Gene/Protein Disease Symptom Drug Enzyme Compound
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 9,689 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Atenolol, a cardio selective beta-adrenergic blocker, frequently prescribed in various cardiac ailments, has not been thoroughly investigated for its adverse reaction profile in Indian patient. The present ADR monitoring study which was open, prospective and collaborative was therefore planned. A total of 440 patients with various heart disease were enrolled after a strict inclusion and exclusion criteria from Maulana Azad Medical College, New Delhi and J.N. Medical College, Aligarh. fifteen patients dropped out leaving 435 for final analysis. Cold extremities occurred in 1.18% headache and dizziness in 1.41% breathlessness in 0.94% oedema in 0.70% and bradycardia in 0.47%. Adverse drug reaction in our study were less than those reported from Western countries. Better patient selection, optimal dose could have reduced the frequency of ADR in the present study. Racial factor and season might be operating to bring down ADR to atenolol in Indian patients.
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PMID:Monitoring the adverse profile of atenolol--a collaborative study. 827 98

Propranolol, a nonselective beta-adrenergic blocking agent, although prescribed frequently, has not been monitored for its adverse reactions in Indian population. A collaborative ADR monitoring study was planned in 2661 hypertensive patients. Exclusion criteria were associated circulatory insufficiency, heart block, left ventricular failure, diabetic mellitus and airway obstruction. The incidence of ADR was 2.1%, which is lower than reported incidence of 8.7 to 43.7 percent in other studies. This could be attributed to improper selection of patients, differences in methodology of monitoring, or to racial variation. In the present study ADR of fatigue (1.1%), dizziness (0.4%) and headache (0.2%) constituted the bulk. Additional reaction of pain in chest (0.2%), heart block (0.1%), hypoglycemia (0.1%), loss of libido (0.1%) and shock (0.03%), were also observed.
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PMID:Adverse reactions to propranolol, a non-selective beta-adrenergic blocking agent in hypertensive patients--a collaborative study. 844 49

This paper reviews the safety data for levofloxacin utilizing reports from clinical and post-marketing surveillance trials. The side effect incidence rates are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were lower. Four clinical trials were reported. Levofloxacin achieved superior clinical and microbiological results compared to ceftriaxone/macrolide combination, and was better tolerated. Results comparing IV azithromycin plus ceftriaxone versus 500 mg levofloxacin in hospitalised CAP demonstrated that levofloxacin performed better, with more adverse events associated with the comparators (levofloxacin 5.3%, comparators 9.3%). High-dose levofloxacin (750 mg) was also evaluated and found to be well tolerated. Surveillance data reported low ADR rates for levofloxacin: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhoea, dizziness, and vomiting 0.3%. Worldwide and US surveillance data confirmed that tendon rupture occurred in less than 4 per million prescriptions, taste perversion in less than 3 per million, convulsions in 2 per million, and photosensitivity, hepatitis, hepatic failure, QT prolongation, torsade de pointes or empyema all in less than 1 per million.
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PMID:Latest industry information on the safety profile of levofloxacin in the US. 1154 87

This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.
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PMID:[Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background]. 2724 17

Male erectile dysfunction is common and frustrating after the age of forty years. Erectile dysfunction is a cause of misery, relationship difficulties, and significantly reduced quality of life. Sildenafil citrate (Viagra) has shown promising results in recently published clinical trials. Sildenafil is a potent and competitive inhibitor of cGMp specific phosphodiesterase-5, predominant isoenzyme in the human corpus cavernosum. It is effective in erectile dysfunction of diverse origin, however it requires a patent vascular system to be effective. It is not effective in patients with endocrinal impotence, loss of libido, premature ejaculation or infertility. Its main adverse effects are headache, flushing, dyspepsia, diarrhoea, nasal congestion, indigestion, visual disturbances, dizziness and rash. Ventricular tachycardia and acute myocardial infraction have been reported in patients of ischaemic heart disease after consumption of sildenafil. Six deaths have been reported in patients taking nitrates. In India it is likely to be prescribed by a primary care physician without complete evaluation of patient on complaint of impotence. Hence the ethical question of who should prescribe this drug should be addressed by medical fraternity and proper guidelines formulated to avoid misuse of sildenafil. Phosphodiesterase is distributed in nerve, central nervous system, and systemic vasculature, hence long-term effects of drug on these tissues has to be ascertained. It should be made mandatory to report all adverse drug reactions to ADR monitoring centres. It is a wonder for those who require it, but has potentially dangerous adverse effects and drug interactions and hence is and not a wonder pill for all kinds of impotence.
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PMID:VIAGRA : IS IT A WONDER DRUG ? 2736 78

This paper is to report the implementation and results of safety monitoring of Shenfu injection. Prospective, multicenter, large sample, registry-type centralized hospital monitoring mode was used, and the three-level quality control and anti-omissive mechanisms were used strictly. In the monitoring was carried out in 28 hospitals and lasted for 4 years. 30 106 patients were registered; ADE occurred in 114 patients, and ADR was identified in 23 patients with an incidence rate of 0.076% for ADR [95% confidence interval (0.045%,0.108%), which was in a rare level. The main ADRs included rash, pruritus, discomfort at the site of the infusion, nausea, vomiting, abdominal pain, dizziness, chest tightness, heart palpitations, chills, fever and dyspnea. No severe ADRs were found in the monitoring. This paper also fund that history of allergy, methods of administration, dosage, solvent, concentration, and combined medication may affect the incidence of ADR in the use of Shenfu injection.
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PMID:[Clinical safety imtensive hospital monitoring on Shenfu injection with 30 106 cases]. 2913 50

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.
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PMID:[Analysis of adverse reactions of Xianling Gubao preparation based on real world SRS data]. 3249 87

In order to understand the characteristics of adverse drug reaction/adverse event(ADR/AE) of Ginkgo biloba Dropping Pills and evaluate the safety of clinical use after marketing, 407 ADR/AE case report data of Ginkgo biloba Dropping Pills collected by National Center for ADR Monitoring System during 2009-2018 was systematically analyzed, and its general characteristics were analyzed using descriptive statistical methods. The results showed that among the 407 cases of spontaneous reporting system(SRS) data, 401 cases were general ADR/AE, accounting for 98.5%, and 6 cases were severe ADR/AE, accounting for 1.5%; there were more females than males(171/150) in ADR/AE, and they were mainly middle-aged and elderly people aged 45-64 years(152 cases, accounting for 37.35%); gastrointestinal system(23.89%) was mostly involved in ADR/AE. The top ten clinical symptoms were nausea(15.49%), dizziness(9.88%), vomiting(8.11%), rash(5.60%), chest tightness(5.46%), palpitations(5.31%), pruritus(4.72%), headache(4.57%), abdominal distension(3.83%), gastric dysfunction(3.54%); proportional reporting ratio(PRR) and Bayesian confidence progressive neural network method(BCPNN) were adopted to mine ADR/AE warning signals. Due to the small sample size, there were only 0-2 ADR/AE cases with various symptoms in many quarters, with no warning signal by PRR and BCPNN methods. The findings suggest that ADR/AE of Ginkgo biloba Dropping Pills based on SRS system was not recorded in the package insert, and further active monitoring studies shall be conducted to improve relevant ADR/AE information and pay attention to its clinical drug safety issues.
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PMID:[Analysis of adverse drug reaction/adverse event and early warning signal mining of Ginkgo biloba Dropping Pills based on SRS data]. 3249 88

To explore the general characteristics of adverse drug reactions/adverse events(ADR/AE) in patients after using Shujin Jianyao Pills, and explore risk warning signals, this study analyzed 166 cases of ADR/AE reports of Shujin Jianyao Pills collected from 2005 to 2017 based on the National Center for ADR Monitoring spontaneous reporting system(SRS). And the descriptive statistical method was used to analyze general characteristics. The results showed that among the 166 ADR/AE cases, 106 cases were female patients, accounting for 63.86%. Middle-aged and elderly people aged 45 to 64 accounted for the largest proportion(82 cases, 49.40%), which were followed by elderly aged 65 and over(48 cases, 28.91%). ADR/AE involved a wide range of systems and organs, of which skin and its accessories were the most damaged(30 cases, 12.93%), which were followed by systemic damage(27 cases, 11.64%). The top 10 ADR/AE manifestations were rash(15 cases, 6.33%), nausea(14 cases, 5.91%), dizziness(14 cases, 5.91%), abdominal pain(12 cases, 5.06%), pruritus(11 cases, 4.64%), low back pain(11 cases, 4.64%), vomiting(10 cases, 4.22%), hepatocyte damage(9 cases, 3.80%), headache(9 cases, 3.80%), and diarrhea(7 cases, 2.95%). Bayesian confidence propagation neural network(BCPNN) was used to mine the ADR/AE risk early warning signal of Shujin Jianyao Pills, and the propensity score method was used to control the balance of confounding factors. The results suggested warning signs for nausea, diarrhea, rash, and dizziness, vomiting, abdominal pain, headache, liver cell damage. This study provides a basis for the post-marke-ting safety evaluation of Shujin Jianyao Pills, and can provide guidance for its rational clinical use and risk management.
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PMID:[ADR/AE early warning analysis of Shujin Jianyao Pills based on spontaneous reporting system]. 3289 41