| Kai Qin,Yi Cheng,Xianglin Yuan,Jing Zhang,Le Huang. Efficacy and safety of berberine in the prophylactic treatment of acute radiation proctitis in postoperative patients with cervical cancer: a randomized controlled study. Oncol Transl Med, 2021, 7: 1-6. |
| 黄连素预防性治疗宫颈癌术后患者急性放射性直肠炎的一项随机对照研究 |
| Efficacy and safety of berberine in the prophylactic treatment of acute radiation proctitis in postoperative patients with cervical cancer: a randomized controlled study |
| Received:September 16, 2020 Revised:January 30, 2021 |
| DOI：10.1007/s10330-020-0455-5 |
| 中文关键词: 黄连素, 宫颈癌术后患者,调强放射治疗，急性放射性直肠炎 |
| 英文关键词: berberine; adjvuant therapy; cervical cancer; intensity-modulated radiation therapy (IMRT); acute radiation proctitis |
| 基金项目:湖北省卫生健康委员会面上项目(WJ2019M118) |
| Author Name | Affiliation | E-mail | | Kai Qin | Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 30030, China | qinkaitj@126.com | | Yi Cheng | Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 30030, China | | | Xianglin Yuan | Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 30030, China | | | Jing Zhang | Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 30030, China | | | Le Huang* | Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 30030, China | huang7181@163.com |
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| 中文摘要: |
| 目的:探讨黄连素预防宫颈癌术后患者急性放射性直肠炎的疗效和安全性。方法:2016年7月至2019年10月我院就诊的120例宫颈癌术后患者通过随机数字表法将患者随机分为治疗组(黄连素300mg，每日3次，n = 60)和对照组(维生素C片100mg，每日3次，n = 60)。所有患者接受盆腔调强放射治疗(IMRT)和每周同步增敏化疗。通过比较两组间直肠和小肠受照体积百分比、急性放射性直肠炎和膀胱炎的发生率、发病时间、严重程度和持续时间的差异。同时比较调强放疗的完成率、完成时间、增敏化疗次数和放疗期间的生活质量。结果:两组患者的年龄、FIGO分期、病理类型、并发症、高危因素及直肠和小肠剂量分布(V20、V30、V40和V50)无统计学差异(P>0.05)。两组均未发生3级及以上急性放射性直肠炎。两组间急性放射性膀胱炎、2级急性放射性直肠炎的发生率、IMRT完成率和致敏化疗频率无显著差异。黄连素预防性治疗后，治疗组1级急性放射性直肠炎的发生率、1级放射性直肠炎的发生时间和放疗完成时间均低于对照组，差异有统计学意义(P < 0.05)。治疗组放疗后SF-36评分为67.53±4.21，优于对照组(64.90±6.32)，差异有统计学意义(P < 0.05)。治疗组3 - 4级中性粒细胞减少症的发生率为10%，低于对照组(31.7%，P = 0.003)。未发现与黄连素有关的不良反应。结论:口服黄连素预防处方可降低1级急性放射性直肠炎的发生率、发病时间和持续时间，提高宫颈癌术后同步放化疗患者的生活质量。 |
| 英文摘要: |
| Objective The aiom of this study was to study the efficacy and safety of berberine as a prophylactic
treatment of acute radiation proctitis in postoperative patients with cervical cancer.
Methods A total of 120 postoperative patients with cervical cancer were enrolled between July 2016 and
October 2019, and randomly divided into a treatment group (berberine 300 mg three times a day, n = 60)
and a control group (receiving vitamin C tablets, 100 mg three times a day; n = 60) using the random number
table method. All patients received pelvic intensity-modulated radiation therapy (IMRT) and concurrent
sensitizing chemotherapy weekly. The difference in the percentage of irradiation volume to the rectum and
small intestine as well as the incidence, onset time, severity, and duration of acute radiation proctitis and
cystitis during radiotherapy were compared between the two groups. The completion rate, completion time,
number of chemotherapy sessions, and quality of life during radiotherapy were also compared.
Results There were no statistical differences in age, FIGO stage, pathological type, complications, highrisk factors, and rectum and small intestine irradiation dose distribution (V20, V30, V40, and V50) between
the two groups (P > 0.05). No acute radiation proctitis of grade 3 or above occurred in the two groups.
There was no significant difference in the incidence of acute radiation cystitis, grade 2 acute radiation
proctitis, completion rate of IMRT, and frequency of sensitization chemotherapy between the two groups.
After prophylactic treatment with berberine, the incidence of grade 1 acute radiation proctitis, occurrence
of grade 1 radiation proctitis, and completion time of radiotherapy in the treatment group were significantly
lower than those in the control group (P < 0.05). The SF-36 score of the treatment group after radiotherapy
was 67.53 ± 4.21, which was significantly better than that of the control group (64.90 ± 6.32; P < 0.05). The
incidence of grade 3-4 neutropenia in the treatment group was 10% and lower than that in the control group
(31.7%, P = 0.003). No adverse reactions related to berberine were observed.
Conclusion Prophylactic prescription with oral berberine can reduce the incidence, onset time, and
duration of grade 1 acute radiation proctitis, and improve the quality of life of postoperative patients with
cervical cancer receiving concurrent chemoradiotherapy. |
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