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医学博士,副教授,擅长治疗各种原因引起的慢性肝病,尤其对自身免疫性肝炎有丰富的诊疗经验。参与国家“十二五”传染病防治科技重大专项课题3项,主持国际、国内多中心II期和III期肝病药物临床试验16项,发表SCI论文8篇。工作勤勤恳恳,任劳任怨,学习认认真真,戒骄戒躁,生活平平淡淡,一箪一瓢。拼搏的道路上既品尝了奋斗时的艰辛,更享受了收获时的快乐。不懈努力的我相信只有付出,才有收获。

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My Submission course  

2013-07-22 11:24:32|  分类: 人生经历 |  标签: |举报 |字号 订阅

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Proface

I have read an article whose title is Clinical, Virologic, Histologic, and Biochemical Outcomes After Successful HCV Therapy: A 5-Year Follow-up of 150 Patients published in Hepatology in March 2009 which is a top journal in the field of liver diseases one year ago. At that time I thought that all those data presented in the article were real-life and were not very complex. And I also have some research data similar to the article, and I can also write an paper to submit Hepatology.

Part One

I happened to perform my further study at department of pathology in Beijing Ditan Hospital from May to August last year and relatively I have enough time to engage in write the paper under the help of teachers. After a month, my manuscript was finished, which was Long-term Follow-up Outcomes of Chronic Hepatitis C Patients with Sustained Virological Response to Interferon α and Ribavirin. Without carefully polishing, I submitted it to Hepatology at the end of August 2012. Two weeks later, the peer revision decisions came back which were disillusionary. This is my first SCI submission. There affiliate the decision as follows.

September 14, 2012

Dear Mr. Wang:

The above manuscript has been reviewed by the editors of HEPATOLOGY and two experts in the field. Unfortunately, it was not recommended for further consideration.

We have enclosed the reviews and hope that you find them helpful as you seek other publication opportunities. We regret that the disposition is not favorable, but would like to thank you for your continued support of the journal.

Sincerely,

Dr. Donald Jensen                           Dr. Michael H. Nathanson

Associate Editor, HEPATOLOGY        Editor, HEPATOLOGY

Reviewers' Comments to Author:

Reviewer: 1

Wang and colleagues present long term data on a large subset of patients with SVR after hepatitis C treatment.

Comments:

1. The authors comment that previous studies have been limited by different patient populations, therapeutic schedules and HCV RNA detection methods but they do not offer convincing data that there study does not suffer these same limitations.  Over a 10 year span the HCV RNA detection methods have certainly changed.  The authors should provide more information on what was used and when.  The authors report the use of only 1 assay.  Is this because they used banked blood to capture those tested before this became available?

2. Why were liver biopsies only requested on those with stage 2 or greater fibrosis pretreatment?  This is logical but the reasoning should be supplied. It should also then be clarified how many patients fell into this category and how many then agreed to biopsy.

3. Clinical outcomes:  this section can be made more succinct.  I would also suggest adding the change in platelets for those with cirrhosis and advanced fibrosis.

4. The discussion on those patients with persistently increased liver enzymes is confusing.  It needs to be stated early how many patients had relapse and these should not be analyzed with the others (or at least qualified).

5. Virologic outcome:  9% late relapse is a very high percentage.  This needs to be expanded. At what point did these patients relapse?  Is there a chance they were reinfected?  I don’t think that repeatedly positive RNA is needed, only the statement that a positive value was confirmed.  You should consider offering clinical data on this subset separately.  How long were they treated?  Did they have weight based on flat dosing of RBV?

6. Histologic outcomes:  the clearest way to report this would be to break it into more simplistic terms.  208 were stage 2 or greater of which x% agreed to have a repeat biopsy.  Of these x% improved by 1 stage and x% by 2 or more.  You need to also report how many were unchanged and how many were worse.  For those that were worse you should clearly state if there was an alternative explanation (such as NASH or relapse of HCV). Resolution of advanced fibrosis is important and as you did this should be highlighted at the end.

7. 13 patients had grade 3 periportal hepatitis.  These patients should also be expanded on.  Were these the patients with relapse?  Did they have an alternative diagnosis?

8. Table 1:  You should also put the number of patients with stage 2 fibrosis (as this was the cut off for the long term histology study) and those with Stage 0-1.

9. Histologic data on the 11 with relapse is probably not necessary.  These subjects are expected to have abnormal biopsies.

10. Tab3 is not necessary. 

Reviewer: 2

The authors must be congratulated for the very long follow-up.

1. As stated by the authors, the major limitation is the small number (n=32) of patients with baseline advanced fibrosis and paired biopsies. These patients are the group at the higher risk of long-term complications.

2. Abstract: the first sentence is too strong and must be modified, introducing the 10 years follow-up. The authors should focus on the population with 117 paired biopsies.

3. Patients with detectable RNA after the first SVR should be excluded from the main analysis.

4. If available details on alcohol consumption and metabolic factors at baseline should be given in Table 1.

5. Table 3 should be given in a supplementary file.

6. There is too many results repeated in the discussion section. The authors should discuss more the limitations of such study, including the absence of “control groups”, the variability of biopsy sampling even for cirrhosis and the possibility of using validated non-invasive biomarkers on larger population.

Part Two

After a long time modification, I submitted it to Journal of Viral Hepatitis  on 18 June, 2013, and on 2 July, the status was rejected.

Decision Letter (JVH-00312-2013)

Subject: Journal of Viral Hepatitis - Manuscript JVH-00312-2013

Body: Thank you for submitting this manuscript to The Journal of Viral Hepatitis. This is a medium sized study examining the outcome of HCV infection after therapy with interferon and ribavirin. There is little new information here and therefore the study is unlikely to be regarded as a high priority for publication in The Journal Of Viral Hepatitis so we are returning your paper so that you can resubmit to an alternative journal without undue delay. At present The Journal is only able to publish 20% of submitted manuscripts and we are sorry that your paper was not assigned a high priority.

Yours sincerely

Professor Graham Foster, Editor

Professor Howard Thomas, Editor in Chief

Date Sent: 02-Jul-2013

Part Three

On 8 July, 2013, I submitted the manuscript to World Journal of Gastrointestinal which is hosted by Chinese after a modification again. Now four decisions have come as follows. At first, it was 3 reviewers to review my manuscript. they were 00051373, 00058444 and 02445719, but the 00051373's comment about my manuscript was not related with my manuscript, so the chief-editor arranged another reviewer, namely 00181443, to review again, so there were 4 reviewers.

No. 1 Reviewed by 00051373 2013-07-10 23:15

Comments to author Manuscript No. 4590 Manuscript Title A ten-year follow-up of Chronic Hepatitis C Patients with Sustained Virological Response to Interferon α plus Ribavirin Reviewer comments 1. This is a single arm study for chronic C hepatitis patients treated with IFN and ribavirin. Absent of control group is a major factor to affect the acceptance. 2. No IRB prove study is not accepted in the mordent clinical study. 3. Treatment agent dosage is not clear such as IFN alpha 2 aor alpha 2b and dosage of ribavirin is 800, 1000 or 1200 mg daily. Because of the treatment response is related to the 80-80-80 rule of different IFN and dosage of ribavirin. 4. Lack of detail viral load of HCV in cpm data and the treatment period in 4 weeks, 12 weeks and 24 weeks 5. No detail discussion the complication with IFN and ribavirin 6. Lower power view of pathological figure is difficult to see the histological change before, during and after treatment of IFN. 7. The result is needs to build up a new table.

Classification: Grade A(excellent); Grade B(Very Goog); Grade C(Good); Grade D(Fair); √Grade E(Poor)

Language evaluation: Grade A: priority publishing; √Grade B: minor language polishing; Grade C: a great deal of language polishing; Grade D: rejected

Conclusion: Accept; High priority for publication; √Rejection; Minor revision; Major revision

No. 2 Reviewed by 00058444 2013-07-16 16:41

1. In the Introduction Section, the authors claimed that “At present, the combined therapy of interferon α plus ribavirin was considered as standard treatment for patients with chronic hepatitis C infection, because it achieved high sustained virological response (SVR), ranging from 50-80%.” The results were based on the combination therapy of pegIFN and ribavirin. In addition, the standard treatment for patients with genotype 1 CHC in Western countries is triple therapy with pegIFN, ribavirin and first generation protease inhibitors. The authors should correct their statement and add references. 2. The authors should provide the regimens of interferon α plus ribavirin combined therapy in the text and Table 1. 3. Did the authors check the serum HCV RNA by Roche Cobas TaqMan kit (with a detection limit of 15 IU/mL) 10 years ago? 4. The authors should provide the method for HCV genotype examination. 5. The authors should provide a table or a figure to compare the histological changes of liver biopsy before treatment and 10years later. 6. The authors stated that “Five patients developed decompensated liver cirrhosis even undergoing anti-HCV treatment of interferon α or pegylated interferon α-2a/b and ribavirin more than once in the course of long-term follow-up. Among them, three had repeatedly elevated ALT or AST with positive HCV RNA and cirrhosis pretreatment. The other two only had repeatedly positive HCV RNA.”(first Paragraph of Results Section). Did these patients fit the definition of sustained virologic response (SVR)? 7. The authors stated that “Virological relapse occurred in 27 patients.” In the Abstract. But they also presented that serum HCV RNA was negative in every sample of the 296 patients (91%), and positive at least once in the rest 29 patients (9%) in this study (Virologic Outcomes Paragraph, Results Section). What data were correct? The relapse rate was too high in this study as compared to previous reports. The authors should explain this discrepancy. 8. The Results Section and Discussion Section were too redundant. 9. The Fig. 2 could be deleted.

Classification: Grade A(excellent); Grade B(Very Goog); Grade C(Good); √Grade D(Fair); Grade E(Poor)

Language evaluation: Grade A: priority publishing; Grade B: minor language polishing; √Grade C: a great deal of language polishing; Grade D: rejected

Conclusion: Accept; High priority for publication; Rejection; Minor revision; √Major revision

No. 3 Reviewed by 02445719 2013-07-19 01:03AM

Long-term F-U of a cohort of patients with CHC after SVR is not very original. I would suggest to change the Title as it does not reflect the more interesting part of the study: The paired liver biopsies in 117 patients after SVR. Actually, I would restrict the study only to those with baseline and post-treatment biopsy after such a long follow-up period. The reason is that long-term F-U is not a novelty but the impact of SVR on clinical outcome with accurate information on histology is less well characterized and provide important information. major comments: 1)Those who develop clinical decompensation were patients with baseline cirrhosis or advanced fibrosis (Eg Ishak 5 or 6?) 2)Please stratify by HCV genotypes. 3)In those who the stage and grade progressed after SVR, were there factors involved in this outcome (Eg alcohol abuse, baseline liver steatosis?)

Classification: Grade A(excellent); Grade B(Very Goog); Grade C(Good); √Grade D(Fair); Grade E(Poor)

Language evaluation: Grade A: priority publishing; Grade B: minor language polishing; √Grade C: a great deal of language polishing; Grade D: rejected

Conclusion: Accept; High priority for publication; Rejection; Minor revision; √Major revision

No. 4 Reviewed by 00181443   2013-07-21 10:31AM

Wang et al. described the long term outcome of hepatitis C patients after the clearance of HCV. This study included a large number of patients with paired liver biopsy. The results are interesting but there are several important questions to be answered. 1. Evaluation of liver biopsy: The authors should clearly indicate the validity of liver biopsy specimen. The gauge of the biopsy needle, the length of the specimen, the number of portal tracts included in the specimen should be described. The authors should also describe whether the diagnosis was made by a single or pleural pathologists, if plural, the number of pathologists who made diagnosis, and the accordance of the diagnosis between pathologists. This information is especially important in this kind of study describing pathological evaluation. 2. High incidence of HCV RNA reappearance after SVR: Criteria for the determination of SVR should be made clear. Was it determined based on only 1 point at 24 weeks after the completion of IFN therapy? The authors should also describe the time point at which HCV RNA reappeared. The authors should also discuss about the possibility of re-infection. 3. Paired biopsy: Only 117 patients were evaluated by paired biopsy. There may be a selection bias. The authors should show in the table, the precise clinical information of patients with and without paired biopsy with statistical comparison. The table should include biochemical and histological data at baseline (pre-treatment), at the determination of SVR, and at second biopsy or last follow up point.

Classification: Grade A(excellent); Grade B(Very Goog); √Grade C(Good); Grade D(Fair); Grade E(Poor)

Language evaluation: Grade A: priority publishing; √Grade B: minor language polishing; Grade C: a great deal of language polishing; Grade D: rejected

Conclusion: Accept; High priority for publication; Rejection; Minor revision; √Major revision

Now the editor committee have not made a final decision to my manuscript, waiting, waiting, and waiting again.

 


 

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