Adverse Drug Reactions Journal

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综述

Clinical application and safety of pramipexole

2007, 9(2): 77-80.

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中药不良反应

Anaphylactic shock in association with Shengmai injection

2007, 9(2): 80-80.

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论著

Studies on dose-response relationship and safety of entecavir for treating hepatitis B virus infection

Ma Xiuyun;Cai Haodong;Xu Yanli;Bu Zhijun;Cao Chuanmei

2007, 9(2): 81-84.

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Objective: To evaluate the dose-response relationship and safety of entecavir for treating chronic hepatitis B virus infection. Methods: In a randomized, double-blind, placebo-controlled study, the patients with hepatitis B virus infection and without previous antiviral therapy were assigned to following 3 groups in the ratio of one to one to one: entecavir 0.5 mg/d group, entecavir 0.1 mg/d group, and placebo group. The patients were treated for 28 d. The postdosing follow-up was 56 d. And then the patients in the three groups were treated with entecavir 0.5 mg/d during the 48 weeks open-label treatment phase of the study. The postdosing follow-up was 24 weeks. Results: The entecavir 0.5 mg/d had more potent antiviral activity than that of entecavir 0.1 mg/d, and the HBV DNA breakthrough was slower after discontinuation of the drug. In the end of open-label treatment phase, the HBV DNA levels were decreased to < 0.7 mmol/ml in 81.6% patients, and the rate of HBeAg/anti-Hbe seroconversion was 7.9%. But the HBV DNA levels were increased again in 80% patients after the drug withdrawal. There were no statistically differences (P=0.428) in the incidence of adverse events between the entecavir therapy group and placebo group, the serious adverse reactions related to the entecavir were not found during the open-label treatment phase. Conclusion: Entecavir has potent antiviral activity against HBV, and its antiviral effect is related to the dosage. The entecavir 0.5 mg/d is more effective and safer in treating patients with chronic hepatitis B virus infection.

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论著

Studies on efficacy and safety of fexofenadine in treating seasonal allergic rhinitis and chronic idiopathic urticaria

Wang Ruiqi①;Zhang Hongyu①;Wang Zhongyan②;Xue Weiguo③;Yang Xueyuan④;Liu Quanzhong⑤;Li Ming⑥; Zheng Qingshan⑦

2007, 9(2): 85-90.

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Objective: To observe the efficacy and safety of fexofenadine in treating seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU). Methods: In a double-blind, double-dummy, randomized, controlled, multicenter phase Ⅱ clinical trial, the efficacy and safety of fexofenadine (60 mg twice daily) were compared with cetirizine (10 mg/d) in the treatment of SAR and CIU. The duration of treatment was 14 d for patients with SAR and 28 d for patients with CIU. Results: One hundred and forty-four patients with SAR entered the trial. Of the 144 patients, 64 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptom score reducing index and overall effective rate in fexofenadine group were 0.719±0.182 and 85.94%, respectively. There were statistically deferences between the fexofenadine group and cetirizine group (P<0.05). One hundred and forty-four patients with CIU entered the trial. Of the 144 patients, 67 receiving fexofenadine and 68 receiving cetirizine were included in PPS. The symptoms score reducing index and overall effective rate in fexofenadine group were 0.771±0.269 and 80.60%, recpectively. There were no marked differences between the two groups (P>0.05). There were no serious adverse reactions in the two groups. The incidence of adverse reactions in the fexofenadine and cetirizine groups was 17.6% and 16.9%, respectively, and there were no significantstastistically deferences between the two groups (P>0.05). The manifestations of adverse reactions in the two groups were similar, and the main of them was drowsiness and dry mouth. There were no obvious changes of ECG after dosing in the two groups, and no significant differences of QTc before and after dosing between the two groups (P>0.05). Conclusion: Fexofenadine is an effective and safe medication for treating seasonal allergic rhinitis and chronic idiopathic urticaria.

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病例报告

Severe drug eruption,leukemoid reaction,and hepatitis in relation to meloxicam

2007, 9(2): 90-90.

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论著

Observations on efficacy and safety of aripiprazole used for treating patients with senile schizophrenia

Du Biao①②;Xiang Zhiguo②

2007, 9(2): 91-94.

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Objective: To observe the efficacy and safety of aripiprazole used for treating patients with senile schizophrenia. Methods: Seventy patients with senile schizophrenia were randomly divided into following two groups: aripiprazole group [17 males, 18 females, age(66.2±2.4) years] and haloperidol group [18 males, 17 females, age(65.4±2.4) years].The initial dosages for the aripiprazole and haloperidol groups were 510 mg/d and 2 mg/d respectively, and then adjusted to (12.8±3.3) mg/d and (7.3±3.6) mg/d respectively according to the condition of disease. The duration of therapy was 8 weeks. PANSS was used to assess the clinical efficacy, and TESS was used to assess adverse reactions. Results: The effective rate in the aripiprazole and haloperidol groups was 88.6% and 85.7% respectively. There were no stastistically deferences between the two groups (P>0.05). The adverse reactions of aripiprazole were mild and less. Conclusion:Aripiprazole is an effective and safe drug used for treating patients with senile schizophrenia.

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病例报告

Renal dysfunction and gastrointestinal bleeding associated with pemetrexed

2007, 9(2): 94-94.

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调查研究

Investigation and analysis of psychotropic adverse event in emergency patients

Zhai Wei①;Zhang Liming②;Yan Wei②;Qin Ying③;Zhan Siyan③;Liang Jianhui④;Cui Yimin②

2007, 9(2): 95-99.

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Objective: To understand the prevalence of psychotropic adyerse event in emergency patients in order to provide scientific basis for the safe use ang control of psychotropic drugs.Methosa:During the period from December 2005 to March 2006,the adverse drug events of emergency patients were investigated by use of a questionnaire in 9 emergency deperyment of general hospitals and 2 emergency medical centres.The adverse events of psychotropic drugs were analysed and compardwith that of non-psychotropic drugs.Results:Of the 339 cases of adverse events,psychotropic adverse events were 241 cases(71.09%)，and most of them were non-medical use including suicide(68.46%),drug abuse and drug dependence(2.90%).The psychotropic adverse events were mainly caused by catalog Ⅱ psychotropic drug,and the most common drug was diazepam(33.33%).Compared with the patients receiving non-psychotropic drugs,the patients receiving psychotropic drugs were younger,their dosages,emergency treatment,hospital adnission,and death were significant higher.Conclusion:Psychotropic adverse events are common in emergency patients.Therefore,it is necessary to strengthen the monitoring and prevention strategies.

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病例报告

Corneal epithelium extensive exfoliation produced by compound sulfamethoxazole sodium eye drops

2007, 9(2): 99-99.

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调查研究

Seizures induced by fluoroquinolones in 54 cases:a review of domestic literature

Yuan Jin;Yao Xiaoli

2007, 9(2): 100-102.

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Objective: To understand the occurrence and clinical features of seizures induced by fluoroquinolones. Methods: The reported cases with seizures induced by fluoroquinolones from CBMdisc (1978-01-2006-06) and CHDL(1994-01-2006-06) were collected and analyzed. Results: Fifty-four patients with fluoroquinolones-induced seizures (31 males, 23 females) were collected. Five of them had a previous history of epilepsy. The common causative medications, in the order of frequency, were ciprofloxacin, ofloxacin, levofloxacin, norfloxacin, and so on. Forty three patients were administered intravenously, and 7 patients were administered orally. Six patients were coadministered with theophylline-containing preparations. Of the 54 patients, 47 were generalized tonic-clonic seizures, 7 were partial seizures. The time of onset of seizures was 10 min to 6 d after fluoroquinolones use. The duration of seizures was 20 s to 10 min. The seizure frequency was 1 to 5 times. After drug withdrawal or systematic…更多 therapy, all the patients had recovered and were discharged, except one patient died from neurospongioma and cerebral infarction. Conclusion: Seizures might be induced by intravenous or oral administration of fluoroquinolones. Clinicans should be aware of the risks of fluoroquinolones-induced seizures in order to be beneficial to safe drug use.

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安全合理用药

Psoriasis induced by tumor necrosis factor-α inhibitor

2007, 9(2): 103-105.

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安全合理用药

Oxcarbazepin safety in clinical practice

2007, 9(2): 105-107.

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安全合理用药

Common drugs causing upper gastrointestinal hemorrhage

2007, 9(2): 108-111.

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病例报告

Conjunctival congestion induced by rat nerve growth factor

2007, 9(2): 111-111.

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相互作用

Interactions of warfarin and its safe use

2007, 9(2): 112-116.

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病例报告

Severe oral ulceration and diarrhea resulting from capecitabine

2007, 9(2): 116-116.

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滥用误用

Pharmacological characteristics of tramadol and investigation of its dependence

2007, 9(2): 117-120.

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中毒救治

Adverse reactions of common antidotes and their prevention and management

2007, 9(2): 121-124.

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病例报告

Death from acute severe hepatitis induced by nimesulide in a child

2007, 9(2): 130-131.

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A 9-year-old boy with rheumatoid disease took nimesulide 50 mg twice daily. He developed asthenia, anorexia, and jaundice after 77 d of nimesulide therapy. Laboratory tests revealed the following values: Tbil 325.0 μmol/L, Dbil 216.9 μmol/L, ALT 916 U/L, ALB 35.5 g/L, γ-GT 750 U/L, and ALP 480 U/L. The boy lapsed into a coma on day 2 after admission. He received symptomatic therapy, and underwent phasmapheresis and continuous veno-venous hemofiltration treatment. The patient died from hepatic failure.

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病例报告

Polymyositis complicated by interstitial pneumonia after peginterferon α-2a use

2007, 9(2): 131-132.

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A 53-year-old woman with chronic viral hepatitis B was administered with peginterferon α-2a 135 μg/week subcuta-neously for 18 doses. After a 18 d discontinuation of the drug, she occurred cough and dyspnea. Myodynamia of both upper limbs was grade Ⅳ and both lower limbs was grade Ⅲ, A chest x-ray showed interstitial inflammation in the lungs. Laboratory tests revealed CK-MB 329 U/L and CK 4 099 U/L. The levels of CK-MB and CK in the patient were decreased to 13 U/L and 40 U/L respectively, after antiviral therapy, symptomatic therapy and pulse methylprednisolon therapy .

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病例报告

Hyperglycemia induced by low-dose aspirin in 2 cases

2007, 9(2): 132-133.

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病例报告

Sinus tachycardia caused by omeprazole:2 case reports

2007, 9(2): 133-134.

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病例报告