Objective:To investigate the effects of intraoperative irrigation with hypothermic 3% sodium chloride solution on surgery effect and post-tonsillectomy pain in adults.Methods:A total of 120 adult patients with the plasma tonsillectomy from January to December 2020 in the First Affiliated Hospital of Soochow University were divided into observation group A, observation group B, observation group C and control group according to random number table method, with 30 cases in each group. During operation, observation group A used hypothermia 3% sodium chloride, observation group B used room temperature 3% sodium chloride, observation group C used hypothermia 0.9% sodium chloride, control group used room temperature 0.9% sodium chloride. The quality of surgical field quality, operation time, blood loss in operation, duration of catheter, the postoperative wound pain at 24, 48, 72 h after operation were compared among four groups.Results:The surgical field quality scores were (2.07 ± 0.87) points in the observation group A, significantly lower than in the observation group B (2.57 ± 0.73) points, observation group C (2.60 ± 0.56) points and control group (3.10 ± 0.66) points, the differences were statistically significant ( t=2.71, 2.89, 5.61, all P<0.01). Amounts of blood loss in operation were (9.13 ± 1.74), (10.03 ± 2.81), (10.50 ± 2.09) ml in the observation group A, observation group B and observation group C, significantly lower than in the control group (15.23 ± 3.64) ml, the differences were statistically significant ( t=8.85, 7.54, 6.87, all P<0.01). At 24 h after operation, the scores of Numerical Rating Scale(NRS) were (3.23 ± 0.77), (3.53 ± 0.63), (3.80 ± 0.89) points in the observation group A, observation group B and observation group C, significantly lower than in the control group (4.43 ± 1.17) points. At 48 h after operation, the scores of NRS were (2.37 ± 0.72) points in the observation group A, significantly lower than in the control group (2.93 ± 0.83) points, the differences were statistically significant ( t values were 2.77-5.25, all P<0.01).There was no significant difference in operation time, duration of catheter and wound pain 72 hours after operation among the four groups ( P>0.05). Conclusions:Intraoperative use of hypothermic 3% sodium chloride solution can reduce the amount of blood loss in operation in adult patients with plasma tonsillectomy, increase the clarity of visual field, and effectively reduce postoperative pain.

Objective:To construct a Soochow University model of comfortable medical procedures during peri-anesthesia period for patients undergoing radical resection of lung cancer through thoracoscope.Methods:In this prospective study, eight hundreds and sixty patients undergoing radical resection of lung cancer through thoracoscope were enrolled in our hospital in 2018.During peri-anesthesia period, the 860 patients were randomly(by the random number table method)divided into the control group(the group C receiving routine medical procedures, n=430)and the comfort group(the group S receiving the comfortable medical procedures of Soochow University model, n=430). The scores of Visual Analogue Scale(VAS), Richmond Agitation-Sedation Scale(RASS), and Thirsty Analogue Scale(TAS)were recorded at 5 min after extubation(T1), at out of the post-anesthesia care unit(T2), at 1 h(T3), 6 h(T4), 12 h(T5), 24 h(T6), 2 d(T7)and 3 d after surgery(T8)in two groups.The incidences of postoperative sore throat(POST), nausea and vomiting(PONV), catheter-related bladder discomfort(CRBD), thirst and hypothermia were recorded at T2, T6 and T8, respectively.Meanwhile, the peri-anesthesia comfort questionnaire(PCQ)and peri-anesthesia satisfaction questionnaire(PSO)were completed at T6 and T8.Results:The incidences of POST(48.6% vs.16.2%), PONV(24.9% vs.13.0%), CRBD(78.8% vs.20.9%)and thirst(74.9% vs.20.0%)were higher in the group C than in the group S at T2( P<0.05). The comfort score and satisfaction score were lower in the group C than in the group S at T6(3.14±1.04 vs.4.92±1.42, 2.67±0.89 vs.3.30±1.01)and at T8(3.84±1.83 vs.5.05±1.77, 2.74±0.84 vs.3.26±1.06)( P<0.05). Conclusions:The Soochow University model of comfortable medical procedures during peri-anesthesia period for patients undergoing radical resection of lung cancer through thoracoscope has been successfully constructed, and this model can reduce the incidence of complications, and improve the comfort and satisfaction during peri-anesthesia period.

OBJECTIVE To learn the common proto col deviation （PD）in the process of drug clinical trials and discuss the methods and precautions for preventing and reducing PD so as to provide reference for the standardization of drug clinical trials. METHODS According to Good Clinical Practice ，Notice on Issuing Guidelines for Planning and Reporting of Data Management and Statistical Analysis of Drug Clinical Trials ，Guidelines for Ethical Review of Drug Clinical Trials ，ICH E 3，ICH E 6（R2）and other regulations ，the PD reported in the relevant projects managed by the author from March 2017 to February 2022，as well as the PD found in the submission materials and project quality control ，were sorted out and statistically analyzed. RESULTS & CONCLUSIONS A total of 39 drug clinical trials were included ，and 212 subjects were selected. In all projects ，258 PDs were reported，including 28 major PD （accounting for 10.85％）and 230 ordinary PD （accounting for 89.15％）. The report of PD mainly included missed inspections/tests （93 reports，accounting for 36.05％），lack of visits （36 reports，accounting for 13.95％）， inspection/testing out-of-window （29 reports，accounting for 11.24％），dosage and usage of test drugs （28 reports，accounting for 10.85％），drug over-temperature/missing temperature （21 reports，accounting for 8.14％），etc. Avoiding and reducing the occurrence of PD requires the efforts of multiple parties ：the sponsor designs a reasonable protocol with appropriate interview rate and window period after listening to the opinions of multiple parties ；the investigators and clinical research coordinator should strengthen their own learning and training ，and be familiar with the protocol ，Good Clinical Practice and corresponding regulations；the compliance education of the subjects should be strengthened ；the institutional offices and ethics committees should conduct multi-angle and whole-process supervision and management when a drug clinical trial is approved ，in progress ，and jsyj- concluded，to ensure the safety rights and interests of the zdcxX0079） subjects and the quality of clinical trials. On this basis ，all parties should communicate effectively and timely ，report PD in time ，and conduct special studies on major PD that have com occurred and key links that are prone to PD.

OBJECTIVE To provide a reference for improving the relevant standard operating procedures （SOP） and biological sample management in drug clinical trials. METHODS According to Good Clinical Practice， Data On-site Verification Points of Drugs Clinical Trials， Human Genetic Resources Management Regulations Implementation Rules， Qualification Examination Rules of Drug Clinical Trials Institution， based on the experience of managing clinical trials programs， the irregularities in biological samples management were analyzed by using statistical quality control tables and protocol deviation （PD） reported by sponsors， in the context of the quality control of drug clinical trials projects managed by the author from July 2016 to May 2023. The precautions in various aspects of sample management were put forward. RESULTS & CONCLUSIONS A total of 101 biospecimen- related irregularities were found in the 60 drug clinical trials projects. Biological sample collection， preservation， and handling were the aspects with the highest incidence of irregular operations in biological sample management， accounting for 37.62%， 25.74%， and 21.78%， respectively. Regulating the management of biospecimens requires multiple efforts. The institutional office and the ethics committee carefully reviewed the consistency of the protocols， informed consent， and genetic office application involving biospecimen collection and handling when the project was initiated. Institutional office quality controllers should pay attention to the attendance and training of authorized personnel at project initiation. The principal investigator， research nurse， collector， handler， transporter， relevant personnel of the central laboratory， and institutional office quality controller have their roles during the project implementation phase. On this basis， all parties involved in the management of biological samples should do a good job of effective communication， find problems and report them in time， and conduct special studies on key aspects.

OBJECTIVE： To provide references for improving the standard operating procedures of drug management in clinical trials and drug management in clinical trials. METHODS： According to Good Clinical Practice （GCP）， Data On-site Verification Points of Drugs Clinical Trial， Qualification Examination Rules of Drug Clinical Trial Institution， based on the quality control project carried out in our hospital since July 2016， the matters needing attention in the non-standard operation and key process of drug management in clinical trial were summarized， and the improvement measures were discussed. RESULTS & CONCLUSIONS： Non-standard drug management is a high-incidence link of non-standard operation in the trial process. Among them， the acceptance， distribution and use of drugs are the three links with the highest incidence of non-standard operation of drug management in the trial process. Therefore， when formulating the relevant management system， each institution should pay attention to it according to its own situation； such as， when accepting drugs in clinical trials， attention should be paid to checking the intact degree of drug packaging； drugs transported in cold chain should also be checked for temperature records and rejected in case of over-temperature； the copies of the waybill should be kept in file with the original to avoid fading of the thermosensitive paper； whether the relevant characteristics of the control drugs and placebos meet the requirements. Institutions can standardize the key links of drug management in the trial process， the time of project establishment， project start-up， quality control and supervision， formulate and constantly improve the relevant drug management system and standard operating procedures （SOP）. For example， when starting a project， attention should be paid to the participation of drug administrators in the training and signature of start-up meeting， whether the design of the form is complete， standardized and operable. It is necessary for clinical trial institutions to pay attention to the standardization and precision of drug management and the key links in clinical trials.