Objective To evaluate the safety and tolerance of medicinal charcoal enteric-coated tablets in healthy volunteers. Methods A total of 44 healthy volunteers were randomly divided into 6 single-dose groups (0.5 g, 2 g, 4 g, 6 g, 8 g and 10 g) and a multiple-dose group (3 g, 3 times a day, for 14 days). The safety profile and tolerance were evaluated by observing symptoms, vital signs, and laboratory tests. Results No serious adverse event was reported for any volunteer. Abdominal distension occurred in 2 volunteers in the 4 g dose group and the 6 g dose group. One volunteer in the 8 g dose group experienced nausea and vomiting. Transient decrease in white blood cell count was observed in one volunteer in the 10 g dose group. Abdominal distension occurred in 2 volunteers of the multiple-dose group. Conclusion Based on our findings, the maximum tolerated dose of medicinal charcoal enteric-coated tablets in Chinese healthy volunteers is 10 g. The recommended dose for subsequent clinical trials is 3 g, 3 times a day.
药物上市前须经过人体试验，参与药物临床试验的受试者将承担不同程度的风险，我国GCP明确规定要充分保障受试者的权益，伦理委员会和知情同意书是保障受试者权益的主要措施，但在实际中仍存在不少问题。为此，如何切实保障受试者的权益，是临床试验所要解决的一个重要问题。
ObjectiveIn order to improve the prevention and treatment of bronchial asthma, the prevalence and risk factors of asthma in Chengdu among residents over 14 years old were investigated.MethodsA cross-sectional survey was conducted in Chengdu. The inhabitants (age > 14 years) recruited in this household questionnaire survey were through multi-stage cluster random sampling. Univariate and multivariate logistic regression were used to analyze the risk factors of asthma.ResultsA total of 3 477 subjects were finally recruited in this study. Of them, 131 were asthmatic patients; and the prevalence rate was 3.8%. There were significant differences observed in the prevalence of asthma among people of different ages, residences, occupations and educational levels (χ2=191.084, P<0.05; χ2=9.114, P<0.05; χ2=114.268, P<0.05; χ2=62.123, P<0.05). Univariate regression analysis showed that the risk factors of asthma included five factors (measles, chickenpox, pneumonia, tracheobronchitis and intestinal parasitic diseases) related to childhood illness, and two factors (asthma and chronic bronchitis) related to the first-degree relatives (P<0.05). In addition, active smoking history was a risk factor for asthma in men (P<0.05). Multivariate logistic regression indicated that measles, pneumonia, tracheobronchitis, intestinal parasitic diseases in childhood and first-degree relatives suffering from asthma were independent risk factors for asthma.ConclusionsThis study describes the epidemiological characteristics of asthma in Chengdu among adolescents (age>14 years) and adults. The history of measles, pneumonia, tracheobronchitis, and intestinal parasitic diseases in childhood, and first-degree relatives suffering from asthma are the independent risk factors for asthma. In addition, active smoking history is a risk factor for asthma in men.
Objective To evaluate the clinical efficacy and safety of pazufloxacin for the treatment of moderate and severe acute bacterial respiratory infections.Methods A multicenter randomized controlled trial was conducted to compare the efficacy and safety of pazufloxacin versus levofloxacin. Patients in the pazufloxacin group were treated with pazufloxacin (500 mg twice daily for 7 to 10 days), and patients in the levofloxacin group were treated with levofloxacin (300 mg twice daily for 7 to 10 days). Results A total of 134 patients were enrolled in the study, 68 cases in pazufloxacin group and 66 cases in levofloxacin group were assessable for clinical efficacy by full analysis set(FAS). At the end of the treatment, in FAS analysis the total cure rates and effective rates were 52.9% and 86.7% in pazufloxacin group, 57.6% and 87.9% in levofloxacin group, in PPS analysis the total cure rats and effective rates were 57.1% and 93.7% in pazufloxacin group respectively, 61.3% and 93.6% in levofloxacin group. The bacterial clearance rates were 92.5% and 94.3% respectively. There were no statistically significant differences between the two groups. Adverse reactions were observed in 16.2% of patients in the pazufloxacin group and in 16.7% of patients in the levofloxacin group. These reactions were mainly local stimulation, nausea and diarrhea. No serious adverse event was reported in either group. Conclusion Pazufloxacin is as effective and safe as levofloxacin for the treatment of moderate to severe acute respiratory infections.
目的 评价LB-SDS2.0型酸性氧化电位水生成机生成的酸性氧化电位水对皮肤（手）消毒的有效性和安全性。 方法 2006年2月－8月将90例健康志愿受试者随机分为3组，各组30例。A组用LB-SDS2.0型酸性氧化电位水生成机生成的酸性氧化电位水（试验产品）消毒2 min，B组用试验产品消毒4 min，C组（对照组）用聚维酮碘溶液擦拭3 min。检测消毒后菌落总数和致病菌，以及受试者不良反应情况。 结果 按照Ⅲ类区域工作人员洗手消毒标准，A、C组合格率均为100%，B组为96.7%；按照Ⅰ、Ⅱ类区域工作人员洗手消毒标准，A组合格率为86.7%；B组合格率为93.3%，C组合格率为100%。各组受试者试验后生命体征均无临床意义的改变，未出现任何不良反应。 结论 试验产品消毒手是安全有效的，可推荐用在Ⅲ类区域工作人员中使用，并进一步观察其安全性和有效性。建议扩大样本含量进一步评价其试验产品是否适用于Ⅰ、Ⅱ类区域工作人员洗手消毒。
Objective To assess the tolerability and safety of Yinhuang injection in Chinese healthy volunteers. Methods Thirty-two healthy subjects were enrolled in the single-dose study. Each subject was administered one of the seven doses of 40, 120, 240, 320, 400, 480, and 560 mg, respectively, by intravenous injection. The sample sizes were 2, 4, 6, 6, 6, 4 and 4, respectively, for each dose group. Twelve healthy subjects were enrolled in the multi-dose study. The subjects in the lower dose group were administered 240 mg and the subjects in the higher dose group were administered 400 mg Yinhuang by intravenous injection once a day for consecutive 7 days. The sample sizes for both groups were 6. The safety was evaluated based on clinical symptoms, vital signs, physical examinations, electrocardiogram (ECG), laboratory tests and adverse events. All analyses were performed by using the software package SAS version 9.1. T-test and analysis of variance were used for continuous variables. Chi-square test and Fisher’s exact test were used for categorical variables.Results A total of 44 healthy volunteers completed the tolerance test. No serious adverse event and clinically significant changes in vital signs, ECG and laboratory tests were found in both single-dose groups and multi-dose groups. Among two mild adverse events, dizziness occurred in one subject in 480 mg dose group in the single-dose trial, which was probably related to the experimental drug. Conclusion Yinhuang injection is safe and well-tolerated in Chinese healthy subjects after administration of single-doses (40-560 mg) and multi-doses (240-400 mg once a day for consecutive 7 days). The maximum-tolerated dose of Yinhuang injection is at 560 mg in the single-dose trial. The dose regimen of 240-400 mg a day is recommended for phase II study.
【摘要】 目的 评价麻敏维C缓释胶囊（每粒含盐酸伪麻黄碱90 mg和马来酸氯苯那敏4 mg）在人体的生物等效性。 方法 于2006年6月采用随机交叉自身前后对照试验设计，26例受试者分别单次和多次空腹口服麻敏维C缓释胶囊（试验制剂）和复方盐酸伪麻黄碱缓释胶囊（参比制剂），与不同时间点取血样，采用液-质联用（HPLC/MS）法测定人血浆中盐酸伪麻黄碱和马来酸氯苯那敏的浓度，以DAS软件计算药物代谢动力学参数，并进行生物等效性评价。 结果 单次给药后，两组分的主要药物代谢动力学参数无统计学意义（Pgt;0.05）。试验制剂中马来酸氯苯那敏和盐酸伪麻黄碱生物利用度分别为104.31%和109.19%。多次给药后，两组分的主要药物代谢动力学参数无统计学意义（Pgt;0.05）。试验制剂的马来酸氯苯那敏和盐酸伪麻黄碱的生物利用度分别为103.58%和99.37%。 结论 麻敏维C缓释胶囊和复方盐酸伪麻黄碱缓释胶囊具有生物等效性。【Abstract】 Objective To investigate the bioequivalence of delayed-release capsule of ephedrine-chlorphenamine-vitamin C. Methods In June 2006, 26 healthy volunteers were administrated with delayed-release capsule of ephedrine-chlorphenamine-vitamin C or delayed-release capsule of ephedrine-chlorphenamine in a randomized and two-way crossover design with single or multiple dosage. The plasma concentrations were determined by HPLC/MS method. The pharmacokinetic parameters and bioequivalence were calculated by DAS software. Results After single dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 104.31% in chlorphenamine and 109.19% in ephedrine, respectively. After multiple dose administration, no significant differences were found in tmax, Cmax, t1/2, and AUC0-t between the two preparations. The relative bioavailability of the test preparation was 103.58% in chlorphenamine and 99.37% in ephedrine, respectively. Conclusion Delayed-release capsule of ephedrine-chlophenamine-vitamin C is equivalent to the reference preparation.