The Effect of <italic style="font-style: italic">Fufang Banmao Capsule</italic> （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study

Jie HOU; Ke SHI; Yao LIU; Jialiang CHEN; Qun ZHANG; Xianbo WANG

doi:10.13288/j.11-2166/r.2022.13.011

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The Effect of Fufang Banmao Capsule （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study

更新时间：2022-06-24

- The Effect of Fufang Banmao Capsule （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study
- Journal of Traditional Chinese Medicine Vol. 63, Issue 13, Pages: 1249-1255(2022)
- 作者机构：
  
  1.北京中医药大学东直门医院，北京市东城区海运仓5号，100700
  2.首都医科大学附属北京地坛医院
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.13.011
  CLC：
- Received：20 January 2022，
  
  Revised：2022-03-14，
  
  Published：02 July 2022
- 稿件说明：
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侯杰,时克,刘遥等.复方斑蝥胶囊辅助治疗对原发性肝癌脾虚血瘀证患者三年生存情况影响的回顾性研究[J].中医杂志,2022,63(13):1249-1255.

HOU Jie,SHI Ke,LIU Yao,et al.The Effect of Fufang Banmao Capsule （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study[J].Journal of Traditional Chinese Medicine,2022,63(13):1249-1255.
侯杰,时克,刘遥等.复方斑蝥胶囊辅助治疗对原发性肝癌脾虚血瘀证患者三年生存情况影响的回顾性研究[J].中医杂志,2022,63(13):1249-1255. DOI： 10.13288/j.11-2166/r.2022.13.011.

HOU Jie,SHI Ke,LIU Yao,et al.The Effect of Fufang Banmao Capsule （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study[J].Journal of Traditional Chinese Medicine,2022,63(13):1249-1255. DOI： 10.13288/j.11-2166/r.2022.13.011.

摘要

目的

探讨复方斑蝥胶囊辅助西医治疗对原发性肝癌（PLC）脾虚血瘀证患者三年生存情况的影响。

方法

回顾性收集首次诊断为PLC并辨证为脾虚血瘀证的住院患者资料，根据是否加服复方斑蝥胶囊≥3个月，将患者分为复方斑蝥胶囊组和西医治疗组。西医治疗组患者根据适应症情况给予包括手术切除、微创疗法和姑息治疗等在内的治疗方案；复方斑蝥胶囊组在西医治疗组的基础上服用至少3个月的复方斑蝥胶囊（每次0.75 g，每日2次）。将丙氨酸氨基转移酶（ALT）、门冬氨酸氨基转移酶（AST）、总胆红素（TBIL）、中性粒细胞-淋巴细胞比值（NLR）、血小板（PLT）、白蛋白（ALB）、凝血酶原活动度（PTA）、血红蛋白（Hb）、甲胎蛋白（AFP）≥400 ng/ml、Child-Pugh分级、巴塞罗那临床肝癌（BCLC）分期、服用复方斑蝥胶囊、西医治疗方式作为变量，采用单因素和多因素Cox回归分析探讨影响PLC患者三年生存的因素，比较两组患者三年生存率和服用复方斑蝥胶囊不同累计时间患者的三年生存率，比较两组不同BCLC分期、不同Child-Pugh分级、乙型肝炎和非乙型肝炎病因患者的三年生存率。

结果

共纳入患者406例，倾向性评分匹配（PSM）前，西医治疗组272例，复方斑蝥胶囊组134例，两组患者基线指标存在差异；PSM后，两组各117例患者，两组关键的基线指标表现出平衡性。单因素Cox回归分析显示，ALT、AST、TBIL、NLR、PLT、ALB、PTA、Hb、AFP≥400 ng/ml、Child-Pugh分级、BCLC分期、服用复方斑蝥胶囊及西医治疗方式是患者三年生存的影响因素；多因素Cox回归分析显示，AST、TBIL、NLR、PLT、AFP≥400 ng/ml、Child-Pugh B/C级、手术切除、微创治疗、服用复方斑蝥胶囊是患者三年生存的独立影响因素。PSM前，西医治疗组三年生存率为30.5%（83例/272例），复方斑蝥胶囊组为74.6%（100例/134例）；PSM后，西医治疗组三年生存率为60.7%（71例/117例），三年平均生存时间为25.17个月，复方斑蝥胶囊组分别为74.4%（87例/117例）及29.91个月。PSM后，复方斑蝥胶囊组的三年生存率高于西医治疗组（P=0.013），且服用复方斑蝥胶囊＞12个月的患者三年生存率明显提高（

＜0.001）；对于BCLC 0-A期、BCLC B-D期、Child-Pugh B/C级、乙型肝炎病因患者，复方斑蝥胶囊组较西医治疗组均有更高的三年生存率（

=0.045、

=0.028、

=0.011）。

结论

复方斑蝥胶囊辅助西医治疗可延长PLC脾虚血瘀证患者生存时间，提高三年生存率，且服用复方斑蝥胶囊1年以上者生存获益更多。

Abstract

Objective

To investigate the effect of

Fufang Banmao

Capsule

（复方斑蝥胶囊， FFBMC） combined with western medicine on the three-year survival of patients with primary liver cancer （PLC） and spleen deficiency and blood stasis syndrome.

Methods

Data on hospitalized patients with first PLC were retrospectively collected， and the patients were divided into western medicine group and FFBMC group according to whether FFBMC was additionally used. Western medicine group received surgical resection， minimally invasive therapy and palliative treatment according to the condition. Additionally， the FFBMC group took FFBMC （0.75 g per time， twice daily）for at least 3 months. Univariate and multivariate Cox regression analysis was conducted to explore the affecting factors of the 3-year survival of patients with PLC， including alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， total bilirubin （TBIL）， neutrophil-lymphocyte ratio （NLR）， platelet （PLT）， albumin （ALB）， prothrombin activity （PTA）， hemoglobin （Hb）， alpha-fetoprotein （AFP） ≥ 400 ng/ml， Child-Pugh grade， Barcelona Clinic Liver Cancer （BCLC）， taking FFBMC， western medicine type. The 3-year overall survival rate was compared between the two groups and between the different courses of FFBMC； the subgroup analyses in terms of different BCLC stages， different Child-Pugh grades， and hepatitis B type versus non-hepatitis B type were performed on the 3-year overall survival rate.

Results

A total of 406 cases were included， with 272 cases in the western medicine group and 134 cases in the FFBMC group showing imbalance baseline data between groups； after propensity score matching （PSM）， 117 cases in each group were matched obtaining comparability in critical baseline indicators. Univariate Cox regression analysis showed that AST， TBIL， NLR， PLT， ALT， ALB， PTA， Hb， AFP ≥ 400 ng/ml， Child-Pugh grades， BCLC staging， taking FFBMC， and western medicine type were the influencing factors of 3-year survival of PLC patients. Multivariate Cox regression showed that AST， TBIL， NLR， PLT， AFP≥400 ng/ml， Child-Pugh B/C grade， surgical resection， minimally invasive treatment， and taking FFBMC were independent influencing factors affecting the 3-year survival. Before PSM， the 3-year survival rate in the western medicine group was 30.5% （83/272）， while that of the FFBMC group was 74.6% （100/134）. After PSM， the 3-year overall survival rate in the wes-tern medicine group was 60.7% （71/117）， and the average three-year survival time was 25.17 months， while those of the FFBMC group were 74.4% （87/117） and 29.91 months， respectively. After PSM， the 3-year overall survival rate of the FFBMC group was higher than that of the western medicine group （

= 0.013）， and patients who took FFBMC for more than 12 months had higher survival rate （

＜0.001）. For patients in the subgroup of BCLC stage 0-A， BCLC stage B-D， Child-Pugh grade B/C， and hepatitis B-related PLC， the FFBMC group had a higher 3-year survival rate than the western medicinet group （

= 0.045，

= 0.028，

= 0.028 and

= 0.011， respectively）.

Conclusion

FFBMC in addition to western medicine can prolong the survival time and increase the 3-year survival rate of PLC patients with spleen deficiency and blood stasis syndrome， and those who take FFBMC for more than 1 year show more benefits.

关键词

Keywords

references

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The Effect of Fufang Banmao Capsule （复方斑蝥胶囊） Combined with Western Medicine on the Survival of Patients with Primary Liver Cancer and Spleen Deficiency and Blood Stasis Syndrome： A Retrospective Study

DOI：10.13288/j.11-2166/r.2022.13.011

摘要

Abstract

关键词

Keywords

references