[关键词]
[摘要]
【目的】观察生地泻心汤联合质子泵抑制剂治疗胃热壅盛型急性非静脉曲张性上消化道出血 (ANVUGIB) 的临床疗效。 【方法】将2024年1月至2024年12月广州中医药大学东莞医院收治的62例胃热壅盛型ANVUGIB患者,按随机数字表法随机 分为试验组和对照组,每组各31例。对照组给予奥美拉唑钠等常规西医治疗,试验组在对照组的基础上加用生地泻心汤治 疗,疗程均为7 d并随访8周。观察2组患者治疗前后中医证候积分、血液学指标[血红蛋白 (Hb) 、红细胞计数 (RBC) 、平均 红细胞压积 (Hct) 、白蛋白 (ALB) ]及组织灌注与代谢指标[尿素氮/血肌酐 (BUN/Cr) 比值、乳酸 (Lac) 水平]的变化情况,比较2组 患者的止血时间、开放饮食时间、住院时长、住院费用及再出血率,评估2组患者的临床疗效和用药安全性。 【结果】(1) 疗 效方面,治疗7 d后,试验组的总有效率为90.32% (28/31) ,对照组为74.19% (23/31) ,组间比较 (χ2 检验) ,试验组的疗效明 显优于对照组 (P<0.05) 。 (2) 病情转归及治疗成本方面,相比对照组,试验组的止血时间、开放饮食时间及住院时长均显著 缩短 (P<0.05) ,住院费用显著降低 (P<0.05) 。 (3) 中医证候方面,治疗后,2组患者的胃脘灼痛、脘腹胀满、反酸嘈杂、烦 躁不安、口干欲饮、小便短赤、粪便干结积分及中医证候总积分均较治疗前下降 (P<0.05) ,且试验组对脘腹胀满、反酸嘈 杂、烦躁不安、小便短赤、粪便干结积分及中医证候总积分的下降幅度均明显优于对照组 (P<0.05) ,而2组患者对胃脘灼 痛、口干欲饮积分的下降作用相当,差异均无统计学意义 (P>0.05) 。 (4) 血液学指标方面,治疗后,2组患者的Hb、Hct水平 均较治疗前升高 (P<0.05) ,RBC、ALB水平均较治疗前有升高趋势,但差异均无统计学意义 (P>0.05) ;治疗后组间比较, 试验组对Hb、Hct水平的升高幅度均明显优于对照组 (P<0.05) ,而2组患者对RBC、ALB水平的升高作用相当,差异均无 统计学意义 (P>0.05) 。 (5) 组织灌注与代谢指标方面,治疗后,2组患者的BUN/Cr比值和Lac水平均较治疗前降低 (P<0.05) , 且试验组对BUN/Cr比值和Lac水平的降低作用均明显优于对照组 (P<0.05) 。 (6) 再出血率方面,2组患者的早期再出血率及 迟发性再出血率比较,差异均无统计学意义 (P>0.05) 。 (7) 安全性方面,治疗过程中,2组患者均无明显不良反应及不良事 件发生。 【结论】生地泻心汤联合质子泵抑制剂治疗胃热壅盛型ANVUGIB患者,疗效显著,可有效改善患者的血液指标,纠 正组织低灌注,缓解临床症状,缩短止血时间与住院周期,降低医疗成本,且安全性良好。
[Key word]
[Abstract]
Objective To observe the clinical efficacy of Shengdi Xiexin Decoction combined with proton pump inhibitors (PPIs) in the treatment of acute non-variceal upper gastrointestinal bleeding (ANVUGIB) with stomach- heat congestion syndrome. Methods Sixty-two patients with ANVUGIB of stomach-heat congestion syndrome admitted to Dongguan Hospital of Guangzhou University of Chinese Medicine between January and December 2024 were randomly divided into a treatment group (n=31) and a control group (n=31) using a random number table. The control group received conventional western therapy (e.g.,Omeprazole Sodium),while the treatment group additionally received Shengdi Xiexin Decoction. Both groups were treated for 7 days,followed by 8 weeks of follow-up. The changes in traditional Chinese medicine (TCM) syndrome scores, hematological parameters [hemoglobin (Hb) ,red blood cells (RBC) ,hematocrit (Hct) ,albumin (ALB) ],tissue perfusion and metabolic markers [blood urea nitrogen/creatinine ratio (BUN/Cr) ,lactate (Lac) levels],hemostasis time,time to resume oral diet,hospital stay duration,hospitalization costs,and rebleeding rates were observed to evaluate the clinical efficacy and drug safety. Results (1) After 7 days of treatment,the total effective rate was significantly higher in the treatment group (90.32%,28/31) than that in the control group (74.19%,23/31) . The intergroup comparison (by chi-square test) showed that the treatment group,efficacy was superior to that of the control group (P<0.05) . (2) The treatment group showed significantly short hemostasis time,time to resume oral diet,and hospital stay duration (P<0.05),as well as significantly low hospitalization costs (P<0.05) compared to the control group. (3) Both groups exhibited significant reductions in the scores of epigastric burning pain,abdominal distension, acid regurgitation,restlessness,excessive thirst,scanty dark uring and dry stools,and total TCM syndrome scores (P<0.05) . The treatment group demonstrated significantly greater improvements in the scores of abdominal distension,acid regurgitation,restlessness,dark uring and dry stools,and total TCM syndrome scores (P< 0.05) ,while no significant differences were observed in epigastric burning pain and excessive thirst (P>0.05) . (4) Hb and Hct levels increased significantly in both groups (P<0.05), with a greater increase in the treatment group (P<0.05) . Although RBC and ALB levels showed an upward trend,no significant differences were observed between groups (P>0.05) . Following treatment,intergroup comparisons revealed that the treatment group demonstrated significantly greater increases in Hb and Hct levels than the control group (P<0.05) . In contrast, the two groups showed comparable effects in elevating RBC and ALB levels, with no statistically significant differences (P>0.05) . (5) BUN/Cr ratio and Lac levels decreased significantly in both groups (P< 0.05) ,with a more pronounced reduction in the treatment group (P<0.05). (6) No significant differences were found in early or delayed rebleeding rates between groups (P>0.05) . (7) Neither group experienced significant adverse events. Conclusion Shengdi Xiexin Decoction combined with PPIs significantly improves clinical outcomes in ANVUGIB patients with stomach-heat congestion syndrome. It is effective on enhancing hematological parameters, correcting tissue hypoperfusion, alleviating symptoms, shortening hemostasis time and hospitalization durations,and reducing medical costs,demonstrating excellent safety.
[中图分类号]
R259.732
[基金项目]
广东省基础与应用基础-区域联合-青年基金项目 (编号:2021A1515110419) ;东莞市卫健局“周正东莞市名中医药专家传承 工作室”建设项目 (编号:东卫函[2020]136号)