Seizures with single therapeutic dose of isoniazid

Isoniazid (INH) is an integral component of treatment of tuberculosis. An acute overdose is potentially fatal and is characterised by the clinical triad of repetitive seizures unresponsive to the usual anticonvulsants, metabolic acidosis with a high anion gap and coma. A case of isoniazid induced seizures after therapeutic dose of 600 mg. as a part of CAT I thrice weekly intermittent anti-tuberculosis regimen for pulmonary tuberculosis is reported. The frequency of the usage of Isoniazid as antituberculosis therapy requires that physicians be aware of such toxicity.     

药品不良反应1393例报告分析

目的了解药品不良反应(ADR)发生的特点及一般规律,为临床合理用药提供依据。方法采用回顾性研究方法,对2008-01～2011-06收集到的1 393例ADR报告进行统计分析。结果 1393例ADR报告中,共计1 666例次药品引起ADR,涉及品种211种,其中约5%涉及2种以上药物联用。其中抗微生物类药的ADR发生率最高(860例次,占51.62%),其次为营养支持及能量代谢药(150例,占9%);发生ADR主要的给药途径为静脉注射(1 211例,占86.93%);药物剂型中以注射剂为主(1 518例次,占91.12%);ADR累及器官或系统主要为皮肤及其附件(760例,占54.56%),其次为全身性和消化系统。ADR转归中,1 389例ADR治愈或好转,2例出现后遗症,死亡2例。结论 ADR的发生与诸多因素有关,临床需加强ADR的监测和报告,以促进临床安全合理用药。     

老年患者药物不良反应分析

目的 分析老年患者药物不良反应（ADR）发生的特点,以利于临床上提高监测和应对。方法 回顾性地分析国家药品不良反应监测中心数据库收集的南京医科大学第一附属医院2012年1月至2014年11月＞65岁的老年患者的ADR报告。结果 共收集212例次老年患者ADR报告（占总体ADR的 21.3%）,其中男性91例次,女性121例次,平均年龄（75.25±6.43）岁;91例次发生于门急诊（42.9%）,114例次发生于住院非ICU（53.78%）;涉及药品98种,主要为抗感染药物（30.66%）,其次为中枢神经系统药物（26.42%）;用药途径主要是静脉滴注（86.32%）;ADR所累及的器官或系统损害主要是全身性损害（23.10%）,其次是皮肤及其附件损害（19.49%）,主要表现为过敏样反应、皮疹。结论 本研究反映了我院老年患者发生ADR的主要风险药物、给药途径、临床表现等,应重点关注应用高风险药物的人群,用药过程中密切监测。对门急诊、院外老年患者的用药安全及口服药物的安全性也应加以重视。由于存在漏报现象,本研究的报告率仅能从一定程度上反映老年患者ADR的发生情况,应进一步重视和加强老年患者ADR的监测上报工作。     

National adverse drug reaction surveillance. 1986

The collection of adverse drug reaction (ADR) reports by the Food and Drug Administration serves to provide additional information on the toxic reactions of drugs that often cannot be known before a drug is marketed. In 1986, a total of 53,547 ADR reports were received; 56% of these were made by US health care professionals based on observations made during usual clinical practice. The 1986 total represents an increase of 14% in ADR reporting over 1985, continuing a trend begun in 1981. While these increases are encouraging, US reporting rates are far below many other countries, and further encouragement of reporting must be done. Of these ADR reports, 24% involved serious reactions and 20% involved new drugs. An ADR report should be seen as a professional responsibility; reports are carefully analyzed and used.     

Acute lung injury as a possible adverse drug reaction related to gefitinib.

Gefitinib is a potent drug used in the treatment of nonsmall-cell lung cancer (NSCLC). Gefitinib acts by inhibition of the epidermal growth factor receptor tyrosine kinase. Clinical trials have confirmed the efficacy of gefitinib for NSCLC. Adverse drug reactions, although frequent, are mild, and include acne-like skin rash and diarrhoea. The present study describes the case of a 56-yr-old male with NSCLC who, 4 weeks after treatment with gefitinib, suffered from a severe alveolar haemorrhage diagnosed by bronchoalveolar lavage. This is the first case report of an acute life-threatening lung injury in a patient with nonsmall-cell lung cancer who had been given gefitinib.     

Unexpected frequency, duration and spectrum of adverse events after therapeutic dose of mefloquine in healthy adults.

The frequency and spectrum of adverse events associated with the antimalarial therapeutic regimen of mefloquine (MQ) (750 and 500 mg at an interval of 6 h) was assessed in 22 healthy volunteers who were monitored for 21 days following drug administration. An unexpected high frequency of side effects of any grade were reported by all 22 subjects. The most commonly reported symptoms were vertigo (96%), followed by nausea (82%) and headache (73%). Participants suffering from severe (grade 3) vertigo (73%) required bed rest and specific medication for 1 to 4 days. More females than males reported severe adverse reactions. The majority (77.3%) of the participants (f: 8/12, m: 9/10) showed symptom resolution within 3 weeks (510 h) after drug administration. Biochemical and haematological findings stayed within the normal range of values, but showed nevertheless a significant rise of Na, Cl, Ca, bilirubin, GGT and LDH. The unexpectedly high frequency and severity of adverse reactions after normal therapeutic dosage of MQ in healthy subjects may influence future recommendations regarding the use of MQ for stand-by treatment of suspected malaria in travellers.     

National adverse drug reaction reporting. 1984-1989

Surveillance of adverse reactions due to pharmaceuticals is important because the drug approval process cannot totally assure safety and because new knowledge is bound to accrue after drugs enter usual medical practice. Reporting of reactions to the Food and Drug Administration increased markedly between 1985 and 1989 and totaled 261,515 reports for this period. A large part of this increase was due to new legal requirements, which ensure that manufacturers report reactions to the Food and Drug Administration. Most reaction reports originated with practicing physicians who contacted drug manufacturers. High proportions of the reports involved new drugs and serious reactions. Reaction surveillance leads to 50 to 100 important safety investigations annually and to numerous changes in product information. Health care providers must continue to report suspect adverse reactions to the Food and Drug Administration and manufacturers if pharmaceutical use and safety are to improve.     

滥用尼美舒利颗粒致不良反应7例临床分析

目的分析7例滥用尼美舒利颗粒致不良反应的临床资料,防止滥用尼美舒利颗粒提供借鉴。方法对7例因发热家长自购尼美舒利颗粒服用引起不良反应的患儿临床资料进行回顾性分析。结果 7例患儿均有不同程度的消化、神经系统症状,且预后不良,其中1例死亡。结论 1岁以内小儿滥用尼美舒利颗粒可导致严重不良反应和致死风险,应遵医嘱和说明书合理用药。     

Epidemiological survey of hyperuricemia as an adverse reaction to antituberculous therapy with pyrazinamide

PURPOSE: Pyrazinamide is an antituberculous drug that is administered as a two-month course during treatment of pulmonary tuberculosis. Adverse reactions to pyrazinamide have been reported to include hyperuricemia. We performed a retrospective multicenter epidemiological survey to assess the relationship between various patient characteristics and the uric acid level, the changes of uric acid during pyrazinamide administration, and the use of medications for uric acid control as well as attacks of gout or arthralgia at the onset of hyperuricemia. A total of 226 patients who were admitted to four hospitals with pulmonary tuberculosis between January and December 2006 and received short-term intensive pyrazinamide therapy were studied. RESULTS: There were 172 men and 54 women with an average age of 59.5 years and an average body mass index of 19.8 kg/m2. The average serum uric acid concentration before pyrazinamide treatment was 4.73 +/- 1.78 mg/dl, while the average uric acid level after pyrazinamide treatment was 10.63 +/- 2.67 mg/dl, which was significantly higher than the pretreatment level (p<0.0001). During treatment, hyperuricemia (Serum uric acid > or = 8 mg/dl) was reported in 84.5% of patients and arthralgia developed in 4.42%. Although the therapy instituted in 51 patients (22.57%) had to be interrupted or discontinued due to liver dysfunction and skin rashes, which were probably caused by isoniazid and rifampicin, no patient ceased taking pyrazinamide due to an increase of uric acid. Drugs for uric acid control were administered to 21 patients (9.29%). Pyrazinamide is an important agent for intensive short-term antituberculous therapy. Hyperuricemia due to this drug can be managed by observation and does not require interruption of administration.     

中药注射剂发生不良反应的原因分析

目的分析中药注射剂在临床应用中发生不良反应原因,总结经验教训,指导临床合理应用。方法统计近几年来我院2 180例次用中药注射剂发生不良反应(ADR)的病例,通过查阅临床上ADR报告,寻找中药注射剂不良反应的相关因素。结果 2180例中发生不良反应者共有39例次,原因是多方面的,有药物本身因素、制剂生产过程的质量控制问题、临床使用环节及个体差异问题等。结论中药注射剂仍有较高不良反应发生率,加强中药注射剂的生产管理和临床监测,坚持合理用药,是用药安全的保证。     

Socio-demographic factors related to the prevalence of adverse drug reaction at hospital admission in an elderly population

To identify and to measure the association between socio-demographic factors and the prevalence of adverse drug reaction at hospital admission in an elderly population, we carried out a cross-sectional study on a sample of 19,070 patients of the Gruppo Italiano di Farmacoepidemiologia nell'Anziano data base (Italy). The following socio-demographic variables were considered as independent variables: gender, age, education, living arrangement, widowhood/widowerhood, and alcohol and tobacco habit. We estimated the association of these variables with diagnosis of any adverse drug reaction at hospital admission. We used a logistic regression model to obtain estimates of this association, taking into account hepatic and renal diseases, number of diseases, number of drugs used, albumin index (indicator of nutritional condition) and cognitive function. Out of the 19,070 patients included in our study, 878 (4.3%) were diagnosed with an adverse drug reaction at admission. The multivariate analysis shows that none of the socio-demographic variables and health habits considered are associated with adverse drug reactions at admission. A worse nutritional condition of the subject (OR = 1.39; 95% CI: 1.17-1.64), the number of drugs consumed in the month previous to the admission (OR = 1.74; 95% CI: 1.47-2.08) and the presence of renal disease (OR = 1.76; 95% CI: 1.41-2.55) are associated with ADR at hospital admission. Our results suggest that special attention should be paid to avoid adverse drug reactions in elderly people with nutritional problems, renal failure or those who are using two drugs or more. Additional precautions should be taken with people with cognitive impairment, because of their reduced capacity to report their symptoms.     

Rheumatoid arthritis complicated with acute interstitial pneumonia induced by leflunomide as an adverse reaction

A 49-year-old Japanese man with rheumatoid arthritis acutely developed a skin eruption and severe non-productive cough seventeen days after the administration of leflunomide. Because all bacteriology findings were negative, steroid pulse-therapy was initiated promptly due to the rapidity of chest X-ray progression and the deterioration of arterial blood oxygen pressure. Although cough was induced by methotrexate, interstitial pneumonia was not detected clinically before leflunomide administration. He finally died of respiratory failure 128 days after the onset of acute interstitial pneumonia. According to the post-market surveillance, as high as approximately 1.1% of the patients on,leflunomide have developed interstitial pneumonia in Japan. It is important to emphasize that acute interstitial pneumonia due to leflunomide is a very severe and potentially fatal side effect.     

老年患者服用小剂量肠溶阿司匹林的不良反应和有效性分析

目的调查小剂量肠溶阿司匹林在年龄≥75岁老年患者中使用的不良反应及有效性。方法选择长期服用肠溶阿司匹林100mg/d的心脑血管病及糖尿病患者,年龄≥75岁226例(老年组),年龄<75岁270例(成年组),比较2组在服用阿司匹林过程中的不良反应。另对坚持服用阿司匹林的老年组患者178例,成年组患者249例检测血小板聚集率。结果老年组阿司匹林不良反应发生率明显高于成年组(43.8%vs 23.7%,P<0.01)。老年组与成年组血小板聚集率差异无统计学意义(11.3%vs 12.7%,P>0.05)。结论年龄≥75岁老年人长期服用小剂量肠溶阿司匹林与成年人同样有效,但不良反应明显增加,需要仔细评价风险并密切监测。