OBJECTIVE: To assess the benefits and harms of medication, percutaneous and surgical interventions for treating uncomplicated hepatic cystic echinococcosis.
METHODS: We searched CENTRAL, MEDLINE, two other databases and two trial registries to 4 May 2023. We searched the reference lists of included studies, and contacted experts and researchers in the field for relevant studies.
METHODS: We included randomized controlled trials (RCTs) in people with a diagnosis of uncomplicated hepatic cystic echinococcosis of World Health Organization (WHO) cyst stage CE1, CE2, CE3a or CE3b comparing either oral medication (albendazole) to albendazole plus percutaneous interventions, or to surgery plus albendazole. Studies comparing praziquantel plus albendazole to albendazole alone prior to or following an invasive intervention (surgery or percutaneous treatment) were eligible for inclusion.
METHODS: We used standard Cochrane methods. Our primary outcomes were symptom improvement, recurrence, inactive cyst at 12 months and all-cause mortality at 30 days. Our secondary outcomes were development of secondary echinococcosis, complications of treatment and duration of hospital stay. We used GRADE to assess the certainty of evidence.
RESULTS: We included three RCTs with 180 adults and children with hepatic cystic echinococcosis. Two studies enrolled people aged 5 to 72 years, and one study enrolled children aged 6 to 14 years. One study compared standard catheterization plus albendazole with puncture, aspiration, injection and re-aspiration (PAIR) plus albendazole, and two studies compared laparoscopic surgery plus albendazole with open surgery plus albendazole. The three RCTs were published between 2020 and 2022 and conducted in India, Pakistan and Turkey. There were no other comparisons. Standard catheterization plus albendazole versus PAIR plus albendazole The cyst stages were CE1 and CE3a. The evidence is very uncertain about the effect of standard catheterization plus albendazole compared with PAIR plus albendazole on cyst recurrence (risk ratio (RR) 3.67, 95% confidence interval (CI) 0.16 to 84.66; 1 study, 38 participants; very low-certainty evidence). The evidence is very uncertain about the effects of standard catheterization plus albendazole on 30-day all-cause mortality and development of secondary echinococcosis compared to open surgery plus albendazole. There were no cases of mortality at 30 days or secondary echinococcosis (1 study, 38 participants; very low-certainty evidence). Major complications were reported by cyst and not by participant. Standard catheterization plus albendazole may increase major cyst complications compared with PAIR plus albendazole, but the evidence is very uncertain (RR 10.74, 95% CI 1.39 to 82.67; 1 study, 53 cysts; very low-certainty evidence). Standard catheterization plus albendazole may make little to no difference on minor complications compared with PAIR plus albendazole, but the evidence is very uncertain (RR 1.03, 95% CI 0.60 to 1.77; 1 study, 38 participants; very low-certainty evidence). Standard catheterization plus albendazole may increase the median duration of hospital stay compared with PAIR plus albendazole, but the evidence is very uncertain (4 (range 1 to 52) days versus 1 (range 1 to 15) days; 1 study, 38 participants; very low-certainty evidence). Symptom improvement and inactive cysts at 12 months were not reported. Laparoscopic surgery plus albendazole versus open surgery plus albendazole The cyst stages were CE1, CE2, CE3a and CE3b. The evidence is very uncertain about the effect of laparoscopic surgery plus albendazole on cyst recurrence in participants with CE2 and CE3b cysts compared to open surgery plus albendazole (RR 3.00, 95% CI 0.13 to 71.56; 1 study, 82 participants; very low-certainty evidence). The second study involving 60 participants with CE1, CE2 or CE3a cysts reported no recurrence in either group. The evidence is very uncertain about the effect of laparoscopic surgery plus albendazole on 30-day all-cause mortality in participants with CE1, CE2, CE3a or CE3b cysts compared to open surgery plus albendazole. There was no mortality in either group (2 studies, 142 participants; very low-certainty evidence). The evidence is very uncertain about the effect of laparoscopic surgery plus albendazole on major complications in participants with CE1, CE2, CE3a or CE3b cysts compared to open surgery plus albendazole (RR 0.50, 95% CI 0.13 to 1.92; 2 studies, 142 participants; very low-certainty evidence). Laparoscopic surgery plus albendazole may lead to slightly fewer minor complications in participants with CE1, CE2, CE3a or CE3b cysts compared to open surgery plus albendazole (RR 0.13, 95% CI 0.02 to 0.98; 2 studies, 142 participants; low-certainty evidence). Laparoscopic surgery plus albendazole may reduce the duration of hospital stay compared with open surgery plus albendazole (mean difference (MD) -1.90 days, 95% CI -2.99 to -0.82; 2 studies, 142 participants; low-certainty evidence). Symptom improvement, inactive cyst at 12 months and development of secondary echinococcosis were not reported.
CONCLUSIONS: Percutaneous and surgical interventions combined with albendazole can be used to treat uncomplicated hepatic cystic echinococcosis; however, there is a scarcity of randomised evidence directly comparing these interventions. There is very low-certainty evidence to indicate that standard catheterization plus albendazole may lead to fewer cases of recurrence, more major complications and similar complication rates compared to PAIR plus albendazole in adults and children with CE1 and CE3a cysts. There is very low-certainty evidence to indicate that laparoscopic surgery plus albendazole may result in fewer cases of recurrence or fewer major complications compared to open surgery plus albendazole in adults and children with CE1, CE2, CE3a and CE3b cysts. Laparoscopic surgery plus albendazole may lead to slightly fewer minor complications. Firm conclusions cannot be drawn due to the limited number of studies, small sample size and lack of events for some outcomes.
目的:为了评估药物的益处和危害,经皮和外科手术治疗无并发症肝囊型包虫病。
方法:我们搜索了CENTRAL,MEDLINE,到2023年5月4日,另外两个数据库和两个试验登记处。我们搜索了纳入研究的参考列表,并联系该领域的专家和研究人员进行相关研究。
方法:我们纳入了世界卫生组织(WHO)囊肿期CE1,CE2,CE3a或CE3b的无并发症肝囊性包虫病患者的随机对照试验(RCT),比较了口服药物(阿苯达唑)与阿苯达唑加经皮干预措施,或手术加阿苯达唑。在侵入性干预(手术或经皮治疗)之前或之后,将吡喹酮加阿苯达唑与单独阿苯达唑进行比较的研究符合纳入条件。
方法:我们使用标准Cochrane方法。我们的主要结果是症状改善,复发,12个月时囊肿不活跃,30天时全因死亡。我们的次要结果是继发性包虫病的发展,治疗并发症和住院时间。我们使用等级来评估证据的确定性。
结果:我们纳入了三个RCT,其中180名成人和儿童患有肝囊性包虫病。两项研究招募了5至72岁的人,一项研究招募了6至14岁的儿童。一项研究比较了标准导管插入加阿苯达唑与穿刺,抽吸,注射和再抽吸(PAIR)加阿苯达唑,两项研究比较了腹腔镜手术加阿苯达唑与开腹手术加阿苯达唑。三项RCT于2020年至2022年之间发布,并在印度进行,巴基斯坦和土耳其。没有其他比较。标准导管插入术+阿苯达唑与PAIR+阿苯达唑囊肿分期为CE1和CE3a。关于标准导尿加阿苯达唑与PAIR加阿苯达唑对囊肿复发的影响的证据非常不确定(风险比(RR)3.67,95%置信区间(CI)0.16至84.66;1项研究,38名参与者;非常低的确定性证据)。与开放手术加阿苯达唑相比,标准导尿加阿苯达唑对30天全因死亡率和继发性包虫病发展的影响的证据非常不确定。没有30天死亡或继发性包虫病的病例(1项研究,38名参与者;非常低的确定性证据)。主要并发症由囊肿报告,而不是由参与者报告。与PAIR加阿苯达唑相比,标准导管加阿苯达唑可能会增加主要囊肿并发症。但证据非常不确定(RR10.74,95%CI1.39至82.67;1项研究,53个囊肿;非常低的确定性证据)。与PAIR+阿苯达唑相比,标准导管插入术+阿苯达唑对轻微并发症的影响很小或没有差异。但证据非常不确定(RR1.03,95%CI0.60至1.77;1项研究,38名参与者;非常低的确定性证据)。与PAIR联合阿苯达唑相比,标准导尿联合阿苯达唑可能会增加中位住院时间。但证据非常不确定(4(范围1至52)天与1(范围1至15)天;1项研究,38名参与者;非常低的确定性证据)。未报告12个月时的症状改善和不活跃的囊肿。腹腔镜手术加阿苯达唑与开腹手术加阿苯达唑囊肿分期为CE1、CE2、CE3a和CE3b。与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑对CE2和CE3b囊肿参与者囊肿复发的影响的证据非常不确定(RR3.00,95%CI0.13至71.56;1项研究,82名参与者;非常低的确定性证据)。第二项研究涉及60名CE1、CE2或CE3a囊肿参与者,报告两组均无复发。与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑对CE1,CE2,CE3a或CE3b囊肿参与者30天全因死亡率的影响的证据非常不确定。两组均无死亡(2项研究,142名参与者;非常低的确定性证据)。与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑对CE1,CE2,CE3a或CE3b囊肿参与者的主要并发症的影响的证据非常不确定(RR0.50,95%CI0.13至1.92;2项研究,142名参与者;非常低的确定性证据)。与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑可能导致CE1,CE2,CE3a或CE3b囊肿参与者的轻微并发症略少(RR0.13,95%CI0.02至0.98;2项研究,142名参与者;低确定性证据)。与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑可减少住院时间(平均差异(MD)-1.90天,95%CI-2.99至-0.82;2项研究,142名参与者;低确定性证据)。症状改善,未报告12个月时囊肿不活跃和继发性包虫病的发展。
结论:经皮和外科介入联合阿苯达唑可用于治疗单纯性肝囊性包虫病;然而,缺乏直接比较这些干预措施的随机证据.有非常低的确定性证据表明,标准导管插入术加上阿苯达唑可能导致更少的复发病例,在患有CE1和CE3a囊肿的成人和儿童中,与PAIR联合阿苯达唑相比,更多的主要并发症和相似的并发症发生率。有非常低的确定性证据表明,在CE1,CE2,CE3a和CE3b囊肿的成人和儿童中,与开腹手术加阿苯达唑相比,腹腔镜手术加阿苯达唑可能导致更少的复发病例或更少的主要并发症。腹腔镜手术加阿苯达唑可能导致轻微并发症略少。由于研究数量有限,无法得出确切的结论,样本量小,某些结果缺乏事件。