Wei Hao, Sun Yu, Xie Lingling, Jia Yuming, He Jun, Deng Xiaofei, Huang Wei, Hu Yang, Zhu Jiang
Thoracic Oncology Ward, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
Radiotherapy Physics & Technology Center, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
J Integr Complement Med. 2023 Aug;29(8):501-509. doi: 10.1089/jicm.2022.0672. Epub 2023 Mar 30.
Chemotherapy-induced nausea and vomiting (CINV) is one of the most distressing side effects associated with deterioration in the quality of life. This study aimed to assess the clinical value of Huoxiang Zhengqi (HXZQ) oral liquid, a Chinese patent medicine, in combination with 5-HT3 receptor antagonists (RAs) and dexamethasone, in preventing CINV in patients receiving multiday cisplatin-based chemotherapy. In this multicenter, exploratory randomized clinical trial, the authors compared the efficacy of HXZQ oral liquid against a control group receiving a placebo, in combination with 5-HT3 RAs and dexamethasone, in preventing CINV in chemotherapy-naive patients receiving a multiday cisplatin-based regimen between January 2021 and September 2021. The primary endpoint was the complete response (CR) rate. The secondary endpoints included days with no CINV, the incidence of CINV, and life function. Sixty patients were randomized into two groups and included in the study. The CR rate was significantly improved by HXZQ oral liquid in acute CINV (63.33% vs. 33.33%, = 0.020) and CINV beyond the risk phase (96.67% vs. 46.67%, = 0.000). The number of days with no CINV was significantly more in the HXZQ group compared with the control group in the overall phase (18.10 ± 3.64 vs. 12.13 ± 7.63, = 0.002). Significantly higher Functional Living Index-Emesis total and domain scores were observed in the HXZQ group. HXZQ oral liquid combined with 5-HT3 RAs and dexamethasone is a feasible and safe approach to prevent CINV in patients receiving multiday cisplatin-based chemotherapy who cannot use neurokinin 1 RAs. ChiCTR2000040123.
化疗引起的恶心和呕吐（CINV）是与生活质量下降相关的最令人痛苦的副作用之一。本研究旨在评估中成药藿香正气口服液联合5-羟色胺3受体拮抗剂（RAs）和地塞米松在预防接受多日顺铂化疗患者CINV中的临床价值。在这项多中心探索性随机临床试验中，作者比较了藿香正气口服液与接受安慰剂的对照组联合5-羟色胺3 RAs和地塞米松在预防2021年1月至2021年9月接受多日顺铂方案的初治化疗患者CINV中的疗效。主要终点是完全缓解（CR）率。次要终点包括无CINV的天数、CINV的发生率和生活功能。60名患者被随机分为两组并纳入研究。藿香正气口服液在急性CINV（63.33%对33.33%，P = 0.020）和风险期后的CINV（96.67%对46.67%，P = 0.000）中显著提高了CR率。在整个阶段，藿香正气组无CINV的天数明显多于对照组（18.10±3.64对12.13±7.63，P = 0.002）。藿香正气组的功能生活指数-呕吐总分和领域得分显著更高。藿香正气口服液联合5-羟色胺3 RAs和地塞米松是预防不能使用神经激肽1 RAs的接受多日顺铂化疗患者CINV的一种可行且安全的方法。ChiCTR2000040123。
