Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation
Clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones or cholecystitis: a systematic review and economic evaluation
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DOI：
10.3310/hta18550
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发表时间：
2014-08-01
影响因子：
3.6
通讯作者：
Ramsay, Craig
中科院分区：
文献类型：
--
作者：
Brazzelli, Miriam;Cruickshank, Moira;Ramsay, Craig
背景：大约10-15%的成年人患有胆石病，胆石症，女性多于男性。胆囊切除术是患有胆痛或急性胆囊炎并有胆结石证据的人的首选治疗方法。然而，有些人在胆痛或胆囊炎的初始发作后不会复发。由于目前的研究大多集中在疾病的外科治疗上，较少关注保守治疗的后果。目的：确定胆囊切除术与观察/保守治疗相比，在无并发症症状的胆囊结石患者中的临床有效性和成本效益（胆道疼痛）或胆囊炎。数据来源：我们搜索了所有主要的电子数据库（例如MEDLINE、EMBASE、Science Citation Index、Bioscience Information Service，科克伦对照试验中心注册）从1980年到2012年9月，我们联系了该领域的专家。审查方法：证据来自随机对照试验（RCT）和非随机对照研究，这些研究招募了有症状的胆石病患者（仅疼痛发作和/或急性胆囊炎）。两名评价者独立提取数据并评估纳入研究的偏倚风险。采用标准荟萃分析技术对纳入研究的结果进行联合收割机组合。一个从头马尔可夫模型，以评估的成本效益的interventions.Results：两个挪威随机对照试验，涉及201名参与者。在14年的随访期间，88%的随机手术患者和45%的随机观察患者接受了胆囊切除术。随机分配到观察组的受试者更有可能发生胆石相关并发症[风险比= 6.69; 95%置信区间（CI）1.57 - 28.51; p = 0.01]，特别是急性胆囊炎（风险比= 9.55; 95%CI 1.25至73.27; p = 0.03），并且不太可能接受手术（风险比= 0.50; 95% CI 0.34 - 0.73; p = 0.0004），发生手术相关并发症（风险比= 0.36; 95% CI 0.16 - 0.81; p = 0.01）或更具体地说，轻微手术相关并发症（风险比= 0.11; 95% CI 0.02 - 0.56; p = 0.008）。在14年的随访期间，55%的随机观察者不需要手术，12%的随机胆囊切除术者没有接受预定的手术。经济评估的结果表明，平均而言，手术策略比保守治疗策略每例患者多花费1236美元，但平均而言，更有效。保守治疗时需要手术的人数增加对应于保守策略的成本效益降低。经济model.Conclusions中使用的一些参数周围有不确定性：本次评估的结果表明，胆囊切除术仍然是许多有症状的人的治疗选择。然而，观察组中约有一半的人不需要手术或长期遭受并发症，这表明保守治疗方法可能是该组人群手术的有效替代方案。由于目前缺乏证据，在英国设置一个大的，精心设计的，多中心的试验是必要的。
Background: Approximately 10-15% of the adult population suffer from gallstone disease, cholelithiasis, with more women than men being affected. Cholecystectomy is the treatment of choice for people who present with biliary pain or acute cholecystitis and evidence of gallstones. However, some people do not experience a recurrence after an initial episode of biliary pain or cholecystitis. As most of the current research focuses on the surgical management of the disease, less attention has been dedicated to the consequences of conservative management.Objectives: To determine the clinical effectiveness and cost-effectiveness of cholecystectomy compared with observation/conservative management in people presenting with uncomplicated symptomatic gallstones (biliary pain) or cholecystitis.Data sources: We searched all major electronic databases (e.g. MEDLINE, EMBASE, Science Citation Index, Bioscience Information Service, Cochrane Central Register of Controlled Trials) from 1980 to September 2012 and we contacted experts in the field.Review methods: Evidence was considered from randomised controlled trials (RCTs) and non-randomised comparative studies that enrolled people with symptomatic gallstone disease (pain attacks only and/or acute cholecystitis). Two reviewers independently extracted data and assessed the risk of bias of included studies. Standard meta-analysis techniques were used to combine results from included studies. A de novo Markov model was developed to assess the cost-effectiveness of the interventions.Results: Two Norwegian RCTs involving 201 participants were included. Eighty-eight per cent of people randomised to surgery and 45% of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications [risk ratio = 6.69; 95% confidence interval (Cl) 1.57 to 28.51; p = 0.01], in particular acute cholecystitis (risk ratio = 9.55; 95% Cl 1.25 to 73.27; p = 0.03), and less likely to undergo surgery (risk ratio = 0.50; 95% Cl 0.34 to 0.73; p = 0.0004), experience surgery-related complications (risk ratio = 0.36; 95% Cl 0.16 to 0.81; p = 0.01) or, more specifically, minor surgery-related complications (risk ratio = 0.11; 95% Cl 0.02 to 0.56; p = 0.008) than those randomised to surgery. Fifty-five per cent of people randomised to observation did not require an operation during the 14-year follow-up period and 12% of people randomised to cholecystectomy did not undergo the scheduled operation. The results of the economic evaluation suggest that, on average, the surgery strategy costs 1236 more per patient than the conservative management strategy but was, on average, more effective. An increase in the number of people requiring surgery while treated conservatively corresponded to a reduction in the cost-effectiveness of the conservative strategy. There was uncertainty around some of the parameters used in the economic model.Conclusions: The results of this assessment indicate that cholecystectomy is still the treatment of choice for many symptomatic people. However, approximately half of the people in the observation group did not require surgery or suffer complications in the long term indicating that a conservative therapeutic approach may represent a valid alternative to surgery in this group of people. Owing to the dearth of current evidence in the UK setting a large, well-designed, multicentre trial is needed.