性脑卒中短期预后的关系。方法:采用缺血性卒中中医证候因素诊断量表(ISTSFDS)和美国国立卫生研究院卒中量表(NIHSS),于缺血性卒中发病后第1、7、14天对464例缺血性卒中患者的中医证候因素和神经功能缺损程度进行评估。根据卒中发生后第14天NIHSS评分将患者分为短期预后良好组和短期预后不良组。采用logistic回归模型研究中医证候因素与缺血性脑卒中短期预后的相关性。然后用受试者工作特征(ROC)曲线评价logistic回归模型的预测能力。最后,根据logistic回归模型的结果,应用重复测量方差分析探讨血瘀证与脑卒中神经功能缺损程度的相关性。结果:脑卒中后第14天血瘀证(优势比2.924,95%可信区间1.231 ~ 6.946,P=0.015)和第1天niss评分(优势比1.956,95%可信区间1.701 ~ 2.250,P=0.000)是预测缺血性脑卒中短期预后的危险因素。logistic回归模型的ROC曲线下面积为0.95。脑卒中血瘀证患者NIHSS评分有高于无血瘀证患者的趋势,且NIHSS评分随时间点延迟而降低。结论:血瘀证是缺血性脑卒中的危险因素,其诊断可预测短期预后。临床上应用活血化瘀为主的治疗方法可改善脑卒中患者的短期预后。本研究为缺血性脑卒中辨证综合西医结合治疗方案的动态干预提供了依据。
{"title":"[Study on the correlation between traditional Chinese medicine syndrome and short-term prognosis of ischemic stroke using logistic regression model and repeated-measures analysis of variance].","authors":"Lu Liu,&nbsp;Ying Gao","doi":"10.3736/jcim20120906","DOIUrl":"https://doi.org/10.3736/jcim20120906","url":null,"abstract":"<p><strong>Objective: </strong>To investigate the correlation between traditional Chinese medicine (TCM) syndrome and short-term prognosis of ischemic stroke.</p><p><strong>Methods: </strong>TCM syndrome factors and the neurological deficit degree of 464 patients with ischemic stroke were assessed using the Ischemic Stroke TCM Syndrome Factor Diagnostic Scale (ISTSFDS) and National Institutes of Health Stroke Scale (NIHSS) on the 1st, 7th and 14th day from the onset of ischemic stroke. Patients were assigned to the favorable short-term prognosis group and the unfavorable short-term prognosis group, depending on the NIHSS score on the 14th day after onset of stroke. The correlation between TCM syndrome factors and the short-term prognosis of ischemic stroke was studied using the logistic regression model. Then, the receiver operating characteristic (ROC) curves were used to evaluate the predicting capacity of logistic regression mode. Lastly, according to the results of the logistic regression model, the authors investigated the correlation between blood stasis syndrome and the neurological deficit degree of stroke with application of repeated-measures analysis of variance.</p><p><strong>Results: </strong>Blood stasis syndrome (odds ratio=2.924, 95% confidence interval from 1.231 to 6.946, P=0.015) on the 14th day and NISSS score (odds ratio=1.956, 95% confidence interval from 1.701 to 2.250, P=0.000) on the 1st day after onset of stroke were risk factors that could predict short-term prognosis of ischemic stroke. The area under the ROC curves of the logistic regression model was 0.95. There was a tendency for stroke patients with blood stasis syndrome to have higher NIHSS scores than patients without blood stasis syndrome, and there was a decreased NIHSS score with time points delay.</p><p><strong>Conclusion: </strong>Blood stasis syndrome is a risk whose diagnosis could predict short-term prognosis of ischemic stroke. Clinically, the application of treatment focusing on activating blood and resolving stasis can improve the short-term prognosis of stroke patients. This study provides an evidence base for dynamic intervention of a comprehensive integrative medical treatment program based on syndrome differentiation for ischemic stroke.</p>","PeriodicalId":23993,"journal":{"name":"Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine","volume":"10 9","pages":"983-90"},"PeriodicalIF":0.0,"publicationDate":"2012-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30904974","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
[Correlation between facial nerve functional evaluation and efficacy evaluation of acupuncture treatment for Bell's palsy]. [针刺治疗贝尔麻痹面神经功能评价与疗效评价的相关性]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120908
Zhang-ling Zhou, Cheng-xin Li, Yue-bo Jiang, Cong Zuo, Yun Cai, Rui Wang

Objective: To assess and grade facial nerve dysfunction according to the extent of facial paralysis in the clinical course of acupuncture treatment for Bell's palsy, and to observe the interrelationship between the grade, the efficacy and the period of treatment, as well as the effect on prognosis.

Methods: The authors employed the House-Brackmann scale, a commonly used evaluation scale for facial paralysis motor function, and set standards for eye fissure and lips. According to the improved scale, the authors assessed and graded the degree of facial paralysis in terms of facial nerve dysfunction both before and after treatment. The grade was divided into five levels: mild, moderate, moderately severe, severe dysfunction and complete paralysis. The authors gave acupuncture treatment according to the state of the disease without artificially setting the treatment period. The observation was focused on the efficacy and the efficacy was evaluated throughout the entire treatment process.

Results: Fifty-three cases out of 68 patients with Bell's palsy were cured and the overall rate of efficacy was 97%. Statistically significant differences (P<0.01) were perceived among the efficacy of five levels of facial nerve dysfunction. Efficacy was correlated with the damage level of the disease (correlation coefficient r=0.423, P<0.01). The course of treatment also extended with the severity of facial nerve dysfunction (P<0.01).

Conclusion: Differences exist in patients with Bell's palsy in terms of severity of facial nerve dysfunction. Efficacy is reduced in correlation with an increase in facial nerve dysfunction, and the period of treatment varies in need of different levels of facial nerve dysfunction. It is highly necessary to assess and grade patients before observation and treatment in clinical study, and choose corresponding treatment according to severity of damage of the disease.

目的:根据针刺治疗贝尔麻痹临床过程中面神经功能障碍的程度,对面神经功能障碍进行评分和分级,并观察评分、疗效与治疗时间的关系以及对预后的影响。方法:采用面瘫运动功能常用评定量表House-Brackmann量表,制定眼裂、唇裂标准。根据改进后的量表,对治疗前后面神经功能障碍的程度进行评估和分级。等级分为轻度、中度、中度重度、重度功能障碍和完全瘫痪五个级别。作者根据疾病的状态进行针灸治疗,没有人为设定治疗期。重点观察疗效,并在整个治疗过程中进行疗效评价。结果:68例贝尔麻痹患者中53例治愈,总有效率为97%。结论:贝尔麻痹患者面神经功能障碍的严重程度存在差异。疗效随面神经功能障碍的加重而降低,治疗时间因面神经功能障碍程度的不同而不同。在临床研究中,观察治疗前对患者进行评估和分级,并根据疾病损害的严重程度选择相应的治疗方法是非常必要的。
{"title":"[Correlation between facial nerve functional evaluation and efficacy evaluation of acupuncture treatment for Bell's palsy].","authors":"Zhang-ling Zhou,&nbsp;Cheng-xin Li,&nbsp;Yue-bo Jiang,&nbsp;Cong Zuo,&nbsp;Yun Cai,&nbsp;Rui Wang","doi":"10.3736/jcim20120908","DOIUrl":"https://doi.org/10.3736/jcim20120908","url":null,"abstract":"<p><strong>Objective: </strong>To assess and grade facial nerve dysfunction according to the extent of facial paralysis in the clinical course of acupuncture treatment for Bell's palsy, and to observe the interrelationship between the grade, the efficacy and the period of treatment, as well as the effect on prognosis.</p><p><strong>Methods: </strong>The authors employed the House-Brackmann scale, a commonly used evaluation scale for facial paralysis motor function, and set standards for eye fissure and lips. According to the improved scale, the authors assessed and graded the degree of facial paralysis in terms of facial nerve dysfunction both before and after treatment. The grade was divided into five levels: mild, moderate, moderately severe, severe dysfunction and complete paralysis. The authors gave acupuncture treatment according to the state of the disease without artificially setting the treatment period. The observation was focused on the efficacy and the efficacy was evaluated throughout the entire treatment process.</p><p><strong>Results: </strong>Fifty-three cases out of 68 patients with Bell's palsy were cured and the overall rate of efficacy was 97%. Statistically significant differences (P<0.01) were perceived among the efficacy of five levels of facial nerve dysfunction. Efficacy was correlated with the damage level of the disease (correlation coefficient r=0.423, P<0.01). The course of treatment also extended with the severity of facial nerve dysfunction (P<0.01).</p><p><strong>Conclusion: </strong>Differences exist in patients with Bell's palsy in terms of severity of facial nerve dysfunction. Efficacy is reduced in correlation with an increase in facial nerve dysfunction, and the period of treatment varies in need of different levels of facial nerve dysfunction. It is highly necessary to assess and grade patients before observation and treatment in clinical study, and choose corresponding treatment according to severity of damage of the disease.</p>","PeriodicalId":23993,"journal":{"name":"Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine","volume":"10 9","pages":"997-1002"},"PeriodicalIF":0.0,"publicationDate":"2012-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"30904976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Two-factor designs unable to examine the interactions (Part 2). 双因素设计无法检查交互作用(第2部分)。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120903
Liang-ping Hu, Xiao-lei Bao, Chen-long Lü

Two-factor designs are very commonly used in scientific research. If the two factors have interactions, research designs like the factorial design and the orthogonal design can be adopted; however, these designs usually require many experiments. If the two factors have no interaction or the interaction is not statistically significant on result in theory and in specialty, and the measuring error of experimental data under a certain condition (usually one of the experimental conditions that are formed by the complete combination of the levels of the two factors) is allowed in specialty, researchers can use random block design without repeated experiments, balanced incomplete random block design without repeated experiments, single factor design with a repeatedly measured factor, two-factor design without repeated experiments and two-factor nested design. This article introduces the last two design types by examples.

双因素设计在科学研究中非常常用。如果两个因素有交互作用,可以采用析因设计、正交设计等研究设计;然而,这些设计通常需要许多实验。如果两个因素在理论和专业上没有相互作用或相互作用对结果没有统计显著性,并且在特定条件下(通常是由两个因素水平完全组合形成的实验条件之一)允许实验数据的测量误差,研究人员可以采用不重复实验的随机区组设计,不重复实验的平衡不完全随机区组设计。有重复测量因子的单因素设计、没有重复实验的双因素设计和双因素嵌套设计。本文通过实例介绍了后两种设计类型。
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引用次数: 0
[Effects of acupuncture on lactoferrin content in tears and tear secretion in patients suffering from dry eyes: a randomized controlled trial]. [针刺对干眼症患者泪液中乳铁蛋白含量及泪液分泌的影响:一项随机对照试验]。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120909
Jing-lin Shi, Wan-hong Miao

Background: With the understanding of the immune inflammatory response in the pathogenesis of dry eyes, and the limitations of widely used artificial tears and numerous pharmaceuticals and methods to promote tear secretion, clinicians pay more attention to the therapies that can promote tear secretion actively. Acupuncture treatment for dry eye may meet this requirement.

Objective: To observe the clinical efficacy of acupuncture treatment on dry eye and the effects on duration, and to examine the mechanisms of acupuncture in treating patients with dye eyes.

Design, setting, participants and interventions: The study was performed at Department of Ophthalmology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine from August 2010 to May 2011. Patients with the primary diagnosis of dry eye were enrolled. Sixty-five patients were randomly divided into treatment group and control group, and were given 3 weeks of acupuncture treatment or artificial tear therapy respectively.

Main outcome measures: The enzyme-linked immunosorbent assay was used to detect the lactoferrin content of the tears before and after treatment. In order to evaluate the efficacy of the treatment methods, the Schirmer I test and break-up time were also measured.

Results: Compared with before treatment, the lactoferrin content in the tears of patients in the treatment group increased, break-up time was prolonged and the result of the Schirmer I test showed improvement after 3 weeks of treatment. The indexes mentioned above did not change in the control group after treatment. There were no significant differences in tear lactoferrin and Schirmer I test between one week after treatment and after 3-week treatment in the treatment group, but break-up time was significantly shortened. The result of Schirmer I test in the treatment group was significantly higher than that in the control group one week after treatment.

Conclusion: Acupuncture can increase tear lactoferrin level, extend tear film break-up time and promote tear secretion in patients with dry eye in a time-limited trial. With the end of treatment, the effect decreased.

背景:随着对干眼症发病机制中免疫炎症反应的认识,以及目前广泛应用的人工泪液和众多促进泪液分泌的药物和方法的局限性,临床医生更加重视能够主动促进泪液分泌的治疗方法。针刺治疗干眼症可以满足这一要求。目的:观察针刺治疗干眼症的临床疗效及对病程的影响,探讨针刺治疗染眼症的作用机制。设计、设置、参与者和干预措施:研究于2010年8月至2011年5月在上海中医药大学曙光医院眼科进行。主要诊断为干眼症的患者被纳入研究。65例患者随机分为治疗组和对照组,分别给予3周针灸治疗和人工泪液治疗。主要观察指标:采用酶联免疫吸附法检测治疗前后泪液中乳铁蛋白含量。为了评价处理方法的效果,还测量了Schirmer I试验和破裂时间。结果:与治疗前相比,治疗组患者泪液中乳铁蛋白含量增加,破裂时间延长,治疗3周后Schirmer I试验结果有所改善。对照组治疗后上述指标均无变化。治疗组治疗后1周与治疗后3周撕裂性乳铁蛋白、Schirmer I试验差异无统计学意义,但破裂时间明显缩短。治疗后1周,治疗组Schirmer I试验结果显著高于对照组。结论:针刺可提高干眼症患者泪液乳铁蛋白水平,延长泪膜破裂时间,促进泪液分泌。随着治疗的结束,效果逐渐下降。
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引用次数: 19
Chelidonine isolated from ethanolic extract of Chelidonium majus promotes apoptosis in HeLa cells through p38-p53 and PI3K/AKT signalling pathways. 从白屈菜乙醇提取物中分离得到的白屈菜碱通过p38-p53和PI3K/AKT信号通路促进HeLa细胞凋亡。
Pub Date : 2012-09-01 DOI: 10.3736/jcim20120912
Avijit Paul, Kausik Bishayee, Samrat Ghosh, Avinaba Mukherjee, Sourav Sikdar, Debrup Chakraborty, Naoual Boujedaini, Anisur Rahman Khuda-Bukhsh

Objective: To evaluate the role of chelidonine isolated from ethanolic extract of Chelidonium majus in inducing apoptosis in HeLa cells and to assess the main signalling pathways involved.

Methods: Cells were initially treated with different concentrations of chelidonine for 48 h and the median lethal dose (LD50) value was selected by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay. Morphological analysis of nuclear condensation and DNA damage and fragmentation were measured by 4',6-diamidino-2-phenylindole staining and comet assay. Further, reactive oxygen species (ROS) generation, cell cycle arrest and change in mitochondrial membrane potential were also examined and analyzed by flow cytometry. Evaluation of interaction of drug with CT DNA was investigated by circular dichroism (CD) spectral analysis to find any possible drug-CT DNA interaction. The mRNA and protein expressions of major signal proteins like p38, p53, protein kinase B (AKT), phosphatidylinositol 3-kinases (PI3K), Janus kinase 3 (JAK3), signal transducer and activator of transcription 3 (STAT3) and E6 and E7 oncoproteins as well as the pro-apoptotic genes and antiapoptotic genes were also estimated by reverse transcriptase-polymerase chain reaction and Western blotting.

Results: Based on LD(50) value (30 μg/mL) of chelidonine, three doses were selected, namely, 22.5 μg/mL (D1), 30.0 μg/mL (D2) and 37.5 μg/mL (D3). Results showed that chelidonine inhibited proliferation and induced apoptosis in HeLa cells through generation of ROS, cell cycle arrest at sub-G1 and G0/G1 stage, change in mitochondrial membrane potential and fragmentation of DNA. Results of CD spectra showed effective interaction between chelidonine and calf thymus DNA. Studies of signalling pathway revealed that chelidonine could efficiently induce apoptosis through up-regulation of expressions of p38, p53 and other pro-apoptotic genes and down-regulation of expressions of AKT, PI3K, JAK3, STAT3, E6, E7 and other antiapoptotic genes.

Conclusion: Chelidonine isolated from Chelidonium majus efficiently induced apoptosis in HeLa cells through possible alteration of p38-p53 and AKT/PI3 kinase signalling pathways.

目的:探讨从大Chelidonium乙醇提取物中分离得到的chelidonine在诱导HeLa细胞凋亡中的作用,并探讨其主要信号通路。方法:用不同浓度的chelidonine初始作用细胞48 h,采用3-(4,5-二甲基噻唑-2-基)-2,5-二苯四唑溴化法测定致死中位剂量(LD50)。采用4′,6-二氨基-2-苯基吲哚染色和彗星法检测核凝聚和DNA损伤和断裂的形态学分析。此外,流式细胞术还检测和分析了活性氧(ROS)的产生、细胞周期阻滞和线粒体膜电位的变化。通过圆二色性(CD)光谱分析来评估药物与CT DNA的相互作用,以发现任何可能的药物-CT DNA相互作用。通过逆转录聚合酶链反应和Western blotting检测p38、p53、蛋白激酶B (AKT)、磷脂酰肌醇3-激酶(PI3K)、Janus激酶3 (JAK3)、信号转导和转录激活因子3 (STAT3)、E6和E7癌蛋白等主要信号蛋白的mRNA和蛋白表达,以及促凋亡基因和抗凋亡基因的表达。结果:根据chelidonine的LD(50)值(30 μg/mL),选择22.5 μg/mL (D1)、30.0 μg/mL (D2)和37.5 μg/mL (D3) 3个剂量。结果表明,chelidonine通过ROS的产生、亚G1期和G0/G1期细胞周期阻滞、线粒体膜电位改变和DNA断裂等途径抑制HeLa细胞增殖并诱导凋亡。CD光谱结果表明,白屈碱与小牛胸腺DNA之间存在有效的相互作用。信号通路研究发现,chelidonine通过上调p38、p53等促凋亡基因的表达,下调AKT、PI3K、JAK3、STAT3、E6、E7等抗凋亡基因的表达,有效诱导细胞凋亡。结论:从白屈菜中分离的白屈碱可能通过改变p38-p53和AKT/PI3激酶信号通路有效诱导HeLa细胞凋亡。
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引用次数: 39
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Zhong xi yi jie he xue bao = Journal of Chinese integrative medicine
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