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 correlation between lipoprotein-associated phospholipase A2(Lp-PLA2),hemoglobin glycotion index(HGI)and the severity of type 2 diabetic retinopathy.Methods A total of 120 patients with type 2 diabetes mellitus who were hospitalized in the General Hospital of Hunan Medical University from January 2021 to June 2022 were selected and divided into type 2 diabetes without retinopathy group(NDR group,n=45),non-proliferative diabetic retinopathy group(NPDR group,n=45)and prolifera-tive diabetic retinopathy group(PDR group,n=30).In the same period,50 healthy subjects were randomly selected as control group.The clinical data,Lp-PLA2 and HGI levels of each group were collected and com-pared,and the correlation between different HGI and Lp-PLA2 levels and the severity of the disease was ana-lyzed.Results The levels of Lp-PLA2 and HGI in NDR,NPDR and PDR groups were higher than those in control group(P＜0.05).The proportion of patients with NPDR and PDR in high-Lp-PLA group(H-Lp-PLA2 group)and high-HGI group(H-HGI group)were higher than those in low-HGI group(L-HGI group)and low-Lp-PLA2 group(L-Lp-PLA2 group),and the differences were statistically significant(P＜0.05).Multiple Logistic regression analysis showed that Lp-PLA2 and HGI were risk factors for DR(P＜0.05),and were positively correlated with the severity of type 2 diabetic retinopathy(P＜0.05).Conclusion HGI and Lp-PLA2 are closely related to the severity of retinopathy in type 2 diabetes mellitus,and may be used as new indicators to predict the severity of the disease.

Objective:To analyze the current status of clinical trials of Chinese materia medica for the purpose of registration in China; To provide reference for the research and development of new TCM drugs.Methods:Clinical trials of Chinese materia medica/natural medicine registered in Drug Clinical Trial Registration and Information Disclosure Platform were retrieved from inception to December 31, 2024. Excel 2019 software was used to input and analyze the data such as the number of registered clinical trials, date of first publication, study status, field of indication, trial phases, sponsors, group leader, and design types.Results:A total of 1 137 Chinese materia medica clinical trials had been registered, accounting for 4.12% of the total number registered on the platform. Phase Ⅱ clinical trials accounted for the highest proportion (58.8%), and 99.7% of clinical trials conducted domestically. The sponsors were predominantly domestically pharmaceutical enterprises. These 1 137 clinical trials of Chinese materia medica clinical trials involved 752 drug categories, 28 dosage forms, and 796 varieties (the same class of drugs had different drug dosage forms), with capsules being the most common. The indications primarily focused on respiratory, digestive, cardio-cerebrovascular, neuropsychiatric, gynecological diseases. The group leader of clinical trials was distributed in 28 provinces, among which the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine as the group leader, undertook the most clinical trials of TCM. 89.9% of the clinical trials adopted the randomized controlled trial design, and only 31.9% of the clinical trials purchased insurance for the subjects.Conclusion:The research and development of new TCM drugs has entered a phase of vigorous development. Further efforts are still needed in establishing systematic guidelines for Chinese materia medica clinical trials, accelerating the internationalization of TCM, exploring innovative dosage forms and indications, and strengthening the protection of participants' rights.

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.