Bone grafting is a primary method for treating bone defects. Among various graft materials, xenogeneic bone substitutes are widely used in clinical practice due to their abundant sources, convenient processing and storage, and avoidance of secondary surgeries. With the advancement of domestic production and the limitations of imported products, an increasing number of bone filling or grafting substitute materials isentering clinical trials. Relevant experts have drafted this consensus to enhance the management of medical device clinical trials, protect the rights of participants, and ensure the scientific and effective execution of trials. It summarizes clinical experience in aspects, such as design principles, participant inclusion/exclusion criteria, observation periods, efficacy evaluation metrics, safety assessment indicators, and quality control, to provide guidance for professionals in the field.
Humans ; Bone Substitutes/therapeutic use* ; Randomized Controlled Trials as Topic/methods* ; Consensus ; Bone Transplantation ; Research Design

Objective:To investigate the clinical efficacy of vascular rehabilitation capsules and calcium dobesilate on non-proliferative diabetic retinopathy and its effect on inflammatory factors.Methods:A total of 80 patients with type 2 diabetes and non-proliferative retinopathy diagnosed in the endocrinology department of First People′s Hospital of Huaihua were randomly divided into the control group ( n=40 cases, 72 eyes) and the observation group ( n=40 cases, 76 eyes). The two groups were given conventional basic treatment. The control group was given calcium dobesilate, and the observation group was added with the combination of vascular rehabilitation capsules and treatment for 24 weeks. After treatment, the clinical therapeutic effects of the two groups were evaluated, and the levels of inflammatory factors interleukin-6 (IL-6) and high-sensitivity C-reactive protein (hs-CRP) were analyzed before and after treatment. The occurrence of adverse reactions was monitored during treatment. Results:The total effective rate of the observation group was higher than that of the control group (92.5% vs 75.0%, χ 2=4.501, P<0.05). There was no significant difference in the levels of IL-6 and hs-CRP in the two groups of patients before treatment [(4.41±0.92)pg/ml vs (4.47±0.84)pg/ml, (16.36±4.02)mg/L vs (16.38±3.26)mg/L]; after 12 weeks and 24 weeks of treatment, the levels of IL-6 and hs-CRP in the observation group were significantly lower than those in the control group [12 h: (2.55±0.64)pg/ml vs (2.94±0.59)pg/ml, (12.21±3.48)mg/L vs (14.33±3.04)mg/L; 24 h: (1.93±0.49)pg/ml vs (2.36±0.45)pg/ml, (9.63±3.05)mg/L vs (11.52±2.15)mg/L, all P<0.05]. During the treatment, no serious adverse events occurred in both groups of patients. Conclusions:Vascular rehabilitation capsules combined with calcium dobesilate is an effective treatment for non proliferative diabetic retinopathy. It can improve the clinical efficacy, safety and reduce inflammatory reaction, which is worthy of further clinical application.

Objective To compare the curative effect of Epalrestat and mecobalamine .Methods Epalrestat to treat 48 pa-tionts in DPN and mecobalamine to treat 42,measuring blood sugar ,blood pressure, blood fat and body mass index (BMI) prior and post treatment ,and measuring the MCV and SCV of nervus medianus ,nervus peronaeus connunis and nervus tibialis with EMG .Re-sults The symptom of the two sets have all been improved after the treatment ,and the effective power of Epalrestat and mecobalamine is 92.7% and 80.5% respectively.mean while there is improvement in MCV and SCV of nervus medianus ,nervus peronaeus connunis and nervus tibialis,and is more obvious in the set of Epalrestat ( P <0.01).In the whole process of the treat of the two sets ,no one appear to have adverse reactions .Conclusions Epalrestat has significant curative effect with less adverse reactions , and deserves to be spreaded in clinic.