Deng Bo, Jia Liqun, Tan Huangying, Lou Yanni, Li Xue, Li Yuan, Yu Lili
J Tradit Chin Med. 2017 Feb;37(1):35-42. doi: 10.1016/s0254-6272(17)30024-9.
To evaluate the efficacy of Shengjiangxiexin decoction (SXD), prepared with a formula from Traditional Chinese Medicine (TCM), in reducing irinotecan-induced hematological and gastrointestinal toxicities in patients with UDP-glucuronosyltransferase (UGT)1A128 and UGT1A16 polymorphisms.
This clinical trial included 115 patients receiving irinotecan combined with 5-fluorouracil plus l-leucovorin (FOLFIRI) treatment. All patients consented to UGT1A1*28 and *6 gene polymorphism detection prior to chemotherapy. SXD were administered from 1 day prior to chemotherapy to 6 day post chemotherapy. Chemotherapy induced adverse reactions (neutropenia, diarrhea, nausea, vomiting, anorexia and infection) were recorded, and short-term effect of chemotherapy was evaluated regularly.
A total of 50 patients had *1/*1 wild genotype, 58 patients had single allele variants with genotype *1/*6 or *1/*28 , and 7 patients had two alleles variants with genotype *6/*6, *28/*28 or 6/ 28. In *1/*6 or *1/*28 patients (high risk group), 9 patients (15.5% ) developed Ⅰ-Ⅱ grade diarrhea and no patient developed severe diarrhea; neutropenia occurred in 19 patients (32.8%) and only 3 patients (8.6% ) developed sever neutropenia. There were no significant differences in any toxic effects (neutropenia, diarrhea, nausea, vomiting, anorexia or infection) between *6 or *28 variant patients (high risk group) and wild type patients. No sever toxicity was found in high risk two alleles variants patients (*6/*6, *6/*28 or *28/28). No significant differences were observed between UGT1A16/*28 polymorphisms and clinical response of chemotherapy.
SXD could significantly reduce irinotecan-induced hematological and gastrointestinal toxicities in UGT1A1*28 or *6 variant patients (high risk group), while this treatment didn't affect clinical response of chemotherapy.
评估采用中药配方制备的生姜泻心汤（SXD）对携带尿苷二磷酸葡萄糖醛酸基转移酶（UGT）1A128和UGT1A16基因多态性的患者减轻伊立替康所致血液学和胃肠道毒性的疗效。
本临床试验纳入115例接受伊立替康联合5-氟尿嘧啶加亚叶酸钙（FOLFIRI）治疗的患者。所有患者在化疗前均同意进行UGT1A128和6基因多态性检测。SXD在化疗前1天至化疗后6天给药。记录化疗引起的不良反应（中性粒细胞减少、腹泻、恶心、呕吐、厌食和感染），并定期评估化疗的短期疗效。
共有50例患者为*1/1野生基因型，58例患者为单等位基因变异，基因型为1/6或1/28，7例患者为两个等位基因变异，基因型为6/*6、*28/28或6/28。在1/6或1/*28患者（高风险组）中，9例患者（15.5%）发生Ⅰ-Ⅱ级腹泻，无患者发生严重腹泻；19例患者（32.8%）发生中性粒细胞减少，仅3例患者（8.6%）发生严重中性粒细胞减少。6或28变异患者（高风险组）与野生型患者在任何毒性作用（中性粒细胞减少、腹泻、恶心、呕吐、厌食或感染）方面均无显著差异。高风险双等位基因变异患者（*6/*6、*6/28或28/28）未发现严重毒性。UGT1A16/*28基因多态性与化疗临床反应之间未观察到显著差异。
SXD可显著减轻UGT1A128或6变异患者（高风险组）伊立替康所致的血液学和胃肠道毒性，而该治疗不影响化疗的临床反应。
