The authors briefly introduced the management of clinical test for new drug development, clinical trials for drugs prepared in hospital and post-market drugs, and other types of clinical trials. The mechanism of WHO International Clinical Trial Register Platform (WHO ICTRP), Chinese Clinical Trial Register (ChiCTR) and Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) were also introduced. The authors suggested the trialists to practice the basic philosophy of evidence-based medicine as the rules of their thought and action, and considered that this is the inner guarantee system for the validity of clinical trials.

Objective To systematically review the safety and effectiveness of 6% hydroxyethyl starch (HES) 130/0.4 and crystalloid solution for the patients undergoing elective surgery .Methods We searched the Medline , EMBASE , CENTRAL , CNKI and Wanfang databases for randomized controlled trials involving comparison of the safety and effectiveness of 6% HES 130/0.4 and crystalloid solution for the patients undergoing elective surgery . The major evaluation indexes included intraoperative blood loss , postoperative incidence of dialysis and intraoperative incidence of hypotension . The secondary evaluation indexes included mortality , perioperative incidence of nausea and vomiting , coagulation function , renal function and incidence of adverse events .The two reviewers independently screened ,evaluated and extracted the data .Meta-analysis was performed using the Cochrane Collaboration’s RevMan 5.2 software .Results Ten trials involving 693 patients were included in our meta-analysis .Eight trials were in English and 2 trials were in Chinese .Comparison of the safety and effectiveness of 6% HES 130/0.4 and balanced solution was conducted in 7 trials (498 patients in total) ,and the results showed that 6% HES 130/0.4 reduced the intraoperative incidence of hypotension (OR 0.31 ,95% CI 0.13-0.75 ) and perioperative incidence of nausea and vomiting , (OR 0.08 , 95% CI 0.01 to 0.67 ) in the patients undergoing spinal anesthesia ( P< 0.05 );there was no significant difference in the intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,mortality ,and intraoperative blood loss under general anesthesia or combined spinal-epidural anesthesia between the two solution groups ( P> 0.05 );heterogeneity was found in the urine output under general anesthesia ( P<0.000 01 ,I2 =93% ) .The safety and effectiveness were compared between 6% HES 130/0.4 and normal saline in 3 trials (195 patients in total) and the results showed that there was no significant difference in the intraoperative blood loss ,intraoperative incidence of hypotension ,perioperative incidence of nausea and vomiting ,coagulation function ,renal function ,and incidence of adverse events between the two solution groups ( P> 0.05 ) .Conclusion 6% HES 130/0.4 is safe and effective when applied for the patients undergoing elective surgery .

Objective To investigate the protective effects and possible mechanism of hydrogen sulfide (H2S) against oxidative stress injury induced by hydrogen peroxide (H2O2) in retinal ganglion cell-5 (RGC-5).Methods RGC-5 cells were divided into four groups:RGC-5 group (normal control group),RGC-5 + H2O2 (RGC-5 were cultured in 500 μmol · L-1 H2O2 for 24 hours) group,RGC-5 + NaHS (RGC-5 were cultured in 50 μmol · L-1 NaHS for 30 minutes) + H2O2 (RGC-5 were cultured in 500 μmol · L-1 H2 O2 for 24 hours) group,and RGC-5 + NaHS (RGC-5 were cultured in 50 μmol · L-1 NaHS for 30 minutes) group.Western blots were applied to measure the expression of cytochrome c (Cyt.c) and optic atrophy 1 (OPA1).The fluorescent dye JC-1 assay was chosen to detect the mitochondrial membrane potential (△Ψm).Furthermore,transmission electron microscope was used to observe the morphology of mitochondria.Results Compared with RGC-5 group,the expression of Cyt.c in RGC-5 + H2O2 group decreased in mitochondria,and increased in cytoplasm (all P ＜ 0.05),but there was no statistical difference between RGC-5 group and RGC-5 + NarHS + H2O2 group (all P ＞0.05).Compared with RGC-5 group,the expression of Cyt.c in RGC-5 + NaHS group increased in mitochondria,and decreased in cytoplasm (all P ＜ 0.05).Compared with RGC-5 group,the expression of OPA1 in RGC-5 + H2O2 group decreased in mitochondria,and increased in cytoplasm (all P ＜ 0.05).In RGC-5 + NaHs + H2O2 group and RGC-5 + NaHS group,the expression of OPA1 within and outside the mitochondria had no significant difference compared with RGC-5 group (all P ＞ 0.05).Compared with other three groups,the mitochondrial membrane potential in RGC-5 + H2O2 group obviously decreased,but there was no statistical difference among other three groups (P ＞ 0.05).The mitochondria were globular swelled in RGC-5 group,but in other three groups,the mitochondria had slightly swelled.Conclusion H2S can protect the mitochondrial morphology and functions of RGC? 5 from H2O2-induced oxidative stress via preventing OPA1 release from mitochondria.

OBJECTIVE: To discuss the types of control groups in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the design of control group in future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted in July 2005 to identify RCTs of CHM, and 66 RCTs with CHM for type 2 diabetes mellitus were obtained as the basis for further analysis. RESULTS: Of 66 RCTs with CHM for type 2 diabetes mellitus, 61 (92.4%) trials had both a treatment group and a control group. Twenty-seven (40.9%) RCTs compared CHM plus conventional drug vs conventional drug, 24 (36.4%) compared CHM vs conventional drug, 5 (7.6%) compared CHM vs placebo, 3 (4.5%) compared CHM plus conventional drug vs conventional drug plus placebo, 3 (4.5%) compared CHM plus conventional drug vs other CHM, 1 (1.5%) compared CHM vs no treatment, 1 (1.5%) compared CHM plus placebo vs conventional drug plus placebo, 1 (1.5%) compared CHM vs CHM plus conventional drug vs conventional drug vs placebo, and 1 (1.5%) compared CHM vs conventional drug vs CHM plus conventional drug. CONCLUSION: A variety of control groups were used in RCTs of CHM for type 2 diabetes mellitus, including placebo, active, and no treatment control groups. Justification for selecting particular types of control groups were not provided in the trials reviewed in this study. Different control groups may be appropriate according to the study objectives, and several factors should be considered prior to selecting control groups in future RCTs of CHM. RECOMMENDATIONS: (1) Investigators of CHM who design clinical trials should understand the rationale for selecting different types of control groups; (2) Control groups for RCTs should be selected according to study objectives; (3) Active control groups should select interventions for comparisons that have the strongest evidence of efficacy and prescribe them as recommended; (4) Placebo control groups should select a placebo that mimics the physical characteristics of test intervention as closely as possible and is completely inert; (5) No treatment control groups should only be used when withholding treatment is ethical and objectives outcomes will not be subject to bias due to absent blinding; (6) Crossover control groups may be appropriate in chronic and stable conditions.

Objective To investigate the tendency of quality of life in patients with nasopharyngeal carcinoma (NPC) treated with conventional radiotherapy. Methods Quality of life in NPC patients was assessed using FACT-H&N and NPC-QOL Patients were divided into nine groups according to the treatment period :before treatment group, 0 -20 Gy group, 20 -50 Gy group, > 50 Gy group, 0 -6 months after treatment group, 6 - 12 mouths group, 1 -2 years group, 2 -3 years group and 3 -5 years group. Scores of FACT-H&N and NPC-QOL were compared between the either two groups. Results 450 NPC patients were assessed. The total score of FACT-H&N decreased during the treatment and then increased six months after the treatment. The tendencies of physical and functional well-being were similar. The social/family and emotional well-being did not change significantly along with the treatment but the scores of head and neck well-being and NPC-QOL decreased obviously. Xerotomia was aggravated from the initiation of treatment and became the most severe at 6 - 12 months after treatment. 50% - 60% of the patients with disease-free reported severe xerotomia at 3 -5 years after radiotherapy. Incidence of severe trismus increased up to 14% at 3 -5 years after treatment. Conclusions Quality of life of NPC patients with conventional radiotherapy deteriorates during the treatment period, but recovers to the normal level six months after the treatment. Xerotomia and trismus can affect the quality of life of NPC patients.

OBJECTIVETo assess the effect of iodised salt for preventing iodine deficiency disorders.

METHODCochrane systematic review.

RESULTSFour randomised controlled trials were included. Subgroup analysis performed lay on different ages, interventions and controls. Prevalence of goitre was reduced close to 5% when using distributed iodised salt and market iodised salt plus iodine oil capsule which showed more effective than using market iodised salt alone (OR = 0.10, 95% CI: 0.02 - 0.17). The latter's prevalence of goitre was 14.7%. When using market iodised salt, the iodine urea excretion level showed different results in children group in different countries. Basically, the market iodised salt for preventing iodine deficiency of pregnancy women were effective, but a part of them did not achieve to the ideal status of iodine nutrition.

CONCLUSIONSThe needs to be strictly controlled quality of iodised salt and market iodised salt plus iodised oil capsule thus can effectively reduce the prevalence of iodine deficiency disorders. However there was not enough evidence to support that market iodised salt can effectively eliminate these disorders, particularly in children. More eligibility trials are needed for providing more evidences.

Adult ; Child ; China ; epidemiology ; Goiter ; epidemiology ; prevention & control ; Humans ; Iodine ; administration & dosage ; deficiency ; Randomized Controlled Trials as Topic ; Sodium Chloride, Dietary ; administration & dosage

OBJECTIVE: To discuss the quality of reporting in randomized controlled trials (RCTs) of Chinese herbal medicine (CHM), and to provide suggestions for improving the reporting of future clinical studies in this therapeutic area. METHODS: A search of the Cochrane Library was conducted to identify RCTs of CHM. A revised CONSORT checklist designed for CHM clinical studies was implemented. The revised CONSORT checklist contained 63 items, including the following new items added specifically for CHM: (1) "syndrome of disease" based on Chinese medicine theories; (2) rationale of CHM formula; (3) formula composition; (4) preparation form of CHM; (5) quality control of CHM. RESULTS: The overall reporting quality of the RCTs as assessed with the revised CONSORT checklist varied between 19% and 44%, with a median score of 32% (standard deviation 8%). CONCLUSION: The overall quality of reporting of RCTs of CHM evaluated with a revised CONSORT checklist was poor, reflecting the need for improvements in reporting future clinical trials in this area. RECOMMENDATIONS: To improve the quality of reporting of RCTs of CHM, we recommend adopting a revised CONSORT checklist that includes items specific to CHM. We also recommend that editors of CHM journals require authors to use a structured approach to presenting their trials as a condition of publication.

The STandards for Reporting Interventions in Clinical Trials Of Moxibustion (STRICTOM), in the form of a checklist and descriptions of checklist items, were designed to improve reporting of moxibustion trials, and thereby facilitating their interpretation and replication. The STRICTOM checklist included 7 items and 16 sub-items. These set out reporting guidelines for the moxibustion rationale, details of moxibustion, treatment regimen, other components of treatment, treatment provider background, control and comparator interventions, and precaution measures. In addition, there were descriptions of each item and examples of good reporting. It is intended that the STRICTOM can be used in conjunction with the main CONSORT Statement, extensions for nonpharmacologic treatment and pragmatic trials, and thereby raise the quality of reporting of clinical trials of moxibustion. Further comments will be solicited from the experts of the CONSORT Group, the STRICTA Group, acupuncture and moxibustion societies, and clinical trial authors for optimizing the STRICTOM.

OBJECTIVETo analyze an individual with SMIM1 c.64_80 heterozygous deletional mutation and his family members.

METHODSBased on the molecular basis of Vel negative blood type, PCR primers specific for SMIM1 wild-type allele and c.64_80del allele were designed. PCR-sequence specific primer (PCR-SSP) and Sanger sequencing were employed to determine the genotype of all subjects. Inheritance of the Vel blood group system was investigated by pedigree analysis.

RESULTSPCR-SSP and DNA sequencing demonstrated that the proband was heterozygous for the SMIM1 c.64_80del allele. Pedigree investigation showed that his father had the same mutation, while his mother and elder sister were of wide type. No individual with homozygous c.64_80del allele was found.

CONCLUSIONPCR-SSP and DNA sequencing confirmed that the proband was heterozygous for the c.64_80del mutation. The mutation inherits form his father.

Adult ; Blood Group Antigens ; genetics ; Female ; Gene Deletion ; Genetic Testing ; Homozygote ; Humans ; Male ; Membrane Proteins ; genetics ; Pedigree ; Sequence Analysis, DNA

OBJECTIVE: To screen for Vel- rare blood type donors and determine the frequency of SMIM1 c.64_80del allele in Yili Prefecture of Xinjiang, China. METHODS: DNA pooling and PCR-sequence-specific primers (PCR-SSP) was conducted to screen individuals carrying the SMIM1 c.64_80del variant, and Sanger sequencing of SMIM1 exon 3 was carried out to verify the genotype of those with the variation. SMIM1 intron 2 was also sequenced to identify single nucleotide polymorphisms (SNPs) that may affect the expression of Vel antigen. RESULTS: Among 3328 blood donors, 14 were identified as heterozygotes for the SMIM1 c.64_80del allele, its allele frequency was 0.21%; no homozygous SMIM1 c.64_80 deletions was found. For SNP rs1175550, all of the 14 individuals had an AA genotype, among whom 5 carried heterozygous 7111ins GCA variant in intron 2. CONCLUSION The allelic frequency of SMIM1 c.64_80del in Yili area is approximately 0.21%, which is reported for the first time.
Alleles ; Blood Group Antigens/genetics* ; China ; Gene Frequency ; Genetic Variation/genetics* ; Genotype ; Humans ; Membrane Proteins/genetics* ; Polymorphism, Single Nucleotide/genetics*