中医治疗肝硬化疗效评价研究
摘要
目的：
通过文献研究-专家意见集成-临床研究途径,建立中医药治疗肝硬化多维疗效评价指标体系,充分体现中医药治疗肝硬化疗效优势。
方法：
1.文献研究：收集肝炎后肝硬化疗效评价方法各类文献资料,采用Cochrane协作网提供的RevMan4.2软件进行Meta统计,分析具有中医特色的肝炎后肝硬化化评价指标和评价方法。
2.专家意见集成：采用德尔菲法进行专家问卷研究,在文献研究的基础上编制专家问卷,提出反映中医证候的相关指标,疾病相关的理化指标,疾病相关的病原学指标,功能性指标,通过2轮问卷调查,初步建立肝炎后肝硬化中医临床疗效评价指标。
3.临床研究：采取多中心、随机、对照临床研究方法,观察中医药对肝炎后肝硬化西医疗效评定指标、中医症候疗效评定指标、并发症的发生率、生存质量、社会功能及心理状况的影响。
结果：
1.文献研究：检索出436篇文献,通过阅读标题、摘要及全文,将文献用Jadad量表进行评价、筛选,6篇符合纳入标准,Meta分析提示中医药治疗肝炎后早期肝硬化总有效率优于常规西医治疗,在改善肝纤维化指标透明质酸(HA)、层粘蛋白(LN)、Ⅲ型胶原(PCⅢ)指标优于常规西医治疗,在改善肝功能丙氨酸转氨酶(ALT)、总胆红素(TBIL)、天冬氨酸转氨酶(AST)指标优于常规西医治疗。
2.第一轮调查均数值最小的指标是“肝大”,最大的是“衄血”；第二轮最小的指标是“性欲减退”,最大的是“中医临床症状”。经过两轮指标的合并和删减,最终确立了包含3个层次共52项中医药治疗肝炎后肝硬化疗效评价指标,包括：一级指标4个,二级指标18个,三级指标30个。其中传统的中医症候指标、西医疗效指标、生存质量指标和并发症的发生率4项一级指标的权重系数分别为0.2649、0.2602、0.2354和0.2395。
3.中医药在改善ALT、TT、APPT、PT、Ⅳ_C、DBIL显著优于常规西医治疗(P<0.05或P<0.01)。肝硬化患者各领域得分均低于60,提示肝炎后肝硬化患者多数生存质量不高。治疗后,两组患者各个领域评分及综合评分均有显著提高,较治疗前比较,差异有显著性(P<0.05),尤其在生理及心理领域评分(P<0.01)；与对照组比较,治疗组在心理领域评分及综合评分提高明显,差异有显著性(P<0.05)。采用社会功能缺陷筛选量表、焦虑自评量表(SAS)、抑郁自评量表(SDS),发现两组患者在治疗前多数存在不同程度的社会功能和心理功能缺陷,治疗组患者的社会功能缺陷各类评分指标(社会性退缩、家庭外的社会活动、家庭职能、对外界的兴趣和关心、责任心和计划性)评分均明显低于对照组(p<0.05或p<0.01),提示中医药改善社会功能和心理功能优于常规西医治疗。
结论：
从理化疗效评定指标、中医症候指标、并发症发生率、生存质量、社会功能及心理测试等方面,建立起中医药治疗肝炎后肝硬化多维评价方法体系,可体现中医药治疗多途径、多靶点、整体性调节的临床疗效特点,能比较客观地对中医药临床疗效作出评价,可以为中医临床效应评价提供方法、思路。
Objective:
To form an evaluation system of multi-direction curative effects of TCM on liver cirrhosis and make the most advantages of TCM in treating liver cirrhosis by terms of a process of "study on documents records collect of experts'comments-clinic research".
Methods:
1.study on document records Meta Analyze the collected document records on curative effects of TCM on liver cirrhosis and conclude an evaluation system characterized with TCM.
2.collect experts'comments Set a questionnaire which contains the questions related to the quotes of syndromes, diseases related chemical and etiological index and functional index based on the study of document records and analyze the results of the questionnaire with Delphi method. And then form an evaluation system of multi-direction curative effects of TCM on liver cirrhosis after 2 rounds of investigation.
3.clinical research To observe the curative effects, the incidence rate of complications, the quantity of life, social function and psychological situation in terms of clinical research methods of multi-central, random and contrast.
Results:
1.study on document records Among 436 records we retrieved,6 were qualified to be embodied after reading of the title, abstracts and whole text and screened by Jadad Scale. We Meta analyzed the 6 embodied texts and the results show that TCM shows a better whole effect in treating cirrhosis in an early stage due to hepatitis, especially in the indexes of HA, LN, PCIII, ALT, TBIL AND AST.
2.The index with minimal mean is "hepatauxe" and the maximum "blooding nose" in the first round of investigation. And in the second round, the index with minimal mean is "hyposexuality" and the maximum "clinical syndromes described in TCM". We finally established 4 primary indexes,18 secondary indexes and 30 third-class indexes through 2 rounds of combination and deletion. Among those established indexes, the weight coefficient of the 4 primary indexes:TCM syndrome, curative effects of regular western medicine, the quality of life and the incidence rate of complications are separately 0.2649、0.2602、0.2354 and 0.2395.
3.TCM shows a significant priority over regular western medicine in ameliorating ALT、TT、APPT、PT、Ⅳ_C and DBIL. The patient with cirrhosis got marks lower than 60 on average, which indicates that they will suffer a bad quality of life later. Two groups of patients got higher marks in all areas after being treated. Compared with before, there's a significant difference (P<0.05) especially in physiology and psychology(P<0.01). Compared with the control group, the treated group also shows a significant difference (P<0.05) when tested in psychological area and overall grade. We found out with social function defection scale, scale of anxiety self-evaluation and scale of depression self-evaluation that most of the patients in the two groups have defection of all degrees either in social or psychological function. The patients in the treated group got lower marks than the control group in social function defection scale (social recession, social activities, domestic function, the interest of the outside world and responsibility) which indicates that TCM has better effects than regular western medicine in social and psychological function.
Concludes:
The form of evaluation system of multi-direction curative effects of TCM on liver cirrhosis based on the indexes of TCM syndromes, the incidence rate of complications, the quality of life, social function and psychological tests either emphasizes on the characters of TCM of multi-channel, multi-target and wholic regulation or evaluate the clinical curative effects of TCM objectively and provide methods and clues for the evaluation of clinical application of TCM.
通过文献研究-专家意见集成-临床研究途径,建立中医药治疗肝硬化多维疗效评价指标体系,充分体现中医药治疗肝硬化疗效优势。
方法：
1.文献研究：收集肝炎后肝硬化疗效评价方法各类文献资料,采用Cochrane协作网提供的RevMan4.2软件进行Meta统计,分析具有中医特色的肝炎后肝硬化化评价指标和评价方法。
2.专家意见集成：采用德尔菲法进行专家问卷研究,在文献研究的基础上编制专家问卷,提出反映中医证候的相关指标,疾病相关的理化指标,疾病相关的病原学指标,功能性指标,通过2轮问卷调查,初步建立肝炎后肝硬化中医临床疗效评价指标。
3.临床研究：采取多中心、随机、对照临床研究方法,观察中医药对肝炎后肝硬化西医疗效评定指标、中医症候疗效评定指标、并发症的发生率、生存质量、社会功能及心理状况的影响。
结果：
1.文献研究：检索出436篇文献,通过阅读标题、摘要及全文,将文献用Jadad量表进行评价、筛选,6篇符合纳入标准,Meta分析提示中医药治疗肝炎后早期肝硬化总有效率优于常规西医治疗,在改善肝纤维化指标透明质酸(HA)、层粘蛋白(LN)、Ⅲ型胶原(PCⅢ)指标优于常规西医治疗,在改善肝功能丙氨酸转氨酶(ALT)、总胆红素(TBIL)、天冬氨酸转氨酶(AST)指标优于常规西医治疗。
2.第一轮调查均数值最小的指标是“肝大”,最大的是“衄血”；第二轮最小的指标是“性欲减退”,最大的是“中医临床症状”。经过两轮指标的合并和删减,最终确立了包含3个层次共52项中医药治疗肝炎后肝硬化疗效评价指标,包括：一级指标4个,二级指标18个,三级指标30个。其中传统的中医症候指标、西医疗效指标、生存质量指标和并发症的发生率4项一级指标的权重系数分别为0.2649、0.2602、0.2354和0.2395。
3.中医药在改善ALT、TT、APPT、PT、Ⅳ_C、DBIL显著优于常规西医治疗(P<0.05或P<0.01)。肝硬化患者各领域得分均低于60,提示肝炎后肝硬化患者多数生存质量不高。治疗后,两组患者各个领域评分及综合评分均有显著提高,较治疗前比较,差异有显著性(P<0.05),尤其在生理及心理领域评分(P<0.01)；与对照组比较,治疗组在心理领域评分及综合评分提高明显,差异有显著性(P<0.05)。采用社会功能缺陷筛选量表、焦虑自评量表(SAS)、抑郁自评量表(SDS),发现两组患者在治疗前多数存在不同程度的社会功能和心理功能缺陷,治疗组患者的社会功能缺陷各类评分指标(社会性退缩、家庭外的社会活动、家庭职能、对外界的兴趣和关心、责任心和计划性)评分均明显低于对照组(p<0.05或p<0.01),提示中医药改善社会功能和心理功能优于常规西医治疗。
结论：
从理化疗效评定指标、中医症候指标、并发症发生率、生存质量、社会功能及心理测试等方面,建立起中医药治疗肝炎后肝硬化多维评价方法体系,可体现中医药治疗多途径、多靶点、整体性调节的临床疗效特点,能比较客观地对中医药临床疗效作出评价,可以为中医临床效应评价提供方法、思路。
Objective:
To form an evaluation system of multi-direction curative effects of TCM on liver cirrhosis and make the most advantages of TCM in treating liver cirrhosis by terms of a process of "study on documents records collect of experts'comments-clinic research".
Methods:
1.study on document records Meta Analyze the collected document records on curative effects of TCM on liver cirrhosis and conclude an evaluation system characterized with TCM.
2.collect experts'comments Set a questionnaire which contains the questions related to the quotes of syndromes, diseases related chemical and etiological index and functional index based on the study of document records and analyze the results of the questionnaire with Delphi method. And then form an evaluation system of multi-direction curative effects of TCM on liver cirrhosis after 2 rounds of investigation.
3.clinical research To observe the curative effects, the incidence rate of complications, the quantity of life, social function and psychological situation in terms of clinical research methods of multi-central, random and contrast.
Results:
1.study on document records Among 436 records we retrieved,6 were qualified to be embodied after reading of the title, abstracts and whole text and screened by Jadad Scale. We Meta analyzed the 6 embodied texts and the results show that TCM shows a better whole effect in treating cirrhosis in an early stage due to hepatitis, especially in the indexes of HA, LN, PCIII, ALT, TBIL AND AST.
2.The index with minimal mean is "hepatauxe" and the maximum "blooding nose" in the first round of investigation. And in the second round, the index with minimal mean is "hyposexuality" and the maximum "clinical syndromes described in TCM". We finally established 4 primary indexes,18 secondary indexes and 30 third-class indexes through 2 rounds of combination and deletion. Among those established indexes, the weight coefficient of the 4 primary indexes:TCM syndrome, curative effects of regular western medicine, the quality of life and the incidence rate of complications are separately 0.2649、0.2602、0.2354 and 0.2395.
3.TCM shows a significant priority over regular western medicine in ameliorating ALT、TT、APPT、PT、Ⅳ_C and DBIL. The patient with cirrhosis got marks lower than 60 on average, which indicates that they will suffer a bad quality of life later. Two groups of patients got higher marks in all areas after being treated. Compared with before, there's a significant difference (P<0.05) especially in physiology and psychology(P<0.01). Compared with the control group, the treated group also shows a significant difference (P<0.05) when tested in psychological area and overall grade. We found out with social function defection scale, scale of anxiety self-evaluation and scale of depression self-evaluation that most of the patients in the two groups have defection of all degrees either in social or psychological function. The patients in the treated group got lower marks than the control group in social function defection scale (social recession, social activities, domestic function, the interest of the outside world and responsibility) which indicates that TCM has better effects than regular western medicine in social and psychological function.
Concludes:
The form of evaluation system of multi-direction curative effects of TCM on liver cirrhosis based on the indexes of TCM syndromes, the incidence rate of complications, the quality of life, social function and psychological tests either emphasizes on the characters of TCM of multi-channel, multi-target and wholic regulation or evaluate the clinical curative effects of TCM objectively and provide methods and clues for the evaluation of clinical application of TCM.
引文
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