The development of Chinese materia medica (CMM) has risen to the level of national strategy. Under the new situation that the pharmaceutical industry implements the "Made in China 2025" strategy, quality control of the production process of CMM is one of the key areas in which the CMM industry needs to accelerate its breakthrough. The key common issues in process design, analysis and detection, process modeling, and manufacturing equipment and other aspects in the field of quality control of CMM production processes was analyzed in the paper. The progress in the three aspects of process understanding, real-time analysis method development and process control strategy establishment in the quality control system of CMM production process was reviewed. Combined with the author's corporate research practices, this paper introduces the application progress of key technologies such as quality by design (QbD), process analytical technology (PAT), experimental design (DOE), and multivariate statistical analysis in the above three research directions, and analyzes the difficulties problems in practical industrial application. The application prospect is prospected. The purpose of this article is to provide reference for CMM enterprises to apply and improve the quality control technology in the production process.

OBJECTIVETo detect aquaporin-1 mRNA (AQP1) expression in human oligohydramnios placenta and fetal membranes.

METHODSPlacenta and fetal membranes samples were obtained from 5 women with oligohydramnios and 5 with normal amniotic fluid volume. AQP-1 mRNA expression in the tissue samples was detected by semi-quantitative RT-PCR.

RESULTSThe expression of AQP1 mRNA was significantly lower in oligohydramnios placenta than in normal pregnancy placenta at term (P<0.05), and also significantly lower in oligohydramnios fetal membranes than in normal fetal membranes at term (P<0.05).

CONCLUSIONAlterations in AQP1 mRNA expressions in human placenta and fetal membranes may play an important role in the disorder of maternal-fetal fluid exchange and amniotic fluid volume.

Adult ; Aquaporin 1 ; genetics ; metabolism ; Extraembryonic Membranes ; metabolism ; Female ; Humans ; Oligohydramnios ; metabolism ; Placenta ; metabolism ; Pregnancy ; Pregnancy Trimester, Third ; RNA, Messenger ; genetics ; metabolism ; Young Adult

OBJECTIVETo explore clinical effects of manipulative reduction with minimally invasive percutaneous plate osteosynthesis in treating distal tibiofibular fractures.

METHODSFrom 2009 to 2011, 60 patients with distal tibiofibular fractures were treated by manipulative reduction with minimally invasive percutaneous plate osteosynthesis. Among them, there were 32 males and 28 females aged from 14 to 70 years old with an average of 41.22 +/- 2.06. According to AO classification of fractures,5 cases were type A1, 22 cases were type A2,21 cases were type A3 and 12 cases were type C1. Operation time, blood loss,time of callus and fracture healing were observed, Mazur scoring of ankle joint were used to evaluate therapeutic.

RESULTSFifty-eight incisions were healed at stage I ,and 2 cases were infected at distal tibial. Operation time was with an average of (62.34 +/- 5.66) min ranged 45 to 90 min;blood loss was 30 to 150 ml with an average of (80.57 +/- 5.59) ml;formation of callus appeared from 4 to 12 weeks,with an average of (8.24 +/- 2.06) weeks, and fracture healing time was from 3 to 6 months, with an average of (4.50 +/- 1.13) months. According to Mazur scoring of ankle joint 40 cases got excellent results, 18 good, and 2 fair.

CONCLUSIONManipulative reduction with minimally invasive percutaneous plate osteosynthesis can obtain reliable fixation. It is a good choice of treating distal tibiofibular fractures by protecting blood supply of fractures.

Adolescent ; Adult ; Aged ; Bone Plates ; Female ; Fracture Fixation, Internal ; instrumentation ; Humans ; Male ; Middle Aged ; Minimally Invasive Surgical Procedures ; Tibial Fractures ; surgery ; Treatment Outcome ; Young Adult

Postpartum hemorrhage (PPH) is one of the most adverse obstetric outcomes.Our aim is to detect the risks of multilevel PPH in different cesarean section (CS) groups [including nulliparous CS with indications,nulliparous CS without indications,repeat cesarean (RC),vaginal birth after cesarean (VBAC),cesarean after vaginal birth (CAVB)].We conducted a retrospective cohort study,and the data on 127 145 women collected from January 2014 to May 2016 and from 35 tertiary hospitals in Shanxi province,China,were reviewed.Based on the measuring results of PPH,an ordered logistic regression model was used to analyze the adjusted PPH risks for each of the CS groups,and comparisons were drawn between them.Finally,a total of 99 066 nulliparous (77.92％) and 28 079 multiparous (22.08％) women were observed.The number of CS cases was 61 117,and the rate for CS was 48.07％.A total of 10 029 women did not show indications for CS and accounted for 16.41％ of the CS parturient,whereas 9103 women underwent a repeated cesarean,with a CS frequency of 14.89％.The number of VBAC cases was 989,whose rate was 9.88％ in prior CS women.The number (proportions) of PPH was 3658 (2.88％) in LI (PPH volume:≥900 and ＜1500 mL),520 (0.41％) in L2 (PPH volume:≥1500 and＜2100 mL),and 201 (0.16％) in L3 (PPH volume:≥2100 mL).The Ln (n=1,2,3,etc.) represented the increasing order of PPH severity.In the adjusted results,compared with spontaneous vaginal delivery (SVD) as the reference group,in the adjusted result for nulliparous,there was a decreased PPH risk in CS with indications (OR:2.32;CI:2.04-2.62),which was lower than that of CS without indications (OR:2.50;CI:2.01-2.96).The highest PPH risk in all subgroups (i.e.nulliparous and multiparous groups) was observed in the RC (OR:3.61;CI:3.16-4.17),which was nearly twice higher than that of the VBAC (OR:1.82;CI:1.33-2.52).CAVB (OR:1.03;CI:0.65-1.62) showed no significant difference with the reference group.Thus,we deemed that CS should be avoided in nulliparous pregnancies unless indicated,to prevent or reduce the rates for the use of RC or VBAC which are high risks of severe PPH to the parturient women.

BACKGROUND: Although a large number of related studies have been carried out, there is still a lack of practical methods to amplify hematopoietic stem cells(HSCs)in vitro.Mesenchymal stem cells(MSCs)secrete a variety of cytokines that promote the HSCs proliferation and inhibit their differentiation. These cytokines play an important role in maintaining the hematopoietic microenvironment and regulating HSCs function. OBJECTIVE:To investigate the effect of bone marrow MSCs on the proliferation of HSCs in vitro under different coculture modes. METHODS:Mesenchymal stem cells from the bone marrow of C57BL/6 mice were cultured in vitro using the whole bone marrow adherent culture. CD117+cells (HSCs) were sorted from passage 3 cells by using miniMACS magnetic beads sorting. Then, CD117+cells were co-cultured with MSCs under different coculture models, including single culture of HSCs (control group), Transwell coculture (upper chamber, HSCs; lower chamber, MSCs) and two-dimensional contact coculture (coculturing HSCs and MSCs in 24-well plates). The morphology of HSCs was observed under phase contrast microscope and fluorescence microscope, and the number of active cells of HSCs was counted at 1, 3, 5, and 7 days after coculture. RESULTS AND CONCLUSION: During the coculture of 1-7 days, the number of HSCs in the two groups was increased with culture time (P <0.05). After 3 days of coculture, HSCs in each group was grown into the logarithmic growth phase, and morphological changes in some HSCs were detected at 5 days of coculture. At 7 days of coculture, the viabilities of HSCs in different culture models were ranked as follows: single culture model < Transwell coculture model < two-dimensional contact coculture model (P < 0.05). These findings suggest that MSCs can effectively promote the proliferation of HSCs in vitro,and the promotion effect is increased under contact coculture conditions.

OBJECTIVETo evaluate the prognostic value of estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor-2 (Her-2) in node-positive breast cancer patients treated by mastectomy.

METHODSThe clinicopathological data of 835 breast cancer patients treated by mastectomy from January 2000 to December 2004 were retrospectively analyzed. All had positive axillary nodes without distant metastases and with the immunohistochemistry staining of ER, PR and Her-2 available. 764 (91.5%) patients received anthracycline- and/or taxanes-based chemotherapy. 464 (55.6%) patients received hormonal therapy. Eight (1%) patients received trastuzumab. Postmastectomy radiotherapy were given to 352 out of 437(80.5%)patients with T3-T4 and/or N2-N3 disease and 68 out of 398(20.9%)patients with T1-2N1 disease. Patients were classified into 4 subgroups according to the status of hormone receptors (ER and PR, Rec) and Her-2: Rec(-)/Her-2(-) (triple negative), Rec(-)/Her-2(+), Rec(+)/Her-2(+) and Rec(+)/Her-2(-). End points were isolated locoregional recurrence (LRR), distant metastases (DM), disease-free survival (DFS) and overall survival (OS).

RESULTS141 (16.9%) patients were Rec(-)/Her-2(-), 99 (11.9%) Rec(-)/Her-2(+), 157 (18.8%) Rec(+)/Her-2(+) and 438 (52.5%) Rec(+)/Her-2(-). Patients with Rec(+)/Her-2(-) breast cancer had a significantly lower 5-year LRR rate than others (6.2% vs. 12.9%, P = 0.004). Compared with patients with Rec(+) breast cancer, patients with Rec(-) breast cancer had significantly higher 5-year DM rate (26.4% vs. 19.7%, P = 0.0008), lower DFS rate (66.7% vs. 75.6%, P = 0.0001) and lower OS rate (71.4% vs. 84.2%, P = 0.0000). In multivariate analysis, Rec(+)/Her-2(-) was significantly associated with lower risk of LRR. Rec(-) was an independent prognostic factor for higher risk of DM, decreased DFS and OS.

CONCLUSIONER, PR and Her-2 are independent prognostic factors for locoregional recurrence and survival in node-positive breast cancer patients treated by mastectomy.

Adult ; Aged ; Aged, 80 and over ; Anthracyclines ; administration & dosage ; Antibodies, Monoclonal ; therapeutic use ; Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Bone Neoplasms ; secondary ; Breast Neoplasms ; metabolism ; pathology ; surgery ; therapy ; Carcinoma, Ductal, Breast ; metabolism ; pathology ; secondary ; surgery ; therapy ; Carcinoma, Lobular ; metabolism ; pathology ; secondary ; surgery ; therapy ; Disease-Free Survival ; Female ; Follow-Up Studies ; Humans ; Lymph Node Excision ; Lymphatic Metastasis ; Mastectomy ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Radiotherapy, Adjuvant ; Receptor, ErbB-2 ; metabolism ; Receptors, Estrogen ; metabolism ; Receptors, Progesterone ; metabolism ; Retrospective Studies ; Survival Rate ; Taxoids ; administration & dosage ; Trastuzumab ; Young Adult

OBJECTIVETo analyze the role of postmastectomy radiotherapy (PMRT) in moderate- and high-risk elderly breast cancer patients.

METHODSThe clinicopathological data of 874 breast cancer patients treated with mastectomy and axillary dissection were retrospectively analyzed. The T1-2N1 patients were defined as moderate- risk (IR) group, and T3-4 and/or N2-3 cases as high-risk (HR) group. The locoregional recurrence (LRR) and overall survival (OS) rates were calculated and compared according to different age groups and radiotherapy status. Kaplan-Meier method and Log-rank test was used for calculation and comparison of the survival curves of different patient groups.

RESULTSThe median follow up time was 47 months. 108 (12.4%) patients were > or = 65 years. For patients who were < 65 and > or = 65 years, 18.1% and 15.3% received PMRT in the IR group, and 82.7% and 52.2% received PMRT in the HR group, respectively. For patients > or = 65 years, the 5-year LRR rates were 0% and 14.2% (P = 0.242) and 5-year OS rates were 100% and 75.2% (P = 0.159) for the PMRT-IR and non-PMRT-IR groups, respectively. The 5-year LRR rates were 0% and 14.1% (P = 0.061), 5-year OS rates were 84.6% and 77.4% (P = 0.597) for the PMRT-HR and non-PMRT-HR groups, respectively. For patients < 65 years, the 5-year LRR rates were 0% and 9.9% (P = 0.035) and 5-year OS rates were 87.0% and 82.1% (P = 0.739) for the PMRT-IR and non-PMRT-groups, respectively. The 5-year LRR rates were 7.2% and 26.1% (P = 0.000), 5-year OS rates were 79.2% and 57.7% (P = 0.000) for the PMRT-HR and non-PMRT-HR groups, respectively.

CONCLUSIONWith the increasing of age, there is a trend of decreasing use of postmastectomy radiotherapy in high-risk breast cancer patients. Postmastectomy radiotherapy can improve the locoregional control for high-risk patients and maybe considered even for those who are > or = 65 years.

Adult ; Age Factors ; Aged ; Aged, 80 and over ; Breast Neoplasms ; pathology ; radiotherapy ; surgery ; Carcinoma, Ductal, Breast ; pathology ; radiotherapy ; surgery ; Female ; Follow-Up Studies ; Humans ; Lymph Node Excision ; Lymphatic Metastasis ; Mastectomy, Modified Radical ; Middle Aged ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Postoperative Care ; Radiotherapy, Adjuvant ; Retrospective Studies ; Survival Rate ; Young Adult

Objective:To understand the infectious status of Lyme disease among patients with arthritis symptoms in Hainan Province, and to provide a theoretical basis for prevention and control of Lyme disease.Methods:From 2013 to 2018, sampling surveys had been conducted in medical institutions in 8 cities in Hainan Province(Haikou, Sanya, Danzhou, Dongfang, Wenchang, Qionghai, Qiongzhong, Wuzhishan), 2 311 patients serum samples were collected with arthritis symptoms, and descriptive research were conducted base on the collected clinical data. The Indirect Fluorescent-Antibody Test (IFA) method was used for preliminary screening of Lyme disease antibody, the Western Blot (WB) method was used for IFA positive samples confirmation. Statistical analysis using χ2 test. Results:2 311 serum samples were tested by IFA, and 166 were positive with the positive rate of 7.18%. Further confirmed by WB method, 62 samples were positive, the positive rate of Lyme disease antibody was 2.68%(62/2 311). The positive rate of Lyme disease antibody among patients with arthritis in different regions of Hainan was statistically significant ( χ2 =40.636, P<0.001), and the positive rate in Qiongzhong city was the highest (8.81%, 14/159). Danzhou′s positive rate was the second highest, 5.62%(5/89). Dongfang city had the lowest positive rate (0.51%, 2/394). The positive rates of Lyme disease serum antibody in men and women were 2.79% (33/1 182) and 2.57% (29/1 129), respectively; the positive rates of antibodies between each age groups were in the range of 1.74% to 3.64%. The antibody positive rate of Lyme disease showed no significant difference between gender and age ( χ2 =0.110, P=0.740 ; χ2 =1.938, P=0.747). Conclusion:Patients with arthritis symptoms caused by Borrelia burgdorferi infection were found in 8 cities in Hainan province, but the Lyme disease antibody positive rate was different among cities, with Qiongzhong County being the highest.

Objective:To understand the infectious status of Lyme disease among patients with arthritis symptoms in Hainan Province, and to provide a theoretical basis for prevention and control of Lyme disease.Methods:From 2013 to 2018, sampling surveys had been conducted in medical institutions in 8 cities in Hainan Province(Haikou, Sanya, Danzhou, Dongfang, Wenchang, Qionghai, Qiongzhong, Wuzhishan), 2 311 patients serum samples were collected with arthritis symptoms, and descriptive research were conducted base on the collected clinical data. The Indirect Fluorescent-Antibody Test (IFA) method was used for preliminary screening of Lyme disease antibody, the Western Blot (WB) method was used for IFA positive samples confirmation. Statistical analysis using χ2 test. Results:2 311 serum samples were tested by IFA, and 166 were positive with the positive rate of 7.18%. Further confirmed by WB method, 62 samples were positive, the positive rate of Lyme disease antibody was 2.68%(62/2 311). The positive rate of Lyme disease antibody among patients with arthritis in different regions of Hainan was statistically significant ( χ2 =40.636, P<0.001), and the positive rate in Qiongzhong city was the highest (8.81%, 14/159). Danzhou′s positive rate was the second highest, 5.62%(5/89). Dongfang city had the lowest positive rate (0.51%, 2/394). The positive rates of Lyme disease serum antibody in men and women were 2.79% (33/1 182) and 2.57% (29/1 129), respectively; the positive rates of antibodies between each age groups were in the range of 1.74% to 3.64%. The antibody positive rate of Lyme disease showed no significant difference between gender and age ( χ2 =0.110, P=0.740 ; χ2 =1.938, P=0.747). Conclusion:Patients with arthritis symptoms caused by Borrelia burgdorferi infection were found in 8 cities in Hainan province, but the Lyme disease antibody positive rate was different among cities, with Qiongzhong County being the highest.

BACKGROUND: The effects of oral contrast agents (OCAs) on dosimetry have not been studied in detail. Therefore, this study aimed to examine the influence of OCAs on dose calculation in volumetric-modulated arc therapy plans for rectal cancer. METHODS: From 2008 to 2016, computed tomography (CT) images were obtained from 33 rectal cancer patients administered OCA with or without intravenous contrast agent (ICA) and 14 patients who received no contrast agent. CT numbers of organs at risk were recorded and converted to electronic densities. Volumetric-modulated arc therapy plans were designed before and after the original densities were replaced with non-enhanced densities. Doses to the planned target volume (PTV) and organs at risk were compared between the plans. RESULTS: OCA significantly increased the mean and maximum densities of the bowels, while the effects of ICA on these parameters depended on the blood supply of the organs. With OCA, the actual doses for PTV were significantly higher than planned and doses to the bowel increased significantly although moderately. However, the increase in the volume receiving a high-range doses was substantial (the absolute change of intestine volume receiving ≥52 Gy: 1.46 [0.05-3.99, cubic centimeter range: -6.74 to 128.12], the absolute change of colon volume receiving ≥50 Gy: 0.34 [0.01-1.53 cc, range: -0.08 to 3.80 cc]. Dose changes due to ICA were insignificant. Pearson correlation showed that dose changes were significantly correlated with a high intestinal volume within or near the PTV (ρ > 0.5, P < 0.05) and with the density of enhanced intestine (ρ > 0.3, P < 0.05). CONCLUSIONS Contrast agents applied in simulation cause underestimation of doses in actual treatment. The overdose due to ICA was slight, while that due to OCA was moderate. The bowel volume receiving ≥50Gy was dramatically increased when OCA within the bowel was absent. Physicians should be aware of these issues if the original plan is barely within clinical tolerance or if a considerable volume of enhanced intestine is within or near the PTV.