两种清洗消毒方法对消化内镜清洗消毒效果的比较

目的比较使用全自动清洗消毒机和传统手工清洗消毒方法对消化内镜清洗消毒效果的影响。方法收集某院消化内镜中心的109条消化内镜,根据编号分为试验组和对照组,试验组采用全自动清洗消毒机进行清洗消毒,对照组采用传统手工清洗消毒方法,对两组内镜不同部位进行采样。采用目测法结合ATP生物荧光检测法检测内镜的清洗质量,采用倾注培养法检测内镜的染菌量。比较两组内镜的清洗、消毒合格率。结果试验组共55条内镜,对照组共54条内镜。试验组内镜清洗总合格率为94.55%,对照组内镜清洗总合格率为83.33%,两组比较差异无统计学意义(P0.05)。其中试验组内镜阀门的清洗合格率高于对照组(96.36%vs85.19%),差异有统计学意义(P0.05),而内镜表面、内镜管腔清洗合格率比较,差异均无统计学意义(均P0.05)。试验组内镜消毒总合格率为96.36%,对照组内镜消毒总合格率为85.19%,两组比较差异有统计学意义(P0.05)。试验组内镜管腔消毒合格率高于对照组(96.36%vs 85.19%),差异有统计学意义(P0.05),而两组内镜表面、阀门两个部位的消毒合格率比较,差异均无统计学意义(均P0.05)。结论全自动清洗消毒机对于消化内镜的清洗消毒效果要优于传统的手工清洗消毒。如采用传统的手工清洗消毒内镜,则需要严格执行软式内镜的清洗消毒规范,最大限度地降低内镜诊治发生交叉感染的风险。     

Developing an effective procedure for cleaning and disinfecting G.I. flexible endoscopes

The field of flexible endoscopy continues to grow at an accelerated pace. The procedures are more aggressive, the patients are sicker, the accessory instruments are more numerous, the infection control issues are more complex and the medicated patient requires more intense observation. Developing in-hospital processing procedures that are logical and supported by a rationale that includes testing is necessary in the absence of coherent, complete recommendations from flexible endoscope manufacturers. These procedures will have the highest probability of compliance and will also have the highest probability of achieving a safe product for patient use.     

Comparison of the cleaning and disinfecting efficacy of four washer-disinfectors for flexible endoscopes

Four washer-disinfectors (AdaptaScope, ETD-2Plus, Innova-E3, LS-2000) were compared. The cleaning and process efficacies of the washer-disinfectors were determined by visible examination and by microbial reduction factor (RF) using the German test method (EN ISO/TS 15883-5). Test pieces were contaminated with blood and Enterococcus faecium. Three cleaners (Cidezyme GI, ETD Cleaner, Liquid 52) and three disinfectants (Cidex OPA-C, ETD Disinfectant, Liquid 44) were used. The cleaning efficacy was also tested with water alone. Effectiveness of Cidezyme GI in the AdaptaScope was determined with an RF of 7.0, in the LS-2000 with an RF of 8.4; Liquid 52 obtained in the LS-2000 an RF of 7.0. The cleaning efficacies with water for the AdaptaScope (RF 2.1) and the LS-2000 (RF 1.2) were significantly different. Microbiological effectiveness of overall processes obtained in the AdaptaScope with Cidezyme GI/Cidex OPA-C (RF 8.4) and in the LS-2000 with Liquid 52/Liquid 44 (RF 9.2) were also significantly different. The test pieces remained contaminated at the end of overall processes in the Innova-E3 and an RF could not be established. In the ETD-2Plus the RFs after the total processes were low (3.7-7.5 and 1.8). The AdaptaScope and LS-2000 consistently produced a microbial reduction, although differences in the efficacy of the overall processes were observed. Processing endoscopes with artificially blocked channels in the AdaptaScope and LS-2000 incurred error messages and the processes stopped whereas the ETD-2Plus and Innova-E3 did not display error messages.     

多酶预处理对消化内镜清洗消毒效果的观察

目的 观察使用多酶预处理后的消化内镜清洗消毒效果.方法 对使用后的消化内镜160条随机分为观察组(多酶组)、对照组(水洗组)各80条,在常规清洗和消毒前分别用多酶液、自来水进行预处理,比较两组内镜的清洁度、喷嘴堵塞、消毒合格率和刷洗时间,以评价清洗消毒效果.结果 两组内镜消毒合格率均100.0％,多酶组内镜表面清洁度及喷嘴堵塞评分、刷洗时间等均优于水洗组.结论 多酶用于消化内镜预处理有效提高了内镜清洗效果,值得临床推广.     

Evaluation of the vaccine efficacy of three digestive protease antigens from Dermanyssus gallinae using an in vivo rearing system

The poultry red mite (PRM), Dermanyssus gallinae, is a hematophagous ectoparasite considered as the major pest in the egg-laying industry. Vaccination is feasible strategy for controlling the haematophagous PRMs. Cathepsin D (CatD), cathepsin L (CatL) and legumain (Lgm) are three endopeptidases participating in digestion of hemoglobin in ticks. The in vitro test and the on-hen feeding device have been used to evaluate the efficacy of vaccines against D. gallinae, however they lacked some of the natural feeding cues for mites, resulting in unreliable results. In the present study, a reliable in vivo rearing system which was nearly close to the natural infestation status of mites was applied to evaluate the efficacy of vaccines against D. gallinae. After vaccinations with rDg-CatD-1, rDg-CatL-1 or rDg-Lgm, chicks developed the antigen-specific IgY immune response to each antigen. The survival rates of D. gallinae in three groups decreased significantly after they fed on the immunized birds. And the oviposition rate and fecundity were significantly reduced by 13.18% and 49.90% in the rDg-CatD-1 immunized group, 5.49% and 38.55% in the rDg-CatL-1 immunized group, respectively. Moreover, immunization with rDg-CatD-1 or rDg-CatL-1 significantly decreased the blood digestion rate of D. gallinae. However, no statistically significant effects on reproduction performance and blood digestion rate of mite were observed in group immunized with rDg-Lgm. Our results demonstrated that immunization with rDg-CatD-1 or rDg-CatL-1 could prevent and control D. gallinae by reducing the survival, reproductive capacity and blood digestion of mite. Importantly, the evaluation system based on the in vivo rearing system was reliable and practical, and it can accurately evaluate the effects of immunization on D. gallinae for pre-screening of potential novel antigens.     

Cleaning efficacy of nine different cleaners in a washer-disinfector designed for flexible endoscopes

Studies on processing endoscopes usually involve the combined cleaning and disinfecting activity. We compared nine cleaning agents designed for automatic processing for cleaning efficacy alone using soft and hard water as controls in 12 different processes in a washer-disinfector. Experiments were performed according to the German Endoscopy Working Group recommendations using transparent Teflon tubes (internal diameter 2mm, length 2m) as test pieces. For each test three pieces contaminated with a blood/test soil containing Enterococcus faecium were used; two for the test and one as a control; each test was repeated three times. Tests were run according to the manufacturer's instructions. Test pieces were assessed visually and microbiologically [log(10) reduction factors (RF) vs. untreated controls]. Soft water alone gave poor visible cleanliness and an RF of 0.3 (SD 0.2), while hard water produced adequate visible cleanliness and an RF of 1.2 (SD 1.0). Five processes gave better visible cleanliness than soft water, but only three were better than hard water. Six processes were worse than soft water and five worse than hard water. Nine processes gave a better microbiological reduction factor than soft water, but the difference was only statistically significant in three. Only one process yielded a significantly higher RF than hard water; three were significantly worse. None of the cleaning processes reached the RF of 4 specified in the US regulations. This study confirms the variability of cleaning processes to dissolve blood residues and reduce the bioburden. We do not recommend abandoning cleaning agents, but suggest that further research is needed to clarify the relationships between washer-disinfectors, cleaning agents, and cleaning performance.     

Estimating vaccine efficacy using auxiliary outcome data and a small validation sample

In vaccine studies, a specific diagnosis of a suspected case by culture or serology of the infectious agent is expensive and difficult. Implementing validation sets in the study is less expensive and is easier to carry out. In studies using validation sets, the non-specific or auxiliary outcome is measured on each participant while the specific outcome is measured only for a small proportion of the participants. Vaccine efficacy, defined as one minus some measure of relative risk, could be severely attenuated if based only on the auxiliary outcome. Applying missing data analysis techniques could thus correct the bias while maintaining statistical efficiency. However, when the sample size in the validation sets is small and the vaccine is highly efficacious, all specific outcomes are likely to be negative in the validation set in the vaccinated group. Two commonly used missing data analysis methods, the mean score method and multiple imputation, depend on the ad hoc continuity correction when none of the specific outcomes are positive and the normality or log-normality assumption of relative risk, which may not hold when the relative risk is highly skewed, to estimate the confidence interval. In this paper, we propose a Bayesian method to estimate vaccine efficacy and its highest probability density (HPD) credible set using Monte Carlo (MC) methods when using auxiliary outcome data and a small validation sample. Comparing the performance of these approaches using data from a field study of influenza vaccine and simulations, we recommend to use the Bayesian method in this situation.     

滤膜法与倾注法两种方法检测内镜消毒效果的结果比较

目的比较滤膜法与倾注法检测内镜的消毒效果。方法选择某院所有科室的全部内镜,采用滤膜法与倾注法对内镜的消毒效果进行检测和评价。结果共采集消毒后内镜192条,其中滤膜法与倾注法各检测96条,按消毒后内镜检出菌落数0、1~10、11~20、21~300、300 CFU/件进行分组,经秩和检验结果显示,鼻咽镜、支气管镜、胃镜和肠镜倾注法和滤膜法检测内镜消毒后菌落数分布,差异均有统计学意义(均P0.05),滤膜法检出的菌落数高于倾注法。倾注法检测内镜消毒效果合格率为91.67%,滤膜法为88.54%,两种方法的合格率比较,差异无统计学意义(χ~2=0.53,P=0.630)。结论滤膜法比倾注法更能检出消毒后内镜残留细菌菌落数,值得推广。     

Nosocomial transmission of imipenem-resistant Pseudomonas aeruginosa following bronchoscopy associated with improper connection to the Steris System 1 processor.

OBJECTIVE: To assess nosocomial transmission of imipenem-resistant Pseudomonas aeruginosa (IRPA) following bronchoscopy during August through October 1998. DESIGN: Traditional and molecular epidemiological investigation of a case series. SETTING: University-affiliated community hospital. PATIENTS: 18 patients with IRPA bronchial-wash isolates. INTERVENTIONS: We reviewed clinical data, performed environmental cultures and molecular analysis of all IRPA isolates, and observed disinfection of bronchoscopes. RESULTS: Of 18 patients who had IRPA isolated from bronchoscopic or postbronchoscopic specimens, 13 underwent bronchoscopy for possible malignancy or undiagnosed pulmonary infiltrates. Following bronchoscopy, 3 patients continued to have IRPA isolated from sputum and demonstrated clinical evidence of infection requiring specific antimicrobial therapy. The remaining 15 patients had no further IRPA isolated and remained clinically well 3 months following bronchoscopy. Pulsed-field gel electrophoresis revealed that all strains except one were >95% related. STERIS SYSTEM 1 had been implemented in July 1998 as an automatic endoscope reprocessor (AER) for all endoscopes and bronchoscopes. Inspection of bronchoscope sterilization cycles revealed incorrect connectors joining the bronchoscope suction channel to the STERIS SYSTEM 1 processor, obstructing peracetic acid flow through the bronchoscope lumen. No malfunction warning was received, and spore strips remained negative. CONCLUSIONS: The similarity of diverse connectors and limited training by the manufacturer regarding AER for bronchoscopes were the two factors responsible for the outbreak. Appropriate connections were implemented, and there was no further bronchoscope contamination. We suggest active surveillance of all bronchoscopy specimen cultures, standardization of connectors of various scopes and automated processors, and systematic education of staff by manufacturers with periodic on-site observation.     

山东省17所医院消化内镜清洗消毒效果调查与分析

目的通过调查山东省不同级别医院消化内镜清洗消毒效果,分析存在的问题并提出改进建议。方法根据《内镜清洗消毒技术操作规范》(2004年版)要求,制定调查方案,对不同级别的17所医院进行现场查看和问卷调查并对使用清洗消毒后的消化内镜进行抽样检测。结果 17所医院消化内镜清洗消毒管理基本符合要求,其中3所二级医院未设置独立洗消间,4所医院清洗消毒流程不规范;抽样检测20条电子胃镜、14条电子肠镜清洗消毒效果,三级及二级医院内镜外表面合格率分别为95.0%、71.4%,内镜活检管道道合格率为80.0%、57.1%,送气送水管道合格率75.0%、71.4%;共检出30株病原体,主要来自活检道及送气送水道,分别占33.3%、26.6%;病原体检出首位的为大肠埃希菌,占36.7%。结论山东省医院消化内镜消毒灭菌比较规范,仍需进一步加大培训管理力度,提升综合管理水平。     

Comparison of the microbicidal efficacy on germ carriers of several tertiary amine compounds with ortho-phthalaldehyde and Perasafe

Several tertiary amine formulations have been marketed as high-level disinfectants (HLDs). This study compared some of these formulations with two accepted HLDs [ortho-phthalaldehyde (OPA) and Perasafe] by determining the bactericidal effect on 52 micro-organisms using a metallic germ carrier, determining the sporicidal effect using a commercial germ carrier (3M spores), and performing a corrosion test on surgical blades with human blood. OPA and Perasafe were significantly more effective than all the tertiary amines tested, and acted within a contact time of 10 min compared with 20 min for the other products. For Gram-negative micro-organisms, Instrunet FA showed no significant differences at 20 min compared with OPA and Perasafe at 10 min. The amines tested did not differ significantly in global bactericidal efficacy. Unlike the tertiary amines, OPA and Perasafe were effective against mycobacteria (15-min contact period), but were not sporicidal. All agents (except one tertiary amine) passed the corrosion test. In conclusion, OPA and Perasafe can be considered as HLDs. However, 15-20 min of contact is required and both products have disadvantages.     

Intralaboratory reproducibility of the German test method of prEN ISO 15883-1 for determination of the cleaning efficacy of washer-disinfectors for flexible endoscopes

In Europe, the evaluation of processing flexible endoscopes in washer-disinfectors (WDs) is performed in accordance with prEN ISO 15883-1, which includes determination of cleaning efficacy. Recent data suggest that large differences are found between cleaning processes when the prEN ISO 15883-1 German test model is applied. Therefore, we analysed 12 separate cleaning processes, and each was assessed by determining the means of three experiments. Transparent test tubes used as test pieces (length 2m, lumen 2mm) were contaminated with a mixture of blood and Enterococcus faecium. The WD used was set to perform the cleaning process alone, which consists of three stages (pre-rinse, cleaning, intermediate rinse). Instead of a cleaning agent, demineralized water was used in all three stages of the cleaning process. The mean bacterial load was 10(11.3)cfu/mL (N=12) in the suspensions of test organism, 10(9.1)cfu/mL (N=12) in the test soils and 10(5.8)cfu/mL (N=12) in the controls (recovery). Mean log(10) reduction factors (RF) for each process, i.e. the difference in microbial loads between the control and the processed tubes, were calculated. The 12 cleaning processes with demineralized water led to a mean RF of 2.2 (range: 1.6-3.2) and excellent visible cleanliness of the test pieces. We found that the prEN ISO 15883-1 German test method leads to reproducible and valid results, and is suitable for determining the cleaning efficacy in WDs.     

Methotrexate and misoprostol for early abortion: A multicenter trial. I. Safety and efficacy

A prospective trial was conducted including 300 pregant women seeking elective abortion to evaluate the safety and efficacy of methotrexate and misoprostol for abortion at ≤56 days gestation. Subjects received methotrexate 50 mg/m² intramuscularly followed 7 days later by misoprostol 800 μg vaginally. The misoprostol dose was repeated the next day if the abortion did not occur. Outcome measures included successful abortion (complete abortion without requiring a surgical procedure), duration of vaginal bleeding, and side effects. Complete abortion occurred in 263/300 (87.7%, 95% CI 83.4, 91.2%) patients. The complete abortion rate was higher for early gestations: 183/202 (90.6%, 95% CI 85.7, 94.2%) at ≤49 days gestation, and 80/98 (81.6%, 95% CI 72.5, 88.7%) from 50–56 days gestation (p=0.038). Abortion occurred in the 24 hours following the initial or repeat misoprostol dose (immediate success) in 65.0%; the remaining 22.7% of women who aborted did so after a delay of 23.6 ± 9.1 (mean ± standard deviation) days. Vaginal bleeding lasted 14 ± 7 days and 11 ± 9 days in immediate success and delayed success patients, respectively. Overall, 69.7%, 87.7%, and 91.7% of patients had passed the pregnancy by 14, 28, and 35 days, respectively, after receiving methotrexate. Methotrexate and misoprostol side effects were minimal. This treatment regimen offers an alternative to surgical abortion or the use of antiprogestins and prostaglandin for medical abortion.     

金蒲胶囊对消化系统肿瘤术后放、化疗作用的临床观察

目的:观察金蒲胶囊对消化系统肿瘤术后放、化疗患者的辅助治疗作用。方法:我院1998～2002年收治的48例消化系统肿瘤术后患者,随机分成两组:采用金蒲胶囊配合放、化疗作为治疗组(28例),未采用金蒲胶囊的为对照组(20例),6周后对两组有关指标进行比较。结果:采用金蒲胶囊组与对照组在对患者的生活质量和白细胞的变化用药组均优于对照组(P<0.05)。结论:对消化系统肿瘤术后患者在放、化疗的同时辅以金蒲胶囊有改善病人的精神状态、提高耐受性及减轻负作用的作用。     

幼儿园灭鼠方法探讨及效果评价

2004年“五一”之前,军区某机关幼儿园鼠类活动日益猖獗,上级要求在短时间内控制鼠害,考虑到幼儿园儿童的安全,我们选择合适时机,在环境治理的基础上,将急性鼠药磷化锌和慢性鼠药大隆结合使用,并在鼠密度下降后,在鼠害重点场所,修建防鼠设施,巩固灭鼠成效,取得了满意效果。