1.A real-world study of first-line albumin-bound paclitaxel in the treatment of advanced pancreatic cancer in China
Juan DU ; Xin QIU ; Jiayao NI ; Qiaoli WANG ; Fan TONG ; Huizi SHA ; Yahui ZHU ; Liang QI ; Wei CAI ; Chao GAO ; Xiaowei WEI ; Minbin CHEN ; Zhuyin QIAN ; Maohuai CAI ; Min TAO ; Cailian WANG ; Guocan ZHENG ; Hua JIANG ; Anwei DAI ; Jun WU ; Minghong ZHAO ; Xiaoqin LI ; Bin LU ; Chunbin WANG ; Baorui LIU
Chinese Journal of Oncology 2024;46(11):1038-1048
Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P<0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.
2.A real-world study of first-line albumin-bound paclitaxel in the treatment of advanced pancreatic cancer in China
Juan DU ; Xin QIU ; Jiayao NI ; Qiaoli WANG ; Fan TONG ; Huizi SHA ; Yahui ZHU ; Liang QI ; Wei CAI ; Chao GAO ; Xiaowei WEI ; Minbin CHEN ; Zhuyin QIAN ; Maohuai CAI ; Min TAO ; Cailian WANG ; Guocan ZHENG ; Hua JIANG ; Anwei DAI ; Jun WU ; Minghong ZHAO ; Xiaoqin LI ; Bin LU ; Chunbin WANG ; Baorui LIU
Chinese Journal of Oncology 2024;46(11):1038-1048
Objective:To observe and evaluate the clinical efficacy and safety of albumin-bound paclitaxel as first-line treatment for patients with advanced pancreatic cancer in China, and to explore the prognosis-related molecules in pancreatic cancer based on next-generation sequencing (NGS) of tumor tissues.Methods:From December 2018 to December 2020, patients with locally advanced or metastatic pancreatic cancer were recruited to accept albumin-bound paclitaxel as first-line treatment in the oncology departments of 24 hospitals in East China. The primary endpoints were overall survival (OS) and treatment related adverse events, and the secondary endpoint was progression-free survival (PFS). Adverse effects were graded using Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0). NGS sequencing on the primary or metastatic tissue samples of pancreatic cancer obtained through surgical resection or biopsy was performed.Results:This study recruited 229 patients, including 70 patients with locally advanced pancreatic cancer (LAPC) and 159 patients with metastatic pancreatic cancer (mPC). The disease control rate was 79.9% and the objective response rate is 36.3%.The common adverse effects during treatment were anaemia (159 cases), leucopenia (170 cases), neutropenia (169 cases), increased aminotransferases (110 cases), and thrombocytopenia (95 cases), and the incidence of grade 3-4 neutropenia is 12.2% (28/229). The median follow-up time was 21.2 months (95% CI: 18.5-23.1 months). The median PFS (mPFS) was 5.3 months (95% CI: 4.37-4.07 months) and the median OS (mOS) was 11.2 months (95% CI: 9.5-12.9 months). The mPFS of patients with LAPC was 7.4 months (95% CI: 6.6-11.2 months), and their mOS was 15.5 months (95% CI: 12.6-NA months). The mPFS of patients with mPC was 3.9 months (95% CI: 3.4-5.1 months), and their mOS was 9.3 months (95% CI: 8.0-10.8 months). Multivariate Cox regression analysis showed that clinical stage ( HR=1.47, 95% CI: 1.06-2.04), primary tumor site ( HR=0.64, 95% CI: 0.48-0.86), Eastern Cooperative Oncology Group Performance Status (ECOG PS) score ( HR=2.66, 95% CI: 1.53-4.65), and whether to combine radiotherapy ( HR=0.65, 95% CI: 0.42-1.00) were independent influencing factors for the PFS of these patients. The primary tumor site ( HR=0.68, 95% CI: 0.48-0.95), ECOG score ( HR=5.82, 95% CI: 3.14-10.82), and whether to combine radiotherapy ( HR=0.58, 95% CI: 0.35-0.96) were independent influencing factors of the OS of these patients. The most frequent gene mutations in these advanced stage pancreatic patients were KRAS (89.66%), TP53 (77.01%), CDKN2A (32.18%), and SMAD4 (21.84%) by NGS of tumor tissues from 87 pancreatic cancer patients with sufficient specimens. Further analysis revealed that mutations in CDKN2B, PTEN, FGF6, and RBBP8 genes were significantly associated with an increased risk of death ( P<0.05). Conclusion:Albumin-bound paclitaxel as first-line treatment demonstrated feasible anti-tumor efficacy and manageable safety for patients with advanced pancreatic cancer in China.
3.Clinical effects of Polygonum cuspidatum on patients with type 2 diabetes mellitus of Dampness-Heat Pattern
Yuan-Ying XU ; Wen-Wen KONG ; Hong-Ping YIN ; Hui-Hui ZHANG ; Xing-Hua CAI ; Bi-Lin XU ; Wen-Jun SHA ; Tao LEI
Chinese Traditional Patent Medicine 2024;46(8):2596-2600
AIM To explore the clinical effects of Polygonum cuspidatum Sieb.et Zucc.on patients with type 2 diabetes mellitus of Dampness-Heat Pattern.METHODS One hundred and forty patients were randomly assigned into control group(70 cases)for 8-week intervention of conventional treatment,and observation group(70 cases)for 8-week intervention of both P.cuspidatum granules and conventional treatment.The changes in body weight,BMI,blood glucose indices(FBG,2 h PG,HbA1C,GA),blood lipid indices(TC,TG,HDL-C,LDL-C,ApoA-I,ApoB,ApoA,ApoE,sdLDL-C),liver function indices(ALT,AST),fatty liver progression,TyG,HSI,TCM syndrome score and effects were detected.RESULTS The observation group demonstrated higher total effective rates of TCM syndromes than the control group(P<0.01),along with slighter fatty liver progression(P<0.01).After the treatment,the observation group displayed decreased body weight,BMI,FBG,GA,TG,ApoE,TyG,HSI,ALT and TCM syndrome score(P<0.05,P<0.01),and 2 h PG,TyG,HSI,ALT,TCM syndrome score were lower than those in the control group(P<0.05,P<0.01).CONCLUSION For the patients with type 2 diabetes mellitus of Dampness-Heat Pattern,P.cuspidatum can improve glucose and lipid metabolism disorders,which is worthy of clinical popularization and application.
4.A multicenter study of neonatal stroke in Shenzhen,China
Li-Xiu SHI ; Jin-Xing FENG ; Yan-Fang WEI ; Xin-Ru LU ; Yu-Xi ZHANG ; Lin-Ying YANG ; Sheng-Nan HE ; Pei-Juan CHEN ; Jing HAN ; Cheng CHEN ; Hui-Ying TU ; Zhang-Bin YU ; Jin-Jie HUANG ; Shu-Juan ZENG ; Wan-Ling CHEN ; Ying LIU ; Yan-Ping GUO ; Jiao-Yu MAO ; Xiao-Dong LI ; Qian-Shen ZHANG ; Zhi-Li XIE ; Mei-Ying HUANG ; Kun-Shan YAN ; Er-Ya YING ; Jun CHEN ; Yan-Rong WANG ; Ya-Ping LIU ; Bo SONG ; Hua-Yan LIU ; Xiao-Dong XIAO ; Hong TANG ; Yu-Na WANG ; Yin-Sha CAI ; Qi LONG ; Han-Qiang XU ; Hui-Zhan WANG ; Qian SUN ; Fang HAN ; Rui-Biao ZHANG ; Chuan-Zhong YANG ; Lei DOU ; Hui-Ju SHI ; Rui WANG ; Ping JIANG ; Shenzhen Neonatal Data Network
Chinese Journal of Contemporary Pediatrics 2024;26(5):450-455
Objective To investigate the incidence rate,clinical characteristics,and prognosis of neonatal stroke in Shenzhen,China.Methods Led by Shenzhen Children's Hospital,the Shenzhen Neonatal Data Collaboration Network organized 21 institutions to collect 36 cases of neonatal stroke from January 2020 to December 2022.The incidence,clinical characteristics,treatment,and prognosis of neonatal stroke in Shenzhen were analyzed.Results The incidence rate of neonatal stroke in 21 hospitals from 2020 to 2022 was 1/15 137,1/6 060,and 1/7 704,respectively.Ischemic stroke accounted for 75%(27/36);boys accounted for 64%(23/36).Among the 36 neonates,31(86%)had disease onset within 3 days after birth,and 19(53%)had convulsion as the initial presentation.Cerebral MRI showed that 22 neonates(61%)had left cerebral infarction and 13(36%)had basal ganglia infarction.Magnetic resonance angiography was performed for 12 neonates,among whom 9(75%)had involvement of the middle cerebral artery.Electroencephalography was performed for 29 neonates,with sharp waves in 21 neonates(72%)and seizures in 10 neonates(34%).Symptomatic/supportive treatment varied across different hospitals.Neonatal Behavioral Neurological Assessment was performed for 12 neonates(33%,12/36),with a mean score of(32±4)points.The prognosis of 27 neonates was followed up to around 12 months of age,with 44%(12/27)of the neonates having a good prognosis.Conclusions Ischemic stroke is the main type of neonatal stroke,often with convulsions as the initial presentation,involvement of the middle cerebral artery,sharp waves on electroencephalography,and a relatively low neurodevelopment score.Symptomatic/supportive treatment is the main treatment method,and some neonates tend to have a poor prognosis.
5.Herbal Textual Research on Coptidis Rhizoma in Famous Classical Formulas
Chu-chu ZHANG ; Si-hong LIU ; Sha-sha LI ; Yan DONG ; Hua-min ZHANG ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Hong-jun YANG ; Bing LI ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):275-285
Through the combing of ancient books of Chinese herbal medicine in the past dynasties, a textual research of Coptidis Rhizoma involved the name, origin, medicinal parts, producing area, quality evaluation, harvesting and processing methods in famous classical formulas was conducted in this paper. After textual research, the mainstream varieties of Coptidis Rhizoma in the Ranunculaceae family before Tang and Song dynasties were Coptis chinensis and C. chinensis var. brevisepala, after the Ming and Qing dynasties, C. deltoidea, C. teeta and C. omeiensis were gradually praised. In ancient times, the authentic producing area of Coptidis Rhizoma has the characteristics of gradually moving to the west. The eastern Coptidis Rhizoma was highly praised in the early stage, while in the later stage, western Coptidis Rhizoma like chicken feet was highly praised. In the early stage, western Coptidis Rhizoma probably originated from C. chinensis and its genus, while Coptidis Rhizoma like chicken feet was cultivated, and no wild species has been found so far. As Coptidis Rhizoma has mixed use of multiple origins in ancient books of past dynasties, based on the current shortage of market resources in C. teeta and C. deltoidea, there are also endangered and protected plants of C. chinensis var. brevisepala and C. omeiensis, combined with the mainstream medicines and resources of past generations, it is recommended to choose C. chinensis as the base of the formulas. In ancient times, there were many processing methods for Coptidis Rhizoma, such as frying and wine-, ginger-, honey-processed. In the process of developing famous classical formulas, the appropriate processing specifications of Coptidis Rhizoma should be selected based on the original source records and the requirements of the medicinal material.
6.Epidemiological and clinical characteristics of melioidosis in Haikou City in 2000 - 2020
Shicheng KUANG ; Chengwang ZHONG ; Wanting ZHENG ; Qingying WANG ; Cancan LIN ; Jiarui CAI ; Siyu WU ; Hua WU ; Sha XIAO ; Biao WU
Chinese Journal of Endemiology 2022;41(2):149-154
Objective:To understand the epidemiological and clinical characteristics of melioidosis in Haikou City, to rise the people's awareness of melioidosis and to provide basis for prevention and control of the disease.Methods:The clinical data of 254 patients with melioidosis treated in 4 Class A tertiary hospitals in Haikou City from January 2000 to September 2020 were collected, and the epidemiological characteristics, clinical manifestations, infection site, prognosis and drug sensitivity were retrospectively analyzed.Results:Among 254 patients with melioidosis, 226 males (88.98%) and 28 females (11.02%), and the gender ratio was 8.07 ∶ 1.00. Farmers were the main occupation, accounting for 37.80% (96/254). The median age was 53 years old, mainly in 41 - 80 years old, accounting for 83.46% (212/254). Han nationality was the most, accounting for 89.76% (228/254). The onset season was mainly in summer and autumn, and the peak was from August to October (117 cases). Patients were mainly distributed in coastal areas, among which Haikou City (49 cases) was the most, followed by Dongfang City (46 cases), Danzhou City (23 cases) and Wenchang City (21 cases). Totally 196 cases (77.17%) had basic diseases, diabetes was the most common (162 cases). The main symptoms of admission were fever (211 cases), followed by cough (108 cases) and expectoration (88 cases). The infection sites were mainly blood (104 cases, 40.94%), lung (60 cases, 23.62%), liver and spleen (32 cases, 12.60%). Totally 195 patients were treated with sensitive antibiotics, at discharge, 37 cases (18.97%) were cured, 129 cases (66.15%) improved, 18 cases (9.23%) did not heal, 7 cases (3.59%) died and 4 cases (2.05%) were discharged voluntarily. Results of drug sensitivity tests from 2010 to 2020 showed that the sensitivity rates of Burkholderia pseudomallei to imipenem (142 cases), meropenem (16 cases) and ceftazidime (141 cases) were all 100.00%, and the sensitivity rates of doxycycline (25 cases) and compound sulfamethoxazole (142 cases) were 92.00% (23/25) and 99.30% (141/142), respectively. Conclusions:Males, farmers, middle-aged and elderly people and people with diabetes and other basic diseases are the high incidence population of melioidosis in Haikou City. The incidence peak is in summer and autumn. The common clinical manifestations are fever, pulmonary infection, abscess of liver and spleen, etc. In the treatment, Burkholderia pseudomallei is more sensitive to imipenem, meropenem and ceftazidime.
7.Textual research principles and suggestions on function and indication of ancient classical formulas.
Bing LI ; Si-Hong LIU ; Chu-Chu ZHANG ; Zhi-Lai ZHAN ; Qiu-Jie CAI ; Sha-Sha LI ; Yan DONG ; Hong-Jun YANG ; Hua-Min ZHANG
China Journal of Chinese Materia Medica 2021;46(7):1846-1850
Indication and functions is an important key information in the research and development of the ancient classical formulas, which directly affects the clinical positioning of the compound formulas and their reasonable, effective and safe use after marke-ting. It is also the embodiment of the ultimate vitality of ancient classical formulas. Due to the particularity of ancient classical formulas, it is of great significance to accurately define and describe the functions and indications of classical formulas to exert their unqiue advantages. Based on the analysis of the provenances, classification of clinical indications, and functions of 100 prescriptions in the Catalogue of Ancient Classical Formulas(First Batch), this paper summarized the incompleteness, irregularity and inconsistency in the original text, the differences in terminology between ancient and modern times, and the evolution of the meanings of prescriptions in different dynasties. In addition, under the guidance of the general principle of textual researh on ancient classical formulas, which is to inherit the essence, make the past serve the present, link up the past and the present, and bulid consensus, this paper proposed the following ideas: respecting the original meanings and provenances of ancient classical formulas, taking full consideration of the development and evolution, serving the current clinical application and health needs, accurately linking up the ancient and modern terminologies, standardizing the expression of traditional Chinese medicine(TCM) terminology, highlighting the characteristics of TCM, attaching importance to the textual research principles and suggestions of post-marketing evidence-based and clinical positioning research, so as to determine the the functions and indications of the ancient classical formulas in a scientific, standardized and reasonable way and better guide the clinical application of the classical formulas.
Drugs, Chinese Herbal
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Medicine, Chinese Traditional
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Oils, Volatile
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Prescriptions
8.Modified Da-chai-hu Decoction regulates the expression of occludin and NF-κB to alleviate organ injury in severe acute pancreatitis rats.
Guang ZHAO ; Yu-Zhen ZHUO ; Li-Hua CUI ; Cai-Xia LI ; Sha-Yan CHEN ; Dan LI ; Jun-Hong LIU ; Di-Hua LI ; Nai-Qiang CUI ; Shu-Kun ZHANG
Chinese Journal of Natural Medicines (English Ed.) 2019;17(5):355-362
Modified Da-chai-hu Decoction (MDD), a traditional Chinese medicinal formulation, which was empirically generated from Da-chai-hu decoction, has been utilized to treat severe acute pancreatitis (SAP) for decades. The aim of the present study was to explore its potential organprotective mechanism in SAP. In the present study, rat SAP model was induced by retrograde injection of 3.5% sodium taurocholate into the biliopancreatic duct, MDD (23.35 g/kg body weight, twelve times the clinical dose) were orally given at 2 h before and 10 h after injection. At 12 h after model induction, blood was taken from vena cava for analysis of amylase, diamine oxidase (DAO), pulmonary surfactant protein-A (SP-A), and C-reactive protein (CRP). Histopathological change of pancreas, ileum and lung was assayed by H&E staining, myeloperoxidase (MPO) activity were determinated using colorimetric assay, and the expressions of occludin and nuclear factor-κB (NF-κB) were detected by real-time RT-PCR and western blot, respectively. In addition, the tissue concentrations of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and monocyte chemoattractant protein-1 (MCP-1) were measured by enzyme-linked immunosorbent assay (ELISA). The results showed that in SAP rats, MDD significantly alleviated histopathological damage, depressed the MPO activity and the concentrations of TNF-α, IL-1β, and MCP-1 of pancreas, ileum and lung, and reduced the serum levels of amylase [(3283.4 ± 585.5) U·Lvs (5626.4 ± 795.1)U·L], DAO [(1100.1 ± 334.3) U·Lvs (1666.4 ± 525.3) U·L] and CRP [(7.6 ± 1.2) μg·mLvs (17.8 ± 3.8) μg·mL]. However, the serum SP-A concentration [(106.1 ± 16.6) pg·mLvs (90.1 ± 14.9) pg·mL] was elevated when treated SAP rats with MDD. Furthermore, MDD increased the occludin expression and reduced the NF-κB expression in pancreas, ileum and lung of SAP rats. Our findings suggested that MDD administration was an effective therapeutic approach for SAP treatment. It could up-regulate occludin expression to protect intercellular tight junction and down-regulate NF-κB expression to inhibit inflammatory reaction of pancreas, ileum and lung.
9.Detection effect of an automatic identification system of Schistosoma japonicum miracidia
Pei-Cai YANG ; Yi-Sha HE ; Hong-Ying ZHANG ; Yuan GAO ; Wei ZHOU ; Yun-Hua GONG ; Ke ZHANG
Chinese Journal of Schistosomiasis Control 2018;30(4):433-435
10.Rapid detection of novel avian influenza virus subtype H7N9 by multiplex real-time RT-PCR.
Bao-Zheng LUO ; Qiu-Hua MO ; Ru-Shu LI ; Qing-Ru BO ; Hai-Nie XU ; Cai-Hua SHA ; Xiu-Yun LIAO
Chinese Journal of Virology 2014;30(1):1-5
In order to develop a rapid detection kit for novel avian influenza virus (AIV) subtype H7N9, two sets of specific primers and probes were designed based on the nucleotide sequences of hemagglutinin antigen (HA) and neuraminidase antigen (NA) of novel H7N9 virus (2013) available in GenBank to establish the method of TaqMan probe-based multiplex real-time RT-PCR for rapid detection of AIV subtype H7N9. The primer and probe of HA were for all H7 subtype AIVs, while the primer and probe of NA were only for novel N9 subtype AIVs. The results showed that this method had high sensitivity and specificity. This method was applicable to the testing of positive standard sample with a minimum concentration of 10 copies/microL; it not only distinguished H7 subtype from H1, H3, H5, H6, and H9 subtypes, but also distinguished novel N9 subtype from traditional N9 subtype. A total of 2700 samples from Zhuhai, China were tested by this method, and the results were as expected. For the advantages of sensitivity and specificity, the method holds promise for wide application.
Animals
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Birds
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virology
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Influenza A Virus, H7N9 Subtype
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genetics
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isolation & purification
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physiology
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Influenza in Birds
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prevention & control
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virology
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Real-Time Polymerase Chain Reaction
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methods
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Species Specificity
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Taq Polymerase
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metabolism
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Time Factors

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