Prevention and Nursing of Adverse Reactions of Novel Coronavirus Inactivated Vaccine (Vero Cells)

Objective:To discuss and analyze the causes of adverse reactions caused by the inactivated novel coronavirus vaccine(Vero cells),and to propose methods of prevention and care.Methods:A questionnaire was used to randomly select 229 adults who were vaccinated with the inactivated novel coronavirus vaccine(Vero cells)at Xi’an People’s Hospital(Xi’an Fourth Hospital).The adverse reactions were statistically analyzed.Results:Among the 229 adults vaccinated with the inactivated novel coronavirus vaccine(Vero cells),30 experienced vaccination reactions.The main reaction was local induration at the inoculation site,and dizziness was the primary systemic symptom.Conclusion:To reduce the incidence of adverse reactions to the inactivated novel coronavirus vaccine(Vero cells),it is necessary to effectively evaluate the health status of adults before vaccination,select the correct vaccination site,and strictly implement the rules of 3-inspections,7-checks,and 1-verification.Standardizing the operation process and providing thorough health education after vaccination can effectively reduce the occurrence of adverse reactions.

Protective Effect of Oral Steroid Premedication: Adverse Reactions to Nonionic Iodine Contrast Media for Computed Tomography

This study aimed to investigate the protective effect of oral steroid premedication in terms of adverse reactions to non-ionic contrast media. We investigated the incidence of adverse reactions among patients who underwent contrast-enhanced computed tomography. Patients in the premedication group took 30 mg of prednisolone orally the night before and on the morning of the scheduled computed tomography. Sixty-five patients received the same contrast media. Among them, 56 took prednisolone orally prior to the procedure (premedication without change of contrast media group) and nine without premedication (no premedication and no change of contrast media group). In total, 379 patients received different contrast media. Among them, 340 took prednisolone orally (premedication with change of contrast media group), while 39 did not take the premedication (no premedication with change of contrast media group). The adverse reaction rates in the premedication with change of contrast media and no premedication with change of contrast media groups were 1.8% (6/340 cases) and 2.6% (1/39 cases) (P = 0.54), respectively. The incidence of adverse reaction after the administration of non-ionic iodinated contrast media did not differ significantly based on whether an oral steroid was administered prior to compute tomography. Our evaluation is limited due to the small sample size of the contrast media-changed group. However, even if premedication with steroids is effective, it may only result in an adverse reaction reduction rate of ≤3%.

Why Don’t We Adequately Identify and Manage Adverse Drug Reactions despite Having the Needed Information?

Importance/Objective: Adverse Drug Reactions (ADRs) are unavoidable, but recognizing and addressing ADRs early can improve wellness and prevent permanent injury. We suggest that available medical information and digital/electronic methods could be used to manage this major healthcare problem for individual patients in real time. Methods: We searched the available digital applications and three literature databases using the medical subject heading terms, adverse drug reaction reporting systems or management, filtered by clinical trial or systemic reviews, to detect publications with data about ADR identification and management approaches. We reviewed the reports that had abstract or summary data or proposed or implemented methods or systems with potential to identify or manage ADRs in clinical settings. Results: The vast majority of the 481 reports used retrospectively collected data for groups of patients or were limited to surveying one population group or class of medication. The reports showed potential and definite associations of ADRs for specific drugs and problems, mostly, but not exclusively, for patients in hospitals and nursing homes. No reports described complete methods to collect comprehensive data on ADRs for individual patients in a healthcare system. The digital applications have ADR information, but all are too cumbersome or incomplete for use in active clinical settings. Several studies suggested that providing information about potential ADRs to clinicians can reduce these problems. Conclusion and Relevance: Although investigators and government agencies agree with the need, there is no comprehensive ADR management program in current use. Informing the patient’s healthcare practitioners of potential ADRs at the point of service has the potential for reduction of these complications, which should improve healthcare and reduce unneeded costs.

Incidence of adverse reactions to COVID-19 vaccination:A meta-analysis of randomized controlled trials

Objective:To systematically evaluate the incidence of adverse reactions to coronavirus disease 2019(COVID-19)vaccination.Methods:We systematically searched PubMed,Embase,The Cochrane Library,Web of Science,CNKI,WanFang Data,and VIP Database from the inception of each database to August 31,2021.Randomized controlled clinical trials(RCTs)on the safety of different types of COVID-19 vaccines were retrieved and analyzed.A random or fixed-effects model was used with an odds ratio as the effect size.The quality of each reference was evaluated.The incidence of the adverse reactions of the placebo group and the vaccination group was compared.Heterogeneity and publication bias were taken care of by meta-regression and sub-group analyses.Results:A total of 13 articles were included,with 81287 subjects.Compared with the placebo group,the vaccination group showed a higher combined risk ratio(RR)of total adverse reactions(RR=1.67,95%CI:1.46-1.91,P<0.01),local adverse reactions(RR=2.86,95%CI:2.11-3.87,P<0.01),systemic adverse reactions(RR=1.25,95%CI:0.92-1.72,P=0.16),pain(RR=2.55,95%CI:1.75-3.70,P<0.01),swelling(RR=4.16,95%CI:1.71-10.17,P=0.002),fever(RR=2.34,95%CI:1.84-2.97,P<0.01),fatigue(RR=1.36,95%CI:1.32-1.41,P<0.01)and headache(RR=1.22,95%CI:1.18-1.26,P<0.01).The subgroup analysis showed the incidence of adverse reactions of the vaccination group after injection of the three COVID-19 vaccines(inactivated viral vaccines,mRNA vaccines and adenovirus vector vaccines)was higher than that of the placebo group,and the difference between the placebo group and the vaccination group in the mRNA vaccine subgroup and the adenovirus vector vaccine subgroup was statistically significant(P<0.01).The incidence of adverse reactions after injection of COVID-19 vaccine in subgroups of different ages was significantly higher than that in the placebo group(P<0.01).Conclusions:COVID-19 vaccines have a good safety,among which adenovirus vector vaccine has the highest incidence of adverse reactions.Both adolescents and adults vaccinated with novel coronavirus vaccine have a certain proportion of adverse reactions,but the symptoms are mild and can be relieved by themselves.Our meta-analysis can help boost global awareness of vaccine safety,promote mass vaccination,help build regional and global immune barriers and effectively curb the recurrency of COVID-19.

Safely Using TCM Herbs: Adverse Reaction and Precautions (Continued)

Chan su (Venenum Bufonis,蟾酥)Its main active and toxic constituent is bufotoxin, which has a function similar to digitalis glycosides.Adverse reactions and toxicity: Chan su, althoughit is used in patent preparations, is traditionally known for its toxicity and is seldom used in decoctions. Toxicity is often due to over dosage of the patents, such as Liushenwan (六神丸) and Houzhengwan (喉症丸). After administration

The effects of Chinese herbal medicines on Madopar dose and adverse reaction during the maintenance phase of Parkinson's disease:a systematic review with meta-analysis

Background:Parkinson’s disease is a progressive neurodegenerative disease,and is usually treated with levodopa combined with dopa decarboxylase inhibitor like Madopar.In order to improve the efficacy and reduce adverse reactions,Chinese herbal medicines are usually applied with Madopar to treat Parkinson’s disease in clinic.According to the results of certain randomized controlled trials,levodopa drugs combined with Chinese herbal medicines could achieve better effects like the improvement of clinical symptoms,the reduced incidence of adverse reactions,and the reduced dose of levodopa drugs(especially in the maintenance phase).However,not all the randomized controlled trials showed favorable effect on Parkinson’s disease.Therefore,it is necessary to find out how to effectively combine Chinese herbal medicines with Madopar.In order to evaluate the effects of Chinese herbal medicines on Madopar dose and adverse reaction during the maintenance phase of Parkinson’s disease,a meta-analysis was conducted.Methods:A systematic research was carried out for randomized controlled trials of combined Chinese herbal medicines and Madopar treatment for Parkinson’s disease during the maintenance phase published till August 2019.The primary outcome was the Madopar dose and secondary outcome was the incidence of adverse reaction.Data were pooled and analyzed with RevMan 5.3.Results:A total of 18 studies were included with 1,169 cases.However,study quality evaluation showed low methodological quality.Meta-analyses showed that the dose of Madopar in the treatment group was significantly lower than that in the control group,and the incidence of adverse reactions in the treatment group was also significantly lower than that in the control group.However,the correlation analysis showed that the reduction of Madopar dose was not related to the reduction of incidence of adverse reactions(P>0.05).There existed publication bias on the primary outcome and secondary outcome.Conclusions:Chinese herbal medicines could reduce the Madopar dose and adverse reaction during the maintenance phase of Parkinson’s disease treatment.This conclusion must be considered cautiously,for lack of studies of high quality.

Clinical analysis of 198 cases of western medicine adverse reaction

Objective: To discuss the clinical symptoms of western medicine adverse reaction, and to provide basis for clinical rational drug use. Methods: Clinical data of 198 patients with adverse drug reactions were retrospectively analyzed in our hospital. Adverse reactions clinical manifestations, the types of drugs and the route of medication were summarized. Results: The first two common adverse reactions were anti-infective drugs and cardiovascular system drugs respectively. In-tramuscular injection and intravenous administration were two main routes of medication for adverse drug reactions. The main clinical symptoms of adverse reactions were digestive tract and anaphylactic shock etc. After treatment, 184 patients recovered and 14 patients got better. Conclusions: In order to reduce the incidence of adverse reactions as far as possible, clinicians should do a good job of rational use of drugs and attach importance to the safety of drug use. Adverse reactions monitoring can reduce the occurrence of adverse reactions and ensure the safety of clinical treatment.

Effect of Bevacizumab Combined with Neoadjuvant Chemotherapy in Advanced Ovarian Cancer and the Occurrence of Adverse Reactions

Objective:To explore the effect of bevacizumab combined with neoadjuvant chemotherapy in advanced ovarian cancer and the occurrence of adverse reactions.Methods:A total of 80 patients with advanced ovarian cancer,treated in Affiliated People's Hospital of Inner Mongolia Medical University from June 2019 to December 2020,were randomly divided into two groups.In the chemotherapy group,40 patients were treated with neoadjuvant chemotherapy,while in the combined group,another 40 patients were treated with bevacizumab combined with neoadjuvant chemotherapy.The therapeutic effects were compared at the end of the treatment cycle.Results:There was no significant difference in the levels of CA125,CEA,and VEGF between the two groups before treatment.However,after the treatment cycle,the levels of CA125,CEA,and VEGF in the combined group were significantly better than those in the chemotherapy group(P<0.05).At the same time,the incidence of adverse reactions of the chemotherapy group was 67.50%,which was significantly higher than that of the combined group(35.00%;P<0.05).Conclusion:Bevacizumab combined with neoadjuvant chemotherapy for patients with advanced ovarian cancer has significant curative effect.The combined therapy reduces the levels of tumor markers and inflammatory factors,improves patients'quality of life,as well as reduces adverse reactions.It has high clinical promotion value.

Analysis of Adverse Reactions in the Treatment of COVID-19 with Three Chinese Patent Medicines and Three Herbal Formulas

Objective To explore the rules and characteristics of the adverse drug reactions(ADRs)of three Chinese patent medicines and three herbal formulas for the treatment of COVID-19,and to provide a reference for clinical safe medication.Methods The cases and ADR reports of the three Chinese patent medicines and three herbal formulas in PubMed,Web of Science,Springer Link,CNKI,Wanfang and VIP database were retrieved from December 2019 to May 2021.Then we extracted and analyzed the effective information included in the literature.Results and Conclusion According to the pre-developed retrieval plan,a total of 136 documents were obtained,and a total of 6 documents met the inclusion criteria finally.553 patients used three Chinese patent medicines and three herbal formulas,and there were 133 cases of adverse reactions.The adverse reactions of patients taking the three Chinese patent medicines and three herbal formulas can all be explained under the theory of traditional Chinese medicine,and the adverse reactions can be eliminated by adding or subtracting the flavor of the medicine or stopping the medicine.

Clinical features of adverse reactions associated with telbivudine

AIM: To analyze the clinical features and risk factors of adverse reactions associated with telbivudine. METHODS: Clinical data were collected from cases that presented with serious adverse reactions to telbivudine. We analyzed general information and medicine status, clinical features, results of examination, and misdiagnosis. RESULTS: Out of 105 patients who were treated with telbivudine for hepatitis B in an outpatient department from January, 2007 to January, 2008, five presented with serious adverse drug reactions. Most of these five patients had used other nucleoside analogues in the past. Four were treated with a combination of telbivudine and interferon or another nucleoside analogue, while the other received an increased dose of telbivudine. The main adverse reactions were myalgia and general weakness. This was accompanied by cardiac arrhythmia in one patient, and nervous symptoms in three. Serum creatine kinase was elevated. The rate of misdiagnosis was high. CONCLUSION: The adverse reactions were related to telbivudine, but the biological mechanism of the reactions is not yet clear. Combination therapy with interferon or another nucleoside analogue and a high dose may increase the risk of adverse reactions.

Clinical observation of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer

Objective: To observe the efficacy of Shenmai injection in the treatment for adverse reactions of chemotherapy on advanced non-small cell lung cancer (NSCLC). Methods: 45 NSCLC patients with stages IIIb-IV were randomly divided into two groups: the treatment group (treated by chemotherapy combined with Shenmai injection) and the control group (treated by chemotherapy only). The efficacy of the two groups was evaluated after 3 cycles of treatment. Results: There was no significant difference between the two groups in the recent curative effects (P > 0.05), while there were significant differences between them in Karnofsky score and weight (P < 0.05). The treatment group was better than the control group in preventing leucopenia and decreased hemoglobin, and significant differences were found between them (P < 0.05). The incidence of thrombocytopenia, nausea and vomiting, hepatic and renal dysfunction in the treatment group was lower than that in the control group, but no significant differences were found between them (P > 0.05). Conclusion: Shenmai injection would not influence the efficacy of chemotherapy on advanced NSCLC patients, while it could improve the quality of life, increase the body weight of patients, alleviate adverse reactions of chemotherapy as myelosuppression so as to improve the tolerance of organism to chemotherapy.

Attention and Intervention of Oncologists on Oxaliplatin-induced Adverse Reactions in China' Mainland:A Cross-sectional Internet-based Survey

Objective This cross-sectional study aimed to investigate the current attention and intervention of oncologists on oxaliplatin(OXA)-induced adverse reactions(ADRs).Methods In 31 provinces or administrative regions across China,401 oncologists were surveyed through a self-designed questionnaire.The survey queried the basic information of respondents,clinical use of OXA,OXA-induced ADRs,and relative interventions.Chi-square tests and multiple logistic regression were used to explore the sociodemographic factors influencing the safety perception of OXA and the relevant interventions.Results The survey showed that the age of respondents was mainly distributed between 30 and 40 years and the working period for most oncologists was no more than 5 years.Oncologists with long working years were more willing to conduct patient education and inquire about ADRs than those with short working years.The rate of ADRs reported by oncologists with intermediate professional titles was significantly higher than that reported by oncologists with junior and senior professional titles.Conclusion Our findings indicate that oncologists in China's Mainland are concerned about OXA-induced ADRs,but the reporting of ADRs still needs to be strengthened.Therefore,training and educational programs are urgently needed to improve the risk management of OXA-induced ADRs among oncologists.

A Case of Adverse Reaction to Booster Dose of COVID-19 Vaccination: Could D-Dimer Elevation Suggest Increased Clotting Risk?

We report the clinical case of a 40-year-old Italian woman, who soon after her booster vaccination with mRNA-1273 after the two previous vaccinations with BNT162b2, developed severe headache, high fever, and Musculo-skeletal pain. She went to the emergency department, where computerized tomography (CT) scans of chest and brain were performed, resulting in both negative for pathologic findings. On the contrary, white blood count was strongly lowered and D-dimer severely elevated. She improved after treatment with enoxaparin and the blood analyses returned in the normal range after ten days. This case supports the hypothesis that COVID-19 vaccines could increase blood clotting in some predisposed subjects. Therefore, we believe that robust and well-designed clinical trials, considering the evaluation of D-dimer levels, should be performed to eliminate any doubts on this issue.

Analysis of the adverse reactions of atezolizumab: A real-world study based on FAERS database

Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.

Study on the Management Effect of Pharmaceutical Care on Adverse Reactions of Traditional Chinese Medicines in Joint Surgery and Neurology

Objective:In general hospitals,pharmaceutical care was carried out to reduce the incidence of adverse drug reactions(ADR),and this effect was significant.It can significantly reduce the incidence of adverse drug reactions and improve the safety of drug therapy.The Joint Surgery Department and the Department of Neurology of Changle County People's Hospital in Shandong province were investigated for the effect of pharmaceutical care on reducing adverse drug reactions.Methods:120 patients were selected from the Department of Joint Surgery and Neurology,Changle County People's Hospital,Shandong Province from May 2015 to May 2020.According to the random table method,the patients were divided into experimental group(60 cases)and control group(60 cases).Control group:routine drug therapy.Experimental group:pharmaceutical care treatment was carried out jointly,and the incidence of adverse reactions was compared between the two groups.Results:The incidence of adverse reactions in experimental group was lower than that in control group.Conclusion:In general hospitals,pharmaceutical care is effective in reducing adverse drug reactions,which can significantly reduce the incidence of adverse drug reactions.At the same time,this improves the safety of drug treatment,which is worthy of clinical promotion.

A case of adverse reactions of immune thrombocytopenic purpura caused by poliovirus vaccine

The child patient, male, 4 months and 16 days old, was vaccinated orally by Type I Type III Live Attenuated Oral Poliomyelitis Vaccine (human diploid cells) at 10:45 a.m. on June 1st of 2016 in Shaoxian Community Health Service Center of our hospital. Two hours after vaccination, the child patient showed erythema scattered on the upper of the left knee, on the right calf and on the abdomen. The forearm of the left upper limb was scattered with punctate rashes. He was admitted to Department of Pediatrics of our hospital at 12:32 on June 1st of 2016. The diagnosis was 'immune thrombocytopenic purpura'. After admission, the child patient received expert consultation and systematic treatment, consequently getting better.

"Endogenous wind " Theory theory in the prevention and treatment of anti-tumor treatment-related adverse reaction related research progress

The treatment of malignant tumor is mainly based on modern medical treatment,after treatment,there are many adverse reactions,such as dizziness,headache,fever,numbness of limbs,pruritus,rash,spasm,phalacrosis,elevated blood pressure,anemia,myelosuppression,impaired functions of liver and kidney."Endogenous wind"is a part of Traditional Chinese medicine,and the researches are mainly focused on tumor metastasis and treatment.The researches on the adverse reactions associated with the treatment of malignant tumors are less.This paper is built on the theory of"endogenous wind"of Chinese medicine,and initially analyzes the progress of the research on adverse reactions of malignant tumors after treatment by modern medical means.

A Personalized Adverse Drug Reaction Early Warning Method Based on Contextual Ontology and Rules Learning

Background: The fatality of adverse drug reactions (ADR) has become one of the major causes of the non-natural disease deaths globally, with the issue of drug safety emerging as a common topic of concern. Objective: The personalized ADR early warning method, based on contextual ontology and rule learning, proposed in this study aims to provide a reference method for personalized health and medical information services. Methods: First, the patient data is formalized, and the user contextual ontology is constructed, reflecting the characteristics of the patient population. The concept of ontology rule learning is then proposed, which is to mine the rules contained in the data set through machine learning to improve the efficiency and scientificity of ontology rule generation. Based on the contextual ontology of ADR, the high-level context information is identified and predicted by means of reasoning, so the occurrence of the specific adverse reaction in patients from different populations is extracted. Results: Finally, using diabetes drugs as an example, contextual information is identified and predicted through reasoning, to mine the occurrence of specific adverse reactions in different patient populations, and realize personalized medication decision-making and early warning of ADR.

Prevalence and Risk Factors Associated with Adverse Drug Reactions among Previously Treated Tuberculosis Patients in China

We assessed the incidence of adverse drug reactions （ADRs） with anti-TB medications and evaluated the risk factors for developing ADRs in previously treated tuberculosis patients in China. All patients received the first-line anti-TB regimen （2HREZS/6HRE） as recommended by the national guidelines.

Anlotinib-induced sick sinus syndrome:Two case reports

BACKGROUND This manuscript describes the first known cases of sick sinus syndrome(SSS)associated with the use of anlotinib in non-small cell lung cancer patients,highlighting the need for increased vigilance and cardiac monitoring.CASE SUMMARY Two patients with non-small cell lung cancer developed SSS after 15 months and 5 months of anlotinib treatment,respectively,presenting with syncope and palpit-ations.Electrocardiogram confirmed SSS,and different treatment approaches were taken for each patient.One patient received a dual-chamber permanent pacemaker,while the other discontinued the medication and experienced symptom resolution.CONCLUSION Anlotinib can induce SSS,suggesting that cardiac monitoring is crucial during anlotinib treatment.Individualized management strategies are necessary for affected individuals.