Abdel-Rahman Omar, ElHalawani Hesham, Essam-Eldin Shaimaa
a Clinical Oncology Department, Faculty of Medicine , Ain Shams University , Cairo 11665 , Egypt.
Expert Opin Drug Saf. 2016 Jan;15(1):5-20. doi: 10.1517/14740338.2016.1105959. Epub 2015 Oct 29.
We performed a meta-analysis of the risk of oral and gastrointestinal (GI) mucosal injury associated with S-1-based regimens.
Randomized phase II and III trials of patients with solid tumors on S-1; describing events of all-grade and high-grade stomatitis and diarrhea constituted the eligible studies.
After exclusion of ineligible studies, a total of 26 clinical trials were considered eligible for the meta-analysis. The odds ratio (OR) of all-grade and high-grade stomatitis for S-1 vs. non-fluoropyrimidine controls was 4.39 [95% CI: 1.05, 18.37; p = 0.04] and 5.64 [95% CI: 1.46, 21.77; p = 0.01], respectively; while the OR of all-grade and high-grade stomatitis for S-1 vs. infusional 5-fluorouracil (5-FU) control was -1.01 [95% CI: 0.22, 4.63; p = 0.99] and 0.32 [95% CI: 0.20, 0.49; p < 0.00001], respectively. The OR of all-grade and high-grade diarrhea for S-1 vs. non-fluoropyrimidine controls was 2.48 [95% CI: 2.12, 2.90; p < 0.00001] and 1.95 [95% CI: 1.29, 2.96; p = 0.002], respectively; while the OR of all-grade and high-grade diarrhea for S-1 vs. infusional 5-FU control was -1.03 [95% CI: 0.87, 1.22; p = 0.76] and 2.52 [95% CI: 1.80, 3.52; p < 0.00001], respectively.
Compared to non-fluoropyrimidine control, patients treated with S-1-based regimens have an increased risk of all-grade and high-grade stomatitis and diarrhea; while on the other hand, patients treated with infusional 5-FU have a greater risk of high-grade stomatitis and diarrhea compared to patients treated with S-1-based regimens.
我们对基于S-1的治疗方案相关的口腔和胃肠道（GI）黏膜损伤风险进行了一项荟萃分析。
对接受S-1治疗的实体瘤患者进行的随机II期和III期试验；描述所有级别和高级别口腔炎及腹泻事件的研究构成合格研究。
排除不合格研究后，共有26项临床试验被认为符合荟萃分析的条件。S-1与非氟嘧啶对照相比，所有级别和高级别口腔炎的优势比（OR）分别为4.39 [95%置信区间：1.05, 18.37；p = 0.04]和5.64 [95%置信区间：1.46, 21.77；p = 0.01]；而S-1与静脉输注5-氟尿嘧啶（5-FU）对照相比，所有级别和高级别口腔炎的OR分别为-1.01 [95%置信区间：0.22, 4.63；p = 0.99]和0.32 [95%置信区间：0.20, 0.49；p < 0.00001]。S-1与非氟嘧啶对照相比，所有级别和高级别腹泻的OR分别为2.48 [95%置信区间：2.12, 2.90；p < 0.00001]和1.95 [95%置信区间：1.29, 2.96；p = 0.002]；而S-1与静脉输注5-FU对照相比，所有级别和高级别腹泻的OR分别为-1.03 [95%置信区间：0.87, 1.22；p = 0.76]和2.52 [95%置信区间：1.80, 3.52；p < 0.00001]。
与非氟嘧啶对照相比，接受基于S-1治疗方案的患者发生所有级别和高级别口腔炎及腹泻的风险增加；而另一方面，与接受基于S-1治疗方案的患者相比，接受静脉输注5-FU治疗的患者发生高级别口腔炎和腹泻的风险更高。
