Currently,the research or publications related to the clinical comprehensive evaluation of Chinese patent medicine are increasing,which attracts the broad attention of all circles. According to the completed clinical evaluation report on Chinese patent medicine,there are still practical problems and technical difficulties such as unclear responsibility of the evaluation organization,unclear evaluation subject,miscellaneous evaluation objects,and incomplete and nonstandard evaluation process. In terms of evaluation standards and specifications,there are different types of specifications or guidelines with different emphases issued by different academic groups or relevant institutions. The professional guideline is required to guide the standardized and efficient clinical comprehensive evaluation of Chinese patent medicine and further improve the authority and quality of evaluation. In combination with the characteristics of Chinese patent medicine and the latest research achievement at home and abroad,the detailed specifications were formulated from six aspects including design,theme selection,content and index,outcome,application and appraisal,and quality control. The guideline was developed based on the guideline development requirements of China Assoication of Chinese medicine. After several rounds of expert consensus and public consultation,the current version of the guideline has been developed.
Medicine, Chinese Traditional ; Nonprescription Drugs ; Consensus ; China ; Reference Standards ; Drugs, Chinese Herbal

Objective By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at one time,to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis.Metbods Comparative analyses of 3 clamp structures,namely,the aligning tooth structure (original,clamp A),the staggered tooth structure (clamp B),a combination structure with page break angle and staggered tooth (clamp C),were performed to analyze pressure and its distribution on tissues when clamping the stomach wall.Displacement of 7.5 mm was then applied on the clamps to simulate the effect from operating procedures of the device and tissue kick-back.Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft,with the stress of 10.39 kPa and 10.11 kPa,respectively.The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth.For clamp A and B,the longer the distance to shaft,the larger pressure on stomach tissues.While for clamp C,the pressure on device-tissue interface showed little change along the path.Under tensile displacement,clamp A and B slipped off from the tissue when displacements reached to 5.0 mm and 6.5 mm,respectively,while clamp C did not slip off.Conclusions Clamp with page break angle and staggered tooth can exert the uniform maximum pressure to tissues and provide a larger contact area away from the rotating shaft,thus improving the anti-slippage and performance of the novel endoscopic closing device.

By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at a time, to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis. Methods Comparative analyses of three clamp structures, namely, the aligning tooth structure (original, clamp A), the staggered tooth structure (clamp B), a combination structure with page break angle and staggered tooth (clamp C), were performed to analyze pressure and its distribution on tissues when clamping the stomach wall. Displacement of 7.5 mm was then applied on the clamps to simulate the effect of the operating procedures of the device and tissue kick-back. Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft, with the stress being 10.39 kPa and 10.11 kPa, respectively. The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth. For clamp A and B, the longer the distance to shaft, the larger pressure on stomach tissues. While for clamp C, the pressure on device-tissue interface showed little change along the path. Under tensile displacement, clamp A and B slipped off from the tissue when displacements reached to 5 mm and 6.5 mm, respectively, while clamp C did not. Conclusions　Clamp with page break angle and staggered tooth can exert the uniform max pressure to tissues and provide a larger contact area away from the rotating shaft, thus improving anti-slippage and performance of the novel endoscopic closing device.

Objective To analyze the relationship of closed staple height with tissue damage and compression pressure, so as to provide theoretical references and guidance for the surgeon to choose the appropriate staple cartridge and height, as well as improve the safety of operation. Methods The finite element model of stapled colorectal end-to-end anastomosis was established based on analysis of staple-tissue interaction. Large intestine tissues with different wall thicknesses (1.0-1.5 mm) were compressed by closed staples with 4 different height to compare changes in stress distributions and average radial pressure. Results When the tissues were compressed by closed staple with height of 1.0, 1.1, 1.2 and 1.5 mm, respectively, the average radial stress of compressed tissues with wall thicknesses of 1.2, 1.3, 1.4, and 1.5 mm were 56.0, 58.6, 59.7 and 57.3 kPa, respectively, which was close to the optimal compression pressure. Stress concentrations were found in contact area of the staple and tissues，with the maximum stress being 2 783, 1 750, 1940 and 2 030 kPa, respectively. Conclusions Tissue damage cannot be completely avoided in anastomotic surgery, and stress concentration is generally located near contact region of the staple and tissues. The optimal closed staple height ranges in 50%-60% of the uncompressed tissue height.

Objective To design a novel endoscopic successive hemostasis and closing device, and to validate whether the device can meet the needs of tissue closure by finite element analysis. Methods By using the novel device, the target tissue was clamped and the clip was then pushed to pierce the tissue. Under the compression between the clip and the inner side of the grasper, the thinner arms of the clip were forced to bend and close to stay in the tissue, and then the inverse displacement of 2 mm was applied on the clip. The elastic limit and tensile strength of the clip were set as 239.0 and 901.0 MPa, respectively. Results Deformation did not occur in the piercing process of the clip, with the maximum stress of 212.6 MPa. The deformed shape of the clip in the bending process matched its design expectation, with the maximum stress of 727.7 MPa. The maximum stress of the clip was 75.8 MPa under 2-mm inverse displacement. Material failure was not found in the bending process or with 2-mm inverse displacement, and the maximum stress in the whole process was 741.0 MPa. Conclusions The novel endoscopic successive hemostasis and closing device proposed in this study can deploy 4 clips at one time, together with an independent grasper for gathering tissues, which can shorten the reloading time and improve the accuracy of clip deployment. The effectiveness and safety of the device is also proved by using finite element method.

Clinical breakpoints are used in phaseⅡorⅢclinical trials to categorize microorganisms if susceptibility to new tested antibacterial agents that means the patient infected by the pathogen will be enrolled the study or not.The role of this consensus is to define procedure and required data to setting breakpoints and how to revaluate it in clinical trials.

OBJECTIVETo study the expressions of cystathionine-beta-synthase (CBS) and cystathionine-gamma-lyase (CSE) in the corpus cavernosum smooth muscle of castrated rats and their roles in erectile dysfunction after castration.

METHODSWe randomly assigned 40 eight-week-old male SD rats to groups A (2-week sham-operation), B (4-week sham-operation), C (2-week castration) and D (4-week castration). We determined the level of serum testosterone (T) and the expressions of CBS and CSE in the corpus cavernosum smooth muscle of the rats after operation using immunohistochemistry and RT-PCR.

RESULTSThe T level was significantly decreased in groups C ([11.85 +/- 6.73] nmol/L) and D ([1.96 +/- 1.23] nmol/L) as compared with A ([89.65 +/- 17.13] nmol/L) and B ([106.75 +/- 19.68] nmol/L) (P < 0.05). CBS and CSE were expressed in all groups of rats, but the relative expressions of CBS and CSE mRNA were significantly lower in groups C (0.93 +/- 0.14 and 0.87 +/- 0.20) and D (0.79 +/- 0.17 and 0.71 +/- 0.12) than in A (2.13 +/- 0.65 and 1.93 +/- 0.15) and B (2.07 +/- 0.53 and 1.89 +/- 0.45) (P < 0. 05), so were the optical density values (IA) of the CBS and CSE proteins, 130.35 +/- 23.56 and 93.56 +/- 36.64 in group C and 80.29 +/- 29.65 and 58.56 +/- 19.95 in group D, as compared with 310.57 +/- 130.56 and 269.56 +/- 116.76 in group A and 349.68 +/-112.35 and 298.35 +/- 100.76 in group B (P < 0.05). The androgen level was positively correlated with the expressions of CBS and CSE in the corpus cavernosum smooth muscle of the rats.

CONCLUSIONAndrogen regulates erectile function via the expressions of CBS and CSE.

Animals ; Cystathionine beta-Synthase ; metabolism ; Cystathionine gamma-Lyase ; metabolism ; Male ; Muscle, Smooth ; enzymology ; Orchiectomy ; Penis ; enzymology ; Rats ; Rats, Sprague-Dawley ; Testosterone ; blood

OBJECTIVE: To investigate the effect of the course and menopause on the change of bone mineral density (BMD) in female patients with hyperthyroidism. METHODS: BMDs of hip and lumbar vertebrae were measured by dual-energy X-rays absorptiometry(DEXA) in the female patients (n=192, aged 14 approximately 72). Patients were divided into 2 groups (premenopausal and postmenopausal)and 2 subgroups(short-course and long-course). The BMDs were compared between those of age-matched, weight-matched, height-matched and body mass index matched control subgroups. RESULTS: In the premenopausal hyperthyroidic patients, only the BMDs of the second and total lumbar vertebrae with long-course were significantly lower than those of short-course group(P< 0.05). In the post-menopausal group with the long-course,each BMD measured had a lower level compared with that with short-course, of which the hip and the second lumber vertebrae were evident (P< 0.01). CONCLUSION The course and menopause have an effect on the BMDs in female patients with hyperthyroidism.
Adolescent ; Adult ; Aged ; Bone Density ; Female ; Hip Joint ; Humans ; Hyperthyroidism ; metabolism ; Lumbar Vertebrae ; Menopause ; metabolism ; Middle Aged

OBJECTIVETo probe into clinical value of comprehensive program of acupuncture, moxibustion and massage as main for treatment of cervical spondylopathy of the nerve root type.

METHODSFive centers, single blind, randomized controlled method were used, 660 cases were divided into a treatment group of 317 cases and a control group of 311 cases. They were treated respectively with comprehensive program of acupuncture, moxibustion and massage as main, and comprehensive program of physical therapy as main. Establish syndrome detection scale and multiply dimensional effect assessment indexes, and evaluate the therapeutic effects and safety.

RESULTSThe cured rate, the cured-markedly effective rate were 42.9%, 64.4% in the treatment group, respectively, better than 16.7%, 36.3% in the control group (P<0.01); after treatment of 2 weeks, clinical symptoms improved in the both groups, but the treatment group was better than the control group in the improvement degrees of neck-shoulder-limb pain, neck rigidity, abnormality of cervical anteflexion, etc. (P<0.01 or P<0.05); the treatment group was shorter than the control group in the time of producing the effect and therapeutic course (P<0.01).

CONCLUSIONComprehensive program of acupuncture, moxibustion and massage as main is safe and effective for treatment of cervical spondylopathy, with a better therapeutic effect compared with the comprehensive program of physical therapy.

Acupuncture Therapy ; Humans ; Massage ; Moxibustion ; Single-Blind Method ; Spinal Diseases