Virological response with fully active etravirine: pooled results from the DUET-1 and DUET-2 trials

The objective of this subanalysis of the Phase III DUET trials was to examine virological response to an etravirine-containing regimen in patients harbouring virus fully sensitive to etravirine. Full etravirine sensitivity was defined as fold change in 50% effective concentration (FC) ≤3 or weighted genotypic score ≤2. At Week 48 in the etravirine group, 74% of patients with etravirine FC ≤3 and 77% with etravirine genotypic score ≤2 had viral load <50 HIV-1 RNA copies/mL, versus 48% and 46%, respectively, in the placebo group (P < 0.0001). Response rates increased with baseline phenotypic sensitivity score, but were consistently higher with etravirine (56-82%) than placebo (2-72%). Similar observations were made in patients harbouring virus with full etravirine and darunavir sensitivity. Our findings support current recommendations to include three active agents in treatment-experienced patients' regimens.     

Evaluating the role of etravirine in the second-line antiretroviral therapy after failing an initial non-nucleoside reverse transcriptase inhibitor-based regimen in a resource-limited setting

Etravirine demonstrates activity against NNRTI-resistant HIV-1 but its efficacy depends on the number of etravirine resistance-associated mutations (RAMs). This study aimed to evaluate the role of etravirine in the second regimen in a resource-limited setting. Genotype resistance assay was conducted in a cohort of HIV-infected patients who experienced virological failure from an initial NNRTI-based regimen. We focused on etravirine-RAMs previously described: V90I, A98G, L100I, K101E/P, V106I, V179D/F, Y181C/I/V, and G190A/S. Frequency and predicting factors for 2 etravirine-RAMs. Etravirine may have activity for using in the second regimen in most patients in resource-limited setting who fail an initial NNRTI-based regimen. Genotype testing is needed to identify this group. Some of these patients, indicated by genotype results, may be able to use etravirine plus 2 active NRTIs for second ART regimen. This strategy may be an option for patients who cannot afford or tolerate protease inhibitor. Prospective study to evaluate this strategy should be conducted in resource-limited setting.     

Etravirine-based highly active antiretroviral therapy in HIV-1-infected paediatric patients

Background

We evaluated the efficacy, safety and tolerability of etravirine in paediatric patients vertically infected with HIV‐1.

Methods

A multicentre retrospective study of 23 multidrug‐resistant paediatric patients (five children and 18 adolescents) enrolled in the study from 1 September 2007 to 28 February 2010 was carried out. We performed a longitudinal analysis of immunological, virological and clinical data.

Results

The median age of the patients was 14.2 years [interquartile range (IQR) 12.5–15.8 years]. At baseline, the median HIV‐1 RNA was 29 000 (4.5 log₁₀) HIV‐1 RNA copies/mL (range 4300‐83 000 copies/mL), the median CD4 T‐cell count was 445 cells/μL (range 221–655 cells/μL) and the median CD4 percentage was 19.6% (IQR 13.0‐31.0). Remarkably, 16 of 23 patients (70%) harboured one or more etravirine‐associated resistance mutations. The backbone regimen included at least two fully active drugs in 91% of patients. After etravirine‐based therapy, 20 patients (87%) achieved HIV‐1 RNA<400 copies/mL and 18 of 23 (78%) achieved HIV‐1 RNA<50 copies/mL: three (13%) within the first month, seven (30%) within the first 4 months, and six (26%) between the 5th and 8th months. CD4 T‐cell recovery was observed in 19 patients (83%). The median follow‐up time was 48.4 weeks (IQR 35.7–63.4 weeks); four patients (17%) were exposed to etravirine for >120 weeks. Three mild/short‐term and two moderate skin rashes were observed in the adolescents. Laboratory abnormalities included hypercholesterolaemia (11 of 23 patients), hypertriglyceridaemia (eight of 23 patients), and reduced high‐density lipoprotein cholesterol (10 of 23 patients). Adherence was complete in seven patients (30%). No patients showed complete resistance to etravirine after follow‐up. However, three of 21 patients (14%) who initially showed intermediate resistance interrupted etravirine treatment because of virological failure.

Conclusions

We observed a sustained antiviral response and improved immunological parameters in multidrug‐resistant paediatric patients, most of whom had received etravirine as part of salvage regimens with at least two fully active drugs.     

Short communication: high effectiveness of etravirine in routine clinical practice in treatment-experienced HIV type 1-infected patients

The effectiveness of etravirine has not been thoroughly investigated in routine clinical practice, where adherence rates and the heterogeneous nature of patients differ from the clinical trial setting. We evaluated the effectiveness of rescue regimens containing etravirine and the factors associated with treatment response. Multicenter retrospective cohort of all consecutive patients was recruited in a routine clinical practice setting. Patients were taking rescue regimens containing etravirine plus an optimized background regimen. The primary endpoint was the percentage of patients with HIV-1 RNA <50 copies/ml at week 48. The secondary endpoints were those factors associated with treatment response to etravirine. Endpoints were evaluated using univariate and multivariate analysis. A total of 122 patients were included with a median viral load of 11,938 (1055-55,500) copies/ml at baseline. The most frequent drugs in the backbone were darunavir/ritonavir in 98 (80.3%) patients and raltegravir in 76 (62.3%). In the full dataset analysis, 73% (89/122; 95% CI, 64-81%) of patients responded to treatment at week 48; in the on-treatment analysis, 82% (89/109; 95% CI, 71-87%) responded. The factors associated with treatment failure to etravirine [HR (95% CI)] were baseline CD4(+) T cell count <200 cells/mm(3) [2.45 (1.17-5.16)] and use of raltegravir [0.47 (0.22-0.99)] and darunavir [0.45 (0.21-0.98)] as backbone drugs. Skin rash was the only adverse event directly related to etravirine and led to withdrawal in three patients (2.5%). In routine clinical practice, rescue ETR-containing regimens are well tolerated and achieve rates of virological suppression higher than those observed in its pivotal clinical trials, especially when combined with darunavir and raltegravir.     

Increased risk of leukemia relapse with high-dose cyclosporine A after allogeneic marrow transplantation for acute leukemia

Eighty-one patients with acute myeloid leukemia (ANLL, n = 44) or acute lymphoblastic leukemia (ALL, n = 37), aged 10 to 50 years were randomized to receive 1 mg/kg per day (n = 41, group A) or 5 mg/kg per day (n = 40, group B) of cyclosporine A (CyA) from day -1 to day +20 after bone marrow transplant (BMT). All patients received CyA orally thereafter. All patients were prepared with cyclophosphamide (CY) 120 mg/kg and fractionated total body irradiation (TBI), and received unfractionated BM from an HLA-identical sibling. The two groups were comparable for diagnosis, disease status, French-American-British (FAB) classification, WBC count at diagnosis, cytogenetic abnormalities, extramedullary disease before BMT, donor/recipient age and sex, number of cells infused, and number of days with intravenous (IV) CyA. Median follow-up for surviving patients in group A was 983 v 632 days in group B. Patients in group A had lower serum levels of CyA (295 v 686 ng/mL, P = .004), lower bilirubin levels (1.9 v 2.6 mg/dL, P = .07), lower creatinine levels (0.9 v 1.4 mg/dL, P = .06), and a lower proportion of CD8+ cells in the peripheral blood (PB) within day +21 (19% v 28%, P = .07). First day to 0.5 x 10(9)/L neutrophils was comparable in the two groups (13 v 14 days; P = .1). In a Cox model, the actuarial risk of acute graft-v-host disease (GVHD) grade II+, after stratification for age (less than 20 years greater than) was significantly lower in group B patients (0.54, P = .04). The actuarial risk of developing chronic GVHD was comparable (P = .9). Actuarial transplant-related mortality (TRM) at 240 days was 28% and 26% (P = .8) in group A and B: the major cause of death was GVHD in group A (P = .02) and multiorgan toxicity in group B (P = .07). The actuarial risk of relapse at 2 years overall was 20% in group A and 52% in group B (P = .001); it was 9% v 43%, respectively, for patients in first remission (P = .0001) and 48% v 63% for patients in non-first complete remission (CR) (P = .1). Actuarial 2-year disease-free survival (DFS) in group A and B was 58% v 32% (P = .02) for all patients, 71% v 35% (P = .01), in first remissions, and 30% v 23% (P = .2) in advanced disease.(ABSTRACT TRUNCATED AT 400 WORDS)     

Treatment of patients with HCV infection with or without liver biopsy

Expert consensus recommends liver biopsy before therapy for chronic hepatitis C. A cost effectiveness analysis suggested that the best strategy in the management of patients was to treat without biopsy. We compared therapy in patients who did, or did not undergo biopsy. Hepatitis C virus (HCV)-positive patients (78) who did not agree to (n = 57) or with contraindications to liver biopsy (n = 21) (group A) were matched for age, sex and genotype with those who consented (group B). Before therapy (interferon/ribavirin for 12 months), a clinical diagnosis of chronic hepatitis, on the basis of standard biochemical and ultrasonographic parameters. The two groups showed similar baseline characteristics. A noninvasive, diagnosis of chronic hepatitis was made in 75.6% of group A, and in 83.3% of group B (P = 0.26). Concordance between clinical and histological diagnosis in group B amounted to 91%. End-of-therapy virological response was 52.6% in group A, and 57.7% in group B (P = 0.63). Sustained virological response was 41.0% [95% confidence interval (CI) 30.1-51.9] and 43.6% (95% CI 32.6-54.6) in the two groups (P = 0.87). Predictors of sustained response were noninvasive diagnosis of chronic hepatitis (P = 0.006), lack of portal hypertension (P = 0.037), platelets >10(5)/mm3 (P = 0.007), prothrombin >70% (P = 0.02), and genotype 2 or 3 (P < 0.0001). At multivariate analysis, genotype (P < 0.0001) and platelets (P = 0.004) maintained their predictive power. In most patients with HCV infection, virological clearance after therapy can be achieved irrespective of whatever a liver biopsy might show.     

免疫治疗相关性甲状腺功能异常与不可切除/晚期肝细胞癌患者预后改善相关

摘要 目的：探讨免疫治疗相关性甲状腺功能异常与不可切除/晚期肝细胞癌（HCC）患者预后改善的相关性。方法：回顾性分析45例接受免疫检查点抑制剂（ICIs）治疗的不可切除/晚期HCC患者。根据ICIs治疗过程中是否出现免疫相关性甲状腺功能异常分为甲状腺功能正常组（28例）和异常组（17例）,比较2组患者的预后和免疫应答情况,主要终点指标为中位总生存期（OS）、无进展生存期（PFS）,次要终点指标为疾病控制率（DCR）。结果：所有患者的中位OS、PFS分别为10.8个月（95% CI ：3.0~18.6）和5.0个月（95% CI ：3.0~12.2）。正常组中位OS为5.8个月（95% CI ：3.7~7.9）,异常组中位OS尚未达到（ P =0.026）。异常组中位PFS长于正常组（8.2个月 vs. 3.1个月, P =0.011）,DCR高于正常组（52.9% vs. 21.5%,P =0.030）。多因素Cox回归分析显示,甲状腺功能异常是达到6个月OS（ HR=0.213,95%CI ：0.048~0.944, P =0.042）和PFS（ HR=0.383,95%CI：0.151~0.967,P =0.042）的独立影响因素;甲状腺功能异常（ HR=0.403 ,95%CI：0.185~0.877,P =0.022）、基线无大血管侵犯（MVI）（ HR=2.848,95%CI：1.406~5.768,P =0.004）、Child-Pugh A级（ HR=2.404,95%：1.099~5.255,P =0.028）与12个月PFS相关。结论：免疫治疗相关性甲状腺功能异常的不可切除/晚期HCC患者预期生存和免疫应答效果更佳。治疗期间出现甲状腺功能异常、基线无MVI、Child-Pugh A级与患者预后改善相关。     

老年人严重创伤的临床分析

目的 评价老年人严重创伤致伤原因的构成及预后.方法 回顾性分析严重创伤患者1090例的临床资料,其中老年组60～91岁168例,中年组(36～59岁)517例、青年组(18～35岁)405例.用简明损伤定级(AIS2005)和损伤严重程度评分(ISS)标准进行评估,所有患者ISS≥16分.比较三组的损伤严重度、损伤部位数、致伤原因、致伤部位、急诊手术、伤前的原有疾病、伤后继发感染、脏器功能不全、入住重症监护病房(ICU)的例数、ICU的住院时间及最终预后.结果 老年组主要致伤原因是意外伤害(64例,占38.1%),其次是交通事故(63例,占37.5%),中年和青年组主要致伤原因是交通事故(分别为246例和153例,占47.6%和37.8%),其次是高处坠落(分别为128例和102例,占24.8%和25.2%);老年、中年和青年组主要损伤部位均是头胸部(分别为155例、411例和321例,占92.3%、79.5%和79.3%);三组的损伤部位数F=8.299,P＜0.01、急诊手术x2=14.88,P=0.001、伤前原有疾病x2=254.6,P＜0.01、伤后继发感染x2=10.54,P=0.005、入住ICU的例数x2=15.62,P＜0.01和ICU住院时间F=5.760,P=0.005等差异均有统计学意义,损伤程度的差异虽无统计学意义(F=2.950,P=0.053),但老年组分别与中年、青年组比较,差异均有统计学意义(t值分别为2.325、2.128,P值分别为0.034、0.021);三组的脏器功能不全的发生率差异无统计学意义(x2=1.142,P=0.565);三组的治愈率及未愈而自动出院率的差异均有统计学意义(分别x2=13.77,P=0.001和x2=6.025,P=0.049),病死率差异无统计学意义;三组的主要死亡原因是严重的头部损伤.结论 对于老年严重创伤患者应减少意外伤害和交通事故,积极采取有效的救治措施是提高治愈率、降低未愈及病死率的关键.

Abstract：

Objective To evaluate the causes and prognosis of severe trauma in the elderly.Methods The 168 patients in elderly group (aged 60 to 91 years), 517 in middle-aged group (aged 36to 59 years) and 405 in young group (aged 18 to 35 years) were evaluated using an abbreviated injury scale (AIS2005) and injury severity score (ISS). All patients with ISS ≥ 16 were selected during a seven-year period. The injury severity, injury site number, cause of injury, injury site, emergency operation, diseases before injury, secondary infection after injury, development of multiple organ dysfunction, number of patients with Intensive Care Unit (ICU) stay, length of stay in ICU and prognosis were compared among three groups. Results The main cause of injury was accident (64patients, 38.1%), followed by traffic accident (63 patients, 37.5%) in elderly group. The traffic accident was major cause of injury in middle-aged and young group (246 patients, 47.6%; 153patients, 37.8%, respectively), followed by fall from high places (128 patients, 24.8%; 102 patients, 25.2%, respectively). The main injury sites were head and chest in elderly, middle-aged and young group (155 patients, 92.3%; 411 patients, 79.5%; 321 patients, 79.3%, respectively).There were significant differences among three groups in injury site number, emergency operation,pre-injury diseases, secondary infection after injury, number of patients with ICU stay and length of stay in ICU (F=8. 299, P＜0.01; x2= 14.88, P=0.001; x2=254.6, P＜0.01; x2=10. 54, P=0. 005; x2 = 15.62, P＜0.01; F= 5.760, P= 0.005, respectively ). In spite of injury severity (F=2.950, P= 0.053), there were significant differences between elderly group and middle-aged or young group (t=2.325, P=0.021; t=2.128, P=0.034, respectively). The incidence of multiple organ dysfunction had no significant difference among the three groups (x2 = 1.142, P= 0.565). The cure rate and unhealed automatically discharged patients had significant differences (x2 = 13.77, P= 0. 001;x2 =6.025, P= 0.049, respectively). The mortalities were similar (x2 = 1.397, P= 0.497). The leading cause of death among three groups was a serious head injury. Conclusions For elderly patients, it is important to reduce accidental injuries and traffic accidents, to improve the cure rate,and to reduce the unhealed and mortality rate.     

The dismal outcome in patients with acute leukaemia who relapse after an autograft is improved if a second autograft or a matched allograft is performed. Acute Leukaemia Working Party of the European Group for Blood and Marrow Transplantation (EBMT)

All patients receiving autografts for acute leukaemia in remission between 1 January 1981 and 31 December 1996 and reported to the European Group for Blood and Marrow Transplantation and had a relapse, were included. The patients underwent an allograft (n = 90, group A), were treated with chemotherapy (n = 2584, group B) or received a second autograft (n = 74, group C). The 2-year survival after relapse was 32 +/- 5%, 11 +/- 1% and 42 +/- 6% in groups A, B and C, respectively. In group A, those with an HLA-A, -B and -DR compatible related or unrelated donor had a 2-year survival of 37 +/- 7% compared to 13 +/- 8% for those receiving a graft from an HLA mismatched donor (n = 20). The following factors were associated with better survival in multivariate analyses: an interval from first autograft to relapse >5 months (P < 0.00001), a first autograft performed later than 1991 (P < 0.00001), patient age below 26 years (median, P < 0.002), group B vs HLA mismatches from group A (P = 0.002), group C vs group B (P < 0.005), patients who were not treated with total body irradiation at first autograft (P < 0.02) and patients in first remission at first autograft (P = 0.02). To conclude, the poor outcome in these patients was improved if a second autograft was feasible (P < 0.005), or if an HLA-matched allograft was performed (NS). Bone Marrow Transplantation (2000).     

Impact of age-related comorbidity on results of colorectal cancer surgery

AIM: To analyze the correlation between preexisting comorbidity and other clinicopathological features, short-term surgical outcome and long-term survival in elderly patients with colorectal cancer (CRC). METHODS: According to age, 403 patients operated on for CRC in our department were divided into group A (< 70 years old) and group B (≥ 70 years old) and analyzed statistically.RESULTS: Rectal localization prevailed in group A (31.6% vs 19.7%, P = 0.027), whereas the percentage of R0 resect ions was 77% in the two groups.Comorbidity rate was 46.2% and 69.1% for group A and B, respectively ( P < 0.001), with a huge difference as regards cardiovascular diseases. Overall, postoperative morbidity was 16.9% and 20.8% in group A and B,respectively ( P = 0.367), whereas mortality was limited to group B (4.5%, P = 0.001). In both groups, patients who suffered from postoperative complications had a higher overall comorbidity rate, with preexisting cardiovascular diseases prevailing in group B ( P = 0.003).Overall 5-year survival rate was significantly better for group A (75.2% vs 55%, P = 0.006), whereas no significant difference was observed considering diseasespecific survival (76.3% vs 76.9%, P = 0.674).CONCLUSION: In spite of an increase in postoperative mortality and a lower overall long-term survival for patients aged ≥ 70 years old, it should be considered that, even in the elderly group, a significant number of patients is alive 5 years after CRC resection.     

Long-term effects of proglumide on resection of cardiac adenocarcinoma

AIM: Patients with advanced stage cardiac adenocarcinoma have a very poor prognosis. Surgery is the first choice of treatment for this kind of patients. Peptide hormone gastrin is a recognized growth factor for gastric cancer, and gastrin receptor antagonist proglumide can block the effects of gastrin. The aim of this study was to investigate the actions of proglumide as an adjuvant treatment to improve the postoperative long-term survival rate of patients with cardiac adenocarcinoma. METHODS: We performed a randomized, controlled study of gastrin receptor antagonist proglumide in 301 patients with cardiac adenocarcinoma after proximal subtotal gastrectomy. The oral dose of 0.4 g proglumide thrice daily preprandially was maintained for more than 5 years in 153 cases (proglumide treatment group). In the control group, 148 patients underwent operation only. In clinicopathologic features, there was no significant difference between the two groups (P>0.05). All patients were followed up during their lifetime, and the survival rates were analyzed combined with clinicopathologic factors by SPSS 11.5 statistical software. RESULTS: The 1,3,5 and 10-year survival rate of the patients was 88.4%, 48.8%, 22.6% and 13.4%, respectively. The 1,3,5 and 10-year survival rate of the proglumide treatment group was 90.2%, 49.7%, 26.8% and 17.6% compared to 86.5%, 48.0%, 18.2% and 8.9% of the control group. There was a significant difference between the two groups (P= 0.0460). The patients in proglumide treatment group had no obvious side effects after administration of the drug, and no definite hepatic and renal function damage was found. According to single factor log-rank analysis, the long-term survival rate was correlated with the primary tumor position (P= 0.0205), length of the tumor (P= 0.0000), property of the operation (P= 0.0000), histopathologic grading (P = 0.0003), infiltrating degree of the tumor (/>= 0.0000), influence of lymph node metastasis (P = 0.0000), clinicopathologic staging (P= 0.0000) and administration of proglumide (P = 0.0460). Cox regression analysis demonstrated the infiltrating degree of tumor (P= 0.000), influence of lymph node metastasis (P= 0.039) and the clinicopathologic staging (P = 0.003) were independent prognostic factors. Administration of proglumide (P= 0.081), length of the tumor (P = 0.304), radical status of the resection (P= 0.224) and histopathologic types (P= 0.072) were not the independent prognostic factors. CONCLUSION: Proglumide is convenient to use with no obvious toxic side effects, and prolonged postoperative administration of proglumide as a postoperative adjuvant treatment can increase the survival rate of patients after resection of cardiac adenocarcinoma. Proglumide may provide a new effective approach of endocrinotherapy for patients with gastric cardiac cancer.     

Revascularization in severe left ventricular dysfunction: outcome comparison of drug-eluting stent implantation versus coronary artery by-pass grafting.

OBJECTIVE: We compared the outcome of drug eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction with the outcome of a similar group of patients undergoing coronary artery by-pass grafting (CABG). BACKGROUND: Revascularization provides long-term benefits in patients with severe LV dysfunction. However the modality to achieve it is still unsettled in this high risk group of patients. METHODS: Two-hundred-twenty patients (20% women) with severe LV dysfunction (LV Ejection Fraction 相似文献   

前瞻队列研究节段性肺静脉电隔离与胺碘酮及胺碘酮联合氯沙坦治疗孤立性阵发性心房颤动

目的比较节段性肺静脉电隔离和胺碘酮及胺碘酮联合氯沙坦对孤立性阵发性心房颤动（房颤）患者维持窦性心律（窦律）的疗效。方法选择154例孤立性阵发性房颤患者分为节段性肺静脉电隔离治疗组（Ⅰ组,n=51）、胺碘酮组（Ⅱ组,n=52）、胺碘酮＋氯沙坦组（Ⅲ组,n=51）。治疗随访时间为1年,研究的一级终点为12导联心电图和24小时Hoher证实的持续30秒以上的症状性房性快速性心律失常复发。结果在12个月的随访期间,Ⅰ、Ⅱ、Ⅲ组分别有11例（21．6％）、24例（46．2％）、12例（23．5％）到达了一级终点（P〈0．05）。Kaplan—Meier生存分析显示,Ⅰ组和Ⅲ组对窦律维持率均高于Ⅱ组（P=0．009和0．018,log—rank检验）;Ⅰ组和Ⅲ组对窦律的维持率差异无统计学意义（P：0．814）。同Ⅱ组相比,Ⅲ组降低了54％的房颤复发风险（RR=0．46,95％可信区间0．225～0．953,P：0．036）,Ⅰ组降低了59％的房颤复发风险（RR=0．41,95％可信区间0．200～0．848,P：0．016）。三组间不良事件的发生率分别为3．9％、9．6％和7．8％,差异无统计学意义（P〉0．05）。结论节段性肺静脉电隔离和胺碘酮联合氯沙坦对孤立性阵发性房颤患者窦律的维持疗效相当,均明显优于单用胺碘酮治疗。     

抗酿酒酵母细胞抗体在原发性胆汁性肝硬化患者中的临床意义

目的 检测原发性胆汁性肝硬化(PBC)患者血清抗酿酒酵母细胞抗体(ASCA),探讨其在PBC中的阳性状况和临床意义.方法 采用酶联免疫吸附试验(ELISA)检测162例PBC患者、44例自身免疫性肝炎(AIH)患者、41例肝病对照组(LDC)患者、144例炎症性肠病(IBD)患者及35名健康体检者血清ASCA的IgA和IgG亚型.采用χ2检验和非参数U检验进行分析.结果 ASCA-IgA在PBC患者中的阳性率为24.1%,高于溃疡性结肠炎(UC)组11.6%(χ2=5.5,P＜0.05)和健康对照组0(χ2=10.5,P＜0.01),与AIH组(20.5%)、LDC组(14.6%)和克罗恩病(CD)组(34.5%)比较,差异无统计学意义(P＞0.05);ASCA-IgG在PBC患者中的阳性率为11.1%,明显低于CD组27.6%(χ2=8.9,P＜0.01),高于健康对照组0(χ2=10.5,P＜0.01),与AIH组(15.9%)、LDC组(7.3%)和UC组(8.1%)比较,差异无统计学意义(P＞0.05);ASCA-IgA和IgG同时阳性的PBC患者仅占6.2%,显著低于CD组17.2%(χ2=6.3,P＜0.05);ASCA-IgA或IgG阳性的PBC患者占29.0%,显著低于CD组44.8%(χ2=4.8,P＜0.05),高于UC组(χ2=5.9,P＜0.05)和健康对照组(χ2=13.3,P＜0.01).抗GP210抗体阳性的PBC患者ASCA阳性率高于抗GP210抗体阴性PBC患者(38.6%和23.8%,χ2=3.9,P＜0.05);抗线粒体抗体(AMA)、抗SP100抗体阳性和阴性PBC患者间ASCA的阳性率差异无统计学意义.ASCA-IgA阳性PBC患者总胆红素、直接胆红素、总胆汁酸、乳酸脱氢酶(LD)、IgA、IgM、红细胞沉降率(ESR)高于ASCA-IgA阴性PBC患者,而白蛋白(ALB)、白蛋白/球蛋白和胆碱酯酶低于ASCA-IgA阴性PBC患者(P均＜0.05).ASCA-IgG阳性PBC患者与阴性患者间肝功能损伤指标和免疫功能指标差异均无统计学意义.结论 ASCA并不是IBD特异性自身抗体,在PBC患者有较高的阳性率,且以IgA亚型为主.ASCA-IgA与PBC患者肝功能损伤指标和免疫活动指标改变有关,而ASCA-IgG与PBC患者肝功能损伤指标和免疫活动指标改变无关.     

Cladribine with or without prednisone in the treatment of previously treated and untreated B-cell chronic lymphocytic leukaemia - updated results of the multicentre study of 378 patients

Between January 1992 and January 1999, we treated 378 B-chronic lymphocytic leukaemia (CLL) patients with cladribine (2-CdA), and 255 of the patients were also treated with prednisone. A total of 194 patients were previously untreated, and 184 had relapsed or refractory disease after previous other therapy. Complete response (CR) was obtained in 111 (29.4%) and partial response (PR) in 138 (36.5%) patients, giving an overall response (OR) rate of 65.9%. CR and OR were achieved more frequently in patients in whom 2-CdA was a first-line treatment (45.4% and 82.5% respectively) than in the pretreated group (12.5% and 48.4% respectively) (P < 0.0001). The median duration of OR for previously untreated patients was 14.7 months and for pretreated patients 13.5 months (P = 0.09). The median survival evaluated from the beginning of 2-CdA treatment was shorter in the pretreated group (16.3 months) than in the untreated group (19.4 months) (P < 0.0001). A total of 117 (63.9%) patients died in the pretreated group and 63 (32.6%) in the untreated group. In pretreated patients, 2-CdA + prednisone (P) and 2-CdA alone resulted in similar OR (51.0% and 45.0% respectively; P = 0.4). In contrast, in untreated patients, 2-CdA + P produced a higher OR (85.4%) than 2-CdA alone (72.1%) (P = 0.04). Infections and fever of unknown origin, observed in 91 (49.4%) pretreated and 74 (38.1%) untreated patients (P = 0.03), were the most frequent toxic effects. Our results indicate that 2-CdA is an effective, relatively well-tolerated drug, especially in previously untreated CLL.     

信息化随访干预措施对HBV感染患者依从性影响分析

目的通过信息化随访方式干预慢性乙型病毒性肝炎患者,对比分析其对患者疾病及用药依从性影响。方法收集2014年10月至2017年10月惠州市第六人民医院门诊及住院部诊断为慢性乙型病毒性肝炎、乙肝肝硬化患者,剔除不符合纳入条件患者,共纳入符合条件患者264例,有42例合并肝硬化。对纳入患者采取分层随机抽样方法进行分组,最终微信+电话随访组87例,电话随访组88例,对照组89例。随访并对比三组在2年后肝功能、肝硬化人数及停用恩替卡韦时间等不同差异。结果随访年后三组在失访人数上差异存在统计学意义,其中A组与B组2年后两组在ALT(Z=-3.218,P=0.02)、AST(Z=-2.749,P=0.03)、Alb(Z=1.746,P=0.04)、乙肝病毒DNA(Z=-3.231,P=0.02)指标差异具有统计学意义,而TBil、FIB-4指数、APRI、γ-GT指标差异无统计学意义。A组与C组2年后对比结果显示,两组在ALT(Z=-11.089,P<0.001)、AST(Z=-9.247,P=0.01)、TBil(Z=-7.623,P=0.01)、APRI(Z=-4.834,P=0.01)、γ-GT(Z=-2.867,P=0.03)、Alb(Z=3.187,P=0.02)、乙肝病毒DNA(Z=-10.078,P<0.001)指标差异具有统计学意义,而FIB-4指数指标差异无统计学意义。B组与C组2年后两组对比结果显示,两组在ALT(Z=-1.275,P=0.04)、AST(Z=-2.045,P=0.03)、TBil(Z=-3.762,P=0.02)、APRI(Z=-1.461,P=0.04)、γ-GT(Z=-2.254,P=0.03)、乙肝病毒DNA(Z=-1.782,P=0.04)指标差异具有统计学意义,而Alb、FIB-4指数指标差异无统计学意义。随访2年后A组肝硬化人数为12人,B组为16人,C组为24人。A组与B组(χ²=0.945,P=0.408)、B组与C组肝硬化人数(χ²=2.741,P=0.103)差异无统计学意义,而A、C两组肝硬化人数差异有统计学意义(χ²=6.843,P=0.013)。在2年时间内,A组有15例患者暂停使用恩替卡韦,B组有28例,C组有61例,三组停用恩替卡韦人数差异有统计学意义(χ²=25.061,P<0.001),通过Kaplan-meier分析,结果显示A组使用恩替卡韦时间长于B组(83.0%vs 68.5%,χ²=5.754,P=0.016)及C组(83.0%vs 33.7%,χ²=61.601,P<0.001),而B组使用时间长于C组(63.5%vs 33.7%,χ²=32.451,P<0.001)。结论通过对患者强化信息化干预,可以使患者服用抗乙肝病毒药物依从性提高,降低患者肝功能异常发生及肝硬化发病率。     

房室结折返性心动过速冷冻消融与射频消融治疗对比分析

目的 探讨经导管冷冻消融与射频消融治疗房室结折返性心动过速的有效性和安全性.方法 对304例房室结折返性心动过速行导管消融术病例行回顾性分析,其中冷冻组67例,射频组237例,比较两组成功率、慢径完全阻断率、房室传导阻滞率和复发率的差异.结果 两组消融成功率(冷冻组98.5%与射频组97.0%,P=0.820)、慢径完全阻断率(冷冻组98.5%与射频组91.6%,P=0.088)、房室传导阻滞率(冷冻组0与射频组2.5%,P=0.413)、复发率(冷冻组0与射频组1.7%,P=0.643)差异均无统计学意义,但冷冻组慢径完全阻断率有优于射频组的趋势.结论 冷冻消融治疗房室结折返性心动过速安全有效,较射频消融术有潜在优势.

Abstract：

Objective To compare the efficacy and safety between cryoablation (Cryo) and radiofrequency (RF) ablation for treating patients with atrioventricular nodal reentrant tachycardia (AVNRT). Methods Patients with AVNRT (n=304) were divided into Cryo group (n=67) and RF group (n=237). The procedure success rate, complete slow pathway block rate, atrioventricular block rate and relapse rate were compared between two groups. Results There was no statistically difference between 2 groups in the success rate (Cryo group 98.5% vs RF group 97.0%, P=0.820), complete slow pathway block rate (Cryo group 98.5% vs RF group 91.6%, P=0.088), atrioventricular block rate (Cryo group 0 vs RF group 2.5%, P=0.413), relapse rate (Cryo group 0 vs RF group 1.7%, P=0.643). But Cryo group had more advantage than RF group. Conclusion Efficacy and safety were comparable between cryoablation and radiofrequency ablation for treating patients with AVNRT.