Background: Achieving the long terms goals of antiretroviral treatment (ART) requires a careful approach during treatment initiation that takes into account patient’s psychosocial state, availability and accessibilit...Background: Achieving the long terms goals of antiretroviral treatment (ART) requires a careful approach during treatment initiation that takes into account patient’s psychosocial state, availability and accessibility of treatment combinations, and adherence support. Adverse drug reactions that occur during the initial phases have a bearing on treatment outcomes and thus need to be monitored and treated. Objective: This study was done to assess length of time (survival time) it took for clinically significant adverse drug reactions to occur in patients taking Nucleoside Reverse Transcriptase Inhibitors (N(t)RTI) available for treatment of Human Immunodeficiency Virus (HIV) infection in Zimbabwe. Methods: A retrospective cohort of patient data collected from January 2009 to December 2012 was extracted from an Electronic Health Record database. Data from patients who were initiated on antiretroviral (ARV) drug regimens containing N(t)RTI drugs were analysed for survival time. A sample of 205 patient files was extracted for the time period for survival analysis using adverse drug reactions due to N(t)RTI drugs. Results: After data extraction, a total of 205 patient records were used in determining the time to event analysis of ADR’s in the cohort. The age range for the patients included in the study was 9 - 76 with a mean of 41 years (s.d = 14.8). Patients initiated on stavudine had a lower survival time before a clinically significant ADR compared to tenofovir (-365 days, p-value < 0.0005). Patients on zidovudine also had a less time before a significant reaction compared to those on tenofovir (-230 days;p-value = 0.008). Patients on zidovudine fared better compared to those on stavudine (-134 days;p-value < 0.0005). The mean survival time was highest for tenofovir (618 days), followed by zidovudine (388 days), and then stavudine (254 days).Conclusion: Patients on tenofovir have a longer survival time before a clinically significant adverse reaction. Treatment programmes need to continue commencing patients on tenofovir containing regimens as patients can be maintained for longer periods on this regimen.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
BACKGROUND Novel oral anticoagulants(NOACs)are commonly used for the anticoagulation of patients with atrial fibrillation.Reports of thrombocytopenic toxicity of NOACs are limited.In this report,we present a case of t...BACKGROUND Novel oral anticoagulants(NOACs)are commonly used for the anticoagulation of patients with atrial fibrillation.Reports of thrombocytopenic toxicity of NOACs are limited.In this report,we present a case of thrombocytopenia likely induced by rivaroxaban,which is an extremely rare adverse drug reaction.CASE SUMMARY A 70-year-old man presented to the cardiovascular department with a chief complaint of intermittent chest tightness and dyspnea over the last five years.Vital signs were within normal limits at presentation,with a heart rate of 65 beats/min,blood pressure of 138/78 mmHg,respiratory rate of 19 breaths/min,and temperature of 36.1°C.Laboratory tests indicated a platelet count of 163×109/L on admission.Anticoagulant therapy with rivaroxaban,a NOAC,was started on the second day of hospitalization.The platelet count decreased to 30×109/L on hospital day 11 and then 10×109/L on day 12.Rivaroxaban was stopped on day 13 when the platelet count decreased to 5×109/L.After the cessation of rivaroxaban,the platelet count returned to normal.The patient was diagnosed with thrombocytopenia,which was likely induced by rivaroxaban.The incidence of thrombocytopenic toxicity of NOACs is extremely low.CONCLUSION Thrombocytopenia during anticoagulation therapy may be associated with a high risk of life-threatening bleeding.For elderly patients,changes in platelet count should be carefully monitored at the beginning of NOAC treatment,and we should be on the alert for bleeding events as well.展开更多
BACKGROUND Latamoxef shows excellent antibacterial activity against anaerobic bacteria such as Bacteroides fragilis.Reports of thrombocytopenic toxicity of latamoxef are limited.This report presents a case of severe t...BACKGROUND Latamoxef shows excellent antibacterial activity against anaerobic bacteria such as Bacteroides fragilis.Reports of thrombocytopenic toxicity of latamoxef are limited.This report presents a case of severe thrombocytopenia possibly induced by latamoxef,an infrequent adverse drug reaction in a young patient with tuberculosis and Crohn's disease in China.CASE SUMMARY We reported a case of severe thrombocytopenia induced by latamoxef in a 28-year-old man with tuberculosis and Crohn's disease.On admission,the patient presented with a cough productive of bloody sputum,a chest computed tomogram suggested scattered mottled,high-density shadows in both lungs.Laboratory tests indicated a platelet count of 140000/μL.Considered a pulmonary bacterial infection,the patient received anti-infection therapy with latamoxef(dose:2.0 g)intravenously Q12h.On the 9th day of treatment,the platelet count decreased to 44000/μL.On the 12th day,scattered purpura and ecchymosis appeared on the patient’s limbs and trunk,and the platelet count decreased to 9000/μL after latamoxef treatment for 15 d.Three days after discontinuation of latamoxef,the platelet count recovered to 157000/μL,and the area of scattered purpura and ecchymosis on the limbs and trunk decreased.The platelet counts remained in the normal range,and no thrombocytopenia was found at follow-up 15 mo after discharge.CONCLUSION For patients treated with latamoxef,platelet counts should be carefully followed,and caregivers should be vigilant for the appearance of scattered ecchymosis.展开更多
[Objectives] To make a systematic evaluation on the therapeutic efficacy and safety of Yiqi Huoxue traditional Chinese drugs combined with western medicine in treatment of coronary heart disease( CHD) after coronary r...[Objectives] To make a systematic evaluation on the therapeutic efficacy and safety of Yiqi Huoxue traditional Chinese drugs combined with western medicine in treatment of coronary heart disease( CHD) after coronary revascularization. [Methods] The literatures were retrieved from China Knowledge Infrastructure( CNKI),Chinese science and technology journal full-text database( VIP database,VIP),Wanfang Data,the Chinese biomedical Database,Pub Med,Embase,and the Cochrane Library. The retrieval time was set to the creation of the database to January 2017. The randomized controlled trial( RCT) was conducted on the comparison between Yiqi Huoxue Chinese drugs combined with western medicine and the western medicine alone in the treatment of CHD after coronary revascularization. The literature information was extracted and the methodological quality of the included literature was evaluated according to the bias risk assessment tool developed by the Cochrane Collaboration. Meta-analysis was performed with the aid of Rev Man 5. 3 software. Coronary artery restenosis rate,angina pectoris treatment efficiency,left ventricular ejection fraction( LVEF),left ventricular end-diastolic volume( LVEDV),B-type natriuretic peptide( BNP),6-minute walk test( 6 MWT),and adverse reactions were analyzed. [Results] A total of 29 articles were included,a total of2 518 patients,the literature quality was low. Meta-analysis results showed that compared with the treatment by western medicine alone,Yiqi Huoxue Chinese drugs combined with western medicine could further reduce coronary restenosis rate[RR = 0. 45,95% CI( 0. 34,0. 60),P <0. 000 01],improve the angina pectoris treatment efficiency[RR = 1. 13,95% CI( 1. 05,1. 21),P = 0. 000 5],raise LVEF[WMD = 4. 25,95% CI( 3. 46,5. 04),P < 0. 000 01],reduce LVEDV[WMD =-10. 41,95% CI(-17. 88,-2. 95),P = 0. 006],decrease the plasma BNP level[WMD =-32. 32,95% CI(-44. 92,-19. 72),P < 0. 000 01],and increase 6 MWT distance(WMD = 62. 25,95% CI( 21. 71,102. 78),P = 0. 003)[Conclusions]Yiqi Huoxue Chinese drugs combined with western medicine can alleviate the symptoms of angina pectoris,reduce the rate of coronary restenosis,improve heart function and improve exercise capacity,thereby improving clinical efficacy in patients with CHD after coronary revascularization.展开更多
目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、...目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、PubMed、Web of Science等中英文数据库,对VDZ相关肺毒性的病例报道进行汇总分析。结果该患者在使用VDZ期间发生间质性肺炎,予抗菌药物经验性抗感染治疗无改善;停用VDZ并予甲泼尼龙治疗后,患者的症状及影像学检查均有改善但仍提示间质性肺炎。经Naranjo's不良反应评估量表评估并根据我国《药品不良反应报告和监测工作手册》判断,VDZ与间质性肺炎的关联性均为“很可能”。文献分析结果显示,纳入的29例患者(含本文报道的患者)中,男性19例、女性10例,平均年龄(49.24±17.06)岁;肺毒性主要包括VDZ相关性肺炎、嗜酸性粒细胞肺炎、肺肉芽肿或坏死性结节、间质性肺损伤等,多发生在用药后24周以内(58.62%),主要临床表现为咳嗽、呼吸困难、发热等;绝大多数患者经停药和/或给予糖皮质激素等治疗后好转或康复,1例患者因呼吸衰竭死亡。结论肺毒性为VDZ较罕见的不良反应,起病隐匿且症状无特异性。一旦患者出现咳嗽、呼吸困难等症状,临床应早期判断、及时停药,并给予糖皮质激素等对症治疗,以保障患者用药安全。展开更多
Objective:To compare the safety differences between Chinese medicine(CM)and Western medicine(WM)based on Chinese Spontaneous Reporting Database(CSRD).Methods:Reports of adverse events(AEs)caused by CM and WM in the CS...Objective:To compare the safety differences between Chinese medicine(CM)and Western medicine(WM)based on Chinese Spontaneous Reporting Database(CSRD).Methods:Reports of adverse events(AEs)caused by CM and WM in the CSRD between 2010 and 2011 were selected.The following assessment indicators were constructed:the proportion of serious AEs(PSE),the average number of AEs(ANA),and the coverage rate of AEs(CRA).Further comparisons were also conducted,including the drugs with the most reported serious AEs,the AEs with the biggest report number,and the 5 serious AEs of interest(including death,anaphylactic shock,coma,dyspnea and abnormal liver function).Results:The PSE,ANA and CRA of WM were 1.09,8.23 and 2.35 times higher than those of CM,respectively.The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM.The AEs with the most reports were rash,pruritus,nausea,dizziness and vomiting for both CM and WM.The proportions of CM and WM in anaphylactic shock and coma were similar.For abnormal liver function and death,the proportions of WM were 5.47 and 3.00 times higher than those of CM,respectively.Conclusion:Based on CSRD,CM was safer than WM at the average level from the perspective of adverse drug reactions.展开更多
目的:了解抗癫痫药物不良反应(adverse drug reaction,ADR)的发生规律及特点。方法:提取我院上报至国家药品不良反应监测系统的抗癫痫药ADR报告进行分析。结果:共收集69例抗癫痫药ADR,涉及药品6种,包括丙戊酸钠、奥卡西平、卡马西平、...目的:了解抗癫痫药物不良反应(adverse drug reaction,ADR)的发生规律及特点。方法:提取我院上报至国家药品不良反应监测系统的抗癫痫药ADR报告进行分析。结果:共收集69例抗癫痫药ADR,涉及药品6种,包括丙戊酸钠、奥卡西平、卡马西平、拉莫三嗪、左乙拉西坦及苯妥英钠。ADR以神经系统最为常见,主要表现为头晕、嗜睡、头痛等,其次为肝胆、胃肠及代谢系统疾病。结论:临床应关注抗癫痫药ADR,加强用药监测。展开更多
目的探讨司美格鲁肽致药品不良反应(ADR)的特点,为其临床安全应用提供参考。方法以“司美格鲁肽”“不良反应”等的中英文为检索词,检索PubMed、Web of Science、SpringerLink、中国知网、中华医学期刊全文数据库、万方医学网及维普医...目的探讨司美格鲁肽致药品不良反应(ADR)的特点,为其临床安全应用提供参考。方法以“司美格鲁肽”“不良反应”等的中英文为检索词,检索PubMed、Web of Science、SpringerLink、中国知网、中华医学期刊全文数据库、万方医学网及维普医药信息资源系统,收集司美格鲁肽致ADR的病例报道并进行分析。结果共纳入14篇文献,共计17例患者。17例患者中,女性9例、男性8例,年龄25~80岁;8例患者合并应用2种及2种以上药物;8例患者以0.25 mg为起始剂量;大多ADR(94.12%)发生在用药后6个月内;16例患者经停药和/或对症治疗后均好转或痊愈;11例患者未提及后续是否继续使用司美格鲁肽;9例患者进行了ADR相关性评价,断定为“肯定”“很可能”“可能”“有可能”的分别有1、3、1、4例。司美格鲁肽致ADR可累及多个器官或系统,以消化系统最多(35.29%),其次为皮肤组织(29.41%);其中,急性胃扩张、重度肝损伤、结石性胆囊炎、大疱性类天疱疮、嗜酸性筋膜炎、急性肾损伤、急性间质性肾炎、抑郁症、急性溶血性贫血均为药品说明书未记载的ADR。结论司美格鲁肽所致ADR可发生在各年龄段,以用药后6个月内发生为主,主要累及消化系统、皮肤组织等。临床使用时,应重点加强对肝肾功能不全、神经精神疾病、葡萄糖-6-磷酸脱氢酶缺乏症等人群的药学监护,出现相关ADR时应及时停药和/或对症治疗,以保障患者的用药安全。展开更多
目的分析艾曲泊帕(Eltrombopag)在儿童患者中致不良反应(Adverse drug reaction,ADR)的临床特点和一般规律,为其临床合理、安全使用提供参考。方法检索中国知网(CNKI)、万方、维普(VIP)、PubMed等数据库收录的艾曲泊帕致儿童不良反应相...目的分析艾曲泊帕(Eltrombopag)在儿童患者中致不良反应(Adverse drug reaction,ADR)的临床特点和一般规律,为其临床合理、安全使用提供参考。方法检索中国知网(CNKI)、万方、维普(VIP)、PubMed等数据库收录的艾曲泊帕致儿童不良反应相关病例报道,检索时限为建库至2023年5月,并对纳入文献进行统计与分析。结果共纳入文献22篇,应用艾曲泊帕治疗的患儿共800例,ADR共计246例,主要累及消化系统和血液系统,绝大多数ADR为轻症,可自行缓解,或经减停药、对症处理后缓解。结论儿童群体应用艾曲泊帕整体耐受性良好,但仍需加强监测,保障用药安全。展开更多
文摘Background: Achieving the long terms goals of antiretroviral treatment (ART) requires a careful approach during treatment initiation that takes into account patient’s psychosocial state, availability and accessibility of treatment combinations, and adherence support. Adverse drug reactions that occur during the initial phases have a bearing on treatment outcomes and thus need to be monitored and treated. Objective: This study was done to assess length of time (survival time) it took for clinically significant adverse drug reactions to occur in patients taking Nucleoside Reverse Transcriptase Inhibitors (N(t)RTI) available for treatment of Human Immunodeficiency Virus (HIV) infection in Zimbabwe. Methods: A retrospective cohort of patient data collected from January 2009 to December 2012 was extracted from an Electronic Health Record database. Data from patients who were initiated on antiretroviral (ARV) drug regimens containing N(t)RTI drugs were analysed for survival time. A sample of 205 patient files was extracted for the time period for survival analysis using adverse drug reactions due to N(t)RTI drugs. Results: After data extraction, a total of 205 patient records were used in determining the time to event analysis of ADR’s in the cohort. The age range for the patients included in the study was 9 - 76 with a mean of 41 years (s.d = 14.8). Patients initiated on stavudine had a lower survival time before a clinically significant ADR compared to tenofovir (-365 days, p-value < 0.0005). Patients on zidovudine also had a less time before a significant reaction compared to those on tenofovir (-230 days;p-value = 0.008). Patients on zidovudine fared better compared to those on stavudine (-134 days;p-value < 0.0005). The mean survival time was highest for tenofovir (618 days), followed by zidovudine (388 days), and then stavudine (254 days).Conclusion: Patients on tenofovir have a longer survival time before a clinically significant adverse reaction. Treatment programmes need to continue commencing patients on tenofovir containing regimens as patients can be maintained for longer periods on this regimen.
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BACKGROUND Novel oral anticoagulants(NOACs)are commonly used for the anticoagulation of patients with atrial fibrillation.Reports of thrombocytopenic toxicity of NOACs are limited.In this report,we present a case of thrombocytopenia likely induced by rivaroxaban,which is an extremely rare adverse drug reaction.CASE SUMMARY A 70-year-old man presented to the cardiovascular department with a chief complaint of intermittent chest tightness and dyspnea over the last five years.Vital signs were within normal limits at presentation,with a heart rate of 65 beats/min,blood pressure of 138/78 mmHg,respiratory rate of 19 breaths/min,and temperature of 36.1°C.Laboratory tests indicated a platelet count of 163×109/L on admission.Anticoagulant therapy with rivaroxaban,a NOAC,was started on the second day of hospitalization.The platelet count decreased to 30×109/L on hospital day 11 and then 10×109/L on day 12.Rivaroxaban was stopped on day 13 when the platelet count decreased to 5×109/L.After the cessation of rivaroxaban,the platelet count returned to normal.The patient was diagnosed with thrombocytopenia,which was likely induced by rivaroxaban.The incidence of thrombocytopenic toxicity of NOACs is extremely low.CONCLUSION Thrombocytopenia during anticoagulation therapy may be associated with a high risk of life-threatening bleeding.For elderly patients,changes in platelet count should be carefully monitored at the beginning of NOAC treatment,and we should be on the alert for bleeding events as well.
基金Supported by the Special Research Fund of Hospital Pharmacy of Zhejiang Pharmaceutical Society,No. 2019ZYY27Zhejiang Medical and Health Science and Technology Plan,No. 2020KY741 and No. 2021KY910
文摘BACKGROUND Latamoxef shows excellent antibacterial activity against anaerobic bacteria such as Bacteroides fragilis.Reports of thrombocytopenic toxicity of latamoxef are limited.This report presents a case of severe thrombocytopenia possibly induced by latamoxef,an infrequent adverse drug reaction in a young patient with tuberculosis and Crohn's disease in China.CASE SUMMARY We reported a case of severe thrombocytopenia induced by latamoxef in a 28-year-old man with tuberculosis and Crohn's disease.On admission,the patient presented with a cough productive of bloody sputum,a chest computed tomogram suggested scattered mottled,high-density shadows in both lungs.Laboratory tests indicated a platelet count of 140000/μL.Considered a pulmonary bacterial infection,the patient received anti-infection therapy with latamoxef(dose:2.0 g)intravenously Q12h.On the 9th day of treatment,the platelet count decreased to 44000/μL.On the 12th day,scattered purpura and ecchymosis appeared on the patient’s limbs and trunk,and the platelet count decreased to 9000/μL after latamoxef treatment for 15 d.Three days after discontinuation of latamoxef,the platelet count recovered to 157000/μL,and the area of scattered purpura and ecchymosis on the limbs and trunk decreased.The platelet counts remained in the normal range,and no thrombocytopenia was found at follow-up 15 mo after discharge.CONCLUSION For patients treated with latamoxef,platelet counts should be carefully followed,and caregivers should be vigilant for the appearance of scattered ecchymosis.
基金Supported by Project of National Natural Science Foundation of China(81460675)
文摘[Objectives] To make a systematic evaluation on the therapeutic efficacy and safety of Yiqi Huoxue traditional Chinese drugs combined with western medicine in treatment of coronary heart disease( CHD) after coronary revascularization. [Methods] The literatures were retrieved from China Knowledge Infrastructure( CNKI),Chinese science and technology journal full-text database( VIP database,VIP),Wanfang Data,the Chinese biomedical Database,Pub Med,Embase,and the Cochrane Library. The retrieval time was set to the creation of the database to January 2017. The randomized controlled trial( RCT) was conducted on the comparison between Yiqi Huoxue Chinese drugs combined with western medicine and the western medicine alone in the treatment of CHD after coronary revascularization. The literature information was extracted and the methodological quality of the included literature was evaluated according to the bias risk assessment tool developed by the Cochrane Collaboration. Meta-analysis was performed with the aid of Rev Man 5. 3 software. Coronary artery restenosis rate,angina pectoris treatment efficiency,left ventricular ejection fraction( LVEF),left ventricular end-diastolic volume( LVEDV),B-type natriuretic peptide( BNP),6-minute walk test( 6 MWT),and adverse reactions were analyzed. [Results] A total of 29 articles were included,a total of2 518 patients,the literature quality was low. Meta-analysis results showed that compared with the treatment by western medicine alone,Yiqi Huoxue Chinese drugs combined with western medicine could further reduce coronary restenosis rate[RR = 0. 45,95% CI( 0. 34,0. 60),P <0. 000 01],improve the angina pectoris treatment efficiency[RR = 1. 13,95% CI( 1. 05,1. 21),P = 0. 000 5],raise LVEF[WMD = 4. 25,95% CI( 3. 46,5. 04),P < 0. 000 01],reduce LVEDV[WMD =-10. 41,95% CI(-17. 88,-2. 95),P = 0. 006],decrease the plasma BNP level[WMD =-32. 32,95% CI(-44. 92,-19. 72),P < 0. 000 01],and increase 6 MWT distance(WMD = 62. 25,95% CI( 21. 71,102. 78),P = 0. 003)[Conclusions]Yiqi Huoxue Chinese drugs combined with western medicine can alleviate the symptoms of angina pectoris,reduce the rate of coronary restenosis,improve heart function and improve exercise capacity,thereby improving clinical efficacy in patients with CHD after coronary revascularization.
文摘目的介绍1例维得利珠单抗(VDZ)致间质性肺炎的病例,汇总分析该药相关肺毒性的发生特点,为临床安全用药提供参考。方法从临床药师角度出发,回顾性分析1例VDZ致间质性肺炎患者的诊治过程,并进行不良反应相关性分析;检索中国知网、维普网、PubMed、Web of Science等中英文数据库,对VDZ相关肺毒性的病例报道进行汇总分析。结果该患者在使用VDZ期间发生间质性肺炎,予抗菌药物经验性抗感染治疗无改善;停用VDZ并予甲泼尼龙治疗后,患者的症状及影像学检查均有改善但仍提示间质性肺炎。经Naranjo's不良反应评估量表评估并根据我国《药品不良反应报告和监测工作手册》判断,VDZ与间质性肺炎的关联性均为“很可能”。文献分析结果显示,纳入的29例患者(含本文报道的患者)中,男性19例、女性10例,平均年龄(49.24±17.06)岁;肺毒性主要包括VDZ相关性肺炎、嗜酸性粒细胞肺炎、肺肉芽肿或坏死性结节、间质性肺损伤等,多发生在用药后24周以内(58.62%),主要临床表现为咳嗽、呼吸困难、发热等;绝大多数患者经停药和/或给予糖皮质激素等治疗后好转或康复,1例患者因呼吸衰竭死亡。结论肺毒性为VDZ较罕见的不良反应,起病隐匿且症状无特异性。一旦患者出现咳嗽、呼吸困难等症状,临床应早期判断、及时停药,并给予糖皮质激素等对症治疗,以保障患者用药安全。
基金the Major Project of Philosophy and Social Science Research in Jiangsu Universities(No.2020SJZDA102)the Postgraduate Research&Practice Innovation Program of Jiangsu Province(No.SJCX20_0223)。
文摘Objective:To compare the safety differences between Chinese medicine(CM)and Western medicine(WM)based on Chinese Spontaneous Reporting Database(CSRD).Methods:Reports of adverse events(AEs)caused by CM and WM in the CSRD between 2010 and 2011 were selected.The following assessment indicators were constructed:the proportion of serious AEs(PSE),the average number of AEs(ANA),and the coverage rate of AEs(CRA).Further comparisons were also conducted,including the drugs with the most reported serious AEs,the AEs with the biggest report number,and the 5 serious AEs of interest(including death,anaphylactic shock,coma,dyspnea and abnormal liver function).Results:The PSE,ANA and CRA of WM were 1.09,8.23 and 2.35 times higher than those of CM,respectively.The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM.The AEs with the most reports were rash,pruritus,nausea,dizziness and vomiting for both CM and WM.The proportions of CM and WM in anaphylactic shock and coma were similar.For abnormal liver function and death,the proportions of WM were 5.47 and 3.00 times higher than those of CM,respectively.Conclusion:Based on CSRD,CM was safer than WM at the average level from the perspective of adverse drug reactions.
文摘目的:了解抗癫痫药物不良反应(adverse drug reaction,ADR)的发生规律及特点。方法:提取我院上报至国家药品不良反应监测系统的抗癫痫药ADR报告进行分析。结果:共收集69例抗癫痫药ADR,涉及药品6种,包括丙戊酸钠、奥卡西平、卡马西平、拉莫三嗪、左乙拉西坦及苯妥英钠。ADR以神经系统最为常见,主要表现为头晕、嗜睡、头痛等,其次为肝胆、胃肠及代谢系统疾病。结论:临床应关注抗癫痫药ADR,加强用药监测。
文摘目的探讨司美格鲁肽致药品不良反应(ADR)的特点,为其临床安全应用提供参考。方法以“司美格鲁肽”“不良反应”等的中英文为检索词,检索PubMed、Web of Science、SpringerLink、中国知网、中华医学期刊全文数据库、万方医学网及维普医药信息资源系统,收集司美格鲁肽致ADR的病例报道并进行分析。结果共纳入14篇文献,共计17例患者。17例患者中,女性9例、男性8例,年龄25~80岁;8例患者合并应用2种及2种以上药物;8例患者以0.25 mg为起始剂量;大多ADR(94.12%)发生在用药后6个月内;16例患者经停药和/或对症治疗后均好转或痊愈;11例患者未提及后续是否继续使用司美格鲁肽;9例患者进行了ADR相关性评价,断定为“肯定”“很可能”“可能”“有可能”的分别有1、3、1、4例。司美格鲁肽致ADR可累及多个器官或系统,以消化系统最多(35.29%),其次为皮肤组织(29.41%);其中,急性胃扩张、重度肝损伤、结石性胆囊炎、大疱性类天疱疮、嗜酸性筋膜炎、急性肾损伤、急性间质性肾炎、抑郁症、急性溶血性贫血均为药品说明书未记载的ADR。结论司美格鲁肽所致ADR可发生在各年龄段,以用药后6个月内发生为主,主要累及消化系统、皮肤组织等。临床使用时,应重点加强对肝肾功能不全、神经精神疾病、葡萄糖-6-磷酸脱氢酶缺乏症等人群的药学监护,出现相关ADR时应及时停药和/或对症治疗,以保障患者的用药安全。
文摘目的分析艾曲泊帕(Eltrombopag)在儿童患者中致不良反应(Adverse drug reaction,ADR)的临床特点和一般规律,为其临床合理、安全使用提供参考。方法检索中国知网(CNKI)、万方、维普(VIP)、PubMed等数据库收录的艾曲泊帕致儿童不良反应相关病例报道,检索时限为建库至2023年5月,并对纳入文献进行统计与分析。结果共纳入文献22篇,应用艾曲泊帕治疗的患儿共800例,ADR共计246例,主要累及消化系统和血液系统,绝大多数ADR为轻症,可自行缓解,或经减停药、对症处理后缓解。结论儿童群体应用艾曲泊帕整体耐受性良好,但仍需加强监测,保障用药安全。