Clinical analysis of 45 cases of drug-induced liver injury induced by bulbil of dioscorea bulbifera L / 国际中医中药杂志

Objective To explore the characteristics, diagnosis, treatment and prognosis of liver injury caused by the deficiency of dioscorea bulbifera L.. Methods The general data, clinical manifestation and laboratory examination of 45 cases of liver injury diagnosed as Yoshimoto associated liver injury from November 2014 to June 2017 were classified and reviewed with the standards of drug liver injury classification recommended by the Council of international medical organizations. Results The number of male patients was 26, and female 19. The medication time ranged from 1 week to 2 years and the main biochemical performance was abnormal, namely ALT, AST, TBil, DBil, ALP and GGT. Of the 45 cases, the average values of ALT, AST were 608.11 ± 411.30 U/L and 505.38 ± 342.15 U/L. The TBil of 42 case rised with the mean value 170.10 ± 136.86 μmol/L, and the ALP of 22 cases with 182.38 ± 55.15 U/L. The GGT of 43 cases rised with the mean 223.12 ± 131.85 U/L. Clinical classification included 38 cases were liver cell injury, none was cholestasis, 5 mixed types and 2 cases of liver biochemical examination abnormality. One patient died while the other patients recovered. Conclusions Although the pathogenesis of the liver cell induced injury type with dioscorea bulbifera L. remains unclear, the reasonable and appropriate use of medication and regular liver biochemical tests is necessary.

Analysis of adverse drug reactions induced by compound Kushen injection in Qingdao central hospital / 国际中医中药杂志

Objective The adverse drug reaction (ADR) reports of compound Kushen injection in Qingdao Central Hospital were analyzed to improve the level of safe and rational use of drugs.Methods We investigated 35 cases of severe ADR reports induced by compound Kushen injection in Qingdao Central Hospital from 2016.09 to 2018.03 retrospectively.Then the type of report,relevance evaluation and prognosis,ADR occurrence and recovered time,involved system/organs and main clinical manifestations were analyzed.Results The new moderate and new severe ADR incident were 51.4％ of 35 ADR reports.Twenty-nine cases of the ADR were occurred 30 minutes after injection.Twenty-three cases of ADR clinical symptoms can be recovered after 30 minutes.The main ADR was the digestive system reaction,followed by the neural system,respiratory system and cardiovascular system.Conclusions It is important to pay attention to the occurrence of compound Kushen injection ADR and strengthen its monitoring.

Desensibilización al ácido acetil-salicílico como tratamiento para la enfermedad respiratoria exacerbada por antiinflamatorios no esteroides / Desensitization to acetyl-salicylic acid as a treatment for non-steroid anti-inflammatory drugs (NSAIDs)-exacerbated respiratory disease

La coexistencia de hipersensibilidad al ácido acetil salicílico (ASA) y a otros antiinflamatorios no esteroides (AINE) con enfermedad de la vía aérea superior (rinosinusitis/poliposis nasosinusal) o inferior (asma) se denomina enfermedad respiratoria exacerbada por ASA (EREA). Las opciones de tratamiento incluyen la evitación de todos los analgésicos inhibidores de la ciclooxigenasa 1 (COX-1) o la desensibilización a ASA, continuando su consumo diario. Esta última opción terapéutica ha demostrado mejorar la calidad de vida, reducir la formación de pólipos nasosinusales, los episodios de sinusitis infecciosa, la frecuencia de las hospitalizaciones y de las cirugías para resección de pólipos; también mejora la hiposmia y reduce la necesidad de tratamiento con esteroides sistémicos. Se han usado múltiples esquemas de desensibilización, tratando de reducir el riesgo asociado con el procedimiento y los efectos adversos derivados del consumo crónico de ASA. En este artículo se presentan una revisión de los diferentes esquemas de desensibilización y dos casos clínicos ilustrativos que sirven de ejemplo para comprender mejor los factores que influyen en la elección del tratamiento para los pacientes con esta enfermedad.

The coexistence of hypersensitivity to acetylsalicylic acid (ASA) and other NSAIDs with disease of the upper or the lower airways (rhinosinusitis/sinonasal polyposis, or asthma) is defined as NSAIDs-exacerbated respiratory disease. Treatment options include the avoidance of all analgesics that inhibit COX-1 or ASA desensitization, continuing its daily consumption. The latter treatment has shown to improve quality of life, reduce the formation of sinonasal polyps, the episodes of sinus infection, the frequency of hospitalizations and surgeries for resection of polyps and the need for systemic steroid treatment. Multiple desensitization schedules have been used, trying to reduce the risk associated with the procedure and the adverse effects of chronic use of ASA. In this paper we present a review of the different methods of desensitization and two illustrative clinical cases to help understand the factors that influence the choice of treatment for these patients.

Safety of compound Qinghuang powder in patients with myelodysplastic syndromes / 国际中医中药杂志

Objective To evaluate the safety of compound Qinghuang powder for myelodysplastic syndromes(MDS). Methods A total of108 patients with MDSwere collected, 60 patients were treated with Qinghuang powder(Qinghuang powder group)and 48 with compound Qinghuang powder(compound Qinghuang group). The treatment time of 3 months was as one course, and all the patients were treated for more than one course. The patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. The adverse reactions were recorded during the treatment. Results The overall incidence of adverse reactions in the compound Qinghuang powder group was significantly lower than that in the Qinghuang powder group(18.75% vs. 41.7%; χ2=6.492, P<0.05). None in the compound Qinghuang powder group and 3 patients in the compound Qinghuang powder group developed moderate to severe adverse reactions. The incidences of various adverse reactions in the compound Qinghuang powder group were lower than those in the Qinghuang powder group, especially, lower limb swelling (4.17%vs. 25%;χ2=9.205, P<0.05) epigastric discomfort(18.75% vs. 41.67%; χ2=6.492, P<0.05). Twenty patients who developed adverse reactions in the Qinghuang powder group changed to receive compound Qinghuang powder. Among them, 5 patients (25%) maintained adverse reactions. The various adverse reactions after changing to compound Qinghuang powder were decreased, especially, facial swelling (10% vs. 30%; χ2=2.50, P<0.05), leg swelling (5%vs. 45%;χ2=8.533, P<0.05), and abdominal pain and diarrhea(10%vs. 30%;χ2=2.50, P<0.05). No patient developed liver or kidney dysfunction after the treatment with Qinghuang powder or Compound Qinghuang powder. Conclusion Compound Qinghuang powder is safer than Qinghuang powder in the treatment of MDS.

<b>2. Comparison of the Onset Time Profile among the Interferon Formulations in Adverse Drug Reaction of Suicide- or Diabetes-Related</b> / 薬剤疫学

Japanese Adverse Drug Event Report database (Abbreviation; JADER) was disclosed April 2012 and will be expected to have a major role in the establishment of the adequate information for the proper usage of drugs. In this paper, we were compared using the shape parameters that were estimated by fitting the Weibull distribution, whether the adverse drug reaction of suicide- or diabetes-related onset time profiles vary depending on the type of interferon formulations. The data were used JADER of August 2013. The combined number of adverse drug reaction and drug that duplicates removed was 702,925. In diabetes-related side effects, the distribution of adverse drug reaction time was different among formulations. The shape parameters of the Weibull distribution are 1.49 (1.09-1.94), 0.84 (0.66-1.05) and 1.07 (0.92-1.23)(point estimates and two-sided 95% confidence interval) in interferon-α,-β and peginterferon, respectively. Interferon-α is categorized as the wear-out failure type adverse drug reaction onset time profile from which its 95% confidence interval exceeds 1. Peginterferon is classified as the random failures type from which its point estimates is almost 1. Since the upper 95% confidence interval is near 1, the time profile of interferon-β is close to the early failures type. We conclude that the combination of the shape parameter of the Weibull distribution and the visual inspection, like histogram and box plot, is useful in the monitoring of adverse drug reaction onset time profile.

<b>3. Evaluation of Drug Induced Severe Eruption Cases in the Japanese Adverse Drug Event Report Database and Commonality of the Reported Drugs</b> / 薬剤疫学

From April 2012, Japanese Adverse Drug Event Report database (JADER) has become downloadable for utilization in the public, under the specified acceptable use policy. Given the situation, we focused on the severe eruptions which cases are increased in the public Relief System for Sufferers from Adverse Drug Reactions, for the purpose to analyze the characteristics of typical severe eruptions and a trend or a commonality in the corresponding reported drugs, by utilizing JADER. Disproportionate reporting obtained with ROR (Reporting Odds Ratio) and distribution parameter estimations obtained with Weibull distribution fit for the onset time of drug adverse reactions, were applied for the analysis in addition to the summary of frequency. We obtained 10,171 cases of severe eruptions from JADER, after exclusion of duplicated reports. In the Drug Induced Hypersensitivity Syndrome (DIHS), which has characteristics in clinical time course and causal drugs, we confirmed that typical causal drugs such as anti-epilepsy are frequently reported in JADER. On the other hand, drugs other than typical causal drugs also showed high ROR signal values. In the estimation of Weibull distribution shape parameter fit for drug adverse reaction onset time, DIHS gave estimation apparently different from other severe eruptions. Coincide with the estimation, histogram of onset time for DIHS showed the peak at around 20 days after drug administration, which is later than other severe eruptions. We conclude that analytical approach to obtaining information from multiple aspects of JADER data should be a useful effort for the persons who are engaged in preventive action for drug adverse reactions.

Epidemiological Characteristics of Adverse Reaction Induced by Chinese Activating Blood Herbal Injection / 中国中医药信息杂志

Objective To investigate the epidemiological characteristics of adverse reaction induced by Chinese activating blood herbal injection. Methods Domestic medicinal periodicals issued during 1972-2011 were searched, and 566 adverse drug reaction (ADR) cases were analyzed by database establishment and statistic method. Results Totally 566 ADR cases involving 16 different kinds of traditional Chinese medicine injection were collected, and 139 cases were related to Fufang Danshen Injection. The incidence of ADR was 51.77%(293 cases) in the male and 48.23%(273 cases) in the female. Average age of patients was (55.01±16.07) years old. The incidence of circulation system damage (206 cases, 23.22%) dominated in ADRs. The number of ADR which occurred within half an hour was 357 cases (64.79%) and the original disease most were cardiovascular and cerebrovascular diseases (384 cases, 67.84%). Conclusion ADR induced by Chinese activating blood herbal injection are commonly seen in middle-aged and elderly people, and often involved circulation system.

Monitoring of PDCA quality improvement process for drug adverse reaction management / 中华医院管理杂志

Objective Patient safety is key to quality of care in hospital management, for which drug safety is critical. General hospitals are challenged with how to monitor drug adverse reaction (ADR), and motivate their staff to report ADRs in building a hospital safety culture. Methods The PDCA cycle quality improvement process was called into play, to set the ADR criteria and analyze data of inpatients' ADRs from 2005 to 2009, which was followed by measures proposed for ADR continuous improvement. Results A total of 2850 ADR cases were reported in the past 5 years, averaging 570 cases per year. The ADR incidence rate was 3. 28%, of which 43 were severe ADR cases, or 0. 49% of the total cases, accounting for 1. 51% of all the ADR cases. Year to year, the quantity and quality of ADR reporting have been improving in the hospital, witnessing an initial culture of drug safety. In 2008, the hospital was awarded as an advanced ADR center in Beijing. Conclusion The PDCA cycle is an effective means for ADR management, as it can improve the awareness of the medical staff for proactive ADR reporting. Sustained circular management against ADRs can minimize risks and maximize patient safety.Under-reporting and the corrective measures shall be watched over by the hospital in the future.

Analyses of Adverse Reactions in 40 Drugs / 国际中医中药杂志

Objective According to the analyses of adverse drug reactions (ADR) in clinic, we supply reasonable drug information for clinical usage to reduce recurrence of adverse reactions. Methods Analyze the ADR reports of our hospital from April, 2007 to December, 2008 and make statistical analysis by terms of age of patients, kinds of drugs, route of administration, clinical manifestation, and recovery, etc. Result The incidence rate of ADR in the female is more than the male. ADR mainly involves with the skin, nervous system, respiratory system, and digestive system. Clinical manifestations mainly show as rash, local swelling, erythema, irritations, dizziness, headache, fever, sweating, shiver, chest tightness, short breath, heart palpitation, dyspnea, sickness, vomiting, abdominal pain and distension etc. Conclusion Antibiotics should be reasonably used; Traditional Chinese medicinal injection should be used according to syndrome differentiation and be avoided used with the combination with other medicines. Dosage and injecting speed should also be strictly controlled to reduce and avoid ADR happening again.

Some opinions of monitoring the adverse drug reactions in hospitals throughout the country in 1998:

Among adverse drug reactions, the anaphylactic shock is most severe and easily causes death. The cause of anaphylactic shock can be drugs (especially antibiotics), intravenous solution, and allergy, poison and microbial, the data of the anaphylactic shock in hospitals throughout the country has been reported. In order to limit the adverse drug reactions, it should know the medical history as well as have ready the drugs and equipment for timely management.

Analysis of 65 Cases of Ciprofloxacin Lactate-induced Adverse Reactions / 中国药房

OBJECTIVE:To investigate the characteristics of ARDs induced by ciprofloxacin lactate.METHODS:Using philometric method,65 cases developing drug adverse reactions to ciprofloxacin lactate,reported in domestic journals during the past 2 years,were analysed.RESULTS:Of the ARDs in 65 cases,40 were allergic reactions(61.5%),13 reactions of nervous system(12.3%),3 kidney function damage(4.6%),1 liver function damage,1 cardiovascular reaction(1.5%) and 6 reactions of urinary system.CONCLUSION:The ARDs should be under consideration in choice of ciprofloxalin lactate.