With the improvement of China’s scientific research capabilities， the number of innovative drug enterprises and clinical trials has increased， and disputes over damage compensation have also risen accordingly. It has become a consensus to resolve such disputes through institutionalization. Given the similarities between China and India in terms of population and development level， this study analyzed India’s compensation mechanism for clinical trial damage， including the definition of damage， compensation procedures， and calculation methods. Through a comparison of the mechanisms between China and India， this paper put forward suggestions for improving China’s compensation mechanism for clinical trial damage， that is， clarifying the compensation process for clinical trial damage， the scope and calculation methods of damage compensation， and the compensation ratio corresponding to the correlation between damage and clinical trials. It also proposed to use disability weights to measure the participants’ health status before their enrollment in clinical trials， and to calculate the amount of compensation for disability and death based on their health status.

Objective To investigate the effects of chronic restraint stress for 28 days(day and night)on mood and cognitive-like behavior in male and female ICR mice,to provide a basis for the selection of sex and restraint period in chronic restraint stress model animals.Methods A total of 72 male and female(1∶1)ICR mice were divided into six groups:male control,daytime restraint,and nighttime restraint groups,and female control,daytime restraint,and nighttime restraint groups.Mice in all but the control groups were bound for 10 h/d and restrained continuously for 28 days to establish a chronic restraint stress model.The emotional and cognitive behaviors induced by restraint in male and female mice at different times were observed by open field,Y maze,novel inhibition feeding,elevated cross maze,tail suspension,forced swimming,and dark-avoidance experiments.Results In the tail suspension experiment,the immobility time of male mice in the daytime restraint group was significantly increased compared with that in the control group(P＜0.05),and the immobility times of male mice in the daytime and nighttime restraint groups were also significantly increased in the forced swimming experiment,compared with those in the control group(P＜0.05).There was no significant difference between the female daytime restraint and female control groups in the novelty inhibition feeding experiment,but the feeding latency of the nighttime restraint group was significantly longer than that of the control group(P＜0.05)and the daytime restraint group(P＜0.05).The feeding latency of female mice was significantly longer than that of males during nighttime restraint(P＜0.05).In the open field test,compared with the male control group,the female control group showed a significant decrease in central area time and the ratio of central area time to peripheral area time(P＜0.05).Compared with the female control group,the female daytime restraint group exhibited a significant decrease in central area time and the ratio of central area time to peripheral area time(P＜0.05).There was no significant difference between the groups in the elevated cross maze and Y maze experiments.There was no significant difference in dark latency between the daytime restraint group and the control group,but darkness latency was significantly shorter in the nighttime restraint group compared with those in the control group(P＜0.05).When male and female mice were combined,the immobility time in the daytime restraint group was significantly increased in the tail suspension experiment(P＜0.05),the immobility times of mice in the daytime and nighttime restraint groups were significantly increased in the forced swimming experiment(P＜0.01,P＜0.05),and the central zone time and the ratio of central area time to peripheral area time of daytime restraint mice were significantly shorter compared with those in the control group(P＜0.05,P＜0.01).There was no significant difference in the central zone time and the ratio of central area time to peripheral area time in the nighttime restraint groups,and no significant difference in average speed or total distance between the daytime and nighttime restraint groups.Conclusions Male mice exhibited depression after 28 d of chronic restraint stress during the daytime,while female mice were prone to anxiety after 28 d of chronic restraint stress.Male mice experienced learning and memory impairment after 28 d of chronic restraint stress during the night.

Objective:To investigate the impact of magnolol(MG)on liver injury in rats with severe acute pancreatitis(SAP)through receptor interacting protein kinase(RIPK)1/RIPK3/mixed lineage kinase domain-like protein(MLKL)signaling pathway and its mechanism.Methods:The SAP rat model was induced by sodium taurocholate.The rats were randomly grouped into sham operation group(Sham group),model group(SAP group),MG group,RIPK1 inhibitor Necrostatin-1 group(Nec-1 group),and magnolol+RIPK1 inhibitor Necrostatin-1 group(MG+Nec-1 group).The pathological tissue morphology of pancreas and liver were observed by HE staining;the apoptosis rate of hepatocyte was observed by TUNEL staining;an automated biochemical analyzer was used to deter-mine serum ALT,AST and AMY contents;ELISA kits were used to detect the contents of TNF-α,IL-1β and IL-6;Western blot was used to detect the protein expression levels of p-RIPK1,RIPK1,p-RIPK3,RIPK3,p-MLKL and MLKL.Results:Compared with Sham group,pancreatic and hepatic cells in SAP group had edema and hemorrhage,and inflammatory cells increased,the expression levels of serum ALT,AST,AMY,TNF-α,IL-1β,IL-6,and p-RIPK1/RIPK1,p-RIPK3/RIPK3,p-MLKL/MLKL ratio in liver tissue were obviously increased(P<0.05).Compared with SAP group,pancreatic and liver injury in MG group and Nec-1 group were obviously reduced,the expression levels of serum ALT,AST,AMY,TNF-α,IL-1β,IL-6 and p-RIPK1/RIPK1,p-RIPK3/RIPK3,p-MLKL/MLKL ratio in liver tissue were obviously decreased(P<0.05),the MG and Nec-1 groups showed no significant differences in any measured indices(P>0.05);the effect on SAP in MG+Nec-1 group was better than that in MG group and Nec-1 group.Conclu-sion:MG can alleviate liver injury in SAP rats by inhibiting RIPK1/RIPK3/MLKL signaling pathway.

Objective To investigate the effects of chronic restraint stress for 28 days(day and night)on mood and cognitive-like behavior in male and female ICR mice,to provide a basis for the selection of sex and restraint period in chronic restraint stress model animals.Methods A total of 72 male and female(1∶1)ICR mice were divided into six groups:male control,daytime restraint,and nighttime restraint groups,and female control,daytime restraint,and nighttime restraint groups.Mice in all but the control groups were bound for 10 h/d and restrained continuously for 28 days to establish a chronic restraint stress model.The emotional and cognitive behaviors induced by restraint in male and female mice at different times were observed by open field,Y maze,novel inhibition feeding,elevated cross maze,tail suspension,forced swimming,and dark-avoidance experiments.Results In the tail suspension experiment,the immobility time of male mice in the daytime restraint group was significantly increased compared with that in the control group(P＜0.05),and the immobility times of male mice in the daytime and nighttime restraint groups were also significantly increased in the forced swimming experiment,compared with those in the control group(P＜0.05).There was no significant difference between the female daytime restraint and female control groups in the novelty inhibition feeding experiment,but the feeding latency of the nighttime restraint group was significantly longer than that of the control group(P＜0.05)and the daytime restraint group(P＜0.05).The feeding latency of female mice was significantly longer than that of males during nighttime restraint(P＜0.05).In the open field test,compared with the male control group,the female control group showed a significant decrease in central area time and the ratio of central area time to peripheral area time(P＜0.05).Compared with the female control group,the female daytime restraint group exhibited a significant decrease in central area time and the ratio of central area time to peripheral area time(P＜0.05).There was no significant difference between the groups in the elevated cross maze and Y maze experiments.There was no significant difference in dark latency between the daytime restraint group and the control group,but darkness latency was significantly shorter in the nighttime restraint group compared with those in the control group(P＜0.05).When male and female mice were combined,the immobility time in the daytime restraint group was significantly increased in the tail suspension experiment(P＜0.05),the immobility times of mice in the daytime and nighttime restraint groups were significantly increased in the forced swimming experiment(P＜0.01,P＜0.05),and the central zone time and the ratio of central area time to peripheral area time of daytime restraint mice were significantly shorter compared with those in the control group(P＜0.05,P＜0.01).There was no significant difference in the central zone time and the ratio of central area time to peripheral area time in the nighttime restraint groups,and no significant difference in average speed or total distance between the daytime and nighttime restraint groups.Conclusions Male mice exhibited depression after 28 d of chronic restraint stress during the daytime,while female mice were prone to anxiety after 28 d of chronic restraint stress.Male mice experienced learning and memory impairment after 28 d of chronic restraint stress during the night.

Purpose: This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas. Methods: We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023. Results: All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05). Conclusion LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.

Purpose: This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas. Methods: We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023. Results: All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05). Conclusion LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.

Purpose: This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas. Methods: We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023. Results: All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05). Conclusion LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.

Purpose: This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas. Methods: We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023. Results: All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05). Conclusion LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.

Purpose: This study aimed to evaluate the long-term efficacy of the ligation of the intersphincteric fistula tract (LIFT) procedure in treating high transsphincteric fistulas. Methods: We conducted a retrospective study to evaluate the success rate of LIFT treatment in 82 patients with high transsphincteric fistulas involving at least one-third of the external sphincter. This study was carried out across 2 centers from November 2009 to February 2023. Results: All patients underwent successful surgery with a median operative time of 48.9 minutes (range, 20–80 minutes), and no intraoperative or postoperative complications were reported. The median follow-up duration was 85.5 months (range, 4–120 months), with 5 patients (6.1%) lost to follow-up. Treatment was successful in 62 patients, whose symptoms disappeared and both the external opening and the intersphincteric incision completely healed, yielding an overall efficiency rate of 80.5%. There were 15 cases (19.5%) of treatment failure, including 6 (7.8%) that converted to intersphincteric anal fistula and 9 (11.7%) that experienced persistent or recurrent fistulas. Only 1 patient reported minor overflow during the postoperative follow-up, but no other patients reported any significant discomfort. There were no statistically significant differences between patients with surgical success and those with treatment failure in terms of fistula length, history of previous abscess or anal fistula surgery, number of external orifices or fistulas, and location of fistulas (all P>0.05). Conclusion LIFT is a safe and effective sphincter-preserving procedure that yields satisfactory healing outcomes and has minimal impact on anal function.

Objective To explore the application effect of multimodal analgesia combined with goal-di-rected fluid therapy based on enhanced recovery after surgery(ERAS)in the anesthesia management of pa-tients undergoing orthopedic robot-assisted pedicle internal fixation.Methods Eighty patients with lumbar fractures who underwent robot-assisted surgery in Huai'an 82 Hospital from February 2024 to February 2025 were selected as the research objects and divided into the ERAS group and the control group according to the random number table method,with 40 cases in each group.The ERAS group received multimodal analgesia combined with goal-directed fluid therapy based on ERAS,while the control group adopted the traditional an-esthesia protocol.The hemodynamic indicators[heart rate,mean arterial pressure(MAP)]before the start of anesthesia(T0),immediately before the operation(T1),at the end of the operation(T2),and at the time of postoperative recovery(T3),as well as the IL-6 levels at T0,24 hours after the operation(T4),48 hours after the operation(T5),and 72 hours after the operation(T6)were compared between the two groups.Recorded the postoperative recovery time,visual analogue scale(VAS)score,incidence of complications and hospital stay,as well as perioperative infusion management parameters[total infusion volume,positive fluid balance volume,the compliance rate of stroke volume variation(SVV),etc.].Results Compared with the control group,the proportion of MAP fluctuations≤±10%(87.5%vs.62.5%),and the proportion of basal heart rate increase≤20%(95.0%vs.70.0%)in the ERAS group were higher than those in the control group(P<0.05).At T4,the IL-6 levels in both groups were the highest,while the IL-6 levels from T4 to T6 in the ERAS group were lower than those in the control group(P<0.05).Compared with control group,wake times[(18.5±3.2)min vs.(25.1±4.5)min],bed time for the first time[(8.2±2.1)h vs.(20.5±4.3)h],the length of time[(4.2±1.1)d vs.(6.5±1.3)d]in the ERAS group were shorter,24-hour resting VAS score(2.1±0.6 vs.3.8±0.9)and the incidence of complications(20.0%vs.57.5%)were lower,the total infusion volume[(1 850±220)mL vs.(2 550±310)mL],the amount of colloid solution[(620±95)mL vs.(850±120)mL],and the positive balance volume of liquid[(320±90)mL vs.(1 120±210)mL]were less,the intraoperative urine volume[(0.55±0.08)mL·kg-1·h-1 vs.(0.30±0.10)mL·kg-1·h-1]was more,the differences were statistically significant(P<0.05).The compliance rate of SVV in the ERAS group was 95.0%(38/40).Conclusion Multimodal analgesia combined with goal-directed fluid therapy based on ERAS can effectively stabilize the perioperative physiological state of patients undergoing robot-assisted spinal sur-gery,accelerate postoperative functional recovery and reduce complications.