The ethical issues are different at different research stages of drug discovery.At the preclinical trial phase,laboratory animals are indispensable.The medical animal ethics committees need to approve and supervise animal testing during the experiment whether it adheres to the principles of animal protection,animal welfare principles and ethicalprinciples.At the phase of clinical trials,the subject of drug is human.The medical ethics committee should take full account of the ethical issues arising from the special medicine,special populations and disease in the process of trial and formulate detailed and feasible clauses,thus to ensure the scientificity of the trial and the rights and interests of subjects and promote new drug discovery and integrate with international standards.

Objective To investigate the mechanism of recombinant human bone morphogenetic protein-2(rhBMP-2)in repairing hematopoietic injury in mice irradiated with γ-ray.To prepare SRY gene probe and study the effect of rhBMP-2 in repairing hematopoietic injury in mice by in situ hybridization.Methods Twenty-two BALB/c female mice were randomly divided into the irradiated group and BMP treated group,respectively.Bone marrow cells of normal male mice were transplanted into 22 female mice post-irradiation to 8.5 Gy of 60 Co γ rays.The left femurs of the survived female mice were re-irradiated with 9 Gy 14 days later.Mice in BMP treated group were given rhBMP-2 20 mg/kg while those in control group were treated with 0.9% saline by intraperitoneal injection every day for 6 days.These mice were killed 14 days later and paraffin sections of femurs were made.The SRY gene was detected with in situ hybridization.Results There were more positive blots in the left femurs of the mice in irradiated group than those in BMP treated group(T=155.0,P＜0.05).The number of positive blots between the left femurs of the mice in irradiated group and the right femurs of the mice in two groups was not significantly different(T=92.0,78.5,P＞0.05).The number of positive blots in the left femurs of the mice in BMPtreated group was significantly less than those in the right femurs of the mice in two groups(T=155.0,55.0,P＜0.05).Conclusions No donor cell of male mice was detected in the left femurs of BMP treated group,suggesting that rhBMP-2 promoted the restoration of residuary bone marrow cells.Thus,rhBMP-2 promotes the proliferation or differentiation of residuary mesenchymal stem cells,improves hematopoietic microenvironment and accelerates the hematopoietic restoration.

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.