Prognosis value of Chinese Ocular Fundus Diseases Society classification for proliferative diabetic retinopathy on postoperative visual acuity after pars plana vitrectomy in type 2 diabetes.

AIM: To compare the postoperative visual acuity among eyes with proliferative diabetic retinopathy (PDR) of different stages after pars plana vitrectomy (PPV) in type 2 diabetic patients. METHODS: A retrospective study was conducted for PDR eyes undergoing PPV in type 2 diabetic patients. All patients were divided into three groups based on Chinese Ocular Fundus Diseases Society (COFDS) classification for PDR: Group A (primary vitreous hemorrhage), Group B (primary fibrovascular proliferation) and Group C (primary vitreous hemorrhage and/or fibrovascular proliferative combined with retinal detachment). The postoperative visual acuity and the change between postoperative and preoperative visual acuity were compared among three groups. The associated risk factors for postoperative visual acuity were analyzed in the univariate and multiple linear aggression. RESULTS: In total, 195 eyes of 195 patients were collected in this study, including 71 eyes of 71 patients in Group A, 75 eyes of 75 patients in Group B and 49 eyes of 49 patients in Group C. The eyes in Group A got better postoperative best-corrected visual acuity (BCVA) compared to the eyes in Group B and C (0.48±0.48 vs 0.89±0.63, P<0.001; 0.48±0.48 vs 1.04±0.67, P<0.001; respectively). The eyes in Group A got more improvement of BCVA compared to the eyes in Group B and C (1.07±0.70 vs 0.73±0.68, P=0.004; 1.07±0.70 vs 0.77±0.78, P=0.024; respectively). In the multiple linear regression analysis, primary fibro-proliferative type (ß=0.194, 95%CI=0.060-0.447, P=0.01), retinal detachment type (ß=0.244, 95%CI=0.132-0.579, P=0.02), baseline logMAR BCVA (ß=0.192, 95%CI=0.068-0.345, P=0.004), silicone oil tamponade (ß=0.272, 95%CI=0.173-0.528, P<0.001) was positively correlated with postoperative logMAR BCVA. Eyes undergoing phacovitrectomy had better postoperative BCVA (ß=-0.144, 95%CI=-0.389 to -0.027, P=0.025). CONCLUSION: PDR eyes of primary vitreous hemorrhage type usually have better visual acuity prognosis compared to primary fibrovascular proliferation type and retinal detachment type. COFDS classification for PDR may have a high prognostic value for postoperative visual outcome and surgical management indications.

Evaluation of efficacy and safety of Qiangzhu-qinggan formula as an adjunctive therapy in adult patients with severe influenza: study protocol for a randomized parallel placebo-controlled double-blind multicenter trial.

BACKGROUND: Influenza can fall into three categories according to severity: mild influenza, severe influenza, and critical influenza. Severe influenza can result in critical illness and sometimes death particularly in patients with comorbidities, advanced age, or pregnancy. Neuraminidase inhibitors (NAIs) are the only antiviral drugs in widespread use for influenza. However, the effectiveness of NAIs against severe influenza is uncertain. New effective drugs or regimens are therefore urgently needed. Qiangzhu-qinggan (QZQG) formula has been found to be effective against influenza virus infection during long-term application in China, which lacks support of evidence-based clinical trial till now. This study is designed to assess the efficacy and safety of QZQG formula as an adjuvant therapy in adult patients with severe influenza. METHODS: This protocol is drawn up in accordance with the SPIRIT guidelines and CONSORT Extension for Chinese herbal medicine formulas. This is a randomized, placebo-controlled, double-blind, multicenter trial. Two hundred twenty-eight adults with severe influenza are randomly assigned in a 1:1 ratio to QZQG or placebo for 7 days. All participants need to receive 1 day of screening before randomization, 7 days of intervention, and 21 days of observation after randomization. The primary outcome is the proportion of clinical improvement, defined as the proportion of patients who met the criteria of 3 points or less in the seven-category ordinal scale or 2 points or less in National Early Warning Score 2 within 7 days after randomization. DISCUSSION: This is the first randomized, controlled, parallel, double-blind clinical trial to evaluate the efficacy and safety of traditional Chinese herbal formula granules as an adjuvant therapy in adult patients with severe influenza. This study aims to redefine the value of traditional Chinese herbal medicines in the treatment of virus-related respiratory infectious diseases and serves as an example of evidence-based clinical trials of other Chinese herbal medicines.

Efficacy of integrating short-course chemotherapy with Chinese herbs to treat multi-drug resistant pulmonary tuberculosis in China: a study protocol.

BACKGROUND: Tuberculosis (TB) caused Mycobacterium tuberculosis (M.tb) is one of infectious disease that lead a large number of morbidity and mortality all over the world. Although no reliable evidence has been found, it is considered that combining chemotherapeutic drugs with Chinese herbs can significantly improves the cure rate and the clinical therapeutic effect. METHODS: Multi-drug resistant pulmonary tuberculosis (MDR-PTB, n = 258) patients with Qi-yin deficiency syndrome will be randomly assigned into a treatment group (n = 172) or control/placebo group (n = 86). The treatment group will receive the chemotherapeutic drugs combined with Chinese herbs granules (1 + 3 granules), while the control group will receive the chemotherapeutic drugs combined with Chinese herbs placebo (1 + 3 placebo granules). In addition, MDR-PTB (n = 312) patients with Yin deficiency lung heat syndrome will be randomly assigned to a treatment (n = 208) or control/placebo (n = 104) group. The treatment group will receive the chemotherapeutic regimen combined with Chinese herbs granules (2 + 4 granules), while the control group will receive the chemotherapeutic drugs and Chinese herbs placebo (2 + 4 placebo granules). The primary outcome is cure rate, the secondary outcomes included time to sputum culture conversion, lesion absorption rate and cavity closure rate. BACTEC™ MGIT™ automated mycobacterial detection system will be used to evaluate the M.tb infection and drug resistance. Chi-square test and Cox regression will be conducted with SAS 9.4 Statistical software to analyze the data. DISCUSSION: The treatment cycle for MDR-PTB using standardized modern medicine could cause lengthy substantial side effects. Chinese herbs have been used for many years to treat MDR-PTB, but are without high-quality evidence. Hence, it is unknown whether Chinese herbs enhances the clinical therapeutic effect of synthetic drugs for treating MDR-PTB. Therefore, this study will be conducted to evaluate the clinical therapeutic effect of combining Chinese herbs and chemotherapeutic drugs to treat MDR-PTB cases. It will assist in screening new therapeutic drugs and establishing treatment plan that aims to improve the clinical therapeutic effect for MDR-PTB patients. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (ChiCTR1900027720) on 24 November 2019 (prospective registered).

Dexmedetomidine protects against degeneration of dopaminergic neurons and improves motor activity in Parkinson's disease mice model.

Parkinson's disease (PD) is the result of dopaminergic (DA) neuronal death in the substantianigra pars compacta (SNc). Current treatments for PD such as L-dopa are limited in effectiveness and fail to address the cause. Targeted anti-inflammatory therapies, particularly directed at nuclear factor kappa B (NF-κB) activity in alleviating degeneration of DA-neurons is of evolving interest. In the present study, we hypothesised that dexmedetomidine (DEX), an alpha-2 receptor adrenergic agonist, suppress the inflammatory responses associated with PD and restores dopaminergic levels by alleviating substantia nigral degeneration. Male mice (C57Bl/10, 8-11 months old and of 34-40 g of weight) were divided into: the control, 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), and MPTP + dexmedetomidine (MPTP + DEX) (n = 26 each group). Dex restored dopamine levels in SNpc of MPTP-induced PD mice model. Results of immunohisto staining revealed that Dex treatment post-MPTP induction restored TH-positive cells, with only 12.37% increase (##p < 0.01 vs MPTP) on the third day and a steep 55% increase (###p < 0.001 vs MPTP) following the seventh day of Dex treatment. Moreover, the expressions of proinflammatory markers regulated by NF-κB were diminished in Dex + MPTP group. In addition, cylinder test revealed that Dex treatment improved asymmetric limb usage pattern in MPTP induced mice over the course of 7 days. Hence, in this study, we provided insight on the effect of Dex in the inhibition of NF-κB1 regulated proinflammatory mediators to improve dopamine levels and reduce SNpc dopaminergic neuronal degeneration.

Peripheral lymphocyte subset variation predicts prostate cancer carbon ion radiotherapy outcomes.

The immune system plays a complementary role in the cytotoxic activity of radiotherapy. Here, we examined changes in immune cell subsets after heavy ion therapy for prostate cancer. The lymphocyte counts were compared with acute radiotherapy-related toxicity, defined according to the Common Terminology Criteria for Adverse Events, and short-term local efficacy, defined based on prostate-specific antigen concentrations. Confirmed prostate cancer patients who had not received previous radiotherapy were administered carbon ion radiotherapy (CIR) in daily fractions of 2.74 GyE with a total dose of 63-66 GyE. Lymphocyte subset counts were investigated before, during and after radiotherapy, and at a 1 month follow-up. Most notable among our findings, the CD4/CD8 ratio and CD19+ cell counts were consistently higher in patients with a complete response (CR) or partial response (PR) to CIR than in those classified in the stable disease (SD) group (P<0.05 for both). But CD3+ and CD8+ cell counts were lower in the CR and PR groups than in the SD group. These results indicate that variations in peripheral lymphocyte subpopulations are predictive of outcome after CIR for prostate cancer.

[Preliminary clinical study on the posterior lumbar minimally invasive surgery assisted by 3D-Viewer system under a direct vision].

OBJECTIVE: To study the methods and preliminary clinical efficacy of posterior lumbar minimally invasive surgery assisted by 3D-Viewer system under a direct vision and provide rationales for further clinical applications. METHODS: From September 2008 to September 2009, a total of 84 lumbar degenerative disease patients were enrolled and randomly divided into 2 groups (n = 42 each). One group was treated operatively by 3D-Viewer system under a direct vision while another treated with conventional operations. The lumbar paraspinal muscle approach was employed. Surgery was assisted by 3D-Viewer system under a direct vision. The operative duration, intra-operative blood loss volume, CK (creatine kinase) levels at Days 1 & 7 post-operation, atrophic rates of cross-sectional areas of bilateral multifidus muscles on MRI (magnetic resonance imaging) at 12 months post-operation were recorded. At Month 12 post-operation, the therapeutic efficacy was evaluated by Oswestry disability index (ODI) and the post-operative clinical effects assessed. RESULTS: The operative duration, intra-operative blood loss volume and CK level at Days 1 & 7 post-operation were statistically different (P < 0.05); there was significant difference in the atrophic rates of cross-sectional areas of bilateral multifidus muscles on MRI and the improvement rates of ODI (P < 0.001); the therapeutic efficacy of the invasive group was significantly better than that of the group treated with traditional operations (P < 0.05). CONCLUSION: The 3D-Viewer technique reduces the risk of damage. As an ideal minimally invasive procedure, it may achieve satisfactory outcomes for spinal diseases.

[The correlation between the level of serum VEGF and bFGF with metastasis and prognosis of osteosarcoma].

AIM: To investigate the correlation between the level of serum VEGF and bFGF with metastasis and re- currence of osteosarcoma. METHODS: 52 patients with osteosarcoma and 60 healthy people as control group were selected. The serum contents of VEGF and bFGF were determined with ELISA before and after operation. RESULTS: The serum contents of VEGF and bFGF before operation were significantly higher than that in control group ( P < 0.01). The serum contents of VEGF and bFGF after operation descreased significantly but were significantly higher than that in control group(P<0. 01). The serum contents of VEGF and bFGF before operation were positively related to the size of primarily tumor, Enneking type and tumor differentiation(P<0.05). The serum contents of VEGF and bFGF before and after operation were different significantly between recurrence and metastasis positive group with recurrence and metastasis negative group ( P < 0. 01). The Cox proportional hazards model showed that the serum contents of VEGF and bFGF before and after operation were an independent factor of the recurrence and metastasis for osteosar- coma patients after operative ( P <0. 01). CONCLUSION: The serum contents of VEGF and bFGF before and after operation can offer valuable assessments in evaluation of progression and metastasis prognosis.

[Metrx quadrant system in the surgery of lumbar spondylolisthesis: preliminary clinical application].

OBJECTIVE: To evaluate the clinical efficacy and minimal invasiveness of quadrant posterior distraction system in the posterior lumbar spondylolisthesis (LS) surgery. METHODS: Sixty-one LS patients were randomly divided into two groups: quadrant posterior minimally invasive surgery system as invasive group (n = 30) and traditional open surgery as open group (n = 31). The clinical outcome of pain relief was assessed by the scoring systems of visual analogue scale (VAS) and Oswestry disability index (ODI) for low back pain. Radiographic assessment: preoperative and 1-day, 3-month and last follow-up (12 months) radiographs were analyzed including the index of relative posterior disc height. RESULTS: The scores of VAS and ODI of invasive group were less than open group at Months 3 and 12 post-operation (P < 0.01). Relative posterior disc height of intra-operation and Month 3 was not significantly different (P > 0.05). And there was only statistical significance difference within 12 months (P < 0.05). At Month 12 post-operation, the fluctuating rate was slight. CONCLUSION: The minimally invasive operation with Quadrant is less traumatic to the patients than traditional open operation in the protection of spinal stability, postoperative rehabilitation and radiographs. This new minimally invasive spine technique should be popularized.

[Prevention of dura adherence in spinal canal after microendoscopic discectomy by different methods: a clinical study of 165 cases].

OBJECTIVE: To evaluate the effects of different methods in prevention of post-operational scar formation and dura adherence in the spinal canal after microendoscopic discectomy (MED). METHODS: 165 patients undergoing MED were randomly divided into 3 equal groups: Group A, with the yellow ligament dissected and with the space between vertebral laminae sprinkled with sodium hyaluronate before the closing of the incision; Group B, with the yellow ligament reserved; and Group C, with the yellow ligament reserved and with the space between vertebral laminae sprinkled with sodium hyaluronate before the closing of the incision. All the patients were followed up 2, 4, and 8 weeks, and 1 and 2 years after the operation. Japanese Orthopedic Association (JOA) scoring system was used to evaluate the outcomes. RESULTS: The JOA scores 2 weeks after MED were not significantly different among the 3 groups; and from then on the JOA scores of Groups B and C were all higher than those of group A (A and B: t(4w) = 0.602, t(8w) = 0.701, t(1y) = 0.623, t(2y) = 0.654; A and C: t(4w) = 0.833, t(8w) = 0.759, t(1y) = 0.714, t(2y) = 0.771, all P < 0.05), however, there were not significantly differences at all time points between Groups B and C (B and C: t(2w) = 0.041, t(4w) = 0.135, t(8w) = 0.980, t(1y) = 0.530, t(2y) = 0.103, all P > 0.05). CT showed that a great amount of scar was seen, surrounding the dura mater sac and nerve roots in Group A, and there was a great amount of scar outside the yellow ligament and no remarkable compression of dura mater sac and nerve roots in Groups B and C. CONCLUSION: Reservation of yellow ligament effectively prevents scar adhesion inside the vertebral canal after MED. Sprinkling of sodium hyaluronate is also effective, however, its effect only lasts a short time.