裴氏软肝消痞丸配合西医治疗原发性肝癌的临床研究

裴氏软肝消痞丸配合西医治疗原发性肝癌的临床研究

董琴琴

摘要

目的： 通过临床试验研究，以原发性肝癌患者的瘤体缓解率、肝肾功能、血常规、AFP值、卡氏评分为指标，观察裴氏软肝消痞丸治疗原发性肝癌的临床疗效。探讨运用裴氏中西医结合学术思想治疗本病的特色与优势。为中西医结合治疗原发性肝癌提供理论依据。

方法： 2011年12月至2012年12月在甘肃省肿瘤医院中西医结合科符合纳入标准的原发性肝癌住院病例70例，根据患者入院顺序按照随机数字法分为治疗组和对照组，每组35例。两组病人均给予基础治疗，即西医常规治疗。治疗组在给予西医常规治疗的基础上加裴氏软肝消痞丸，餐后口服，一次一包，一日两次，一个月为一个疗程。观察用药前后病人的瘤体缓解率、AFP、肝功能、卡氏评分来评价裴氏软肝消痞丸对原发性肝癌的临床疗效。并检测治疗前后血常规、肾功能等来评价药物的安全性。

结果：

1. 治疗组可以明显改善患者瘤体缓解率，与对照组比较（P<0.05），有统计学意义。
2. 治疗组可明显改善患者临床症状、卡氏评分，优于对照组（P<0.05），差异有统计学意义。
3. 治疗组在降低AFP值方面明显优于对照组（P<0.05），差异有统计学意义。
4. 在改善肝脏功能方面，治疗组优于对照组（P<0.05），有统计学意义。
5. 在肾功能损害、血常规异常等方面，治疗组与对照组无明显差异（P>0.05）。

结论： 裴氏软肝消痞丸配合西医治疗原发性肝癌可抑制肿瘤生长，明显改善患者生存质量，能起到减毒增效作用。安全可靠。体现中西医结合治疗本病较单纯西医治疗的特色与优势。

关键词： 裴氏软肝消痞丸；原发性肝癌；中西医结合；临床研究

裴正学系列方药的研究

ABSTRACT

Objectives: Through the clinical trials research, observed Pei Shi Ruangan Xiaopi Pills' clinical effect of primary liver cancer by the index of primary liver cancer patients' remission rate, the function of liver and renal, blood tests, value of Kamofsky grade. Discuss Pei Shi's academic thought of the combination of traditional Chinese and Western medicine' characteristics and advantages in treating this disease. Provided theoretical basis for treatment of primary liver cancer with traditional Chinese and Western medicine.

Methods: Fitted in 70 cases of primary liver cancer inpatients which were in accordance with the inclusive criteria from December 2011 to December 2012 in combination of Chinese traditional and Western medicine dept of Gansu province Tumor Hospital. According to the order of admission divided the 70 cases into treatment group and control group by completely randomized digital table, with 35 cases in each group. During the treatment, the two groups were given basic treatment that was the Western medicine convention treatment. The treatment group after admission on the basis of the basic treatment were used Pei Shi Ruangan Xiaopi Pills for one month. Took one bag two times per day with water after dinner. Observed the changes of patients' remission rate, the function of liver and renal, blood tests, value of Kamofsky grade before and after taking drug to evaluate Pei Shi Ruangan Xiaopi Pills' clinical effect of primary liver cancer. And detected blood tests and renal function before and after taking drugs to evaluate the Pei Shi Ruangan Xiaopi Pills' security.

Results:

1. The treatment group improved the remission rate more marked than control group (p<0.05), there were statistically significants.

2. The treatment group could significantly improve clinical symptoms, Kamofsky grade, better than the control group (p<0.05), the differences were statistically significant.

3. The treatment group in reducing AFP values in significantly better than the control group (p<0.05), the differences were statistically significant.

4. In the aspect of improving the function of liver, the treatment group' curative effect was better than the control group's. And the differences were statistically significant.

5. In areas such as the function of renal, blood tests, between the treatment group and the control group (p>0.5), the differences were not statistically significant.

Conclusion: Pei Shi Ruangan Xiaopi Pills combined with Western medicine in treating primary liver cancer could inhibit tumor growth, significantly improved the quality of inpatients' life, could play to reduce toxicity. Safe and reliable. Reflected the characteristics and advantages in treating this disease by the combination of traditional Chinese and Western medicine.

裴正学系列方药的研究

关键词： 裴氏软肝消痞丸；原发性肝癌；中西医结合；临床试验研究

前言

裴氏软肝消痞丸是裴正学教授集50年临床经验总结出来的治疗原发性肝癌、胃癌的有效方药。软肝消痞丸可提高患者机体免疫力，减少手术并发症、放化疗的副作用，临床症状改善明显，生存质量得到提高，防治肿瘤的转移和复发，具有一定的临床使用价值。

原发性肝癌（primary liver carcinoma，PLC）是世界常见的恶性肿瘤之一，我国每年大约有34.7/10万人死于PLC，占全世界肝癌死亡人数的53%左右[1-2]。此病具有进展迅速、预后不良、病死率极高等特点[3-4]。临床确诊时多数患者已属中晚期，已经丧失手术和介入栓塞治疗的机会[5-6]，严重危害着人类的生命健康。

PLC的病因尚不明确，可能与下列因素相关：病毒感染、黄曲霉素、饮水污染、肝硬化、亚硝胺类等。PLC病理类型有三种：①肝细胞型肝癌（HCC），此种病理类型占90%左右；②胆管型肝癌（ICC）；③混合型肝癌。早期小肝癌仍以外科手术切除为主；其次，介入治疗、放化疗、射频消融、生物治疗、中医中药等。但是PLC发现时大部分已属中晚期，已经产生肝内转移、肝外转移、肝硬化或其他合并症，错过了手术和介入治疗的机会。并且PLC对于化疗药物不敏感，化疗的细胞毒性作用使患者难以耐受。近来，有人提出炎症是癌症的好朋友，炎症的微环境可以促进癌细胞的生长，被认为是癌症七个特征之一[7]，抗感染治疗可抑制癌症的产生、进一步的发展、转移，提高机体的免疫力及对药物的反应性。众多研究表明，中医中药辅助治疗各类恶性肿瘤疗效较好[8-10]。

肝癌的5年生存率达到了一个瓶颈期，其主要问题是癌症的转移和复发。过度治疗和刺激会促进肝癌的转移[11]。且小肝癌也有很高的转移可能，而不只是晚期癌的表现[12]。中医中药是我国文化宝库，历史悠久，博大精深。现代医者利用先进的科研手段验证了在提高全身免疫系统、防治癌前病变、抑制癌细胞生长、减缓转移、复发等方面有它的巨大优势。

本临床试验研究，采用裴氏软肝消痞丸配合西医治疗PLC患者临床随机对照方法，观察患者瘤体缓解率、肝功能改善、生存质量情况及肾功能损害及血常规异常。验证裴氏软肝消痞丸治疗PLC的临床疗效，探讨裴氏中西医结合学术思想治疗较单纯西医治疗本病的特色与优势，为裴氏软肝消痞丸治疗PLC提供临床依据。

立题依据