According to Standard Protocol Items: Recommendations for Interventional Trials, Consolidated Standard of Reporting Trials 2010 Statement (CONSORT), CONSORT Extension for Non-Pharmacologic Treatment Interventions (CONSORT for NPT) and Good Clinical Practice, the detailed requirements for protocol writing, reporting, and practicing of clinical trial were classified and summarized in this article. By combining the practical situation of clinical trial of external treatment of TCM such as tuina, the requirernents for clinical trial protocol writing of external treatment of TCM were analyzed and acquired which could improve the quality of clinical trial protocol of external treatment of TCM, thus to provide references for standardized execution of TMC clinical trial and reports of research results.
Clinical Protocols ; standards ; Clinical Trials as Topic ; methods ; standards ; Humans ; Massage ; standards ; Quality Control ; Reference Standards

Many specific therapeutic antibody drugs have been developed for different indications. In drug development, it has been found that the antibody isotype framework can not only affect the physical and chemical properties of therapeutic antibodies, but also influence the activity and therapeutic effect. As a result, IgG isotype selection should be considered carefully in antibody drug development strategies. Because of the unique biological characteristics, IgG4 isotype has been used in some therapeutic antibodies for which effector functions are not desired. In order to provide new ideas for the development of antibody drugs, the research and application progress of IgG4 isotype in therapeutic antibody drug development has been reviewed.
Drug Design ; Humans ; Immunoglobulin G ; chemistry ; pharmacology

Objective To investigate the efifcacy of thalidomide combined with VAD in treatment of elderly multiple myeloma(MM). Methods 76 cases of elderly MM were randomly divided into two groups, control group (n=38) were treated with VAD alone while the observation group (n=38) were treated with thalidomide and VAD. Clinical efifcacy and adverse reactions in two groups were compared. Results The total effective rate in observation group was 84.21%, which was signiifcantly higher than 55.26%in control group (P<0.05). After treatment, the M protein, myeloma cells andβ2-microglobulin in observation group were (20.77±4.15)×10-2μg/mL, (12.84±2.85)×10-2μg/mL and (2.48±0.53)μg/mL, which were signiifcantly lower than before treatment and control group(P<0.05). Hemoglobin in observation group was (108.83±5.81) g/L, which was signiifcantly higher than before treatment and control group(P<0.05). The adverse reactions were nausea, vomiting, drowsiness, constipation, infection and rash and so on in two groups after treatment, and there was no signiifcant difference between two groups. Conclusion Thalidomide combined with VAD regimen has a better effect in treatment of elderly multiple myeloma than single VAD, has less adverse reactions and well tolerated.

0, P

Objective To explore the efficacy of bismuth containing quadruple therapy in the treatment of peptic ulcer in patients with Helicobacter pylori.Methods We selected 307 peptic ulcer patients with Helicobacter pylori.infection,and randomly divided them into observation group (152 cases)and control group (155 cases).The observation group received quadruple therapy:colloidal bismuth pectin,pantoprazole,amoxicillin and furazolidone, 14d.The control group received the standard triple therapy:pantoprazole,clarithromycin and amoxicillin,14d.The ulcer healing rate,H.pylori eradication rate and adverse reaction were compared between the two groups.Results The ulcer healing rates,remission rates,H.pylori eradication rates in the observation group were 93.5%,92.7%, 94.8%,92.3% respectively,which in the control group were 83.4%,82.7%,84.1%,80.6% respectively,there were statistically significant differences (χ2 =4.15,4.9,6,0.94,all P <0.05).The incidence of adverse reactions did not differ significantly between the two groups (P >0.05).Conclusion Bismuth containing quadruple therapy is associated with a higher rate of H.pylori eradication compared with the standard triple therapy.

ObjectiveTo study the correlation of urinary iodine and thyroid function in elderly men in Harbin,and to provide the basis for formulation of health measures for the elderly.MethodsSeventy five cases of clinically healthy elderly men were enrolled for check-up of urinary iodine,thyroid function and B-ultrasound in Geriatric Ward the Forth Affiliated Hospital of Harbin Medical University in 2010.The subjects of investigation were divided into iodine appropriate and iodine sufficient groups and thyroid function parameters and B-ultrasound results were compared.ResultsThe average age of the 75 cases of healthy elderly men was (79.07 ± 4.78) years old and the median of urinary iodine was 198.4 μg/L.There were 62.67％ (47/75) elderly males whose iodine nutritional status was appropriate,but there were still some individuals(6.67％,5/75) in the iodine excess state.The level of TSH of the iodine appropriate group [(1.91 ± 0.82)mU/L] was lower than that iodine sufficient group [(4.98 ±0.60)mU/L,t =12.58,P ＜ 0.05],while the level of FT3 of the iodine appropriate group[(4.71 ± 0.56)pmol/L]was higher than that iodine sufficient group[(3.31 ± 0.43)pmol/L,t =12.18,P ＜ 0.05].But the difference of FT4between the two groups [(14.91 ± 3.12),(14.06 ± 2.79)pmol/L] was not statistically significant (t =1.40,P ＞0.05].The thyroid volume of iodine sufficient group[(20.9 ± 6.1 )cm3] was higher than that iodine appropriate group [(17.9 ± 5.6)cm3,t =2.11,P ＜ 0.05].ConclusionsSufficient quantities of iodine intake may affect the thyroid of elderly people.Whether the quantity of iodine intake of the elderly population should be decreased or not need to be further studied.

Objective To assess the efficacy and safety of ketogenic diet(KD) on refractory epilepsy in children.Methods KD treatment was designed to observe the effects for 12 weeks.Totally 22 children with 16 boys and 6 girls were enrolled in the study.The epileptic syndromes included infantile spasms(13 cases),Lennox-Gastaut syndrome(4 cases),Dravet syndrome(2 cases),and the unclassified(3 cases).The KD was prepared according to the modified Johns Hopkins regimen.Urinary ketones were measured every day to ensure that ketosis state and parents′ diaries were kept to find out when it started to work and the change of seizure frequency.Effects of KD was evaluated by Engel standard.Blood chemistry was done at baseline,4 weeks and 12 weeks to analyze the effects of KD on metabolism.Side effects were monitored and treated.Results All cases completed the KD regimen for at least 2 weeks,19 cases for at least 4 weeks,and 10 cases for at least 12 weeks.Sixteen out of 22 children experienced the seizure reduction within 3 weeks(1-15 d),especially in the first week,and seizure free appeared within 5 weeks(1-32 d) in 8 cases.Overall,the diet achieved the seizure-free in 36.4%(8/22 cases) and an over 90% of seizure frequency reduction in 22.7%(5/22 cases).The efficacy of KD seemed not correlated with the sex,age,etiopathogenisis,and syndromes and so on.Blood chemistry suggested a normal range of glucose level at 4 weeks,though higher than that at the baseline.The blood triglyceride and total cholesterol level at 12 weeks increased strikingly,even beyond the normal range compared with the baseline.The side effects mainly including transient gastrointestinal symptoms and metabolic disturbances were mostly tolerable.Conclusions KD is probably a feasible therapy on refractory epilepsy in children,with quick and high efficacy and few side effects.

As a new type of carbon nanomaterials, fluorescent carbon dots (fluorescent CDs) have many advantages when compared with the traditional fluorescent probes. They are photoluminescence stable and resistance to photo bleaching. Moreover, they are excellent in biocompatibility, low-toxic and easy to modify. All these above make them a promising optical image material as a probe in optical image. This article reviews structure, the common carbon sources, the preparation methods, and the light-emitting principles of the carbon dots. We also introduce the research progress of fluorescent carbon dots in biomedicine, and the problems need to be resolved in the study of fluorescent CDs.
Carbon ; chemistry ; Fluorescent Dyes ; chemistry ; Nanostructures ; chemistry ; Quantum Dots ; chemistry

Objective: To evaluate the situation for chronic disease management in China, and to seek the method for improving the collaborative management for chronic diseases in community. Methods: We searched literature between January 2008 and November 2013 from the Database, such as China Academic Journal Full-Text Database, and PubMed. The screening was strictly in accordance with the inclusion and exclusion criteria and a summary was made among the selected literature based on a collaboration model. Results: We got 698 articles atfer rough screen and ifnally selected 33. All studies were involved in patient’s self-management support, but only 9 studies mentioned the communication within the team, and 11 showed a clear team division of labor. Conclusion: Chronic disease community management in China displays some disadvantages. It really needs a general service team with clear roles and responsibilities for team members to improve the service ability of team members and provide patients with various forms of self-management services.

Objective To explore the causes of death and life expectancy after elimination of main causes of disease in residents of Tianjin. Methods The death registry data of Tianjin residents in 2014 were collected and coded in“international classification of disease, 10th edition”. The crude death rate and life expectancy after elimination of main causes of disease were calculated, respectively. Results In 2014, the crude death rate in Tianjin residents was 70.708 per million, while in male and female were 78.728 and 62.637 per million respectively. The main cause of death in Tianjin residents was non-communicable disease. The top four death causes were heart disease, cancer, cerebrovascular disease and respiratory disease, accounting for 31.5%, 23.6%, 22.2% and 8.3% of the total death. The top four life expectancy lost diseases were heart disease, cerebrovascular disease, cancer and respiratory disease, with a 6.46 year, 3.28 year, 3.11 year and 1.25 year life increase respectively. Conclusion Non-communicable diseases are the major reason of death and life expectancy lost disease in Tianjin residents, which needs urgent effective intervention to control.