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According the practice of ethical review work in Guangdong Provincial Hospital of Chinese Medi-cine, this article summarized the following experiences: It should keep pace with the times and constantly adjust the type of Ethics Committee to adapt to the development of medical research; accept international and domestic certification to promote construction by certification; enhance the researchers' consciousness of ethical review and the subjects' protection awareness;conduct effective sites visits to professional group or research group;communi-cate and collaborate among multi -disciplinary to promote the development of ethical review work and so on. Through the above practices, the quantity and quality of Ethics Committee' s ethical review in the hospital had been improved greatly, and it is hoped that these practical experiences could provide reference for ethics committee in other institutions.
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In traditional biomedical research, a series of mechanism and measures had been taken for identity protection of data subjects, such as data disclosure in aggregated methods, information restricted in public only after identified variables removal and etc. The purpose of such process was aimed to properly keep confidentiality of health information for the target subjects in research. As the protection of subject privacy was viewed as one of the most essential principle of medical ethics in human research, the effects to fulfill and accomplish such process can help to maintain the trust and support among participants and social public. Currently, such traditional modes of privacy safeguard are widely-applied in genetics and genomics study. However, the universal applicability also causes a number of controversies, and the effectiveness remains to be proven. Nowadays, the risk assessments of data subjects’ privacy call for taking the whole“data context” into consideration, not just self-restricted in isolation and confined to quality control of data disclosure. With the soaring increasing of data resources in research involved human subjects, the issues of releasing genetic data have caused more and more public attention, especially for the sensitive domains of privacy protection. Based on the core problem and principles, this article attempted to discuss the controversial bioethical issues such as data context, data-intruder concept, privacy of data subject, identity control of releasing data, potential risk of individual identification, privacy protection of data subject, and etc. We hope these considerations can provide references to the bioethical understanding of biobanks research and decision-making of ethic review.
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Objective To systematically evaluate the effectiveness and safety of resuscitation-inducing acupuncture for post-stroke dysphasia. Methods The randomized controlled trials ( RCTs) of resuscitation-inducing acupuncture for post-stroke dysphasia were searched in the domestic and overseas databases such as CBM, CNKI, Weipu VIP, Wanfang Data, PubMed, Web of Science, EMbase and the Cochrane Library ( from the founded date to December of 2014) . Literature screening, information extracting and literature quality assessment were done by 2 reviewers independently. RevMan5.3.0 software was used for Meta analysis. Results A total of 8 RCTs were included into the analysis, involving in 766 cases. The results of Meta analysis showed:( 1) for patients in the recovery stage of stroke, 4-week resuscitation-inducing acupuncture combined with routine treatment including internal medicine plus swallowing function training or not had better efficiency than the control group without resuscitation-inducing acupuncture (P<0.001) ; (2) for patients in the acute stage, the difference of efficiency between the combination group and the control group was insignificant (P=0.05); (3) The efficiency of resuscitation-inducing acupuncture combined with routine treatment for the complication of pulmonary infection stayed uncertain. Conclusion Resuscitation-inducing acupuncture combined with routine treatment is recommended to the patients with dysphasia in the recovery stage of recovery. But the cure time window, treatment course and effectiveness evaluation still need to be confirmed by more large-scale, high-quality randomized controlled trials.
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Due to the differences between Chinese and Western cultures, Chinese version of foreign research instruments may not be totally applicable for use in evaluating the therapeutic effect of traditional Chinese medicine (TCM). Great efforts have been made by Chinese researchers to develop scales for evaluation of the therapeutic effects of TCM. This study aims to understand the current situation of research in the development of evaluation instrument in TCM.
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To evaluate the consistency of tongue manifestation and pulse condition observed by traditional Chinese medicine clinicians.
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To select appropriate descriptors for responses of the Health Scale of Traditional Chinese Medicine (HSTCM).
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The members of guideline development of traditional Chinese medicine and integrative medicine were not chosen according to strict standards at present. The major problems in clinical guideline development include the insufficiency of evidence and the missing recommendation according to evidence reliability. In order to establish a clinical guideline for the treatment, we should abide by the principle for guideline development in this field. Firstly, a guideline development group must be set up and the evidences are needed to be classified correctly. To facilitate the clinical practice, the recommendations in the treatment guideline should be divided into different classes and the referring recommendation reasons should be given at the same time. Only when the guideline development principles and procedures are strictly followed can a clinical guideline for the treatment suitable to the situation in China be established.
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OBJECTIVE: To test the reliability and validity of Health Scale of Traditional Chinese Medicine (HSTCM) by means of questionnaires. METHODS: A cross-sectional survey was conducted at Liwan Community of Guangzhou, Old People's Home in Guangzhou and Outpatient Department of the Second Affiliated Hospital of Guangzhou University of Chinese Medicine. A total of 652 Chinese individuals (over 18 years old) were assessed with the 88-item version of HSTCM and World Health Organization Quality of Life Measure-Abbreviated Version (WHOQOL-BREF), which were randomly delivered to them. Some socioeconomic characteristics were registered. RESULTS: A test-retest reliability (15-day interval) was found among the 76 persons who completed the questionnaires by themselves. Intra-class correlation coefficient (ICC) was 0.93. Associated 95% confidence interval (CI) was 0.89-0.96. Split-half reliability was 0.79. Inter-investigator reliability (0.93) was also good, and the ICC of HSTCM was 0.90 (95%CI 0.67-0.97). The correlation between HSTCM and WHOQOL-BREF was -0.66. The correlations of HSTCM and questionnaire deliver order, investigator, interview date and interview time were 0.06, -0.12, -0.17 and 0.20 respectively. The correlation between HSTCM and self-rated health (0.46) was greater than that between HSTCM and chronic illness (0.28). Divided by individuals with or without chronic illness, area under the ROC (receiver operator characteristic) curve for HSTCM was 0.67 (95%CI 0.63-0.71). CONCLUSION: It indicates that the HSTCM is conceptually valid with satisfactory psychometric properties and forms a basis for further applications in clinical research of traditional or integrative medicine.
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OBJECTIVE: To explore the composition characteristics of traditional Chinese medicine (TCM) syndromes in patients with acute ischemic stroke of yin or yang syndrome by investigating the characteristics of TCM syndromes at different periods after onset. METHODS: One thousand two hundred and forty-six patients with acute ischemic stroke were admitted in twenty hospitals. According to the "diagnostic criteria of syndrome differentiation of stroke", the characteristics of syndromes in the patients were investigated at the periods of 1-3 days, 4-10 days and 11-30 days after they had ischemic stroke. General distribution of six basic syndromes was compared between the patients with yin syndrome and the patients with yang syndrome at the three periods. The six basic syndromes were wind syndrome, pathogenic fire syndrome, phlegm syndrome, blood stasis syndrome, qi deficiency syndrome, and syndrome of yin deficiency and yang hyperactivity. RESULTS: The percentages of wind, pathogenic fire, and phlegm syndromes in the patients were decreased at the period of 11-30 days as compared with the period of 1-3 days (87.1% vs 79.3%, 52.1% vs 38.7% and 67.1% vs 57.4% respectively, P0.05). There were no differences in the distribution of yin and yang syndromes among the three periods (P>0.05). The percentages of syndromes of wind, pathogenic fire, phlegm, and yin deficiency and yang hyperactivity were higher (P<0.01), and the percentages of syndromes of blood stasis and qi deficiency were lower (P<0.05, P<0.01) in patients with yang syndrome than in patients with yin syndrome. The complex of three syndromes was the most frequent composition pattern in the patients at the three periods. The percentages of complex syndromes of four or five syndromes were higher, and the percentages of single-syndromes and complex syndromes of two syndromes were lower in patients with yang syndrome than in patients with yin syndrome (P<0.05, P<0.01). The most frequent complex syndromes in patients with yin syndrome were complex syndrome of wind, phlegm, blood stasis and qi deficiency, and complex syndrome of wind, phlegm and qi deficiency; while the most frequent complex syndromes in patients with yang syndrome were complex syndrome of wind, pathogenic fire, phlegm and qi deficiency, and complex syndrome of wind, pathogenic fire and phlegm. CONCLUSION: The main discrimination between the yin and yang syndromes is that the yang syndrome is characterized by pathogenic fire. The syndromes of phlegm, qi deficiency, and blood stasis are not associated with the diagnosis of yin or yang syndrome.
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Objective To evaluate the reliability and validity of Morisky questionnaire in measurement of the compliance with hypertensive medications. Methods Seventy-four eligible subjects were selected and asked to fill a Morisky questionnaire about their adherence in taking antihypertensive drugs during the past 1 month; nineteen of them received two surveys at 3～7 day intervals. The internal consistency (Cronbach ? coefficients),test-retest reliability (interclass correlation coefficients),construct validity and convergent validity were calculated. Results The Cronbach ? coefficient of the questionnaire was 0.749 and the interclass correlation coefficients between the items and the total scores of the questionnaires ranged from 0.71 to 1.00. Factor analysis yielded one factor with an accumulated contribution rate of 57.3%,and the loading values of all items on this factor were above 0.6. The Spearman correlation coefficients between the Morisky scores and the adherence assessment by the subjects themselves were over 0.3 (P
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Objective To research the effect of Shengmai capsules on cadiocyte apoptosis with chronic congestive heart failure (CHF) in rats. Methods Seventy five SD female rats were randomly divided into 5 groups:sham-operation group (A), CHF model group (B), CHF model treated by Shengmai capsules group (C), CHF model treated by Captopril group (D), CHF model treated by Shengmai capsule and Captopril group (E). Suprarenal abdominal artery constriction was operated to prepare CHF rat models. After 7 weeks treating respectively, the apoptosis rate of cadiocyte and the content of myocardia Bcl-2 in rats were detected. Results Apoptotic cells ratio of myocardia was higher in group B than in group A (P
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BACKGROUND: At present, the scale for evaluating cervical vertigo symptoms and functions applied in clinic can evaluate the overall curative effect in patients with cervical spondylosis of vertebral artery type (CSA).However, this scale lacks the content of functional status and emotional function for evaluating daily life function.OBJECTIVE: To develop a functional scale for cervical spondylosis of vertebral artery type (FS-CSA) including functional status and emotional function based on the vertigo disorder scale made abroad.DESIGN: Cross-sectional survey, interview evaluation after pretest, internal consistency, retest consistency and construct validity were measured by the method of Chronbach's c, Pearson correlation coefficients and factor analysis, respectively.SETTING: Clinical Epidemiology/DME Center, Guangzhou University of Traditional Chinese Medicine.PARTICIPANTS: Totally 111 consecutive patients with CSA, 30 men and 81 women aged 31 to 72 years, in the Clinic for Cervical Spondylosis of Guangdong Provincial Hospital of Traditional Chinese Medicine were recruited from May 2001 to March 2002. Altogether 36 patients had risk factors of vertebral-base artery atherosclerosis. There were 14 cases of mild vertigo, 61 cases of moderate vertigo, and 36 cases of severe vertigo. Informed consent was obtained from the participants.METHODS: FS-CSA was made according to clinical actual condition Functional status (going for a walk during the day by yourself, walking around the house in the dark, doing strenuous housework, social activity,traveling for business or recreation, getting into or out of bed, reading books or newspaper; each item was divided into three categories "No,anxious, worried about your illness, and feeling frustrated; each item consisted of three categories "No, Sometimes, and Yes"). Patients with CSA were evaluated by means of interview and 14 of them were retested. Internal consistency, construct validity and correlation coefficients of the scale were measured with SPSS 10.0 software.tional status dimensionality, emotional functional dimensionality as well as internal consistency of the total scale in FS-CAS: Chronbach's α value was 0.875 9, 0.645 3 and 0.859 5, respectively; retest consistency value was extracted common factor was consistent with the two dimensionalities.tool quantifies the life quality of the patients with CSA and can make a uate curative effects of drugs or screen the best treatment scheme; therefore, it has clinical application value.
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Objective:To research the effect of Shengmai capsules on the matrix metalloproteinase(MMPs)& tissue inhibitor of metalloproteinase(TIMPs)in chronic congestive heart failure(CHF)rats.Methods:75 SD female rats weredivided randomly into 5 groups:sham-operation group(A),CHF model group(B),CHF model treated by Shengmai capsules group(Shengmai capsule group,C),CHF model treated by Captopril group(Captopril group,D),CHF model treated by Shengmai capsule and Captopril group(shengmai capsule&captopril group,E),15 rats each group.Suprarenal abdominal artery constriction was operated to prepare CHF rat models.After 7 week treating respectively,the contents of MMP-3&TIMP-1 of cardiac muscle in rats were detected.Results:The content of cardiac MMP-3 was higher in group B than in group A(P
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【Objective】To investigate the influence of acupuncture on the power of brain electrical activity mapping(BEAM) and hippocampal amino acid neurotransmitters in acute epilepsy rats.【Methods】Forty SD rats were randomized into groups A(normal),B(model),C(treated with acupuncture) and D(treated with sodium valproate).Group C was pretreated with acupuncture on acupoints of Dazhui and Fenglong and with needling through Ganshu toward Danshu.Group D was pretreated with sodium valproate by gastric gavage.The treatment in groups C and D lasted 3 days.Except group A,the mice in other 3 groups received intraperitoneal injection of sodium penicillin to induce acute epilepsy.Within seventy to eighty-five minutes after modeling,different frequency-band power of BEAM in rat brain middle Pz region was detected,and rats hippocampal contents of excitatory amino acids such as glutamic acid(Glu) and aspartic acid(ASP) as well as inhibitory amino acids such as gamma-aminobutyric acid(GABA),glycine(Gly),alanine(Ala) and taurine(Tau) were examined.【Results】Power of frequency band ?,?,?_1,?_2,?_1 and ?_2 in group B increased(P
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Objective To evaluate the surgical treatment of old patients with acute perforated gastroduodenal ulcer. Method The age, complications, duration of the disease history, operative method, systemic inflammatory response syndrome (SISR) and multiple organ dysfunction syndrome (MODS) in 89 old patients with acute perforated gastroduodenal ulcers were analyzed retrospectively. Results Simple closure operation was performed in 78 cases and subtotal gastrectomy in the other 11 cases. Twelve patients died. The mortality and complications rate were significantly lower in the patients less than 70 -year old than those in the patients more than 70-year old (P
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ObjectiveTo investigate the causes of postoperative recurrence of hyperthyroidism, and the indications for and modality of reoperation. Method Data of 31 reoperative cases with postoperative recurrence of hyperthyroidism were analyzed retrospectively.ResultsAll 31 patients were cured by reoperation. The incidence of complication was 6 5%,which was not significantly different compared with primary operation treatment. Conclusions Not enough amount of resection of the thyoid in the primary surgery caused postoperative recurrence of hyperthyroidism. Secondary operation was the therapy of choice for the treatment of postoperative recurrence. Careful intraoperative dissection helps to avoid injuries of recurrent nerve, and parathyroid and massive bleeding. Enough residual volume of the thyroid gland should be removed to prevent postoperative re-recurrence.
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Up to now, advantages and disadvantages in the treatment of hypertensive middle_ and large_amount cerebral hemorrhage (HMLCH) by western medicine or traditional Chinese medicine,or by medical treatment or surgical treatment still exist. Mortality and disablement rate remain high. Western medicine combined with Chinese herbal medicine shows better effect in treating HMLCH, but the related research is preliminary. Therefore, thoughts of establishing comprehensive therapeutic protocols for HMLCH are presented as follows. Western medicine combined with Chinese herbal medicine is the fundamental therapeutic principle. Proper surgical operation should be employed promptly to clear away hemotoma and relieve the symptoms first according to the situation of the patient, hospital and the surgeon. Clearing heat and calming the liver, removing blood stasis and phlegm, relaxing the bowels and restoring consciousness are the fundamental therapeutic methods for HMLCH with yang_excess syndrome, and reinforcing Qi and activating blood circulation, removing phlegm and dredging channels, relaxing the bowels and restoring consciousness for yin_excess syndrome. Routine treatment and symptomatic treatment also should be taken into account.
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Objective To observe the effects of Bushen Yizhi Decociton (BYD) on somatostatin-like (SS-like)neurons in hippocampal gyrus of rat models with Alzheimer's disease(AD). Methods Fifteen-month_old AD rat models were established by intraperitoneral injection of D-galactose for 4 weeks combined with ibotenic acid injection into bilateral nucleus basalis of Meynert. AD model rats were randomly allocated to AD model group(Group C), Hup-A treatment group(Group D) and BYD treatment groups (Group E and Group F,treated with high dosage and low dosage respectively), and 10 normal aged rats (Group B)and 10 normal youth rats (Group A)served as the normal control groups. The methods of immunohistochemistry and dig_labeling c-DNA probe in situ hibridization were used to detect the number of SS-like immunoreactive positive and SS mRNA expressed positive neurons in hippocampal CA1 and CA3 fields and the dentate gyrus. Results The number and optic density of SS-like immunoreactive positive and SS mRNA expressed positive neurons were higher in BYD treatment groups than those in Group C (P
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Based on the principle of evidence-based medicine, the efficacy and safety of consciousness-restoring and orifice-opening (CROO) acupuncture manipulation in treating stroke are systematically assessed. All reports of clinical trials of CROO acupuncture manipulation in treating stroke were collected and random-effect model of Meta-analysis was performed by using the statistical software of Review Manager (RevMan4.1). Sensitivity and heterogeneity were analyzed and tested; funnel-plot analysis was used to identify the publication bias. Comprehensive efficacy (Odds Ratio, OR) of CROO acupuncture manipulation in treating stroke was: OR of cure and markedly effective rate between groups being 3.65 and 95% confidence interval (CI) in the range of 1.70～7.83, OR for decreasing long-term death rate being 0.21 and 95% CI in the range of 0.08～0.52. Stratified analysis showed that OR of stroke sequela was 4.01 and OR of cerebral vascular infarction was 4.45. Adverse drug reaction was not found in all of the reports. Funnel-plot analysis showed the possible existence of publication bias. [ Conclusion]CROO acupuncture manipulation has certain effect in treating stroke, especially in treating acute stage of cerebral vascular infarction, and could reduce long-term death rate of stroke. Heterogeneity may result from the difference of trial designs and inclusive criteria. Funnel-plot analysis shows the possible existence of publication bias. This conclusion is rather limited and will get more evidence if multi-center, double-blinded, randomized and controlled trials could be carried out.
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Objective To obtain an accurate prevalence of dementia and Alzheimer's disease (AD) in large sample of ≥75 year old elderly living in Guangzhou city. Methods From August 1994 to December 1995, the study was conducted in Liwan District of Guangzhou, China. A two stage cluster sampling design was used to obtain a large sample. ‘Jiedao’ (resident unit in China) was the primary sampling units (PSU),‘Jumin Xiaozu’ (resident group) was the secondary sampling units (SSU). Systematic sampling and simple random sampling procedures were used for the first and second stages, respectively. The study was divided into two phases: a door to door survey of the entire sample aged ≥75 years (4 735 persons), followed by a clinical examination of suspected cases for positive and differential diagnosis. In the first phase, mini mental status examination (MMSE) was used as screening method for dementia. In the second phase, dementia and AD were clinically diagnosed according to the criteria of Diagnostic and Statistical Manual for Mental Disorders (DSM III R) , National Institute of Neurological and Communicative Disorders (NINCDS) and Stroke Alzheimer's Disease and Related Disorders Association (ADRDA). Results The sensitivity and specificity of MMSE were 0 7451 and 0 7496 respectively while the positive predictive value was 0 2251. The prevalence of dementia in individuals aged 75 years and over was 8 90%, in which male and female were found to be 2 91% and 13 11%, and that of AD was 7 49%, male and female found to be 2 01% and 11 36% respectively. The prevalence of vascular dementia (VD) was 1 16%. Of the subjects with dementia, 84 24% was diagnosed Alzheimer's disease, 13% VD, and 2 76% dementia with other causes. The proportion of AD increased obviously by every 5 years. Conclusions The prevalence of dementia in ≥ 75 year persons was lower in Guangzhou than that in Shanghai, but was higher than that in other regional studies within China. In ≥75 year male and/or poorly educated female were more easily suffered from AD. The proportion of AD in dementia was higher in this study than that in others. These figures indicated that as a screening tool for dementia MMSE need improving and should be combined with ADL and POD together.