Validation is an essential requirement of GMP in current World. Requirement of GMP Validation of ASEAN: (1) Validation on manufacturing process. (2) Validation on quantitative method. 3. Validation on equipment. 4. Validation on hygienic standard and hygienic procedures. Results: (1) Guarantee manufacture to have a products, which respond regulated quality. (2) Respond regulated requirement of decree
Jurisprudence ; Pharmaceutical Preparations ; Drug Industry

Background: The male infertility accounts for approximately 40%-50%, in which the cases without sperms in semen occupy nearly 5% for Obstructive Azoospermia (OA). Percutaneous Epididymal Sperm Aspiration (PESA) in combination with serum FSH (Follicle Stimulating Hormone) test was effective in the diagnosis and treatment of this disease. Objectives: To evaluate preliminarily the results of the technique of PESA in the diagnosis of OA and in combination with intracytoplasmic sperm injection (ICSI) for treating male infertility. Subjects and method: A longitudinal, interventional study was carried out on 110 cases of male infertility treated at the Assisted Reproductive Technology Center of National Hospital of Obstetrics and Gynecology from August 7th 2005 to July 30th 2006. All patients underwent PESA and then testicular fine needle aspiration (TEFNA) if necessary. Results: The mean age of patients was 34.75+/-6.68 years. Among 110 patients, 54 cases (49.1%) had post-operative diagnoses of OA, 56 cases (50.9%) were diagnosed with complete azoospermia after PESA and TEFNA procedures. There were correlations between the volume of left and right testis and the probability of sperms in testing samples (p= 0.03 and =0.05, respectively). Also, serum FSH concentration related to the positive result of sperm test (p< 0.0001). Conclusion: PESA is less-invasive and exact method to the diagnosis of azoospermia. It should be done PESA for patients with testis volume >=10ml and serum FSH concentration <20mIU/mL.
azoospermia ; Percutaneous Epididymal Sperm Aspiration

Background: Mitral valve diseases are the most frequent in the cardiac valvular acquired diseases. Valvuloplasty is a very good surgical treatment, also its techniques are difficult. Objective: (1) To describe features of valvular lesion and technique of valvuloplasty. (2) To evaluate the effects of these operations. Subject and Method: 95 cases of mitral valve reconstruction were studied and described retrospectively about pre- operative features, mitral valvuloplasty, and post-operative results. Results: Pre-operative cardiac failure >=2 nd level (NYHA) is 96.8%, with 100% of mitral valve insufficiency, 28.4% associated with valvular stenosis. Mean age of patient is 34.5 +/- 13.2. Each case must do an average 4/15 valvuloplasty techniques, the most frequent are: mitral valvular ring (67.4%), commissurotomy (57.9%), cordage section (45.3%)\u2026 Early post \u2013 operative result is very good: no mortality, mitral valvular function is improved significantly than pre-operative (p<0.001), no severe mitral stenosis or insufficiency. Long-term post operative control (3 months, 3 years, 5 years post \u2013 operation) present the stability of this valvuloplasty with high survival frequency (96.8% in 3 months, 96.2% in 3 years, 93.4% in 5 years), in the 78.5% ranges a good level, re-operation is only required in 3 cases with valvular replacement. Conclusions: Although the difficult technique of valvuloplasty \u2013 especially in rheumatic lesion, mitral valve reconstruction is a good and safe technique to treat the mitral valve diseases.
Alkali burn ; Steroid

Background: Many research works showed that menstruation is caused by the sudden reduction of the estrogens and progesterone to low levels of secretion at the end of the menstrual cycle. However, it should be investigated to which levels the concentration of these two hormones sharply reduces to cause menstruation. Objective: To determine estradiol concentration at the beginning of menstruation, the second day of menstruation and the ending of menstruation during the menstrual cycle. Subject and methods: 30 women with the normal menstrual cycle and 30 women with the long menstrual cycle were used as subjects to determine estradiol concentration at the day at the beginning of menstruation, the second day of menstruation and the last day of menstruation during the menstrual cycle. Result and Conclusion: In the women group with the normal menstrual cycle, the estradiol concentration: at the day at the beginning of menstruation is 159.93 \xb1 51.29 pmol/L, at the second day of menstruation is 170.58 \xb1 46.54 pmol/L and at the lastday of menstruation is 177.55 \xb1 46.42 pmol/L. In women in the group with long menstrual cycle, the estradiol concentration: at the day of beginning of menstruation is 154.55 \xb1 61.60 pmol/L and at the last day of menstruation is 154.55 \xb1 61.60 pmol/L.
menstrual cycle ; estrogen ; estradiol

Background: In the procedure of tendon transfer to treat low radial nerve palsy, recovering movement amplitude for toes is not difficult. It is more important to select the appropriate motive muscle. Previously, pillar muscle was commonly used as motivation for stretching fingers, but many authors opposed this because it\u2019s affecting the function of the hand. Objectives: To evaluate the clinical features of low radial nerve palsy and the outcomes of the treatment of non-recoverable low radial nerve palsy by Smith's procedure of tendon transfer. Subjects and methods: 36 patients suffering from irreversible low radial nerve palsy were treated by Smith's procedure of tendon transfer from Jan 2000 to Jan 2008. Mean follow-up was 23 months. Outcomes assessment was based on Tajima's criteria. Results: All 30 patients were satisfied with the operation and were greatly improved both their functional and aesthetic aspects. In term of biomechanics, the Flexor Carpi Radialis (FCR) is more suitable for reconstruction of the Extensor Digitorum Communis (EDC) in comparison with the flexor carpi ulnaris (FeU) or the power density spectrum. The patients showed good movements of the wrist and fingers/ the thumb moved independently with satisfactory extension and abduction/ the grip strength was rapidly improving. Conclusions: The use of the FCR for reconstruction of the EDC is a suitable choice and Smith's procedure of tendon transfer is a good procedure for the treatment of irreversible radial nerve palsy.
procedure of tendon transfer ; Non-recoverable low radial nerve palsy

Background: Flail chest is a severe condition of thoracic trauma, and it requires diagnosis and treatment as soon as possible. From year 2000, we developed an improved technique of open fixation in order to adapt the situations of Vietnam health settings. Objectives: To report preliminary results of application of improved open fixation technique in Viet Duc Hospital from 2001 to 2006. Subjects and method: This descriptive, prospective and retrospective study involved 19 patients with flail chest due to closed thoracic trauma or multiple traumas, treated by open fixation technique. The parameters included features of patients, characteristics of this technique and postoperative progression.Results: Of 19 patients, there were 16 males and 3 females, mean age: 47.8 years. All patients presented obvious signs of flail chest preoperatively, but only 9 cases were treated by open fixation technique and pleural drainage immediately. This technique canbe applied in all sugical settings with single local anaesthesia, and any kind of common surgical threads. The most suitable initial pulled weight is 2000 g. All cases of flail chest required pleural drainage. All patients had good outcomes with open fixation technique, no death. There were 3 patients with postoperative complications, all were severe multiple trauma patients. Conclusion: Improved open fixation technique applied in Viet Duc Hospital is simple, effective and safe, and can be widely used in all surgical settings.
Flail Chest ; Flank Pain/ therapy ;

Background: Gastric cancer is a common disease in the world. For treatment, gastrectomy is still considered as the first choice. However, recovering of postoperative gastrointestinal circulation remains a controversial issue. Objectives: To assess the early results of 2 methods as gastroduodenostomy (Billroth I type) and gastrojejunostomy (Billroth type II) in recovering of gastrointestinal circulation. Subjects and method: A descriptive, retrospective study was conducted on 98 patients (61 males, 37 females, mean aged 48.1\xb112.7), were confirmed diagnosed with gastric cancer, treated in Military Central Hospital N.108 from May, 2001 to December, 2005. Results: Tumor positions were seen in 1/3 lower and 1/3 middle of gastric organ (59.2% and 40.8%, respective). There was no significant difference for invasive level of tumor between 2 groups (P>0.05). 62.2% patients with invasive level of tumor in stage of T4 in both 2 groups. Generally, the lesion between 2 forms of ulcer and rough differed significantly. The patients with and without metastatic lymph nodes were 57 and 41 patients, respective. All of patients were conducted with lymph node dissection at the stage of DIII-DIV. The difference between 2 groups for surgical time was no statistic significant. Conclusion: Billroth type I method combined with lymph nodes dissection was a safe and feasible technique in treatment of gastric cancer.
Stomach Neoplasms/ surgery ; Gastrectomy ; Lymph Node Excision ;

Human Interleukin-11 (hIL-11) is a multifunctional cytokine which plays an important role in regulating the proliferation and differentiation of cells in the hematopoeitic,lymphoid system etc. To obtain the IL-1 1 cDNA, a primary culture of Chinese fetal lung fibroblast was prepared from fresh tissue. Then the human IL-11 cDNA without the N-terminal signal peptide sequence was cloned by RT-PCR from the cells induced by PMA. The sequnce indicated that there are three bases different from those previously reported,but with no change of the amino acids. The cDNA was inserted into the 3′ end of trxcA gene in thioredoxin gene fusion expression system pTRXFUS to construct the trxA and hIL-1 1 fusion expression vector, and expressed in E. coli. The fusion hIL-11 accounts for more than 20 % of the total bacteria proteins.The expression product is present in soluble forms and has the full biological and immunological activities.

Background/Aims: Accurate neoplastic prediction can significantly decrease costs associated with pathology and unnecessary colorectal polypectomies. Narrow band imaging (NBI) and dual-focus (DF) mode are promising emerging optical technologies for recognizing neoplastic features of colorectal polyps digitally. This study aimed to clarify the clinical usefulness of NBI with and without DF assistance in the neoplastic prediction of small colorectal polyps (<10 mm). Methods: This cross-sectional study included 530 small colorectal polyps from 343 consecutive patients who underwent colonoscopy at the University Medical Center from September 2020 to May 2021. Each polyp was endoscopically diagnosed in three successive steps using white-light endoscopy (WLE), NBI, and NBI-DF and retrieved for histopathological assessment. The diagnostic accuracy of each modality was evaluated with reference to histopathology. Results: There were 295 neoplastic polyps and 235 non-neoplastic polyps. The overall accuracies of WLE, WLE+NBI, and WLE+NBI+NBI-DF in the neoplastic prediction of colorectal polyps were 70.8%, 87.4%, and 90.8%, respectively (p<0.001). The accuracy of WLE+NBI+NBI-DF was significantly higher than that of WLE+NBI in the polyp size ≤5 mm subgroup (87.3% vs. 90.1%, p<0.001). Conclusions NBI improved the real-time neoplastic prediction of small colorectal polyps. The DF mode was especially useful in polyps ≤5 mm in size.

Heat shock protein gp96 is a glycoprotein which was found several years ago. Besides its function as a molecular chaperone, it is also reported to play important roles both in innate immunity and adaptive immunity. Gp96 can stimulate the maturation of antigen presenting cells (especially dendritic cells) and the secretion of cytokines. Gp96 and its associated peptides could stimulate peptide specific cytotoxic T lymphocyte reaction (CTL), which was very promising in the designing of anti-virus and anti-tumor vaccines. However the expression level of whole length gp96 was relatively low in E. coli and the purity of gp96 are not very suitable for further study. We successfully cloned the carboxy terminal fragment (560aa-751aa) of murine gp96 into the pGEX-6p-1 vector and expressed in BL21 strain. This fragment contains the peptide binding domain and the dimerization domain. After purification, the recombinant fusion protein was cleaved with the PreScission Protease and analyzed by Gelfiltration. The results show that this fragment may be related to the dimerization of gp96 and make an foundation for further investigations of the protein.
Animals ; Antigens, Neoplasm ; genetics ; Blotting, Western ; Chromatography, Gel ; Cloning, Molecular ; Mice ; Peptide Fragments ; genetics ; Recombinant Fusion Proteins ; biosynthesis ; isolation & purification