胃宁颗粒联合化疗治疗进展期胃癌的临床研究

Clinical observation on Weining granules combined with chemotherapy in the treatment of advanced gastric cancer

目的观察胃宁颗粒联合化疗治疗进展期胃癌的临床疗效。方法采取多中心随机对照临床试验,将80例胃癌不能行手术切除或术后复发的患者随机分为治疗组和对照组各40例,治疗组服用胃宁颗粒联合化疗,对照组单纯化疗,3个疗程后进行中医药整体性临床疗效、生存质量、毒副反应等评估。结果治疗12周后,治疗组各主要症状均比治疗前有改善(P<0.05),对嗳气、纳差、乏力改善显著优于对照组(P<0.05)。实体瘤近期疗效,治疗组有效率52.5%,对照组25.0%,两者有显著差别(P<0.05)。生存质量,躯体功能、角色功能、情绪功能、社会功能、疼痛、总体健康,治疗组改善情况优于对照组(P<0.05);治疗组还在恶心呕吐、食欲丧失、腹泻方面较治疗前有显著改善(P<0.05),而对照组无显著性差别(P>0.05)。毒副反应,治疗组Ⅲ级及以上毒副作用的发生率与对照组比较,差异有显著性意义(P<0.05),此外无其他安全指标出现明显异常。结论胃宁颗粒联合化疗治疗进展期胃癌可以改善患者主要中医临床症状,提高患者生存质量,减少化疗引起的毒副反应,未发现与其相关的不良反应,是治疗进展期胃癌安全有效的方法。

Objective To investigate the clinical efficacy of the Weining granules combined with chemotherapy in the treatment of advanced gastric cancer. Methods In a multicenter, randomized controlled clinical trial, 80 patients with unresectable or postoperative recurrent gastric cancer were randomly assigned in a 1：1 ratio to receive chemotherapy alone （control group） or combined with the Weining granules （treatment group）. After 3 courses of treatment, overall clinical efficacy, quality of life and safety profiles were assessed. Results The Weining granules given in combination with chemotherapy for 12 weeks in the treatment group were associated with improved symptoms from baseline （P 〈 0.05 ）. The combination therapy significantly improved belching, anorexia and fatigue, compared with chemotherapy alone （ P 〈 0.05 ）. Solid tumors were significantly more likely to respond to the combination therapy than to the monotherapy （52.5% vs. 25.0%, P 〈 0.05）. Quality of life, physical function, role function, emotional function, social function, pain and overall health were improved to a significantly greater extent with the combination therapy than with chemotherapy alone （P 〈 0.05）. Significant improvements in nausea, vomiting, appetite loss, and diarrhea from baseline were observed in patients receiving the Weining granules plus chemotherapy （P 〈 0.05 ） , but not in those receiving chemotherapy alone （ P 〉 0. 05 ）. No significant differences in safety parameters were found between the combination-therapy group and the monotherapy group, except that patients receiving the combination therapy were significantly more likely to experience grade III or higher toxicities. Conclusions Overall, the addition of the Weining granules to chemotherapy can result in improved clinical symptoms, enhanced quality of life, and reduced chemotherapy-induced toxicities in patients with advanced gastric cancer. No adverse event that is considered to be related to the granules is reported. Therefore, the Weining granule appears to be an effective and safe option for the treatment of advanced gastric cancer.