葡萄糖酸锑钠和两性霉素B脂质体治疗黑热病有效性和安全性的回顾性分析

Efficacy and safety of sodium stibogluconate and liposomal amphotericin B in the treatment of Kala‑azar:a retrospective analysis

目的探讨葡萄糖酸锑钠(SSG)和两性霉素B脂质体(L⁃AmB)单药及2药联用在我国黑热病(又称内脏利什曼病)治疗中的有效性和安全性。方法收集2012年1月至2021年12月在兰州大学第一医院住院的黑热病患者的临床资料,包括患者人口学信息、黑热病临床特征、既往治疗史、治疗药物、临床疗效和治疗期间的药物不良反应(ADR)等。对SSG治疗(SSG组)和L⁃AmB或SSG+L⁃AmB治疗(L⁃AmB/SSG+L⁃AmB组)患者的临床特征、疗效及SSG和L⁃AmB相关ADR的发生情况做描述性统计分析。结果共44例患者纳入分析,男性25例,女性19例;儿童25例(56.8%),成人19例(43.2%)。37例(84.1%)患者接受SSG治疗(SSG组),32例为初治者,5例为经治者;7例(15.9%)接受了L⁃AmB治疗(L⁃AmB/SSG+L⁃AmB组),均为经治者,其中L⁃AmB单药治疗2例,联合SSG治疗5例。SSG组中32例初治患者中29例(90.6%)临床痊愈,5例经治患者经延长疗程后均获临床痊愈。L⁃AmB/SSG+L⁃AmB组7例患者采用小剂量长疗程的给药方案均获临床痊愈。SSG的常见ADR为肝功能异常和胰酶升高,L⁃AmB的常见ADR为低钾血症和轻度血清肌酐升高。结论SSG对黑热病初治患者的疗效可达90%以上,仍可作为黑热病治疗的首选药物,治疗期间应注意监测肝功能和胰酶。经治患者,尤其是多次复发的患者应选择L⁃AmB或SSG+L⁃AmB方案治疗。L⁃AmB小剂量长疗程给药可以获得较好的疗效且可降低ADR的发生风险,治疗期间应注意监测电解质和肾功能。

Objective To explore the efficacy and safety of sodium stibogluconate(SSG)and liposomal amphotericin(L⁃AmB)as well as their combination regimen in the treatment of Kala⁃azar(also known as visceral leishmaniasis)in China.Methods Clinical data of patients with Kala⁃azar hospitalized in the First Hospital of Lanzhou University from January 2012 to December 2021 were collected,including patient demographic information,clinical characteristics of Kala⁃azar,previous treatment history,therapeutic drugs,clinical efficacy and adverse drug reactions(ADRs)in the treatment.The clinical characteristics,effi⁃cacy and occurrence of ADRs related to SSG and L⁃AmB in patients treated with SSG(SSG group)and L⁃AmB or SSG+L⁃AmB(L⁃AmB or SSG+L⁃AmB group)were analyzed by descriptive statistics.Results A total of 44 patients were included in the analysis,including 25 males and 19 females;25 were children(56.8%)and 19 were adults(43.2%).Thirty⁃seven patients(84.1%)were treated with SSG(SSG group),which was used as an initial treatment in 32 patients and was used also in previous treatment in 5 patients.Seven patients(15.9%)were treated with L⁃AmB,including 2 with L⁃AmB monotherapy and 5 with SSG+L⁃AmB,and all of them have been treated with SSG before.Among the 32 patients used SSG as initial treat⁃ments in the SSG group,29(90.6%)were clinically cured.All the 5 patients,who had been treated before,were also clinically cured after prolonged treatments.Seven patients in the L⁃AmB or SSG+L⁃AmB group were treated with a low⁃dose and long⁃term L⁃AmB regimen,and all of them were cured without Kala⁃azar recurrence.The common ADRs of SSG were abnormal liver function and elevated pancreatic enzymes;the common ADRs of L⁃AmB were hypokalemia and mild elevation of serum creatinine.Conclusions The efficacy of SSG in initial treatment of patients with Kala⁃azar is more than 90%,and it can still be used as the preferred drug to treat Kala⁃azar.The monitoring of liver function and pancreatic enzymes should be paid attention to during the treatment.For patients that have been treated before,especially those with multiple Kala⁃azar recurrences,L⁃AmB or SSG+L⁃AmB should be advised.Low dose and long⁃term administration of L⁃AmB can obtain better efficacy and reduce the risk of ADR,and electrolytes and renal function should be monitored during the treatment.