Objective:To explore the role of internal stenting for preventing biliary anastomotic complications during complex duct-to-duct biliary reconstruction of orthotopic liver transplantation.Methods:From December 1, 2018 to April 30, 2020, intraductal stent was placed in 6 cases of complex biliary tract reconstruction during liver transplantation. Postoperative prognosis, recovery of bilirubin and biliary enzymes, management of intraductal stent and occurrence of postoperative biliary complications were observed.Results:All of them recovered and were discharged smoothly and bilirubin and biliary enzymes normalized before discharge. The average peak values of total bilirubin, alkaline phosphatase, total bile acid and γ-glutamyl transpeptidase were 83.8±56.4 μmol/L, 151.5±76.3 U/L, 301.7±177.0 U/L and 98.4±80.9 μmol/L and the average turning points of total bilirubin, alkaline phosphatase, total bile acid and γ-glutamyl transpeptidase 2.3±1.0, 3.0±1.1, 3.8±1.2 and 1.8±0.8 days; average time of complete recovery of total bilirubin, alkaline phosphatase, total bile acid and γ-glutamyl transpeptidase 7.7±5.1, 5.0±4.9, 23.5±7.6 and 3.8±2.4 days respectively. Intraductal stent was removed by gastroduodenoscopy ( n=3) and slipped off ( n=3). Except for one case of asymptomatic anastomotic stricture at 1 year post-operation, no biliary complications occurred during follow-ups. Conclusions:The placement of intraductal stent during complex biliary reconstruction of liver transplantation can effectively promote the recovery of postoperative liver function, enhance the quality-of-life of patients, effectively avoid the occurrence of biliary anastomotic complications and ensure the safety of patients.

Objective:To investigate the clinical evaluation effects of Corona Virus Disease 2019 (COVID-19) risk assessment scale on preoperative and surgical risk of liver transplantation during the COVID-19 outbreak.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 6 liver transplant recipients who were admitted to Southern Theater Command General Hospital of PLA between January 20 and March 27, 2020 were collected. There were 5 males and 1 female, aged from 42.0 to 62.0 years, with a median age of 53.0 years. There were 6 donors including 5 males and 1 female, aged from 24.0 to 60.0 years, with a median age of 41.5 years. All the donor livers were obtained through the China Organ Transplant Response System. Liver transplantation was performed in the fixed negative pressure operating room, and secondary protective measures were adopted for low-risk donors. Classic orthotopic liver transplantation or Piggyback liver transplantation was performed according to the specific situations of the recipients. Medical staffs in the ward were exposed to the secondary protective measures, and the three-grade protective measures were adopted for medical staffs when the liver transplant recipients had fever or suspected infection. Observation indicators: (1) risk assessment of COVID-19 on liver transplant recipients; (2) risk assessment of COVID-19 on medical staffs of liver transplantation; (3) treatment situations of liver transplant recipients; (4) postoperative situations of liver transplant recipients; (5) follow-up of liver transplant recipients; (6) infection of medical staffs of liver transplantation. Follow-up was performed using outpatient examination or telephone interview to detect whether liver transplant recipients had suspected or confirmed COVID-19 infection up to March 2020. Medical staffs who were involved in organ acquisition, transplantation surgery and ward management were followed up to detect whether they had suspected or confirmed COVID-19 infection within 14 days. Measurement data with normal distribution were represented as Mean± SD, and measurement data with skewed distribution were described as M (range). Count data were expressed as absolute numbers. Results:(1) Risk assessment of COVID-19 on liver transplant recipients: all the 6 recipients and their related families were confirmed no contact with suspected COVID-19 patients or travel history in the epidemic area within 14 days. Of the 6 recipients, 1 was diagnosed with fever with body temperature of 38.1 ℃ and was tested negative for chest computer tomography (CT) examination and nucleic acid test for COVID-19; 1 was diagnosed with fever and hypoxemia with body temperature of 38.5 ℃ and was tested negative for nucleic acid test for COVID-19, and the results of chest CT examination showed large amount of pleural effusion in both lungs without invasive pneumonia; other 4 recipients had no clinical symptoms of COVID-19 with negative results of chest CT examination and nucleic acid test for COVID-19. Five of the 6 recipients had no history of contact with COVID-19 patients and 1 recipient had treatment history at hospital of risk level 1. The preoperative risk level of COVID-19 was low in all the 6 liver transplant recipients. (2) Risk assessment of COVID-19 on medical staffs of liver transplantation: of the 6 recipients, 5 had the waiting hospital of risk level 0 and 1 had the waiting hospital of risk level 1. Six recipients had the transplant hospital of risk level 0. (3) Treatment situations of liver transplant recipients: of the 6 recipients, 2 underwent classic orthotopic liver transplantation and 4 underwent piggyback liver transplantation. The cold ischemia time of liver, time of anhepatic phase, volume of intraoperative blood loss, operation time, treatment time at intensive care unit of the 6 recipients were (5.9±2.4)hours, (49±14)minutes, 1 500 mL(range, 800-1 800 mL), (8.9±2.1)hours, 2 days(range, 1-4 days), respectively. Of the 6 recipients, 2 required adjustment of the immunosuppression program, and 4 did not change the immunosuppression program. (4) Postoperative situations of liver transplant recipients: of the 6 recipients, 5 had no postoperative serious infection and 1 had postoperative serious infection. The 5 recipients without postoperative serious infection had the range of the highest temperature as 37.8-38.5 ℃, and returned to normal temperature within postoperative 3 days. All of the 5 recipients who had no postoperative serious infection received chest CT examination with no obvious manifestation of viral pneumonia and were tested negative for nucleic acid test for COVID-19 at 1 week postoperatively, and then were discharged from hospital. One recipient who had postoperative serious infection had gastrointestinal fistula and repeated fever at postoperative 7 days with the highest temperature as 39.2 ℃. This recipient had body temperature returned to normal and good function of the graft after treatment in the isolation ward with active drainage, and was transferred back to local hospital for further rehabilitation treatment. The duration of hospital stay of the 6 recipients were 30 days(range, 15-74 days). (5) Follow-up of liver transplant recipients: all the 6 recipients were followed up for 31.5 days(range, 12.0-64.0 days) with the normal body temperature, and they had negative results of viral pneumonia for chest CT examination and nucleic acid test for COVID-19. (6) Infection of medical staffs of liver transplantation: surgeons, nurses, anesthetists, medical staffs at ICU and medical staffs at liver transplantation center who participated in liver transplantation had good health within postoperative 14 days, without suspected or confirmed cases of COVID-19 infection.Conclusions:The COVID-19 risk assessment scale has good safety for liver transplant recipients during the COVID-19 outbreak. It is suggested that organ transplantation can be carried out in low-risk recipients and cautiously carried out in recipients of uncertain risk, but organ transplantation should not be carried out in high-risk recipients.

OBJECTIVE To investigate the marketing status， general characteristics， and time trends of rare disease drugs in China. METHODS Based on 121 kinds of rare diseases included in the First Batch of Rare Disease Catalog， the names and marketing approval information of corresponding drugs with indications were obtained from the databases of the Center for Drug Evaluation， National Medical Products Administration and Yaozhi.com， and the relevant characteristic variables were extracted for descriptive statistical analysis. RESULTS As of December 31， 2022， only 32 of 121 rare diseases have therapeutic drugs available for treatment on the market in China， and 79 rare disease drugs have been approved. Among them， 46.84% of the drugs are domestic drugs， 88.61% of the drugs are approved for use in both adults and children； 67.09% are chemicals and 59.49% are injections. According to the ATC classification， Category A （digestive system drugs） is the most， accounting for 20.25%. The number of rare disease drugs on the market each year is the highest in 2021， with an overall upward trend from 2018 to 2021 and a downward trend in 2022. Among rare disease drugs on the market each year， according to the ATC classification， the number of Category L （antineoplastics and immune inhibitors） will be the largest in 2021， being 5. By dosage form， oral medicines were marketed in the largest number in 2022， and injectable medicines in 2021. CONCLUSIONS In recent years， the number of approved rare disease drugs in China has been continuously increasing， but it is still far from meeting the needs of patients， and there is still a lack of domestically approved rare disease drugs. We should further accelerate the research and development of rare disease drugs， and promote the import and replication of rare disease drugs.

OBJECTIVE To investigate the marketing status， general characteristics， and time trends of rare disease drugs in China. METHODS Based on 121 kinds of rare diseases included in the First Batch of Rare Disease Catalog， the names and marketing approval information of corresponding drugs with indications were obtained from the databases of the Center for Drug Evaluation， National Medical Products Administration and Yaozhi.com， and the relevant characteristic variables were extracted for descriptive statistical analysis. RESULTS As of December 31， 2022， only 32 of 121 rare diseases have therapeutic drugs available for treatment on the market in China， and 79 rare disease drugs have been approved. Among them， 46.84% of the drugs are domestic drugs， 88.61% of the drugs are approved for use in both adults and children； 67.09% are chemicals and 59.49% are injections. According to the ATC classification， Category A （digestive system drugs） is the most， accounting for 20.25%. The number of rare disease drugs on the market each year is the highest in 2021， with an overall upward trend from 2018 to 2021 and a downward trend in 2022. Among rare disease drugs on the market each year， according to the ATC classification， the number of Category L （antineoplastics and immune inhibitors） will be the largest in 2021， being 5. By dosage form， oral medicines were marketed in the largest number in 2022， and injectable medicines in 2021. CONCLUSIONS In recent years， the number of approved rare disease drugs in China has been continuously increasing， but it is still far from meeting the needs of patients， and there is still a lack of domestically approved rare disease drugs. We should further accelerate the research and development of rare disease drugs， and promote the import and replication of rare disease drugs.