Mining and analysis of adverse drug event signals of cinacalcet and etelcalcetide / 中国药房

OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of cinacalcet and etelcalcetide， to provide a reference for safe drug use in the clinic. METHODS ADE reports related to cinacalcet and etelcalcetide were extracted from the FDA Adverse Event Reporting System from January 1st， 2004 to June 30th， 2023 using the OpenVigil online tool. The Bayesian confidence propagation neural network method was adopted to detect the signals of ADE from the key organ systems. The signals were encoded according to the preferred term in the ADE terminology set of the Medical Dictionary for Regulatory Activities （26.0 edition）. RESULTS A total 41 709 and 1 710 ADE reports were extracted， and 29 and 45 safety signals were detected in key systems for cinacalcet and etelcalcetide， respectively； 20 and 36 positive signals were not included in the drug instructions. Hypocalcemia/decreased serum calcium， abnormal blood parathyroid hormone （PTH）/increased or decreased serum PTH were common ADEs of the two drugs， which were detected in the study. Among the signals not included in the drug instructions， new moderate and strong signals were detected， such as cinacalcet-induced calcification defense （metabolic and nutritional diseases）， bone starvation syndrome and high conversion bone diseases （musculoskeletal and connective tissue diseases） as well as etelcalcetide-induced sudden death， necrosis and treatment of non-responders （general disorders， administration site）， unstable angina pectoris， myocardial ischemia （cardiac diseases）， intestinal perforation， gastric antrum vasodilation and gastric ulcer （gastrointestinal diseases）. CONCLUSIONS In the clinical application of the two drugs， apart from the common ADEs such as hypocalcemia and abnormal blood PTH， the surveillance of some new potential ADEs should also be carried out， such as bone starvation syndrome， calcification defense， ventricular disease and other cinacalcet-induced ADEs， sudden death， myocardial ischemia， unstable angina pectoris， intestinal perforation， gastric ulcer and other etecalcetide-induced ADEs. If new ADEs appear， clinic should promptly assess the benefits and risks， and update the treatment plan and pharmacological monitoring plan to ensure the safety of patient medication.

Analysis and identification of a case of pegaspargase-induced acute pancreatitis and literature review / 中国药房

OBJE CTIVE To investigate the clinical characteristics of a dverse drug reactions of asparaginase-associated pancreatitis（AAP），so as to provide reference for clinical safe medication. METHODS Analysis and identification were performed on a severe adverse reaction case of acute pancreatitis complicated with diabetic ketoacidosis and liver injury in a patient with acute lymphoblastic leukemia in our hospital after using pegaspargase. Retrieved from Wanfang database ，CNKI，PubMed and Embase database，case reports of AAP were collected and summarized in terms of patient demographics ，drug use ，incubation period and adverse reaction outcome. Combined with this case ，the disease characteristics and potential risk factors of AAP were analyzed and discussed. RESULTS After analysis and identification ，it was determined that AAP occurred in this patient. A total of 47 case reports were retrieved from the database ，and a total of 52 patients（including this patient ）were included in the analysis ，including 29 males and 23 females，mainly minors （65.4％）. L-asparaginase was the main asparaginase preparation that causes AAP （80.8％）. Gastrointestinal symptoms were the main prodromal symptoms （92.3％），which could be accompanied by other asparaginase related adverse reactions. AAP could occur after 1-33 times of administration ，and the median latency was 14 days after administration；compared with children ，median latency of AAP in adult patients was shortened significantly （11 d vs. 16 d，P＝ 0.049）；the median latency of AAP had longer tendency in patients treated with pegaspargase than that of L-asparaginase （17 d vs. 12.5 d，P＝0.490）. Of the cases included in the analysis ，8 patients died due to AAP ，1 of which was related to re-exposure to asparaginase preparations. CONCLUSIONS Acute pancreatitis is a serious and potentially fatal adverse drug reaction of ； asparaginase preparations. Clinical medical staff should pay attention to the characteristics of AAP ，consider the possibility ： of AAP when the patients have gastrointestinal symptoms and do a good job in patient education and pharmaceutical care to minimize the damage caused by AAP to patients.

Experimental research on the characteristics of pancreatic cells regeneration in an animal model for isolated pancreatic trauma / 重庆医学

Objective To study the relationships between tissue damage and the ability of the pancreatic cells to regenerate ,and analyze the alteration of the pancreatic cells regeneration .Methods Sixty rats were divided into two groups :impact group(the pan‐creas was injured by a BIM‐Ⅲ biotical impact machine ,40 rats) and control group(sham operated ,20 rats) .All rats were sacrificed at 6 h ,24 h ,72 h ,7 d after operation .The level of AMS ,LPS in the serum were detected by spectrophotometry ,pancreatic cells re‐generation were examined and analyzed by TUNEL staining and flow cytomertry ,and the Bcl‐2 and Bax expression were measured by Western blot .Results In the impact groups ,LPS was activated later than AMS ,and lasted persistently .The results from TUNEL stain ,flow cytometry and Western blot indicated that pancreatic trauma induces cell death and the compensatory prolifera‐tion of pancreatic cells .The characteristics of pancreatic cells regeneration in the animal model of isolated pancreatic trauma indicate that the proper remedial time is in the first 24h after the pancreatic trauma .Conclusion Detecting AMS and LPS at the same time can help us to determine the exocrine function of pancrease .

Prospective study on the treatment of traumatic biliary stricture by balloon dilatation / 中华消化外科杂志

Objective To investigate the efficacy of balloon dilatation in the treatment of traumatic biliary stricture(TBS).Methods Eighty-one patients with TBS who had been admitted into General Hospital of Chengdu Command from February 1997 to February 2007 were divided into 2 groups.In the control group,40 patients underwent choledoco-jeiunostomy with T tube stenting in the anastomotic stoma for 6 months.In the balloon dilatation group,41 patients received implantation of the balloon catheters along with the two arms of the T tube in the anastomotic stoma.The efficacy of different surgical procedures were analyzed by chi-square test.Results Seven patients in the control group were failed with a failure rate of 18%.Of the 7 palients,6 were transferred to receive balloon dilatation and 5 were cured.In the balloon dilatation group,only 1 patient was failed and the failure rate was 2%.The diameter of the anastomotic stoma ilq the balloon dilatation group was dilated gradually to 12 mm in 3 months.The difference upon the success rate of the operation between the 2 groups had statistical significance (x2=5.10,P＜0.05).Conclusions Balloon dilatation is effective in the treatment of TBS.

Prolene hernia system in the tension-free repair operation of inguinal saddle hernia / 国际外科学杂志

Objective To explore the therapeutic efficacy and operation experience of Prolene Hernia System (PHS) in the tension-free repair operation of inguinal saddle hernia. Methods All 41 cases using PHS were selected as the subjects of this study and the results were analyzed. Results All patients were performed operation under the local anesthesia, and lasted from 25 min to 60 min. They had been keeping in ward for observation from 24 h to 72 h. No serotal swelling, hematoma, and incisional wound infection hap-pened after the operation. The follow-up time had been lasting from 6 months to 42 months, and none of pa-tients catehed a relapse or had the sensation of the foreign bodies. Conclusions Using PHS is safe and ef-fective in the tension-free repair operation, and it is more suited to inguinal saddle hernia. The key of opera-tion success is attaching importance to operation skills.

Effect of pancreatic elastase on expression of TNF-? and IL-1? in Kupffer cells induced by lipopolysacchride / 解放军医学杂志

Objective To evaluate the effect of pancreatic elastase on the expression of TNF ? and IL 1? in Kupffer cells induced by lipopolysacchride. Method Cultivating Kupffer cells were divided into 3 groups. In group A, physiological saline was added into the culture medium as control (control group). Lipopolysacchride (LPS) was added instead of saline in group B (LPS group). In group C both lipopolysacchride and pancreatic elastase were added to the cultere medium (LPS+elastase group). The expressions of TNF ?, IL 1? and TLR4 mRNA in Kupffer cells were determined by RT PCR, and concentrations of TNF ? and IL 1? in the culture media by ELISA. Results The results of both RT PCR and ELISA indicated that the expressions of TNF ? and IL 1? in group C was significantly higher than that in group B. Conclusion It was concluded that pancreatic proteases such as elastase could enhance the expressions of TNF ? and IL 1? of hepatic Kupffer cells induced by lipopolysacchride, and the results the might offer the explanation why inflammatory reaction could be amplified in the course of acute pancreatitis

Emergency damage control treatment for the severe abdomen trauma of 192 cases / 中国现代普通外科进展

Objective: To explore the application experiences and effects of emergency damage contro(lDC)treatment for severe abdomen trauma. Methods: The clinical data of 192 patients with severe abdomen trauma were selected as the object of this study. A retrospective analysis was done on therapy condition and effects of emergency damage control treatments. Results: Pre-hospital emergency care was performed in all 192 patients, damage control operations (DCO)were done in 186 cases, 184 cases entered surgical intensive care unit (SICU)for resuscitation, and 177 cases were adopted corresponding reoperations after SICU resuscitation. The abnomal DCO indices recovered gradually in the 72 hours after DCO. The cure rate was 90.7% with 174 cases, and the incidence of complication was as low as 2.3% with 4 cases after reoperations, and the 4 cases all healed by conservative treatments. Mortality rate was 6.2% with 12 cases, and it caused by associated organs injuries, severe primary disease and secondary infection of other organs. Conclusion: Emergency damage control treatment modus should be chosen positively and eligibly under indication to severe abdomen trauma patients. According to the difference of location and degree of injury, eligible therapies by stages are the key managements.