Psychometrics of chronic liver disease questionnaire in Chinese chronic hepatitis B patients

AIM: To evaluate psychometrics of the Chinese (mainland) chronic liver disease questionnaire (CLDQ) in patients with chronic hepatitis B (CHB). METHODS: A cross-sectional sample of 460 Chinese patients with CHB was selected from the Outpatient Department of the Eighth Hospital of Xi'an, including CHB (CHB without cirrhosis) (n = 323) and CHB-related cirrhosis (n = 137). The psychometrics includes reliability, validity and sensitivity. Internal consistency reliability was measured using Cronbach's α. Convergent and discriminant validity was evaluated by item-scale correlation. Factorial validity was explored by principal component analysis with varimax rotation. Sensitivity was assessed using Cohen's effect size (ES), and independent sample t test between CHB and CHB-related cirrhosis groups and between alanine aminotransferase (ALT) normal and abnormal groups after stratifying the disease (CHB and CHB-related cirrhosis).RESULTS: Internal consistency reliability of the CLDQ was 0.83 (range: 0.65-0.90). Most of the hypothesized item-scale correlations were 0.40 or over, and all of such hypothesized correlations were higher than the alternative ones, indicating satisfactory convergent and discriminant validity. Six factors were extracted after varimax rotation from the 29 items of CLDQ. The eligible Cohen's ES with statistically significant independent sample t test was found in the overall CLDQ and abdominal, systematic, activity scales (CHB vs CHBrelated cirrhosis), and in the overall CLDQ and abdominal scale in the stratification of patients with CHB (ALT normal vs abnormal). CONCLUSION: The CLDQ has acceptable reliability, validity and sensitivity in Chinese (mainland) patients with CHB.

Chronic liver disease questionnaire:Translation and validation in Thais

AIM:Quality of life (QOL) is a concept that incorporates many aspects of life beyond“health”.The chronic liver disease questionnaire (CLDQ) was developed to evaluate the impact of chronic liver diseases (CLD) on QOL.The objectives of this study were to translate and validate a liver specific questionnaire,the CLDQ. METHODS:The CLDQ was formally translated from the original version to Thai language with permission.The translation process included forward translation,back translation,cross-cultural adaptation and a pretest.Reliability and validity of the translated version was examined in CLD patients.Enrolled subjects included CLD and normal subjects with age- and sex-matched.Collected data were demography, physical findings and biochemical tests.All subjects were asked to complete the translated versions of CLDQ and SF- 36,which was previously validated.Cronbach's alpha and test-retest were performed for reliability analysis.One-way Anova or non-parametric method was used to determine discriminant validity.Speerman's rank correlation was used to assess convergent validity.P-value<0.05 was considered statistically significant. RESULTS:A total of 200 subjects were recruited into the study,with 150 CLD and 50 normal subjects.Mean ages (SD) were 47.3(11.7) and 49.1(8.5) years,respectively.The number of chronic hepatitis:cirrhosis was 76:74,and the ratio of cirrhotic patients classified as Child A:B:C was 37 (50%):26(35%):11(15%).Cronbach's alpha of the overall CLDQ scores was 0.96 and of all domains were higher than 0.93.Item-total correlation was>0.45.Test-retest reliability done at 1 to 4 wk apart was 0.88 for the average CLDQ score and from 0.68 to 0.90 for domain scores.The CLDQ was found to have discriminant validity.The highest scores of CLDQ domains were in the normal group,scores were lower in the compensated group and lowest in the decompensated group.The significant correlation between domains of the CLDQ and SF-36 was found.The average CLDQ score was strongly correlated with the general health domain of SF-36.(P=0.69:P=0.01). CONCLUSION:The translated CLDQ is valid and applicable in Thais with CLD.CLDQ reveals that QOL in these patients is lower than that in normal population.QOL is more impaired in advanced stage of CLD.

Translation and validation of the Greek chronic liver disease questionnaire

AIM:To translate into Greek and validate the chronic liver disease questionnaire (CLDQ).METHODS:Two hundred and six consecutive adult patients with the diagnosis of a chronic liver disease from 2 general hospitals in Athens were enrolled in the study from May to September 2008.In order to assess their quality of life (QOL) the CLDQ was applied.The instrument was translated from English,back translated and reviewed in focus groups within the framework of a large multicenter study.The measurements that were performed included:2 independent sample t tests,oneway analysis of variance,reliability coefficients,explanatory factor analysis using a varimax rotation and the principal components method.RESULTS:One hundred and twenty five (61%) patients were men,half were aged 40-59 years and > 33% were > 60 years old.Among the patients,48 (23%) were hospitalized and 97 (47%) were cirrhotic according to the Child-Pugh score.The internal consistency of the Greek CLDQ version using Cronbach's alpha coefficient was found to be 0.93.Exploratory factor analysis identified 7 domains accounting for 65% of the variance of CLDQ items and only partially overlapping with those found in the original version.The area under the receiver operating characteristics curve was calculated at 0.813 and the logistic estimate for the threshold score of 167.50 provided a sensitivity of 74.3% and a specificity of 71.6% for the model.CONCLUSION:Our data confirmed the validity of the Greek version of the CLDQ in identifying the QOL among patients with chronic liver disease.

Validation of the chronic liver disease questionnaire in Serbian patients

AIM:To translate into Serbian and to investigate the validity of the cross-culturally adapted the chronic liver disease questionnaire(CLDQ).METHODS:The questionnaire was validated in 103 consecutive CLD patients treated between October 2009 and October 2010 at the Clinic for Gastroenterology,Clinical Centre of Serbia,Belgrade(Serbia).Exclusion criteria were:age < 18 years,psychiatric disorders,acute complications of CLD(acute liver failure,variceal bleeding,and spontaneous bacterial peritonitis),hepatic encephalopathy(grade > 2)and liver transplantation.Evaluation of the CLDQ was done based on the following parameters:(1)acceptance is shown by the proportion of missing items;(2)internal reliabilities were assessed for multiple item scales by using Cronbach alpha coefficient;and(3)in order to assess whether the allocation of items in the domain corresponds to their distribution in the original questionnaire(construction validity),an exploratory factor analysis was conducted.Discriminatory validity was determined by comparing the corresponding CLDQ score/sub-score in patients with different severity of the diseases.RESULTS:The Serbian version of CLDQ questionnaire completed 98% patients.Proportion of missing items was 0.06%.The total time needed to fill the questionnaire was ranged from 8 to 15 min.Assistance in completing the questionnaire required 4.8% patients,while 2.9% needed help in reading,and 1.9% involved writing assistance.The mean age of the selected patients was 53.8 ± 12.9 years and 54.4% were men.Average CLDQ score was 4.62 ± 1.11.Cronbach's alpha for the whole scale was 0.93.Reliability for all domains was above 0.70,except for the domain "Activity"(0.49).The exploratory factor analysis model revealed 6 factors with eigenvalue of greater than 1,explaining 69.7% of cumulative variance.The majority of the items(66%)in the Serbian version of the CLDQ presented the highest loading weight in the domain assigned by the CLDQ developers:"Fatigue"(5/5),"Emotional function"(6/8),"Worry"(5/5),"Abdominal symptoms"(0/3),"Activity"(0/3),"Systemic symptoms"(3/5).The scales "Fatigue" and "Worry" fully corresponded to the original.The factor analysis also revealed that the factors "Activity" and "Abdominal symptoms" could not be replicated,and two new domains "Sleep" and "Nutrition" were established.Analysis of the CLDQ score/sub-score distribution according to disease severity demonstrated that patients without cirrhosis had lower total CLDQ score(4.86 ± 1.05)than those with cirrhosis Child's C(4.31 ± 0.97).Statistically significant difference was detected for the domains "Abdominal symptoms" [F(3)= 5.818,P = 0.001] and "Fatigue" [F(3)= 3.39,P = 0.021].Post hoc analysis revealed that patients with liver cirrhosis Child's C had significantly lower sub-score "Abdominal symptoms" than patients without cirrhosis or liver cirrhosis Child's A or B.For domain "Fatigue",patients with cirrhosis Child's C had significantly lower score,than non-cirrhotic patients.CONCLUSION:The Serbian version of CLDQ is well accepted and represents a valid and reliable instrument in Serbian sample of CLD patients.

COVID-19 emergency: Changes in quality of life perception in patients with chronic liver disease-An Italian single-centre study

BACKGROUND In December 2019,the coronavirus disease-2019(COVID-19)emerged and rapidly spread worldwide,becoming a global health threat and having a tremendous impact on the quality of life(QOL)of individuals.AIM To evaluate the awareness of patients with chronic liver disease(CLD)regarding the COVID-19 emergency and how it impacted on their QOL.METHODS Patients with an established diagnosis of CLD(cirrhosis,autoimmune hepatitis,primary biliary cholangitis,and primary sclerosing cholangitis)who had been evaluated at our Outpatient Liver Disease Clinic during the 6-mo period preceding the start of Italian lockdown(March 8,2020)were enrolled.Participants were asked to complete a two-part questionnaire,administered by telephone according to governmental restrictions:The first section assessed patients’basic knowledge regarding COVID-19,and the second evaluated the impact of the COVID-19 emergency on their QOL.We used the Italian version of the CLD questionnaire(CLDQ-I).With the aim of evaluating possible changes in the QOL items addressed,the questionnaire was administered to patients at the time of telephone contact with the specific request to recall their QOL perceptions during two different time points.In detail,patients were asked to recall these perceptions first during time 0(t0),a period comprising the 2 wk preceding the date of ministerial lockdown decree(from February 23 to March 7,2020);then,in the course of the same phone call,they were asked to recall the same items as experienced throughout time 1(t1),the second predetermined time frame encompassing the 2 wk(from April 6 to April 19)preceding our telephone contact and questionnaire administration.All data are expressed as number(%),and continuous variables are reported as the median(interquartile range).The data were compared using the Wilcoxon paired non-parametric test.RESULTS A total of 111 patients were enrolled,of whom 81 completed the questionnaire.Forty-nine had liver cirrhosis,and all of them had compensated disease;32 patients had autoimmune liver disease.The majority(93.8%)of patients were aware of COVID-19 transmission modalities and on how to recognize the most common alarm symptoms(93.8%).Five of 32(15.6%)patients with autoimmune liver disease reported having had the need to receive more information about the way to manage their liver disease therapy during lockdown and nine(28.2%)thought about modifying their therapy without consulting their liver disease specialist.About the impact on QOL,all CLDQ-I total scores were significantly worsened during time t1 as compared to time t0.CONCLUSION The COVID-19 epidemic has had a significant impact on the QOL of our population of patients,despite a good knowledge of preventive measure and means of virus transmission.

人本位护理模式对乙型肝炎患者CLDQ评分、遵医行为及主观幸福感评分的影响

目的探讨人本位护理模式对乙型肝炎患者慢性肝病问卷(CLDQ)评分、遵医行为及主观幸福感的影响。方法选取2015年9月至2018年9月于宝鸡市中心医院感染科就诊的乙型肝炎患者118例,按照随机数表法分为对照组和观察组,每组59例。对照组患者给予常规护理,观察组患者给予人本位护理,所在患者均随访3个月。比较两组患者入院时、出院时及出院3个月后的CLDQ评分、主观幸福感指数和遵医行为;比较两组患者出院时的护理满意度。结果出院时及出院3个月后,两组患者CLDQ评分中的各项评分明显高于入院时,出院3个月后明显高于出院时,且观察组患者出院时及出院3个月后的CLDQ评分各项评分和总分明显高于对照组,差异均有统计学意义(P<0.05);出院时及出院3个月后,两组患者的遵医行为占比明显高于入院时,出院3个月后明显高于出院时,且观察组患者出院时及出院3个月后的遵医行为占比明显高于对照组,差异均有统计学意义(P<0.05);出院时及出院3个月后,两组患者主观幸福感得分明显低于入院时,且观察组患者出院时及出院3个月后的主观幸福感得分明显低于对照组,差异均有统计学意义(P<0.05);出院时,观察组患者的护理满意度为84.75%,明显高于对照组的55.93%,差异有统计学意义(P<0.05)。结论人本位护理模式用于乙型肝炎患者可显著改善患者的生活质量,提高治疗依从性、主观幸福感和护理满意度。

肝硬化患者肝移植术后生存质量的变化

目的调查肝硬化患者肝移植前后生存质量的变化情况。方法研究对象为在中山大学附属第三医院移植中心行首次肝移植手术的68例肝硬化患者。分别在术前,术后0～6个月、7～12个月、12个月以上对患者进行问卷调查。问卷采用健康调查简表(medical outcome study 36-item short form health survey,SF-36)与疾病专用调查表——慢性肝病问卷(chronic liver disease questionaire,CLDQ)。结果在肝移植术前,肝硬化患者的SF-36和CLDQ各维度评分均偏低。术后各时段SF-36的生理机能、躯体疼痛、一般健康、精力和CLDQ的腹部症状、乏力、全身症状、活动评分均较术前明显升高(均为P<0.05);与术前比较,术后0～6个月SF-36的生理职能、社会功能、情感职能、精神健康和CLDQ的情感功能、焦虑评分差异无统计学意义(均为P>0.05),但术后7～12个月、术后12个月以上述维度评分比较差异均有统计学意义(均为P<0.05);术后随着时间的推移,两表各维度得分逐步升高。结论肝硬化肝移植患者术后的生存质量与术前比较有明显改善,术后早期以生理功能方面改善明显,随时间的推移,生存质量其他指标如心理状态和社会功能也得到明显的改善。

慢性肝病问卷在乙肝病毒携带者中的初步试用

目的:初步评价Younossi的慢性肝病问卷(CLDQ)试用于我国乙型肝炎病毒携带者生存质量的信度和效度。方法:采用CLDQ对乙肝病毒携带者进行调查。结果:共108例乙型肝炎病毒携带者完成调查。研究结果显示CLDQ内部一致性信度较高,与其他研究一致;特征根大于1的公因子有6个,能解释总方差的66.89%;结构效度分析未与原量表设计完全一致。结论:CLDQ用于我国乙型肝炎病毒携带者生存质量评价时有一定的信度和效度,但仍需改进,并对其用于此部分人群时的修改提供了建议。

非酒精性脂肪肝与非酒精性脂肪肝炎患者健康相关生活质量调查比较

目的通过慢性肝病调查问卷,比较非酒精性脂肪肝与非酒精性脂肪肝炎对患者健康相关生活质量的影响,为后续治疗提供依据与指导。方法选择2014年11月至2015年12月成都市第六人民医院门诊非酒精性肝病患者63例,按非酒精性脂肪肝病临床类型分组,其中非酒精性脂肪肝患者44例,非酒精性脂肪肝炎患者19例,采用慢性肝病问卷量表进行健康相关生活质量调查。比较两组患者评分负担总体情况和在腹部症状、疲劳、全身症状、活动、情感功能、焦虑6个维度的分布。在组内分别评估性别、病程时间、肥胖、代谢性疾病等对患者慢性肝病问卷评分的影响。结果 63例非酒精性脂肪肝病患者问卷评分在各个维度综合评分为(5.66±0.50)分。非酒精性脂肪肝炎患者评分低于非酒精性脂肪肝患者,差异有统计学意义(P=0.0004),以焦虑(P=0.0081)、活动(P=0.0275)、情感功能(P=0.0243)维度最为突出。在非酒精性脂肪肝组,肥胖(P=0.0135)与慢性代谢性疾病(P=0.0162)患者问卷评分更低;但在非酒精性脂肪肝炎组,病程>6个月患者评分低于对照组,差异有统计学意义(P=0.0020)。结论非酒精性脂肪肝炎对患者健康相关生活质量影响高于非酒精性脂肪肝,其差异主要体现在活动、情感和焦虑纬度。可以对不同临床特点患者在相应维度进行针对性干预。

白花香莲解毒方联合阿德福韦酯对HBeAg阳性慢性乙型肝炎患者病毒学及生存质量的影响

目的:通过观察壮药白花香莲解毒方联合阿德福韦酯对HBeAg阳性的慢性乙型肝炎(CHB)患者病毒学及生存质量的影响,评估其临床疗效。方法:采用多中心随机临床研究方法,将240例HBeAg阳性的CHB患者随机分为治疗组和对照组,对照组给予阿德福韦酯胶囊10mg/次,1次/d,治疗组在对照组基础上加用白花香莲解毒方,两次/d,疗程为48周。分别观察治疗12周、24周、48周两组患者在病毒学、生存质量(QOL)、慢性肝病量表(CLDQ)评分情况。结果:①病毒学方面:从治疗12周始,治疗组HBV DNA下降的对数值与对照组比较,差异有显著性意义(P<0.05);治疗组治疗12周、24周病毒学应答率分别为65.48%(74例)、82.3%(92例),对照组为51.78%(58例)、70.53%(79例),差异有显著性意义(P<0.05);治疗48周,两组患者总的病毒学应答率比较差异无显著性意义(P>0.05);治疗组治疗12周、24周、48周的HBV DNA阴转率分别为22.12%(25例)、43.36%(49例)、57.52%(65例),对照组为11.61%(13例)、21.4%(24例)、32.14%(36例),差异有显著性意义(P<0.05)。②QOL方面:治疗24周,治疗组在生理领域、心理领域改善作用优于对照组;治疗48周治疗组在总的生存质量、总的健康状况、生理领域、心理领域、社会关系领域均优于对照组,两组比较差异有显著性意义(P<0.05)。③CLDQ评分方面:治疗24周,治疗组患者在乏力、情感功能、焦虑三方面改善程度优于对照组;治疗48周治疗组患者在乏力、全身症状、情感功能、焦虑四方面改善程度优于对照组,两组比较差异有显著性意义(P<0.05)。④不良事件:两组患者主要不良反应为头痛、腹痛、恶心;研究期间共发生磷酸肌酸激酶(CK)升高9例,发生率为4%。结论:白花香莲解毒方联合阿德福韦酯治疗HBeAg阳性CHB患者,能显著提高其对HBV DNA的抑制作用,改善患者生存质量。

男性慢性肝病患者性功能评估分析

目的：研究男性慢性肝病患者性功能状况。方法：对66例慢性肝病患者,以采用国际勃起功能指数（IIEF-5）为评价指标。采用问卷调查的方式患者自行填写,总结患者的得分。同时收集患者年龄和体重指数（BMI）资料。结果：66例男性患者中IIEF-5评分最高为25分,最低为3分其中≥21分30例,12-20分21例,8-11分7例,〈7分8例。无勃起功能障碍（ED）的为45.5%（30/66）,有ED 54.5%（36/66）,其中轻度ED 31.8%（21/66）,中度ED 10.6%（7/66）,重度ED 12.1%（8/66）。在Child-Pugh A、B级与C级相比较中发现：（1）勃起功能指数存在显著性差异（均p〈0.01）;（2）五项评价指标中,除了第一项评价指标差异无显著性外,其余四项均存在显著性差异（均P〈0.001）。结论：慢性肝病患者存在性功能障碍,Child-Pugh C级患者性功能障碍较为严重,应加强对慢性肝病患者性功能障碍的治疗,以提高患者的生存质量。

基于IMB模型的认知干预护理在肝硬化患者中的应用

目的探讨信息-动机-行为(IMB)引导认知干预护理对肝硬化患者生存质量和心理状况的影响。方法回顾性分析2017年10月至2019年4月在延安大学附属医院治疗的84例肝硬化患者的诊疗状况,根据护理方式不同分为观察组44例和对照组40例。观察组患者给予IMB引导认知干预护理,对照组患者给予常规护理,两组均护理至患者出院。护理前及随访3个月后,采用慢性肝病问卷(CLDQ)对两组患者的总分进行比较,从全身症状、腹部症状、活动、疲劳、焦虑、情感职能等6个维度对两组患者的生存质量进行评分比较;护理前及随访3个月后,采用抑郁自评表(SDS)和焦虑自评表(SAS)对两组患者的心理状况进行评分比较。结果护理前,两组患者的CLDQ总分比较,差异无统计学意义(P>0.05);随访3个月后,观察组患者的CLDQ总分为(31.98±9.67)分,明显高于对照组的(27.82±9.30)分,差异有统计学意义(P<0.05);护理前,两组患者的全身症状、腹部症状、活动、疲劳、焦虑、情感职能等6个维度的评分比较差异均无统计学意义(P>0.05);随访3个月后,观察组和对照组患者的全身症状[(5.84±0.82)分vs(4.61±0.97)分]、焦虑[(4.91±0.70)分vs(4.38±0.86)分]、情感职能[(5.54±0.74)分vs(4.35±0.70)分]3个维度的评分比较,观察组明显高于对照组,差异均有统计学意义(P<0.05),但两组患者在腹部症状、活动、疲劳3个维度的评分比较差异均无统计学意义(P>0.05);护理前,两组患者的SDS、SAS评分比较差异均无统计学意义(P>0.05);随访3个月后,观察组和对照组患者的SDS评分[(30.42±5.38)分vs(39.70±4.97)分]和SAS评分[(40.53±4.08)分vs(47.26±4.25)分]比较,观察组明显低于对照组,差异均有统计学意义(P<0.05)。结论对肝硬化患者进行IMB引导认知干预护理可明显改善患者生存质量和心理状况,值得推广应用。

解郁消脂方对非酒精性脂肪性肝炎的临床疗效及生活质量的影响

目的探讨解郁消脂方治疗非酒精性脂肪性肝炎的临床疗效及对生活质量的影响。方法收集2016年1月～2017年12月非酒精性脂肪性肝炎患者81例,采用随机数字法分为治疗组和对照组,治疗组41例,对照组40例。两组均给予多烯磷脂酰胆碱胶囊,治疗组加用解郁消脂方,疗程12周。结果两组愈显率比较,治疗组82.93%,对照组62.50%,差异明显(P<0.05);治疗后ALT:治疗组(38.80±9.36)U/L,对照组(46.13±12.48)U/L,差异有统计学意义(P<0.05)。治疗后慢性肝病问卷量表(CLDQ)综合评分:治疗组(5.71±0.13)分,对照组(5.34±0.17)分,差异有统计学意义(P<0.05)。结论解郁消脂方应用在非酒精性脂肪性肝炎患者中可以明显提高临床疗效,降低转氨酶,减轻患者临床症状,改善生活质量,值得在临床上推广应用。

Malnutrition negatively impacts the quality of life of patients with cirrhosis: An observational study

AIMTo verify how malnutrition is related to health-related quality of life (HRQL) impairment in patients with cirrhosis. METHODSData was retrospectively abstracted from medical records and obtained by direct interview. We included patients with cirrhosis from any etiology, evaluated at the Liver Clinic from Gastroenterology Department in a tertiary healthcare center, from June 2014 to June 2016. Child-Pugh score, data about complications, and demographic, clinical and anthropometric characteristics of patients were obtained. Nutritional status was evaluated by the Subjective Global Assessment (SGA). HRQL was evaluated through the Chronic Liver Disease Questionnaire. Patients were requested to assess their global HRQL with the following code: 0 = impairment of HRQL, when it was compared with other healthy subjects; 1 = good HRQL, if it was similar to the quality of life of other healthy subjects. To compare the primary outcome between malnourished and well-nourished groups, the χ2 test, Fisher’s exact test or Student’s t-test were used, based on the variable type. Associations between predictor variables and deterioration of HRQL were determined by calculating the hazard ratio and 95% confidence interval using Cox proportional hazards regression. RESULTSA total of 127 patients with cirrhosis were included, and the mean age was 54.1 ± 12.3 years-old. According to Child-Pugh scoring, 25 (19.7%) were classified as A (compensated), 76 (59.8%) as B, and 26 (20.5%) as C (B/C = decompensated). According to SGA, 58 (45.7%) patients were classified as well-nourished. Sixty-nine patients identified HRQL as good, and 76 patients (59.8%) perceived impairment of their HRQL. Multivariate analysis to determine associations between predictor variables and self-perception of an impairment of HRQL found strong association with malnutrition (P P CONCLUSIONMalnutrition is a key factor related to impairment of HRQL in patients with cirrhosis.

核苷类似物抗病毒治疗对慢性HBV感染者短期生存质量的影响

目的:观察核苷类似物抗病毒治疗3个月对慢性HBV感染者生存质量的影响。方法:使用慢性肝病问卷(CLDQ)对慢性HBV感染者抗病毒治疗前及抗病毒治疗3个月进行生存质量评定,并分析抗病毒前后HBVDNA、ALT、AST、TBIL、ALB、PTA变化,了解抗病毒治疗对患者生存质量的影响与病毒载量、肝功能的变化之间的关系。结果:抗病毒治疗3个月后,患者的所有领域生存质量评分均高于治疗前(P<0.05),同时HBVDNA、转氨酶、总胆红素较治疗前下降(P<0.05)。结论:抗病毒治疗不但降低病毒载量、改善肝功能,同时可改善患者生存质量,对有抗病毒治疗指征的患者,应进行抗病毒治疗。

温经开郁法治疗慢性乙型肝炎的随机平行对照研究

目的:探究温经开郁法对慢性乙型肝炎(CHB)的疗效。方法:选取2016年6月至2019年1月广东省中西医结合医院收治的CHB患者26例作为研究对象,按照就诊顺序编号随机分为对照组和观察组,每组13例。对照组予恩替卡韦治疗,观察组在对照组基础上加用温经开郁颗粒,均同时治疗24周。观察2组患者治疗前、完成治疗后淋巴细胞亚群、谷丙转氨酶(ALT)、谷草转氨酶(AST)、ALT/AST比值、谷氨酰转移酶(GGT)、透明质酸酶(HA)、层黏蛋白(LN)、Ⅲ型前胶原N端肽(PⅢNP)、Ⅳ型胶原(CⅣ)、乙肝病毒脱氧核糖核酸(HBV-DNA)、慢性肝病问卷(CLDQ)评分变化并比较,并进行疗效评价。结果:1)对照组治疗前、完成治疗后CD4^+、CD8^+、CD4^+/CD8^+比较,差异无统计学意义(P>0.05),完成治疗后观察组CD4^+、CD4^+/CD8^+较治疗前均显著升高,CD8+较治疗前显著下降(P<0.05),完成治疗后观察组CD4^+、CD4^+/CD8^+显著高于对照组,CD8^+显著低于对照组(P<0.05)。2)完成治疗后2组患者ALT、AST、ALT/AST比值、GGT较治疗前均显著下降(P<0.05),且观察组以上指标下降均显著低于对照组(P<0.05)。3)完成治疗后2组患者HA、LN、PⅢNP、CⅣ较治疗前均显著下降(P<0.05),完成治疗后观察组以上指标均显著低于对照组(P<0.05)。4)完成治疗后2组患者腹部症状、困乏、系统症状、活动能力、情感、焦虑积分较治疗前均显著升高(P<0.05),完成治疗后观察组以上积分均显著高于对照组(P<0.05)。5)完成治疗后观察组显效率、总有效率均显著高于对照组比较,差异有统计学意义(P<0.05)。结论:温经开郁法能提高CHB免疫功能,改善肝功能和肝纤维化,提高生命质量。

慢性肝病量表在乙型肝炎肝硬化中的应用评价

目的评价慢性肝病量表（CLDQ）在乙型肝炎肝硬化中应用的信度和效度。方法将CLDQ用于297例乙型肝炎肝硬化患者的自评，同时评定患者肝功能Child分级，并以117例健康者为对照。通过条目分析、精密度分析、信度分析、探索性因子分析，以及反应度、区分度分析对量表进行总体评价。计数资料用疋。检验，计量资料两组间比较用两独立样本t检验，多组间比较用单因素方差分析，两两比较用Scheffe法。内部一致性以Cronbach＇s α系数、Gunman分半系数考察，相关性分析用Pearson相关系数，或Spearman相关系数以，方差分析考察区分度，结构效度检验用探索性因子分析的主成分法，并进行最大方差正交旋转。结果量表条目、量表整体及各维度无明显地板效应；条目的天花板效应大部分为30％～60％，腹部症状、活动和焦虑3个维度的天花板效应〈30％。总量表的内部一致性较好（Cronbach’s α=0．905），不同维度的内部一致性（Cronbach＇s α）为0．442～0．848；总量表与各维度相关系数均〉0．6（P值均〈0．01）。健康组量表总得分、各维度得分显著高于患者组垆值均〈0．01），患者组量表总得分和其中的4个维度得分在与不同肝功能分级之间呈现梯度变化，Child分级越重得分越低。探索性因子分析提取的7个公因子与原维度有中等的吻合度。结论CLDQ在乙型肝炎肝硬化中的应用具有较好的信度、内容效度、反应度和区分度，精密度和结构效度中等，可有效用于对乙型肝炎肝硬化患者的生活质量以及疗效的评价。

初探中医药干预对代偿期乙型肝炎肝硬化患者生活质量的影响

目的:观测A方(以益气健脾,疏肝理气,软坚通络为治则)、B方[以益气健脾,疏肝理气,软坚通络,滋阴养血(柔肝)为治则]对代偿期乙型肝炎肝硬化患者生活质量的影响,为阐释中医肝脏象理论提供依据。方法:采用区组随机对照盲法的临床试验设计方案,将144例患者随机分为A、B、C组,分别给予A、B和C方(模拟剂),干预6个月。采用慢性肝脏疾病特异性量表[简称CLDQ,含6个因子:腹部症状(AS)、困乏(FA)、系统症状(SS)、活动(AC)、情感功能(EF)和焦虑(WO)],从总分值和因子分值两个方面对受试者的生活质量进行评定,并以性别及活动与静止期为分层因素进行比较。结果:干预后,3组患者的CLDQ总分值及因子分值均有不同程度的改善。除FA(C组>B组>A组)外,3组间差异均无统计学意义。男性同女性相比,B组女性的总分值、AS、FA、AC及WO改善幅度较大(P<0.05);活动期同静止期相比,C组活动期的FA改善幅度较大(P<0.05)。结论:三方对患者生活质量均有一定程度的改善,A方对男性生活质量的改善效果较好,B方对女性的效果较好,但对活动期较差。A、B两方在性别和分期间的效应差异,为阐释中医"肝藏血主疏泄"理论及指导临床运用中医药干预该病提供一定启示。

中医慢性肝病患者报告结局指标量表建立的理论结构模型构想

为了建立具有中医特色的慢性肝病患者报告结局指标(patient reported outcomes,PRO)量表,本研究遵循国际PRO量表研制规范,结合"形神统一"、"天人合一"、"肝体阴而用阳"、"七情"等中医学理论学说,构建中医慢性肝病PRO量表理论结构模型。包括生理、心理、独立性以及社会自然4大领域。其中生理领域包含血虚、阴虚、出血、气机失畅、脾胃运化失常、胆汁排泄异常6大方面;心理领域包含肝脏相关情绪与一般疾病情绪两方面;独立性领域包含日常生活与学习工作两方面;社会自然领域包含社会关系、社会环境以及自然适应能力3方面。

慢性丙型肝炎合并冷球蛋白血症患者抗病毒治疗后生存质量的变化

目的探讨抗病毒治疗对慢性丙型肝炎（CHC）合并冷球蛋白血症患者生存质量（QOL）的影响。方法随机选取2009年2月至2014年10月在河北省玉田县医院及石家庄市第五医院就诊的CHC合并冷球蛋白血症75例患者的临床资料进行回顾性分析。以采用聚乙二醇干扰素α-2a联合利巴韦林抗病毒治疗的40例为治疗组,采用常规保肝治疗的35例为对照组,疗程48周。比较分析两组患者治疗前、治疗24、48周时生化、病毒学指标及慢性肝病问卷（CLDQ）评分的变化情况。结果 （1）治疗组治疗24、48周时ALT、TBIL值及HCV RNA载量低于对照组,ALB高于对照组,差异有统计学意义（P均〈0.05）。（2）治疗组治疗48周时冷球蛋白检出率为42.5%（17/40）,病毒学应答率（HCV RNA〈10~3拷贝/ml）为72.5%（29/40）;而对照组两者均无变化。（3）治疗组治疗48周时CLDQ评分均较治疗前明显提高,差异有统计学意义（P均〈0.05）,对照组治疗48周时腹部症状、全身症状评分较治疗前明显降低,差异具有统计学意义（P均〈0.05）;治疗组治疗24周时乏力评分明显高于对照组（P〈0.05）,但腹部症状、全身症状、活动、情感功能、焦虑评分差异不明显（P均〉0.05）,治疗48周时乏力、全身症状、活动、情感功能、焦虑评分明显高于对照组（P均〈0.05）,但腹部症状差异不明显（P〉0.05）。结论抗病毒治疗可以明显改善CHC合并冷球蛋白血症患者的生存质量。