半夏泻心汤加减联合TP方案治疗晚期食管鳞癌的临床研究

Clinical Study of Modified Banxia Xiexin Decoction Combined with TP Regimen in Treating Advanced Esophageal Squamous Cell Carcinoma:A Prospective,Interventional,Randomized Controlled Trial

目的本研究通过观察半夏泻心汤加减联合紫杉醇+顺铂方案(TP方案)化疗对晚期食管鳞癌临床疗效、毒副反应、营养状况的影响,评价其有效性及安全性。方法本研究纳入遂宁市中心医院符合纳排标准的食管鳞癌患者142例,随机分为试验组和对照组,试验组71例,对照组71例。试验组使用半夏泻心汤加减联合TP方案化疗,每3周调整处方1次,连续中药治疗,对照组仅给予TP方案化疗。两组化疗均以3周为一个给药周期,最多治疗6个周期。观察两组患者近期疗效、无进展生存期(progression-free survival,PFS)、毒副反应及营养状况。结果试验组客观缓解率(objective response rate,ORR)为45.46%,对照组ORR为38.57%,两组对比,差异不具有统计学意义(χ^(2)=0.661,P=0.416)。试验组疾病控制率(disease control rate,DCR)为72.73%,对照组DCR为51.43%,两组对比,试验组优于对照组,差异具有统计学意义(χ^(2)=6.525,P=0.011)。试验组中位无进展生存期(progression-free survival,PFS)为5.9个月,对照组中位PFS为4.5个月,两组对比,试验组优于对照组,差异具有统计学意义(χ^(2)=31.597,P=0.000)。恶心呕吐程度,试验组明显优于对照组,差异具有统计学意义(P=0.001)。两组PG-SGA评分对比,试验组优于对照组,差异具有统计学意义(χ^(2)=19.799,P=0.000)。结论本研究提示半夏泻心汤加减干预提高了晚期食管鳞癌化疗的近期临床疗效、PFS,减轻了化疗毒副反应,改善了患者营养状况,具有临床应用价值。

Objective This study evaluated the efficacy and safety of modified Banxia Xiexin Decoction combined with paclitaxel+cisplatin regimen(TP regimen)for advanced esophageal squamous cell carcinoma(ESCC)by observing its clinical efficacy,toxic and side effects,and influence on nutritional status.Methods In this study,142 patients with advanced ESCC who met the criteria and were hospitalized in Suining Central Hospital were randomly divided into experimental group(71 cases)and control group(71 cases).The experimental group received modified Banxia Xiexin Decoction combined with TP regimen chemotherapy,and the Chinese herbal prescription was adjusted once every 3 weeks for continuous treatment.The control group was only given TP regimen chemotherapy.TP regimen chemotherapy in both groups was administered for 3 weeks,with a maximum of 6 cycles.The short-term efficacy,progression-free survival(PFS),toxicity and side effects and nutritional status of the two groups were observed.Results The objective response rate(ORR)in the experimental group was 45.46%and the ORR in the control group was 38.57%.The difference between the two groups was not statistically significant(χ^(2)=0.661,P=0.416).The disease control rate(DCR)in the experimental group 72.73%and that in the control group was 51.43%,and the intergroup comparison presented statistically significant difference(χ^(2)=6.525,P=0.011).The median PFS of the experimental group was 5.9 months,and that of the control group was 4.5 months.The intergroup comparison showed that the median PFS of the experimental group was superior to that of the control group,and the difference was statistically significant(χ^(2)=31.597,P=0.000).The improvement of the degree of nausea and vomiting in the experimental group was significantly was superior to that of the control group,and the difference was statistically significant(P=0.001).Comparison of PG-SGA scores between the two groups showed that the experimental group was superior to the control group,and the difference was statistically significant(χ^(2)=19.799,P=0.000).Conclusion It is suggested that the intervention of modified Banxia Xiexin Decoction can enhance the short-term clinical efficacy and PFS of chemotherapy for advanced ESCC,relieve the adverse reactions of chemotherapy,and improve the nutritional status of the patients,which has clinical application value.