1.Clinical analysis of 76 cases of erlotinib-induced skin rash in the treatment of non-small cell lung cancer
Tumor 2010;(4):338-342
Objective:To evaluate the relationship between erlotinib-induced skin rash and clinical outcome and explore the effective way to prevent skin rash. Methods:The data from 76 non-small cell lung cancer(NSCLC) patients who experienced erlotinib-induced skin rash from Dec 2005 to Sep 2008 were collected. All the patients were confirmed with NSCLC by pathological and cytological examination and received erlotinib 150 mg/d till they had progressive disease or intolerable adverse reaction. The severity of skin rash was recorded and graded according to National Cancer Institute-Common Toxicity Criteria (NCI-CTC). The therapeutic outcome of skin rash was observed. Results:The skin rash develops as early as 3 days after commencement of erlotinib therapy, with median onset at 8 days. Twenty-seven (35.5%) patients experienced grade 1 skin rash, 44 patients (57.9%) had grade 2 and 5 cases (6.6%) had grade 3 skin rash. A statistically significant correlation was observed between skin rash and erlotinib therapy. The disease-controlling rate was 63.0% for grade 1 skin rash patients including 5 cases with partial remission and 12 cases with stable disease and 91.8% for grade 2/3 skin rash patients including 32 cases with partial remission and 13 cases with stable disease (P<0.05). The median time to progression(TTP) and median overall survival(OS) were prolonged in patients experienced grade 2/3 skin rash compared with those in patients with grade 1 skin rash (TTP: 5.1 months vs 9.7 months, P<0.01; OS: 10.0 months vs 14.6 months, P<0.01). The skin rash was alleviated in 60 out of 76 patients (78.9%). Conclusion:Skin rash is a potent surrogate marker of favorable outcome in patients who received erlotinib treatment. It was tolerable to most patients. Appropriate therapy may be useful in decreasing the severity of skin rash.
2.Analysis of drug free for patients with severe mental illness and follow -up of 82 cases
Xinlian MA ; Linghua WANG ; Caili WANG ; Yan LI ; Minqiang ZHAO ; Ziqiang WANG
Chinese Journal of Primary Medicine and Pharmacy 2017;24(6):931-933,934
Objective Toanalyzedrugfreeforpatientswithseverementalillnessandfollow-upof82cases, inordertoprovidebasisforthedivisionoffreedelivery.Methods 82severementalillnesspatientswhowereincon-formity with the conditions of rescue,were given free drug and followed up for 2 years.Before the admission and fol-lowed up for 2 years,the social function evaluation(SDSS)and compliance were evaluated,the recurrence rate was compared.Results Comparisonofcompliance:beforetheadmission,thecompletecompliancein33cases,thepartial compliance in 27 cases,22 cases of non-compliance;After 2 years follow-up,the complete compliance in 52 cases, the partial compliance in 21 cases,9 cases of non-compliance.The difference was statistically significant(u=3.34, P<0.01).Comparison of social function:social withdrawal:before the admission (1.32 ±0.75)points,after 2 years follow-up (0.96 ±0.34)points,the difference was statistically significant(t=3.93,P<0.001 );Family activities:before the admission (1.44 ±0.69)points,after 2 years follow-up (0.87 ±0.31)points,the difference was statisti-cally significant (t=6.78,P<0.001);Personal care:before the admission (1.29 ±0.68)points,after 2 years follow-up (0.95 ±0.62)points,the difference was statistically significant(t=3.33,P<0.001);Interest in the outside world:before the admission (1.23 ±0.63)points,after 2 years follow-up (0.97 ±0.41)points,the difference was statistically significant(t=3.05,P<0.025);The total score:before the admission (15.42 ±7.23)points,after 2 years follow-up (9.56 ±6.89)points,the difference was statistically significant(t=5.28,P<0.001).Compari-son of the recurrence rate:2 years before the admission,the recurrence in 33 cases (40.2%),after 2 years follow-up the recurrence in 15 cases(18.3%),the difference was statistically significant (χ2 =10.64,P<0.001).Conclusion Drug free for patients with severe mental illness and follow-up can improve the social function and the implementation of free administration of patients with severe mental illness,and reduce the recurrence rate and improve compliance.
3.Diagnostic value of serum Mp1p antigen detection for Talaromyces marneffei infection in acquired immune deficiency syndrome patients
Linghua LI ; Saiyin XIAO ; Yan HE ; Fengyu HU ; Wanshan CHEN ; Huali LEI ; Xiaoping TANG ; Weiping CAI
Chinese Journal of Infectious Diseases 2017;35(3):157-160
Objective To explore the diagnostic value of Talaromyces marneffei (T.marneffei)-specific mannose glycoprotein Mp1p antigen for T.marneffei infection in acquired immune deficiency syndrome (AIDS) patients.Methods All cases were recruited in this study from January 2012 to June 2015 in Guangzhou No.8 People′s Hospital, including 184 AIDS patients with T.marneffei infection confirmatively diagnosed by culture, and 205 controls including 176 AIDS patients without T.marneffei infection and 29 health controls.Double antibody sandwich enzyme linked immunosorbent assay and fluoroimmunoassay combined with double-antibody sandwich were both utilized to detect serum Mp1p antigen levels, and their sensitivity and specificity for diagnosing T.marneffei infection in patients with AIDS were analyzed.x2 test and t test were used for statistical analysis.Results The ratio of males to females and age of the study group were both comparable to those of the control group (x2=0.019, P=0.889;t=1.810,P=0.07, respecitvley).The sensitivities of double antibody sandwich enzyme linked immunosorbent assay and fluoroimmunoassay combined with double-antibody sandwich were 82.07%(151/184) and 83.15%(153/184), respectively (x2=0.076, P=0.783).The specificities were 93.17%(191/205) and 92.68%(190/205), respectively (x2=0.037, P=0.847).The accuracy values were 87.92%(342/389) and 88.17%(343/389), respectively (x2=0.012, P=0.912).The false positive rates were 6.83%(14/205) and 7.32%(15/205), respectively.The false negative rates were 17.93%(33/184) and 16.85%(31/184), respectively (x2=0.049, P=0.829).The positive predictive values were 91.52%(151/165) and 91.07%(153/168), respectively (x2=0.021, P=0.886).The negative predictive values were 85.27%(191/224) and 85.97%(190/221), respectively (x2=0.045, P=0.832).The Kappa values were 0.83 and 0.80, respectively.Conclusion Detection of serum Mp1p antigen of T.marneffei possesses high specificity and sensitivity, which may be utilized for rapid and early diagnosis of T.marneffei infection in patients with AIDS.
4.Non-nucleoside reverse transcriptase inhibitors (NNRTIs)resistance-related gene mutations among AIDS patients with antiviral treatment failure in Guangdong province 2015
Yun LAN ; Weiping CAI ; Linghua LI ; Xiaoli CAI ; Yan HE ; Xiaoping TANG ; Fengyu HU ; Junbin LI ; Weilie CHEN ; Liya LI
Chinese Journal of Clinical Infectious Diseases 2017;10(1):14-19
Objective To investigate the prevalence and characteristics of non-nucleoside reverse transcriptase inhibitors (NNRTIs)resistance-related gene mutations among the AIDS patients with virological suppression failure in Guangdong Province 2015.Methods Plasma samples from AIDS patients receiving highly active antiretroviral therapy for more than one year with viral loads > 1000 copies/mL from Guangdong province (except Shenzhen)were collected from January to December 2015.Total 612 HIV-1 gene fragments were amplified from plasma samples using self-developed lab method.Sub-genotypes were determined by phylogenetic tree according to the sequences,NNRTIs resistance-related mutations were determined in Stanford University HIV-1 Drug Resistance Database. The NNRTIs-resistance, the relationships of NNRTIs resistance-related mutations with baseline CD4 +T lymphocyte counts,transmission routes,antiviral regimens and HIV-1 genotypes were analyzed.SPSS 17.0 software was used to analyze the data.Results In 612 patients with virological suppression failure,the main NNRTIs resistance-related mutations were K103 (26.80%),Y181 (14.71 %),V179 (13.73%),G190 (11 .44%) and V106 (10.62%).The susceptibility rate of 310 patients (50.65%)to NNRTIs had changed,the highly resistant rate to nevirapine was 49.51 %,which was higher than that of efavirenz (43.14%),etravirine (5.56%) and rilpivirine (12.25%),respectively,and the differences were statistically significant (χ2 =5.00,296.3 and 198.0,all P <0.05).The incidence rate of drug resistance in patients with baseline CD4 +T lymphocyte counts >200 cells/μL was lower than that in those with baseline CD4 +T lymphocyte counts <200 cells/μL (χ2 =17.93,P <0.01 );the incidence rate of drug resistance was lower in intravenous drug abusers than that of sexually transmitted patients (χ2 =44.21 ,P <0.01 );while the incidence of drug resistance in patients receiving NVP-containing regimens was higher than that in those receiving EFV-containing regimens (χ2 =8.93,P <0.01 ),and the incidence rate was higher in patients with CRF01 _AE than that in those with CRF07_BC and CRF08 _BC (χ2 =8.46 and 8.47,P <0.01 ).Conclusions The results suggest that compliance education and follow-up should be strengthened in patients with high baseline CD4 +T lymphocyte counts and intravenous drug users,and patients with liver diseases should avoid using drugs containing NVP regimens.
5.Effect of preoperative serum sodium concentration on the early prognosis of liver transplantation recipients
Dongyu WANG ; Yabin CHEN ; Yan MA ; Tianran CHEN ; Raman LI ; Linghua WEI ; Panliang WANG ; Wenzhi GUO
International Journal of Surgery 2018;45(6):378-382
Objective To analyze the relationship between preoperative serum sodium concentration and preoperative status of liver transplantation recipients and it's effect on early prognosis. Methods Retrospectively collected the clinical data of 281 patients underwent liver transplantation in First Affiliated Hospital of Zhengzhou University from January 2016 to September 2017. According to the preoperative serum sodium concentration, they were divided into hyponatremia group (< 130 mmol/L) 18 patients, normonatremia group (130-145 mmol/L)232 patients and hypernatremia group(> 145 mmol/L) 31 patients. The SPSS 21.0 statistical software was used to analyze the difference of preoperative MELD score, Child-Pugh score, postoperative survival rate and the incidence of graft dysfunction among three groups. Multivariate comparisons of measurement data were performed using analysis of variance. Pairwise comparisons between groups were performed using the LSD-t test. Chi-square tests were used to compare the count data sets. Results The preoperative MELD score was(19.27 ±7.35) scores, Child-Pugh score was(10.39±2.28) scores, serum creatinine concentration was(95.89 ± 49.40) μmol/L in hyponatremia group, the preoperative MELD score was(12.17土8.79) scores(P=0.001), Child-Pugh score was(8.50±2.68) scores (P =0.004) and serum creatinine was(66.07 ±24.13) μmol/L(P <0.05) in normonatremia group, the difference between two groups were statistically significant. There were no significant difference in the length of postoperative ICU stay and postoperative hospital stay among the three groups, there were no significant difference between the 30th and 90th postoperative survival rates and the incidence of graft dysfunction. Conclusions Hyponatremia is an indicator of poor preoperative status in liver transplantation recipients. Preoperative serum sodium concentration has no significant effect on early prognosis of liver transplantation.
6.Associations between Tensin1 protein and clinicopathological characteristics and prognoses of gastric cancer patients
Yixin CAO ; Xiaoqin LI ; Hongyu WANG ; Jin REN ; Hangang GU ; Linghua YAN ; Wenqi CHEN ; Deqiang WANG
Chinese Journal of Digestive Surgery 2018;17(6):612-618
Objective To investigate the associations between expression of Tensin1 protein and clinicpathological characteristics and prognoses of gastric cancer (GC) patients.Methods The retrospective casecontrol study was conducted.The clinicopathological data of 163 GC patients who were admitted to the Affiliated Hospital of Jiangsu University between July 31,2011 and December 31,2013 were collected.The GC tissues and adjacent normal tissues were taken to paraffin imbedding,and then were detected by immunohistochemistry.Observation indicator:(1) expressions of Tensinl protein in GC tissues and adjacent normal tissues;(2) association between expression of Tensinl protein in GC tissues and clinicopathological characteristics;(3) followup and survival situations;(4) prognostic factors analysis.Follow-up using telephone interview was performed to detect survival up to January 1,2017.Measurement data with skewed distribution were described as M (range).Count data were analyzed using the chi-square test or pairing chi-square test.The survival curve and rate were respectively drawn and calculated using the Kaplan-Meier method,and Log-rank test was used for survival analysis.The univariate analysis and multivariate analysis were done using the COX roportional hazard model.Results (1) Expressions of Tensinl protein in GC tissues and adjacent normal tissues:immunohistochemistry showed that Tensinl protein in GC tissues and adjacent normal tissues mainly expressed in cytoplasm.Of 163 patients,154 (66 with high expression and 88 with low expression) and 9 had respectively positive and negative expressions of Tensinl protein in GC tissues;79 (37 with high expression and 42 with low expression) and 84 had respectively positive and negative expressions of Tensinl protein in adjacent normal tissues,with statistically significant differences in positive expression ratio and expression levels (x2=64.65,12.93,P<0.05).(2) Association between expression of Tensinl protein in GC tissues and clinicopathological characteristics:high expression rate of Tensinl protein in GC tissues were respectively 31.34% (21/67) in GC patients with tumor metastases and 46.88% (45/96) in GC patients without tumor metastasis,with a statistically significant difference (x2 =3.95,P<0.05).(3) Follow-up and survival situations:all the 163 patients were followed up for 3.3-64.7 months,with a median time of 28.7 months.The 3-year cumulative disease-free survival rate and cumulative overall survival rate in GC tissues were 63.12%,74.22% in 66 patients with high expression of Tensinl protein and 47.30%,55.74% in 97 patients with low and negative expressions of Tensin1 protein,showing statistically significant differences in above indicators (x2 =4.58,4.11,P<0.05).Survival analysis of subgroups showed that 3-year cumulative disease-free survival rate in GC tissues of patients with maximum tumor dimension ≥ 5 cm,nerve and / or vascular invasions and stage Ⅲ of TNM staging were 45.98%,62.79%,52.75% in patients with high expression of Tensin1 protein and 18.11%,31.10%,32.80% in patients with low and negative expressions of Tensin1 protein,with a statistically significant difference (x2 =5.85,7.89,4.96,P<0.05).The 3-year cumulative overall survival rate was respectively 66.00%,75.75%,67.93% in patients with high expression of Tensin1 protein and 30.74%,40.15%,44.67% in patients with low and negative expressions of Tensinl protein,with statistically significant differences (x2 =7.59,9.62,4.32,P < 0.05).(4) Prognostic factors analysis:results of univariate analysis showed that maximum tumor dimension,histological grade,nerve and / or vascular invasions,postoperative TNM staging,postoperative adjuvant chemotherapy and expression of Tensin1 protein were related factors affecting prognoses of GC patients [hazard ratio (HR) =3.66,2.45,2.17,3.36,0.41,0.54,95% confidence interval (CI):2.09-6.41,1.43-4.19,1.17-4.04,1.52-7.41,0.23-0.72,0.31-0.96,P<0.05].Results of multivariate analysis showed that maximum tumor dimension ≥ 5 cm and grade Ⅲ of histological grade were independent risk factors affecting prognoses of GC patients (HR=3.21,2.17,95%CI:1.63-6.32,1.18-3.99,P<0.05),and postoperative adjuvant chemotherapy and high expression of Tensin1 protein were independent protective factors affecting prognoses of GC patients (HR=0.50,0.44,95%CI:0.28-0.90,0.24-0.82,P<0.05).Conclusion High expression of Tensin1 protein may inhibit GC metastasis,and it is also an independent protective factor affecting prognoses of GC patients.
8.Incidence of postoperative complications in Chinese patients with gastric or colorectal cancer based on a national, multicenter, prospective, cohort study
Shuqin ZHANG ; Zhouqiao WU ; Bowen HUO ; Huining XU ; Kang ZHAO ; Changqing JING ; Fenglin LIU ; Jiang YU ; Zhengrong LI ; Jian ZHANG ; Lu ZANG ; Hankun HAO ; Chaohui ZHENG ; Yong LI ; Lin FAN ; Hua HUANG ; Pin LIANG ; Bin WU ; Jiaming ZHU ; Zhaojian NIU ; Linghua ZHU ; Wu SONG ; Jun YOU ; Su YAN ; Ziyu LI
Chinese Journal of Gastrointestinal Surgery 2024;27(3):247-260
Objective:To investigate the incidence of postoperative complications in Chinese patients with gastric or colorectal cancer, and to evaluate the risk factors for postoperative complications.Methods:This was a national, multicenter, prospective, registry-based, cohort study of data obtained from the database of the Prevalence of Abdominal Complications After Gastro- enterological Surgery (PACAGE) study sponsored by the China Gastrointestinal Cancer Surgical Union. The PACAGE database prospectively collected general demographic characteristics, protocols for perioperative treatment, and variables associated with postoperative complications in patients treated for gastric or colorectal cancer in 20 medical centers from December 2018 to December 2020. The patients were grouped according to the presence or absence of postoperative complications. Postoperative complications were categorized and graded in accordance with the expert consensus on postoperative complications in gastrointestinal oncology surgery and Clavien-Dindo grading criteria. The incidence of postoperative complications of different grades are presented as bar charts. Independent risk factors for occurrence of postoperative complications were identified by multifactorial unconditional logistic regression.Results:The study cohort comprised 3926 patients with gastric or colorectal cancer, 657 (16.7%) of whom had a total of 876 postoperative complications. Serious complications (Grade III and above) occurred in 4.0% of patients (156/3926). The rate of Grade V complications was 0.2% (7/3926). The cohort included 2271 patients with gastric cancer with a postoperative complication rate of 18.1% (412/2271) and serious complication rate of 4.7% (106/2271); and 1655 with colorectal cancer, with a postoperative complication rate of 14.8% (245/1655) and serious complication rate of 3.0% (50/1655). The incidences of anastomotic leakage in patients with gastric and colorectal cancer were 3.3% (74/2271) and 3.4% (56/1655), respectively. Abdominal infection was the most frequently occurring complication, accounting for 28.7% (164/572) and 39.5% (120/304) of postoperative complications in patients with gastric and colorectal cancer, respectively. The most frequently occurring grade of postoperative complication was Grade II, accounting for 65.4% (374/572) and 56.6% (172/304) of complications in patients with gastric and colorectal cancers, respectively. Multifactorial analysis identified (1) the following independent risk factors for postoperative complications in patients in the gastric cancer group: preoperative comorbidities (OR=2.54, 95%CI: 1.51-4.28, P<0.001), neoadjuvant therapy (OR=1.42, 95%CI:1.06-1.89, P=0.020), high American Society of Anesthesiologists (ASA) scores (ASA score 2 points:OR=1.60, 95% CI: 1.23-2.07, P<0.001, ASA score ≥3 points:OR=0.43, 95% CI: 0.25-0.73, P=0.002), operative time >180 minutes (OR=1.81, 95% CI: 1.42-2.31, P<0.001), intraoperative bleeding >50 mL (OR=1.29,95%CI: 1.01-1.63, P=0.038), and distal gastrectomy compared with total gastrectomy (OR=0.65,95%CI: 0.51-0.83, P<0.001); and (2) the following independent risk factors for postoperative complications in patients in the colorectal cancer group: female (OR=0.60, 95%CI: 0.44-0.80, P<0.001), preoperative comorbidities (OR=2.73, 95%CI: 1.25-5.99, P=0.030), neoadjuvant therapy (OR=1.83, 95%CI:1.23-2.72, P=0.008), laparoscopic surgery (OR=0.47, 95%CI: 0.30-0.72, P=0.022), and abdominoperineal resection compared with low anterior resection (OR=2.74, 95%CI: 1.71-4.41, P<0.001). Conclusion:Postoperative complications associated with various types of infection were the most frequent complications in patients with gastric or colorectal cancer. Although the risk factors for postoperative complications differed between patients with gastric cancer and those with colorectal cancer, the presence of preoperative comorbidities, administration of neoadjuvant therapy, and extent of surgical resection, were the commonest factors associated with postoperative complications in patients of both categories.
9.Incidence of postoperative complications in Chinese patients with gastric or colorectal cancer based on a national, multicenter, prospective, cohort study
Shuqin ZHANG ; Zhouqiao WU ; Bowen HUO ; Huining XU ; Kang ZHAO ; Changqing JING ; Fenglin LIU ; Jiang YU ; Zhengrong LI ; Jian ZHANG ; Lu ZANG ; Hankun HAO ; Chaohui ZHENG ; Yong LI ; Lin FAN ; Hua HUANG ; Pin LIANG ; Bin WU ; Jiaming ZHU ; Zhaojian NIU ; Linghua ZHU ; Wu SONG ; Jun YOU ; Su YAN ; Ziyu LI
Chinese Journal of Gastrointestinal Surgery 2024;27(3):247-260
Objective:To investigate the incidence of postoperative complications in Chinese patients with gastric or colorectal cancer, and to evaluate the risk factors for postoperative complications.Methods:This was a national, multicenter, prospective, registry-based, cohort study of data obtained from the database of the Prevalence of Abdominal Complications After Gastro- enterological Surgery (PACAGE) study sponsored by the China Gastrointestinal Cancer Surgical Union. The PACAGE database prospectively collected general demographic characteristics, protocols for perioperative treatment, and variables associated with postoperative complications in patients treated for gastric or colorectal cancer in 20 medical centers from December 2018 to December 2020. The patients were grouped according to the presence or absence of postoperative complications. Postoperative complications were categorized and graded in accordance with the expert consensus on postoperative complications in gastrointestinal oncology surgery and Clavien-Dindo grading criteria. The incidence of postoperative complications of different grades are presented as bar charts. Independent risk factors for occurrence of postoperative complications were identified by multifactorial unconditional logistic regression.Results:The study cohort comprised 3926 patients with gastric or colorectal cancer, 657 (16.7%) of whom had a total of 876 postoperative complications. Serious complications (Grade III and above) occurred in 4.0% of patients (156/3926). The rate of Grade V complications was 0.2% (7/3926). The cohort included 2271 patients with gastric cancer with a postoperative complication rate of 18.1% (412/2271) and serious complication rate of 4.7% (106/2271); and 1655 with colorectal cancer, with a postoperative complication rate of 14.8% (245/1655) and serious complication rate of 3.0% (50/1655). The incidences of anastomotic leakage in patients with gastric and colorectal cancer were 3.3% (74/2271) and 3.4% (56/1655), respectively. Abdominal infection was the most frequently occurring complication, accounting for 28.7% (164/572) and 39.5% (120/304) of postoperative complications in patients with gastric and colorectal cancer, respectively. The most frequently occurring grade of postoperative complication was Grade II, accounting for 65.4% (374/572) and 56.6% (172/304) of complications in patients with gastric and colorectal cancers, respectively. Multifactorial analysis identified (1) the following independent risk factors for postoperative complications in patients in the gastric cancer group: preoperative comorbidities (OR=2.54, 95%CI: 1.51-4.28, P<0.001), neoadjuvant therapy (OR=1.42, 95%CI:1.06-1.89, P=0.020), high American Society of Anesthesiologists (ASA) scores (ASA score 2 points:OR=1.60, 95% CI: 1.23-2.07, P<0.001, ASA score ≥3 points:OR=0.43, 95% CI: 0.25-0.73, P=0.002), operative time >180 minutes (OR=1.81, 95% CI: 1.42-2.31, P<0.001), intraoperative bleeding >50 mL (OR=1.29,95%CI: 1.01-1.63, P=0.038), and distal gastrectomy compared with total gastrectomy (OR=0.65,95%CI: 0.51-0.83, P<0.001); and (2) the following independent risk factors for postoperative complications in patients in the colorectal cancer group: female (OR=0.60, 95%CI: 0.44-0.80, P<0.001), preoperative comorbidities (OR=2.73, 95%CI: 1.25-5.99, P=0.030), neoadjuvant therapy (OR=1.83, 95%CI:1.23-2.72, P=0.008), laparoscopic surgery (OR=0.47, 95%CI: 0.30-0.72, P=0.022), and abdominoperineal resection compared with low anterior resection (OR=2.74, 95%CI: 1.71-4.41, P<0.001). Conclusion:Postoperative complications associated with various types of infection were the most frequent complications in patients with gastric or colorectal cancer. Although the risk factors for postoperative complications differed between patients with gastric cancer and those with colorectal cancer, the presence of preoperative comorbidities, administration of neoadjuvant therapy, and extent of surgical resection, were the commonest factors associated with postoperative complications in patients of both categories.
10. Discussion on optimal duration of pegylated interferon α combined with ribavirin for chronic hepatitis C in HIV-infected patients
Yingchun KE ; Linghua LI ; Fengyu HU ; Yun LAN ; Yaozu HE ; Xiejie CHEN ; Xiaoping TANG ; Weiping CAI ; Ruichao LU ; Yan HE ; Huiqin LI
Chinese Journal of Hepatology 2018;26(4):282-287
Objective:
To investigate the optimal duration of pegylated-alpha interferon (Peg-INFα) combined with ribavirin (RBV) in treating chronic hepatitis C infection in human immunodeficiency virus (HIV)-infected patients.
Methods:
A multicenter prospective study was conducted. The study subjects were divided into two groups; HIV/HCV co-infections (Group A, n = 158) and control with HCV-monoinfections (Group B, n = 60). All recruited patients received standard Peg-INFα plus RBV therapy. Group A was divided into 3 subgroups according to CD4+ cell counts: A1 subgroup, 79 cases, CD4+ counts > 350 cells /μl, who received anti-HCV before combination antiretroviral therapy(cART); A2 subgroup, 45 cases, CD4+ counts between 200 and 350 cells/μl, who did not start anti-HCV until they could tolerate cART well; A3 subgroup, 34 cases, CD4+ counts < 200 cells /μl, cART was administered first, and anti-HCV therapy was started when CD4+ counts > 200 cells/μl. The anti-HCV efficacy of two groups and 3 subgroups were compared. Statistical analysis for normal distribution and homogeneity of variance data was calculated by t-test and the counting data was analyzed by χ 2 test. The Mann-Whitney U test was used for non-normal data. A one-way analysis of variance (ANOVA) was used for the comparison of multiple groups, followed by SNK method. Multiple independent samples were used for non-parametric tests.
Results:
There was no significant difference in age and baseline HCV RNA levels between groups and subgroups (P > 0.05). By an intent-to-treat (ITT) analysis, in Group A, the ratio of complete early virological response (cEVR) rate was 75.3% (119/158), the ratio of end of treatment virological response (eTVR) rate was 68.4% (108/158), and the ratio of sustained virological response (SVR) rate was 48.7% (77/158); in Group B, the ratio of cEVR rate was 93.3% (56/60), the ratio of eTVR rate was 90.0% (54/60), and the ratio of SVR rate was 71.7% (43/60); The therapeutic index of Group A were lower than those of Group B (P≤0.05). By per-protocol (PP) analysis, the ratio of cEVR rate in Group A [75.2% (88/112)] was still lower than that in Group B [93.3% (56/60)], but no significant differences were found in the ratio of eTVR rate and SVR rate between 2 groups (P > 0.05). Comparing the efficacy of subgroups (A1, A2 and A3) by ITT analysis, the ratios of cEVR rate were respectively 78.5% (62/79), 75.6% (34/45) and 67.6% (23/34); the ratios of eTVR rate were respectively 68.4%(54/79), 80.0%(36/45)and 52.9%(18/34); and the ratios of SVR rate were respectively 41.8%(33/79), 64.4%(29/45)and 44.1%(15/34). The ratio of eTVR in subgroup A2 was obviously higher than that in subgroup A3 and the ratio of SVR in subgroup A2 was statistically higher than that of subgroup A1(P≤0.05). However, by PP analysis, no significant differences of the therapeutic indexes were found among the respective subgroups (P > 0.05).
Conclusion
HIV-HCV co-infected patients would have better anti-HCV efficacy with Peg-INFα-2a plus RBV than HCV- monoinfected patients. The best time for initiating anti-HCV therapy in HIV-HCV co-infected patients is when CD4+ counts 200 cells/ μl.