| 摘要: |
| 目的 观察疏肝健脾解毒方治疗肝内胆管细胞癌术后肝郁脾虚证的临床疗效。方法 本研究为单中心、前瞻性随机对照研究。70例肝内胆管细胞癌术后肝郁脾虚证患者随机分为治疗组35例和对照组35例。入组患者中有乙型肝炎、丙型肝炎病史者继续予抗病毒治疗，必要时予保肝治疗。治疗组加用疏肝健脾解毒方，每日1剂，治疗至少3个月；对照组不予口服中药。治疗3个月后对70例患者的临床症状、Karnofsky功能状态评分（KPS）进行评估。随访4个月至1年计算无进展生存期。结果 两组患者性别、年龄、临床分期及Child-Pugh分级等基线资料的差异无统计学意义（P>0.05），具有可比性。治疗3个月后，治疗组患者主要临床症状得以改善，胁肋胀痛、腹胀、纳呆、倦怠乏力症状改善总有效率均高于对照组（P均<0.05）；治疗组KPS高于对照组（P<0.01）。随访4个月至1年后，治疗组平均无进展生存期为（48.20±7.34）周、无进展生存率为80.00%，对照组平均无进展生存期为（38.30±16.73）周、无进展生存率为57.14%，两组无进展生存率差异有统计学意义（P<0.05）。结论 疏肝健脾解毒方能改善肝内胆管细胞癌术后肝郁脾虚证患者的临床症状，提高患者的生活质量和无进展生存率。 |
| 关键词: 肝内胆管癌 疏肝健脾解毒方 肝郁脾虚证 治疗结果 生活质量 |
| DOI：10.16781/j.0258-879x.2021.01.0103 |
| 投稿时间：2020-03-20修订日期：2020-06-11 |
| 基金项目:上海市卫生和计划生育委员会中医优势病种培育项目（ZYBZ-2017030），上海市进一步加快中医药事业发展三年行动计划：上海特色诊疗技术提升项目（ZYJS-28）. |
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| Shugan Jianpi Jiedu recipe for treatment of liver stagnation and spleen deficiency syndrome after surgical excision of intrahepatic cholangiocarcinoma |
| WAN Qian-qian,YANG Zi-yu,GUO Chen-xu,SHI Liang-hui,WAN Xu-ying* |
(Department of Integrative Medicine, Eastern Hepatobiliary Surgery Hospital, Naval Medical University(Second Military Medical University), Shanghai 201805, China
*Corresponding author) |
| Abstract: |
| Objective To observe the clinical efficacy of Shugan Jianpi Jiedu recipe for treatment of liver stagnation and spleen deficiency syndrome after surgical excision of intrahepatic cholangiocarcinoma (ICC). Methods A single center, prospective, randomized controlled trial was conducted. Seventy patients with liver stagnation and spleen deficiency syndrome after surgical excision of ICC were evenly randomized into two groups (n=35):treatment group and control group. Patients with hepatitis B or hepatitis C history continued antiviral treatment and liver protection treatment if necessary. The treatment group was treated with Shugan Jianpi Jiedu recipe once a day for at least 3 months. The control group was not given oral traditional Chinese medicine. After 3 months of treatment, the clinical symptoms and Karnofsky performance score (KPS) were evaluated. The patients were followed up for 4 months to 1 year to calculate the progression-free survival. Results There were no significant differences in gender, age, clinical stage or Child-Pugh classification between the two groups (all P>0.05). After 3 months of treatment, the main clinical symptoms of the treatment group were improved significantly compared with the control group, including flank swelling, abdominal distension, anorexia and fatigue (all P<0.05), and the KPS was significantly higher than that of the control group (P<0.01). After 4 months to 1 year follow-up, the average progression-free survival was (48.20±7.34) weeks and the progression-free survival rate was 80.00% in the treatment group, while those in the control group were (38.30±16.73) weeks and 57.14%, respectively, with significant difference found in the progression-free survival rates between the two groups (P<0.05). Conclusion Shugan Jianpi Jiedu recipe can improve the clinical symptoms, quality of life and progression-free survival rate of patients with liver stagnation and spleen deficiency syndrome after surgical excision of ICC. |
| Key words: intrahepatic cholangiocarcinoma Shugan Jianpi Jiedu recipe liver stagnation and spleen deficiency syndrome treatment outcome quality of life |
