益气清肝法治疗慢性乙型肝炎临床研究
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摘要
乙型病毒型肝炎是由乙肝病毒感染而引起的一种传染病。据统计，全世界的有3.5亿人为慢性HBV感染者，中国是乙型病毒性肝炎的高发地区，其HBV感染率在10％-54％之间，目前慢性乙型肝炎患者超过3000万，其中10％-20％可变成肝硬化或肝癌，严重威胁着人类健康。在慢性乙型肝炎时，由于机体免疫功能失调，所产生的抗体不足以清除体内的HBV，病毒大量复制，持续不断地导致肝细胞损伤，最终可形成肝硬化甚至突变为肝细胞癌。因此研究确切有效的治疗方法倍受关注。
本文以中医理论为指导，探讨乙型病毒性肝炎的病因、病机及治法。我们认为，慢性乙型病毒肝炎的基本病因是外感湿热疫毒，饮食不节、脾运不健、正气不足、劳倦过度、七情所伤是诱因。基本病机为湿热瘀毒互结，肝牌肾三脏受损，病理因素以湿热、气滞、瘀毒为主。治疗当以清化湿热瘀毒，调养肝脾为法。
本课题研究的目的：观察益气清肝法对慢性乙型肝炎的治疗效果。方法：将80例慢性乙型病毒肝炎患者随机分2组，每组40例，试验组用复方芪珠片。对照组用拉米夫定。疗程均为半年，其中部分病例可延长疗程至1年，治疗结束后随访6个月。结果：治疗组40例中完全应答7例(17.5％)，部分应答14例(35％)，无应答19例(47.5％)，总有效率52.5％；对照组40例中完全应答6例(15％)，部分应答16例(40％)，无应答18例(45％)，总有效率55％，两组治疗前后肝功能、症状、化验均有明显改善。两组在抑制病毒、改善肝功能、抗肝纤维化方面的疗效无明显差异，复方芪珠片在改善胁痛、纳差等临床症状方面优于拉米夫定。
HBV infection is a world-wide problem. It is accounted that there are 350 million chronic HBV infectants in the world, which hit 9th of the human death caused by illnesses published by WHO recently, and prevailed in Asia and Afica especially. Our coutry is a high-incident area of chronic hepatitis which strongly threatened the health of mankind and much attention has been paid to the research of effective treatments. Anti-HBV antibody is lower because of low immunity in chronic hepatitis patients which is not enough to clear out hepatitis B virus inside the body, then lead to a great deal of virus reproduction, continuous liver cell damage, resulted in liver cirrhosis at the end and even turn to liver cancer.
Guided by the theory of traditional Chinese medicine, we explored the etiology, pathology and principle of treatment and suggest that hepatitis B is basically caused by exogenous contamination of heat-dampness and epdemic toxin, improper diet, dysfunction of spleen in transporting and transformation as well as, induced by deficiency of Zheng-qi, over fatigue, emotional depression and liver-qi stagnation. The basic pathologic chang is conbination of heat-dampness and epidemic toxin, damage of liver, spleen, kidey, with dampness, heat, qi-stagnation, blood-stasis, epidemic toxin, phlegm (sometimes) as its pathologic factor. As to treatment, we should pay both attion to disease differentiation and syndrom differentiation, mainly clear out heat-dampness and epidemic toxin at acute stage, while support healthy energy to eliminate evils at chronic stage.
AIM: To investigate the effect of Yi Qi Qing Gan Fa in treating chronic hepatitis B. METHOD: 80 patients with chronic hepatitis B were devided randomizely into treatment group (40) and control group (40) . The patients in treatment group were treated with Fu Fang Qi Zhu Pian , 4 tablets, TID. While the patients in control group were treated with lamivudine 100mg, QD. Some medicines to protect liver like vitamine and insonine could be used in clinic, but patients cant't be given those medicines influencing immunity or virus reproduction like interferon, thymopeptide, virazole, ect .Course of treatment is half an year, and some patients could be treatmented for one year and all the patients were followed-up by half an year after treatment. RESULTS: Among 40 patients in treatment group, 7 responsed totally (17.5%) , 14 responsed partially (35%) , 19 has no responce (47.5%) , those in control group were 6 (15%) , 16 (40%) and 18
(45%) respectively, the general curative effect of treatment group is 52.5% compared 55% in control group (x2 =0.05, P>0.05) ; All the symptoms were improved in treatment group (P<0.05 or P<0.01) , but fatigue and jaudice were improved in control group (P<0.05 or P<0.01) . compared with control group, Fu Fang Qi Zhu Plan has a better effect in improving costalgia, anorexia (P<0.05) ; ALT, AST, GGT, ALP were improved in both groups (P<0.01) and HA, LN, collagen-IV declined varily in both groups (P<0.05) . CONCLUSION: There is no difference between Fu Fang Qi Zhu Pian and lamivudine in anti-virus, improving liver function, anti-fibrosis while Fu. Fang Qi Zhu Pian has a better effect in improving costalgia and anorexia than lamivudine.
本文以中医理论为指导，探讨乙型病毒性肝炎的病因、病机及治法。我们认为，慢性乙型病毒肝炎的基本病因是外感湿热疫毒，饮食不节、脾运不健、正气不足、劳倦过度、七情所伤是诱因。基本病机为湿热瘀毒互结，肝牌肾三脏受损，病理因素以湿热、气滞、瘀毒为主。治疗当以清化湿热瘀毒，调养肝脾为法。
本课题研究的目的：观察益气清肝法对慢性乙型肝炎的治疗效果。方法：将80例慢性乙型病毒肝炎患者随机分2组，每组40例，试验组用复方芪珠片。对照组用拉米夫定。疗程均为半年，其中部分病例可延长疗程至1年，治疗结束后随访6个月。结果：治疗组40例中完全应答7例(17.5％)，部分应答14例(35％)，无应答19例(47.5％)，总有效率52.5％；对照组40例中完全应答6例(15％)，部分应答16例(40％)，无应答18例(45％)，总有效率55％，两组治疗前后肝功能、症状、化验均有明显改善。两组在抑制病毒、改善肝功能、抗肝纤维化方面的疗效无明显差异，复方芪珠片在改善胁痛、纳差等临床症状方面优于拉米夫定。
HBV infection is a world-wide problem. It is accounted that there are 350 million chronic HBV infectants in the world, which hit 9th of the human death caused by illnesses published by WHO recently, and prevailed in Asia and Afica especially. Our coutry is a high-incident area of chronic hepatitis which strongly threatened the health of mankind and much attention has been paid to the research of effective treatments. Anti-HBV antibody is lower because of low immunity in chronic hepatitis patients which is not enough to clear out hepatitis B virus inside the body, then lead to a great deal of virus reproduction, continuous liver cell damage, resulted in liver cirrhosis at the end and even turn to liver cancer.
Guided by the theory of traditional Chinese medicine, we explored the etiology, pathology and principle of treatment and suggest that hepatitis B is basically caused by exogenous contamination of heat-dampness and epdemic toxin, improper diet, dysfunction of spleen in transporting and transformation as well as, induced by deficiency of Zheng-qi, over fatigue, emotional depression and liver-qi stagnation. The basic pathologic chang is conbination of heat-dampness and epidemic toxin, damage of liver, spleen, kidey, with dampness, heat, qi-stagnation, blood-stasis, epidemic toxin, phlegm (sometimes) as its pathologic factor. As to treatment, we should pay both attion to disease differentiation and syndrom differentiation, mainly clear out heat-dampness and epidemic toxin at acute stage, while support healthy energy to eliminate evils at chronic stage.
AIM: To investigate the effect of Yi Qi Qing Gan Fa in treating chronic hepatitis B. METHOD: 80 patients with chronic hepatitis B were devided randomizely into treatment group (40) and control group (40) . The patients in treatment group were treated with Fu Fang Qi Zhu Pian , 4 tablets, TID. While the patients in control group were treated with lamivudine 100mg, QD. Some medicines to protect liver like vitamine and insonine could be used in clinic, but patients cant't be given those medicines influencing immunity or virus reproduction like interferon, thymopeptide, virazole, ect .Course of treatment is half an year, and some patients could be treatmented for one year and all the patients were followed-up by half an year after treatment. RESULTS: Among 40 patients in treatment group, 7 responsed totally (17.5%) , 14 responsed partially (35%) , 19 has no responce (47.5%) , those in control group were 6 (15%) , 16 (40%) and 18
(45%) respectively, the general curative effect of treatment group is 52.5% compared 55% in control group (x2 =0.05, P>0.05) ; All the symptoms were improved in treatment group (P<0.05 or P<0.01) , but fatigue and jaudice were improved in control group (P<0.05 or P<0.01) . compared with control group, Fu Fang Qi Zhu Plan has a better effect in improving costalgia, anorexia (P<0.05) ; ALT, AST, GGT, ALP were improved in both groups (P<0.01) and HA, LN, collagen-IV declined varily in both groups (P<0.05) . CONCLUSION: There is no difference between Fu Fang Qi Zhu Pian and lamivudine in anti-virus, improving liver function, anti-fibrosis while Fu. Fang Qi Zhu Pian has a better effect in improving costalgia and anorexia than lamivudine.
引文
1. Daveys. Geneva: worl Health Organization, 1996:76-82
2．中华医学会传染病与寄生虫病学分会、肝病学分会联合修订．病毒性肝炎防治方案，肝脏，2000，5(4)：258-260
3．国家药监局．中药新药临床研究指导原则，1995：147
2．中华医学会传染病与寄生虫病学分会、肝病学分会联合修订．病毒性肝炎防治方案，肝脏，2000，5(4)：258-260
3．国家药监局．中药新药临床研究指导原则，1995：147