Veregen™ and Fulyzaq are the first two botanical drug products that were approved by the Food and Drug Administration (FDA) to market in the US in recent years. Additional herbal medicines, including Compound Danshen Dripping Pills, Fuzheng Huayu Tablets, Xuezhikang Capsule, Guizhi Fuling Capsule, Kanglaite Capsule and Kanglaite Injection, have filed the investigational new drug (IND) application to the FDA and are in phase II or phase III clinical development. In order to gain better understanding of the process of botanical drug approval in the US, this article examines the aforementioned drugs by looking at their composition, indication, prior clinical experience and clinical development process, and summarizes key features that enabled IND filing and marketing approval by the FDA.
China ; Drug Approval ; legislation & jurisprudence ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Nonprescription Drugs ; therapeutic use ; United States ; United States Food and Drug Administration

OBJECTIVETo investigate the application of the Chinese Urological Association (CUA) Guidelines on Prostatitis and its effects on the clinical practice patterns of diagnosing and treating chronic pelvic pain syndrome (CPPS) among Chinese urologists and andrologists.

METHODSWe conducted a questionnaire investigation on the application of the CUA Guidelines on Prostatitis among the urologists and andrologists of 173 hospitals in 21 cities of China, and performed statistical analyses on all the eligible questionnaires collected.

RESULTSOf the 1 056 questionnaires distributed, 851 (80.6%) were eligible, of which 71.6% were from the urologists or andrologists in grade 3 hospitals, 80.7% of them with senior or intermediate professional titles and 97.5% had studied the CUA Guidelines. Most of the subjects agreed that Type III prostatitis is a clinical syndrome, whose diagnosis should exclude other conditions with similar symptoms, and whose treatment should aim at relieving pain, alleviating urination symptoms and improving the quality of life. Those who had and those who had not studied the CUA Guidelines differed in their viewpoints on CPPS as illustrated in the book. In clinical practice, the most common treatment options for CPPS were psychological therapy (80.7%), medication (80.4%) and life style adjustment (79.6%), and the most frequently used drugs were phytotherapy (80.0%), alpha-blockers (68.9%) and antibiotics (61.0%).

CONCLUSIONCUA Guidelines on Prostatitis has gained a nationwide application and promoted the standardization of the management of CPPS in China.

Humans ; Male ; Pelvic Pain ; diagnosis ; therapy ; Physicians ; Practice Guidelines as Topic ; Prostatitis ; diagnosis ; therapy ; Surveys and Questionnaires

OBJECTIVETo observe the efficacy of Qilin Pills in the treatment of oligoasthenospermia.

METHODSWe conducted a multi-centered open controlled clinical trial by including 220 oligoasthenospermia patients in a trial group and another 110 as controls. The patients in the trial group were treated with Qilin Pills at the dose of 6 g tid, and the controls given Wuziyanzong Pills at 6 g bid, both for a course of 12 weeks. Then we evaluated the clinical effects of Qilin Pills with sperm concentration, the numbers of grade a and grade a + b sperm, and sperm motility as the primary, and the pregnancy rate of the patients'spouses as the secondary therapeutic indexes.

RESULTSA total of 310 patients accomplished the clinical trial, 208 in the trial and 102 in the control group. Compared with the baseline, significant improvement was observed in the semen parameters after 4, 8 and 12 weeks of treatment in both the trial and control groups except sperm density and the number of grade a sperm in the control after 4 weeks (P < 0.01), and the improvement was even more significant in all the semen parameters at the same time points in the trial than in the control group (P < 0.01).

CONCLUSIONQilin Pills can evidently improve the seminal quality of oligoasthenospermia patients with no obvious adverse events.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Male ; Oligospermia ; drug therapy ; Phytotherapy ; Pregnancy ; Pregnancy Rate ; Sperm Count ; Spermatozoa ; drug effects ; Young Adult

OBJECTIVETo determine whether early application of Duo positive airway pressure (DuoPAP), in comparison with nasal continuous positive airway pressure (NCPAP), can reduce the need for endotracheal intubation and mechanical ventilation and decrease the incidence of bronchopulmonary dysplasia (BPD) in preterm neonates with respiratory distress syndrome (RDS).

METHODSIn a single-center, randomized controlled trial, preterm neonates (gestational ages 30-35 weeks) with RDS were randomly assigned to receive DuoPAP (n=34) or NCPAP (n=33) within 6 hours of birth. If the two noninvasive ventilations were not effective, endotracheal intubation and mechanical ventilation were used, and pulmonary surfactant was administered as rescue therapy. The total invasive respiratory support rate and incidence of BPD within 24, 48 and 72 hours of birth were observed. The two groups were compared in terms of PaCO2, PaO2 and oxygenation index (OI) at 1, 12, 24, 48 and 72 hours after using the noninvasive respiratory support.

RESULTSThe total invasive respiratory support rates within 48 and 72 hours after birth were significantly lower in the DuoPAP group than in the NCPAP group (P<0.05). There was no difference in the incidence of BPD between the two groups (P>0.05). The OI in the DuoPAP group was significantly higher than in the NCPAP group at 1, 12, 24, 48 and 72 hours after noninlasive respiratory support (P<0.05). The DuoPAP group showed significantly lower PaCO2 than the NCPAP group at 1, 12, and 24 hours after noninvasive respiratory support (P<0.05). PaO2 was significantly higher in the DuoPAP group than in the NCPAP group at 1 and 12 hours after noninvasive respiratory support (P<0.05).

CONCLUSIONSCompared with NCPAP, early application of DuoPAP can decrease the need for endotracheal intubation and mechanical ventilation in preterm neonates with RDS, showing promise for broad use.

Bronchopulmonary Dysplasia ; epidemiology ; Continuous Positive Airway Pressure ; methods ; Female ; Humans ; Infant, Newborn ; Intermittent Positive-Pressure Ventilation ; methods ; Male ; Noninvasive Ventilation ; methods ; Respiratory Distress Syndrome, Newborn ; therapy

OBJECTIVETo study the expressions of CD55 and CD59 in patients with hyperlipidemia and the effects of atorvastatin on it, and to identify the possible influential factors.

METHODSWe selected 67 patients with hyperlipidemia, and 24 healthy people matched in terms of age, sex and body weight as control. The expressions of CD55 and CD59 on white blood cells were detected by flow cytometry, and their relationships to blood lipids, complement activation indexes (C(5a), sC(5b-9)), inflammatory factors (high sensitivity C-reactive protein (hsCRP), TNF-alpha, IL-6 were analyzed. 24 patients with hyperlipidemia were treated with atorvastatin for 8-12 weeks and the expressions of CD55 and CD59 were measured before and after atorvastatin therapy.

RESULTSThe mean fluorescence intensity (MFI) of CD55 lymphocytes and monocytes were decreased in patients with hyperlipidemia compared with control (2.07 +/- 0.28 vs 2.29 +/- 0.44 and 3.45 +/- 1.02 vs 4.33 +/- 2.32, P < 0.01 and P < 0.05, respectively). CD55 positive lymphocyte MFI was negatively correlated with waist circumference, waist-hip ratio, hsCRP and C(5a). C(5a) was negatively correlated with the MFIs of CD55 positive lymphocytes, monocytes, granulocytes, and positively with TG and diastolic blood pressure. After atorvastatin therapy, the MFIs of CD59 positive lymphocytes, monocytes and granulocytes increased (4.34 +/- 1.16 vs 3.69 +/- 0.76, 4.52 +/- 1.36 vs 3.91 +/- 0.89, 5.67 +/- 1.72 vs 4.56 +/- 1.03, P < 0.05, < 0.05 and < 0.01 respectively), which were not correlated with changes of blood lipids.

CONCLUSIONSThe expression of CD55 is down-regulated in hyperlipidemia, which might be influenced by obesity, abdominal distribution of adipose tissue and inflammatory status of hyperlipidemia, but not by blood lipids. The expression of CD55 is related with complement activation; The expression of CD59 is up-regulated after atorvastatin treatment independently of blood lipids.

Aged ; Atorvastatin Calcium ; CD55 Antigens ; metabolism ; CD59 Antigens ; metabolism ; Case-Control Studies ; Complement Activation ; Gene Expression Regulation ; Heptanoic Acids ; therapeutic use ; Humans ; Hyperlipidemias ; drug therapy ; immunology ; metabolism ; Hypolipidemic Agents ; therapeutic use ; Male ; Middle Aged ; Pyrroles ; therapeutic use

OBJECTIVETo investigate the efficacy and possible action mechanism of Qianlie Beixi Capsule in the treatment of unliquefiable semen.

METHODSA total of 240 patients with unliquefiable semen were randomly divided into a treatment group (n = 180), treated with Qianlie Beixi Capsule, and a control group (n = 60), given compound tablets of zinc and protein. The treatment lasted two courses of 45 days each, and the seminal changes were observed and recorded.

RESULTSOf the patients in the treatment group, 144 were cured, 12 responded and 24 failed to respond to the medication after the first course; and 158 were cured, 7 responded and 15 failed to after the second course, with the effectiveness rate of 91.67%. Meanwhile, sperm motility was obviously improved, with statistically significant difference from that of the controls (P < 0.01).

CONCLUSIONQianlie Beixi Capsule is effective for unliquefiable semen by improving the function of the prostate and shortening the time of seminal liquefaction.

Adult ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Infertility, Male ; drug therapy ; etiology ; Male ; Middle Aged ; Phytotherapy ; Sperm Motility

OBJECTIVEDiscussing the natural history and the influencing factors of HIV infection among former commercial blood and plasma donors engaged in unsafe blood donation practices in China.

METHODSUsing ambispective cohort study, with data obtained from ten counties (districts) from six provinces in the National AIDS Control Demonstration Area. HIV/AIDS cases were found and confirmed prior to July 24, 2006 being former commercial blood. Plasma donors were selected and data regarding infection, incidence, death, and influencing factors was collected. Analysis was performed using SPSS 12.0 statistical analysis software.

RESULTS(1) In 7551 cases of HIV infection, there were 6533 typical progressors (86.52%, 4757 cases of AIDS), 108 rapid progressors (1.43%), 910 long-term non-progressors (12.05%) with 4865 cases progressed to AIDS (64.43%). The median incubation period for HIV progression to AIDS was nine years (95% CI:8.96-9.04). (2) According to data, from a total of 1157 AIDS cases without ARV therapy (23.78% of total AIDS cases), there were 283 confirmed AIDS-related deaths, of which the median survival time was 6 months (95% CI:4-7) and the two and three year fatality rates were 95% and 99%, respectively. (3) The duration of HIV incubation period was irrespective to gender and age at the time of HIV infection (P > 0.05). Length of survival for untreated AIDS showed correlation to gender (P < 0.05) but no correlation with culture, marital status or age at the time of diagnosis of AIDS (P > 0.05).

CONCLUSIONCompared with the UNAIDS theory regarding slow disease progressors among adults, our study showed a longer AIDS incubation period and shorter outlook for untreated survival, but a similar incubation period for other routes of HIV infection.

Acquired Immunodeficiency Syndrome ; epidemiology ; mortality ; Adolescent ; Adult ; Aged ; Blood Donors ; statistics & numerical data ; China ; Female ; HIV Infections ; epidemiology ; mortality ; Humans ; Infectious Disease Incubation Period ; Male ; Middle Aged ; Young Adult

Newcastle disease virus (NDV) and Salmonella Pullorum have significant damaging effects on the poultry industry, but no previous vaccine can protect poultry effectively. In this study, a recombinant-attenuated S. Pullorum strain secreting the NDV hemagglutinin-neuraminidase (HN) protein, C79-13ΔcrpΔasd (pYA-HN), was constructed by using the suicide plasmid pREasd-mediated bacteria homologous recombination method to form a new bivalent vaccine candidate against Newcastle disease (ND) and S. Pullorum disease (PD). The effect of this vaccine candidate was compared with those of the NDV LaSota and C79-13ΔcrpΔasd (pYA) strains. The serum hemagglutination inhibition antibody titers, serum immunoglobulin G (IgG) antibodies, secretory IgA, and stimulation index in lymphocyte proliferation were increased significantly more (p < 0.01) in chickens inoculated with C79-13ΔcrpΔasd (pYA-HN) than with C79-13ΔcrpΔasd (pYA) but were not significantly increased compared with the chickens immunized with the LaSota live vaccine (p > 0.05). Moreover, the novel strain provides 60% and 80% protective efficacy against the NDV virulent strain F48E9 and the S. Pullorum virulent strain C79-13. In summary, in this study, a recombinant-attenuated S. Pullorum strain secreting NDV HN protein was constructed. The generation of the S. Pullorum C79-13ΔcrpΔasd (pYA-HN) strain provides a foundation for the development of an effective living-vector double vaccine against ND and PD.
Animals ; Antibodies ; Bacteria ; Chickens ; Hemagglutination ; HN Protein ; Homologous Recombination ; Immunoglobulin A, Secretory ; Immunoglobulin G ; Lymphocytes ; Methods ; Newcastle disease virus ; Newcastle Disease ; Plasmids ; Poultry ; Salmonella ; Suicide ; Vaccines

OBJECTIVETo investigate the application value of chemiluminescence method (CMIA) detection of Treponema pallidum (TP) specific antibodies in the blood test.

METHODSOver the same period the de novo enzyme linked immunosorbent assay (ELISA) and Abbott chemical luminescence method were used to detect the specific antibody of syphilis in a total of 66298 samples; TP-ELISA negative and TP-CMIA positive unpaid blood donation blood samples for syphilis specific antibody were detected and confirmed by Western blot.

RESULTSBlood samples from 66298 blood donors were detected by TP-ELISA, the positive samples was 250 and the positive rate was 0.38%. The positive samples of TP-CMIA was 297, the positive rate was 0.45%, the difference was statistically significant (P<0.05). The blood samples of 47 unpaid blood donors were confirmed by TP-Western blot method, as a result, 32 samples were positive, 15 were negative, and result detected by TP-ELISA method was negative.

CONCLUSIONTP-CMIA sensitivity is higher than that of TP-ELISA, and possesses higher sensitivity and specificity, and quick detection, simple operation, easy automation, suggesting greater application value in blood detection of Treponema pallidum.

OBJECTIVETo investigate the clinical significance of interleukin-17 (IL-17) level in patients with extranodal NK/T-cell lymphoma(ENKTL).

METHODSEighty patients with nasal ENKTL who received radiotherapy, chemotherapy or radiotherapy combined with chemotherapy from January 2011 to January 2012 were enrolled in the study. Eighty healthy volunteers were selected as the controls (control group). About 5 ml of peripheral blood was collected from all patients and controls. IL-17 level was determined by ELISA. The age, sex, ECOG score, B symptoms, LDH level, lymph node involvment, Ann Arbor stage, IPI, KPI, peripheral blood lymphocyte and lymph node metastasis, number of lymphocytes and monocytes in peripheral blood were recorded. All patients were followed up for 3 year progression-free survival (PFS) and overall survival (OS).

RESULTSThe average IL-17 level in patients with ENKTL was 6.48 pg/ml and the average concentration of IL-17 in control group was 0.56 pg/ml (P<0.01). The level of IL-17 in patients with B-symptoms and lymph node involvement was significantly higher than that in the control group. The differences in IL-17 level were not statistically significant among patients with different age, sex, ECOG, LDH, Ann Arbor stage, IPI, KPI, lymphocyte count and monocyte cell count. The sensitivity and specificity of IL-17 were 74.5% and 73.7% respectively, and the optimal threshold was 3.49 pg/ml and AUC was 0.799 (95% CI: 0.688-0.909) (P<0.01). The PFS and OS were longer in the patients with IL-17≤3.49 pg/ml and longer in the patients without lymph node involvement and Ann Arbor I. Multivariate analysis showed that independent predictors of PFS and OS in patients with ENKTL were plasma IL-17 levels and age (P<0.05).

CONCLUSIONENKTL patients with different clinical characteristics have different levels of IL-17, the different level of IL-17 has different effects on prognosis of patients with ENKTL.