THE PROPERTIES AND LONGITUDINAL EXPERIENCE OF CHINESE TYPE A BOTULINUM TOXIN FOR THE TREATMENT OF FOCAL DYSTONIA AND HEMIFACIAL SPASM

Objective.To introduce the properties of Chinese type A botulinum toxin(CBTXA,made by Lanzhou Institute of Biological Products),and its long?term effect for focal dystonia and hemifacial spasm.Method.The purity and recovery of crude and crystalline toxin were tested.Long?term data from305patients with hemifacial spasm(HFS),blepharospasm(BS)and cervical dystonia(CD)were evalu-ated and subgroups of patients received CBTXA injections between1994and2000in at least six sepa-rate treatment sessions,with follow up for2～8years.The therapeutic results of the last session CBTXA injections were analyzed in comparison with the first session.Result.CBTXA purity was high[(2.55～2.60)×10 7 LD50/mgPr ,A260/A280≤0.55,high molecular substance accounted for99.2%of total proteins].Long term treatment with CBTXA in patients with focal dystonia and HFS was not associated with any decline in benefit,and efficacy may improve slightly with repeat treatments.CBTXA is an excellent long-term treatment of HFS,BS and CD.Conclusion.We conclude that Chinese type A botulinum toxin is of botulinum toxin therapy quality standard according to results obtained from the basic study and long?term clinical applications.The re?injection of CBTXA significantly improves the quality of life of most patients and is a safe,effective and comparatively economical treatment for patients with focal dystonia and HFS.

An Overview of Type E Botulism in China

The geographical distribution of C. botulinum type E and its associated disease, type E botulism in China, is different from that in other areas of the world. Cases of type E botulism generally arise in costal regions. In China, however, type E botuhsm is found primarily in the Qinghai-Tibet plateau of northwest China far from the ocean, at an altitude of approximately 4-5 kin. The foods most commonly associated with the disease are fermented grain and beans as well as raw meat A suspected outbreak of type E botulism poisoning in the central costal region of China in the 1990s prompted the collection and analysis of samples of mud, sand, and fish from the region. The toxin produced by type E botulinum was found in these samples. Surprisingly, though, upon further analysis, the strain isolated from the samples was identified not as type E C. botulinum, but as the neurotoxigenic bacterium Clostridiurn butyricurn.

Clinical Study on Facial Rejuvenation of Non-crosslinked Small Molecule Hyaluronic Acid Combined with Filorga NCTF®BOOST135 HA

Objective To observe the clinical application of non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135HA in facial rejuvenation.Methods A total of 156 patients were selected from the outpatient department of our department from January 2017 to January 2018,including 36 males and 120 females.They were randomly divided into treatment group(82 cases)and control group(74 cases).The age of the treatment group was 25-50 years old,with an average age of 34 years old,while that of the control group was 26-48 years old,with an average age of 35 years old.group A was treated with non-crosslinked small molecule hyaluronic acid combined with Filorga NCTF®BOOST135 HA,while group B was treated with non-crosslinked small molecule hyaluronic acid alone.Through two methods,the facial skin state is analyzed and the therapeutic effect is evaluated.Results Follow-up for 3-6 months after treatment showed that 73 cases were satisfied and 9 cases were not satisfied in group A,with a satisfaction rate of 89.02%.In group B,52 cases were satisfied and 22 cases were dissatisfied,with a satisfaction rate of 70.27%.Conclusion Hyaluronic acid combined with Filorga NCTF®BOOST135 HA is better than hyaluronic acid alone in the treatment of facial rejuvenation,and patients obtain higher satisfaction.

Preparation and antioxidant activity of albumin binding Salen Schiff-base metal complexes

A kind of novel biopolymer antioxidant (BSA/HOSalenM, M=Co, Mn, Zn) is prepared with conjugation, which increases the antioxidant activity of the bovine serum albumin (BSA). The conjugations have been characterized by IR spectra, UV-Vis spectra, Fluorescence spectra, Circular dichroism (CD) spectra and Native-PAGE. The BSA is used as a biopolymer scaffold, and the insoluble Salen Schiff-base metal complexes HOSalenM make axial coordination with the amino acid residues of the BSA. The structure of the BSA is unchanged when the binding rate of HOSalenCo is less than 10. The HOSalenCo conjugations show an excellent hydroxyl radical (·OH) scavenging activity, and the activity (EC50 ) of BSA/HOSalenCo(10) (BSA : HOSalenCo=1 : 10) is improved by two orders of magnitude compared with the BSA, while the activity of the BSA/HOSalenMn is weak and the BSA/HOSalenZn shows no scavenging activity.

Immunogenicity and safety of NVSI-06-07 as a heterologous booster after priming with BBIBP-CorV:a phase 2 trial

The increased coronavirus disease 2019(COVID-19)breakthrough cases pose the need of booster vaccination.We conducted a randomised,double-blinded,controlled,phase 2 trial to assess the immunogenicity and safety of the heterologous prime-boost vaccination with an inactivated COVID-19 vaccine(BBIBP-CorV)followed by a recombinant protein-based vaccine(NVSI-06-07),using homologous boost with BBIBP-CorV as control.Three groups of healthy adults(600 individuals per group)who had completed two-dose BBIBP-CorV vaccinations 1–3 months,4–6 months and≥6 months earlier,respectively,were randomly assigned in a 1:1 ratio to receive either NVSI-06-07 or BBIBP-CorV boost.Immunogenicity assays showed that in NVSI-06-07 groups,neutralizing antibody geometric mean titers(GMTs)against the prototype SARS-CoV-2 increased by 21.01–63.85 folds on day 28 after vaccination,whereas only 4.20–16.78 folds of increases were observed in control groups.For Omicron variant,the neutralizing antibody GMT elicited by homologous boost was 37.91 on day 14,however,a significantly higher neutralizing GMT of 292.53 was induced by heterologous booster.Similar results were obtained for other SARS-CoV-2 variants of concerns(VOCs),including Alpha,Beta and Delta.Both heterologous and homologous boosters have a good safety profile.Local and systemic adverse reactions were absent,mild or moderate in most participants,and the overall safety was quite similar between two booster schemes.Our findings indicated that NVSI-06-07 is safe and immunogenic as a heterologous booster in BBIBP-CorV recipients and was immunogenically superior to the homologous booster against not only SARS-CoV-2 prototype strain but also VOCs,including Omicron.

Safety and immunogenicity of a mosaic vaccine booster against Omicron and other SARS-CoV-2 variants:a randomized phase 2 trial

An ongoing randomized,double-blind,controlled phase 2 trial was conducted to evaluate the safety and immunogenicity of a mosaic-type recombinant vaccine candidate,named NVSI-06-09,as a booster dose in subjects aged 18 years and older from the United Arab Emirates(UAE),who had administered two or three doses of inactivated vaccine BBIBP-CorV at least 6 months prior to enrollment.The participants were randomly assigned with 1:1 to receive a booster dose of NVSI-06-09 or BBIBP-CorV.The primary outcomes were immunogenicity and safety against severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)Omicron variant,and the exploratory outcome was cross-immunogenicity against other circulating strains.Between May 25 and 30,2022,516 adults received booster vaccination with 260 in NVSI-06-09 group and 256 in BBIBP-CorV group.Interim results showed a similar safety profile between two booster groups,with low incidence of adverse reactions of grade 1 or 2.For immunogenicity,by day 14 post-booster,the fold rises in neutralizing antibody geometric mean titers(GMTs)from baseline elicited by NVSI-06-09 were remarkably higher than those by BBIBP-CorV against the prototype strain(19.67 vs 4.47-fold),Omicron BA.1.1(42.35 vs 3.78-fold),BA.2(25.09 vs 2.91-fold),BA.4(22.42 vs 2.69-fold),and BA.5 variants(27.06 vs 4.73-fold).Similarly,the neutralizing GMTs boosted by NVSI-06-09 against Beta and Delta variants were also 6.60-fold and 7.17-fold higher than those by BBIBP-CorV.Our findings indicated that a booster dose of NVSI-06-09 was well-tolerated and elicited broad-spectrum neutralizing responses against divergent SARS-CoV-2 variants,including Omicron and its sub-lineages.