Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.
Clinical Trials, Phase III as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Medical Informatics

Adolescent ; Bone Wires ; Child ; Child, Preschool ; Female ; Fracture Fixation, Internal ; methods ; Humans ; Humeral Fractures ; surgery ; Male

Pulmonary arterial hypertension (PAH), also named as a cancer of cardiovascular disease, is a rare disease and has complicated pathogenesis. Recently, there are more understandings of PAH pathogeneses. According to the pathogenesis and active pathways, the clinically used drugs are classified into several groups incluidng prostacyclin analogues and prostacyclin receptor agonists, endothelin receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase inhibitors, etc. To elevate the efficacy of the drugs, numerous drug delivery systems are developed. This review mainly summarized the pathological mechanism of PAH, drugs and drug delivery approaches in the treatment of PAH.

Traditional Chinese medicine (TCM) reference standards plays an important role in the quality control of Chinese herbal pieces. This paper overviewed the development of TCM reference standards. By analyzing the 2010 edition of Chinese pharmacopoeia, the application of TCM reference standards in the quality control of Chinese herbal pieces was summarized, and the problems exiting in the system were put forward. In the process of improving the quality control level of Chinese herbal pieces, various kinds of advanced methods and technology should be used to research the characteristic reference standards of Chinese herbal pieces, more and more reasonable reference standards should be introduced in the quality control system of Chinese herbal pieces. This article discussed the solutions in the aspect of TCM reference standards, and future development of quality control on Chinese herbal pieces is prospected.
Drugs, Chinese Herbal ; standards ; Humans ; Medicine, Chinese Traditional ; standards ; Quality Control ; Reference Standards

OBJECTIVETo study the extent of retinal vascular development and influencing factors at birth and the relation between retinal vascularization and retinopathy of prematurity (ROP).

METHODSFrom October, 2006 to December 2006, retinal vascularization was screened and evaluated in 84 neonates at different weeks of gestation and birth weights (BWs), had dilated fundus evaluation for zone of retinal vascularization by the 130 degrees lens of a digital fundus camera. The infants' pupils were dilated with 2.5% phenylephrine and 0.5% cyclopentolate eye drops. The study cohort was divided into subgroups depending on the weeks of gestation and birth weights. The control group consisted of healthy term infants. Maternal and neonatal factors were ascertained and analysed.

RESULTSVascularization up to zone I and II was considered to be immature retina; vascularization up to zone III or beyond was considered to be mature retina. In this study, 11 of 12 infants who were born at < 30 weeks of gestation, 12 of 26 infants who were born at < 31 approximately 33 weeks of gestation, 1 of 26 babies who were born at < 34 approximately 36 weeks of gestation and none of 20 babies who were born at < 37-40 weeks of gestation had immature retina; 12 of 15 babies at < 1500 g BW, 8 of 14 infants at 1500 g < BW < 1700 g, 4 of 11 infants at 1700 g < BW < 2000 g and of 44 infants at > 2000 g BW had immature retina. Those infants who were born at > 34 weeks of gestational age and at > 2000 g BW had mature retina. Infants who were born between 31 to 34 weeks of gestation and at 1501 to 2000 g BW had variable extent of retinal vascularization at birth. Vascularization was associated with postconceptional age (F = 31.9193, P = 0.000), birth weight (F = 32.4532, P = 0.000), anemia (F = 36.9391, P = 0.000), surfactant (F = 24.000, P = 0.0000), poor nutrition (F = 4.184, P = 0.041), RDS (F = 17.6191, P = 0.000), cesarean delivery (F = 10.972, P = 0.0022) and oxygen > 48 h (F = 22.076, P = 0.0000). Vascularization was affected mainly by the postconceptional age (95% CI = 1.57-261.728, P = 0.021). At last, 15/24 infants with immature retina developed ROP while none of the infants with mature retina developed ROP (chi2 = 45.1087, P = 0.000).

CONCLUSIONThere is considerable variability in the extent of retinal vascularization in infants who we born between 31 to 34 weeks of gestation. Modifiable maternal and fetal factors could influence extent of vascularization at birth. Immature retina is the critical factor of ROP. Gestational age is the main factor of the immature retina in premature infants.

Birth Weight ; Female ; Humans ; Infant, Newborn ; Infant, Premature ; Male ; Neovascularization, Physiologic ; Retina ; anatomy & histology ; Retinal Vessels ; growth & development

Sulfur fumigation (SF) is a universal phenomenon in primary processing of Traditional Chinese Medicine (TCM) in modern times. In the process, fumigation, sulfur or both of them act on the TCMs. Some active components of TCMs change quantitatively or qualitatively during the processing. At the same time, the sulfur dioxide and heavy metal would remain and cause a serious influence on quality and future development of TCM. This article reviews the chemical compositions change after SF to study the change law and their influence on quality. This article provide references for SF in TCMs' processing for a better and safer quality.
Drug Contamination ; Fumigation ; methods ; Medicine, Chinese Traditional ; methods ; Quality Control ; Sulfur ; chemistry ; Technology, Pharmaceutical ; methods

Infestation, moldy and other phenomenon in the processing and storage of Chinese herbal medicines is a problem that faced in the production of Chinese traditional medicine. The low productivity of traditional processing methods can not guarantee the quality of Chinese herbal medicines. Sulfur fumigation is the first choice of grassroots to process the Chinese herbal medicine with its low cost and easy operation. Sulfur fumigation can solve some problems in the processing and storage of Chinese herbal medicines, but modern pharmacological studies show that long-term use of Chinese traditional medicine which is fumigated by sulfur can cause some serious harm to human liver, kidney and other organs. This paper conducts a review about the application history of sulfur fumigation, its influence to the quality of Chinese herbal medicines as well as domestic and foreign limits to sulfur quantity, and a brief introduction of the status of modern processing technologies in the processing of food and some Chinese herbal medicines, the problems ex- isting in the Chinese herbal medicines processing, which can provide a reference basis for the further research, development and application of investigating alternative technologies of sulfur fumigation.
Fumigation ; adverse effects ; methods ; Medicine, Chinese Traditional ; methods ; Quality Control ; Social Control, Formal ; Sulfur ; chemistry ; Technology, Pharmaceutical ; methods

Objective To study the influence and dose effect of ultrasound on the contraction of uterine smooth muscle in rats.Methods Estradiol benzoate was injected into rats three days before conducting an in-vitro experiment.Their uteri were resected and irradiated with ultrasound(0.8 MHz,3 W/cm~2,0-40 rain).The contrac- tion frequency and amplitude were recorded using an MS-302 biological experiment system.Results It could be seen that the contraction frequency and amplitude,and general contractile activity were significantly increased during ultrasonic irradiation(P＜0.01).The increased contraction frequency and amplitude lasted for ten minutes,and then the normal contraction pattern resumed.The contraction frequency as well as the percentage change in eontraction fre- quency were highest during the first 15 minutes of ultrasonic irradiation;the contraction amplitude as well as the per- centage change in amplitude were highest during 40 minutes of ultrasonic irradiation.Contraction activity was at its highest for 30 minutes,but the percentage change in activity was highest for 20 minutes.Conclusions Ultrasound can induce uterine smooth muscle contraction in rats.This biological effect is related to the irradiation time.

OBJECTIVETo evaluate the efficacy of early continuous hyperthermic peritoneal perfusion (CHPP) on patients of advanced gastric carcinoma after surgical resection.

METHODSSeventy patients were divided into control and treatment group. Patients in treatment group received CHPP 1 or 2 days postoperatively. Treatment was administered daily consecutively for 4 days. Patients in control group underwent resection of gastric carcinoma without CHPP. Chemotherapy was administered of Calcium Folinate and 5-Fluorouracil (LF regimen) intravenously for 6 cycles in both groups two or three weeks postoperatively. Survival and recurrence in both groups were observed and compared.

RESULTSOne-year survival and recurrence rates were 83.3% and 8.3% in treatment group, 79.4% and 11.7% in control group, there were no significant differences between the two groups. Three-year survival and recurrence rates were 63.9% and 19.4 in treatment group, 39.8% and 44.1% in control group, there were significant differences between the two groups.

CONCLUSIONEarly administration of CHPP to patients with advanced gastric carcinoma after surgery may be advantageous for preventing peritoneal metastasis and recurrence, thus may prolong survival time.

Chemotherapy, Cancer, Regional Perfusion ; Female ; Humans ; Hyperthermia, Induced ; Male ; Middle Aged ; Neoplasm Staging ; Perfusion ; Postoperative Period ; Stomach Neoplasms ; drug therapy ; pathology ; Treatment Outcome

BACKGROUNDA bioactive compound from Paecilomyces tenuipes (BCPT) has an inhibitory effect on monoamine oxidase A (MAO-A) and monoamine oxidase B (MAO-B) in vitro and in vivo, which indicates BCPT may be a potential antidepressant. In this study we aimed to study the antidepressant effects of BCPT in the chronic unpredictable stress (CUS) model in rats and explore underlying mechanisms in the hypothalamic-pituitary-adrenal (HPA) axis.

METHODSThe antidepressant effects of BCPT were studied in the chronic unpredictable stress model in rats. Animals were housed isolated, except the control group. Rats were exposed daily to different random stressors from day 1 to 21. Awarding response was detected by calculating the 24-hour consumption of sucrose water. Cortisol (CORT) and adrenocorticotropic hormone (ATCH) contents in serum and arginine vasopressin (AVP) contents in the pituitary body were detected by radio immunoassays. Total RNA of hippocampus or hypothalamus was extracted and subjected to reverse transcription-polymerase chain reaction (RT-PCR) for the measurement of corticotrophin releasing hormone (CRH) mRNA or mineralocorticoid receptor (MR) mRNA and glucocorticoid receptor (GR) mRNA levels. Statistical analyses were performed using one way analysis of variance (ANOVA) followed by Student-Newman-Keuls (SNK) test.

RESULTSChronic unpredictable stress resulted in reduction of sensitivity to reward and abnormality in the HPA axis in the animal model. BCPT improved the reward reaction as measured by increasing sucrose consumption, remarkably reduced serum CORT and ACTH levels and the AVP content in the pituitary body in the CUS-treated rats, decreased the expression of CRH mRNA, enhanced the expression of hippocampus MR mRNA, GR mRNA and decreased the ratio of MR/GR.

CONCLUSIONSBCPT has potentially antidepressant-like activity and normalized the HPA axis hyperactivity in a CUS model of depression in rats. This may be an important mechanism of its antidepressant effect.

Animals ; Antidepressive Agents ; pharmacology ; Chronic Disease ; Corticotropin-Releasing Hormone ; genetics ; Hydrocortisone ; blood ; Hypothalamo-Hypophyseal System ; drug effects ; physiology ; Male ; Monoamine Oxidase Inhibitors ; pharmacology ; Paecilomyces ; chemistry ; RNA, Messenger ; analysis ; Rats ; Rats, Sprague-Dawley ; Receptors, Glucocorticoid ; genetics ; Receptors, Mineralocorticoid ; genetics ; Stress, Psychological ; physiopathology ; Sucrose ; administration & dosage