“医”与“法”

2003年8月中,惠氏百宫制药有限公司邀请广东地区各大医院的专家和医院管理人员在广东东莞举行了一场别开生面的研讨会。会议包括两个议题:一是“特治星治疗严重呼吸道感染”的学术研讨;二是“医疗纠纷处理的新规则与新思路”的研讨。会上“热点”不断,台上、台下观点撞击精彩纷呈,这里我们摘录片段与大家共享。     

Laboratory Verification of "heavy" and "light" users of cannabis

For various experimental studies it is often desirable to classify categories of cannabis use. For instance, in a study of the kinetics of δ-9-tetrahydrocannabinol (THC) in man, we wanted to see if there were differences between “heavy” and “light” users of the drug. “Heavy” use was defined as once daily or more, while “light” use was defined as sporadic or occasional, no more frequent than once monthly.Previously, we had found that the 11-oic acid of THC was not only the major metabolite to appear in the urine but also that its appearance in urine was prompt and lasted for at least 72 hours after a single exposure [1]. We decided to use the presence of this material in urine as a marker for heavy and light use; one would expect to find it regularly in heavy users and rarely, if at all, among light users. All subjects entering the study declared their pattern of use and then were asked to provide a spontaneously voided urine, to be used for analysis of THC-11-oic acid.     

以"豆"祛"痘"

虽然早已过了青春期,但我那略显"婴儿肥"的脸上还是会不时地出现些小痘痘.为了消除这些可恶的家伙,我还真是没少折腾,又是吃药、吃保健品,又是用化妆品,可痘痘却大有"野火烧不尽,春风吹又生"之势,看来要消灭它们可不是件容易的事.     

Activity of "reversed" diamidines against Trypanosoma cruzi "in vitro"

Chagas' disease is an important parasitic illness caused by the flagellated protozoan Trypanosoma cruzi. The disease affects nearly 17 million individuals in endemic areas of Latin America and the current chemotherapy is quite unsatisfactory based on nitroheterocyclic agents (nifurtimox and benznidazol). The need for new compounds with different modes of action is clear. Due to the broad-spectrum antimicrobial activity of the aromatic dicationic compounds, this study focused on the activity of four such diamidines (DB811, DB889, DB786, DB702) and a closely related diguanidine (DB711) against bloodstream trypomastigotes as well as intracellular amastigotes of T. cruzi in vitro. Additional studies were also conducted to access the toxicity of the compounds against mammalian cells in vitro. Our data show that the four diamidines compounds presented early and high anti-parasitic activity (IC50 in low-micromolecular range) exhibiting trypanocidal dose-dependent effects against both trypomastigote and amastigote forms of T. cruzi 2h after drug treatment. Most of the diamidines compounds (except the DB702) exerted high anti-parasitic activity and low toxicity to the mammalian cells. Our results show the activity of reversed diamidines against T. cruzi and suggested that the compounds merit in vivo studies.     

"Sick" or "hooked": smokers' perceptions of their addiction

A postal questionnaire was completed by 233 smokers who had contacted a television company for help with stopping smoking. Subjects recorded how well each of 20 statements described their feelings about their own smoking. These responses were submitted to a principal components analysis which revealed two interpretable factors. The first ('Sick') reflected a tendency to see smoking as a sickness, and a greater concern over health consequences. The second ('Hooked') reflected a feeling of inability to give up smoking, and a resentment at other's attempts at dissuasion. Subjects with higher 'Sick' factor scores perceived greater potential benefit in their stopping (in terms of a reduction of risk of cancer). Higher 'Hooked' factor scores were given by females, older smokers, those who described themselves as more extremely addicted, and those who saw less benefit for themselves in stopping.     

"Central" and "peripheral" benzodiazepines and kinetics of lindane-induced toxicity

Because hypothermia and anorexia were previously found to be more sensitive indices of the effects of lindane than were convulsions, these endpoints were used to quantify the ability of benzodiazepines (BDs) and phenytoin either to ameliorate or exacerbate the toxicity of lindane in the rat. After administration of lindane (40 or 50 mg/kg) in oil per os, toxicity was counteracted by phenytoin and the "central" BD agonists diazepam and clonazepam, but was worsened by Ro 5-4864 a "peripheral" BD agonist. Clonazepam and diazepam were each more effective in counteracting lindane-induced anorexia than in stimulating food intake, presumably because the animals had been fasted and probably even controls ate maximally when food was presented. Diazepam alone (3 injections in 1 day) produced withdrawal-induced decreased food intake the following day. Clonazepam and diazepam alone each transiently decreased colonic temperature, yet effectively blocked the more severe hypothermia produced by lindane. Ro 5-4864 by itself did not produce any measurable effects, yet exacerbated all of the effects, including lethal effects, of lindane. The present findings are compatible with other evidence that lindane and Ro 5-4864 act at the picrotoxinin receptor of the GABAA-activated chloride channel and that systemic administration of agents acting at this site may produce a constellation of effects, including seizures, hypothermia and anorexia.     

论"返工"与"重新加工"的GMP管理

目的:对药品生产企业返工和重新加工等相关问题提出处理原则和解决方案.方法:对返工和重新加工的涵义进行辨析和界定,对两者如何进行管理及其规范管理的深层次含义进行探讨.结论与结论:返工与重新加工在实际生产过程中会对产品质量产生一定的影响,必须纳入GMP,进行规范化管理.     

A genomic "roadmap" to "better" drugs

Utilization of pharmacogenomic information has the potential to significantly improve treatment outcome and markedly reduce the rate of attrition of drugs in clinical development. A major gap that limits our ability to utilize pharmacogenomic information in drug discovery, drug development or clinical practice is that we often do not know the genetic variants responsible for inter-individual differences in drug metabolism or drug response. We examine emerging genomic methods that can fill this gap; these methods can be used to generate new information about drug metabolism or mechanism of action, or to identify predictors of drug response. Although they have not yet had their full impact, a wider application of these emerging genomic technologies has the potential to significantly improve the safety of drugs, the quality of patient care and the efficiency of clinical drug development.     

准确度和精密度术语在《中国药典》中的应用探析

目的:阐述《中国药典》中准确度、精密度术语的应用现状,探讨对取样量的要求以及正确应用准确度、精密度术语的方法。方法:对1990年至今的各版《中国药典》和2005、2010年版英文版《中国药典》凡例和附录中这两个术语的应用进行分析,比较JJF 1059、JJF 1001、GB/T 6379、VIM和GUM定义以及JJF 1094测量仪器特性评定的要求。结果与结论:《中国药典》在准确度、精密度术语的应用中,出现与测量仪器准确度、准确度等级术语相混淆的现象,对取样要求的陈述也有待规范。《中国药典》凡例对液体取样"精密量取"的要求应符合所用量具准确度等级的要求,而并非符合"移液管的精密度"。建议规范并统一相关术语的应用,以促进行业交流、实验室认可和国际互认。     

"Hooked" or "sick": addicts' perceptions of their addiction.

In a study concerned with addicts' perceptions of their own dependence on drugs, 40 outpatients (30 male, 10 female) attending a London drug dependence clinic were individually administered a 15-item attitude questionnaire and an abbreviated (10-item) measure of locus of control. Subjects' own agreements with most of the 15 items correlated highly with their estimates of the responses of other drug clinic patients to these items, but showed little relation to locus of control.A principal components analysis conducted on these ratings revealed two factors which together accounted for 31.5% of the variance. Factor 1, labelled as “Hooked” loaded most heavily on items reflecting a perceived inability to give up drugs. Factor 2, labelled as “Sick”, reflected a perception of one'' addiction as a sickness which doctors could cure, and an acknowledgement of personal problems generally. The 14 subjects whose preferred drug was heroin did not differ, on average, from the remaining 26 in terms of their scores on Factor 1, but obtained significantly lower scores than the others on the “Sick” factor. Implications for treatment, and for the concept of the “sick role” in relation dependence, are discussed.