Evaluation of the safety of a non-animal stabilized hyaluronic acid (NASHA – Q-Medical, Sweden) in European countries: a retrospective study from 1997 to 2001

BACKGROUND: In Europe, several filler devices are currently on the market for use in aesthetic dermatology and some of them cause severe, permanent, adverse reactions. Since 1996 a non-animal stabilized hyaluronic acid (NASHA) from Q-Medical, Sweden, has been introduced and is becoming a leading product in aesthetic dermatology. Hyaluronic acid has no species specificity and skin testing is not recommended before treatment. OBJECTIVE: Our purpose was to evaluate the incidence of adverse reactions from 1997 to 2001 and the safety of NASHA after injections into the skin for aesthetic reasons. METHOD: Surveys were sent to physicians in European countries that agreed to participate. This is a retrospective study. A total of 12 344 syringes were sold by the Q-Medical to these physicians and we evaluated the total number of patients treated to 35% of this number (4320). We separated immediate hypersensitivity reactions from delayed reactions and analysed infectious and other types of reactions. RESULTS: From 1997 until 2001, 34 cases of hypersensitivity were reported: 16 cases of immediate hypersensitivity and 18 cases of delayed. The global risk of sensitivity is 0.8%. Since 2000, the amount of protein in the raw product has decreased and the incidence of hypersensitivity reactions is around 0.6%. As 50% of these reactions are immediate and resolved within less than 3 weeks, the risk of strong but transient, delayed reaction is around 0.3%. Four cases of abscess were reported. They were all sterile. No bacterial infection was found. Herpetic recurrence is possible after lip augmentation according to the technique of injection. No systemic reactions were reported. CONCLUSION: NASHA is a very useful and safe filler product. Skin testing does not seem to be necessary.     

持续靶控输注异丙酚复合硬膜外麻醉用于上腹部手术探讨

目的:评价持续靶控输注异丙酚复合硬膜外阻滞有用于上腹部手术的可行性。方法:30例胃癌手术患者,ASAⅠ～Ⅱ级。随机分成靶控输注异丙酚全麻(T)组15例,靶控异丙酚复合硬膜外阻滞(T+E)组15例。结果:(T+E)组术后躁动、芬太尼、丙泊酚的用量低于(T)组(P<0.05)。异丙酚单位标准化剂量亦较低。两组苏醒时间相似。诱导后两组血压均显著下降(P<0.05),T+E组在诱导后DBP的下降幅度较T组更为显著(P<0.05),T组在探查、术毕、拨管后的SBP、DBP、MAP比(T+E)组显著增高(P<0.05)。两组诱导后至术毕BIS、SEF显著下降,两组间的比较无统计学意义(P>0.05)。结论:靶控输注异丙酚复合硬膜外阻滞用于上腹部手术是可行的,具有异丙酚、芬太尼的用量少、苏醒快、术后躁动少,麻醉深度易于调控,血液动力学较稳定,是一种良好的麻醉方式。     

止咳枇杷冲剂中枇杷叶和桔梗的薄层色谱鉴别研究

研究止咳枇杷冲剂中枇杷叶和桔梗的薄层色谱鉴别方法。分别取枇杷叶和桔梗药材，制剂及阴性制剂的醋酸乙酯提取液，在硅胶板上前者以ψ（氯仿：甲醇：水）=2：2.25:1.5展开，后者以ψ（正已烷：氯仿：甲醇）=5：4：0.3展开，磷钼酸乙醇溶液显色，在两者供试吕色谱中与各自对照药材色谱相应位置上，分别有相同的蓝绿色特征斑点；阴性制剂色谱图中无此斑点，因此该方法可作为这两味中药的鉴别方法。     

儿科住院病人药物不良反应监测

通过4家医院儿科病人为期1年的药物不良反应协作监测，对1856例住院病人的药物不良反应进行前瞻性观察。发现107例发生了药物不良反应，发生率为5．8％。其中A型反应79例（73．8％），B型28例（26．2％）。药物不良反应致停药者48例，需处理者31例，致死者1例。因药物不良反应致住院者27例、不良反应发生率与庄院时间，共用药物数量，疾病构成有关。小儿某些生理特征对药物不良反应发生有显著影响。     

临床输液监控系统的设计

本文针对临床输液过程中出现的漏、停、输液速度改变等各种问题，讨论了一由单台微机和多个单片机通讯实现的多床输液自动监控、自动反应、自动报答系统的可行性，并给出了主要部分的硬件、软件设计方法。     

Frequency of adverse reactions to radiopharmaceuticals in Europe

A prospective survey was performed in 17 nuclear medicine departments during 1996 in an attempt to provide reliable data on the prevalence of adverse reactions to radiopharmaceuticals. All adverse events following radiopharmaceutical administration were recorded, irrespective of the severity or likelihood of causality, and subsequently analysed using an algorithm developed by Silberstein et al., designed to establish a cause-effect relationship. A prevalence of 11 events per 105 administrations was obtained (95% confidence limits 3.3–19.2). No serious of life-threatening events were reported. This rate is slightly higher than that obtained in a larger scale study in the United States (2.3 events per 105 administrations, 95% confidence limits 1.2–3.4). The difference may be due to the decision to include or exclude vasovagal events from the analysis, the way in which the algorithm was used and the comparative size and time scale of the two studies. The prevalence of adverse reactions is approximately 1000-fold than less that occurring with iodinated contrast media and drugs.     

Comparative study of TRUE Test and Finn Chamber patch test techniques in Singapore

This is a report on a comparative study of the reactivity of TRUE Test and Finn Chamber patch test techniques. 413 patients attending a contact dermatitis clinic in Singapore were simultaneously patch tested with panels 1 and 2 of the TRUE Test standard series and with corresponding allergens (Hermal, Hamburg) using Finn Chambers. The left/right application of the TRUE Test and Finn Chambers was randomized. The concordance of positive patch test reactions to the 2 test techniques was studied. The number of patient with positive reactions was 38% and 42% for TRUE Test and Finn Chamber techniques, respectively (n.s.). The overall concordance of positive patch test reactions was 64% (209/328). 13% (42/328) of positive reactions appeared on TRUE Test only and 24% (77/328) on Finn Chamber only. When only relevant positive reactions were considered, the concordance rate was 67%; 11.6% of positive reactions appeared on TRUE Test only and 21% on Finn Chamber only. Positive reactions to p-phenylenediamine (PPD) and neomycin were more frequent with the Finn Chamber technique than with TRUE Test, i.e., false negative reactions to PPD and neomycin were more likely to occur with TRUE Test. It appeared that the TRUE Test and Finn Chamber techniques were comparable when used for patch testing. However false negative and false positive patch test reactions can occur when using either technique.     

Immunological and respiratory reactions in workers exposed to organic dusts

The relationship of skin reactivity and serum immunoglobulin E (IgE) levels to the prevalence of chronic respiratory symptoms and to ventilatory capacity is examined in workers exposed to different organic aerosols. The results from group of control workers similarly tested are also presented. Workers exposed to occupational allergens had positive skin tests more frequently than did controls, except for soy bean workers. Workers with positive skin tests to occupational allergens had a higher prevalence of almost all symptoms than those with negative skin tests although the differences did not always reach statistical significance. Workers with positive skin reactions in general had significantly higher serum IgE levels than did workers with negative skin reactions. There were across-shift reductions of ventilatory capacity in all groups of exposed workers, varying for forced vital capacity from 1.7% to 13.3%, for forced expiratory volume from 0.4%–21.9%, for maximum flow rates at 50% from 1.5% to 16.1% and for maximum flow rates at the last 25% of control vital capacity from 0% to 24.9%. There was, however, no correlation between acute and chronic lung function changes and skin reactivity or IgE values. Our data suggest that although exposure to organic aerosols may be associated with frequent immunologic reactions, these findings do not predict objective respiratory impairment.The research was supported in part by grant no. JBP 733 from the National Institutes of Health, Bethesda, Md., USA, and by grant no. RO1 OHO-2593-04 from the National Institutes of Occupational Safety and Health, Centers for Disease Control, Atlanta, Ga., USA     

A new synthesis of Rink's polymer, 4-(2′,4′-dimethoxyphenylhydroxymethyl) phenoxymethylpolystyrene

For solid-phase peptide synthesis, 2, 4-dimethoxy-4′ -hydroxybenzhydrol linker was prepared via lithium borohydride reduction of 2, 4-dimethoxy-4′-hydroxybenzophenone. The potassium salt of the linker was coupled to chloromethylpolystyrene. This method proved to be better than use of the cesium salt. This new synthesis gave a polymer with appropriate structure and a good degree of substitution.