明晰医学试验研究与医学临床治疗之间界限的意义

在医学生命科学领域中,存在着医学试验研究和医学临床治疗两种不同性质的行为,这两种行为形成两对对应关系,即试验者和受试者、医生和患者,明晰这两对关系的界限,方可进一步研究这两对关系中双方应该遵循的规律,以便制定法律法规指导、规范医学试验研究和医学临床治疗行为,保障各自的权益。

再论明晰医学临床试验研究与医学临床治疗之间界限的意义

明晰医学临床试验研究与医学临床治疗之间界限意义的一个重要目的就是明晰医学临床试验研究中的意外事故与医学临床治疗中的意外事故之间的本质区别,循此线索,探索"保护医学临床试验研究中意外事故的受试者(伤害者)的权益和利益的方法"。同时,寻求达成"医学临床试验研究意外事故鉴定委员会对受试者(伤害者)进行鉴定"这一概念和行为的共识,从而达到从制度建设的层面上保障医学临床试验研究中受试者权益和利益的目的。

腹腔镜在妇科临床医学治疗中的应用分析

目的本文主要是分析和探讨腹腔镜在妇科临床医学治疗中的应用状况。方法选择2014年2月至2015年2月来威海市文登区人民医院妇科接受治疗的200例患者临床资料作为研究对象,随机将其分为实验组和对照组,每组患者有100例,其中实验组患者接受腹腔镜手术治疗,对照组患者接受常规性的手术治疗,对两组患者的手术时间、术后肠道功能恢复时间、术中出血量以及住院时间进行分析和比较。结果两组患者的手术时间不存在明显的差异,但是,实验组患者的术后肠道功能恢复时间、术中出血量、住院天数要优于对照组,差异较为明显(P<0.05),具有统计学意义。结论腹腔镜集治疗、诊断、微创为一体,在临床医学治疗活动中的运用能够从根本上改善传统手术治疗过程中存在的弊端,从根本上减轻患者所需要承受的痛苦,值得在今后的妇科临床医学治疗活动中进行使用和推广。

中西医治疗甲状腺功能亢进症的研究进展

甲状腺功能亢进症指甲状腺腺体不适当地持续合成和分泌过多甲状腺激素而引起的内分泌疾病,简称甲亢。其病程复杂缠绵,易反复发作。现代临床上,主要通过使用抗甲状腺药物、施行放射性131I疗法和进行外科手术等手段来减轻甲亢的症状。这些方法能够在某种程度上缓解患者的不适,然而,从长期效果来看,服用抗甲状腺药物可能会导致治疗周期过长,并可能引起一些病人出现肝脏损伤、骨髓受抑或药物过敏反应。接受放射性131I的患者很有可能会经历甲状腺功能减退的后果,而外科手术则有概率造成喉返神经损伤以及手术疤痕等副作用,这些都会对患者产生负面影响。中医治疗的手段主要采用中药内服、中药外敷等治疗方法,取得了较好的临床效果。本篇文章综合梳理了近期关于使用西医、中医和中西医结合疗法治疗甲状腺功能亢进症的研究论文,并得到以下结论:中西医结合的治疗方法可以明显优化临床效果,具体体现在缩减疗程时间、减少西药用药量与副作用、降低病情复发率以及提升患者的依从性等方面,故此该方法应被大规模用于治疗甲状腺功能亢进,旨在为临床治疗提供建议和借鉴。

2型糖尿病医学营养治疗临床指南执行现状定量研究分析

目的调查北京市各级医院T2DM患者医学营养治疗(MNT)临床指南执行现状和对于DM前期IR和代谢免疫营养干预情况。方法2022年11~12月对北京市58家医院营养科和内分泌科以定量问卷方式,调查MNT临床指南执行现状。结果参与调查的医院T2DM患者MNT指南执行比例为86%,83%的医师对T2DM患者进行“营养饮食评估和诊断”,执行人以营养师为主(84%),主要使用营养风险筛查量表进行营养筛查(97%),“IR评估”的比例为70%,新近评估及推荐在T2DM患者日常管理控制方面占比较低,仅29%的医生推荐使用“甜味剂”,38%的医生采用“免疫干预”进行辅助治疗,70%的医生推荐使用免疫营养物质,但对于能干预IR的免疫相关营养物质的认识有明显差异。结论北京市各级医院T2DM患者MNT临床指南执行需要改善,应加大培训和落实MNT在T2DM临床治疗的执行。

腹腔镜在妇科临床医学治疗上的应用

随着我国医疗卫生事业的发展,各种高新科技在临床领域的应用,解决了大量的医学难题。文章主要讲述腹腔镜检查方法,并探析腹腔镜技术在妇科临床医学上的应用。

Overview on metabolomics in traditional Chinese medicine

Metabolomics has been widely used in the modern research of traditional Chinese medicine （TCM）. At the same time, the world is increasingly concerned about TCM, and many studies have been conducted to investigate different aspects of TCM. Among these studies, metabolomic approach has been implemented to facilitate TCM development. The current methods for TCM research are diverse, including nuclear magnetic resonance, gas chromatography-mass spectrometry, and liquid chromatographymass spectrometry. Using these techniques, some advantageous results have been obtained in the studies of TCM, such as diagnosis and treatment, quality control, and mechanisms of action. It is believed that the further development of metabo-lomic analytical techniques is benefcial to the modernization of TCM. This review summarizes potential applications of metabolomics in the area of TCM. Guidelines for good practice for the application of metabolomics in TCM research are also proposed, and the special role of metabolomics in TCM is highlighted.

The expression of TGF-β_1,ADAM12 and HB-EGF in primary hepatic carcinoma

Objective: To detect the expression and location of TGF-β1, ADAM12 and HB-EGF in primary hepatic carcinoma and study their effect on the growth and metastasis of hepatoma carcinoma cell. Methods: TGF-β1, ADAM12 and HB-EGF were detected by RT-PCR and immunohistochemistry in 30 cases of hepatic carcinoma tissues, 30 cases of adjacent carci- noma tissues and 5 cases of normal hepatic tissues. Results: RT-PCR analyses showed that the mRNA expression of TGF-β1, ADAM12 and HB-EGF were markedly increased in each hepatic carcinoma tissue compared with its adjacent tissue (P < 0.01), but no signal was detected in normal hepatic tissue. Immunohistochemistry showed the same outcome on the expression of above three factors in hepatic tissues as RT-PCR. Proteins location analyses showed the proteins of TGF-β1, ADAM12 and HB-EGF all distributed in the stroma of hepatic carcinoma tissues. The positive correlation was found between TGF-β1 and ADAM12 (r = 0.6137, P < 0.05), as well as ADAM12 and HB-EGF (r = 0.5763, P < 0.05). The protein expression of TGF-β1, ADAM12 and HB-EGF were correlated with the size of tumors, degree of differentiation of hepatoma carcinoma cells, portal vein thrombus and the metastasis of absorbent glands, especially with hepatic cirrhosis caused by hepatitis B virus. Conclu- sion: TGF-β1, ADAM12 and HB-EGF possibly play an important role in the process of growth, invasion and metastasis of hepatoma carcinoma cell, meanwhile, the above three factors may collectively participate in the transition from hepatic cirrhosis caused by hepatitis B virus to hepatocellular carcinoma.

A novel understanding about oxidization of glucose in term of Wuxing TCM theory

Yin-yang theory and Wuxing theory are the core parts of Traditional Chinese Medicine（TCM）. Most of researches on Wuxing theory are based on the paradigm of TCM or Traditional Chinese Culture. It is an evitable challenge to interpret Wuxing theory in the term of biomolecular, biochemistry, stem cell and so on. The oxidation of glucose is the important pathway in cell and there are five basic factors which will be responsible for the undergoing of this reaction. The relationships among these factors are similar to Wuxing theory just like inter-promotion and inter-restraint. So, this understanding on Wuxing theory maybe take some advancement for the modernization of TCM.

Development of Intellectual Negative Pressure Aspirator

Along with the development of biomedical ergigineering, negative pressure aspirator is more and more widely applied in clinical treatment and patients rescuing. The study of negative pressure aspi- rator is an important goal pursued in emergency treatment, became it can boost aid success. Given this need, this device based on MXT8051 single-chip is developed. The device can use Pulse Width Modulation （PWM） signal to drive the motor of negative pressure pump and it can adjust the motor＇s speed through the Proportional In- tegral Derivative （PID） algorithm to realize the setting negative pressure rapidly, aoctarately and stably. The control requiroemnt is accomplishedthrough the nmn-machine interface. This device has the advantage of simple operation, low cost and good practicability.

Prevalence of left ventricular dyssynchrony in patients with heart failure assessed by a novel programmer-cardioGRAF

Objectives Left ventricular systolic dyssynchrony is the most important determinant of response to cardiac resynchronization therapy （CRT）, playing a vital role to predict improvement of systolic function or LV reverse remodeling. CardioGRAF is a novel programmer based on the ECG gated single photon emission computed tomography （G-SPECT） imaging to detect LV systolic and diastolic dyssynchrony simultaneously. This study was to investigate the prevalence of systolic and diastolic left ventricular （LV） dyssynchrony in patients with heart failure. Methods We retrospectively studied 69 patients with heart disease, including 31 patients who had symptoms of heart failure （NYHA class Ⅱ-Ⅲ）, and 38 patients who had no symptoms of heart failure. （NYHA class Ⅰ）. G- SPECT data were analyzed by cardiaGRAF, and measurements included the time to end systole （TES）, the time to peak ejection （TPE）, the time to peak filling （TPF）, TES＋TPF and maximal difference （MD） of each parameters were obtained, using the 95th percentile of the control group as a cutoffof 150 ms for MD-TES, 139 ms for MD-TPE, 345 ms for MD-TPF and 315 ms for MD-TES＋TPF. Results The prevalence of LV systolic dyssynchrony was significantly higher in heart failure patients with reduced LV ejection fraction （LVEF）〈45% （72% for MD-TES; 64% for MD-TPE） compared with heart failure patients with preserved LVEF=45% （14% for both MD-TES and MD-TPE; P=0.002, P=0.005, respectively）; The prevalence of MD-TES〈150 ms was higher in NYHA class Ⅲ patients （64%） compared with NYHA class Ilpatients （27%, P=0.049）. However, the prevalence of the LV diastolic dyssynchrony were high but not difference between NYHA class III（47% for both MD-TPF and MD-TES＋TPF） and class Ⅲ（63% for MD-TPF; 69% for MD-TES＋TPF; P=NS） patients as well as between patients with preserved LVEF （43% for both MD-TPF and MD-TES＋TPF） and patients with reduced LVEF（64% for MD-TPF; 72% for MD-TES＋TPF; P=NS）. Conclusions The prevalence of LV systolic dyssynchrony was high in heart failure patients with reduced LVEF. Diastolic dyssynchrony was common in patients with heart failure. CardioGRAF maybe a useful method to detect LV dyssynchrony （J Gerlatr Cardio12009; 6：151-156）.

Clinical Observation on the Common Acne Treated with the Five,ioint Therapy of the Traditional Medicine

Objective： The curative effect of the common acne treated by the five-joint therapy of traditional Chinese medicine was observed. Methods： 360 cases with the common acne were treated using five methods （embedding acupuncture point into traditional Chinese medicine soaked catgut; traditional Chinese medicine facial mask; taking traditional Chinese medicine orally; auricular point stimulation; discerning and cupping therapy） for 4-8 weeks, and then the improvements of the patients in clinical skin lesion were observed and also compared using the historical control method and the treatment method in the literature history. Results： The total effective rate was I00%, the cure rate was 56.39%, and the efficiency was 30.56%. Conclusion： The curative effect of the common ache treated by the five-joint therapy of traditional Chinese medicine is significant and also obviously better than that of the control method in this paper. Therefore, it is worthy of popularization and application.

Reality of evidence-based practice in palliative care

There has been a paradigm shift in medicine away from tradition, anecdote and theoretical reasoning from the basic sciences towards evidence-based medicine(EBM). In palliative care however, statistically significant benefits may be marginal and may not be related to clinical meaningfulness. The typical treatment vs. placebo comparison necessitated by ‘gold standard' randomised controlled trials(RCTs) is not necessarily applicable. The complex multimorbidity of end of life care involves considerations of the patient's physical, psychological, social and spiritual needs. In addition, the field of palliative care covers a heterogeneous group of chronic and incurable diseases no longer limited to cancer. Adequate sample sizes can be difficult to achieve, reducing the power of studies and high attrition rates can result in inadequate follow up periods. This review uses examples of the management of cancer-related fatigue and death rattle(noisy breathing) to demonstrate the current state of EBM in palliative care. The future of EBM in palliative care needs to be as diverse as the patients who ultimately derive benefit. Non-RCT methodologies of equivalent quality, validity and size conducted by collaborative research networks using a ‘mixed methods approach' are likely to pose the correct clinical questions and derive evidencebased yet clinically relevant outcomes.

Survey on skin aging status and related influential factors in Southeast China

Objective： To investigate cutaneous aging patterns of residents in Hangzhou, Zhejiang, China, and their contributing factors. Methods： Eight hundred and forty-eight Hangzhou residents received the survey between March 2004 and September 2004. Results： Facial wrinkling first occurred at 21 years of age and skin elasticity began to lose at 22 years of age. In middle-aged and old people, facial wrinkling and looseness escalated with the increase of ultraviolet （UV）-exposure time, indicating the accelerating effect of a higher accumulative dose of UV radiation on skin aging. Only Fitzpatrick types Ⅱ, Ⅲ and Ⅳ were found in the skin phototypes of residents in Hangzhou area, and Fitzpatrick type Ⅱ seemed to be much more subject to severe wrinkling, elasticity destruction and skin tumors than types Ⅲ and Ⅳ. The oily skin was more protected against wrinkling and facial looseness than dry skin. However, as to concomitant cutaneous diseases, no difference was found among different skin types. Conclusion： Age, solar-exposure time, Fitzpatrick type and skin type are the associated forces in promoting skin aging, and emotional factor seems to be another independent risk factor. The age of 49 years and 2 h/d of solar-exposure time seem to be the turning points responsible for dramatic changes of cutaneous appearance in the process of skin aging in Southeast China.

The Extraarticular Symptoms Influence ACR Response in the Treatment of Rheumatoid Arthritis with Biomedicine: A Single-blind, Randomized, Controlled, Multicenter Trial in 194 patients

Objective: The extraarticular symptoms are important in the pattern differentiation of traditional Chinese medicine (TCM), and the present study is designed in an attempt to find the associations between the extraarticular symptoms and American College of Rheumatology (ACR) Response in 194 cases of rheumatoid arthritis (RA) treated with biomedicine. Methods: The data were obtained from a randomized clinical trial. One hundred ninety-four RA patients were treated with the biomedical therapy (diclofenec, methotrexate and sulfasalazine). ACR20 response in 24 weeks was used for the efficacy evaluation. Eighteen symptoms (including 13 extraarticular symptoms) that TCM practitioners focus on were collected for exploration on the association between the symptoms and the efficacy of the biomedical therapy with association rules method. Results: After 24 weeks, a total of 135 patients receiving biomedicine had achieved an ACR20 response. The association rules analysis on each symptom showed that soreness in the waist was more associated with ACR20 response, but with lower support (selected sample size based, 20.10% and 14.95% respectively); cold intolerance and cold joint were found to be associated with ACR20 response with higher support (48.97% and 53.61% respectively), and the confidences (predicted effective rate) were 73.08% and 71.23% respectively. The associations between combination of symptoms (among them, there was at least one extraarticular symptom) and ACR20 response indicated that cold intolerance or cold joint with higher confidence and support were the most important extraarticular symptoms. Conclusion: The RA patients with "cold intolerance" and "cold joints", which are the extraarticular symptoms that TCM practitioners focus on, may show higher ACR20 response when treated with the biomedical approach.

Effect of Bufei granule on stable chronic obstructive pulmonary disease: a randomized, double blinded, placebo-controlled, and multicenter clinical study

OBJECTIVE: To study the therapeutic effect Bufei granule, which is a traditional Chinese drug that can enhance the immune function of the lung, on patients with stable chronic obstructive pulmonary disease(COPD).METHODS: This is a randomized, double blinded,placebo-controlled, and multicenter clinical study.Three medical centers in Tianjin, China, participated in the trial. A total of 140 patients with stable COPD were enrolled and randomized into two groups, with 70 patients in each. The treatment group was treated with Bufei granule, while the control group received Bufei placebo. The pharmacological treatment lasted for 12 weeks from the date of enrollment. Then, the indexes of patients were observed. Data were analyzed to study the effect of Bufei granule, with the frequency of acute exacerbation as the primary outcome. Traditional Chinese Medicine syndromes,Modified British Medical Research Council dyspnea scale score, St.George's respiratory questionnaire scores, pulmonary function, and serum inflammatory marker levels [including interleukin-6(IL-6), interleukin-8, tumor necrosis factor-α, and transformation growth factor-β1]were the secondary outcomes.RESULTS: During the 12-week treatment, treatment and control groups had no adverse reactions.The analysis of the indexes obtained from all patients showed that the therapeutic effect in the treatment group was significantly better than that in the control group because most of the similar probabilities of primary and secondary outcomes were less than 0.05,except for the level of IL-6.CONCLUSION: Bufei granule can treat patients with stable COPD by lowering the frequency of acute exacerbation, improving the quality of life,and alleviating the severity of inflammation.

Integrated treatment for lower-limb stage Ⅱ thromboangiitis obliterans by interventional therapy and oral administration of Chinese medicine: a randomized controlled clinical trial

OBJECTIVE： To observe if integrated treatment is better than other therapies for lower-limb stage Ⅱ thromboangiitis obliterans （TAO）. METHODS： Ninety lower-limb stage Ⅱ or worse TAO patients were randomly divided into three groups： group A （30 cases） treated by intervention and oral administration of Chinese medicine; group B （30 cases） treated by intervention alone; and group C （30 cases） treated only with oral adminis- tration of Chinese medicine. Therapeutic effects were observed, including the cure rate; the recurrence rate after one month, three months, six months, nine months, and one year; the ankle brachial indexes; the incidence of complications; and the level of C-reactive protein and erythrocyte sedimentation rate.RESULTS： Group A had significantly better clinically curative effects, related indexes, and outcomes during the long-term follow-up survey, than that of groups B and C. CONCLUSION： Integrated treatment is more effective for treating lower-limb stage Ⅱ or worseTAO.