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 random...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.展开更多
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 s...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.展开更多
Although most people believe that herbal remedies are relatively safe to use, some are toxic or possess adverse reactions, especially when used incorrectly.Commonly used TCM herbs with known adverse reactions, as well...Although most people believe that herbal remedies are relatively safe to use, some are toxic or possess adverse reactions, especially when used incorrectly.Commonly used TCM herbs with known adverse reactions, as well as the most toxic herbs in the Pharmacopoeia of People’s Republic of China are listed as follows:展开更多
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 random...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.展开更多
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 unde...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%.展开更多
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,WanFan...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.展开更多
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 u...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.展开更多
The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor ...The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor and pre-cancer skin disease admitted to our hospital from January 20,2018 to September 18,2018 were selected,and all of them adopted photodynamic therapy.The 100 patients included 40 cases of basal cell carcinoma,14 cases of squamous cell carcinoma,7 cases of proliferative erythema,9 cases of Bowen’s disease and 39 cases of solar keratosis.Among the 100 patients,77 cases had excellent curative effect,18 cases had good effect and 5 cases had poor effect,and the overall effective rate was 95%(95/100).After 6 months of follow-up,5 cases of basal cell carcinoma,2 cases of squamous cell carcinoma,0 cases of proliferative erythra,1 case of Bowen’s disease and 3 cases of solar keratosis recurred,with an overall recurrence rate of 14%(14/100).The adverse reactions of pruritus were 90%(90/100),81%(81/100),90%(90/100)and 3%(3/100).Therefore,the application of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases is not only effective,but also safe and not easy to relapse.展开更多
Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gas...Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gastrodin-related preparations in clinical practice,and gastrodin injections are the most widely used.This article will summarize pharmacology and adverse reactions of gastrodin to evaluate its safety,effectiveness and quality control.Gastrodin has pharmacological effects on central nervous system(vertigo,headache,insomnia,neurasthenia,convulsions and epilepsy,etc.),cardiovascular system and other diseases(osteoporosis,osteoarthritis and bone injury,etc.),but we still need to pay attention to its clinical adverse reactions(some patients may have dry mouth and nose,dizziness and stomach discomfort).In addition,further research is needed in other fields,such as health products,food,cosmetics,etc.We also need to further develop and explore the new pharmacological effects of gastrodin and expand its medicinal value.展开更多
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 react...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.展开更多
Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hi...Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hirudin derivatives such as lepirudin,desirudin and bivalirudin,and the third is new hirudin preparations such as hirudin-bovine serum albumin(BSA)nanoparticles,polydopamine fitted titanium dioxide nanoparticles systems and recombinant hirudins-2(rhv2)-loaded picmice.The pharmacological effects and adverse reactions of hirudin were reviewed to evaluate its safety,efficacy and quality control.Hirudin has obvious pharmacological effects on cardio-cerebrovascular diseases(coronary atherosclerotic heart disease,myocardial infarction,hyperlipidemia,cerebral infarction,arteriosclerosis obliterans of lower extremities),angiogenesis(fracture,skinflaptransplantation),tissue fibrosis,tumor,ophthalmopathy,hyperuricemia and female infertility.However,attention should be paid to clinical adverse reactions(bleeding,allergic reaction,infection,cutaneous pseudolymphoma).展开更多
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. W...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.展开更多
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 acr...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.展开更多
Objective The aim of this study was to analyze whether Jinlong capsule could decrease adverse reactions after transcatheter arterial chemoembolization(TACE) in patients with hepatocellular carcinoma. Methods Eighty-tw...Objective The aim of this study was to analyze whether Jinlong capsule could decrease adverse reactions after transcatheter arterial chemoembolization(TACE) in patients with hepatocellular carcinoma. Methods Eighty-two patients with hepatocellular carcinoma were randomly divided into the control group and experimental group. On the first day after TACE, the experimental group started receiving four Jinlong capsules orally three times daily, whereas the control group did not receive the treatment.Results The incidences of erythropenia and thrombocytopenia in the experimental group was lower than those in the control group(P = 0.040 and 0.033, respectively). The differences in serum levels of aminotransferase, albumin, potassium, and sodium between the two groups were significant(P = 0.034, 0.034, 0.013, and 0.044, respectively). The mean durations of stomachache and abdominal distension in the experimental group was significantly shorter than those in the control group(P = 0.004 and 0.021, respectively). However, there were no significant differences in the incidences of nausea, fever, and vomiting between the two groups(P = 0.490, 0.495, and 0.585, respectively). Conclusion The reduction in the incidence rate and duration of partial adverse reactions after TACE was observed in hepatocellular carcinoma patients treated with Jinlong capsule compared to untreated patients, suggesting possible beneficial effects exerted by Jinlong capsule on the reduction of TACE-induced liver damage, thereby improving liver function and, consequently, the quality of life.展开更多
Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical...Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.展开更多
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,trea...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.展开更多
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 digit...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.展开更多
Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions af...Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions after chemotherapy for non-Hodgkin lymphoma(NHL).Methods:A total of 60 cases with NHL under chemotherapy were divided into two groups by hospitalization order,with 30 cases in each group.The control group was treated with routine nursing and the observation group was additionally given point application with Da Hueng(Rhizome Rhei Crude)powder plus moxa-salt hot compress on the umbilicus,to compare the effect in preventing gastrointestinal adverse reactions after chemotherapy between the two groups.Results:The occurrence rates of constipation,nausea,vomiting and poor appetite on the second day and fifth day after chemotherapy were obviously lower in the observation group than those in the control group,with statistically significant differences between the two groups(all P〈0.05).Conclusion;The point application with De Hueng(Rhizome Rhei Crude)powder at Shenque(CV 8)plus maxa-salt hot compress on the umbilicus can produce more significant efficacy in preventing the gastrointestinal adverse reactions after chemotherapy for NHL than routine nursing.Moreover,it is simple and easy to be used and popularized.展开更多
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 ...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.展开更多
A systematic summary was used to evaluate case reports of adverse drug reactions(ADRs)caused by linezolid,and to explore the effects and severity on human organs or systems in the real world.The databases,such as PubM...A systematic summary was used to evaluate case reports of adverse drug reactions(ADRs)caused by linezolid,and to explore the effects and severity on human organs or systems in the real world.The databases,such as PubMed,Embase,Cochrane Library,and CINAHL,were searched using“linezolid”+“case reports”as search terms from the establishment of each database to 31 st December 2019,and the case reports on ADRs related to linezolid were collected.A total of 159 case reports were finally included in the analysis,including 189 patients.The ratio of male to female was 0.89:1,and the average age was(52.42±23.43)years old.The results showed that linezolid-related severe ADRs mainly occurred in the nervous system(n=86)and blood system(n=44),followed by the metabolic system(n=31)and gastrointestinal system(n=18).Other systems reported less frequently were the skin tissue(n=6),renal and urinary system(n=3),cardiovascular systems(n=2),and hepatobiliary system(n=2).The most common linezolid-related ADRs were serotonin syndrome(n=40),followed by optic neuropathy(n=25)and thrombocytopenia(n=22).The most severe ADR was lactic acidosis(n=29),and its death rate was as high as 31.0%.In the blood system ADRs,11 cases had underlying diseases of renal impairment,and four of them died.Moreover,22 cases with thrombocytopenia were mainly elderly over 65 years old(n=17),and there were also one infant and one child with thrombocytopenia.We first reported that lactic acidosis and blood system ADRs mostly occurred within 28 d,and the nervous system ADRs mostly occurred after 28 d.Besides,irreversible auditory neuropathy(n=1),hypophosphatemia(n=1),bradycardia(n=1),and tooth discoloration mostly occurring in minors(n=5)were the linezolid-related ADRs,which were not described in the instructions,related guidelines,and clinical trials of linezolid.The most severe linezolid-related ADRs was lactic acidosis that occurred within 28 d.Renal damage and special populations might be the main risk factors in the blood system ADRs.Minor linezolid-related ADRs were rare,while there were still some cases of auditory neuropathy,hypophosphatemia,bradycardia,and tooth discoloration.展开更多
文摘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.
文摘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.
文摘Although most people believe that herbal remedies are relatively safe to use, some are toxic or possess adverse reactions, especially when used incorrectly.Commonly used TCM herbs with known adverse reactions, as well as the most toxic herbs in the Pharmacopoeia of People’s Republic of China are listed as follows:
文摘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.
文摘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%.
基金funded the Province Natural Science key Foundation of Hainan(No:ZDYFXGFY2020004 and No:ZDYF 2019125)the National Natural Science Foundation of China(No:81960351)Hainan Province Clinical Medical Center.
文摘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.
文摘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.
文摘The purpose of the study was to investigate the efficacy and safety of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases.First of all,100 patients with malignant skin tumor and pre-cancer skin disease admitted to our hospital from January 20,2018 to September 18,2018 were selected,and all of them adopted photodynamic therapy.The 100 patients included 40 cases of basal cell carcinoma,14 cases of squamous cell carcinoma,7 cases of proliferative erythema,9 cases of Bowen’s disease and 39 cases of solar keratosis.Among the 100 patients,77 cases had excellent curative effect,18 cases had good effect and 5 cases had poor effect,and the overall effective rate was 95%(95/100).After 6 months of follow-up,5 cases of basal cell carcinoma,2 cases of squamous cell carcinoma,0 cases of proliferative erythra,1 case of Bowen’s disease and 3 cases of solar keratosis recurred,with an overall recurrence rate of 14%(14/100).The adverse reactions of pruritus were 90%(90/100),81%(81/100),90%(90/100)and 3%(3/100).Therefore,the application of photodynamic therapy in the treatment of malignant skin tumors and precancerous skin diseases is not only effective,but also safe and not easy to relapse.
文摘Gastrodin(4-hydroxymethylphenyl-β-d-glucopyranoside)is an active ingredient with high content,which is isolated from the rhizome of Gastrodia elata.Gastrodin injections,tablets and capsules are currently the main gastrodin-related preparations in clinical practice,and gastrodin injections are the most widely used.This article will summarize pharmacology and adverse reactions of gastrodin to evaluate its safety,effectiveness and quality control.Gastrodin has pharmacological effects on central nervous system(vertigo,headache,insomnia,neurasthenia,convulsions and epilepsy,etc.),cardiovascular system and other diseases(osteoporosis,osteoarthritis and bone injury,etc.),but we still need to pay attention to its clinical adverse reactions(some patients may have dry mouth and nose,dizziness and stomach discomfort).In addition,further research is needed in other fields,such as health products,food,cosmetics,etc.We also need to further develop and explore the new pharmacological effects of gastrodin and expand its medicinal value.
基金Key Research Project of Scientific and Educational Innovation in the Institute of Educational Science,Chinese Academy of Management Sciences(Grant No:KJCX5406).
文摘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.
文摘Hirudin is an active ingredient extracted from leeches(Hirudo).At present,there are many hirudin preparations on the market,which are roughly divided into three categories,the first is natural hirudin,the second is hirudin derivatives such as lepirudin,desirudin and bivalirudin,and the third is new hirudin preparations such as hirudin-bovine serum albumin(BSA)nanoparticles,polydopamine fitted titanium dioxide nanoparticles systems and recombinant hirudins-2(rhv2)-loaded picmice.The pharmacological effects and adverse reactions of hirudin were reviewed to evaluate its safety,efficacy and quality control.Hirudin has obvious pharmacological effects on cardio-cerebrovascular diseases(coronary atherosclerotic heart disease,myocardial infarction,hyperlipidemia,cerebral infarction,arteriosclerosis obliterans of lower extremities),angiogenesis(fracture,skinflaptransplantation),tissue fibrosis,tumor,ophthalmopathy,hyperuricemia and female infertility.However,attention should be paid to clinical adverse reactions(bleeding,allergic reaction,infection,cutaneous pseudolymphoma).
文摘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.
基金supported by the Clinical Toxicology Foundation of the Chinese Society of Toxicology(No.CST2020CT107)the Research Project of the Drug Clinical Evaluation Professional Committee of the China Pharmaceutical Association(No.CPA-Z06-ZC-2021-004).
文摘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.
基金Supported by a grant from the Scientific Innovation Foundation of Xinjiang Medical University(No.XJC2013118)
文摘Objective The aim of this study was to analyze whether Jinlong capsule could decrease adverse reactions after transcatheter arterial chemoembolization(TACE) in patients with hepatocellular carcinoma. Methods Eighty-two patients with hepatocellular carcinoma were randomly divided into the control group and experimental group. On the first day after TACE, the experimental group started receiving four Jinlong capsules orally three times daily, whereas the control group did not receive the treatment.Results The incidences of erythropenia and thrombocytopenia in the experimental group was lower than those in the control group(P = 0.040 and 0.033, respectively). The differences in serum levels of aminotransferase, albumin, potassium, and sodium between the two groups were significant(P = 0.034, 0.034, 0.013, and 0.044, respectively). The mean durations of stomachache and abdominal distension in the experimental group was significantly shorter than those in the control group(P = 0.004 and 0.021, respectively). However, there were no significant differences in the incidences of nausea, fever, and vomiting between the two groups(P = 0.490, 0.495, and 0.585, respectively). Conclusion The reduction in the incidence rate and duration of partial adverse reactions after TACE was observed in hepatocellular carcinoma patients treated with Jinlong capsule compared to untreated patients, suggesting possible beneficial effects exerted by Jinlong capsule on the reduction of TACE-induced liver damage, thereby improving liver function and, consequently, the quality of life.
基金This research was financially supported by The National Key R&D Program of China(Grant No.2019YFC1709802).
文摘Objective:This article systematically analyses the effects of adverse drug events/adverse drug reactions(ADEs/ADRs)of oral Indigo Naturalis(Qingdai)preparations in order to provide references for its rational clinical application.Methods:All clinical studies reporting ADE/ADR related to the oral administration of Qingdai preparations were searched through electronic databases,including PubMed,the Cochrane Library,Embase,China National Knowledge Infrastructure(CNKI),China Biology Medicine disc(CBM),VIP Information Chinese Journal Service Platform(VIP),and Wanfang database,from inception to September 27,2020.Information were extracted from these literatures,including primary disease,type of adverse reactions,dose,treatment,outcomes and so on.Incidence of ADE/ADR was estimated,as well as distribution of primary diseases and victim organs and systems were analyzed.Results:A total of 682 articles were included,with 651 clinical population studies and 31 case reports.Among them,604 detailed ADR/AE involving 33459 patients using oral Qingdai preparations,and a total of 5061 cases were found to present adverse events,including 2827 cases of digestive system(abdominal pain,diarrhea,etc.),469 cases of blood system damage(thrombocytopenia,leukopenia,anemia,etc.),313 cases of liver damage(abnormal liver function,liver toxicity,elevated liver enzymes,etc.),327 cases of nervous system reactions(headache,dizziness,poor sleep,etc.)and 1186 cases of other systems and organs.Severe adverse events(SAEs)mainly were liver damage,and could be relived after symptomatic treatment.Conclusion:From the systematic information retrieval and analysis,it is found that oral Qingdai preparations application may clinically cause ADEs/ADRs in terms of gastrointestinal tract and liver damage.Therefore,when using oral Qingdai preparations,liver and stomach protection should be done.At the same time,pay close attention to various biochemical indicators and the patient's drug response during the treatment process,and,if necessary,deal with it in time so as not to deteriorate the condition.Moreover,active surveillance system should be conducted to monitor ADE/ADR,so as to establish a clearer causal relationship between the drug and the adverse event.
文摘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.
文摘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.
文摘Objective:To observe the clinical efficacy of point application with De Huang(Rhizome Rhei Crude)powder at Shenque(CV 8)plus moxa-salt hot compress on the umbilicus for preventing gastrointestinal adverse reactions after chemotherapy for non-Hodgkin lymphoma(NHL).Methods:A total of 60 cases with NHL under chemotherapy were divided into two groups by hospitalization order,with 30 cases in each group.The control group was treated with routine nursing and the observation group was additionally given point application with Da Hueng(Rhizome Rhei Crude)powder plus moxa-salt hot compress on the umbilicus,to compare the effect in preventing gastrointestinal adverse reactions after chemotherapy between the two groups.Results:The occurrence rates of constipation,nausea,vomiting and poor appetite on the second day and fifth day after chemotherapy were obviously lower in the observation group than those in the control group,with statistically significant differences between the two groups(all P〈0.05).Conclusion;The point application with De Hueng(Rhizome Rhei Crude)powder at Shenque(CV 8)plus maxa-salt hot compress on the umbilicus can produce more significant efficacy in preventing the gastrointestinal adverse reactions after chemotherapy for NHL than routine nursing.Moreover,it is simple and easy to be used and popularized.
基金supported by the National Science and Technology Major Project of China(2008ZX10003-009)the National Science and Technology Major Project of China(2013ZX10003-015)
文摘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.
文摘A systematic summary was used to evaluate case reports of adverse drug reactions(ADRs)caused by linezolid,and to explore the effects and severity on human organs or systems in the real world.The databases,such as PubMed,Embase,Cochrane Library,and CINAHL,were searched using“linezolid”+“case reports”as search terms from the establishment of each database to 31 st December 2019,and the case reports on ADRs related to linezolid were collected.A total of 159 case reports were finally included in the analysis,including 189 patients.The ratio of male to female was 0.89:1,and the average age was(52.42±23.43)years old.The results showed that linezolid-related severe ADRs mainly occurred in the nervous system(n=86)and blood system(n=44),followed by the metabolic system(n=31)and gastrointestinal system(n=18).Other systems reported less frequently were the skin tissue(n=6),renal and urinary system(n=3),cardiovascular systems(n=2),and hepatobiliary system(n=2).The most common linezolid-related ADRs were serotonin syndrome(n=40),followed by optic neuropathy(n=25)and thrombocytopenia(n=22).The most severe ADR was lactic acidosis(n=29),and its death rate was as high as 31.0%.In the blood system ADRs,11 cases had underlying diseases of renal impairment,and four of them died.Moreover,22 cases with thrombocytopenia were mainly elderly over 65 years old(n=17),and there were also one infant and one child with thrombocytopenia.We first reported that lactic acidosis and blood system ADRs mostly occurred within 28 d,and the nervous system ADRs mostly occurred after 28 d.Besides,irreversible auditory neuropathy(n=1),hypophosphatemia(n=1),bradycardia(n=1),and tooth discoloration mostly occurring in minors(n=5)were the linezolid-related ADRs,which were not described in the instructions,related guidelines,and clinical trials of linezolid.The most severe linezolid-related ADRs was lactic acidosis that occurred within 28 d.Renal damage and special populations might be the main risk factors in the blood system ADRs.Minor linezolid-related ADRs were rare,while there were still some cases of auditory neuropathy,hypophosphatemia,bradycardia,and tooth discoloration.