Development of shared traditional Chinese medicine pharmacy from the perspective of primary medical care / 中国药房

In order to make the shared traditional Chinese medicine （TCM） pharmacy develop more efficiently and normatively at the grass-roots level， using the “shared TCM pharmacy” as the retrieval word， this paper uses the literature research method to retrieve the reports， documents and policies from CNKI， the websites of people’s governments at all levels， the official websites of the State Administration of Traditional Chinese Medicine， people.com， China News Network， Xinhua News and other platforms before May 20， 2022， sort out the development mode and history of two “Internet plus” TCM pharmacies， namely “shared TCM pharmacies” and “smart TCM pharmacies”， and compare them with each other. Combined with the actual work of community hospitals and community service centers （stations）， the necessity and advantages （such as reducing the costs of the intermediate links of drug circulation and standardizing the grass-roots drug use process） of the development of “shared TCM pharmacy” are obtained from the perspective of primary medical care. Combined with the current situation of the promotion and application of shared TCM pharmacy in county medical communities， it is concluded that the shared TCM pharmacy should be further constructed from four aspects： improving the work process of drug centralized procurement under the background of normalization， improving the compatibility and synchronization of the whole process dispensing information system module， unifying pharmaceutical services and personnel training， defining the authority of data query and clarifying the boundaries of patient privacy to further build a shared TCM pharmacy. Finally， it integrates information technology， summarizes the definition of shared TCM pharmacy and its future construction direction， and provides reference for the next development of shared TCM pharmacy at the grass-roots level.

Research progress in the proteomics of crystal-cell interaction in pathogenesis of calcium oxalate kidney stones / 国际生物医学工程杂志

Nephrolithiasis/urolithiasis have long been a global public health problem because of their high incidence. The most common chemical component causing nephrolithiasis/urolithiasis is calcium oxalate, which forms stone lesions through the processes of crystalline formation, crystal growth, aggregation, crystal-cell adhesion, and invasion of the interstitial extracellular matrix of the kidney. In these processes, crystal-cell interactions are crucial. Proteomics has been widely used in the study of nephrolithiasis/urolithiasis. In this paper, the progress of proteomics of calcium oxalate crystal-cell interaction in nephrolithiasis/urolithiasis was reviewed with the aim of better understanding the pathogenesis of kidney stones.

The relationship between short-term serum albumin level and postoperative urogenic sepsis after mPCNL / 中华泌尿外科杂志

Objective:To investigate the predictive value of serum albumin (Alb) levels in the early postoperative period (within 1 hour) for urosepsis after minimally invasive percutaneous nephrolithotomy (mPCNL).Methods:The clinical data of 160 patients treated by single channel holmium laser mPCNL in urolithiasis treatment center of the second hospital of Tianjin Medical University from January 2019 to January 2020 were retrospectively analyzed. The patients were divided into the sepsis group and the non-sepsis group according to whether the patients developed urosepsis after the operation. There were 110 cases of male, and 50 cases of female, with average age of(51.8±11.9), including 68 cases with hypertension, 26 cases with diabetes, 12 patients with history of preoperative fever, 16 cases with history of endoscopic lithotomy surgery, 6 patients with preoperative catheter, 24 patients with positive preoperative urine culture, 12 patients with positive preoperative nitrite volume, 32 cases with preoperative routine urine leucocyte(+ + + ). The operative time and infusion volume were recorded during the operation. Blood samples were collected from all patients within 1 hour after surgery to detect blood routine and serum albumin (Alb), and the change of haemorrhagic white blood cells and serum albumin were calculated. Univariate and multivariate analyses were used to statistically analyze the relevant clinical parameters to identify the independent risk factors for urosepsis after mPCNL surgery. The ROC curve was established and the area under the comparison curve was calculated to analyze the predictive value of independent risk factors for postoperative urosepsis.Results:There were 13 patients (8.1%) in the sepsis group, including 7 males and 6 females, with an average age of (53.1±8.2) years. There were 147 patients (91.9%) in the non-sepsis group, including 103 males and 44 females, with an average age of (51.7±12.1)years. Single factor analysis showed the infectious stones (38.5% and 8.8%), surgery duration [(94.6±26.2)min and(63.6±24.5)min], a positive urine culture (46.2% and 12.2%), positive urinary nitrite (30.8% and 5.4%), strong positive urinary leukocyte (61.5% and 11.3%), postoperative albumin levels [(34.2±2.7)g/L and(40.7±6.2)g/L]and changes of serum albumin levels within one hour after surgery [(18.3±4.6)% and(3.8±14.3)%] between the sepsis group and the non-sepsis group had significant differences ( P<0.05). Multiariable logistic regression analysis showed the strong positive urine leucocyte ( OR=57.704, 95% CI 2.407-1383.427, P=0.012), postoperative blood leucocyte level within one hour after surgery ( OR=2.406, 95% CI 1.154-3.627, P=0.014) and the change of serum albumin levels after surgery ( OR=1.373, 95% CI 1.083-1.740, P=0.009) were independent risk factors for sepsis. ROC curve analysis indicated that the AUC of the change amplitude of serum albumin level was 0.926, which was significantly higher than the AUC of the qualitative results of blood leukocyte and the AUC of urinary leukocyte( P<0.01). Conclusions:The positive urinary leucocyte, the change of serum albumin levels after surgery within one hour and the leucocyte level are independent risk factors for postoperative urosepsis after mPCNL. The change of serum albumin level in the early postoperative period has a strong predictive value for the early diagnosis of postoperative sepsis.

Application of potassium sodium hydrogen citrate in the treatment of renal uric acid calculi with heavy load and literature review / 中华泌尿外科杂志

Objective:To investigate the effect of potassium sodium hydrogen citrate in the treatment of renal uric acid calculi with heavy load.Methods:The clinical data of 6 patients with intrarenal high-load uric acid calculi (long diameter >4 cm) treated with potassium sodium hydrogen citrate in our hospital from January 2018 to July 2020 were reviewed. All of the patients were male. Their ages ranged from 42 to 66 years, with an average age of 51.3 years old. The average length to diameter was 6.0(4.1-7.6) cm. The average density of stone was 475 (418-535) HU. The average blood uric acid was 453.3(258.7-570.0)μmol/L, and all patients had a urine pH ≤5.5. The blood uric acid level was higher than normal serum uric acid level before treatment, and 3 cases had a history of gout. Stone composition analysis revealed 100% uric acid stone in two patients before treatment. The remaining patients were more likely to have uric acid calculi before treatment. None of the patients had a history of urinary tract infection. All patients were treated with oral potassium sodium hydrogen citrate. During the treatment, the starting dose was 10g/ day, which was divided into 2.5 g after breakfast, 2.5 g after lunch and 5.0 g after dinner. The dose was adjusted according to the pH value of urine, and the urine pH was maintained between 6.5-7.0. CT plain scan was repeated every 2-3 months during the treatment period to evaluate the treatment effect.Result:After 2.5-8.0 months’ treatment, the stone load of all the patients was reduced to different degrees, and the average length diameter was shortened by 3.2cm, among which two patients’ stones disappeared. CT scan showed the stone edge changed from smooth to rough after the treatment, and there would be worm erosion defect and cavity on the surface and inside of the stone, showing obvious stone dissolution phenomenon.Conclusions:Potassium sodium hydrogen citrate has a good therapeutic effect on renal uric acid calculi with heavy load. Non-infected patients with uric acid calculi should be treated with potassium sodium hydrogen citrate.

Countermeasures to the construction of standardized residency training / 中华医学教育探索杂志

This study firstly reviews the history and current situation of course construction, then combines closely with the objectives and the summary of current situation of the standardized residency training, and finally puts forward concrete countermeasures from the several angles, such as teaching objectives, teaching team development, teaching content and forms, as well as evaluation mechanism, advocating the promotion of problem-based learning (PBL), medical simulation teaching (MST), literature discussion and other teaching methods, encouraging the integration of humanities education and clinical guidelines into teaching, and adopting objective structured clinical examination + standardized patient (OSCE+SP) assessment method and conducting two-way assessment, so as to assist in the education development of the standardized residency training.

Basic science related to tendinopathy: Microbiomechanics and stress shielding / 中国组织工程研究

BACKGROUND: Tendon is a special connective tissue that can transmit the force generated by the muscle to the bone through the enthesis. The occurrence of tendinopathy is closely related to the mechanical characteristics of tendon and enthesis and its micro-structure, but the specific mechanism still remains controversial OBJECTIVE: To summarize the micro-structure of tendon and en thesis, the biomechanical characteristics of tendon, the healing and repair of tendon injuries, and the biomechanical factors related to chronic tendinopathy. METHODS: CNKI, VIP, CBM, WanFang, PubMed and Embase databases were searched. The articles concerning micro-structure of tendon and enthesis, relationship between tendinopathy/enthesis and stress, and biomechanical mechanisms of tendinopathy/enthesis were selected. RESULTS AND CONCLUSION: The biomechanical properties of tendon and enthesis are closely related to their microstructures. The biomechanical properties of tendon are reduced due to the damage of their microstructures in the process of repair. The occurrence and development of chronic tendinopathy are related to the microstructures and biomechanical characteristics of enthesis. Compression load and stress shielding of enthesis may play a key role, but further high-quality studies on the specific mechanism are still required.

Application of metformin in the treatment of non-diabetic diseases / 国际生物医学工程杂志

Metformin is currently the first-line drug for the treatment of type 2 diabetes, and it is the most widely used oral hypoglycemic drug in the world. In addition to its significant hypoglycemic effect, metformin also has potential therapeutic effects on diseases such as tumors, obesity, thyroid diseases, polycystic ovarian diseases and cardiovascular diseases. However, the specific mechanism of action of metformin is still unclear. A large number of studies have shown that the regulation of energy metabolism by metformin is not only the core of its mechanism of action in the treatment of type 2 diabetes, but also an important mechanism for its therapeutic effects in diseases such as tumors and cardiovascular diseases. In this paper, the clinical application and related drug mechanisms of metformin in the treatment of non-diabetic diseases were summarized, so as to provide reference for the majority of medical workers, and look forward to a more in-depth exploration of its drug mechanism and clinical application in the future.

Meta analysis on application effect of quality control circle in complications after PICC catheterization / 重庆医学

Objective To systematically evaluate the application effect of the quality control circle(QCC)in the complications after PICC catheterization.Methods The randomized controlled trials(RCTs)on the application effect of QCC after PICC catheter-ization were retrieved from the Cochane library,PubMed,EMBASE,Chinese Biomedical literature Database(CBM),China Academic Journal Full-text Database(CNKI),VIP and Wangfang Database by computer.The literatures were selected according to the inclu-sion and exclusion criteria.The two valuators independently retrieved and screened the literatures,extracted the data,evaluated the methodological quality of included literatures and conducted the cross check.Then the meta analysis was performed by using Rev-Man 5.3 software.Results A total of 7 914 articles were retrieved,finally 14 RCTs were included,involving 2 728 patients.The oc-currence rates of phlebitis,catheter obstruction,unplanned extubation and catheter-related blood flow infection in the intervention group were lower than those in the control group,the difference was statistically significant(OR=0.28,95% CI:0.16-0.48,P<0.01;OR=0.27,95% CI:0.17-0.42,P<0.01,OR=0.27,95% CI:0.18 -0.39,P<0.01;OR=0.25,95% CI:0.13 -0.49,P<0.01).Conclusion Using QCC is conducive to reduce the complication incidence rate after PICC catheterization.

Clinical study on transurethral plasmakinetic enucleation of prostate in the treatment of benign prostate hyperplasia diagnosed by transrectal biopsy of prostate / 中华老年医学杂志

Objective To evaluate the efficiency and safety of transurethral plasmakinetic enucleation of prostate(PKEP) in the treatment of patients with benign prostate hyperplasia(BPH) after transrectal prostate biopsy(TRPB).Methods A total of 88 BPH patients who underwent PKEP in our hospital during Jan.2012 to May 2015 were retrospectively analyzed and followedup.38 patients underwent TRPB before PKEP were defined as TRPB group,and 50 patients underwent PKEP with no TRPB were defined as control group.The baseline data,perioperative data and postoperative follow-up outcomes were recorded and compared between the two groups.Results The mean age of the 88 patients were 69.7 years.Compared with control group,TRPB group showed that age was younger(t=2.62,P＜ 0.05)and prostate specific antigen(PSA) level was higher(t=13.64,P＜0.01).Operation duration was longer in TRPB group than in control group (93.6 ± 31.0) min vs.(77.9 ± 17.3) min (t =2.6 4,P ＜ 0.05).There were no significant differences in the preoperative data,blood loss,continuous bladder irrigation duration after operation and period of catheterization between two groups (all P ＞ 0.05).Trans-operative time was significantly shortened when the time interval between TRPB and PKEP is more than 4 weeks(P＜ 0.01),while blood loss was similar in the two groups(P＞ 0.0 5).There were no adverse events of blood transfusion,transurethral resection syndrome and injury of bladder or rectal in both two groups.There were no significant differences in maximum flow rate(Qmax),international prostate symptom score(IPSS) or quality of life(QOL) scores between the two groups at 3,6 and 12 months of follow up(all P＞ 0.05).Conclusions PKEP after TRPB is a safe and effective treatment for BPH patient.When the time interval between TRPB and PKEP is more than 4 weeks,the performing of PKEP operation would reduce the difficulty of operative procedure and increase the safety.

Risk factors of urethral recurrences following radical cystectomy for bladder cancer / 中华泌尿外科杂志

Objective To evaluated the risk factors of urethral recurrence ( UR) following radical cystectomy ( RC) in patients with bladder urothelial carcinoma.Methods The clinical data of 350 male patients who underwent RC between January 2005 and January 2013 were retrospectively analyzed.The mean age was 63 years (rang 46-76) years.176 cases had the history of non-muscle-invasive bladder cancer.15 cases were were found the tumor invasion into the prostatic urethral.The way of urinary diversion after RC included 172 cases were orthotopic neobladder, 90 cases were cutaneous diversion and 88 cases were ileal couduitin.331 cases underwent preoperation intravesical instillation.36 cases underwent systemic chemotherapy after operation.148 cases were found the multiple tumor lesions, which was more than 2 sites. The pathological stage was more than T2 satge in 189 cases.And 177 cases were diagnosed as high-grade urothelial carcinoma.Multivariate Cox regression analyses were used to evaluate the risk factors associated with the UR.Results There were 350 cases in this study, UR was observed in 28 cases ( 8%).On multivariate Cox regression analyses, previous history of NMIBC (HR=15.205,95%CI 3.718-62.180,P<0.001), prostate urethral involvement(HR=5.233,95%CI 1.106-24.754,P=0.037) and Non-orthotopic neobladder(HR=6.656,95%CI 1.840-24.077,P=0.004)which the operation of cutaneous diversion and ileal couduit , were independent risk factors of UR following RC.Intravesical instillation before operation ( HR =0.470, 95%CI 0.010-0.217, P <0.001 ) was the protective factor of the UR.Conclusions Previous history of NMIBC, prostatic urethral involvement and Non-orthotopic neobladder were independent risk factors of UR.Intravesical instillation before operation was protective factor of UR.Urethrectomy for patients with high risk factors and intravesical instillation before operation were important.

Tendinopathy and the extracellular matrix：to deeply study the key proteins and enzymes in the bone-tendon junction / 中国组织工程研究

BACKGROUND:In recent years, research on tendinopathy is becoming a hot topic in the sports medicine and rehabilitation, and the extracelular matrix plays a considerable role in the occurrence, development and healing of tendinopathy. OBJECTIVE: To explore the relationship between tendinopathy and the extracelular matrix. METHODS: CNKI, VIP, CBM, Wanfang, PubMed and Embase were retrieved for articles related to colagen, protein, glycoprotein and matrix remodeling published since 2000. RESULTS AND CONCLUSION:After tendinopathy, there are obvious changes in colagen, proteoglycans, glycoprotein and related enzymes; and these changes also affect the reconstruction and repair of tendinopathy. Currently, most of researches focus on the tendon rather than the bone-tendon junction. This means that there are no in-depth studies on the correlation between many important proteins and tendinopathy, and the effects of exercise intervention.

Clinical pathological features of primary bladder mucinous adenocarcinoma / 中华泌尿外科杂志

Objective To analyze the features of onset, clinical pathological characteristics about the primary bladder mucinous adenocarcinoma.Methods From January 1990 to June 2015, we retrospectively reviewed the data from 15 patients diagnosed as primary bladder mucinous adenocarcinoma, including 10 male patients and 5 female patients.Their mean age was 58 years old, ranged from 41 to 78 years old.Among the fifteen patients, the initial symptoms included hematuria in 13 cases, lower abdominal pain in 1 case and urinary irritation symptom in 1 case.The ultrasound and CT scan revealed bladder tumors, which the size ranged from 2 to 6 cm.The location of bladder tumors included front wall in 12 cases, trigone zone in 2 cases and top wall in 1 case.Nine cases was suspected as tumor from urachal remnants.Eleven patients underwent partial cystectomy, three patients accepted the radical cystectomy and one case accepted transurethral resection of bladder tumor (TURBT).Result Pathological diagnosis was bladder mucinous adenocarcinoma in all patients, including nine from urachal remnant and the others from urothelimn.The tumor exhibited the mushroom liked prominence, which was associated with surface ulceration and infiltrated into the depth of bladder.Meanwhile, it was covered with thick mucinous substances.The histologic examination revealed the presence of andenoid structure, composed by various degree of diferenfiated mucinous cells.In cases with adenocarcinomas from urachus, the residue of urachal tissue could be noticed.The bladder mucous was intact or ulcerated.No sign of metaplasia was observed.In the pathological diagnosis, the classification included grade Ⅲ in 3 cases, grade Ⅱ in 7 cases and grade Ⅰ in 5 cases.Ten persons reported the information of the follow up.Eight of them, whose tumor originated from urachus, accepted bladder-sparing surgery.One died from acute myocardial infarction after 23 months postoperatively.And one died from cerebral hemorrhage 45 months postoperatively.The others have been followed up from 8 to 65 months with no sign of recurrence.In two cases with urothelial carcinoma, one was found the new urothelial carcinoma 50 months after TURBT and one died from cancer metastasis 29 months after partial cystectomy.Conclusions Primary mucinous adenocarcinoma of the bladder possess the relatively high malignant tendency.The hematuria is the main initial symptoms.The histologic examination revealed the presence of different differentiated mucinous cells and formed the andenoid structure.The case with urachal remnant adenocarcinoma has the better prognosis than other types.

Development of a novel reporter gene method for determination of ADCC potency of anti-CD20 monoclonal antibody / 药学学报

The biological activity of ADCC by anti-CD20 monoclonal antibody was determined by BioGlo™ Luciferase Assay System using Jurkat/NFAT-luc+FcγRIIIa cell line as effector cell and WIL2-S cell line as target cell. The developed method was verified for specificity, precision and accuracy. Anti-CD20 monoclonal antibody showed a dose-response mode by the developed method, and the determination result complied with the following four-parameter equation: y = (A-D)/[1 + (X/C)(B)] + D. The optimized parameters of the method were determined including the antibodies diluted concentration (18,000 ng·mL(-1)), dilution rate (1:5), the ratio of effector cell and target cell (6:1), and induction time (6 h). The values of eight independent tests have passed a statistical test for curve regression analysis, linear or parallelism, which showed the method possessed good specificity. Four different dilute groups of recovery rates sample were determined for 3 times, and the result showed mean relative potencies of (44.39±3.93)%, (72.74±2.78)%, (128.28±7.01)% and (168.19±2.70)% respectively, with a variation coefficient of less than 10%, and the recoveries of (88.78±7.85)%, (96.99±3.70)%, (102.63±5.61)% and (112.12±1.80)% respectively. A novel reporter gene method for determination of biological activity of ADCC by anti-CD20 monoclonal antibody was successfully developed, which showed strong specificity, good reproducibility and high accuracy, and might be used routinely.

N terminal sequencing for practical detection of monoclonal antibody / 生物工程学报

Here we discuss whether N terminal sequencing is appropriate as one of the conventional control methods for monoclonal antibody products. We determined the N terminal sequences of two monoclonal antibody products targeting two antigens separately with both Edman degradation and mass peptide spectrometry. We also identified the characteristic peptide fragments with mass spectrometry. Furthermore, we analyzed their heterogeneity with ion exchange chromatography, capillary zone electrophoresis and Imaged Capillary Isoelectric Focusing. Edman degradation method showed that the N terminal 15 amino acids of heavy and light chains of the two monoclonal antibodies were identical. Peptide mass spectrometry demonstrated that T1 peptide fragments of heavy and light chains of the two antibodies were also the same. But in contrast, peptide mapping and the three analytical methods for heterogeneity analysis could effectively identify and differentiate the two antibodies. The N terminal sequences of two monoclonal antibodies are identical because the number of framework sequences of humanized or human monoclonal antibodies is relatively limited, so whether N terminal sequencing analysis could be regulated as one of the practical control methods should be carefully discussed. Our work also proves that the above analytical methods could combinatorially applied to the identification of monoclonal antibody products, and are more objective compared to N terminal sequencing.

Lumbar epidural injection of methylene blue affects the spinal cord and spinal ganglia structures / 中国组织工程研究

BACKGROUND:Methylene blue can hinder abnormal pain conduction via the sensory nerve, and its mechanism is to block bradykinin-induced hyperalgesia and eliminate pain caused by local tissue inflammation. OBJECTIVE:To observe the influence of methylene blue solution on the lumbar spinal cord and spinal ganglia function of rats, and to investigate whether methylene blue is safe for treating discogenic low back pain. METHODTotal y 120 Wistar rats were randomly divided into five groupthree experimental groups, a saline control group and a blank control group, n=24 in each group. Lumbar segmental dura was exposed in rats. In the three experimental groups, 0.2, 1, and 2 mL methylene blue were injected epidural y, respectively. The saline control group was subjected to the epidural injection of 1 mL saline. In the blank control group, there was no treatment. Six rats from each group were selected randomly and perfused at 30 minutes, 2 hours, 24 hours, 72 hours after injection, respectively. Then, the corresponding segments of the spinal cord and ganglions were removed. Hematoxylin eosin staining was used for comparing histological and structural changes under light microscope. RESULTS AND CONCLUSION:Hematoxylin-eosin staining showed that at 30 minutes, 2 hours, 24 hours and 72 hours after injection of methylene blue, the spinal dorsal side exhibited the structural integrity, clear boundaries between the white matter and gray matter, dense nerve fibers in the white matter, and round or oval nuclei of glial cells among fibers;dense nerve fibers in the posterior horn of gray matter;light-colored neuronal nuclei with prominent nucleoli;a bundle of nerve fibers among cellpopulations. There was no significant change in tissue structure of lumbar spinal cord and spinal ganglia between the experimental groups and the saline control group or between the experimental groups and the blank control group. Thus, the epidural injection of 1%methylene blue has no significant effect on the spinal cord and spinal nerve structures.

Size heterogeneity analysis of monoclonal antibody products / 中华微生物学和免疫学杂志

Objective To compare the capability of capillary electrophoresis-sodium dodecyl sul-fate ( CE-SDS) and size exclusion-high performance liquid chromatography ( SE-HPLC) for analysis of size heterogeneity of monoclonal antibody products .Methods The size heterogeneity of one humanized anti-VEGF monoclonal antibody was analyzed by using non-reduced and reduced CE-SDS, and conventional , de-natured and denatured reduced SE-HPLC.Results The percentage of aggregates detected by non-reduced CE-SDS (0.82%±0.01%) was equal to that by using denatured SE-HPLC (1.05%±0.02%), but it was significantly lower than that by using conventional SE-HPLC analysis (5.08%±0.10%).With regard to fragments analyzed with non-reduced antibodies, its percentage was (7.12±0.04)% measured by non-re-duced CE-SDS analysis that was significantly higher than that by conventional SE -HPLC analysis (0.02%± 0.01%) and denatured SE-HPLC analysis (0.62%±0.01%).Using reduced antibodies , the percentage of fragments was (3.19±0.50)%tested by reduced CE-SDS analysis that was significantly higher than that by using denatured reduced SE-HPLC analysis (0.07%±0.01%).Conclusion Conventional SE-HPLC was more objective than CE-SDS for content analysis of aggregates , as both the covalent and non-covalent forms of aggregates could be detected .Non-reduced CE-SDS could demonstrate the content of clips , while reduced CE-SDS showed the degraded fragments .Therefore, CE-SDS had an advantage over conventional SE-HPLC for content analysis of fragments .The use of the two analytical methods in combination provided solid techni-cal supports for the quality control of size heterogeneity of monoclonal antibodies .

Comparative study of size and charge heterogeneities of anti-TNF-αantibodies by high performance liquid chromatography / 中华微生物学和免疫学杂志

Objective To analyze the differences of size and charge heterogeneities between origi-nal humanized anti-TNF-αantibody and four similar biotherapeutic products ( SBP ) .Methods The size exclusion chromatography ( SEC-HPLC ) and weak cation exchange chromatography ( WCX-HPLC ) were used to analyze the size and charge heterogeneities , respectively.Carboxypeptidase B (CpB) treatment was employed to analyze the source of charge heterogeneity of the antibody products .Results Four SBPs showed the same pattern with the originator in SEC-HPLC, and no significant difference with the percentage of mono-mer was observed .The percentages of the aggregates of SBP-3 and SBP-4 were a little higher than those of the originator .The charge distribution of SBPs was significantly different from the originator ′s, especially in the basic region .The results from the samples treated with CpB indicated that the difference of charge distri -bution in the basic region might be caused by the C-terminal lysine variants .Conclusion Four SBPs showed similar size heterogeneity with the originator , but significant differences with charge heterogeneity were observed among them .The study suggested that more attention should be paid to the charge heterogene -ity analysis of the biosimilar products .

Determination of drug antibody ratio in an antibody-drug conjugate / 药学学报

This paper reports the determination of the drug antibody ratio in an antibody-drug conjugate with two methods, i.e. LC-MS and UV/VIS, and to provide a reliable method to scientifically evaluate and effectively control the drug antibody ratio. Deglycosylated sample was analyzed with C4 column followed by MS, and the number of conjugated drugs in the antibody was determined by the molecular weight increase due to the addition of different number of drugs to the antibody, and then drug antibody ratio was calculated by weighted average of different number of drugs conjugated to the antibody. Optical density at 252 and 280 nm was measured with UV/VIS, and due to the difference of extinction coefficients between the antibody and the drug, the drug antibody ratio was calculated from linear equation with two unknowns. The drug antibody ratio was 3.21 and 3.25 respectively measured by the two methods, and the results were similar with the two methods. Our study indicated that both methods, LC-MS and UV/VIS, could be applied to the analysis of drug antibody ratio of the antibody drug conjugate.

Anterior approach or combined anterior and posterior approaches for severe ossification of cervical posterior longitudinal ligament / 中国组织工程研究

BACKGROUND:It is controversial whether anterior approach alone, or combined anterior and posterior approaches were used for high level and multiple segments of severe ossification of cervical posterior longitudinal ligament. OBJECTIVE:To explore the difference of anterior approach versus combined anterior and posterior approaches for the treatment of high level and multiple segments of severe ossification of cervical posterior longitudinal ligament. METHODS:A total of 21 cases of high level and multiple segments of severe ossification of cervical posterior longitudinal ligament were included in this study. There were 9 males, aged 56-72 years, and 12 females, aged 58-70 years. We used anterior decompression and titanium mesh bone graft fusion in 11 cases which lesion located between C2-5 vertebra, and ossification excision, combined anterior (titanium mesh plate and screw) and posterior (lateral mass screw) approaches in 10 cases which between C3-7 vertebra. Japanese Orthopaedic Association score system was used to evaluate the results. The excellent and good rate and improvement rate were calculated. RESULTS AND CONCLUSION:The excellent and good rate was 90%and improvement rate was 82%in 10 cases using combined anterior and posterior approaches. The excellent and good rate was 73%and improvement rate was 73%in 11 cases using anterior treatment alone. Significant differences in the excellent and good rate and improvement rate were detected between the two groups (P<0.05). These suggested that combined anterior and posterior approaches for high level and multiple segments of severe ossification of cervical posterior longitudinal ligament is a better operative procedure.

Study of the biological characteristics and antitumor activity of recombinant IFN-α-2B-BCG / 中华微生物学和免疫学杂志

Objective To investigate the biological characteristics of recombinant hIFN-α-2B-BCG and its direct effect to bladder tumor cells in vitro. Methods BCG and recombinant BCG(rBCG) wild-type growth and morphology were compared. After 10 generations, hIFN-α-2B content was analyzed by ELISA, of bacteria in vivo and in vitro. The effects of rBCG on bladder cancer cells EJ, MB49, were detected by elec-tron microscopy and cell inhibitory rate from MTT. Results The normal BCG and rBCG had no significant difference in growth phase. They were both positive for acid-fast stain, maintaining the characteristics of cell's connection. While rBCG slightly larger than normal BCG, no else abnormality was obvious between them. IFN-α-2B was 997.2 pg/ml in secretions, 99.3 pg. In bacteria in vivo, 990.3 pg/ml in 10th genera-tion's sections, of rBCG. Compared with 1st generation, rBCG had no significant differences in morphology and interferon expression. Normal BCG and rBCG both had, anti-proliferation directly on bladder tumor cell in vitro, the rBCG is most effective in all. After rBCG cultivated with bladder tumor cell together, tumor cell's slow proliferation, detach, quantity decreasing and death were observed under microscope. Different degeneration in degree on most of tumor cells, disorganization on organelle, aggregation on chromatin, pyc-nosis on nucleolus, and cytoplasm lysis were on tumor cell under transmission electro microscopy. MTT as-say showed rBCG inhibited the proliferation of bladder caner cell and more active than normal BCG. Conclu-sion These results suggest that the rBCG have the same characteristics in growth phase as normal BCG, and stable properties in interferon expression and morphology by generations, rBCG has more anti-tumor effects in vitro than normal BCG.