Regulation and new drug application of botanical drugs in the world / 中国药理学与毒理学杂志

This review summarizes the developmental history of natural products and research status of botanical products in different oversea countries. This paper outlines the regulation for new drug application of botanical drugs from the USA, European Union, and Japan. It also uses the Vergen (the first botanical drug approved by US FDA) as an example to discuss how to meet regulatory require-ments for new drug applications.

Research progress on the effect of long non-coding RNA H19 on osteogenic differentiation and bone diseases / 生理学报

A growing number of studies have shown that long non-coding RNAs (lncRNAs) widely participate in the process of osteogenic differentiation of stem cells, regulate the proliferation and apoptosis of a variety of stem cells and osteoblasts, and play an important role in maintaining the balance of bone metabolism. LncRNA H19 regulates the expression of microRNAs (miRNAs) as upstream gene or through direct adsorption, changes the expressions of osteogenic differentiation related genes (RUNX2, OCN, etc.) via Wnt/β-catenin, transforming growth factor β (TGF-β) and Notch signal transduction pathways, and consequently adjusts the process of bone formation. This paper reviews some research progress on the effect of lncRNA H19 on bone diseases, which may help to understand the function and mechanism of lncRNA H19 in regulating the occurrence and development of bone diseases and provide more reliable theoretical basis for the prevention and treatment of bone metabolism related diseases.

Preliminary study of HCT-CI score system for prognosis prediction in elderly patients with acute myeloid leukemia after chemotherapy / 中华血液学杂志

<p><b>OBJECTIVE</b>To investigate the value of the HCT-CI score in chemotherapy risk assessment and prognosis of elderly patients with acute myeloid leukemia (AML).</p><p><b>METHODS</b>The clinical data of 116 AML patients older than 60 years in the department of Hematology, Henan Provincial People's Hospital from January 2000 to December 2010 were analyzed retrospectively. All patients received cytarabine-based regimens, including protocol DA, MA, IA, AA or CAG, followed by cytarabine-based postremission treatment. (1) Comorbidities were evaluated by using HCT-CI score, the early death rates and median survival time were compared among these different groups. (2) These prognostic factors were analyzed by univariate and multivariate analyses.</p><p><b>RESULTS</b>(1) All 116 cases were followed-up. The patient cohort was divided into those with HCT-CI scores of 0, 1 or 2, or ≥ 3. Early death rates were 3.7%, 12.1% and 23.21% in above three groups, respectively (P < 0.01). Overall survival were 345, 225 and 113 days, respectively (P < 0.01). (2) HCT-CI score ≥ 3 (P < 0.01), antecedent MDS history (P = 0.035), high-risk karyotype (P = 0.018), white blood cells at diagnosis ≥ 100×10(9)/L (P = 0.041) were independent adverse prognostic factors with multivariate analysis.</p><p><b>CONCLUSION</b>(1) The HCT-CI score can objectively assess elderly AML patients with comorbidities and predict chemotherapy risk in older patients receiving AML induction therapy. (2) Antecedent MDS history, high-risk karyotype, high white blood cell, and HCT-CI score ≥ 3 are independent adverse prognostic factors of elderly AML patients.</p>

Study on the diagnostic value of lung biopsy in hematologic patients with lung infection / 中华血液学杂志

<p><b>OBJECTIVE</b>To evaluate the diagnostic value and safety of percutaneous lung biopsy in hematologic patients with lung infection.</p><p><b>METHODS</b>28 cases hematologic patients received CT-guided percutaneous lung biopsy when they developed a fever associated with pulmonary nodules or lumps in CT scan whose clinical diagnosis were unclear during or after chemotherapy. Sample of each lesion were drawn twice. The lung tissue was re-scanned after lung biopsy to check up in order to discover bleeding and pneumothorax. Biopsy tissue was examined by bacteria culture, acid-fast staining and pathology. Pathological examination contained HE staining, acid-fast stain, PAS stain, TB-DNA, methenamine silver and others.</p><p><b>RESULTS</b>28 cases contain 24 males and 4 females. Median age was 40 15 - 77 years old. Blood tests were as follows: 3 cases with HGB > 110 g/L, 9 with HGB 90 - 110 g/L, 12 with HGB 60 - 89 g/L, 4 with HGB < 60 g/L. 8 with WBC > 10×10(9)/L, 6 with WBC (4 - 10)×10(9)/L, 13 with WBC < 4×10(9)/L, 1 with WBC < 2×10(9)/L; 14 with PLT > 100×10(9)/L, 5 with PLT (50 - 100)×10(9)/L, 5 with PLT < 50×10(9)/L, 4 with PLT < 30×10(9)/L. 4 cases had mild extended PT, 3 mild extended APTT, 3 FIB lower than normal. Lung CT scans were as follows: 4 cases with simply lesion in right lung, 4 with simply lesion in left lung, 20 with lesions in bilateral lung. 8 cases were diagnosed as fungal infection, 3 as tuberculosis infection, 1 as lung cancer, 1 as pulmonary infiltration of lymphoma, 1 as pulmonary infiltration of leukemia, and 14 as inflammatory changes with no specific diagnosis. 4 cases came with pneumothorax during lung biopsy, mild to moderate in 3 cases and severe in 1 case. Severe patient turned better after CT-guided suction. 3 cases with mild hemoptysis turned better after treatment.</p><p><b>CONCLUSION</b>When hematopathy patients are with pulmonary nodules or lumps in CT scan whose clinical diagnosis is unclear, CT-guided percutaneous lung biopsy is safe and conducive to early diagnosis and conducive to early rehabilitation of patients if the coagulation function is basically normal and platelet count is not too low.</p>

Risk factors and prognosis for patients with residual tumor after radiofrequency ablation of hepatocellular carcinoma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the risk factors and prognosis of patients with residual tumor after radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC).</p><p><b>METHODS</b>The clinicopathological data of 114 patients with HCC undergoing RFA in our hospital from May 2000 to March 2007 were retrospectively studied, and the prognostic factors of residual tumor were analyzed.</p><p><b>RESULTS</b>After one session of RFA, 90 patients had complete ablation and 24 had residual tumor. The median overall survivals in the complete ablation group and residual tumor group were 40 and 29 months, respectively. There was no statistically significant difference between those two groups (P = 0.242). 24 patients with residual tumor were re-treated by RFA or hepatectomy or TACE. Among them 11 patients achieved complete response and 13 incomplete response, their median overall survival were 53 and 28 months, respectively. There was no significant difference between first complete ablation group and second complete response group (P = 0.658). However, compared with the first complete ablation group, the incomplete response group had poor prognosis (P = 0.012). Multivariate analysis showed that tumor size > 3 cm (P = 0.007) and proximity to a large vessel (P = 0.042) were independent risk factors for residual tumor after RFA.</p><p><b>CONCLUSION</b>Tumor size > 3 cm and proximity to a large vessel are independent risk factors for residual tumor after RFA. Further treatment of residual tumor is necessary to eliminate the tumor and improve prognosis.</p>

Significance of multidrug resistance gene-associated proteins in the postoperative adjuvant chemotherapy for gastric carcinoma and the prognosis / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To investigate the expression of multidrug resistance (MDR) gene-associated proteins (MRP) in gastric carcinoma, and their effects on the postoperative adjuvant chemotherapy and the prognosis of patients.</p><p><b>METHODS</b>The expressions of ToPo II, MRP, GST-pi in 99 patients with gastric carcinoma were detected by immunohistochemistry. The expression and its relationship to the pathological data were analyzed. The positive expression of MRP and GST-pi, and the negative expression of ToPo II were considered as risk factors. Patients were divided into two groups: a high risk drug-resistant group (2-3 risk factors) and the low risk drug-resistant group (0-1 risk factors). Postoperative recurrence, survival rate, and efficacy of adjuvant chemotherapy were compared between two groups.</p><p><b>RESULTS</b>The positive rate of ToPo II was 74.7%, and the expression was associated with types and differentiation of the tumor. The positive rate of GST-pi was 49.5%, and the expression was related to the gender and the differentiation. The positive rate of MRP was 40.4%, and there was no relationship between the MRP expression and the pathological finding. There were no significant differences in the recurrence, time to recurrence, and the 5-year survival rate between the positive and negative group of the three proteins (P>0.05). Recurrence was found in 25 cases(55.6%) in the high risk drug-resistant group and the mean time to recurrence was (15.2+/-8.1) months. The time to recurrence was shorter in the low risk drug-resistant group [(21.3+/-11.1) months, P<0.05] , but there was no significant difference in the recurrence rate between two groups (P>0.05). The 5-year survival rate of the high risk drug-resistant group and the low risk drug-resistant group was 44.4% and 55.6% (P>0.05). The 5-year survival rates of patients with or without chemotherapy in the high risk drug-resistant group were 45.8% and 42.9% (P>0.05). The 5-year survival rates of patients with or without chemotherapy in the low risk drug-resistant group were 70.4% and 40.7%. The survival rate of patients with chemotherapy was higher than that of the patients without chemotherapy (P<0.05).</p><p><b>CONCLUSIONS</b>The expression of ToPo II, MRP and GST-pi is associated with the efficacy of postoperative adjuvant chemotherapy. Chemotherapy appears to be more beneficial to patients with low risk drug-resistance.</p>

Prognostic factors and outcome in patients with intrahepatic recurrence after hepatectomy for hepatocellular carcinoma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To investigate the prognostic factors and treatment choice for intrahepatic recurrence after hepatectomy in patients with hepatocellular carcinoma (HCC).</p><p><b>METHODS</b>Clinicopathological data of 184 HCC patients with intrahepatic recurrence after hepatectomy were collected. The influences of twenty one clinicopathological factors and treatment modalities on the survival after recurrence were retrospectively analyzed.</p><p><b>RESULTS</b>Univariate analysis showed that preoperative serum alpha-fetoprotein (AFP) >100 ng/ml, microscopic venous invasion, patients classified as Child-Pugh class B or C at diagnosis of recurrence, multiple recurrence foci and early recurrence (< or =12 months) were poor prognostic factors. Cox multivariate analysis showed that Child-Pugh class at diagnosis of recurrence, number of recurrent foci and time to recurrence were independent risk factors for survival in patients with recurrence. Median survival after recurrence was 34 months, 23 months, 15 months and 9 months, respectively, in patients treated by repeated hepatectomy, local ablation therapy, transcatheter arterial chemoembolization (TACE) or non-treatment in 69 patients with solitary recurrence. There were statistically significant differences among these four groups (P < 0.05).</p><p><b>CONCLUSION</b>classification of Child-Pugh class A at the first time of diagnosis, solitary recurrence, late recurrence (> 12 months), and intrahepatic recurrence occurred after repeated hepatectomy or local ablation therapy are better prognostic factors in patients with HCC recurrence.</p>

The role of vascular resection and reconstruction in the treatment of hilar cholangiocarcinoma / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To evaluate the role of vascular resection and reconstruction in the treatment of hilar cholangiocarcinoma.</p><p><b>METHODS</b>117 patients with potentially resectable hilar cholangiocarcinoma underwent exploration. Twenty-one patients had exploration or drainage only due to distant metastases, and the other 96 patients received surgical resection. Thirty-one of those had vascular resection and reconstruction, including portal vein resection alone in 21 patients, combined hepatic artery and portal vein resection in 2 and hepatic artery resection alone in 8. Therefore, the patients were divided into four groups: non-surgical resection (21), portal vain resection (21), hepatic artery resection (10) and non-vascular resection (65) and their clinical data were reviewed retrospectively.</p><p><b>RESULTS</b>The hepatic artery resection group had significantly higher perioperative morbidity and mortality rate (80.0% and 20.0%) than non-vascular resection group (16.9% and 1.5%), respectively, (P < 0.05), while no significant difference was found between the portal vein resection alone group and the non-vascular resection group (P > 0.05). Of all resected vessel specimens, vascular wall invasion beyond the adventitia was pathologically confirmed in 82.6% of the portal veins and 50.0% of the hepatic arteries. The 1-, 3- and 5-year survival rates were 59.0%, 34.0%, and 16.0% in the non-vascular resection group, versus 44.0%, 23.0% and 11.0% in the portal vein resection alone group (P < 0.05) and 18.0%, 0 and 0 in the hepatic artery resection group (P < 0.01), respectively, with a significant difference among the three groups. The 1-, 3- and 5-year survival rates in the non-surgical resection group were 13.0%, 0 and 0, respectively, which were similar to those in the hepatic artery resection group. Though a significant difference in survival rates existed between the portal vein resection alone group and non-resected group (P < 0.001), no significant difference was found between the hepatic artery resection group and non-resected group (P > 0.05).</p><p><b>CONCLUSION</b>Both portal vein and hepatic artery resection can improve resection rate for hilar cholangiocarcinoma, and portal vein resection may improve the prognosis in selected patients. However, hepatic artery resection can not improve survival and may even lead to an increase of perioperative morbidity and mortality.</p>

Comparison of endoscopic ultrasonography with computer-assisted tomography in the determination of preoperative stage and resectability of pancreatic and ampullary cancers / 中华肿瘤杂志

<p><b>OBJECTIVE</b>To study and compare the accuracy and sensitivity of endoscopic ultrasonography (EUS) and CT scaning in determination of preoperative stage and vascular invasion by pancreatic and ampullary cancers.</p><p><b>METHODS</b>Fourty-two pancreatic cancer patients and 18 ampullary cancer patients were studied. With patients prepared according to conventional endoscopy, Olympus EUM-30 scope 1 set with a side view and 360 degrees rotate and switchable scanning probe [ultrasound frequency (7.5/12 MHz)], was introduced to the descending duodenum through the esophagus. Gas within the duodenum and stomach was aspirated. Then, in order to to facilitate ultrasound transmission, 200 ml deaerated water was injected into the duodenum and 500 ml into the stomach to distend it. The structures of each part of pancreatic head and ampullary together with surrounding vessels were scanned. Then, the scope was withdrawn to the gastric antrum, body and fundus gradually, while the pancreatic body and tail were scanned.</p><p><b>RESULTS</b>Between Apr. 1996 to May 2004, a total of 42 pancreatic cancer patients and 18 ampullary cancer patients were examined by EUS. Meanwhile, all these 58 patients received preoperative CT scaning. The results of stage and vascular invasion determined by EUS in this series were as following; pancreatic cancer group (n = 42): accuracy in T2-4 stage was 100.0% (5/5), 75.0% (9/12) and 48.0% (12/25), respectively; ampullary cancer group (n = 18): T1-4 stage was 75.0% (3/4), 66.7% (2/3), 75.0% (6/8) and 33.3% (1/3), respectively; the accuracy in N stage: P-group: 80.0% in N1 (4/5), 90.0% in N0 (9/10); A-group: 50.0% in N1 (3/6), 91.0% in N0 (10/11). The sensitivity, specificity of vascular invasion, resectability and unresectablilty determined by EUS and CT as compared with surgical findings during operation was 52.9% (9/17), 93.1% (27/29), 77.1% (27/35) and 81.8% (9/11) for EUS (n = 60), respectively; and 11.8% (2/17), 92.6% (25/27), 62.5% (25/40) and 50.0% (2/4) for CT (n = 58), respectively.</p><p><b>CONCLUSION</b>Endoscopic ultrosonography being one of the best image examinations to determine the stage and vascular invasion for pancreatic and ampullary cancer paitients is able to detect small pancreatic or ampullary cancer less than 2.0 cm in diameter due to its high resolution; but can not detect the secondary multiple distal metastases such as spread into the liver, peritonium or hepatoduodenal ligament, etc. due to its ultrasound depth limitation.</p>

The value of MRCP combined with MRI in the preoperative assessment of hilar cholangiocarcinoma / 肿瘤研究与临床

0.5 cm or beneficial anatomical vari- ations displayed on MRCP,were obviously improved and there were no significantly different among the 4 types hilar eholangiocarcinoma.Conclusion MRCP could accurately make the preoperative diagnosis and type of hilar cholangiocarcinoma; the image of second branch of bile duct and the variation of the confluence of hepatic hilar displayed on MRCP has great clinical significance for operative regimes of hilar cholangiocar- cinoma,especially for typeⅣ.It does benefit not only to improve the resection and radical rate of some hilar cholangiocarcinomas, but also to select suitable method of biliary enteric anastomosis and avoid injuring the bile duct in operation.

Surgical treatment and survival analysis of recurrent carcinoma within gastric remnant:a report of 60 cases / 中华胃肠外科杂志

<p><b>OBJECTIVE</b>To study the surgical treatment effect and factors influencing prognosis of recurrent carcinoma within gastric remnant.</p><p><b>METHODS</b>From 1990 to 2003, clinical data of 60 patients underwent surgical operation again because of recurrence carcinoma within gastric remnant after radical resection were reviewed retrospectively.</p><p><b>RESULTS</b>The mean survival time was 32.6 months and the median survival time was 27.0 months. Thirty-seven patients (61.7%) received radical resection with the mean survival time of 45.0 months. Twenty-three patients received palliative treatment with the mean survival time of 12.7 months (P< 0.001). Univariate analysis showed that the clinical stages, pathologic classification, radical resection, peritoneal seeding, liver metastasis, the expression of CD44v6, PCNA and MVD were significantly correlated with survival time (P< 0.01), but were not correlated with sex,age,recurrence time after the first operation (P> 0.05). Multivariate analysis revealed that the clinical stages, peritoneal seeding and radical resection were independent prognostic factors.</p><p><b>CONCLUSIONS</b>The clinical stages, peritoneal seeding and radical resection are independent prognostic factors of recurrent carcinoma within gastric remnant. The radical resection maybe the most effective way to treat the recurrent carcinoma within gastric remnant.</p>

Preventive effect of hepatic arterial infusion (DDS) against post-operative recurrence of hepato-cellular carcinoma / 中国癌症杂志

Purpose:To explore the preventive effect of hepatic arterial infusion (DDS) against recurrence of hepato- cellular carcinoma (HCC) after radical resection.Methods:From Jan,1996 to May,1998,287 patients of HCC after radical resection were randomly divided into four groups:intra-hepatic arterial infusion(97),intra-portal vein(80),intra-hepatic artery and portal vein (60),control (50).All patients received chemotherapy for two years and observed for postoperative recurrence of HCC.Results:The postoperative recurrence rate of HCC with intra-hepatic arterial infusion was significantly lower than that of intra-portal vein (P0.05).The 1～、2～ and 3～year survival rate of intra-hepatic arterial infusion was significantly higher than any of the other groups.Conclusions:Intra-hepatic arterial infusion (DDS) through gastro-duodenal artery can effectively pro- long the postoperative survival and decrease the post-operative recurrence rate of HCC.The preventive method of DDS through gastro-duodenal artery was safer and effective.