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生长抑素与吲哚美辛单药或联合治疗对高危高淀粉酶血症和胰腺炎后内镜逆行胰胆管造影患者的影响:一项随机研究。

Effects of Somatostatin and Indomethacin Mono or Combination Therapy on High-risk Hyperamylasemia and Post-pancreatitis Endoscopic Retrograde Cholangiopancreatography Patients: A Randomized Study.

机构信息

Department of Digestive Internal Medicine, Southern Medical University Pingxiang Hospital, Pingxiang, People's Republic of China.

Department of International School of Nursing, Hainan Medical University, Haikou, People's Republic of China.

出版信息

Surg Laparosc Endosc Percutan Tech. 2023 Oct 1;33(5):474-479. doi: 10.1097/SLE.0000000000001202.

DOI:10.1097/SLE.0000000000001202
PMID:37523580
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10545056/
Abstract

BACKGROUND

Endoscopic retrograde cholangiopancreatography (ERCP) is a minimally invasive technique widely used to diagnose and treat pancreatic and biliary diseases; however, it is linked with imminent hyperamylasemia and post-ERCP pancreatitis (PEP). Somatostatin and indomethacin are the classic recommended drugs used for PEP prevention.

OBJECTIVE

To elucidate the effects of somatostatin and indomethacin mono or in combination to prevent hyperamylasemia and PEP in high-risk individuals.

METHODS

Altogether 1458 patients who underwent ERCP in our hospital from January 2016 to May 2022 were included in this investigation and categorized into 4 groups based on the treatment regimen: placebo, indomethacin, somatostatin, and indomethacin + somatostatin. The pre operation and post operation (at 6, 12, and 24 h) hospitalization cost, length of stay, the occurrence of hyperamylasemia and PEP, levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), IL-8, and VAS pain score were determined in the 4 groups. In all the groups, VAS and IL-6, TNF-α, and IL-8 levels substantially increased in the pretreatment and decreased sequentially from 6 to 24 h post operation. The individuals in the indomethacin revealed substantially reduced hyperamylasemia, VAS, and levels of IL-6, TNF-α, and IL-8, 6 h post operation, whereas the hospitalization fee, length of stay, PEP incidence, VAS, levels of IL-6, TNF-α, and IL-8, 12 and 24 h post operation were not statistically important in comparison with the individuals who received placebo therapy. The somatostatin and the indomethacin + somatostatin groups indicated markedly alleviated hospitalization fee, length of stay, the occurrence of hyperamylasemia and PEP, VAS, and the levels of IL-6, TNF-α, and IL-8 at 6, 12, and 24 h post operation compared with the placebo cohort. Furthermore, compared with the indomethacin group, the above-determined factors notably reduced at 6, 12, and 24 h post operation in somatostatin and indomethacin + somatostatin groups. It was also observed that the indomethacin + somatostatin group has substantially decreased the occurrence of hyperamylasemia, VAS score, and levels of IL-6, TNF-α, and IL-8, 6 hours post operation, while at 12 and 24 h post operation, the hospitalization fee, length of stay and incidence of PEP, VAS, levels of IL-6, TNF-α, and IL-8 were not statistically important compared with the somatostatin group. It is also worth noting that the side effects of both drugs are rare and mild.

RESULTS

For high-risk PEP patients, indomethacin and somatostatin can efficiently alleviate post-operative hyperamylasemia and improve their life standard within 6 hours and 24 hours, respectively. Indomethacin is suitable for individuals who underwent simple, short-duration ERCP with expected mild post-operative abdominal pain, whereas somatostatin is given to patients with complicated, long-duration ERCP and expected severe post-operative abdominal pain. Their combinational therapy produces a synergistic effect and can reduce the incidence of hyperamylasemia, thereby improving patients' quality of life within 6 h and is also effective against individuals who received a more complicated, longer-duration ERCP and were expected to have severer and longer post-operative abdominal pain.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c28d/10545056/a3f801685aa9/sle-33-474-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c28d/10545056/a3f801685aa9/sle-33-474-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c28d/10545056/a3f801685aa9/sle-33-474-g001.jpg
摘要

背景

内镜逆行胰胆管造影术(ERCP)是一种广泛用于诊断和治疗胰腺和胆道疾病的微创技术;然而,它与急性高淀粉酶血症和内镜逆行胰胆管造影术后胰腺炎(PEP)有关。生长抑素和吲哚美辛是预防 PEP 的经典推荐药物。

目的

阐明生长抑素和吲哚美辛单独或联合用于预防高危人群高淀粉酶血症和 PEP 的效果。

方法

本研究共纳入 2016 年 1 月至 2022 年 5 月在我院接受 ERCP 的 1458 例患者,并根据治疗方案分为 4 组:安慰剂、吲哚美辛、生长抑素和吲哚美辛+生长抑素。在 4 组中,分别测定术前和术后(术后 6、12 和 24 小时)住院费用、住院时间、高淀粉酶血症和 PEP 的发生情况、肿瘤坏死因子-α(TNF-α)、白细胞介素-6(IL-6)、白细胞介素-8(IL-8)和视觉模拟评分(VAS)疼痛评分。在所有组中,VAS 和 IL-6、TNF-α和 IL-8 水平在预处理时显著增加,并从术后 6 小时开始依次降低。吲哚美辛组术后 6 小时高淀粉酶血症、VAS 和 IL-6、TNF-α和 IL-8 水平显著降低,而安慰剂治疗组的住院费用、住院时间、PEP 发生率、VAS、IL-6、TNF-α和 IL-8 水平在术后 12 和 24 小时无统计学意义。生长抑素和吲哚美辛+生长抑素组在术后 6、12 和 24 小时的住院费用、住院时间、高淀粉酶血症和 PEP 发生率、VAS 和 IL-6、TNF-α和 IL-8 水平明显低于安慰剂组。此外,与吲哚美辛组相比,生长抑素和吲哚美辛+生长抑素组在术后 6、12 和 24 小时时上述各项指标明显降低。还观察到,吲哚美辛+生长抑素组在术后 6 小时时高淀粉酶血症、VAS 评分和 IL-6、TNF-α和 IL-8 水平显著降低,而在术后 12 和 24 小时时,与生长抑素组相比,住院费用、住院时间和 PEP 发生率、VAS、IL-6、TNF-α和 IL-8 水平无统计学意义。值得注意的是,两种药物的副作用都很少且轻微。

结果

对于高危 PEP 患者,吲哚美辛和生长抑素可有效缓解术后高淀粉酶血症,并分别在术后 6 小时和 24 小时内提高患者的生活质量。吲哚美辛适用于预期术后腹痛较轻、简单、短时间 ERCP 的患者,而生长抑素适用于预期术后腹痛较重、复杂、长时间 ERCP 的患者。它们的联合治疗具有协同作用,可以降低高淀粉酶血症的发生率,从而在 6 小时内提高患者的生活质量,对接受更复杂、更长时间 ERCP 且预计术后腹痛更严重、持续时间更长的患者也有效。

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