乙肝长乐片治疗慢性乙型肝炎（肝脾湿热证）的临床研究
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摘要
目的
研究乙肝长乐片治疗慢性乙型肝炎肝脾湿热证患者的有效性和安全性。
方法
选择年龄18～65岁的男性或女性,中医辨证为肝脾湿热证的慢性乙型肝炎为观察对象。
采用随机、双盲、双模拟、阳性药平行对照的临床试验,将已确诊为慢性乙型肝炎肝脾湿热证患者70例按1:1比例随机分为治疗组与对照组。实验组每次给予乙肝长乐片5片十复方益肝丸模拟剂4 g,口服,每日3次。对照组每次给予复方益肝丸4g十乙肝长乐片模拟剂5片,口服,每日3次。入选病例接受12周的试验或对照药物治疗,治疗结束后进行3个月随访。试验期内不得合并使用能影响本病疗效的降酶退黄的中西药物。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、DBiL、ALP、GGT、A/G)、HBV-M、HBV-DNA定量和肝脾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)。
实验结束,完成病例报告表后,进行数据录入、揭盲及数据统计分析(统计方法为:计量资料采用t检验,用(?)±s进行统计描述,采用配对t检验比较组内前后差异,计数资料采用x口检验,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)。完成统计分析报告后,进行本次临床研究的总结,对乙肝长乐片治疗慢性乙型肝炎肝脾湿热证的有效性和安全性作出判断。
结果
研究中有1例病人因被发现合并服用其它护肝降酶药物而不符合入组条件被剔除(揭盲后,显示为对照组1例),脱落率为1.43%,故共有69例病人(治疗组35例、对照组34例)。按研究方案完成12周治疗及3个月随访,病人依从性良好。
1.总体疗效比较:治疗组分别为30例(85.7%),3例(8.6%),2例(5.7%),显效率85.7%,总有效率94.3%;对照组显效23例(67.6%),有效6例(17.6%),无效5例(14.7%),显效率67.6%,总有效率85.3%,治疗组疗效优于对照组,但是两者比较无显著差异(P＞0.05)。
2.血清ALT、AST、TBiL、DBiL下降疗效比较:
(1)血清ALT、AST:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.01);两组间比较:治疗组临床治愈12例(34.3%),显效20例(57.1%),有效2例,总有效率97.1%;对照组临床治愈7例(20.6%),显效16例(47.05%),有效2例,总有效率85.3%,两组比较治疗组的显效率和总有效率高于对照组,但两组间比较差别无统计学意义。(P＞0.05)
(2)血清TBiL、DBiL:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.01);两组间比较:治疗组显效9例、有效12例,显效率为25.7%、总有效率60.0%;对照组显效5例、有效9例,显效率为14.7%、总有效率为41.2%,治疗组略高于对照组,但比较差别无统计学意义。(P＞0.05)
3.中医证候改善疗效比较:治疗组和对照组治疗前后比较,疗效非常显著(P＜0.01);两组间比较:治疗组临床治愈14例(40.0%),显效18例(51.4%),有效2例,总有效率97.1%;对照组临床治愈11例(32.4%),显效15例(44.1%),有效5例,总有效率91.2%,治疗组的中医证候疗效和有效率高于对照组,但两组差别比较无统计学意义。(P＞0.05)
4.血浆蛋白疗效治疗组和对照组治疗前后比较均有所改善(P＜0.05);但两组间比较无统计学意义。(P＞0.05)
5.HBV病毒标记物:两组HBV病毒标记物(HBsAg、抗-HBs、HBeAg、抗-HBe、抗-HBc及HBV-DNA定量)指标变化不明显,未作统计学处理。
6.肝脾B超检查:两组肝脾B超检查变化无统计学意义。
7.安全性结果:治疗前、后两组病例的血、粪常规,肾功能及心电图均无明显改变。治疗组未发生任何不良事件,对照组有一例病人因被发现在实验过程中合并服用其它护肝降酶药物而不符合入组条件被剔除。
结论
乙肝长乐片能明显改善慢性乙型肝炎肝脾湿热型患者的症状、体征,及血清ALT、AST、TbiL、DBil等实验室指标,具有明显的护肝、降酶、退黄及改善症状体征的作用,疗效优于复方益肝丸。乙肝长乐片在临床试验过程中安全性较好,未发现与之相关的不良反应,对慢乙肝患者的血常规、尿常规、大便常规、肾功能及心电图均无不良影响,说明乙肝长乐片适用于治疗慢性乙型肝炎肝脾湿热型患者,是一种有效、安全的治疗慢性乙型肝炎的中药制剂。
Objective
To observe the effect of Yiganchangle tablet on patients of liver-spleen dampness-heat syndrome with chronic hepatitis B. Meanwhile this research try to investigate the functional mechanism of Yiganchangle Tablet and provide scientific clinical basic for its product and use.
Methods
Choose the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B as observing objects.
Seventy cases were randomly divided into 2 groups,each 35,one for treatment and the other for control,observed by double blind method. For treatment group,treated by Yiganchangle tablet,otherwise in control group,Compound pill for Nourishing Liver was used.The treatment course of this research is 12 weeks,3 months for the follow-up visit.The study was designed to investigate the changes of clinical syndrome,physical sign,liver function before and after the treatment by physical and lab test.Observing change of the clinical symptom physical sign、Traditional Chinese medicine syndrome integral、Hepatic function(concluding ALT、AST、Tbil、DbiL、ALP、GGT、ALB and GELO)、HBV-M、HBV-DNA quantity、B supersonic wave on liver and spleen,and secure index(concluding blood、urine、stool routine and renal function、ECG),comparing the tharapeutic efficacy of both drugs.
Results
1.The curative effect of enzyme dropping:The treated group: clinical cured rate is 34.3%,obvious effective rate is 57.1%,total effective rate is 97.1%;The controlled group:clinical cured rate 20.6%,obvious effective rate is 47.1%,total effective rate is 85.3%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)
2.The curative effect of traditional Chinese medicine syndrome:The treated groups:obvious effective rate is 91.4%,total progressive rate is 97.1%;The controlled group:obvious effective rate is 76.5%,total effective rate is 91.2%.The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05).
3.The curative effect of TBi1、DBi1:The treated groups:obvious effective rate is 25.7%,total progressive rate is 60.0%;The controlled group:obvious effective rate is 14.7%,total effective rate is 41.2%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)
4.The curative effect of blood plasma albumen:There are obvious progress on two groups in the end of experiment(P＜0.05),but there isn't statistics difference between two groups(P＞0.05).
5.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.
Conclusion:
Yiganchangle tablet have the same curative effect on chronic hepatitis B of liver-spleen dampness-heat syndrome as the Compound pill for Nourishing Liver,and its long-term curative effect is better than the compared drug.Yiganchangle tablet can well improve symptom and physical sign of the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B,progress Hepatic function,lighten the damage of liver.It have not the serious side effects in this clinical research.The Yiganchangle Tablet is the effectual and secure medication to liver-spleen dampness-heat syndrome with chronic hepatitis B from the research.
研究乙肝长乐片治疗慢性乙型肝炎肝脾湿热证患者的有效性和安全性。
方法
选择年龄18～65岁的男性或女性,中医辨证为肝脾湿热证的慢性乙型肝炎为观察对象。
采用随机、双盲、双模拟、阳性药平行对照的临床试验,将已确诊为慢性乙型肝炎肝脾湿热证患者70例按1:1比例随机分为治疗组与对照组。实验组每次给予乙肝长乐片5片十复方益肝丸模拟剂4 g,口服,每日3次。对照组每次给予复方益肝丸4g十乙肝长乐片模拟剂5片,口服,每日3次。入选病例接受12周的试验或对照药物治疗,治疗结束后进行3个月随访。试验期内不得合并使用能影响本病疗效的降酶退黄的中西药物。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、DBiL、ALP、GGT、A/G)、HBV-M、HBV-DNA定量和肝脾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)。
实验结束,完成病例报告表后,进行数据录入、揭盲及数据统计分析(统计方法为:计量资料采用t检验,用(?)±s进行统计描述,采用配对t检验比较组内前后差异,计数资料采用x口检验,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)。完成统计分析报告后,进行本次临床研究的总结,对乙肝长乐片治疗慢性乙型肝炎肝脾湿热证的有效性和安全性作出判断。
结果
研究中有1例病人因被发现合并服用其它护肝降酶药物而不符合入组条件被剔除(揭盲后,显示为对照组1例),脱落率为1.43%,故共有69例病人(治疗组35例、对照组34例)。按研究方案完成12周治疗及3个月随访,病人依从性良好。
1.总体疗效比较:治疗组分别为30例(85.7%),3例(8.6%),2例(5.7%),显效率85.7%,总有效率94.3%;对照组显效23例(67.6%),有效6例(17.6%),无效5例(14.7%),显效率67.6%,总有效率85.3%,治疗组疗效优于对照组,但是两者比较无显著差异(P＞0.05)。
2.血清ALT、AST、TBiL、DBiL下降疗效比较:
(1)血清ALT、AST:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.01);两组间比较:治疗组临床治愈12例(34.3%),显效20例(57.1%),有效2例,总有效率97.1%;对照组临床治愈7例(20.6%),显效16例(47.05%),有效2例,总有效率85.3%,两组比较治疗组的显效率和总有效率高于对照组,但两组间比较差别无统计学意义。(P＞0.05)
(2)血清TBiL、DBiL:治疗组和对照组治疗前后比较,均有非常显著疗效(P＜0.01);两组间比较:治疗组显效9例、有效12例,显效率为25.7%、总有效率60.0%;对照组显效5例、有效9例,显效率为14.7%、总有效率为41.2%,治疗组略高于对照组,但比较差别无统计学意义。(P＞0.05)
3.中医证候改善疗效比较:治疗组和对照组治疗前后比较,疗效非常显著(P＜0.01);两组间比较:治疗组临床治愈14例(40.0%),显效18例(51.4%),有效2例,总有效率97.1%;对照组临床治愈11例(32.4%),显效15例(44.1%),有效5例,总有效率91.2%,治疗组的中医证候疗效和有效率高于对照组,但两组差别比较无统计学意义。(P＞0.05)
4.血浆蛋白疗效治疗组和对照组治疗前后比较均有所改善(P＜0.05);但两组间比较无统计学意义。(P＞0.05)
5.HBV病毒标记物:两组HBV病毒标记物(HBsAg、抗-HBs、HBeAg、抗-HBe、抗-HBc及HBV-DNA定量)指标变化不明显,未作统计学处理。
6.肝脾B超检查:两组肝脾B超检查变化无统计学意义。
7.安全性结果:治疗前、后两组病例的血、粪常规,肾功能及心电图均无明显改变。治疗组未发生任何不良事件,对照组有一例病人因被发现在实验过程中合并服用其它护肝降酶药物而不符合入组条件被剔除。
结论
乙肝长乐片能明显改善慢性乙型肝炎肝脾湿热型患者的症状、体征,及血清ALT、AST、TbiL、DBil等实验室指标,具有明显的护肝、降酶、退黄及改善症状体征的作用,疗效优于复方益肝丸。乙肝长乐片在临床试验过程中安全性较好,未发现与之相关的不良反应,对慢乙肝患者的血常规、尿常规、大便常规、肾功能及心电图均无不良影响,说明乙肝长乐片适用于治疗慢性乙型肝炎肝脾湿热型患者,是一种有效、安全的治疗慢性乙型肝炎的中药制剂。
Objective
To observe the effect of Yiganchangle tablet on patients of liver-spleen dampness-heat syndrome with chronic hepatitis B. Meanwhile this research try to investigate the functional mechanism of Yiganchangle Tablet and provide scientific clinical basic for its product and use.
Methods
Choose the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B as observing objects.
Seventy cases were randomly divided into 2 groups,each 35,one for treatment and the other for control,observed by double blind method. For treatment group,treated by Yiganchangle tablet,otherwise in control group,Compound pill for Nourishing Liver was used.The treatment course of this research is 12 weeks,3 months for the follow-up visit.The study was designed to investigate the changes of clinical syndrome,physical sign,liver function before and after the treatment by physical and lab test.Observing change of the clinical symptom physical sign、Traditional Chinese medicine syndrome integral、Hepatic function(concluding ALT、AST、Tbil、DbiL、ALP、GGT、ALB and GELO)、HBV-M、HBV-DNA quantity、B supersonic wave on liver and spleen,and secure index(concluding blood、urine、stool routine and renal function、ECG),comparing the tharapeutic efficacy of both drugs.
Results
1.The curative effect of enzyme dropping:The treated group: clinical cured rate is 34.3%,obvious effective rate is 57.1%,total effective rate is 97.1%;The controlled group:clinical cured rate 20.6%,obvious effective rate is 47.1%,total effective rate is 85.3%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)
2.The curative effect of traditional Chinese medicine syndrome:The treated groups:obvious effective rate is 91.4%,total progressive rate is 97.1%;The controlled group:obvious effective rate is 76.5%,total effective rate is 91.2%.The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05).
3.The curative effect of TBi1、DBi1:The treated groups:obvious effective rate is 25.7%,total progressive rate is 60.0%;The controlled group:obvious effective rate is 14.7%,total effective rate is 41.2%. The effective rate of treated group was better than that of the controlled group,but there aren't statistics difference between two groups(P＞0.05)
4.The curative effect of blood plasma albumen:There are obvious progress on two groups in the end of experiment(P＜0.05),but there isn't statistics difference between two groups(P＞0.05).
5.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.
Conclusion:
Yiganchangle tablet have the same curative effect on chronic hepatitis B of liver-spleen dampness-heat syndrome as the Compound pill for Nourishing Liver,and its long-term curative effect is better than the compared drug.Yiganchangle tablet can well improve symptom and physical sign of the patients of liver-spleen dampness-heat syndrome with chronic hepatitis B,progress Hepatic function,lighten the damage of liver.It have not the serious side effects in this clinical research.The Yiganchangle Tablet is the effectual and secure medication to liver-spleen dampness-heat syndrome with chronic hepatitis B from the research.
引文
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