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Objective:To evaluate and compare the clinical efficacy and safety of three different medicated eye patches in the treatment of Demodex blepharitis. Methods:A multicenter, randomized, double-blind, parallel-controlled clinical trial was conducted.A total of 140 patients (280 eyes) with Demodex blepharitis were recruited in Shanghai Jing'an District Shibei Hospital, Xi'an Fourth Hospital and Kunming First People's Hospital from July 2021 to December 2022.The affected eyes were randomly divided into tea tree oil group, okra oil group, basal fluid control group and metronidazole group by the random number table method.Eye patches containing 20% tea tree oil, 1% okra oil, prepared base solution and 2% metronidazole were applied to the eyes for 28 days by the double-blind method.The count of Demodex was evaluated before treatment and on days 14 and 28 of treatment.Ocular surface symptoms were scored according to Ocular Surface Disease Index (OSDI). The degree of congestion at the eyelid margin and cylindrical dandruff at the root of eyelashes were scored under a slit lamp microscope.The effective rate was calculated according to the comprehensive scores above, and the adverse reactions of the subjects were observed.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Shanghai Jing'an District Shibei Hospital (No.YL-20200320-05). All the subjects were informed of the significance, purpose and method of the study.Written informed consent was obtained from each subject before any medical examination. Results:All subjects completed the treatment and follow-up, and the loss to follow-up rate was 0%.After 14 and 28 days of treatment, the Demodex count was significantly decreased in all groups compared with before treatment (all at P<0.05). After 28 days of treatment, the number of Demodex in tea tree oil group, okra oil group and metronidazole group were significantly lower than that in basal fluid control group, with statistically significant differences (all at P<0.05). The OSDI score, palpebral margin congestion score and cylindrical dandruff score on 14 and 28 days after treatment in tea tree oil group, okra oil group and metronidazole group were significantly lower than before treatment, showing statistically significant differences (all at P<0.05). After 28 days of treatment, the effective rates of tea tree oil group, okra oil group and metronidazole group were 71.4%, 71.4% and 62.9%, respectively, which were significantly higher than 25.7% in basal solution control group.No serious local or systemic adverse reactions were found during the treatment and follow-up. Conclusions:Eye patches containing tea tree oil, okra oil and metronidazole have significant effects on the treatment of Demodex blepharitis, which can improve the biological environment of the palpebral margin and eliminate the inflammation related to blepharitis.
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Clinical trail report is a summary of the process and results of clinical trail, an important basis to support the effectiveness and safety evaluation of drug marketing and an important technical data required for drug registration. Safety analysis is the main part and the most common issue of clinical trial report. In this article, it is summarized and analyzed the common problems found in the safety analysis part of the clinical trial report of new drugs of traditional Chinese medicine(TCM) in combination with the clinical professional evaluation of the application for marketing license of innovative TCM. The common problems in writing the safety aspects of clinical trail reports were summarized and analyzed, including the omissions of adverse events and laboratory test results, the failure to provide a detailed list of laboratory test outliers, the lack of professional depth in the analysis of the causal relationship between adverse events and TCM. In view of the common problems, it is suggested that the drug use degree, adverse events and adverse reactions, as well as laboratory examination should be considered. Check the three dimensions for necessary medical analysis, collation and summary and continuously improve the quality of safety analysis in clinical trial reports.
Subject(s)
Clinical Trials as Topic , Drugs, Chinese Herbal/adverse effects , Medicine, Chinese TraditionalABSTRACT
Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) is an imaging method that uses magnetic resonance technology to perform objective, quantitative, and noninvasive assessment of fat in the whole liver. This article mainly analyzes the correlation between MRI-PDFF value and the “gold index” nonalcoholic steatohepatitis (NASH) liver histological evaluation and explores its advantages and disadvantages as a noninvasive evaluation index for NASH clinical trials. Current studies have shown that MRI-PDFF, as an emerging noninvasive technique, is suitable for quantifying liver fat content and evaluating the degree of hepatic steatosis, but it cannot replace liver biopsy as a tool for the diagnosis of NASH. Meanwhile, the relative reduction in MRI-PDFF after drug intervention is not only highly correlated with the improvement of fat deposition, but also correlated with the improvement of inflammation and ballooning degeneration, and MRI-PDFF can predict the overall improvement of liver histology to a certain extent. Therefore, MRI-PDFF is considered a potential surrogate endpoint for NASH clinical trials.
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At present, SARS-CoV-2 is raging, and novel coronavirus pneumonia (COVID-19) has caused more than 35 million confirmed patients and more than 500 000 cases death, which seriously endanger human health, socioeconomic development, as well as global medical and public health systems. COVID-19 is highly contagious, has a long incubation period, and causes many death cases due to lack of effective specific treatment. Mesenchymal stem cells have powerful anti-inflammatory and immunoregulatory functions, and can effectively reduce the cytokine storm caused by coronavirus in patients, and improve the pulmonary fibrosis of patients, promote the repair of damaged lung tissue, and reduce the mortality. Currently, a number of related clinical trials of mesenchymal stem cell treatment of COVID-19 have been conducted, and have confirmed the safety and efficacy, suggesting a good clinical application prospect. While progress has been made in mesenchymal stem cell therapy for COVID-19, we should also catch sight of the problems and challenges faced by mesenchymal stem cell clinical trials under severe epidemic situation, including clinical trials design, stem cell quality management, and ethics in treatment. Only by paying attention to these can we guarantee the safe and effective development of mesenchymal stem cell clinical trials in the treatment of COVID-19.
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Humans , Betacoronavirus , COVID-19 , Clinical Trials as Topic , Coronavirus Infections/therapy , Mesenchymal Stem Cell Transplantation , Mesenchymal Stem Cells/cytology , Pandemics , Pneumonia, Viral/therapy , SARS-CoV-2ABSTRACT
AIM: To estimate the treatment effect before and after patients stopped taking the drug, based on the combination of withdrawal randomized study and active extension trial design. METHODS: The short term treatment effect was estimated separately by the traditional method of using first stage data and the method of taking second or third stage data into consideration. And the treatment difference between long term and short term, also the treatment difference after patients discontinued from treatment were further assessed. The robustness of the result was tested by simulation assumed different scenario. RESULTS: The standard error (0.17) of the treatment effect estimation used more stage data was less than that of only used the first stage (Standard error: 0.19), besides much powerful for those treatment effect could be stabilized in the short period. CONCLUSION: Compared with the method only utilized the data of the first stage, the method developed here utilized second or third stage data. The utilization of more information leaded to decreasing of standard deviation and increasing of validity for the estimation of treatment effect. But the results will be influenced by the time required for the stabilization of the treatment effect, since the method was based on certain assumptions.
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The technical review for clinical trials of implantable sacral nerve stimulation system needs to focus on the basic principles of trials, clinical institutition and design elements of clinical trial protocols.
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Objective: To evaluate the efficacy and safety of different dosages of Pudilan Xiaoyan Oral Liquid (PXOL) in treatment of infantile acute pharyngitis-tonsillitis with lung-stomach excess-heat syndrome. Methods: A randomized controlled, double-blind, positive drug parallel controlled, and multi-center clinical trial was conducted. Totally 324 children from seven research centers were included, 108 cases in experimental high dose group (A Group), 108 cases in experimental low dose group (B Group), 54 cases in positive medicine group (Xiaoer yanbian Granula, C Group), and 54 cases in placebo group (D Group), with the ratios of 2:2:1:1.5 in a course. Results: (1) Totally 317 cases were in full analysis set (FAS), 284 cases in per-protocol set (PPS) and 324 cases in Safety Set (SS). (2) Evaluation on effectiveness: There was significant difference (P<0.001) between each two groups in the total effective rate of pharyngalgia and pharyngeal swelling. A Group and B Group were both superior to D Group, and were non-inferior to C Group. B Group was non-inferior to A Group. There was significant difference (P<0.001) between each two groups in total effective rate of syndrome of traditional Chinese medicine. There was significant difference (P<0.05) between each two groups in the median time of improving pharyngalgia syndrome. There was significant difference (P<0.001) between each two groups in the median time of pharyngalgia syndrome disappearing. There were significant differences (P<0.05) between each two groups in total effective rate of halitosis, cough, thirst, deep-colored urine, and dry stool. The analysis on PPS agrees with that of FAS. (3) Evaluation on safety: No adverse reactions in clinical significant laboratory examination were found during the trial. Conclusion: High and low dosages of PXOL show advantages over placebo and are non-inferior to the positive medicine Xiaoer Yanbian Granula. High dose group does not show advantage comparing with low dose group. No adverse reactions are found during the trial. Low dose therapy is recommended.
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Background It has been reported that orthokeratology has the effects of slowing down myopia progression and axial elongation.However,the affecting mechanism of orthokeratology wearing on ocular peripheral refraction is still not elucidated.Objective This study was to observe and compare the changes of ocular peripheral refraction and relative peripheral refraction (RPR) in low to moderate myopic eyes of children after wearing orthokeratology lens and spectacles for 6 months.Methods A randomized controlled clinical trial was carried out after approval of Ethic Committee of Beijing Tongren Hospital and informed consent of guardians of the children.One hundred myopic children aged (ll.0±1.9) years were recruited in Beijing Tongren Hospital from June 2014 to January 2015,with the diopter of-0.50 to-6.00 D.The subjects were randomized into orthokeratology group and spectacles group by the process PLAN PROC of software SAS 9.1.3,50 for each group.The subjects in the orthokeratology group wore orthokeratology lens for 6 months and those in the spectacles group wore spectacles for the same period.An infrared open-field autorefractor was employed to measure the refraction at central 0°,temporal 15°,temporal 30°,nasal 15°and nasal 30° radial lines before and after wearing lens for the assessment and comparison of the changes of peripheral refraction and RPR.Results There was no significant difference in spherical equivalent between the orthokeratology group and the spectacles group before wearing lens ([-3.35±1.31] D versus [-3.01± 1.15] D,P =0.20).The peripheral refraction values in the orthokeratology group were (-2.28 ± 1.60),(-3.28±1.41),(-3.40±1.23),(-3.38±1.12) and (-2.09±1.29)D at nasal 15°and nasal30°,central,temporal 15° and temporal 30°radial lines before wearing lens,and reduced by (0.29±1.67),(0.85±1.66),(0.92±1.76) and (0.66±1.66) D at nasal 30°,nasal 15°,central and temporal 15° after wearing lens,respectively,with significant differences at nasal 15°,central and temporal 15°(all at P＜0.05).The peripheral refraction values in the spectacles group were (-1.88±1.30),(-2.66±1.18),(-2.89±1.27) and (-1.94±1.31)D at nasal 15°,nasal 30°,temporal 15 ° and temporal 30°,radial lines before wearing lens and increased by (-0.25±0.80),(-0.43 ±0.67),(-0.32±0.64) and (-0.22±0.75)D after wearing lens,respectively,with significant differences between before and after wearing lens (all at P＜0.05).The RPR shifted from hyperopia defocus to myopia defocus before and after wearing lens in temporal 15° and 30° radial lines in the orthokeratology group,and at various radial lines in the spectacles group,the RPR showed gradually worsening of hyperopia defocus.Conclusions Long-term wearing of orthokeratology results in a hyperopia shifting in myopic children by exposing the peripheral retina towards relative myopia defocus,whereas wearing spectacles leads to a relative hyperopia defocus on retina.Thus,orthokeratology may slow down the myopia progression.
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Although there are numerous case resource,there still exist a relatively long distance in clinical research in China in comparison with developing countries because of inadequate recognition and funding,which has greatly affected the development of standardization of clinical medical in China for the past few decades.With the deepening of recognition and increasing of special support to clinical medical research in China,the development based on clinic research will face new opportunities.As a result,it is necessary for ophthalmologists to explore clinical issues,leverage from the mega trend of clinical research and deliver high-quality results.To achieve this goal,ophthalmologists will have to constantly update their knowledge base,standardize clinical practice and improve diagnosis methods.So far,challenges persist in clinical research in ophthalmology as follows:It is difficult to get funding for clinical research project;It is difficult to get ethnics approval for clinical research project;The research design for forward-looking projects is yet to be standardized;Cross-disciplinary collaboration needs to be enhanced.This review was expected to inspire more attention from clinical research specialists and consequently more highquality clinical studies.
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Clinical trials for medical research subjects of protection in China is still the researchers and sub-jects′cognitive biases, informed consent to carry out the difficult and the lack of follow-up tracking examination questions.Based on the experience and the domestic exploration of a hospital, put forward the Suggestions of per-fecting our country′s subjects protection: establish multi-sectoral cooperation of the subjects protection system, improve the legal consciousness and the consciousness of the subjects, the ethics committee should be field trips, build system of compulsory insurance, adverse drug reaction relief system is established.
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Background The clinical effectiveness of soft corneal contact lens for correction of myopia has been confirmed.Theoretically,aspherical soft hydrophilic corneal contact lens has better visual qualify for myopic eyes,and the lenses have been applied widely.But abnormal tear film,even many cornea and conjuctiva diseases caused by soft contact lens have been reported,so the effectiveness and safety of aspherical soft hydrophilic corneal contact lens are worth concerning.Objective This clinical trail was to compare the effectiveness and safety between aspherical and NUV soft hydrophilic contact lens for myopic eyes.Methods A randomized,double-blind and controlled clinical study was performed under the approval of Ethic Committee of Qingdao Municipal Hospital and informed consent of each patient.One hundred and forty eyes of 70 myopic patients were enrolled in QingdaoMunicipal Hospital from July to October,2012.The subjects were randomized into the trial group and control group using random number table.Aspherical soft hydrophilic contact lenses were worn in the trial group and NUV soft hydrophilic contact lenses were worn in the control group.The characteristics of the lens surface,outcomes and the eye number in different scores of ocular signs and symptoms were assessed before and 15 minutes,1 week,2 weeks and 1 month after wearing lenses.Results The sores of humidity of anterior surface,the sediment in anterior and posterior surface are 0 in both lenses in various time points after wearing.The corrected visual acuity of all the subjects were ≥ 1.0.The eye number of 2-3 scores in various ocular signs was 0 in both groups,but the eye number of 1 score in palpebral conjunctival congestion and limbus congestion were more in the trail group than those in the control group in different time points (all at P＜0.05).There were significant differences in corneal fluorescine staining between the groups in different time points (all at P＞0.05).There was no eye for 2-3 scores of eye symptoms in both groups.The eye number for 1 score in foreign body sensation increased in the target-trail group compared to the control group at various time points (P =0.002,0.006,0.005,0.005).However,there was no statistically significant differences in the eye number for 1 score in visual clearness and stability between the two groups at the follow-up duration (all at P＞ 0.05).Conclusions Aspherical soft hydrophilic corneal contact lens has good outcomes in corrected visual acuity for myopia like NUV soft hydrophilic contact lens,but the wearing of aspherical soft hydrophilic corneal contact lens induces more ocular discomfortableness.
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Background Selective laser trabeculoplasty (SLT) is a safe and effective therapy to the treatment of primary open angle glaucoma (POAG),and the clinical application is approved by American FDA.However,the relevant researching outcomes from several single-center study are in dispute owing to non-uniform approach in China.A muhicenter clinical trial is need to verify the effectiveness of SLT for Chinese POAG.Objective This study was to investigate the safety and efficacy of SLT in Chinese POAG patients.Methods A prospective,multicenter and self-controlled clinical trail was designed.Sixty-two eyes of 62 POAG patients with the age of ≥ 18 years were enrolled.Frequency SLT was performed around 360° angle using Lumenis Selecta DuetTM or Lumenis Selecta Ⅱ laser instrument,with the 100 non-overlapping spots,3 ns preset time,400 μm size of laser spot and 0.6 mJ energy.The operated eyes were followed-up for 6 months.The curative effects were checked including intraocular pressure (IOP),IOP-lowing value,number and percentage of IOP-lowing 20％ and 30％.The therapyrelated complications were recorded including the number of conjunctival congestion and cloudy of the anterior chamber.Results The preoperative IOP was (25.7±2.6) mmHg in the 62 eyes.The IOP was significantly lowed 1 day,2 weeks,4 weeks,3 months and 6 months after SLT in comparison with preoperative IOP (all at P＜0.001) with the lowest value of (16.5±4.5)mmHg in postoperative day 1.IOP was stable from 4 weeks to 6 months after operation.The mean lowing-value of IOP was 5.3-9.2 mmHg from 1 day through 6 months after SLT.The percentage of eyes 20％ drop in lOP was 83.9％,and that of 30％ drop was 58.1％ in postoperative day 1.In 6 months after SLT,percentages of eyes 20％ and 30％ drop in IOP were 56.5％ and 27.4％,respectively.Conclusions SLT is a safe and effective method of lowing IOP for POAG eyes in Chinese population.
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As metas da educação ao paciente com artrite reumatoide (AR) visam estimular o sujeito a alcançar o máximo possível de independência funcional e qualidade de vida. O objetivo do trabalho foi verificar os efeitos do programa de extensão Educação ao Paciente Reumático, em um Serviço de Reumatologia, em Vitória/ES. A metodologia utilizada foi um ensaio clínico não controlado do tipo quantitativo. Pacientes foram avaliados ao iniciarem no programa e após quatro semanas, através do Health AssessmentQuestionnaire, do Patient Knowledge Questionnaire e da Escala de autoeficácia para dor crônica. Nos dados foram utilizados o teste t-pareado, para as variáveis paramétricas, e o teste de Wilcoxon, para as não paramétricas, sendo considerado um p<0,05. Os resultados foram os seguintes: cinquenta pacientes com AR participaram do programa, sendo que quinze pacientes compareceram a todos os encontros e dezenove completaram as 1ª e 2ª avaliações; 18,2%completaram o Ensino Médio e 63,6% recebiam até um salário mínimo. Concluiu-se que não houve diferença estatisticamente significativa entre as avaliações iniciais e finais. A amostra utilizada demonstrou que os pacientes não adquiriram mais conhecimentosobre a doença através do programa de educação a curto-prazo, provavelmente devido ao baixo nível de escolaridade, à renda mensal e à falta de adesão dos usuários e familiares...
The goal behind patients education about rheumatoid arthritis (RA) is to stimulate the person to achieve maximum functional independence e a healthy life-style. The point of thiswork was to verify the extension program Education to rheumaticpatient effects, on a Rheumatologic Service, in Vitória/ES. The applied methodology was a non-controlled clinical trial of the quantitative type. Patients were evaluated in the beginning of the program and after four weeks, through the Health AssessmentQuestionnaire, from Patient Knowledge Questionnaire and from the School of auto effi ciency for chronical pain. It was used the t-paired test on the data, for the parametrical variables, and the Wilcoxon test for the non-parametrical ones, been considered p<0.05. The results were: fi fty patients with RA started the program, being that fi fteenattended to all meetings and nineteen had the 1st and 2nd evaluationscompleted; 18.2% fi nished High School and 63.6% had a minimum wage income. We conclude that there was no signifi cant statistical difference between the initial and final evaluations. The used sample showed that the patients did not acquired more knowledge about the disease through the short-term education program, probably due their low level of education, the low income and lack of family support...
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Humans , Male , Female , Arthritis, Rheumatoid , Patient Education as Topic , Clinical Trials as Topic , Hospitals, Teaching , Pilot Projects , User Embracement , Education , Surveys and QuestionnairesABSTRACT
Background Acute bacterial conjunctivitis is a common ocular infectious disease.It can be cured by topical administration of antibiotics,but these antibiotic eye drops often was used several times per day at present.Azithromycin is thought to offer less using times and shorten the duration of treatment.Objective The purpose of this clinical trail was to evaluate the clinical efficacy and safety of topical administration of 1％azithromycin eye drops for the treatment of acute bacterial conjunctivitis.Methods This study was approved by Ethic Committee of Beijing Tongren Hospital and followed the Declaration of Helsinki.Written informed consent was obtained prior to entering into this trial.A randomized,double-blind and placebo-controlled study was designed.One hundred and eighty patients with acute bacterial conjunctivitis were enrolled in Affiliated Hospital of Qingdao Medical College and Qingdao Municipal Hospital from may,2011 to September,2011.Azithromycin eye drops at the concentration of 1％ was topically administered on 89 eyes of 89 patients twice per day initial and once per day later for 9 days in the trial group,and placebo eye drops was used on 91 eyes of 91 patients in the same way in the control group.The inflammation response of all eyes was examined and scored under the slit lamp microscope,and germiculture was carried out.All adverse responses were assessed during the follow-up.Clinical efficacy was evaluated with the clinical cure rate as the primary indicator and bacterial clearance rate as the secondary indicator.The safety of drug was determined,including the ocular irritation sign,lens transparency and intraocular pressure.The differences of the examining results mentioned-above were compared with Chi Square test.Results One hundred and eighty patients completed the clinical trials according to the program without lost and exclusion cases.The clinical cure rate in 89 subjects in the trial group and 91 control individuals was 76.40％ (68/89) and 43.96％ (40/91),respectively,with significant difference between them (x2=19.73,P＜0.01).The bacterial eradication rate was 85.71％ (24/28) in the trial group and 60.53％ (23/38) in the control group,showing a significant difference (x2 =4.99,P＜0.05).Both 1％ azithromycin eye drops and placebo were well-tolerated with a low incidence of adverse events.Conclusions One percent azithromycin eye drops is effective and safe for the treatment of acute bacterial conjunctivitis with less adverse reaction.
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Objective To observe the efficacy and adverse reaction of the test drug hepatitis B immunoglobin on the post market.Method Employed by the methods of multiple center's clinical trials and using the recommended dosage of hepatitis B immunoglobulin for intravenous administration,the clinical efficacy of either prevention or treatment for hepatitis B recurrence and drug related adverse reactions were observed.This consisted of 22.1 months,13 hospitals,and 525 patients with hepatitis B related liver transplantation.Result The results showed a contrasting probability of adverse reactions for different doses among the observation period.Within 6 months postoperatively with a greater or equal to recommended drug dose,the infection rate was less than 4％.In contrast,the infection rate was greater than 12％ in the group with less than the recommended drug dose.Conclusion There was an obvious dose effect relationship,and the drug safety and recommended treatment rationality were verified.
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Introdução: Este estudo foi realizado com o intuito de avaliar efeitos da acupuntura sobre os pacientes com asma leve e moderada persistentes com o uso de beta-2 agonista ou corticoide inalatório. Métodos e casuística: Trata-se de um estudo prospectivo, duplo-cego, randomizado e cruzado com dois braços. Os 74 pacientes com diagnóstico de asma leve/moderada, de acordo com a classificação de GINA 2002/2003, foram divididos em dois grupos, sendo 31 do Grupo I, e 43 do Grupo II inicialmente. Foram realizadas consultas médicas e exames que incluíram espirometria, citologia de escarro induzido, NO expirado, preenchimento de escala de sintoma, questionários de qualidade de vida de asma e de SF 36, e realização de peak-flow, dependendo da Fase do protocolo. A Fase I constituiu-se dos exames pré-intervenção. Na Fase II, foram realizadas 10 sessões de Acupuntura Real no Grupo I e 10 sessões de Acupuntura Sham no Grupo II, na Fase III, houve 4 semana de washout, na Fase IV, houve a troca de técnicas de acupuntura, sendo uma sessão por semana e, na Fase V, realização dos exames. Resultados: Não há diferença nos critérios de avaliação no pré-tratamento entre dois grupos, com exceção de maior celularidade inflamatória no Grupo II. No entanto, houve uma redução significativa de eosinófilos (p = 0,035) e neutrófilos (p = 0,047), e aumento de macrófagos (p = 0,001), melhora da medida de volume do peak-flow (p = 0,01) na fase IV do Grupo II. No Grupo I, na avaliação de escala de sintomas diária, havia menor uso de medicação de resgate (p = 0,043) na Fase II, e, depois de receber a Acupuntura Sham na Fase IV, havia menos tosse (p = 0,007), menos chiado (p = 0,037), menos dispneia (p < 0,001) e menor uso de medicação de resgate (p < 0,001). No Grupo II, após receber o tratamento com a Acupuntura Sham na Fase II, houve diminuição de tosse (p = 0,037), de chiado (p = 0,013) e de dispneia (p = 0,014), e, na...
Introduction: This survey has been conducted in order to evaluate the effects of acupuncture in patients with persistent mild and moderate asthma (according to GINA criteria 2003), using beta agonist and/or inhaled glucocorticoid. Methods and patients: This is a prospective, double blinded, randomized and cross-over study with two branches: 74 patients diagnosed with mild and moderate asthma were divided into two groups: Group I with 31, initiating with real acupuncture and Group II, starting with sham acupuncture. Medical interview and laboratory tests including spirometry, induced sputum citology, exhaled NO measurement, quality of life questionnaire (SF-36 and QQL), besides, daily symptom scores and measurement of peak-flow were performed, in the beginning of the study, and in the end of each phase of treatment. Phase I: laboratory tests and other qualitative measurements. There were 10 real acupuncture weekly sessions to Group I and 10 sham acupuncture sessions to Group II in Phase II. On the other hand, in the Phase IV, there was an exchange between Group I and Group II, which was receiving real acupuncture started to receive sham, and vice-versa, the number of sessions remained the same (10 weekly sessions). Phase III, during the interval between Phase II and Phase IV, there was an interval of 4 weeks of washout. Phase V: laboratory tests and other qualitative measurements. Results: There was no difference beween both the groups in all criteria of evaluation pré treatment, with only na exception: in the Group II there was large inflammatory cell counts. However, there was a significant reduction in eosinophils (p = 0.035) and neutrophils (p = 0.047), and increase of macrophages (p = 0.001), improved peak-flow measurement in the morning (p = 0.01) in Group II (started with sham) in Phase IV. In Daily Symptons Score, there was a significant reduction in use of rescue medication (p = 0.043) in Group I (real acupuncture) in Phase II and after received...
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Humans , Male , Female , Adult , Middle Aged , Acupuncture , Acupuncture Therapy , Asthma , Asthma/immunology , Dyspnea/prevention & control , Eosinophils , Macrophages, Alveolar , Medicine, Chinese Traditional/psychology , Neutrophils , Sickness Impact Profile , Controlled Clinical Trial , Signs and Symptoms, Respiratory , Affective Symptoms/immunologyABSTRACT
Objective: To investigate the inspection mode of ethical issues for multicenter clinical trails in China, and to make analysis and give suggestions while taking into consideration of the international conventions. Methods: Representatives from 21 general hospitals and specialized hospitals from Liaoning province, Jiangsu province, Sichuan province, Guangdong province and Shanghai participated in a training course on promotion of ethical review capability; they were surveyed by anonymous questionnaire. Another 20 clinical trial agencies and ethical committees were interviewed by telephone. The questionnaires were collected and valid questionnaires were subjected to statistical analysis. Results: We found that 65.1% of the interviewees never used a central institutional review board (IRB); the main reasons included that they could not assess the quality of central IRB, they wanted to protect the subjects, they had a poor communication with the IRB, and they could not obtain a satisfactorily-localized informed consent forms. There were 34.9% of the interviewees used a central IRB, because they wanted to shorten the inspection time, avoid influence to the research progress, and to have satisfactory quality of IRB. Conclusion: Central IRB is not widely accepted. The related system needs to be further completed so as to improve the outcome of the inspection. The communication and cooperation between the central and local IRBs should be strengthened.
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Objective To prepare an influenza A(H1N1) split-virus vaccine and observe its safe-ty and effectiveness. Methods According to the process for preparing seasonal flu split-virus vaccine two batches of vaccine were prepared with the flu A (H1N1) vaccine virus strain recommended by WHO. The pilot products were tested against the requirements of flu split-virus vaccine. Results The quality of the pi-lot vaccine has been tested by National Control Laboratory and conformed to the requirements. Nine hundred and sixty volunteers received one dose of vaccine containing either 15 μg or 30 μg of hemagglutinin. The re-suits indicated the both seroconversion rate and protection rate were higher the 70%. The GMT of HIAb of the volunteers who received 1 dose of 15 μg increased significantly by 15, 39, 37 and 25 times compared to those before vaccination in the age groups of 3-11, 12-17, 18-59 and ≥60, respectively. And 26, 72, 68 and 36 times rise were found in the postvaccinated volunteers of 30 μg group. The total adverse reaction rates of 15 μg and 30 μg dose group were 29.38% and 43.75%, respectively. The grade 2 adverse reaction rates of 15 μg and 30 μg dose group were 6.25% and 15.42%, and the grade 3 adverse reaction rates of 15 μg and 30 μg dose group were 0.83% and 1.46%, respectively. No serious adverse reactions were found. Conclusion The influenza A (H1N1) split-virus vaccine prepared according to the requirements of season-al flu vaccine is safe and effective.
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Investigators' financial conflict of interest(COI)in clinical trials may compromise the well-being of subjects and the objectivity and accountability of the research results.Lots of COI policies have been made in US to deal with such issues.This paper analyzed tIle policies governing investigators' financial COIs in clinical trials at the 21 medical schools which received the largest amount of research funds from the NIH.critically reviewed the different requirements of disclosure with the principles of respects for persons,justice,and beneficence.
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A lot of clinical trials of adjuvant treatment in breast cancer have been done,among which,a number of key clinical trails have changed our clinical practice,this has lead to multi-modality treatment instead of operation alone in breast cancer treatment.These key clinical trails were reviewed and evaluated in this article.