BACKGROUND:In recent years,pentoxifyIline has been found to have a wide range of anti-fibrosis capacity However,there are few studies explore the suppress effect of pentoxifyIline on fibroblasts in human keloid.and the maximum inhibitory concentration remains poorly understood.OBJECTIVE:To study the effect of pentoxifyIline on proliferation activity of human keloid fibroblasts and to select the maximum inhibitory concentrationMETHODS:Human keloid fibroblasts were used as original cells,passaged till the 5~(th) to the 8~(th) generations.and then divided into the experimental and control groups.PentoxifyIline with concentrations of 0.1,0.25,0.5,1.0,2.0 and 3.0 g/L were added to the experimental group.The effects of different concentrations of pentoxifylline on proliferation of keloid fibroblasts were detected by MTT chromometry.RESULT AND CONCLUSION:Compared with the control group,the inhibitory effect of pentoxifylline on the proliferation of keloid fibroblasts was more evident in the experimental group(P＜0.05)The inhibition rates of pentoxifylline on proliferation of keloid fibroblasts showed apparently time-and dose-effect relationships within the concentration of 0.1-2.0 g/L.which presented a greatest level at 96 hours after culture.The maximum inhibitory rate was 53 37%,and the concentration was 2.0 g/L in the experimental group.Consequently,pentoxifyIline plays a notable inhibitory role in the proliferation of human keloid fibroblasts with concentration of 2.0 g/L at 96 hours after culture.

Objective To introduce the standard procedure of Cattell Braasch maneuver and evaluate the complication and clinical value of this maneuver as a important exploration method in the surgery of pancreatic tumors. Method The clinical data of 13 cases of pancreatic tumors explored by Cattell Braanch maneuver before undergoing tumor resection were analyzed. Results Among these 13 cases there were 6 cases of tumors of the head (the pancreatic adeuocarcinoma in 4 cases, solid pseudo-papillary tumor and endocrine tumor in one each cases) and 7 cases of tumor of the body and tail of the pancreas (adenocarcinoma in 4 cases, solid pseudo-papillary tumor in 1 case, endocrine tumor in 2 cases) Pancreaticoduodenectomy was performed in 6 cases, including segmental resection of the tumor invading the superior mesenteric vein( SMV )with length varying from 3 to 7 cm and direct end-to-end reanastomosis in 3 cases. Distal pancreatectomy plus spleuectomy was performed in the other 7 cases, including the case in which extended tumor resection demanded left nephrectomy. Operations lasted from 2. 5 hrs to 11 hrs, in which only 10 ～ 15 mins were needed for Cattell Braasch maneuver . The blood lose was from 300 ml to 1000 ml. There were neither mortality nor severe complications in these series. Conclusion Cattell Braasch maneuver facilitates the exploration and tumor resection in patients suffering from pancreatic neoplasms especially malignances with better view of the operation field,it helps to avoid incidental iatrogenic injury, and also to the nongraft PV/SMV end-to-end anastomosis after the resection of tumor invaded segment.

Objective To explore the feasibility of a novel incisionless laparoscopic technique in the treatment of colorectal tumor, and evaluate the preliminary clinical result of this technique. Methods The clinical data of 12 consecutive resected specimens of high located rectal or sigmoid tumor removed by traditional laparoscopic surgery were analyzed to probe the indication of this technique and the first 2 cases received incisionless laparoscopic anterior resection. Postoperative follow up was made to evaluate the clinical feasibilities. Results Among 12 explanted fresh specimens there were 1 adenoma and 3 adenocarcinoma cases in which the key steps of the new technique were successfully demonstrated. In two cases, the bowel above the tumor was cut and the distal end was inverted and pulled through the anus laparoscopically, the tumor along with the bowel resected, the stump pushed hack, and intralumen sigmoidproctostomy fashioned. In these two patients, one of sigmoid cancer and one of large rectal adenoma with focal canceration, the mean operation time was 200 min, mean blood lose was 50 ml, mean bowel function recovery time was 1.5 days. After 13 and 15 respective months fullow up there was no complications nor tumor recurrence. Conclusions Ineisionless laparoscopic surgery, while in line with tumor free principles, has the advantage of safety, cost-effectiveness and being cosmetic in selected cases.

Objective:To discuss the role of incision for short-term outcomes of simultaneous resection in synchronous colorec-tal liver metastases (sCRLM). Methods:We reviewed the data of 37 patients who underwent simultaneous resection between January 2009 and December 2014 in our department and compared the short-term outcomes between Mercedes and midline incisions. Results:Mercedes and midline incisions were used in 19 and 18 patients, respectively. The two groups showed similarities in patient characteris-tics, major hepatectomy, surgery time, blood loss, and hilar block time. The midline group comprised more rectal cancer patients (P<0.001). The two groups did not differ significantly in complication incidence (47.4%vs. 16.7%, P=0.08) and postoperative stay time (22.1 ± 9.5 d vs. 17.2 ± 6.7 d, P=0.08). At body mass index (BMI)<25, the complication incidence (P=0.046) and postoperative stay time (P=0.051) were lower in the midline group than in the Mercedes group. Conclusion:Midline incision provided similar exposure in simultaneous resection for sCRLM and was better than Mercedes incision in rectal cancer patients. Patients with midline incision may attain better short-term outcomes if BMI is<25.

The borderline resectable pancreatic cancer is high a controversial hotspot in the field of pancreatic surgery,and the controversy mainly focuses on definition and treatment.Five famous experts and their teams in pancreatic surgery discussed present situation and dilemmas in treatment of borderline resectable pancreatic cancer based on clinical experiences.Professor Hao Chunyi has reviewed and analyzed origin of the definition and treatment model of borderline resectable pancreatic cancer,and proposed that high-level pancreatic disease center and multidisciplinary collaboration diagnosis and treatment may be the best choice for resectable pancreatic cancer.Professor Liu Xubao suggested surgical treatment for most of borderline resectable pancreatic cancer,and whether or not tumor invades adjacent blood vessels and invasion level will be used to decide direct surgery or neoadjuvant therapy.Professor Sun Bei proposed 6 causes,and direct surgery may be more realistic and feasible option for borderline resectable pancreatic cancer.Professors Liang Tingbo and Bai Xueli recommended that neoadjuvant therapy should be performed due to defeat hiding micrometastasis lesions and reduce tumor burden,and there was a higher R0 resection rate and lower lymph node metastasis rate after neoadjuvant therapy,meanwhile,it can also increase cure rate and is benefited to survival.

Objective:To analyze ethical management of subjects′ complaints in drug clinical trials in a cancer hospital.Methods:A retrospective analysis of the complaints of subjects received and properly handled by the ethics committee through telephone, e-mail and on-site reception during the drug clinical trial in our hospital. Case studies were conducted to analyze the reasons for the occurrence of some particular subjects′ complaints, processing procedures and resolution processes.Results:The number of subjects' complaints in clinical trials in our hospital decreased year by year. The ethics committee of our hospital would check it immediately and review it carefully after receiving the subjects′ complaints, and return the review decisions to the subjects and researchers, at the same time, follow up with board meeting report and documentation. Regarding to the reasons of the subject complaint, mainly identified were the failure to participate in clinical trials due to inclusion and exclusion criteria, withdraw by investigators due to safety concerns, and not satisfied with the compensation.Conclusions:When receiving subjects′ complaints, the ethics committee should manage them seriously, verify the reasons in time and follow up properly, act as a communication bridge between subjects, researchers and sponsors, try their best to resolve subjects′ complaints, and protect the rights and interests of subjects.

Objective:To discuss ethical review and management of serious adverse events in anti-tumor drug clinical trials in a grade A tertiary cancer hospital for timely and effective protection of subjects.Methods:The main contents and ethical management of ethical review on serious adverse events were retrospectively analyzed including the number, distribution rules, and whether they were reported in time in clinical trials conducted in our hospital in 2021.Results:A total of 1 789 serious adverse events in 259 clinical trials were reported, with more male subjects than female, with an average age of 59.95 years, mainly concentrated in the 50~59 age and 60~69 age groups, accounting for 27.45% and 42.37% respectively. Digestive oncology department, thoracic oncology department and renal cancer melanoma department ranked in the top three for the number of clinical trials and reports of serious adverse events. The highest incidence of serious adverse events was hospitalization at 63.44% and the lowest incidence was disability at 0.39%. The highest proportion of serious adverse events possibly related to clinical trials was 35.72%. Expected serious adverse events accounted for 65.85% versus 34.15% unexpected ones, and the difference between different correlations of serious adverse events whether they were expected or not.was statistically significant. Among the measures taken by the investigator for the test drugs due to serious adverse events, drug discontinuation was the most, accounting for 42.54%, while 3.07% of the trial plans modified the study protocol/informed consent. Serious adverse events reported within 24 hours accounted for 87.20%, and those reported in 24 hours and beyond accounting for 12.80%. A statistically significant difference of the reporting time between the registered and investigator initiated clinical trials was observed.Conclusions:The ethics committee should attach importance to ethical review and management of serious adverse events, pay attention to whether they were reported timely and accurately, strengthen supervision, and effectively protect the safety and interests of the subjects.

To explore ethical issues related to the protection of AIDS patients' rights in the prevention and treatment of AIDS.This paper elaborated in detail the importance of protecting personal privacy of AIDS patients and protecting them against discrimination and unfair treatment in the prevention and treatment of AIDS.It also expounded the relevant ethical,legal and regulatory basis of AIDS patients'rights protection,and how to protect the individual rights of AIDS patients in AIDS prevention and control,while protecting the public health.

At present,China has not formed a complete ethical review agency certification system,actively participating in international certification and seeking external quality assessment is of great significance for the improvement of standard management and review capacity of ethics committee.Combined with the experience of Peking University Cancer Hospital applying for SIDCER international certification,this paper expounded the responsibilities of ethical secretary in international certification from the overview of international certification system and the work practice during the certification process,to promote the progress ethics committee applying for certification and achieve satisfactory quality assessment results.

Objective To discuss appropriate strategies of site visits in ethical committees ,to enhance the supervision of clinical trials effectively ,and standardize the implementation of clinical research .Methods In consideration of the lack of de-tailed normative description of site visit in ethical guidelines and relevant articles ,as well as the varying degrees of implementa-tion and understanding of site visits among different ethical committees .This article discussed the procedures ,contents and considerations of site visit based on the analysis of numerous site visits cases conducted .Results Site visit is one of the crucial procedures to more comprehensive ,in-depth and truly understanding of the implementation of clinical trials .It is helpful to help sponsors/investigators enhance awareness and compliance with the good clinical practice .It also helps to correct problems time-ly during the implementation process to assure the standardized implementation of follow-up studies ,and finally ,effectively protect the rights and interests and safety of subjects .Conclusions Standardized and efficient site visit strategy of the ethical committee is one of the important regulatory strategies in the implementation of clinical trials and is an effective supplement to the regular review of ethical materials .