Problems and thoughts in clinical safety evaluation of traditional Chinese medicine / 中国中药杂志

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Evaluation methods of clinical efficacy of traditional Chinese medicine / 中国中药杂志

Clinical efficacy is the basis for the development of traditional Chinese medicine(TCM), and the evaluation of clinical efficacy of TCM has always been the focus of attention. The technical and methodological difficulties in the evaluation process often restrict the generation of high-level evidence. Therefore, methodological research should be deepened and innovative practice should be carried out to study the application of scientific research methods in the evaluation of the advantages of TCM. After more than ten years of development, the clinical efficacy evaluation of TCM, on the basis of the initially classic placebo randomized controlled trials, has successively carried out a series of meaningful attempts and explorations in N-of-1 trials, cohort studies, case-control studies, cross-sectional studies, real world studies, narrative medicine studies, systematic evaluation, and other aspects, laying the foundation for the transformation of TCM from "experience" to "evidence". This paper focused on the clinical efficacy evaluation of TCM, summarized the main connotation and development status of efficacy evaluation indicators, standards, and methods, and put forward corresponding countermeasures and suggestions for the problems of indicator selection, standard formulation, and methodology optimization in the research process. It is clear that scientific and objective evaluation of the efficacy of TCM is an urgent problem to be solved at present.

Clinical analysis of 11 cases of pregnancy with ovarian cancer / 中国实用妇科与产科杂志

OBJECTIVE: To analyze the clinical features,diagnosis and treatment plan and clinical outcomes of pregnancy with ovarian cancer.METHODS: Retrospectively analyze the clinical data of 11 pregnant women with ovarian cancer admitted to five hospitals in Dalian from October 2005 to December 2018.RESULTS: The incidence of pregnancy with ovarian cancer was 0.05‰（11/241 770).Among 11 cases of pregnancy with ovarian cancer,7 cases were primary malignant ovarian tumors,of which there was one case without staging during operation,5 cases of stageⅠ,and 1 case of stage ⅢC.The except stage Ⅲ C patient gave up pregnancy,while the other 6 patients chose to terminate pregnancy on the premise of ensuring the survival of the fetus.Four cases were ovarian metastatic tumors,of which 3 were surgically treated,and all4 patients required to retain the fetus and abandon the treatment for malignant tumors.There were 9 neonates,including 4 premature infants,of whom,1 case died 5 minutes after birth and the remaining 8 neonates were healthy.CONCLUSION: The pregnancy with ovarian cancer lacks typical clinical symptoms;the combination of multiple auxiliary examinations is of great significance in the diagnosis of diseases.Diagnosis and staging can be determined according to the intraoperative and postoperative pathological results.We should be alert to metastatic tumors.The individualized treatment plan of the disease should be based on the pregnancy status,the type of tumor pathology and the stage of the tumor,the wishes of the patient and the family.

Enterovirus 71 inhibited interferon signaling by downregulating expression of IRF9 / 中国免疫学杂志

Objective:To explore the mechanism of EV71 antagonizing IFN signaling pathway.Methods: RD cells were infected or un-infected with EV71.Then the cells were treated with or without IFN-β.The four groups (the control group,the EV71 group,the IFN-β group,the EV71+IFN-β group) were detected by molecular biology techniques.The expression of interferon stimulated genes (ISGs) were detected by Real-time PCR,while the protein levels of STAT1 and IRF9 were examined by Western blot assay.By preparing the cytosolic and nuclear fractions,the translocation of p-STAT1 was monitored through Western blot assay.Results:Compared with the IFN-β group,the mRNA level of OAS1,MX1 and ISG54 in the EV71+IFN-β group was down regulated by 47%, 50% and 48%,respectively,indicating that EV71 inhibited the expression of ISGs.The results also showed that EV71 did not effect the protein level and phosphorylation of STAT1.Moreover,we found that p-STAT1 was translocated into neuclear in IFN-β group,while p-STAT1 was located in the cytoplasm in the EV71+IFN-β group.And the expression of IRF9 was boviously down regulated in EV71+IFN-β group compared with that in IFN-β group,suggesting that EV71 blocked the expression of IRF9 induced by IFN-β.Conclusion:EV71 inhibited the IFN signaling pathway by downregulating the expression of IRF9 induced by IFN-β.

Olaparib potentiates the antitumor effect of Taxol on 4T1 breast cancer / 药学学报

Poly (ADP-ribose) polymerase 1/2(PARP1/2) can catalyze the poly (ADP ribose) (PAR) substrate protein modification and play an important role in the regulation of DNA damage repair, cell death and transcriptional activity. The PARP inhibitor olaparib (AZD2281) can be used as a sensitizer of radiotherapy and chemotherapy in the cancer treatment. Through establishment of biological fluorescent labeled 4T1 ectopic breast tumor model, we found that olaparib exhibited a poor effect on 4T1 breast cancer alone. However, in the combination with Taxol, olaparib significantly increased the anti-tumor effect of Taxol, and reduced the PAR levels of the tumor tissues. Importantly, olaparib did not amplify the toxicity of chemotherapy drugs. This study suggests that olaparib is a representative of the PARP inhibitor that can enhance Taxol 's antitumor effect in the 4T1 ectopic breast tumor model, which sets the foundation for future study of the mechanism of olaparib action.

Clinical efficacy of Yougui capsules and Wuziyanzong pills on oligoasthenospermia / 中华男科学杂志

<p><b>OBJECTIVE</b>To investigate the clinical effects of the Chinese traditional medicine Yougui Capsules and Wuziyanzong Pills on sperm viability and motility in patients with oligoasthenospermia.</p><p><b>METHODS</b>A total of 80 infertile men oligoasthenospermia were equally randomized into a trial and a control group, the former treated with Yougui Capsules at 1.68 g tid, while the latter with Wuziyanzong Pills at 6 g bid, both for a course of 12 weeks. The sperm viability and motility of the patients were detected and compared before and after medication.</p><p><b>RESULTS</b>After 12 weeks of medication, the sperm viability and percentages of grade a and grade a + b sperm were (65.7 +/- 13.1), (22.5 +/- 9.1) and (47.6 +/- 15.8)% in the trial group, significantly higher than (38.1 +/- 11.1), (13.2 +/- 6.8) and (24.1 +/- 10.9)% in the control (P<0.05). What's more, the above three parameters of the two groups were also significantly higher than those before medication, which were (31.9 +/- 16.9), (8.2% +/- 3.7) and (15.7 +/- 13.9)% in the former and (31.7 +/- 17.0), (7.9 +/- 4.5) and (16.9 +/- 13.6)% in the latter (P<0.05).</p><p><b>CONCLUSION</b>Both Yougui Capsules and Wuziyanzong Pills can improve sperm viability and motility in patients with oligoasthenospermia, and the former is even more efficacious than the latter.</p>

Microscopic versus laparoscopic varicocelectomy in the treatment of varicocele: effects and complications / 中华男科学杂志

<p><b>OBJECTIVE</b>To compare the effects and postoperative complications of microscopic varicocelectomy (MV) and laparoscopic varicocelectomy (LV) in the treatment of varicocele.</p><p><b>METHODS</b>We assigned 72 varicocele patients to two groups of equal number to be treated by MV and LV. We compared the two groups in the semen parameters before and 3 months after surgery, postoperative complications, and pregnancy rates of the patients'wives.</p><p><b>RESULTS</b>The operative time was significantly longer in the MV than in the LV group (P<0.05). The postoperative hospital stay showed no significant difference between the MV and LV groups ([2.2 +/- 2.7] d vs [2.8 +/- 0.8] d). Sperm concentration, sperm motility and the percentage of grade a + b sperm were significantly increased in both groups after surgery (P<0.05), but with no significant differences between the two. The pregnancy rate was 65.2% in the former and 57.1% in the latter. Postoperative hydrocele occurred in 5 cases in the LV, but none in the MV group. There were no statistically significant differences in recurrence between the two groups (P>0.05).</p><p><b>CONCLUSION</b>MV is superior to LV for its minimal invasiveness, economical anesthesia, faster recovery and lower rates of postoperative complications and recurrence.</p>

Clinical application of the reverse neurocutaneous flap with anterior cutaneous branch of the femoral nerve supplied by the perforator of saphenous artery / 中华整形外科杂志

<p><b>OBJECTIVE</b>To report the operative technique and clinical application of the neurocutaneous flap with anterior cutaneous branch of the femoral nerve supplied by the perforator of saphenous artery.</p><p><b>METHODS</b>The reverse neurocutaneous flap with anterior cutaneous branch of the femoral nerve supplied by the perforator of saphenous artery was used for repairing the defect around knee or at the upper pad of leg. Since Oct. 2005, 16 cases were treated. The flap size ranged from 15 cm x 7 cm to 30 cm x 15 cm. Flap rotation angle ranged from l00 degrees to 180 degrees.</p><p><b>RESULTS</b>13 flaps survived completely. Flap necrosis happened at the 1/7 - 1/5 distal end of the 3 flaps, which healed with dressing or local flap advancement. The patients were followed up for 6 to 24 months with satisfactory functional and cosmetic results. There was no morbidity at the donor site.</p><p><b>CONCLUSION</b>The flap has the advantages of both the perforator flap and the neurocutaneous flap. The size of the neurocutaneous flap with the anterior cutaneous branch of the femoral nerve can be enlarged for the large defect at lower extremity.</p>

DNA damage induces BRCA1 distribution alteration in prostate cancer cell lines / 中华男科学杂志

<p><b>OBJECTIVE</b>To investigate the role of the tumor suppressor gene BRCA1 in response to DNA damage and to confirm that the function of the BRCA1 protein is regulated by a variety of mechanisms including transcriptional control, phosphorylation and protein-protein interaction.</p><p><b>METHODS</b>With the human breast cell line MCF7 as the positive control, we determined the subcellular distribution of BRCA1 in the prostate cancer cell lines LNCaP, DU145 and PC3 by immunohistochemical staining and Western blotting analyses.</p><p><b>RESULTS</b>BRCA1 was present in the prostate cancer cell lines LNCaP, DU145 and PC3. Ionizing radiation induced BRCA1 nuclear export, increasing from 14% to 40% in the cytoplasma (P < 0.01) and decreasing from 46% to 21% in the nuclei (P < 0.01). This DNA damage-induced BRCA1 nuclear export occurred only in the p53 wild-type but not in the p53 mutant cell line. The apoptosis rate of LNCaP cells was as high as 40% after nuclear export, with an obvious increase of cleaved caspase-3, which was correlated with BRCA1 nuclear-cytoplasmic shuttling.</p><p><b>CONCLUSION</b>Cytoplasmic relocalization of the BRCA1 protein may be a mechanism whereby the BRCA1 function is regulated in response to DNA damage. Its induction of a higher rate of cell apoptosis indicates BRCA1 to be another good biomarker for the treatment of prostate cancer.</p>

Acupuncture for chronic prostatitis: a meta-analysis / 中华男科学杂志

<p><b>OBJECTIVE</b>To determine the effect of acupuncture on chronic prostatitis.</p><p><b>METHODS</b>We retrieved all the case-control studies on acupuncture for chronic prostatitis before August 2007 in MEDLINE and CNKI databases, screened the eligible literature according to the selection and exclusion criteria, and performed meta-analyses of the included studies with the software Revman 4. 2.</p><p><b>RESULTS</b>Thirteen eligible reports were identified in this study, including 861 cases and 738 controls. The effectiveness and cure rates were significantly higher in the acupuncture therapy group than in the control, with pooled RR as 1.20 (95% CI, 1.14, 1.25; P < 0.01) and 1.85 (95% CI, 1.63, 2.11; P < 0.01), respectively.</p><p><b>CONCLUSION</b>Acupuncture therapy exhibited a definite effect in the treatment of chronic prostatitis.</p>

Photoselective vaporization of the prostate in the treatment of benign prostatic hyperplasia / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The treatment of symptomatic benign prostatic hyperplasia (BPH) remains a challenge for most urologic surgeons. We studied a cumulative cohort of patients with symptomatic benign prostatic hyperplasia (BPH) who underwent photoselective vaporization of the prostate (PVP) and evaluated the efficacy and safety of this procedure.</p><p><b>METHODS</b>A total of 196 patients with lower urinary tract obstruction symptoms secondary to BPH were treated using laser vaporization of the prostate under sacral canal anesthesia at our institutions. The therapeutic results were assessed using following variables: the safety and efficacy of sacral anesthesia, blood loss, operative time, indwelling catheterization. Preoperative and perioperative parameters were evaluated in the international prostate symptom score (IPSS), quality of life score (QoL), maximal urinary flow rate (Qmax), post-void residual urine volume (PVR) and the change of sexual function. Patients were also assessed for 3-month follow up.</p><p><b>RESULTS</b>PVP was performed successfully for all patients. There were 195 patients under sacral anesthesia and 1 patient under epidural anesthesia. Mean operative time was (45.2 +/- 18.5) minutes. The mean IPSS decreased from (26.6 +/- 3.2) to (5.6 +/- 1.4) and the QoL score decreased from (5.7 +/- 0.4) to (1.6 +/- 0.5), respectively (P < 0.05), while mean Qmax increased from (6.7 +/- 2.5) ml/s preoperatively to (19.6 +/- 2.4) ml/s, PVR decreased from 158.4 to 25.8 ml, respectively (P < 0.05). Average catheterization time was (1.8 +/- 0.9) days. There was no significant blood loss or fluid absorption during the period of PVP. Complications consisted of transient dysuria in 3 patients (1.5%), delayed gross hematuria in 5 patients (2.5%), respectively. Significant improvement in clinical outcomes were noted as early as 3 months after PVP treatment.</p><p><b>CONCLUSIONS</b>PVP is considered as a high satisfaction rate by patient and a minimal postoperative complication. Hence, PVP is a novel, safe, effective and minimal invasive treatment for patients with symptomatic BPH.</p>