In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

OBJECTIVE: To determine imperatorin as the active ingredient of Angelica dahuricae in Jiedu tongqiao pills by HPLC. METHODS: The separation was performed on Waters Symmetryshielb33 C18(250 mm?4.6 mm,5 ?m) column with detection wavelength of 248 nm. The mobile phase consisted of methanol-water (65 ∶ 35) with flow rate of 1.0 mL?min-1.RESULTS:The linear range of imperatirin were 0.15～1.35 ?g. The average recovery was 100.4%(RSD=1.89%,n=9).CONCLUSION: The method is simple, accurate and reproducible for quality control of Jiedu tongqiao pills.

Objective To study the molecular biology of rifampin-depending M. Tuberculosis. Methods The seguence (a 319-bp DNA fragment) of rpoB gene were analyzed by automated DNA sequencing machine. (2) The fingerprints of genomic DNA were obtained by random amplified polymorphic DNA (RAPD) fingerprinting. (3)The protein electrophoresis of bacterium by SDS-polyacrylamide gel (SDS-PAG).(4) The cases of pulmonary tuberculosis by rifampin-depending strains were retrospectively analyzed. Results (1) rpoB gene sequenced: The point mutationrate of rifampin-depending strainswas 96.7%(29/30) and that of rifampin-residtant strains 81.1%(30/37), P

ObjectiveTo investigate the clinical efficacy of Jin’s eye three-needle acupuncture as main therapy for acquired paralytic strabismus.MethodSeventy patients with acquired paralytic strabismus were randomly allocated to acupuncture and Western medication groups. Both groups of enrolled patients took prednisone,methycobal, vitamin B1and vitamin B12. In addition, theacupuncture group received Jin’s eye three-needle acupuncture as main therapy. The clinical therapeutic effects and adverse reactions were observed after four and eight weeks of treatment.ResultThe total efficacy rate was 75.0% in the acupuncture group and 51.6% in the Western medication group after four weeks of treatment and 90.6% in the acupuncture group and 77.4% in the Western medication group after eight weeks of treatment. There were statistically significant differences between the two groups (P<0.05). Patients in the acupuncture group occasionally had acupuncture syncope and local blood stasis. Both groups had no special discomforts.ConclusionJin’s eye three-needle acupuncture has a quick and definite therapeutic effect on acquired paralytic strabismus.

Objective To observed the and - inflammatory effect of Qianlie Tai Granule (QTG) on chronic prostatitis. Methods Three models, asepsis and chronic aseptic prostatitis rat model, acute inflammation mouse model and chronic inflammation rat model, were adopted to observe the pharmacocynamic action of QTG. Results QTG decreased the number of WBC, inhibited the increasing of prostate tissue weight and improve the inflammatory lesion in prostate tissue of chronic aseptic inflammation rats. QTG also had an obvious inhibitory effect on early exudative auricular swelling induced by 2% compound croton oil and late proliferative granuloma induced by 2% agar. Conclusion QTG has an obvious effect for prostatitis. It can inhibit the early and late inflammation .

Adult ; Diagnostic Errors ; Histiocytosis, Sinus ; diagnosis ; Humans ; Male ; Rhinoscleroma ; diagnosis

Objective To investigate the intervention ways of endoscopes in the treatment of esophagus stenosis due to carcinoma of esophagus and improvement of quality. Method 11 cases of advanced carcinoma of esophagus were included in this study. Operation and chemical therapy were unavailable for these patients. Memory trestle with membrane and made of alloy of Nickel－ titanium was inserted under intervention of endoscope. Trestle was posed in stenosis part of esophagus under direction of X－ ray. Trestle could be dilated 3－ 7 days after operation due to its reaction characteristics to temperature. So, redilated therapy was unnecessary. Trestle could reconstruct swallowing tract and made feeding through mouth become available during limited survival time.Results All trestles were successfully inserted.Half－ fluid feeding was available after operation. Obstruction was removed in all patients(100％ ).Conclusion Method described in this study was safe and effective .Effective swallowing tracts were reconstructed in all patients after trestle was planted and quality of life and survival time were both improved.

OBJECTIVETo explore the effects of nano-hydroxyapatite/polyamide 66 (n-HA/PA66) cage on recovering and maintaining lumbar curvature, lumbar heights and fusion rate when used in the transforaminal lumbar interbody fusion.

METHODSFrom February to July 2012, 50 patients with degenerative lumbar disease(lumbar disc herniation in 32 cases and lumbar spondylolisthesis in 18 cases) were treated with transforaminal lumbar interbody fusion using the n-HA/PA66 cage, and their preoperative and postoperative clinical outcomes were analyzed. The patients were followed up for 2, 4, 6 and 8 months after operation, during which the CR and CT film of lumbar vertebra were checked to get relative height of vertebral space, Taillard index,index of lumbar spinal curvature,angle of segmental and full lumbar lordosis. The data were analyzed respectively with pair t-test, analysis of variance or LSD-t-test.

RESULTSAll the patients were followed up, and the duraion ranged from 8 to 13 months, with a mean of 11.32 months. There were significant differences in relative height of vertebral space, Taillard index, index of lumbar spinal curvature, angle of segmental and full lumbar lordosis after surgery, but there were no significant differences in different periods after operation. The fusion time of lumbar ranged from 4 to 8 months.

CONCLUSIONThe n-HA/PA66 cage can recover and maintain lumbar normal stability with higher rate of fusion and less complications.

Adult ; Durapatite ; administration & dosage ; Female ; Humans ; Intervertebral Disc Displacement ; surgery ; Lumbar Vertebrae ; surgery ; Male ; Middle Aged ; Nylons ; Spinal Fusion ; adverse effects ; instrumentation ; methods ; Spondylolisthesis ; surgery ; Tomography, X-Ray Computed

Objective To detect the effective strategy for monitoring the early liver leisure.Methods Two grups,in- cluding clinical symptoms with ALT test and clinical symptoms with PA and ALT test,were used to monitor the liver leis- ure.Results There are 74% of cases founded occurring liver leisure during anti-tuberculosis therapy after administe- ring the latter strategy including clinical symptoms with PA and ALT test.The incidence of occurring liver leisure is 51% at one week,none of the defaults occurred after onset of drug induced liver leisure when they were administered the liver protection drugs,and the rate of treatment completion is 100%,only 27% of patients was detected with liver leisure after using the former strategy including clinical symptoms with ALT test.The incidence of liver leisure is 2% at one week,the frequency of discontinued therapy is 16% after on-set of drug induced liver leisure when they took the liver protecting drug,and the full-time therapy rate is 84%.Conclusion The indicator including clinical symptoms,PA and ALT is prospective strategy in monitoring liver leisure,which can be used to detect the early liver leisure effectively induced by anti-tuberculosis drugs.The anti-tuberculosis therapy can be introduced smoothly,and the incidence of treatment fail- ure will be decreased by using liver protection drug after onset of drug induced liver leisure.

OBJECTIVETo analyze the reasons why anterior decompression and titanium mesh fusion for cervical spondylosis always show poor therapeutic effects, and to investigate the clinical effects of anterior revision surgery in these patients.

METHODSFrom January 2004 to December 2011, 16 patients underwent anterior decompression and titanium mesh fusion for cervical myelopathy were treated with anterior revision surgery. There were 7 males and 9 females with an average age of 61 years old (ranged from 46 to 75 years), including 11 cases with cervical spondylotic myelopathy, 2 cases with nerve root cervical spondylosis and 3 cases with mixed type cervical spondylosis. Average duration from the first operation to reoperation was 7 years(ranged from 4 to 12 years). In the first operation, titanium mesh segment located in C3-C5 (2 cases), C4-C6 (8 cases), C4-C7 (2 cases), C5-C7 (4 cases), and one of them, titanium mesh implantation in C4 and C5,6 intervertebral disk removal and cage fusion. After the first operation, symptom of 13 patients recurred after improvement or disappearance, 2 patients did not show obvious improvement, and 1 patient aggravated. Cervical spine radiography, CT scan and MRI were performed in all patients before re-operation. There were 12 patients with compression of the spinal cord or nerve root caused by degenerative changes in adjacent segments of fusion segments, 4 cases in upper segments, and 8 cases in lower segments; 3 patients with compression of the spinal cord or nerve root caused by vertebral posterior osteophyte of decompressed segments; 1 patient with compression of the spinal cord caused by incomplete anterior decompression. JOA, NDI and Odom classification were used to assess the clinical effects.

RESULTSAll anterior revision surgery were successful with a mean time of 110 min (80 to 150 min) and mean bleeding of 160 ml (30 to 200 ml). There was 30 ml clear drainage fluid in 1 patient suspected of cerebrospinal fluid leakage. But the 2nd day after operation, the tube was removed and the drainage opening was sutured, and the suture incision healed in grade A after 10 days. Other patients had no complications such as dysdipsia, hoarseness, and laryngeal edema, etc. All patients were followed up for 12 to 28 months with an average of 16 months. Two months after operation and at last follow-up, JOA scores and ODI index had obviously improved than preoperation (P < 0.01), and there was significant difference between postoperative 2 months and last follow-up (P < 0.01). At the final follow-up, improvement rate of JOA was (72.9 +/- 0.2)%. According to the standard of Odom, 12 cases got excellent results, 3 good, 1 fair.

CONCLUSIONAfter surgery of cervical decompression and bone graft fusion with titanium mesh, the patients need re-operation because of incomplete decompression, degenerative changes in adjacent segments or newly formed compression factors, and complications caused by implants. Anterior revision surgery can obtain good clinical effects.

Aged ; Cervical Vertebrae ; surgery ; Decompression, Surgical ; methods ; Female ; Humans ; Male ; Middle Aged ; Reoperation ; Spinal Fusion ; methods ; Spondylosis ; surgery ; Surgical Mesh ; Titanium