Analysis of Key Points and Difficulties in Registration Application of Inflatable Bone Expander / 中国医疗器械杂志

With the advantages of inflatable bone expander in the treatment of osteoporotic vertebral compression fractures, the number of applications for registration of such products is increasing. Based on the characteristics of the medical device, this article analyzed and summarized the relevant requirements for the basic information, product performance research, product manufacturing, clinical evaluation, and product instructions that should be focused on the registration application dossiers, as well as comply with the requirements of CMDE. The focus of the registration application for Inflatable Bone Expander should be the standardization of the application dossiers, while the difficulty was the scientific rationality of the research data. Comments and suggestions are provided to relevant practitioners on standardization of registration application dossiers. It may help them to optimize the quality of registration application dossiers while improve the efficiency of registration applications.

Effect of PKP combined with anti osteoporosis drugs on osteoporotic vertebral compression fractures / 中国生化药物杂志

Objective To investigate the clinical effect of PKP combined with anti osteoporosis drugs in the treatment of osteoporotic vertebral compression fractures.Methods 100 cases of osteoporotic vertebral compression fractures treated in our hospital from January 2014 to December 2016 were compression fracture as the research object in the course of the study, and were randomly divided into control group and experimental group,with 50 cases in each group.Patients in the control group were treated with PKP, while the experimental group was treated with PKP combined with anti osteoporosis drugs.The related clinical indicators of the two groups were compared and analyzed.Results After the corresponding treatment, there was no significant difference between the experimental group and the control group in the rate of cement leakage and the amount of bone cement injection.After operation, the ODI index and VAS scoreof the two groups were significantly better than before treatment, the difference was statistically significant(P<0.05), the patient's cone height was well recovered.After 14 to 24 months of follow-up found that, the fracture rate of the experimental group was 10.0%, significantly lower than the control group 24.0%, the difference was statistically significant(P<0.05).Conclusion PKP combined with anti osteoporosis drugs for the treatment of osteoporotic vertebral compression fractures has good clinical effect, can effectively reduce the adjacent segment cone fracture rate, improve the quality of life of patients, with further clinical promotion and application significance.

Study on the application of zoledronic acid in the treatment of osteoporotic vertebral compression fractures with PKP / 中国生化药物杂志

Objective To investigate the application effect of zoledronic acid on PKP after osteoporotic vertebral compression fractures. Methods According to different treatment methods, 80 cases of patients from January 2015 to January 2017 in Xi'an City, Hong hui Red Cross hospital diagnosis and treatment of osteoporotic vertebral compression fractures parallel PKP were divided into two groups. The patients in the control group were not treated with zoledronic acid, and the patients in the observation group were treated with zoledronic acid.The treatment effect and adverse reaction rate were compared between two groups. Results The treatment effect of the observation group was better than that of the control group, and the improvement of the clinical symptoms of the observation group was better than that of the control group, and the incidence of adverse reactions was lower than that of the control group, the difference was statistically significant (P<0.05). Conclusion The effect of zoledronic acid treatment on osteoporotic vertebral compression fractures after PKP is remarkable, which can effectively improve the patients' clinical symptoms, less adverse reactions, is widely used in clinical osteoporotic vertebral compression fractures after PKP holds.

A comparative research between traditional positioning device and a new type percutaneous kyphoplasty positioning device / 中国医学装备

Objective:To compare the accuracy and safety between percutaneous kyphoplasty (PKP) positioning device and traditional positioning device which posit entry point of pedicle of vertebral arch by using the C-arm X-ray.Methods: 117 patients with spinal centrum compression fractures were divided into positioning device group (57 cases) and Kirschner wire group (60 cases) depended on the entry point marked by the preoperative C arm X-ray irradiation. To compare the excellence rate, operation time and exposure times between PKP positioning device and traditional device.Results: The positioning times of the PKP positioning device group and Kirschner wire group were (2.3±0.9)min and (6.8±1.3)min, respectively. The exposure times of the two group were 1.6 times and 4.7 times, respectively. And both of the two differences were statistical significant (t=21.062,t=18.521;P0.05).Conclusion: There are series of advantages in developed PKP positioning device, such as portable, easy and simple control, higher accuracy and safety, less positioning time and exposure times of C arm X-ray.

Application of zoledronic acid combined with psychological intervention in the treatment of osteoporotic vertebral compression fractures after PKP / 中国生化药物杂志

Objective To study the value of zoledronic acid combined with psychological intervention in osteoporotic vertebral compression fractures in percutaneous balloon kyphoplasty (PKP). Methods 72 patients with osteoporotic vertebral fractures underwent PKP operation from August 2013 to August 2015 were randomly divided into observation group and control group,with 36 cases,in each group. The patients in the control group were given salmon calcitonin after operation. The patients in the observation group were given zoledronic acid after operation. Both patients were given psychological care. The total effective rate of clinical treatment and the incidence of secondary osteoporotic vertebral compression fractures,Visual analogue pain scale before and after treatment (VAS), Oswestry dysfunction index questionnaire (ODI) score, bone mineral density T value changes were compared between the two groups. Results The total effective rate was 94.44% in the observation group and 77.78% in the control group (P<0.05). The recurrence fracture rate was significantly lower than that of the control group (P<0.05). After treatment, the scores of VAS and ODI in the observation group were significantly lower than those in the control group (P<0.05). The T value of bone mineral density was significantly higher than that of the control group (P<0.05). Conclusion Zoledronic acid combined with psychological intervention can effectively improve the effective rate of PKP after osteoporotic vertebral compression fractures, increase bone density and reduce the incidence of fracture, which is worthy of clinical application.

Clinical Outcomes of Nd-YAG Laser Membranotomy in Retained Host Corneal Membrane after Keratoplasty

PURPOSE: To evaluate the clinical efficacy and shortcomings of neodymium-doped yttrium aluminum garnet (Nd-YAG) laser membranotomy in inadvertently retained host membrane. METHODS: Among 742 patients who underwent penetrating keratoplasty (PKP) and deep anterior lamellar keratoplasty (DALK) surgery at Seoul St. Mary's Hospital between January 2007 and May 2013 by a single surgeon, 10 patients had a thin, opaque membrane in the anterior chamber observed under slit lamp examination and both a subjective decrease in visual acuity and decrease i best corrected visual acuity. A single surgeon performed membranotomy using the Nd-YAG laser at 4.9 months after graft surgery. In this study we compared the differences in visual acuity, endothelial cell count and correlations between distance from donor endothelium and retained host membrane and endothelial loss before and after the graft surgery. RESULTS: Patients who had Nd-YAG laser membranotomy performed on the retained host membrane showed significant improvements in visual acuity (p = 0.039). Donor endothelial cell count was significantly reduced 1 month after Nd-YAG laser. The average distance between donor endothelium and retained host membrane was 712.0 +/- 217.5 microm. The distance and the decreased donor endothelial cell count were not statistically correlated (R2 = 0.39, p = 0.072). There were no significant complications after the laser membranotomy. CONCLUSIONS: Inadvertently retained host membrane forms close to the donor endothelium as identified on optical coherence tomography (OCT) images. Nd-YAG laser membranotomy significantly affected clear vision but endothelial cell count loss was also observed.

Percutaneous kyphoplasty in treatment of elderly osteoporotic vertebral compression fractures / 中华内分泌外科杂志

Objective To investigate the clinical efficacy of percutaneous kyphoplasty(PKP) in treatment of elderly osteoporotic vertebral compression fractures(OVCF).Methods 122 elderly OVCF patients from Oct.2009 to Oct.2013 in Lihuili Hospital of Ningbo Medical Center were selected,and were randomly divided into group A,and group B.There were 61 cases in each group.Group A received percutaneous kyphoplasty(PKP),and group B were treated with percutaneous vertebroplasty(PVP).The two groups were observed in terms of pain,activity,vertebral compression rate and Cobb angles after treatment.The two groups were followed up at least for 3 months.The postoperative side effects were recorded and analyzed.Results After the treatment,the two groups significantly improved in VAS score and activity(P ＜ 0.05),but no significant difference was found between the two groups (P ＞ 0.05).After the treatment,vertebral compression rate and Cobb angle got better than before in the two groups,but group A recovered more obviously than group B,and the difference had statistical significance (P ＜ 0.05).The postoperative recurrence rate was 18.03 ％ (11/61) in the observation group and 9.84 ％ (6/61) in the control group,and the difference had statistical significance (P ＜ 0.05).Conclusion PKP and PVP can significantly relieve pain,but PKP had better effect than PVP in vertebral body and spinal kyphosis improvement,which is worth of clinical application.

A Case of Double Descemet's Membrane after Penetrating Keratoplasty Converted from Deep Anterior Lamellar Keratoplasty

PURPOSE: To report a case of double Descemet's membrane in a patient who had penetrating keratoplasty after rupture of Descemet's membrane during deep anterior lamellar keratoplasty (DALK). CASE SUMMARY: A 24-year-old female had keratoconus in her right eye and underwent DALK for treatment. Descemet's membrane was ruptured while separating the corneal stroma from Descemet's membrane with the big bubble technique. The operation method was changed from DALK to penetrating keratoplasty. Detached Descemet's membrane was observed in the anterior chamber after suturing. Sterile air was injected into the anterior chamber to attach the Descemet's membrane. Five days after the surgery, Descemet's membrane was detached and a second air injection was performed. Corneal edema was improved but Descemet's membrane was re-detached. Double Descemet's membrane was observed by anterior segment optical coherence tomography (OCT). The detached Descemet's membrane originated from the recipient's cornea and not from the donor's cornea. Detached Descemet's membrane was removed successfully. Patient's cornea was clear and best corrected visual acuity was 20/25. CONCLUSIONS: When penetrating keratoplasty is performed instead of DALK, the surgeon should completely remove the remnant corneal stroma and Descemet's membrane. Remnant Descemet's membrane can be disregarded as it comes from the donor cornea. Unnecessary anterior chamber air injection causes endothelial damage. Anterior segment OCT is a useful tool to identify anatomical structures of transplanted cornea.

A Case of Retained Descemet's Membrane after Penetrating Keratoplasty

PURPOSE: To report a case of retained Descemet's membrane after penetrating keratoplasty (PKP). CASE SUMMARY: A 64-year-old man visited our clinic, complaining of visual disturbance and corneal opacity in his right eye 40 years in duration. On the first visit, his best corrected visual acuity was hand movement on the right eye, and he underwent an uneventful PKP. On the postoperative first day, the patient's visual acuity was 20/200 and slit lamp examination showed a retained Descemet's membrane and pseudo-chamber behind the corneal graft. The corneal graft was edematous, but no intraocular inflammation was observed. The retained Descemet's membrane was surgically removed a quarter at a time. Sutures in one quadrant were removed; the retained Descemet's membrane was lifted with forceps, removed with scissors and knife, and then sutured again. Two months after PKP, the corneal graft remained clear and no intraocular inflammation was observed. An extracapsular cataract extraction (ECCE) was then successfully performed with posterior chamber lens implantation for the senile cataract in his right eye. After the 1-year follow-up, the status of the corneal graft remained clear with a single anterior chamber and best corrected visual acuity improved to 20/100. CONCLUSIONS: Careful post-operative slit-lamp examination is considered important for diagnosis of retained Descemet's membrane after undergoing PKP, and surgical removal can be helpful for maintaining the corneal graft clear.

Percutaneous kyphoplasty for vertebral compression fractures in patients with osteoporosis / 中国矫形外科杂志

[Objective]To evaluate the efficacy of percutaneous kyphoplasty (PKP) in managing vertebral compression fractures due to osteoporosis(OVCF).[Method]Thirty-one OVCFs patients (46 vertebrae) undergoing PKP were retrospectively analyzed.In these patients,there were 9 males and 22 females who were from 61 to 78 years old with averaged 68 years,and the injured vertebrae were from T7 to L3.All the patients had plain X-rays and CT scan as well as MR images preoperatively.With all of the patients,local infiltration anesthesia were performed,20 were injected bilaterally while 11 unilaterally.Before and after operarion,the visual analogue scale (VAS) score was estimated and sagittal index(SI) as well as Cobb′s angle of the vertebrae were measured.The data were statistically analyzed with the method of paired t-test.[Result]The duration of follow up after operetion were 6 to 30 months with a mean of 18 months.The VAS score reduced from 8.7 before operation to 2.5 after operation (P

The variety of eye refraction after penetrating keratoplasties (PKP) / 重庆医科大学学报

Objective:To research eyes refraction varieties and related influence factors undergone PKP.Methods:Sixty-two corneal diseases with PKP were followed up by ophthalmologist concentrating on corneal diseases on month 1,3,6,12,24,36.They had engaged in optometry and tried lens on patients besides regular examination,and had done statistical analysis of refraction change.Results:Eye refraction varieties were remarkable in 12 months especially in 1 to 6 months but stable after 12 months after PKP.Most of them had different degrees and kinds of astigmatism.Conclusion:Eyes refraction varieties were remarkable in 12 months after PKP and astigmatism occurred easily.There were some main factors:conditions before operation,design and manipulation during operation,and complications after surgery.

Human Amniotic Membrane Transplantation for Treatment of Fungal Ulcer

PURPOSE: Various studies on amniotic membrane transplantation for ocular surface reconstruction have been reported. To investigate the effect of human amniotic membrane transplantation on corneal fungal ulcer, we reviewed the records of four fungal ulcer patients. METHODS: Human amniotic membranes were transplanted to the diseased corneas under topical anesthesia within 12 hours. RESULTS: After the mean observation period of 8.5 months, cornea was stabilized in all eyes. No aggravation or rejection were observed. Secondary penetrating keratoplasty was performed in 2 cases. CONCLUSION: Amniotic membrane transplantation may be effective to promote corneal wound healing in refractory fungal ulcer and considered as a useful treatment prior to corneal transplantation.

A Clinical Result of PKP performed on the Family with Congenital Hereditary Endothelial Dystrophy

PURPOSE: Congenital hereditary endothelial dystrophy is a rare disease and is usually characterized by diffuse, bilaterally symmetric corneal opacity and edema inherited by autosomal dominant or recessive pattern. We experienced this rare disease and performed PKP. We report the result with a review of the literature. METHODS: We performed PKP on 7 eyes with congenital corneal opacity inherited by autosomal dominant type, and histopathologically confirmed. We checked preoperative visual acuity, potential visual acuity, intraocular pressure and corneal thickness. Then postoperatively visual acuity, intraocular pressure, corneal thickness and endothelial cell count was checked. RESULTS: After the 1 year follow up, all transplanted cornea survived and there were no rejection. Postoperative visual acuities all increased to potential acuity and the postoperative corneal thickness and endothelial cell count all maintained their normal levels. There was no recurrence of the disease at the 1 year follow up, however secondary glaucoma developed in 2 patients(27.5%), and they were treated by glaucoma surgery. CONCLUSION: The PKP performed on patients of congenital hereditary endothelial dystrophy occurred in one family tree, which has not yet been reported in korea, showed good postoperative results.

A Case of Herpes Zoster Sine Herpete following Pediatric Penetrating Keratoplasty

Herpes zoster ophthalmicus sine herpete(HZSH), which means herpes zoster ophthalmicus(HZO)without skin eruption, is one of the atypical manifestations of varicella-oster virus(VZV)infection. Idiopathic iridocyclitis or acute retinal necrosis without skin lesion secondary to varicella-oster virus are good examples. Diagnosing zoster iridocyclitis without skin eruption is difficult because in the absence of typical skin eruption it is difficult to suspect varicella-zoster virus as the cause of inflammation in the absence of typical skin eruption. We describe here a rare case of a pediatric patient with severe iridocyclitis in a pediatric patient after penetration of keratoplasty in whom VZV DNA was detected using the DNA amplification and polymerase chain reaction(PCR)method. To our best knowledge, this is the first case report of varicella-zoster virus iridocyclitis in a pediatric patient after penetrating keratoplasty.