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目的评价卡泊芬净注射剂经验性治疗粒细胞减少伴持续发热患者的安全性、耐受性和疗效。方法本研究为非对照、开放、多中心临床试验,患者因化疗或接受造血干细胞移植出现中性粒细胞绝对值计数<500×106/L,持续至少96h,入选前接受胃肠外广谱抗菌药治疗至少96h,并且在入选前24h内体温>38.0℃者可入选本研究。统计用药人群发生的严重不良事件、不良事件及其总有效率。结果共入选131例,其中安全性分析集(SS)131例,全分析集(FAS)129例。SS131例中,18例受试者发生24例次临床严重不良事件,均与研究药物无关,发生1例次实验室严重不良事件(血钾降低),与研究药物肯定有关。SS131例中发生与药物有关的非严重不良事件者35例,包括5例同时发生临床不良反应和实验室异常;其中16例发生临床不良反应,多见皮疹、发热、呕吐等;24例发生实验室异常,多见ALT等肝酶升高、血钾降低等。总不良反应发生率为26.7%(35/131),其中临床不良反应发生率为12.2%(16/131),实验室异常发生率为19.1%(25/131)。临床不良反应中91.3%为轻、中度。入选病例中9例(12例次)因不良反应而中止治疗,占6.9%(9/131)。其中6例(9例次)被评价为与试验药物有关,发生率为4.6%(6/131)。FAS和符合方案数据集(PPS)中的总体有效率分别为36.4%(47/129)和40.2%(47/117)。结论卡泊芬净经验性治疗粒细胞减少伴持续发热患者临床不良反应多为轻、中度,患者对其耐受性良好,因药物不良反应中止治疗者少见。卡泊芬净用于经验性治疗粒细胞减少伴发热可获一定疗效。
Objective To evaluate the safety, tolerability and efficacy of caspofungin in the treatment of patients with emphysema on the basis of empirical treatment of neutropenia. METHODS: This study was a non-controlled, open, multicenter clinical trial in which neutrophil count <500 × 106 / L for chemotherapy or hematopoietic stem cell transplantation persisted for at least 96 h before enrolling in a broad-spectrum antimicrobial Drug treatment for at least 96h, and within 24 hours before admission within the body temperature> 38.0 ℃ were eligible for inclusion in this study. Statistics drug population serious adverse events, adverse events and their total efficiency. Results A total of 131 cases were enrolled in the study, including 131 cases of safety analysis set (SS) and 129 cases of total analysis set (FAS). SS131 cases, 18 cases of subjects occurred in 24 cases of clinical serious adverse events, were unrelated to the study drug, one case of laboratory serious adverse events (serum potassium decreased), and research drugs certainly. Thirty-five SSR-related non-serious adverse events occurred in SS131 cases, including 5 cases of concurrent clinical adverse reactions and laboratory abnormalities. Of the 16 cases, clinical adverse reactions occurred, rashes, fever and vomiting were common, and 24 cases occurred Room abnormalities, more common ALT and other liver enzymes, such as lower serum potassium. The total incidence of adverse reactions was 26.7% (35/131). The incidence of clinical adverse reactions was 12.2% (16/131) and laboratory abnormalities were 19.1% (25/131). 91.3% of the clinical adverse reactions were mild and moderate. Among the selected cases, 9 cases (12 cases) discontinued treatment due to adverse reactions, accounting for 6.9% (9/131). Of these, 6 (9 cases) were evaluated as being associated with the test drug, with a rate of 4.6% (6/131). The overall response rates in the FAS and the PPS were 36.4% (47/129) and 40.2% (47/117), respectively. Conclusions Caspofungin empirical treatment of patients with persistent fever and neutropenic clinical adverse reactions are mostly mild, moderate, patients with good tolerance to discontinuation due to adverse drug reactions are rare. Caspofungin for empirical treatment of neutropenia with fever can be a certain effect.