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Gall stone recurrence and its prevention: the British/Belgian Gall Stone Study Groups post-dissolution trial.

机译：胆结石的复发及其预防：英国/比利时胆结石研究小组的溶出后试验。

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The British/Belgian Gall Stone Study Group (BBGSG) post-dissolution trial was a prospective, multicentre, randomised, double blind trial of: (i) low dose ursodeoxycholic acid, (ii) placebo, and (iii) a high fibre, low refined carbohydrate diet in the prevention of gall stone recurrence in patients with complete gall stone dissolution. Further aims included establishing the timing and frequency of recurrence and its association with biliary symptoms, a comparison of the sensitivity of ultrasonography v oral cholecystectography in detecting recurrent stones, and a search for risk factors predicting recurrence. Ninety three patients entered the study, and 82 were followed up for up to five years (mean (SEM) 28 (1.5) months) with six monthly ultrasonography and yearly oral cholecystectography. There were 21 recurrences (26 by oral cholecystectography or ultrasonography, or both), only two of which were symptomatic, which were detected between 12 and 42 months after trial entry. This corresponded to an actuarial recurrence rate of 33.9 (7.0%) by lifetable analysis at 42 months and subsequently. There were four recurrences in the ursodeoxycholic acid, six in the placebo, and 11 in the diet groups, corresponding to 21.9 (9.9)%, 27.4 (10.1)%, and 45.8 (12.4)% respectively at 42 months by lifetable analysis (NS). Variables including age, obesity, menopausal state, pregnancy, and oestrogen containing drugs were not shown to affect recurrence rate. Men had more frequent recurrence than women (NS). Patients who had had multiple stones experienced more recurrences than did those with single stones (NS). Recurrence did not occur in patients who took non-steroidal anti-inflammatory drugs (NSAIDs) (p < 0.02). The stone free interval between stone dissolution and trial entry proved to be important--those stone free > nine months had a recurrence rate of only 12.7 (6.0)% at 42 months compared with 55.4 (12.5)% in those stone free < nine months (p < 0.01). There was imbalance between the ursodeoxycholic acid and placebo groups for this factor, and after applying a statistical correction, the adjusted recurrence rate in the ursodeoxycholic acid group was 15% compared with 30% in both placebo and diet groups (NS). These data suggest that after medical dissolution, the risk of gall stone recurrence is not reduced by a high fibre, low refined carbohydrate diet: it may be lowered, but not abolished, by low dose ursodeoxycholic acid.
机译：英国/比利时胆石研究小组（BBGSG）的溶出后临床试验是一项前瞻性，多中心，随机，双盲试验，涉及以下各项：（i）低剂量熊去氧胆酸，（ii）安慰剂和（iii）高纤维，低精制碳水化合物饮食在预防胆结石完全溶解的患者中预防胆结石复发。进一步的目标包括确定复发的时间和频率及其与胆道症状的关系，比较超声检查与口腔胆囊造影在检测复发结石中的敏感性，以及寻找可预测复发的危险因素。 93名患者进入研究，对82例患者进行了长达5年的随访（平均（SEM）28（1.5）个月），每月进行6个月的超声检查和每年的口服胆囊造影检查。有21例复发（26例通过口腔胆囊造影或超声检查，或两者兼有），只有两个是有症状的，在试验进入后12至42个月内被发现。通过寿命表分析，在42个月及以后的时间里，这相当于精算复发率33.9（7.0％）。寿命表分析（NS），熊去氧胆酸有4例复发，安慰剂有6例，饮食组有11例复发，分别在42个月时分别占21.9（9.9）％，27.4（10.1）％和45.8（12.4）％。 ）。没有显示包括年龄，肥胖，绝经状态，妊娠和含雌激素药物在内的变量会影响复发率。男性比女性（NS）复发频率更高。患有多发结石的患者比单发结石（NS）的患者复发率更高。服用非甾体类抗炎药（NSAID）的患者未发生复发（p <0.02）。结石溶解和试验进入之间的无结石间隔被证明是重要的-结石> 9个月的无结石复发率在42个月时仅为12.7（6.0）％，而结石<9个月的无结石复发率为55.4（12.5）％ （p <0.01）。熊去氧胆酸和安慰剂组之间不平衡，该因素经统计学校正后，熊去氧胆酸组的调整后复发率为15％，而安慰剂和饮食组（NS）均为30％。这些数据表明，药物溶解后，高纤维，低精制碳水化合物饮食不会降低胆结石复发的风险：低剂量的熊去氧胆酸可以降低胆结石复发的风险，但不会消除这种风险。

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