Worldwide sales of biologic drugs exceeded 100 billion USD in 2011. About 32% is from therapeutic monoclonal antibody (mAb). With many blockbuster biopharmaceutical patents expiring over the next decade, there is a great opportunity for biosimilar to enter the worldwide especially emerging market. Both European Medicines Agency (EMA) and Food and Drug Administration (FDA) have introduced regulatory frameworks for the potential approval of biosimilar mAb therapeutics. Rather than providing a highly abbreviated path, as in the case for small molecule chemical drug, approval for biosimilar mAb will require clinical trial and the details will be very much on a case-by-case basis. Since mAb is the dominant category of biologic drugs, mAb will be the focus of this review. First, the United States (US) and European Union (EU) approved mAb and those in phase 3 trials will be reviewed, then strategies on how to win biosimilar competition will be reviewed.

OBJECTIVE: To describe and analyze the clinical characteristics of nasopharyngeal teratoma in infants and improve the levels of diagnosis and treatment to reduce misdiagnosis. METHOD: The clinical data of 11 cases of nasopharyngeal teratoma in infants were reviewed retrospectively and summarized the clinical features. After the preoperative examination of nasopharyngeal endoscopy and imaging (CT or MRI), all patients were under general anesthesia of nasopharyngeal teratoma surgical resection. Of them, 8 cases were used radiofrequency ablation, 3 cases used conventional power systems. RESULT: Eleven cases with neoformation were completely removed, the operation time was 5-15 min, blood loss was 1-5 ml, patients had no significant nasal obstruction, bleeding, eating nasopharyngeal regurgitation, breathing difficulties or other complications. No recurrence was found after 10 months to 9 years followed up. CONCLUSION The nasopharyngeal mass must be kept in mind in the differential diagnosis of breathing difficulties in infants, especially when it exists together with upper airway obstruction symptoms; The low-temperature radiofrequency ablation with endoscopic had the advantages of short time, precise control, less bleeding, clear operative field, little injury and pain, low recurrence, providing a new clinical treatments.
Catheter Ablation ; Child ; Child, Preschool ; Endoscopy ; Humans ; Infant ; Nasal Obstruction ; Nasopharyngeal Neoplasms ; surgery ; Nasopharynx ; pathology ; Neoplasm Recurrence, Local ; Retrospective Studies ; Teratoma ; surgery

Otitis media is a common problem in children, which may cause hearing loss and complications sometimes. This topic will review the definition, causes, types, clinical characteristics and treatments of each type of ear infections in children, by reading recently literatures. It is important to make an accurate diagnosis and choose a appropriate treatment of otitis media in children to avoid antibiotics abusing. Sometime some cases need operations, which are effective, especially in chronic suppurative otitis media and cholesteatoma, and we need further studying focuse on when do the operations and how to shoose them.
Child ; Child, Preschool ; Humans ; Infant ; Otitis Media ; therapy

OBJECTIVE:To investigate the effects of perioperative application of Eucalyptol,limonene and pinene(ELP)en-teric soft capsules on therapeutic efficacy and prognosis in children after grommet insertion of chronic secretory otitis media. METH-ODS:92 cases(145 ears)of chronic secretory otitis media were divided into 2 groups by random number table method,including 46 cases in observation group(68 ears)and 46 cases in control group(77 ears). Both groups received grommet insertion under gen-eral anesthesia by otomicroscope. Control group was not given any drugs;observation group was given ELP enteric soft capsules 1.2 g,bid,from 3 d before operation to 5 d after operation. Subjective therapeutic efficacy and pure tone audiometry of 2 groups were observed 3 days,5 days,2 weeks,1 month and 3 months after surgery as well as acoustic impedance monitoring in children with tube withdrawal from ear 1 month and 3 months after surgery. RESULTS:The total effective rates of observation group 3 days,5 days,2 weeks,1 month and 3 months after surgery were 72.06%,82.35%,85.29%,89.70%and 95.59%;those of con-trol group were 59.74%,66.23%,80.52%,87.01% and 92.21%,with statistical significance(P<0.05). The pure tone audiome-try score of observation group 3 days,5 days,2 weeks,1 month and 3 months after surgery were significantly lower than those of control group,with statistical significance(P<0.05). Therapeutic effective rates of acoustic impedance monitoring in children with tube withdrawal from ear 1 month and 3 months after surgery were 77.78% and 90.48% in observation group,which were signifi-cantly higher than 61.54% and 81.48% in control group,with statistical significance(P<0.05). CONCLUSIONS:The periopera-tive application of ELP enteric soft capsules can significantly improve function recovery and hearing level in children after grommet insertion of chronic secretory otitis media.

Objective To analyze pathogenic bacteria distribution and antimicrobial susceptibility in children with acute otitis media(AOM ) .Methods Otorrhea samples from 146 episodes of AOM were cultured .The antimi‐crobial susceptibility of the main pathogenic bacteria was determined .The results were analyzed by SPSS19 .0 .Re‐sults 1) The strains of bacteria were isolated from 109 children with the positive rate of 74 .66% .Streptococcus pneumoniae (SP ) was the major bacteria(64 episodes ,58 .72% ) ,followed by staphlococcus aureus(SA) (19 epi‐sodes ,17 .43% ) .2) Sp was all sensitive to vancomycin ,levofloxacin ,moderate to penicillin ,amoxicillin ,cefo‐taxime ,and highly resistent to erythromycin and clindamycin .Staphlococcus aureus were all sensitive to vancomy‐cin ,tetracycline ,and Amy card ,and moderate to amoxicillin clavulanic acid potassium ,cefoxitin ,and oxacillin ,all resistent to penicillin and ampicillin .3) The strains of SP in age≤1year ,>1 -3years ,and >3 years respectively were 31(50 .82% ) ,25(56 .82% ) ,8 (19 .51% ) .There were significant differences between them(χ2 =14 .073 ,P=0 .001) .4)The strains of SP in 2012 ,2013 ,2014 respectively were 16(30 .19% ) ,22(48 .89% ) ,26(54 .17% ) ,There were significant differences between them(χ2 =6 .557 ,P=0 .038) .The antimicrobial susceptibility of SP had no sig‐nificant differences among 2012 ,2013 ,2014 ,but a yearly resistance decreasing trend was seen .Conclusion SP was the main bacterial contributor for AOM in Wuhan children .SP detection rate increases every year ,mainly in chil‐dren less than 3 years old .T he antimicrobial susceptibility is stable .

OBJECTIVE: To evaluate the efficacy of sublingual immunotherapy (SLIT) with standardized Dermatophagoides farina drops in monosensitized and polysensitized patients with allergic rhinitis. METHOD: The clinical data of 162 patients treated with standardized Dermatophagoides farina drops were analyzed retrospectively. These patients were divided into the monoallergen sensitized group and polyallergen sensitized group according to the results of skin prick tests. The total nasal symptoms score (TNSS), the total medication score (TMS) and adverse effects (AEs) were evaluated before treatment, 2 year after SLIT treatment and 3 year after drug discontinuance. Result:After SLIT treatment for 2 years and drug discontinuance for 3 years, the TNSS (3. 14[2. 47; 3. 65], 3. 45 [2. 76; 3. 92], respectively) and TMS (0. 42[0. 36; 0. 57],0. 35[0. 26; 0. 44], respectively) in the monoallergen sensitized group were lower than that before the treatment (TNSS: 9. 00 [8. 00; 10. 00], TMS: 2. 16 [1. 88; 2. 37]), which have showed a statistically significant difference(P<0. 05). Similarly, after SLIT treatment for 2 years and drug discontinuance for 3 years, the TNSS (3. 14[2. 46; 3. 63], 4. 23[3. 65; 4. 96], respectively) and TMS (0. 42[0. 36; 0. 58], 0. 50[0. 34; 0. 72], respectively) in the polyallergen sensitized group were lower than that before the treatment (TNSS: 9. 00[8. 00; 10. 00], TMS: 2. 18[1. 95; 2. 37]), which have showed a statistically significant difference(P<0. 05). No statistically significant finding could be observed in monoallergen and polyallergen sensitized group before the treatment and 2 years after treatment, respectively. However, a statistically significant finding could be observed between two groups in the drug discontinuance for 3 years (P<0. 05). Eleven patients suffered local adverse effects, and the incidence of adverse effects showed no significantly difference (P>0. 05). CONCLUSION SLIT with standardized Dermatophagoides farina drops has a long-term efficacy in monosensitized and polysensitized patients with allergic rhinitis. Moreover, a longer SLIT treatment (>2 years) may be necessary to consolidate its efficacy.
Administration, Sublingual ; Animals ; Antigens, Dermatophagoides ; therapeutic use ; Humans ; Pyroglyphidae ; Retrospective Studies ; Rhinitis, Allergic ; therapy ; Skin Tests ; Sublingual Immunotherapy ; Treatment Outcome

OBJECTIVE: To observe and analyze the function and morphology of pharyngeal ostium of the eustachian tubes in secretory otitis media and chronic rhinosinusitis in children under direct vision,in order to provide an objective basis for clinical treatments. METHOD: Fifty cases of secretory otitis media,50 cases of chronic rhinosinusitis and a control group of 50 cases with hoarseness were examined under video laryngoscope to observe the pharyngeal ostium morphological changes of the eustachian tubes, and their functional statuses were tested by using acoustic impedance instrument. All the data were analyzed by statistical methods. RESULT: (1) In the secretory otitis group, the abnomal rate of the pharyngeal ostium of the eustachian tubes was 94% while the chronic rhinosinusitis group was 80%,and between them there was no significant differences (P > 0.05). But both of them had significant differences with the control group (P < 0.05). (2) In the secretory otitis group, the rate of the eustachian tube dysfunction was 70% while the chronic rhinosinusitis group was 26%, and between them there was significant differences (P < 0.05), and both of them have significant differences when compared with the control group (P < 0.05). CONCLUSION There are some abnormal points exist in the function and the morphology of the eustachian tube in secretory otitis media and chronic rhinosinusitis in children. Eustachian tube dysfunction played a dominant role in the pathogenesis of secretory otitis media in children rather than the morphological change did compared to the chronic rhinosinusitis in children.
Case-Control Studies ; Child ; Chronic Disease ; Eustachian Tube ; pathology ; physiopathology ; Humans ; Otitis Media with Effusion ; pathology ; physiopathology ; Rhinitis ; pathology ; physiopathology ; Sinusitis ; pathology ; physiopathology

OBJECTIVE: To observe the clinic features of the sulcus vocalis in children. METHOD: From Jan 1995 to April 2005,56 cases of pediatric sulcus vocalis were found by video-laryngoscopy. All received an operation called sulcus vocalis microdissection and vocal cord plasty with four steps: an incision along the superolateral edge of the sulcus; freeing of the mucosa adhering to the vocal ligament; detachment of the ligamentous fibers; redraping of the mucosa. RESULT: The total effective rate was 96.4% after surgical treatment. CONCLUSION There are 5% sulcus vocalis among children referred for voice disorders. The sulci are frequently found in association with other laryngeal abnormalities. Sulcus vocalis microdissection and vocal cord plasty might be a rational and effective surgical modality.
Child ; Child, Preschool ; Female ; Humans ; Laryngeal Diseases ; congenital ; surgery ; Laryngoscopy ; Male ; Reconstructive Surgical Procedures ; methods ; Vocal Cords ; abnormalities

OBJECTIVE: To analyze the compliance of sublingual desensitization used in allergic rhinitis patients by telephone follow up, and to discuss the influencing factor associate with medicine pause. METHOD: One hundred and thirty-two patients of allergic rhinitis were randomly divided into two groups, 53 cases was in the control group, 79 cases was in telephone follow up group for a period of 6 months of observation. RESULT: Sublingual desensitization treatment for 6 months, 28/53 cases of control group were compliance, 25/53 cases were loss, and compliance rate was 52.8%; 17/27 cases of follow-up group A were compliance, 10/27 cases were loss, and compliance rate was 63.0%; 21/28 cases of follow-up group B were compliance, 7/28 cases were loss, and compliance rate was 75.0%; 22/24 of follow-up group C were compliance, 2/24 cases were loss, and compliance rate was 91.7% (P < 0.05). Significant difference was found in the 4th month after treatment (P < 0.01). Long-term treatment and cure were the main impact factors for compliance. CONCLUSION Timely telephone follow-up education and guidance to patients could improve compliance of patients with sublingual desensitization.
Administration, Sublingual ; Adolescent ; Antigens, Dermatophagoides ; immunology ; Child ; Child, Preschool ; Desensitization, Immunologic ; methods ; Female ; Follow-Up Studies ; Humans ; Male ; Patient Compliance ; Rhinitis, Allergic, Perennial ; psychology ; therapy ; Telephone

OBJECTIVE: To investigate the value of CT and MRI in diagnosing the children with sensorineural hearing loss. METHOD: Ninety-six cases suspected as severe sensorineural hearing loss were examined by CT/MRI system and 3D reconstruction. RESULT: Of 96 cases, 15 cases were found malformation these malformation included Michel, cochlear hypoplasia, commun cavity, Mondini, inner canal straitness, cochlear nerve undeveloped and vestibular aqueduct enlargements. CONCLUSION There are 15.63% inner ear malformation occurred in sensorineural hearing loss children. CT and MRI of inner ear have a great clinical value in diagnosing children sensorineural hearing loss by learning the anatomy.
Child ; Child, Preschool ; Hearing Loss, Sensorineural ; diagnosis ; diagnostic imaging ; Humans ; Infant ; Magnetic Resonance Imaging ; Tomography, X-Ray Computed