Department of Clinical Pharmacy, School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou, China.
Department of Colorectal Surgery, The Affiliated TCM Hospital of Guangzhou Medical University, Guangzhou, China.
Syst Rev. 2023 Aug 22;12(1):146. doi: 10.1186/s13643-023-02294-2.
Chronic radiation proctitis (CRP) is a long-term complication of pelvic radiotherapy that manifests as rectal bleeding, diarrhoea, fistula formation and obstruction. Treatments such as endoscopic argon plasma coagulation, hyperbaric oxygen therapy and rectal topical formalin have imposed a significant medical burden on CRP patients. In contrast, oral therapies offer a more accessible and acceptable option for managing CRP. Here, we conducted a systematic review of the efficacy of oral treatments for CRP to assess their potential as an effective and convenient treatment option for this condition.
We searched the Cochrane Central Register of Controlled Trials, PubMed, Web of Science, China National Knowledge Infrastructure and Chinese VIP in February 2021. We included post-radiotherapy participants with CRP that compared oral medicine alone or in combination with other treatments versus control treatments. The primary outcomes were bleeding, diarrhoea and symptom score. Heterogeneity between studies was checked using Cochrane Q test statistics and I test statistics. The Cochrane risk-of-bias tool was used to assess the quality of the included studies.
We included 10 randomised controlled trials (RCTs) and 1 retrospective study with 898 participants. Three placebo-controlled trials evaluated the effects of oral sucralfate on CRP, with meta-analysis showing no significant different with placebo arm. Four trials on TCM demonstrated significant improvement of symptoms, especially for the 3 trials on oral TCM drinks. Retinyl palmitate and high-fibre diet were found to reduce rectal bleeding. The combination of oral pentoxifylline and tocopherol did not significantly change the process of CRP.
Our study implies that oral TCM drinks, retinyl palmitate and a high-fiber diet showed significant improvement in CRP symptoms, but not with the combination of oral pentoxifylline and tocopherol. Further multicentre, larger-scale RCTs are needed to confirm the efficacy and safety of these treatments and optimize treatment strategies, ultimately improving the quality of life for patients with CRP.
慢性放射性直肠炎（CRP）是盆腔放疗的一种长期并发症，表现为直肠出血、腹泻、瘘管形成和梗阻。内镜氩等离子凝固、高压氧治疗和直肠局部福尔马林等治疗方法给 CRP 患者带来了沉重的医疗负担。相比之下，口服治疗为 CRP 提供了一种更易于接受的选择。在这里，我们对 CRP 的口服治疗效果进行了系统评价，以评估它们作为一种有效且方便的治疗选择的潜力。
我们于 2021 年 2 月检索了 Cochrane 中央对照试验注册库、PubMed、Web of Science、中国国家知识基础设施和中国 VIP 数据库，纳入了比较单独使用口服药物或联合其他治疗与对照组治疗的放射治疗后 CRP 患者。主要结局指标为出血、腹泻和症状评分。使用 Cochrane Q 检验和 I 检验统计量检查研究间的异质性。使用 Cochrane 偏倚风险工具评估纳入研究的质量。
我们纳入了 10 项随机对照试验（RCT）和 1 项回顾性研究，共 898 名参与者。3 项安慰剂对照试验评估了口服硫糖铝对 CRP 的影响，meta 分析显示与安慰剂组无显著差异。4 项中医药试验显示症状有显著改善，尤其是 3 项口服中医药饮品试验。视黄醇棕榈酸酯和高纤维饮食可减少直肠出血。口服己酮可可碱和维生素 E 联合治疗并未显著改变 CRP 进程。
我们的研究表明，口服中医药饮品、视黄醇棕榈酸酯和高纤维饮食可显著改善 CRP 症状，但口服己酮可可碱和维生素 E 联合治疗则不然。需要进一步开展多中心、更大规模的 RCT 以确认这些治疗方法的疗效和安全性，并优化治疗策略，最终提高 CRP 患者的生活质量。
