BACKGROUND Colchicine is a widely used drug to treat inflammatory diseases. Due to its long historical use in medicine, controlled clinical trials have been small and there remains some caution with the use of this drug in patients with co-morbidities. The aim of the study is to systematically examine the side effect profile of colchicine in controlled clinical trials across all published indications. METHODS A systematic review was conducted in accordance with PRISMA methodology. The Cochrane Library, MEDLINE and EMBASE were searched for double-blind controlled trials of oral colchicine in adult patients that reported adverse event data. Meta-analyses were used to determine the relative risk (RR) of adverse events in colchicine users compared to comparator groups. RESULTS A total of 4915 studies were initially identified and after exclusions, 35 randomised controlled trials with placebo (n = 35) or active comparators (n = 5) were included. The most common diseases studied were gout, liver cirrhosis and pericarditis. There were a total of 8659 pooled participants, 4225 participants were randomised to receive colchicine, 3956 to placebo and 411 to an active comparator. Diarrhoea was reported in 17.9% of colchicine users versus 13.1% in comparator groups (RR 2.4, 95% confidence interval (CI) 1.6, 3.7). Any gastrointestinal event was reported in 17.6% of colchicine users and 13.1% of comparators (RR 1.7, 95% CI 1.3, 2.3). Adverse liver events were reported in 1.9% of colchicine users versus 1.1% in the comparator groups (RR 1.6, 95% CI 0.9, 3.0). Muscle events were reported in 4.2% of colchicine users and 3.3% in the comparator groups (RR 1.3, 95% CI 0.8, 1.9). Haematology events were reported in 0.6% of colchicine users and 0.4% of comparator groups (RR 1.34 (0.64, 2.82). No study reported neuropathy events. Other sensory events were reported in 1.1% of colchicine users and 1.5% of comparator groups (RR 1.4, 95% CI 0.3, 6.7). Infectious events were reported in 0.4% of colchicine users and 2.1% of comparator groups (RR 1.0, 95% CI 0.7, 1.5). No study reported death as an adverse event. CONCLUSION Colchicine increases the rate of diarrhoea and gastrointestinal adverse events but does not increase the rate of liver, sensory, muscle, infectious or haematology adverse events or death.

中文翻译：

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口服秋水仙碱使用过程中的不良事件：随机对照试验的系统评价和荟萃分析。

背景技术秋水仙碱是广泛用于治疗炎性疾病的药物。由于其在医学上的悠久历史，受控的临床试验规模很小，在合并症患者中使用此药仍需谨慎。这项研究的目的是在所有已发表的适应症的对照临床试验中系统检查秋水仙碱的副作用。方法按照PRISMA方法进行系统评价。在Cochrane库，MEDLINE和EMBASE中搜索了报告不良事件数据的成年患者口服秋水仙碱的双盲对照试验。荟萃分析被用来确定秋水仙碱使用者与比较组相比不良事件的相对风险（RR）。结果最初鉴定出4915项研究，排除后，纳入了35个使用安慰剂（n = 35）或活性比较剂（n = 5）的随机对照试验。研究的最常见疾病是痛风，肝硬化和心包炎。总共有8659名参与者，随机分配4225名参与者接受秋水仙碱，安慰剂3956名，活跃对照者411名。据报道，秋水仙碱使用者中有17.9％出现腹泻，而比较组中则为13.1％（RR 2.4，95％置信区间（CI）1.6，3.7）。据报道，有17.6％的秋水仙碱使用者和13.1％的比较者发生任何胃肠道事件（RR 1.7、95％CI 1.3、2.3）。1.9％的秋水仙碱使用者报告了不良肝脏事件，而比较组中则为1.1％（RR 1.6、95％CI 0.9、3.0）。在4.2％的秋水仙碱使用者中报告了肌肉事件，在比较组中报告了3.3％的肌肉事件（RR 1.3、95％CI 0.8、1.9）。95％CI 0.3，6.7）。在0.4％的秋水仙碱使用者和2.1％的比较组中报告了感染事件（RR 1.0、95％CI 0.7、1.5）。没有研究报告死亡为不良事件。结论秋水仙碱可增加腹泻和胃肠道不良事件的发生率，但不会增加肝脏，感觉，肌肉，感染性或血液学不良事件或死亡的发生率。95％CI 0.3，6.7）。在0.4％的秋水仙碱使用者和2.1％的比较组中报告了感染事件（RR 1.0、95％CI 0.7、1.5）。没有研究报告死亡为不良事件。结论秋水仙碱可增加腹泻和胃肠道不良事件的发生率，但不会增加肝脏，感觉，肌肉，感染性或血液学不良事件或死亡的发生率。