目的对艾加莫德α治疗全身型重症肌无力的有效性、安全性和经济性进行快速卫生技术评估,为临床合理用药提供循证依据。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、VIP、WanFang Data、SinoMed数据库及卫...目的对艾加莫德α治疗全身型重症肌无力的有效性、安全性和经济性进行快速卫生技术评估,为临床合理用药提供循证依据。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、VIP、WanFang Data、SinoMed数据库及卫生技术评估机构官方网站,搜集艾加莫德α治疗全身型重症肌无力的卫生技术评估报告、系统评价/Meta分析和药物经济学研究,检索时限为建库至2024年6月21日。由2名研究者筛选文献、提取数据、评价文献质量,将研究结果汇总并进行定性描述分析。结果共纳入文献6篇,包括5篇系统评价/Meta分析和1篇药物经济学研究。有效性方面,与安慰剂相比,艾加莫德α可显著降低全身型重症肌无力患者的重症肌无力日常生活能力评分、重症肌无力定量评分和15项重症肌无力生活质量评分,差异有统计学意义(P<0.05),但与巴托利单抗、洛利昔珠单抗、依库珠单抗等其他生物制剂相比,各研究得出的结论不一致。安全性方面,艾加莫德α组与安慰剂组成年全身型重症肌无力患者的不良事件发生率差异无统计学意义(P>0.05),但与其他生物制剂相比,各研究得出的结论不一致。经济学方面,与传统疗法相比,艾加莫德α不具有成本-效果优势。结论艾加莫德α治疗全身型重症肌无力的疗效优于安慰剂,但与其他生物制剂相比无确切结论。在安全性方面,艾加莫德α在成年全身型重症肌无力患者中不良事件发生率与安慰剂相当,与其他生物制剂相比无确切结论。根据美国药物经济学数据,与传统疗法相比,艾加莫德α不具有经济学优势。展开更多
AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and inte...AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and interferon-based therapy (+ribavirin) were consecutively enrolled in a longitudinal study. Patients were treated with conventional interferon alfa-2b (48/98patients; 5 MIU interferon alfa-2b thrice weekly) or peginterferon alfa-2b (50/98 patients; 80-150 μgpeginterferon alfa-2b) in combination with weight-adapted ribavirin (800-1 200 mg/d). Repeated psychometric testing was performed before, three times during and once after antiviral therapy: Depression was evaluated by the Hospital Anxiety and Depression Scale (HADS), anger/hostility by the Symptom Checklist-90 Items Revised (SCL-90-R).RESULTS: Therapy with pegylated interferon alfa-2bproduces comparable scores for depression (ANOVA:P = 0.875) as compared to conventional interferon.Maximums of depression scores were even higher and cases of clinically relevant depression were frequent during therapy with peginterferon. Scores for anger/hostility were comparable for both therapy subgroups.CONCLUSION: Our findings suggest that the extent and frequency of depressive symptoms in total are not reduced by peginterferon. Monitoring and management of neuropsychiatric toxicity especially depression have to be considered as much as in antiviral therapy with unmodified interferon.展开更多
BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained viro...BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population. RESULTS: PegIFN in combination with ribavirin remains an important and relevant option for some patients, achieving SVR rates of up to 79% in genotype 1 and 89% in genotype 2 or 3 infections, which increases for patients with favorable IL28B genotypes. Triple therapy of DAA plus PegIFN/ribavirin is effective in treating difficult-to-cure patients infected with HCV genotype 3 or with resistance-associated variants. Owing to its long history in HCV management, the efficacy, tolerability and long-term outcomes associated with PegIFN alfa-2a are well established and have been validated in large-scale studies and in clinical practice for many populations. Furthermore, emerging data show that IFN-induced SVR is associated with lower incidences of hepatocellular carcinoma compared with DAAs. On the contrary, novel DAAs have yet to be studied in special populations, and long-term outcomes, particularly tumor development and recurrence in patients with cirrhosis and/or hepatocellular carcinoma, and reactivation of HBV in dually infected patients, are still unclear. CONCLUSION: In this interferon-free era, PegIFN-based regimens remain a safe and effective option for selected HCV patients.展开更多
文摘目的对艾加莫德α治疗全身型重症肌无力的有效性、安全性和经济性进行快速卫生技术评估,为临床合理用药提供循证依据。方法计算机检索PubMed、Embase、Web of Science、Cochrane Library、CNKI、VIP、WanFang Data、SinoMed数据库及卫生技术评估机构官方网站,搜集艾加莫德α治疗全身型重症肌无力的卫生技术评估报告、系统评价/Meta分析和药物经济学研究,检索时限为建库至2024年6月21日。由2名研究者筛选文献、提取数据、评价文献质量,将研究结果汇总并进行定性描述分析。结果共纳入文献6篇,包括5篇系统评价/Meta分析和1篇药物经济学研究。有效性方面,与安慰剂相比,艾加莫德α可显著降低全身型重症肌无力患者的重症肌无力日常生活能力评分、重症肌无力定量评分和15项重症肌无力生活质量评分,差异有统计学意义(P<0.05),但与巴托利单抗、洛利昔珠单抗、依库珠单抗等其他生物制剂相比,各研究得出的结论不一致。安全性方面,艾加莫德α组与安慰剂组成年全身型重症肌无力患者的不良事件发生率差异无统计学意义(P>0.05),但与其他生物制剂相比,各研究得出的结论不一致。经济学方面,与传统疗法相比,艾加莫德α不具有成本-效果优势。结论艾加莫德α治疗全身型重症肌无力的疗效优于安慰剂,但与其他生物制剂相比无确切结论。在安全性方面,艾加莫德α在成年全身型重症肌无力患者中不良事件发生率与安慰剂相当,与其他生物制剂相比无确切结论。根据美国药物经济学数据,与传统疗法相比,艾加莫德α不具有经济学优势。
基金Supported by an Unrestricted Grant From Essex Pharma (Munich, Germany), a subsidiary of Schering-Plough (Kenilworth NJ, USA)
文摘AIM: To assess systematically the spectrum and extent of depressive symptoms comparing patient groups receiving peginterferon or conventional interferon.METHODS: Ninety-eight patients with chronic hepatitis C and interferon-based therapy (+ribavirin) were consecutively enrolled in a longitudinal study. Patients were treated with conventional interferon alfa-2b (48/98patients; 5 MIU interferon alfa-2b thrice weekly) or peginterferon alfa-2b (50/98 patients; 80-150 μgpeginterferon alfa-2b) in combination with weight-adapted ribavirin (800-1 200 mg/d). Repeated psychometric testing was performed before, three times during and once after antiviral therapy: Depression was evaluated by the Hospital Anxiety and Depression Scale (HADS), anger/hostility by the Symptom Checklist-90 Items Revised (SCL-90-R).RESULTS: Therapy with pegylated interferon alfa-2bproduces comparable scores for depression (ANOVA:P = 0.875) as compared to conventional interferon.Maximums of depression scores were even higher and cases of clinically relevant depression were frequent during therapy with peginterferon. Scores for anger/hostility were comparable for both therapy subgroups.CONCLUSION: Our findings suggest that the extent and frequency of depressive symptoms in total are not reduced by peginterferon. Monitoring and management of neuropsychiatric toxicity especially depression have to be considered as much as in antiviral therapy with unmodified interferon.
文摘BACKGROUND: The availability of novel direct-acting antivirals (DAAs) represents a new era of curative hepatitis C virus (HCV) treatment, with over 95% of patients infected with HCV genotype 1 achieving sustained virological response (SVR). Nevertheless, the majority of patients globally are unable to access these treatments because of cost and infrastructure constraints and, thus, remain untreated and uncured. DATA SOURCE: Relevant articles of peginterferon (PegIFN)-based treatments in HCV and sofosbuvir-based treatments, simeprevir, daclatasvir/asunaprevir, ritonavir-boosted paritaprevir/ombitasvir/dasabuvir, and grazoprevir/elbasvir, were searched in PubMed database, including general population and special population. RESULTS: PegIFN in combination with ribavirin remains an important and relevant option for some patients, achieving SVR rates of up to 79% in genotype 1 and 89% in genotype 2 or 3 infections, which increases for patients with favorable IL28B genotypes. Triple therapy of DAA plus PegIFN/ribavirin is effective in treating difficult-to-cure patients infected with HCV genotype 3 or with resistance-associated variants. Owing to its long history in HCV management, the efficacy, tolerability and long-term outcomes associated with PegIFN alfa-2a are well established and have been validated in large-scale studies and in clinical practice for many populations. Furthermore, emerging data show that IFN-induced SVR is associated with lower incidences of hepatocellular carcinoma compared with DAAs. On the contrary, novel DAAs have yet to be studied in special populations, and long-term outcomes, particularly tumor development and recurrence in patients with cirrhosis and/or hepatocellular carcinoma, and reactivation of HBV in dually infected patients, are still unclear. CONCLUSION: In this interferon-free era, PegIFN-based regimens remain a safe and effective option for selected HCV patients.
