General characteristics, economic burden, causative drugs and medical errors associated with medical damage litigation involving severe cutaneous adverse drug reactions in China.

WHAT IS KNOWN AND OBJECTIVE: To investigate the general characteristics, economic burden, causative drugs and medical errors associated with litigation involving severe cutaneous adverse drug reactions (SCADRs) in China, with the aims of improving rational medication use and reducing the extent of damage from SCADRs. METHODS: This study analysed 150 lawsuit judgements involving SCADRs from 2005 to 2019, collected from China Judgments Online. RESULTS AND DISCUSSION: In total, 50% of lawsuits stemmed from SCADRs occurring in general hospitals. The average time elapsed from the date of occurrence of the SCADRs to the end of litigation procedures was 1055 days. Of the patients involved, 51% were female and more than two thirds (69%) were under 60 years old. The most common outcome of SCADRs was death (39%), followed by disabilities (30%). The average responsibility of the medical provider was 48 ± 29%. The average amount of compensation was $43 424. Of the cases studied, 51% of SCADRs were Stevens-Johnson syndrome or toxic epidermal necrolysis, which together accounted for 75% of cases with known clinical subtype. The overall average economic burden of SCADRs was $99 178, of which indirect costs made up the largest proportion (more than 60%). The most common causative drug groups were antimicrobial drugs (49%), Chinese patent medicine and Chinese herbal medicine (17%), and antipyretic analgesics (16%). Finally, 61% of medical errors were found to stem from violation of duty of care, 20% from violation of informed consent and 18% from violations related to the medical record writing and management system. WHAT IS NEW AND CONCLUSION: Severe cutaneous adverse drug reactions not only severely affect patient survival and quality of life, but also impose a heavy economic burden in terms of health care and societal costs. Medical providers should be better educated on strategies to reduce risk to patients and establish mechanisms of risk sharing and management.

Development of laparoscopic technology in biliary surgery in the past 23 years: a single-center experience / 南方医科大学学报

<p><b>OBJECTIVE</b>To summarize the 23-year experience of laparoscopic biliary surgery in General Hospital of PLA and evaluate the application of laparoscopic surgery in the treatment of biliary diseases.</p><p><b>METHODS</b>We retrospectively analyzed the clinical data of 11 419 consecutive patients with biliary diseases undergoing laparoscopic surgery from April, 1992 and December, 2014. The disease spectrum was compared between patients treated before December 31, 2003 and those treated after the time point.</p><p><b>RESULTS</b>The 11419 patients receiving laparoscopic surgery accounted for 56.3% of the total patients undergoing biliary surgeries during the 23 years, including 4701 male and 6718 female patients with a mean age of 50.9∓13.2 years (6-93 years). Most (80.83%) of the patients received laparoscopic surgery for gallbladder stones, and 12.53% patients had the operation for gallbladder polyps. The laparoscopic operation rate was 84.81% in patients with gallbladder stones and 34.91% in patients with extrahepatic bile duct stones, but remained low in patients with biliary carcinoma. In laparoscopic operations, laparoscopic cholecystectomy was the most frequent (96.18%) followed by operations for extrahepatic bile duct stones, in which primary suture accounted for 1.38%, traditional T tube drainage for 0.90% and laparoscopic transcystic duct exploration for 0.72%. For malignant tumors, laparoscopic technique was used mainly for the purpose of exploration (0.34%). The application of laparoscopic technique in biliary surgery tended to increase after the year 2004, especially for benign gallbladder diseases and extrahepatic bile duct stones (P<0.05).</p><p><b>CONCLUSION</b>Laparoscopic technique in biliary surgery is gradually replacing the traditional open operation and becomes the gold standard for the treatment of benign biliary diseases.</p>

Clinicopathological characteristics and prognostic factors of intrahepatic biliary cystadenocarcinoma / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Surgical resection is generally considered the main curative treatment for intrahepatic biliary cystadenocarcinoma (IBCA) or suspected IBCAs, but controversy exists regarding the prognosis for IBCAs. This study aimed to describe the clinicopathological characteristics of IBCA and identify prognostic factors that may influence the survival of patients treated with surgical procedures.</p><p><b>METHODS</b>Thirty-four patients with histologically confirmed IBCA treated between January 2000 and June 2014 were included. The clinical characteristics of patients with IBCA were compared with those of 41 patients with intrahepatic biliary cystadenoma (IBC); factors that significant difference were analyzed for prognosis analysis of IBCA using multivariate/univariate Cox proportional hazards regression models. Survival curves were constructed using the Kaplan-Meier method and compared using the log-rank test.</p><p><b>RESULTS</b>IBCAs had a strong female predominance, and the most common presenting symptoms were abdominal pain or discomfort. Compared with IBCs, IBCAs occurred in older patients, in more male patients, and were associated statistically significant abnormal increase in alanine aminotransferase (P = 0.01) and total bilirubin (P = 0.04). Mural nodules were more frequently seen with IBCAs and may associate with malignancy. It was difficult to differentiate between IBC and IBCA based on laboratory examination and imaging findings. Although complete resection is recommended, enucleation with negative margins also achieved good outcomes. Median overall patient survival was 76.2 months; survival at 1, 3, and 5 years was 88.0%, 68.7%, and 45.8%, respectively. Radical resection and noninvasive tumor type were independent prognostic factors for overall survival.</p><p><b>CONCLUSIONS</b>It remains difficult to distinguish between cystadenomas and cystadenocarcinomas based on laboratory examination and image findings. Complete resection is recommended for curative treatment, and patients should be closely followed postoperatively, particularly those with invasive tumors.</p>

Establishment of a stable mouse model of brain death by the method of the gradually increasing intracranial pressure / 中国医学科学院学报

<p><b>OBJECTIVE</b>To establish a stable and modified mouse model of brain death (BD) and to share our experiences in BD induction and maintenance.</p><p><b>METHODS</b>Totally 35 C57BL/6 male mice were randomized into BD group (n=25) or sham control group (n=10). BD was induced by inserting a 2F Fogarty catheter connected to a syringe pump after trepanation of the left frontoparietal area and injecting volume at the speed of 6 μl/min until spontaneous respiration ceased. BD was diagnosed by electroencephalogram, apnea testing,as well as testing of brain stem reflexes. Mechanical ventilation was performed by orotracheal intubation. Right carotid artery was intubated by a PE-10 cannula for the continuous monitoring of mean blood pressure (MAP) and heart rate (HR). The right external jugular vein was catheterized for volume resuscitation.The sham control group underwent the same procedure with catheter insertion but without balloon inflation.Livers were removed and fixed in paraffin to evaluate the histological alterations with the light microscopy.</p><p><b>RESULTS</b>Mouse models of BD were successfully established about 20 minutes after balloon inflation, and the mean balloon volume at the time of BD was (105.77 ± 21.57)μl. The MAP and HR rapidly increased on occurrence of BD and the peak value was (128.28 ± 17.16) mmHg and (434.16 ± 55.75) beat/min, respectively, which were significant higher than those in the sham control group at the same time point (P=0.000). During the 4-hour follow-up time, MAP and HR in 72% (18/25) of BD animals remained haemodynamically stable. No animal died due to anesthesia and surgical operation.Hepatic tissues in BD mice showed mild focal ischemic damages (cellular edema, congestion, and inflammatory infiltration), which were slighter and fewer in sham control group.</p><p><b>CONCLUSION</b>The mouse model of BD was successfully established with lower surgical difficulty and can be performed in a standardized, reproducible and successful way.</p>

Technical points of total laparoscopic choledochal cyst excision / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Choledochal cyst excision and biliary enteric reconstruction constitute the best therapy for choledochal cyst. And laparoscopy is currently used to cure this disease now.</p><p><b>METHODS</b>We retrospectively analyzed the clinical data of 34 cases of total laparoscopic choledochal cyst excision between January 2007 and August 2011. All patients underwent in vitro Roux-en-Y hepatoenterostomy.</p><p><b>RESULTS</b>All 34 patients underwent successful total laparoscopic choledochal cyst excision. The operation time was 200 - 360 minutes. The duration of hospital stay was 3 - 7 days. Follow-up observations lasted 1 - 56 months. One patient developed an anastomotic stoma stricture, but no other cases had postoperative complications. No patients died.</p><p><b>CONCLUSION</b>Total laparoscopic choledochal cyst excision is safe and feasible.</p>

Effect of resection following downstaging of unresectable hepatocelluar carcinoma by transcatheter arterial chemoembolization / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>This retrospective study was undertaken to analyze the outcome of hepatic resection in fifty-two patients with unresectable hepatocellular carcinoma (HCC) between January 2004 and December 2008.</p><p><b>METHODS</b>Among these fifty-two patients, the mean diameter of the tumor was 7.9 cm (4.4 - 15.5 cm, median 8.5 cm) prior to the first transcatheter arterial chemoembolization (TACE). After 1 - 6 times of TACE (median 2), the median tumor diameter was reduced to 4.2 cm (0 - 8.4 cm) prior to resection. The duration between the last TACE treatment and sequential resection varied from one to six months (median 2.7 months). Serum a-fetoprotein (AFP) levels were abnormal in thirty-eight out of the fifty-two patients. In AFP producing HCCs, AFP levels returned to normal (≤ 400 µg/L) in twenty-five out of thirty-eight patients. Hepatic segmentectomy, multiple hepatic segmentectomy or partial hepatic resection were performed in forty-five patients, two underwent extended left hemihepatectomy, and one underwent right posterior branch portal vein thrombectomy. One patient received a right hemihepatectomy and three had left hemihepatectomies.</p><p><b>RESULTS</b>Complete tumor radiological response (CR) occurred in five patients (9.6%). There were three cases of perioperative mortality in the fifty-two patients (5.8%). One patient underwent salvaged orthotopic liver transplantation, and twenty-one patients observed tumor recurrence within two years. The 1-, 3- and 5-year survival rates of the fifty-two patients were 77.0% (n = 40), 55.0% (n = 29), and 52.0% (n = 28), respectively. The median survival time after surgery was 49 months (95% confidence interval 7.5 - 52.7 months).</p><p><b>CONCLUSIONS</b>TACE treatment provides a better chance for HCC resection in patients initially diagnosed with unresectable HCC. Furthermore, liver resection should be performed once the tumor is downstaged to be compatible for successful resection.</p>

Diagnosis and treatment of fungal infection after liver transplantation / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Liver transplantation is the most effective treatment for end-stage liver diseases; however, infections after transplantation can seriously affect the patient's health. The aim of this research was to investigate the diagnosis and treatment of fungal infection following liver transplantation.</p><p><b>METHODS</b>Clinical data for 232 liver transplant patients at risk of fungal infection were examined for the presence of fungus in the blood, fluid, sputum, urine and stools of patients and by chest or abdominal CT scans. Patients diagnosed with a fungal infection were treated with Fluconazole or, if this was not effective, Voriconazole or Amphotericin B. Immunosuppressive therapy was also reviewed.</p><p><b>RESULTS</b>Thirty-seven of 232 (15.9%) patients were diagnosed with a fungal infection, which occurred 4 to 34 days post-transplantation. Candida infections were diagnosed in 23 cases (62.2%) and Aspergillus infections in 12 cases (32.4%). Twenty-one cases were effectively treated with Fluconazole, 11 cases with Voriconazole, and two cases with Amphotericin B; however, three cases were not effectively treated with any of the antifungal agents. Overall, treatment was effective in 91.9% of patients.</p><p><b>CONCLUSIONS</b>Fungal infection has a significant influence on survival rate after liver transplantation. Imaging studies, and pathogenic and biopsy examinations can diagnose fungal infections, which can be effectively treated with antifungal agents such as Fluconazole, Voriconazole or Amphotericin B.</p>

Ex vivo liver resection followed by autotransplantation for end-stage hepatic alveolar echinococcosis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>For patients with end-stage hepatic alveolar echinococcosis (AE), in vivo resection of the involved parts of the liver is usually very difficult, therefore, allogenic liver transplantation is indicated. However, we hypothesize that for selected patents, ex vivo liver resection for thorough elimination of the involved tissues and liver autotransplantation may offer a chance for clinical cure.</p><p><b>METHODS</b>We presented a 24-year-old women with a giant hepatic AE lesion who was treated with hepatectomy, ex vivo resection of the involved tissue and hepatic autotransplantation. The patient had moderate jaundice and advanced hepatic AE lesion which involved segments I, IV, V, VI, VII, VIII and retrohepatic inferior vena cava. The lateral segments (II and III) of the left liver remained normal with over 1000 ml in its volume. No extrahepatic metastases (such as to the lung or brain) could be found. As the first step of treatment, X-ray guided percutaneous transhepatic cholangiodrainage (PTCD) was performed twice for bile drainage in segment III and II separately until her serum total bilirubin decreased gradually from 236 to 88 µmol/L. Total liver resection was then performed, followed by extended right hepatic trisegmentectomy and the entire retrohepatic vena cava was surgically removed en bloc while her hemodynamics parameters were stable. Neither veino-veinous bypass nor temporary intracorporeal cavo-caval or porto-caval shunt was used during the 5.7-hour anhepatic phase. The remained AE-free lateral segments of the left liver were re-implanted in situ. The left hepatic vein was directly anastomosed end-to-end to the suprahepatic inferior vena cava due to the lack of the retrohepatic inferior vena cava with AE total infiltration. Because compensatory retroperitoneal porto-caval collateral circulation developed, we enclosed remained infrahepatic inferior vena cava at renal vein level without any haemodynamics problems.</p><p><b>RESULTS</b>During a 60-day following-up after operation, the patient had a good recovery except for a mildly elevated serum total bilirubin.</p><p><b>CONCLUSIONS</b>As a radical approach, ex vivo liver resection and liver autotransplantation in a case has shown a optimal potential for treatment of the end-stage hepatic AE. Strict compliance with its indications, evaluation of vessels of patients pre-operatively, and precise surgical techniques are the keys to improve the prognosis of patients.</p>

Effect of arterioportal shunting in radical resection of hilar cholangiocarcinoma / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The resection and reconstruction of the hepatic artery is often required in radical surgery for hilar cholangiocarcinoma. In this study, we report our experience in performing arterioportal shunting as an alternative for the arterial reconstruction.</p><p><b>METHODS</b>Four patients with hilar cholangiocarcinoma underwent extended left hepatectomy and caudate lobectomy combined with en bloc resection of the hepatic artery and arterioportal shunting with restriction of the arterial caliber. The efficacy of arterioportal shunting was assessed by computed tomography angiography (CTA).</p><p><b>RESULTS</b>All the four patients recovered uneventfully without any complications. CTA showed a patent shunt and normal liver regeneration. No signs of portal hypertension were found at one year of follow-up.</p><p><b>CONCLUSIONS</b>Arterioportal shunting with restriction of the arterial caliber appears to be a feasible and safe alternative for the microvascular reconstruction after hepatic artery resection in radical surgery for hilar cholangiocarcinoma.</p>