Rethinking the marketing strategy of anti-tumor drugs by single-arm trials supported / 中华肿瘤杂志

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.

Clinical Efficacy of Modified Shenling Baizhu San in Treatment of Hashimoto's Thyroiditis / 中国实验方剂学杂志

Objective:To observe the clinical efficacy of modified Shenling Baizhu San combined with thyroxine tablets in the treatment of Hashimoto's thyroiditis (HT). Method:The 68 patients with HT were randomly divided into treatment group and control group, with 34 patients in each group. Control group was treated with thyroxine tablets alone, while treatment group was treated with modified Shenling Baizhu San in addition to the therapy of control group. Free triiodothyronine (FT3), free Thyroxine (FT4), thyroid stimulating hormone (TSH), serum thyroid peroxidase antibody (TPOAb) and thyroglobulin were observed before and after treatment in the two groups of HT patients. The changes of thyroglobulin antibody (TgAb) and traditional Chinese medicine (TCM) syndrome score, and the safety of TCM prescription were observed. Result:After 3 months of treatment, the effective rate of treatment group was 91.2%, which was significantly higher than 70.6% of control group, with statistically significant difference (PPP3 and FT4 in treatment group and control group increased significantly after 3 months of treatment (PPPPConclusion:Modified Shenling Baizhu San combined with thyroxine tablets in the treatment of HT is more effective than simple thyroxine tablets, which is worthy of further clinical and experimental study.

Isolation of homogeneous polysaccharide from Poria cocos and effect of its sulfated derivatives on migration of human breast cancer MDA-MB-231 cells / 中国中药杂志

SATB1 plays a crucial role in the invasion and metastasis of breast cancer,and inhibition of SATB1 expression can effectively control breast cancer metastasis. In this study,homogeneous polysaccharides were isolated from Poria cocos and their sulfated derivatives were prepared to screen out the polysaccharide compositions with inhibitory effects on SATB1 expression. Smal-molecule components were removed from P. cocos by ethanol extraction,and P. cocos crude polysaccharide PPS was obtained by water extraction and ethanol precipitation. Then PPS was successively separated by DEAE Sepharose fast flow anion-exchange and Superdex-75 gel permeation chromatographic steps to give PPSW-1. The structure of PPSW-1 was identified and its sulfated derivatives were prepared. Then their inhibitory effects on human breast cancer MDA-MB-231 cells were investigated. A kind of polysaccharide,PPSW-1 with inhibitory effect on human breast cancer MDA-MB-231 cells,was obtained from P. cocos,with a relative molecular weight of 3. 06×104,and structure of 1,6-branched 1,3-α-D-galactan. PPSW-1 and its sulfated derivative Sul-W-1 showed good inhibitory effect on cells migration,and the water solubility of Sul-W-1 was better than that of PPSW-1. In addition,it was found that polysaccharide of P. cocos and its sulfated derivative can inhibit expression of SATB1. In this study,a kind of homogeneous polysaccharide with inhibitory effect on human breast cancer MDA-MB-231 cells was isolated from P. cocos,and its sulfated derivative with similar efficacy but better solubility was prepared,laying the foundation for the substance basis study of P. cocos.

Ginsenoside Rb1 Ameliorates Autophagy of Hypoxia Cardiomyocytes from Neonatal Rats via AMP-Activated Protein Kinase Pathway / 中国结合医学杂志

OBJECTIVE@#To investigate whether ginsenoside-Rb1 (Gs-Rb1) improves the CoCl-induced autophagy of cardiomyocytes via upregulation of adenosine 5'-monophosphate-activated protein kinase (AMPK) pathway.@*METHODS@#Ventricles from 1- to 3-day-old Wistar rats were sequentially digested, separated and incubated in Dulbecco's modified Eagle's medium supplemented with 10% fetal bovine serum for 3 days followed by synchronization. Neonatal rat cardiomyocytes were randomly divided into 7 groups: control group (normal level oxygen), hypoxia group (500 μmol/L CoCl), Gs-Rb1 group (200 μmol/L Gs-Rb1 + 500 μmol/L CoCl), Ara A group (500 μmol/L Ara A + 500 μmol/L CoCl), Ara A+ Gs-Rb1 group (500 μmol/L Ara A + 200 μmol/L Gs-Rb1 + 500 μmol/L CoCl), AICAR group [1 mmol/L 5-aminoimidazole-4-carboxamide ribonucleotide (AICAR) + 500 μmol/L CoCl], and AICAR+Gs-Rb1 group (1 mmol/L AICAR + 200 μmol/L Gs-Rb1 + 500 μmol/L CoCl). Cells were treated for 12 h and cell viability was determined by methylthiazolyldiphenyl-tetrazolium bromide (MTT) assay and cardiac troponin I (cTnI) levels were detected by enzyme-linked immunosorbent assay (ELISA). AMPK activity was assessed by 2',7'-dichlorofluorescein diacetate (DCFH-DA) ELISA assay. The protein expressions of Atg4B, Atg5, Atg6, Atg7, microtubule-associated protein 1A/1B-light chain 3 (LC3), P62, and active-cathepsin B were measured by Western blot.@*RESULTS@#Gs-Rb1 significantly improved the cell viability of hypoxia cardiomyocytes (P0.05). Gs-Rb1 significantly down-regulated P62 levels of hypoxic cardiomyocytes (P<0.05). The P62 levels of hypoxic cardiomyocytes were inhibited by Ara A (P<0.05) and were not affected by AICAR (P=0.871).@*CONCLUSION@#Gs-Rb1 may improve the viability of hypoxia cardiomyocytes by ameliorating cell autophagy via the upregulation of AMPK pathway.

Effect on prognosis of degenerative medial meniscal tears underwent arthroscopic surgery / 中国内镜杂志

Obejective To evaluate the outcome at a 2 and 5 year follow-up whether combined arthroscopic surgery followed by exercise therapy was superior to the same exercise therapy alone when treating non-traumatic, degenerative medial meniscal tears. Methods Prospective cohort study was used in this study, 96 middle-aged patients with MRI verified degenerative medial meniscus tear and radiographic osteoarthritis grade ≤ 1 participated in the study. Radiographic examination was done before randomization and after 5 years. The patients were randomly assigned to either arthroscopic treatment followed by exercise therapy for 2 months or to the same exercise therapy alone. At the start of the study and at the follow-ups at 24 and 60 months the patients answered three questionnaires KOOS, Lysholm Knee Scoring Scale and Tegner Activity Scale and made pain ratings on the Visual Analogue Scale (VAS). Results Both groups showed highly significant clinical improvements from baseline to the follow-ups at 24 and 60 months on all subscales of KOOS, Lysholm Knee Scoring Scale and VAS (P = 0.000). No group differences were found at any of the testing occasions. One third of the patients that were treated with exercise therapy alone did not feel better after the treatment but were improved after arthroscopic surgery. According to radiographic findings two patients from each group had a slight progression of their osteoarthritis after 5 years. Conclusion The findings indicate that arthroscopic surgery followed by exercise therapy was not superior to the same exercise therapy alone for this type of patients. Consequently, exercise therapy can be recommended as initial treatment. However, one third of the patients from the exercise group still had disabling knee symptoms after exercise therapy but improved to the same level as the rest of the patients after arthroscopic surgery with partial meniscectomy.

Comparison between the intraocular pressure fluctuations measured at home versus in the clinic / 国际眼科杂志(Guoji Yanke Zazhi)

AIM: To compare intraocular pressure (IOP) fluctuations measured at home and in the clinic over a 24-hour period.METHODS: A prospective investigational study.A total of 120 Chinese participants were selected from five communities in the Chengdu area.Patients underwent a clinical interview and IOP was measured both at home and in the clinic.IOP were measured at 8 a.m., 10 a.m., 12 a.m., 2 p.m., 4 p.m., 6 p.m., 8 p.m., 10 p.m., 2 a.m., 6 a.m.using the same pneumatonometer.Measurements were taken in the sitting position.RESULTS: The average 24-hour IOP measured in the clinic was slightly lower than that at home.The mean difference in 24-hour IOP measurements between home and clinic was 0.27 mmHg.The IOP fluctuation in the clinic was higher than at home (the mean difference was 0.01 mmHg).There was no statistically significant difference in the average 24-hour IOP measured at home vs in the clinic.The average IOP measured at 2 p.m.at home (16.04±5.95 mmHg) was significantly higher compared with the measurement in the clinic (15.43±5.16 mmHg) (P<0.05).The overall agreement between 24-hour IOP measurements made in the clinic and at home in diagnosis of primary open angle glaucoma was 85.0% (K coefficient: 0.68).CONCLUSION: The 24-hour IOP measured in the clinic was similar to that measured at home, and the method of measuring IOP in the clinic is acceptable in diagnosing primary open angle glaucoma.

Protection effect and mechanism of hemin against ischemia/reperfusion injury in rat hearts / 中国应用生理学杂志

<p><b>OBJECTIVE</b>To investigate whether the cardioprotective effect of hemin against ischemia/reperfusion (I/R) injury is through the inhibition of calpain activity, and to explore its underlying mechanism.</p><p><b>METHODS</b>Sixty-four SD rats were randomly divided into eight groups (n = 8): sham, I/R, MDL+ I/R, MDL, hemin + I/R, hemin, and ZnPP + hemin+ I/R, ZnPP. Iangendorff isolated rat heart perfusion model was used. The rat hearts were suffered from 40 min of ischemia followed by 30 min of reperfusion. After that, left ventricular developed pressure (LVDP) was recorded. Infarct size and release of lactate dehydrogenase (LDH) were measured. Calpain, heme oxygenase (HO), and caspase 3 activities were evaluated. Expression of calpastatin protein was detected by Western blot.</p><p><b>RESULTS</b>(1) After suffered from ischemia/reperfusion, the calpain activity and caspase 3 activity increased. MDL28170, an inhibitor of calpain, prevented ischemia/reperfusion induced increases in LDH and infarct size, improved the LVDP recovery. (2) Compared with ischema/reperfusion rat hearts, pretreatment of hemin enhanced the HO-1 activity, decreased the calpain and caspase 3 activities, declined LDH release and infarct size, and improved LVDP recovery. (3) Ischemia/reperfusion reduced the expression of calpastatin protein in rat hearts, which was inhibited by hemin pretreatment. And HO-1 inhibitor could abolish the cardioprotection of hemin.</p><p><b>CONCLUSION</b>Cardioprotective effect of hemin against ischemia/reperfusion injury is through the inhibition of calpain activity, the mechanism might be involved in the increase in calpastatin protein expression.</p>

Recent research progress of traumatic optic nerve injury in rat model / 国际眼科杂志(Guoji Yanke Zazhi)

Traumatic optic nerve injury ( TON) is caused by direct or indirect optic nerve trauma, which is one of a serious complication of craniocerebral trauma. lts prognosis poor and usually bring permanent vision damage. At present, optic nerve injury and regeneration is hot in neurobiology research. To build an ideal experimental animal model is extremely important in research and development in the treatment of optic nerve injury. ln this article, we review the methods of making rat models of traumatic optic neuropathy, clinical similarities, advantages and disadvantages of among these models, to provide reference for more experimental study.

Protective effect of neuroglobin on retinal ganglion cell in glaucoma mice model / 中华实验眼科杂志

Background Neuroglobin (Ngb) is a newly discovered member of globin superfamily.It is thought to regulate cell survival under hypoxia or oxidative stress condition.Ngb is expressed at a high level in retinal neuron,suggesting that retina may be one of important functional sites of Ngb.Objective The aim of this study was to investigate the protective role of endogenous Ngb on retina ganglion cells (RGCs) following chronic high intraocular pressure(IOP)in mice and the underlying mechanisms.Methods This study included the in vitro and in vivo experiment.RGCs derived from adult C57BL/6J wild type(WT) mice and Ngb-transgenic(Ngb-Tg) mice which cultivated by our laboratory were incubated with 5.0,7.5,10.0 mmol/L glutamic acid for 3 days.RGCs survival rate was calculated for the ration of dead and survival cells using a double labeling kit to evaluate the influence of Ngb on RGCs survival rate in the addition of glutamic acid.Chronic ocular hypertension models were established by injection of fluorescent microballon(MB) (10 μm)into the anterior chamber of WT mice and Ngb-Tg mice,The mice were divided into WT control group(n=18),Ngb-Tg control group(n=30),WT+MB single injection group(n=38),Ngb-Tg+MB single injection group (n =38),WT+MB twice injection group (n =6) and Ngb-Tg + twice injection group (n=6).In addition,WT+PBS injection group (n =6) and Ngb-Tg+ PBS injection group (n =6) were designed as negative controls to identify if it can affect IOP or not.The mice were sacrificed on 0 day(control group),3 days and 1,4,8 weeks followed the MB anterior chamber injection.Real-time PCR,Western blot and immunoytochemistry were used respectively for the analysis of the expressions of Ngb mRNA and protein in mouse retina,and the survival rates of RGCs were compared between the two types mice.Dihydroethidium (DHE) in retina was detected after cardiac perfusion and ATP level in mouse retina homogenate was analyzed.Results The RGCs survival rate was significantly higher in Ngb mice compared with WT mice in 5.0,7.5 and 10.0 mmol/L glutamic acid treatcd groups (t =2.810,3.020,3.110,P＜ 0.01).IOP of WT+ MB single injection group and Ngb-Tg+ MB single injection group were elevated in comparison with the WT control group and WT+PBS injection group and the high IOP remained for 4 weeks.Ngb level was raised in the WT+MB single injection group on the third day following injection,but the Ngb concentration remained a high level in the Ngb-Tg mice during the period of the experiment duration.The RGCs apoptosis rate was elevated both in the WT mice and Ngb-Tg mice 1,4,8 weeks after injection of MB,however,the cell apoptosis rate was higher in WT mice than that of Ngb-Tg mice(P＜0.05).DHE content in retina in the Ngb-Tg+MB single injection group was significantly lower than that in the WT+MB single injection group (t =3.212,P=0.008),and ATP content in retina was elevated in the Ngb-Tg+MB single injection group compared with WT+MB single injection group(t =2.864,P＜0.01).Conclusions It is suggested that Ngb might be a neuroprotective molecules against RGCs death by decreasing oxidative stress and improving mitochondria function.

Effect of edge contact on metal-on-metal hip joint replacements / 医用生物力学

Objective To study the contact mechanics of metal-on-metal hip joint replacements under different walking conditions, particularly for the edge contact behavior between the cup and the head of the bearing due to large range movement. Methods The finite element model of a typical hip joint replacement with conformal spherical bearing was established to simulate the edge contact of hip joint replacement under the given cup inclination angles and vertical loads. Results The maximum contact pressure decreased slightly and the contact area increased when the cup inclination angles increased within the range of 0°~60°. When the cup inclination angles were more than 80°, the corresponding contact area moved to the cup edge, the maximum contact pressure and distribution range increased, but the position of the maximum contact pressure moved from the initial contact point to the new point with 6°~9° in the direction of the increasing cup inclination angle to balance the corresponding contact pressure distribution and the loaded human weight. Conclusions Different edge contact behavior of hip joint replacements tends to occur due to the bigger cup inclination angle. Therefore, much attention should be paid to the problem of edge contact for both the clinical surgery and the manufacturing of hip joint replacements.

Intraocular pressure lowering efficacy and safety of travoprost 0.004% as a replacement therapy in patients with open angle glaucoma or ocular hypertension / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>Travoprost has been widely used for the treatment of patients with open-angle glaucoma (OAG) or ocular hypertension (OH). The aim of this study was to evaluate the intraocular pressure (IOP) lowering efficacy of travoprost 0.004% monotherapy in patients previously treated with other topical hypotensive medications, and in previously untreated patients.</p><p><b>METHODS</b>This open-label, 12-week study in 1651 adult patients with ocular hypertension or open-angle glaucoma who were untreated or required a change in therapy (due to either inadequate efficacy or safety issues) as judged by the investigator was conducted at 6 sites in China. Previously treated patients were instructed to discontinue their prior medications at the first visit. All the patients were dosed with travoprost 0.004% once-daily at 8 p.m. in both eyes for 12 weeks. Efficacy and safety evaluations were conducted at week 4 and 12. IOP measurements were performed at the same time of day at the follow-up visits.</p><p><b>RESULTS</b>For patients transitioned to travoprost, mean IOP reductions from baseline in untreated and treated patients with different prior medications at week 12 were: latanoprost, (4.3 +/- 4.6) mmHg; beta-blocker, (6.3 +/- 4.0) mmHg; alpha-agonist, (7.5 +/- 4.3) mmHg; topical carbonic anhydrase inhibitors, (8.0 +/- 4.9) mmHg. All mean IOP changes from baseline were statistically significant (P < 0.001). No treatment-related serious adverse events were reported in this study.</p><p><b>CONCLUSIONS</b>In patients treated with other hypotensive medications or untreated, the IOP reduction with travoprost was significant. The results of this study demonstrated the potential benefit of using travoprost as a replacement therapy in order to ensure adequate IOP control. Travoprost administered once daily was safe and well tolerated in patients with glaucoma or ocular hypertension.</p>

Effect of Safflor injection on the intestine ultrastructure characteristics following intestine ischemia/reperfusion injury in rabbits / 中国应用生理学杂志

<p><b>AIM</b>To explore effects of Safflor (Chinese Tradional Medicine) on the intestine ultrastructure characteristics during intestine ischemia/ reperfusion injury (I/RI) in rabbits.</p><p><b>METHODS</b>Thirty rabbits were randomly divided into three groups: control group (group S), ischemia/reperfusion group (group I/R) and Safflor injection group (group SI). Morphological changes of intestine ischemia/reperfusion in rabbits and the protective effects of Safflor were observed under electric telescope.</p><p><b>RESULTS</b>The intestine ultrastructure was badly injured in group I/R. Mitochondria and intestinal mucosal cells were swellen and endoplasmic reticulum expanded, however, in the SI group the ultrastructural injury of the ischemia greatly ameliorated.</p><p><b>CONCLUSION</b>The ultrastructure injury occurrted after intestine I/RI and Safflor has protective effects on the intestine ultrastructure.</p>

Preparation and spectral characterization of apigenin molecularly imprinted polymer / 药学学报

An apigenin molecularly imprinted polymer was prepared by bulk polymerization using apigenin as template, acrylamide (AA) as a functional monomer, ethylene glycol dimethacrylate (EDMA) as a crosslinking agent, acetonitrile and N, N-dimethylformamide as porogenic solvents, and 2, 2'-azobisisobutyronitrile (AIBN) as an initiator. The interaction between template and functional monomer was proved by ultraviolet visible (UV) spectrophotometry and based on the results, appropriate reaction solvent was selected and the synthesizing process was estimated. The molecularly imprinted polymer structure was analyzed by Fourier Transform Infrared (FT-IR) spectrophotometry. The molecularly imprinted polymer was investigated in equilibrium binding experiment to evaluate its adsorption property, the results showed that the adsorption of apigenin on molecularly imprinted polymer is higher than that on blank polymer in the studied concentration range (0.1-2.5 mmol x L(-1)). Scatchard analysis showed that two classes of binding sites existed in the apigenin imprinted polymers, with their KD and Qmax estimated to be 2.52 x 10(-4), 0.54 x 10(-3) mmol x L(-1) and 2.65, 18.89 micromol x g(-1), respectively. Molecularly imprinted polymer showed higher affinity than blank polymer.

Prevalence and risk factors of pterygium / 国际眼科杂志(Guoji Yanke Zazhi)

Pterygium is a common disorder of ocular surface with unknown etiology and pathogenesis. The epidemiological studies around the world have shown that the prevalence rates range from 0.3% to 37.46%. Pterygium is related to geographic setting, sunlight and ultraviolet exposure,age, gender, economic situation, dry eye syndrome and others. The purpose of this review is to present a summary of the more recent literature about the epidemiological study, paying particular attention to prevalence and risk factors of pterygium.

Comparison of laser epithelial keratomileusis and photorefractive keratectomy for the correction of myopia: a meta-analysis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>It is unclear whether a laser epithelial keratomileusis (LASEK) has any significant advantage over a photorefractive keratectomy (PRK) for correcting myopia. We undertook this meta-analysis of randomized controlled trials to examine possible differences in efficacy, accuracy, safety and side-effects between two methods, LASEK and PRK, for correcting myopia.</p><p><b>METHODS</b>A systematic literature retrieval was conducted in the PubMed, EMBASE, Chinese Bio-medicine Database, and Cochrane Controlled Trials Register to identify potentially relevant randomized controlled trials. The statistical analysis was performed using a RevMan 4.2 software. The results included efficacy outcomes (proportion of eyes with uncorrected visual acuity (UCVA) > or = 20/20 at 1 month and 12 months post-treatment), accuracy outcomes (proportion of eyes within +/-0.50 diopters (D) of target refraction at 1 month and 12 months post-treatment), safety outcomes (loss of > or = 2 lines of best spectacle-corrected visual acuity (BSCVA) at > or = 6 months post-treatment), mean pain scores on day 1 post-treatment, and mean corneal haze scores at 6 and 12 months post-treatment.</p><p><b>RESULTS</b>Seven articles describing a total of 604 eyes with myopia from 0 to -9.0 D were identified in this meta-analysis. The combined results showed that the efficacy and accuracy outcomes between the two groups at 1 month and 12 months post-treatment were comparable. No patient lost > or = 2 lines of BSCVA at > or = 6 months post-treatment in four relevant trials. Compared with PRK, LASEK did not relieve discomfort on day 1 post-treatment or reduce corneal haze intensity at 6 and 12 months post-treatment.</p><p><b>CONCLUSIONS</b>According to the available data, LASEK does not appear to have any advantage over PRK for correcting myopia from 0 to -9.0 D. This meta-analysis focuses mainly on the comparison of the early, mid-term and mid-long term results of the two methods. Additional studies to compare the long-term (> one year) results should be considered.</p>

Transarterial oily chemoembolization combined with interstitial laser thermotherapy for treatment of hepatocellular carcinoma / 南方医科大学学报

<p><b>OBJECTIVE</b>To evaluate the therapeutic effects and adverse effects of transarterial oily chemoembolization combined with interstitial laser thermotherapy (TOCE+ILT) in the treatment of hepatocellular carcinoma.</p><p><b>METHODS</b>Totally 120 patients with hepatocellular carcinoma were randomized into two groups and received interventions with TOCE+ILT or TOCE combined with percutaneous ethanol injection (TOCE+PEI). The treatment was repeated when necessary until the tumor was completely ablated, after which the therapeutic effects were evaluated and the patients were the followed up for observing long-term clinical outcome.</p><p><b>RESULTS</b>Of the 120 patients enrolled in this observation, 105 were followed up for two years (54 in TOCE+ILT group and 51 in TOCE+PEI group). The complete tumor necrosis rate of TOCE+ILT group was significantly higher than that of the TOCE+PEI group (84.8% vs 73.9%,Chi(2)=4.405, P=0.036), and TOCE+ILT was associated with a significantly higher negative conversion rate of AFP positivity (77.8% vs 56.1%, Chi(2)=4.592, P=0.032). The 1-year survival rate were similar between two groups, but the 2-year survival rate was significantly higher in patients with TOCE+ILT (79.6% vs 60.8%, Chi(2)=4.477, P=0.034). The hepatic function was comparable between the two groups before treatment, and 1 week after treatment, the ALT level in patients undergoing TOCE+ILT was significantly lower than that in patients with TOCE+PEI (95.90-/+56.06 U/L vs 116.31-/+45.27 U/L, t=2.04, P=0.043). Post-embolization syndrome was observed in the patients in two groups, but no severe adverse events were found.</p><p><b>CONCLUSION</b>TOCE+ILT has good therapeutic effects and mild side effects in the treatment of hepatocellular carcinoma.</p>

Kinetic model for exopolysaccharides (EPS) of Ganoderma lucidum in batch fermentation / 生物工程学报

The synthetic characteristic of extracellular polysaccharide (EPS) of Ganoderma lucidum performed in batch fermentation was studied. The result showed that the production EPS was partially growth-associated. The cell dry weight (CDW) and EPS reached 15.56 g x L(-1), 3.02 g x L(-1) respectively. The yield of EPS to cell dry weight ( Y(p/x)) was 0.19. Based on the test result of batch fermentation, a kinetic model was proposed by using the Logistic equation for cell growth, the Luedeking Piret equation for EPS production and the Luedeking-piret-like equation for consumption of glucose as substrate. The calculated results of models were compared satisfactorily with experimental data under various glucose concentrations, the average relative error was no more than 5%. The kinetic model had practically guiding producing PES in fermentation of Ganoderma lucidum.

A comparison study of the clinical features between Chinese and Indian primary congenital glaucoma patients / 国际眼科杂志(Guoji Yanke Zazhi)

· AIM: To summarize the clinical features of Chinese primary congenital glaucoma and to investigate the discrepancies of the clinical features between the Chinese and Indian patients.congenital glaucoma patients were reviewed. The clinical features were summarized as several quantifiable clinical parameters and the severity of the disease was evaluated. Both the quantified clinical features and severity were statistically compared with those of the Indian patients, which were cited from the previous published articles.included in the study. In Chinese patients, sex ratio (male to female )was about 2:1, family history was presented in 3 patients (7.5%) and consanguinity was found in one patient (2.5%). The main symptoms and signs observed in Chinese patients spanned a wide spectrum of manifestations. The most frequent signs noted on the initial examination were enlarged eyeball (42.5%) and decreased visual acuity (35.0%). Compared with Indian patients, Chinese patients had a later onset, a delayed diagnosis, more severe corneal changes and more severe optic nerve damages (P＜0.01). The combined tabeculectomy and trabeculotomy operation was preferred by both Chinese and Indian doctors whereas a higher proportion of Indian patients received the combined operation (P＜0.01). The proportions of the severity grade were different between Chinese and Indian patients. Most Chinese patients were in the severe grade while most Indian patients were in the very severe grade (P＜0.01).patients were sporadic and non-consanguineous.Compared with Indian patients, Chinese patients had a relative later onset, a delayed diagnosis and treatment.More attempts are needed in Chinese PCG prevention and treatment.

Serum-free Aggregate Perfusion Culture of CHO Cells:an Ultrasonic and Sedimentation Column Combined Perfusion System / 中国生物工程杂志

Using the character of natural aggregation of CHO cells, and an ultrasonic and sedimentation column combined perfusion system to promote cells aggregation and retention into bioreactor,recombinant CHO cell strain MK3-A2 was cultured,which could secrete rhTNK-tPA, by a serum-free perfusion culture system. The culture periods in this two experiments were as long as 77 and 110 days respectively. The cells density reached 2?107 cells /ml. The average volumetric productivity of rhTNK-tPA was 89 mg/L?d, and the highest one was 216mg/L?d.The cells aggregation rate was approximately 90%, and the diameters of most of them were 285～570?m. During the perfusion culture the cells retention rate almost kept in 95% and the viability of cells was more than 85%.Thus, it means that aggregation culture with such perfusion system could be used to scale up produce biopharmaceuticals instead of microcarrier culture system.

Immunomodulatory function of orally administered thymosin alpha1 / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

<p><b>OBJECTIVE</b>To investigate the immunological function of a yeast expression system for thymosin alpha1 (Talpha1).</p><p><b>METHODS</b>A constructed Talpha1 yeast expression system was used to investigate the immunological function of orally administered Talpha1. Dried yeast containing three different concentration of Talpha1 was fed to normal Balb/c mice and other Balb/c mice whose immunities were inhibited in advance by cyclophosphamide. Synthesized Talpha1 peptide was used as positive control and dried yeast with empty plasmid was used as negative control. CD4(+) and CD8(+) levels were detected by flow cytometry assay. TNF-alpha, IFN-gamma, IL-2, IL-6 and IL-10 levels were detected by liquid chip.</p><p><b>RESULTS</b>In normal Balb/c mice or immune inhibition Balb/c mice, CD8(+) levels were significantly increased. Especially in immune inhibition Balb/c mice, CD8(+) levels in synthesized Talpha1 group (18.77%+/-4.72%), small dose group (13.48%+/-6.17%) and large dose group (22.74%+/-1.09%) were significantly higher than that in empty yeast control group (7.49%+/-2.14%).</p><p><b>CONCLUSION</b>Orally administered Talpha1 has its certain immunomodulatory function.</p>