Allergic reactions of COVID-19 vaccine based on mRNA-LNP and its pharmacokinetics in vivo / 药学学报

Vaccination has been proved to be the most effective strategy to prevent the Corona Virus Disease 2019 (COVID-19). The mRNA vaccine based on nano drug delivery system (NDDS) - lipid nanoparticles (LNP) has been widely used because of its high effectiveness and safety. Although there have been reports of severe allergic reactions caused by mRNA-LNP vaccines, the mechanism and components of anaphylaxis have not been completely clarified yet. This review focuses on two mRNA-LNP vaccines, BNT162b2 and mRNA-1273. After summarizing the structural characteristics, potential allergens, possible allergic reaction mechanism, and pharmacokinetics of mRNA and LNP in vivo, this article then reviews the evaluation methods for patients with allergic history, as well as the regulations of different countries and regions on people who should not be vaccinated, in order to promote more safe injection of vaccines. LNP has become a recognized highly customizable nucleic acid delivery vector, which not only shows its value in mRNA vaccines, but also has great potential in treating rare diseases, cancers and other broad fields in the future. At the moment when mRNA-LNP vaccines open a new era of nano medicine, it is expected to provide some inspiration for safety research in the process of research, development and evaluation of more nano delivery drugs, and promote more nano drugs successfully to market.

Causes and managements of postoperative neurological complications in internal fixation for the treatment of degenerative scoliosis / 中国骨伤

<p><b>OBJECTIVE</b>To investigate the causes and managements of postoperative neurological complications in pedicle screw internal fixation for the treatment of degenerative scoliosis (DS).</p><p><b>METHODS</b>The data of 325 patients with degenerative scoliosis underwent pedicle screw internal fixation was retrospectively analyzed from February 2000 to April 2013. There were 22 patients with postoperative neurological complications. Of them, 16 cases complicated with numbness or pain of lower limb and 6 cases with obvious sensation and motor function decreasing in lower limb. The patients were treated with trophic nerve, dehydration, glucocorticoids, reoperation according to the causes of disease. Postoperative at 3, 6 months and 1 year later, according to VAS scoring and muscule power improvement,the recovery of nerve injury was assessed.</p><p><b>RESULTS</b>Postoperative at 3,6 months and 1 year later,VAS scoring of 16 patients with slightly nerve injury was 2.81 +/- 0.66, 1.94 +/- 0.77, 0.63 +/- 0.62, respectively, and the symptoms had obviously improved than 1 week after operation (P < 0.05). Postoperative at 3 months, among 6 patients with severe nerve injury,muscule power improved in 2 cases and no-improved in 4 cases, with VAS scoring of 4.83 +/- 1.17; postoperative at 6 months,muscule power still had not improved in 3 cases,with VAS scoring of 4.17 +/- 0.75; both of the VAS scoring had not significant difference than 1 week after operation (P > 0.05). One year later, there was no muscule power improvement in 2 cases,with VAS scoring of 3.00 +/- 1.26, there was significant difference than 1 week after operation (P < 0.05).</p><p><b>CONCLUSION</b>The causes of postoperative neurological complication in internal fixation for the treatment of dengenerative scoliosis includes: dragging and torsion injury of spinal marrow and nerve root because of excessive orthopedic of scoliosis; inderect injury of nerve root because of malposition of pedicle screw; nerve functional impairment caused by spinal cord ischemia. Avoiding the above factors could decrease the complication and early discovery and treatment could decrease the adverse outcomes.</p>

Comparative study on the effect of highly active antiretroviral therapy (HAART) in patients with HIV infection acquired by blood transfusion and paid plasma donation / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To study the effect of HAART in patients with AIDS acquire by blood transfusion and paid plasma donation.</p><p><b>METHODS</b>All AIDS patients whose disease was caused by blood transfusion and commercial plasma donation came from the domicile of Hebei Province. In the group of cases of blood transfusion in whom the infection was caused by one-time blood transfusion before and after 1995, there were 189 cases, of whom 105 cases on HAART were designated as observation group, and 84 cases who were not on HAART were designated as control group. The group of AIDS patients who were former commercial plasma donors (FCPDs) had 120 patients who were identified in the survey of 1995, of whom 63 cases on HAART were designated as observation group and 57 cases who were not on HAART were as control group. Onset dates were defined as the dates into the queue. Death due to AIDS was regarded as an outcome event. Subjects who were enrolled into the observation group and control group were epidemiologically followed up regularly. Observation was ended on December 31, 2010.</p><p><b>RESULTS</b>Mortality of patients after HAART from groups of FCPDs and blood recipients were 4.42/100 person-years and 6.13/100 person-years, respectively. The survival rates of HAART groups were 80% in FCPDs for 110 months and 72% in blood recipients for 90 months, respectively. Meanwhile the mortality of no HAART groups were 182.05/100 person-years and 250.66/100 person-years, respectively. Mean survival of patients whose disease was caused by plasma donation and blood transfusion were 4 months and 3 months, respectively.</p><p><b>CONCLUSIONS</b>Whether the HIV infection was caused by plasmapheresis or blood transfusion, the effects of HAART did not show difference. HAART cold reduce the death intensity and prolong survival.</p>

A retrospective cohort study on the natural history of AIDS caused by blood transfusion / 中华流行病学杂志

Objective To study the natural history of AIDS,caused by blood transfusion.Methods All HIV infections and AIDS patients were from Hebei province,including those infected through blood transfusion around 1995,that were identified as through general census of former commercial plasma donors (FCPDs).Among those objects being observed during the incubation period,354 had HIV infections( including 142 cases infected via plasmapheresis and 212 cases caused by transfusion) but had not been treated by HAART before the onset of disease.Objects being observed during the survival period,141 were AIDS patients (including 57 cases infected via plasmapheresis and 84 cases causes by transfusion) but had not been treated by HAART before and after the onset of disease.All infectors and AIDS patients were under follow-up on the progress of illness or death,respectively.Results By December 31,2010,the cumulative incidence among HIV infections was 88.70％ ( 314/354),with the incidence density as 9.14/100 person-years ( 314/3435.75 )and the median incubation period was 113 months.Of 142 HIV infections in the blood donation group and 212 infections in the blood transfusion group,the incubation periods were 112 months and 115 months,respectively.All of the 141 patients died 34 months after the onset,with the death-strength as 204.70/100 person-years (141/68.88) and the period of survival was 4 months.Among those 57 FCPDs infections,they were all died 24 months after the onset,with the death-strength as 250.66/100 person-years (57/22.74) and the survival was 3 months.The other 84 infections who were blood recipients,all died 34 months after the onset,with the death-strength as 182.05/100 person-years (84/ 46.14) and the survival was 4 months.Conclusion Through this study,we noticed that the natural history of all the AIDS patients was caused by blood transmission.It was important to evaluate the natural history of HIV epidemics among both FCPDs and blood recipients,occurred before and after 1995.

Retrospective cohort study on period of incubation and survival among former commercial plasma donors infected with HIV in Hebei province / 中华预防医学杂志

<p><b>OBJECTIVE</b>To examine the state of incubation period and survival time of former commercial plasma donors (FCPDs) infected with HIV.</p><p><b>METHODS</b>All objects infected with HIV were from Hebei province and found from general investigation for FCPDs in 1995. The infector cohort by 142 cases was used to estimate incubation period. In the infector cohort, the time which infectors entered the cohort was their infection time, which was the middle value of the origin date, which was January 1, 1995. The onset of AIDS was defined as an outcome event. End point of observation was Dec 31, 2010. There were 192 months in all from beginning to end. The AIDS cohort by 57 cases was used to estimate the survival of the patients. In the patient cohort, the time of AIDS onset was defined as the time entering the cohort, and death of AIDS was defined as an outcome event. The cumulative incidence ratio, cumulative mortality, illness intensity and mortality intensity were analyzed through Kaplan-Meier.</p><p><b>RESULTS</b>During the observation period, 123 cases of 142 infectors developed into AIDS, the cumulative incidence was 86.42% (123/142) and the intensity was 8.53/100 person-years and the median time of incubation period was 112.0 months (95%CI: 108.8 - 115.2). The death dates of 57 patients were from 1 to 24 months after onset. The cumulative mortality was 100%, and the intensity was 250.66/100 person-years and the median survival time was 3.0 months (95%CI: 1.8 - 4.2). It was estimated that the median time was 115.0 months (9.6 years) from infection to death.</p><p><b>CONCLUSION</b>The median times of incubation and median survival time were 112.0 and 3.0 months, respectively.</p>

Following surveillance on HIV infection after blood transfusion / 中华实验和临床病毒学杂志

<p><b>OBJECTIVE</b>To study epidemiological features of HIV infection after blood transfusion and the situation of transmission among members of family.</p><p><b>METHODS</b>The persons infected with HIV through blood transfusion and their intrafamilial transmission in some city were analyzed and testing methods of ELISA, Western-blot, RT-PCR and subtype analyzing were used. The whole surveillance data came from residents investigation around problem medical centres and HIV monitoring network around Hebei province.</p><p><b>RESULTS</b>173 people infected with HIV after blood transfusion in some city, including 89 cases found in hospital and 84 cases in CDC, accounted for 68.7% (173/252) of all of infected persons by blood transfusion in Hebei province. The rate of intrafamilial transmission, spousal transmission and mother-to-child transmission((MTCT) were 32.0% (49/153),17.0% (26/153) and 32.7% (32/98), respectively. Most of persons infected with HIV were youth among who the female were more than the male. Childbearing and women's ailments were the main cause of blood transfusion from 1990 to 1999, and traumatism surgery took second place. Infected persons by HIV blood, whose time to diagnostic were the year from 1999 to 2009, spread over Kangtai hospital and other hospital which accounted for 45.1% (78/173) and 42.2% (73/173), respectively. The genetype of all patients were B' subtype.</p><p><b>CONCLUSION</b>The medical centers at the grass-roots level in some city resulted in outbreak of infected persons by HIV blood because of having no screening test antibody of HIV for liid blood donors.</p>

Rapid detection of norwalk GII with reverse transcription loop-mediated isothermal amplification / 病毒学报

To develop a reverse transcription-loop-mediated isothermal amplification (RT-LAMP) assay for rapid and sensitive detection of Norwalk GII. 4 primers which recognized 6 distinct regions on the RNA-dependent RNA polymerase gene of Norwalk GII were designed and used for LAMP assay. Norwalk GII RNA was amplified under isothermal conditions (65 degrees C) for 120 min, and LAMP results were then judged with naked eye, SYBR Green I staining, electrophoretic analysis and restriction digestion. To evaluate the specificity of the RT-LAMP, 48 fecal specimens of Norwalk GII and 12 fecal specimens of group A rotaviruses were tested. To compare the sensitivity of the RT-LAMP with that of conventional RT-PCR, Norwalk GII RNA was serially diluted and amplified by RT-LAMP and RT-PCR, respectively. With 46 fecal specimens of Norwalk GII, observation with naked eyes, SYBR Green I staining and electrophoretic analysis were able to detect the PCR products in the RT-LAMP assay. The specificity of RT-LAMP products was also confirmed by digestion of the RT-LAMP products with restriction enzymes. No RNA amplification was observed in 2 fecal specimens of Norwalk GII and 12 fecal specimens of group A rotaviruses. The specificity of the RT-LAMP assay with regard to RT-PCR were 100% for Norwalk GII. The detection limits of RT-LAMP was 15.6 pg/tube for Norwalk GII and similar to that of a RT-PCR assay. Compared to RT-PCR, the RT-LAMP assay has been proven to be a rapid, sensitive, specific and accurate method for detection of the Norwalk GII in fecal specimens, and that RT-LAMP assay is potentially useful for the rapid detection of Norwalk GII from fecal specimens in outbreaks of infectious diarrhea.

Investigation on status of HIV-1 infection among blood recipients from 1994 to 1998 in certain areas of China / 中华流行病学杂志

Objective To study the infection status of HIV-1 among blood recipients from 1994 to 1998 in certain areas of Hebei province. Methods A general investigation was set up among all the people in 15 townships of certain areas from November 2003 to February 2005. An epidemiological investigation was conducted among people who had received blood from donors, during 1994 and 1998. Blood samples were collected. ELISA was used in preliminary screening and Western-blot (WB) was used among people who showed a positive result in the preliminary screening. Results The infection rate of HIV-1 after blood receipt was 15.54% (92/592) , and the infected persons were all appeared in five medical centers of 6 townships which located at the west part of the area. HIV-1 infection happened over the years, and reaching the zenith in the year 1995. Most of the infected persons were young women. Procreation was the main cause of blood transfusion for women and trauma was for men. Conclusion A typical HIV outbreak happened in certain areas after blood transfusion in Hebei.

Retrospective cohort study on the rate of mother-to-child transmission among mothers infected with human immunodeficiency virus type 1 through blood transfusion / 中华流行病学杂志

Objective To study the rate of mother-to-child transmission (MTCT) on HIV-1. Methods All local residents from 8 townships in a region were screened for mothers who had a history of only one blood transfusion and 63 were found HIV-1 positive. A further study on these HIV-1 positive mothers and their children was conducted with the emphasis on the date of receiving blood transfusion, date and type of nationality, history regarding breastfeeding and so on. Sera specimens from 84 children born from 63 HIV-1 positive mothers were screened, using ELISA for HIV-1 antibody, and positive specimens were confirmed by Western-blot. Results The rate of MTCT was 32.1% (27/84) for children with all risk factors related to MTCT. Another 36.8% (7/19) were related to factors on intrauterine, intrapartum and breastfeeding, 35.7% (5/14) to intrapartum and breastfeeding factors, 14.3% (2/14) to intrauterine and intrapartum factors, 37.9% (11/29) to breastfeeding factor alone. By group combination analysis, the MTCT rate was 36.9% (24/65) with breastfeeding, 11.8% (2/17) with artificial feeding, and the former was significantly higher than the latter. Conclusion HIV-1 MTCT rate among mothers caused by a single blood transfusion varied with different risk factors. Breastfeeding played an important role in MTCT, appeared in our study.