丹黄方治疗慢性乙型重型肝炎的临床研究
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摘要
目的
研究丹黄方治疗慢性乙型重型肝炎的疗效、安全性及发病机制。
方法
选择2007年8月至2009年2月,在武汉市医疗救治疗中心住院的48例慢性乙型重型肝炎患者为观察对象。
采用随机、对照的临床试验,将48例患者按1:1比例随机分为对照组与治疗组。对照组以常规卧床休息,护肝降酶退黄、促进肝细胞再生、免疫调节、血浆置换对症支持及抗病毒的西医综合治疗;治疗组在对照组西医综合治疗基础之上,以丹黄方治疗,丹参30g,大黄15g,日1剂,水煎服取汁240ml,分两次服。
以一个月时间为观察期限,观察两组患者治疗前后临床症状体征、中医证候积分、肝功能(ALT、AST、TBiL、AMM、ALB、PTA)和肝脾B超的变化及安全性指标(血、尿、大便常规及肾功能和心电图)。分别检测两组患者治疗前后ET、TNF-α变化情况。
实验结束,进行数据录入及数据统计分析。统计方法为:计量资料采用t检验,用(?)±s进行统计描述,计数资料采用X~2检验,等级资料采用Ridit分析,所有的统计检验均采用双侧检验,P值小于或等于0.05将被认为所检验的差别有统计学意义。
结果
48例患者(治疗组24例、对照组24例),按研究方案完成1个月治疗,病人依从性良好。
1.临床综合疗效比较:治疗组分别为显效5例(20.8%),有效16例(66.7%),无效3例(12.5%),总有效率(87.5%);对照组显效3例(12.5%),有效12例(50.0%),无效9例(37.5%),总有效率(62.5%),治疗组疗效优于对照组,两者比较具有显著差异。(P＜0.05)
2.中医证候改善疗效比较:治疗组和对照组治疗前后中医证候总积分比较,疗效显著(P＜0.05),且治疗结束后,治疗组与对照组证候总积分比较(P＜0.05);两组间比较:治疗组临床显效7例(29.2%),有效15例,总有效率91.6%;对照组临床显效3例(12.5%),有效13例,总有效率66.7%,治疗组的中医证候疗效总有效率高于对照组,两组差别有统计学意义。(P＜0.05)
3.肝功能比较(包括血清ALT、AST、TBiL、AMM下降疗效比较及ALB、PTA疗效比较):
(1)血清ALT、AST:治疗组和对照组治疗前后比较,差异具有统计学意义(P＜0.05),治疗结束后两组间比较:治疗组的疗效高于对照组,但差别无统计学意义。(P＞0.05)
(2)血清TBiL、AMM:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.05);疗程结束后两组间比较:治疗组优于对照组,比较差别有统计学意义。(P＜0.05)
(3)血浆白蛋白及PTA:治疗组和对照组治疗前后ALB比较均有所改善(P＜0.05);但两组间比较差别无统计学意义(P＞0.05);疗程结束后,治疗组PTA改善优于对照组,差异具有统计学意义。(P＜0.05)
4.血清ET、TNF-α治疗前后变化比较:血清ET、TNF-α:治疗组和对照组治疗前后比较,均有所下降,均有疗效(P＜0.05);两组间比较:治疗组下降情况均优于对照组,差异具有统计学意义。(P＜0.05)
5.肝脾B超检查:两组肝脾B超检查变化无统计学意义。
6.安全性结果:治疗前、后两组病例的血、尿、粪常规、肾功能及心电图均无明显改变,未发生任何不良事件。
结论
丹黄方能明显改善慢性乙型重型肝炎患者的临床症状、体征,改善肝功能血清ALT、TBiL、AMM、PTA等指标,具有明显的护肝、降酶、退黄作用,疗效优于单纯西医治疗的对照组,且能有效降低影响慢性重型肝炎发病机制的ET、TNF-α。丹黄方在临床治疗过程中安全性较好,未发现与之相关的不良反应。
Objective:
To observe the treatment and security , pathogenesis of Danhu-angfang on chronic severe hepatitis. Methods:
Choose the patients (with a total of 48 cases) treated from August 2007 to February 2009 and diagnosed as chronic severe hepatitis by wuhan medical treatment center.
Forty eight cases were randomly divided into two groups, each 24, one for treatment and the other for control in clinical trial. The control group were treated by protecting liver cells, debasing the level of transaminase and bilirubin, promoting the regenesis of liver cells, keeping the balance of water, salt and electrolyte, plasma exchange and other integrated supporting treatment and anti-virus therapy for the symptom in western medicine. In the base of the treatments which were used in the control group, the cases in the therapy group taked Danhuangfang of one dosage decocting with water at twice per day.
The control group and the therapy group were treated for one month respectively. To observe the changes of clinical syndrome, traditional Chinese medicine syndrome integral, live function (ALT、AST、TBiL、AMM、ALB、PTA)and B supersonic wave on liver and spleen, and secure index (concluding blood、urine、stool routine and renal function、ECG), complications and prognosis in the two groups after the treatments and detected the change of ET、TNF-αbefore and after the treatment.
After the clinical trial, the data was analyzed, the measuring materials and the grade materials were examined with Chi-square test, T-test and Ridit respectively. All data was analyzed by SPSS.
Results:
1.The curative effect of colligation:
The treated group: clinical obvious effective rate is 20.8%, total effective rate is 87. 5%;
The control group: obvious effective rate is 12. 5%, total effective rate is 62.5%;
The effective rate of treated group was better than that of the control group, and there are obvious statistics difference between two groups (P<0.05).
2.The curative effect of traditional Chinese medicine syndrome:
The treated groups: obvious effective rate is 29.2%, total progressive rate is 91.6%;
The control group: obvious effective rate is 12.5%, total effective rate is 66.7%;
The effective rate of treated group was better than that of the control group, and there are statistics difference between two groups (P<0. 05).
3.The curative effect of liver function (ALT、AST、TBi1、AMM、ALB and PTA):
(1) After the treatment, the effective rate of ALT and AST in the two group were better than before(P<0. 05), the control group is better than the treated group but there is no statistics difference between two groups(P>0. 05).
(2) After the treatment, the effective rate of TBiL and AMM in the two group were better than before (P<0. 05), the control group is better than the treated group and there are statistics differences between two groups (P<0. 05).
(3) After the treatment, the effective rate of ALB in the two group were better than before(P<0. 05), but there isn't any statistics difference between two groups (P>0. 05) , the effective rate of PTA in the two group were better than before(P<0. 05), the control group is better than the treated group ,and there are statistics differences between two groups (P<0. 05).
4. The curative effect of ET and TNF-α: After the treatment, the effective rate of ET and TNF-αin the two groups were better than before(P<0. 05), the control group is better than the treated group and there are statistics differences between two groups (P<0. 05).
5.There is no statistics difference on B supersonic wave between two groups (P>0. 05).
6. The safety index: the two groups were not discovered adverse reaction and harmful effect on cases. There was not abnormal change on blood、urine、stool routine and renal function、ECG of cases.
Conclution:
Danhuangfang can improve clinical syndrome, live function (ALT、AST、TBiL、AMM、ALB、PTA)of chronic severe hepatitis, The effect in the group of dan huang fang was better than the pure western medicine group, and obviously reduced the ET and TNF-α. Danhuangfang have not the serious side effects in this clinical research.
研究丹黄方治疗慢性乙型重型肝炎的疗效、安全性及发病机制。
方法
选择2007年8月至2009年2月,在武汉市医疗救治疗中心住院的48例慢性乙型重型肝炎患者为观察对象。
采用随机、对照的临床试验,将48例患者按1:1比例随机分为对照组与治疗组。对照组以常规卧床休息,护肝降酶退黄、促进肝细胞再生、免疫调节、血浆置换对症支持及抗病毒的西医综合治疗;治疗组在对照组西医综合治疗基础之上,以丹黄方治疗,丹参30g,大黄15g,日1剂,水煎服取汁240ml,分两次服。
以一个月时间为观察期限,观察两组患者治疗前后临床症状体征、中医证候积分、肝功能(ALT、AST、TBiL、AMM、ALB、PTA)和肝脾B超的变化及安全性指标(血、尿、大便常规及肾功能和心电图)。分别检测两组患者治疗前后ET、TNF-α变化情况。
实验结束,进行数据录入及数据统计分析。统计方法为:计量资料采用t检验,用(?)±s进行统计描述,计数资料采用X~2检验,等级资料采用Ridit分析,所有的统计检验均采用双侧检验,P值小于或等于0.05将被认为所检验的差别有统计学意义。
结果
48例患者(治疗组24例、对照组24例),按研究方案完成1个月治疗,病人依从性良好。
1.临床综合疗效比较:治疗组分别为显效5例(20.8%),有效16例(66.7%),无效3例(12.5%),总有效率(87.5%);对照组显效3例(12.5%),有效12例(50.0%),无效9例(37.5%),总有效率(62.5%),治疗组疗效优于对照组,两者比较具有显著差异。(P＜0.05)
2.中医证候改善疗效比较:治疗组和对照组治疗前后中医证候总积分比较,疗效显著(P＜0.05),且治疗结束后,治疗组与对照组证候总积分比较(P＜0.05);两组间比较:治疗组临床显效7例(29.2%),有效15例,总有效率91.6%;对照组临床显效3例(12.5%),有效13例,总有效率66.7%,治疗组的中医证候疗效总有效率高于对照组,两组差别有统计学意义。(P＜0.05)
3.肝功能比较(包括血清ALT、AST、TBiL、AMM下降疗效比较及ALB、PTA疗效比较):
(1)血清ALT、AST:治疗组和对照组治疗前后比较,差异具有统计学意义(P＜0.05),治疗结束后两组间比较:治疗组的疗效高于对照组,但差别无统计学意义。(P＞0.05)
(2)血清TBiL、AMM:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.05);疗程结束后两组间比较:治疗组优于对照组,比较差别有统计学意义。(P＜0.05)
(3)血浆白蛋白及PTA:治疗组和对照组治疗前后ALB比较均有所改善(P＜0.05);但两组间比较差别无统计学意义(P＞0.05);疗程结束后,治疗组PTA改善优于对照组,差异具有统计学意义。(P＜0.05)
4.血清ET、TNF-α治疗前后变化比较:血清ET、TNF-α:治疗组和对照组治疗前后比较,均有所下降,均有疗效(P＜0.05);两组间比较:治疗组下降情况均优于对照组,差异具有统计学意义。(P＜0.05)
5.肝脾B超检查:两组肝脾B超检查变化无统计学意义。
6.安全性结果:治疗前、后两组病例的血、尿、粪常规、肾功能及心电图均无明显改变,未发生任何不良事件。
结论
丹黄方能明显改善慢性乙型重型肝炎患者的临床症状、体征,改善肝功能血清ALT、TBiL、AMM、PTA等指标,具有明显的护肝、降酶、退黄作用,疗效优于单纯西医治疗的对照组,且能有效降低影响慢性重型肝炎发病机制的ET、TNF-α。丹黄方在临床治疗过程中安全性较好,未发现与之相关的不良反应。
Objective:
To observe the treatment and security , pathogenesis of Danhu-angfang on chronic severe hepatitis. Methods:
Choose the patients (with a total of 48 cases) treated from August 2007 to February 2009 and diagnosed as chronic severe hepatitis by wuhan medical treatment center.
Forty eight cases were randomly divided into two groups, each 24, one for treatment and the other for control in clinical trial. The control group were treated by protecting liver cells, debasing the level of transaminase and bilirubin, promoting the regenesis of liver cells, keeping the balance of water, salt and electrolyte, plasma exchange and other integrated supporting treatment and anti-virus therapy for the symptom in western medicine. In the base of the treatments which were used in the control group, the cases in the therapy group taked Danhuangfang of one dosage decocting with water at twice per day.
The control group and the therapy group were treated for one month respectively. To observe the changes of clinical syndrome, traditional Chinese medicine syndrome integral, live function (ALT、AST、TBiL、AMM、ALB、PTA)and B supersonic wave on liver and spleen, and secure index (concluding blood、urine、stool routine and renal function、ECG), complications and prognosis in the two groups after the treatments and detected the change of ET、TNF-αbefore and after the treatment.
After the clinical trial, the data was analyzed, the measuring materials and the grade materials were examined with Chi-square test, T-test and Ridit respectively. All data was analyzed by SPSS.
Results:
1.The curative effect of colligation:
The treated group: clinical obvious effective rate is 20.8%, total effective rate is 87. 5%;
The control group: obvious effective rate is 12. 5%, total effective rate is 62.5%;
The effective rate of treated group was better than that of the control group, and there are obvious statistics difference between two groups (P<0.05).
2.The curative effect of traditional Chinese medicine syndrome:
The treated groups: obvious effective rate is 29.2%, total progressive rate is 91.6%;
The control group: obvious effective rate is 12.5%, total effective rate is 66.7%;
The effective rate of treated group was better than that of the control group, and there are statistics difference between two groups (P<0. 05).
3.The curative effect of liver function (ALT、AST、TBi1、AMM、ALB and PTA):
(1) After the treatment, the effective rate of ALT and AST in the two group were better than before(P<0. 05), the control group is better than the treated group but there is no statistics difference between two groups(P>0. 05).
(2) After the treatment, the effective rate of TBiL and AMM in the two group were better than before (P<0. 05), the control group is better than the treated group and there are statistics differences between two groups (P<0. 05).
(3) After the treatment, the effective rate of ALB in the two group were better than before(P<0. 05), but there isn't any statistics difference between two groups (P>0. 05) , the effective rate of PTA in the two group were better than before(P<0. 05), the control group is better than the treated group ,and there are statistics differences between two groups (P<0. 05).
4. The curative effect of ET and TNF-α: After the treatment, the effective rate of ET and TNF-αin the two groups were better than before(P<0. 05), the control group is better than the treated group and there are statistics differences between two groups (P<0. 05).
5.There is no statistics difference on B supersonic wave between two groups (P>0. 05).
6. The safety index: the two groups were not discovered adverse reaction and harmful effect on cases. There was not abnormal change on blood、urine、stool routine and renal function、ECG of cases.
Conclution:
Danhuangfang can improve clinical syndrome, live function (ALT、AST、TBiL、AMM、ALB、PTA)of chronic severe hepatitis, The effect in the group of dan huang fang was better than the pure western medicine group, and obviously reduced the ET and TNF-α. Danhuangfang have not the serious side effects in this clinical research.
引文
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[1]病毒性肝炎防治方案[J].中华传染病杂志,2001;19(1):56-62.
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[1]病毒性肝炎防治方案[J].中华传染病杂志,2001;19(1):56-62.
[2]何长伦,许家璋等.大剂量赤芍治疗慢性重型肝炎患者对血小板的影响.[J].实用肝脏病杂志,2006;9(6):355-356.
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[4]饶日春,郑瑞丹,林福地.生大黄对慢性重型肝炎患者LPS,TNF-a的影响及其临床意义.[J].南京部队医药,2001;3(5):24-25.
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[6]刘兴旺.中西医结合治疗慢性重型肝炎55例.河南中医学院学报,2003;18(108):50-51.
[7]钟炳图.大黄对急性重型肝炎患者血清TNF、IL-1及IL-6的影响.[J].浙江中西医结合杂志,2006;16(2):97-98.
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[9]毛德文,邱华,李雅等人.解毒化瘀颗粒治疗重型肝炎的疗效观察.广西中医药,2004;27(4):4-6.
[10]王兴,吴长健等人.促肝细胞生长素联合复方丹参注射液治疗慢性重型肝炎临床疗效观察.[J].江苏临床医学杂志,1999;3(4):317-318.
[11]马素平,赵文霞,张永艳,等.益气活血颗粒联合单重血浆置换治疗慢性重型肝炎36例.[J].中国中医药信息杂志,2006;13(6):57-58.
[12]李芹,李丹,张良宏.重肝合剂对慢性重型肝炎肝功能指标的改善作用.[J].中医药临床杂志,2006;18(4):387-388.
[13]黄峰,刘凤莉.小柴胡颗粒加大黄粉胶囊治疗重型肝炎30 例.[J].现代中医药,2007;27(3):7-9.
[14]张文才,赵华,牛国地等人.大黄牡丹汤加减治疗重型肝炎疗效观察.[J].湖北中医杂志,2003;25(3):10.
[15]黄学军.茵陈术附汤加味治疗慢性重型肝炎26例.[J].国际中医中药杂志,2008;30(5):350-352.
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[17]梁宏,王柳飞,蓝景泉等.大黄赤芍汤灌肠治疗重型肝炎疗效观察.[J].中原医刊,2006;5(9):34-35.
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[20]刘志斌.竹花重肝煎治疗重型肝炎高黄疸60例.[J].湖北中医杂志,2008;30(5):31.
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[28]王振常,毛德文,黄古叶.加用大黄煎剂灌肠治疗重型肝炎并发肝性脑病疗效观察,广西中医学院学报,2006;9(4):7-8.
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