Compliance and adverse drug reactions: a prospective study with ethinylestradiol using continuous compliance monitoring

Summary This study examined the relationship between adverse reactions and patient compliance with ethinylestradiol at 40 g twice daily versus 20 g four times daily. In a randomized study 61 female patients with primary- infertility were prescribed the drug twice daily (n = 31) or four times daily (n = 30). Ethinylestradiol was administered for 7 days before the sperm cervical mucus penetration-test was performed for hormonal standardization of the cervical mucus quality. Drug compliance was measured by continuous monitoring using the Medication Event Monitoring System. Two parameters were evaluated: percentage of prescribed doses taken (administration compliance) and adherence to the prescribed dose schedule (regimen compliance, number of days with two or four dosing events recorded). Adverse drug reactions were assessed using a standardized questionnaire. Fourty-four women experienced side effects, of which 81% were rated by patients as being mild. Patient compliance was higher with the twice daily than with the four times daily regimen: 85% versus 65% prescribed doses taken (P<0.05). There was no significant difference in compliance comparing patients with and without adverse reactions (82% versus 72%, respectively), but compliance was lower and more irregular with at least 3 versus one or two adverse reactions reported: 54% versus 84% in administration compliance and 31% versus 58% in regimen compliance (P<0.05). Compliance was also lower in patients with nausea and vomiting than in those without these symptoms, 59% versus 91% and 34% versus 66% (P<0.005), respectively, and lower with moderate or severe compared to mild side effects; 48% versus 85% and 25% versus 59% (P<0.005). Thus the mere occurrence of side effects was not associated with low compliance. However, the number and nature of symptoms and their intensity as perceived by patients may have considerably influenced drug use behavior.Abbreviations ADR adverse drug reactions - SCMPT sperm cervical mucus penetration-test Prof. Dr. E. Weber died 7 December 1992     

Effects of synchronous pulsatile extracorporeal membrane oxygenation in an endotoxin-induced shock model: an experimental study

A synchronous pulsatile venoarterial device for extracorporeal membrane oxygenation (ECMO) was designed to accomplish more effective circulatory support for neonates. The effect of this device was studied using an endotoxin-induced shock model, compared with conventional nonpulsatile ECMO. Twenty puppies weighing 1.6 to 4.0 kg were given endotoxin (5 mg/kg) intravenously. Thirty minutes after the administration of endotoxin, 10 were placed on pulsatile ECMO, and the others were placed on nonpulsatile ECMO, and they were studied for an additional 180 min. Peak blood pressure, arterial pH, base excess, and renal blood flow were significantly higher in the pulsatile group than in the nonpulsatile group. Serum lactate and serum noradrenaline were significantly lower in the pulsatile group than in the nonpulsatile group. These results indicate that pulsatile ECMO may provide more effective cardiopulmonary support in the treatment of neonates with serious circulatory failure that has failed to be supported by nonpulsatile ECMO.     

Bacteriology of Hemodialysis Fluids: Are Current Methodologies Meaningful?

Reports of increasing endotoxic reactions in dialysis centers using high-flux dialyzers and high contamination in liquid bicarbonate concentrates have resulted in concern for the microbial contamination of dialysate. The influence of salt-supplemented media on the recovery of bacterial contaminants from the fluids used in hemodialysis has been examined. This study found a negative influence of a 2% NaCl supplementation of growth media for both purified water and dialysate. Salt-supplemented pour plate cultures of bicarbonate concentrate samples were not statistically different from nonsupplemented cultures (p = 0.2). The influence of the bicarbonate salt on recovery in the pour plates was not addressed. The different media recommended for monitoring microbial contamination of dialysis fluids were compared. As previously reported, both water and dialysate collected from a relatively large geographic area showed higher recoveries on Reasoner's R2A agar than on media recommended by the Association for Advancement of Medical Instrumentation (AAMI) standards (p < 0.0001). Standard methods agar (SMA) and trypticase soy agar (TSA) produced the next highest recovery for water and dialysate, respectively. The higher recoveries generally observed on R2A or SMA suggest that to provide better patient safety these media should be selected for monitoring bacterial contamination of water, and R2A, SMA, or TSA for dialysate. The variability in the species identified across the three fluids and variability in counts observed in the different fluids suggest that significant dialysate contamination may occur from sources other than the water and bicarbonate concentrates.     

Risks of BCG intralesional therapy: an experience with melanoma.

A nearly fatal allergic reaction to intratumor BCG injections was associated with a complete remission of recurrent malignant melanoma. Clinical course and histologic sections suggested both anaphylactic and Arthus reactions. The occurrence of reactions at BCG injection sites as well as at uninjected sites of tumor suggests common BCG and melanoma antigens. The management of events involved in this often fatal postimmunotherapy complication involves the early administration of parenteral fluids, antituberculous therapy, antihistamines, and possible steroids. The prophylactic use of antihistamines and an in-hospital administration of intralesional BCG immunotherapy are strongly suggested. In the future, prophylactic INH may prove to be both therapeutically efficacious and protective against infectious complications.     

Administration of obidoxime tablets to man

Twenty-four male volunteers were given obidoxime tablets in quantities ranging from 1.84–3.58 g in a single dose, or 7.36 g divided into 4 equal doses. With the lowest dose, average peak plasma level of the drug was 1.9 g/ml and after the highest single dose it was 5.6 g/ml, both attained 1.5 h after administration. In the multiple-dosed individuals, plasma levels of the oxime increased gradually following each additional dose, reaching a peak of 3.5 g/ml after the last dose.Thirteen individuals complained of one or more of the following side effects: pallor, nausea, pyrosis, headache, generalized weakness, sore throat, and paresthesia of the face muscles.Activities of blood cholinesterase, glutamic oxalacetic transaminase, glutamic pyruvic transaminase, as well as hematocrit values, heart rate, and blood pressure were not affected.It is postulated that due to the undesirable side effects, the general use of obidoxime tablets should not be recommended. However, prophylactic oral treatment with obidoxime could be considered for persons at high risk of organophosphate poisoning or when parenteral administration might not be feasible.     

利培酮与氯丙嗪治疗精神分裂症对心电图的影响

目的 :了解和比较利培酮与氯丙嗪对心电图的影响。方法 :对服用利培酮及氯丙嗪的精神分裂症患者分别定期心电图检查 ,时间为服药后 2、4周。结果 :利培酮组和氯丙嗪组出现异常分别为 11.5 %和 4 2 .5 % ,两者有显著性差异 (P <0 .0 5 )。结论 :利培酮对心电图影响明显低于氯丙嗪。     

药物不良事件的防范研究

目的：探讨心内科病房药物不良事件(ADE)的防范特征。方法：由药师深入心内科病房，集中监测药物不良事件。主要监测内容是药物不良事件的存在与否，可否防范及严重程度。结果：5个月研究期间共鉴定ADE64次，其中28％可以防范。在重度ADE中，50．0％可防范；在中度ADE中，33．3％可防范；在轻度ADE中，可防范的比例最少，为13．6％。结论：药物不良事件中有相当一部分可以防范，而且越是严重的ADE就越有可能被防范。应该采取有效的措施来防范药物不良事件。     

739例心血管类药物不良反应分析

目的:调查心血管类药物ADR的临床特点及产生原因。方法:从1998年～2001年4月公开发行的国内70余种医药学期刊中收集到心血管类药物不良反应个案776例,其中符合药物不良反应判定标准的739例,按照不良反应类别进行归纳、统计和分析。结果:心血管类药物的不良反应共涉及人体7个系统,其中呼吸系统所占的比例最大(29.8%);涉及相关药物六大类,以ACEI类药物较为常见(230例);重度不良反应46例,死亡15例,死亡占2.03％;51岁以上年龄组的不良反应(78.9％)高于其 他年龄组;口服给药(65.5％)较其他给药途径发生的比例高。结论:心血管类药物ADR的发生与药物的药理作用、给药途径、合并用药及患者的年龄、个体差异、饮食习惯等有关。     

中药不良反应及其发生因素

药品不良反应(ADR)问题越来越突出。2003年媒体关于中药ADR的大讨论引起海内外各界的强烈关注。本文从理清中药ADR概念入手，界定了中药ADR的范畴，并从药品、医生、药师、护士、病人、企业、管理因素以及其他社会因素等方面分析探讨了其发生原因，指出并澄清部分模糊认识，提出一些新观点和设想，以期服务于中药现代化和国际化。