Incidence Of Gastrointestinal Adverse Reactions Research Articles

Efficacy and Safety of Oral Supplementation with Liposomal Iron in Non-Dialysis Chronic Kidney Disease Patients with Iron Deficiency.

Iron deficiency is common in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). Oral iron supplementation is recommended in these patients, but it is associated with a higher incidence of gastrointestinal adverse reactions. Liposomal iron therapy has been proposed as a new iron formulation, improving iron bioavailability with less side effects; however, few data are available in patients with NDD-CKD. We designed a single-arm pilot study to evaluate the efficacy of liposomal iron administered for six months in correcting iron deficiency (defined as serum ferritin < 100 ng/mL and/or transferrin saturation < 20%) in patients with NDD-CKD stages 1-5. The primary endpoints were the achievement of serum ferritin ≥ 100 ng/mL and transferrin saturation ≥ 20%. Secondary outcomes were hemoglobin (Hb) changes and the safety of liposomal iron. The efficacy population included 34/38 patients, who completed at least one visit after baseline. Liposomal iron increased the achievement of transferrin saturation targets from 11.8% at baseline to 50.0% at month 6 (p = 0.002), while no significant correction of serum ferritin (p = 0.214) and Hb was found (p = 0.465). When patients were stratified by anemia (Hb < 12 g/dL in women and Hb < 13 g/dL in men), a significant improvement of transferrin saturation was observed only in anemic patients (from 13.3 ± 5.8% to 20.2 ± 8.1%, p = 0.012). Hb values slightly increased at month 6 only in anemic patients (+0.60 g/dL, 95%CI -0.27 to +1.48), but not in those without anemia (+0.08 g/dL, 95%CI -0.73 to +0.88). In patients taking at least one dose of liposomal iron (safety population, n = 38), the study drug was discontinued in eight patients due to death (n = 2), a switch to intravenous iron (n = 2), and the occurrence of side effects (n = 4). The use of liposomal iron in patients with NDD-CKD is associated with a partial correction of transferrin saturation, with no significant effect on iron storage and Hb levels.

Tirzepatide as a novel effective and safe strategy for treating obesity: a systematic review and meta-analysis of randomized controlled trials.

To systematically evaluate the efficacy and safety of a new hypoglycemic drug, tirzepatide, for treating obesity based on indicators such as BMI, waist circumference, and body weight. A search formula was written using search terms such as "tirzepatide," "overweight," and "obesity." A comprehensive search was conducted on databases such as PubMed, Cochrane Library, Embase, and Web of Science using a computer. Random controlled trial (RCT) literature was selected based on inclusion and exclusion criteria. After extracting the data, literature bias risk assessment and meta-analysis were conducted using RevMan 5.4 software. The search deadline is from the establishment of each database to May 2023. A total of 12 randomized controlled trials were included, with a total of 11,758 patients. Meta analysis results showed that compared with the glucagon like peptide-1 receptor agonist (GLP-1 RAs), placebo and insulin groups, tirzepatide could significantly reduce the BMI (body mass index) of patients [MD = -1.71, 95% CI (-2.46, -0.95), p < 0.00001], [MD = -3.99, 95% CI (-3.69, -2.45), p < 0.00001], [MD = -4.02, 95% CI (-4.72, -3.31), p < 00.00001]. In terms of decreasing waist circumference, tirzepatide has a more significant advantage [MD = -4.08, 95% CI (-5.77, -2.39), p < 0.00001], [MD = -7.71, 95% CI (-10.17, -5.25), p < 0.00001], [MD = -9.15, 95% CI (-10.02, -8.29), p < 0.00001]. In the analysis of body weight, tirzepatide showed a more significant reduction effect compared to the control group [MD = -5.65, 95% CI (-7.47, -3.82), p < 0.001], [MD = -10.06, 95% CI (-12.86, -7.25), p < 0.001], [MD = -10.63, 95% CI (-12.42, -8.84), p < 0.001]. In comparison with placebo, tirzepatide had a prominent advantage in weight loss ≥20% and ≥25% [RR = 30.43, 95% CI (19.56, 47.33), p < 0.00001], [RR = 37.25, 95% CI (26.03, 53.30), p < 0.00001]. Subgroup analysis showed a dose-dependent therapeutic effect. In terms of safety, compared with the placebo and insulin groups, the incidence of gastrointestinal adverse reactions was markedly higher in the tirzepatide group, slightly higher to the GLP-1 RAs group. The hypoglycemic (<70 mg/dL) risk of tirzepatide was slightly higher to that of placebo and GLP-1 RAs, but significantly lower than that of the insulin group [RR = 0.46, 95% CI (0.36, 0.58), p < 0.001]. The incidence of other adverse events, including pancreatitis, cholecystitis, major adverse cardiovascular events-4, hypersensitivity reactions, and neoplasms did not show significant statistical differences compared to the control group (p > 0.05). Tirzepatide, as a weight loss drug, significantly reduces BMI, waist circumference and body weight while gastrointestinal adverse reactions need to be vigilant. Overall, its efficacy is significant and its safety is high.

Interaction of antituberculosis drugs with food

The peculiarities of the development and evolution of tuberculosis require a rich and varied diet to restore the nutritional status, reduce the incidence of gastrointestinal adverse reactions and increase adherence to treatment. Food can modify the pharmacokinetic parameters (Cmax, AUC, Tmax) and thus influence the effectiveness of antituberculosis drugs or contribute to the development of resistance. Rifampicin and isoniazid need to be taken on an empty stomach. Food does not significantly influence the pharmacokinetic parameters of pyrazinamide and ethambutol. Calcium-rich products will decrease the absorption of fluoroquinolones. Acidic drinks reduce the absorption and Cmax of cycloserine/terizidone and increase the absorption of paraaminosalicylic acid. Pharmacodynamic interaction can be observed when isoniazid is combined with products containing tyramine and histamine, with increased manifestations of adverse reactions.

Clinical Impact of Tiered Nursing on Postoperative Recovery and Nutritional Status of General Surgery Patients Receiving Nasogastric Enteral Nutrition Support

This research attempted to clarify the clinical impact of tiered nursing on the postoperative recovery and nutritional status of general surgery patients receiving nasogastric enteral nutrition support. Eighty patients undergoing surgery requiring nasogastric enteral nutrition support in the Department of General Surgery of Shengjing Hospital, affiliated with China Medical University, from June 2021 to June 2023 were randomly divided into a control group and an experimental group using computer-assisted drawing. Each group consisted of 40 patients. During the nutritional support period, the control group received conventional nursing, whereas the experimental group received tiered nursing care. The incidence of gastrointestinal adverse reactions and serum albumin and prealbumin scores in the experimental group were lower than in the control group. The first postoperative time of exhaustion, defecation, oral intake, and overall length of stay was shorter in the experimental group than in the control group. The 36-Item Short Form Survey scores were higher in the experimental group than in the control group. In summary, tiered nursing intervention for general surgery patients receiving nasogastric enteral nutrition support can maintain postoperative gastrointestinal comfort, shorten gastrointestinal function recovery and overall recovery times, and elevate postoperative quality of life.

Comparative efficacy of various CHIs combined with western medicine for non-small cell lung cancer: A bayesian network meta-analysis of randomized controlled trials.

Background: Given the limitations of Western medicine (WM) for the treatment of non-small cell lung cancer (NSCLC) and the wide exploration of Chinese herbal injections (CHIs), systematically evaluate the efficacy of Various CHIs Combined with WM for Non-small Cell Lung Cancer. In this study, we performed a network meta-analysis to evaluate the comparative efficacy of 16 CHIs combined with WM regimens for the treatment of NSCLC. Methods: Literature databases were searched from their inception to November 2021, and all randomized control trials (RCTs) involving NSCLC patients treated with a combination of Chinese and WM were retrieved. Outcomes, including disease control rate, survival quality score, incidence of gastrointestinal adverse reactions, incidence of leukopenia, and incidence of thrombocytopenia, were analyzed using RevMan (5.3), Stata17, and R software. Surface under the cumulative ranking curve (SUCRA) probability values were calculated to rank the treatments examined, and clustering analysis was used to compare the effects of CHIs on different outcomes. Results: A total of 389 studies involving 31,263 patients and 16 CHIs were included. The 16 CHIs were: Aidi injection (ADI), Huachansu injection (HCSI), oil of Ophiopogon injection (OOMI), disodium cantharidinate and vitamin B6 injection (DCI), Shenfu injection (SFI), Shenmai injection (SMI), Shenqi Fuzheng injection (SQFZI), Chansu injection (CSI), Delisheng injection (DLSI), Fufang Kushen injection (FFKSI), Huangqi injection (HQI), Kangai injection (KAI), Kanglaite injection (KLTI), Shengmai injection (SI), Xiangguduotang injection (XGDTI), and Xiaoaiping injection (XAPI). The results of the network meta-analysis showed that, with WM treatment as a co-intervention, CSI was most likely to improve the disease control rate (SUCRA = 80.90%), HQI had the highest probability of being the best option for improving the survival quality score (SUCRA = 82.60%), DCI had the highest probability of reducing the incidence of gastrointestinal adverse reactions (SUCRA = 85.50%), HCSI + WM had the highest probability of reducing the incidence of thrombocytopenia (SUCRA = 91.30%), while SMI had the highest probability of reducing the incidence of leukopenia (SUCRA = 79.10%). Conclusion: CHIs combined with WM is proved to be more effective than WM alone, which may be beneficial to NSCLC patients. SMI + WM and DCI + WM are most likely the optimal CHI to improve disease control rates, survival quality score, and reduce adverse effects. This study has limitations; therefore, higher quality RCTs and real-world evidence are required to support our conclusions.

Application Value of Nutrition Support Team in Chemotherapy Period of Colon Cancer Based on Internet Multidisciplinary Treatment Mode.

Objective To explore the application value of the nutrition support team in chemotherapy period of colon cancer based on the internet multidisciplinary treatment mode. Methods For the method of retrospective study, 90 patients with colon cancer admitted to our hospital from August 2018 to August 2020 were selected as the study subjects. They were equally divided into the experimental group (n = 45) and the control group (n = 45) according to the order of initials and the method of parity group. The control group was given conventional nutrition support, and the experimental group was given the nutrition support under the internet multidisciplinary treatment mode. The serum tumor marker levels (CEA and CA19-9), immune function indexes, nutrition indicators, and the incidence of adverse reactions were compared between the two groups before and after intervention. Results The serum tumor marker levels in the experimental group after intervention were significantly lower than those in the control group (P < 0.001). The immune function indexes in the experimental group after intervention were significantly better than those in the control group (P < 0.001). The nutrition indicators in the experimental group after intervention were significantly better than those in the control group (P < 0.001). The incidence of gastrointestinal adverse reactions above grade 2 in the experimental group was significantly lower than that in the control group (P < 0.05). There were 20 patients with myelosuppression, 2 patients with neurotoxicity, and 1 patient with hand and foot syndrome in the experimental group, while 22 patients with myelosuppression, 4 patients with neurotoxicity, and 2 patients with hand and foot syndrome in the control group, with no significant difference in the incidence of adverse reactions between the two groups (P > 0.05). Conclusion The nutrition support team under the internet multidisciplinary treatment mode can improve the immune function of chemotherapy patients with colon cancer and enhance their nutritional level, thereby reducing the incidence of adverse reactions and improving the chemotherapy effects.

Effects of the Ultrasound-Guided Stellate Ganglion Block on Hemodynamics, Stress Response, and Gastrointestinal Function in Postoperative Patients with Colorectal Cancer.

Objective The aim of the study was to study the effects of the ultrasound-guided stellate ganglion block on hemodynamics, stressful response, and postoperative gastrointestinal functions in patients with colorectal cancer. Methods A total of 100 patients with colorectal cancer hospitalized from January 2021 to December 2021 were selected. After anesthesia induction, the right stellate ganglion block was performed under ultrasound guidance in the research group and the general anesthesia was performed in the control group. The heart rate (HR), mean arterial pressure (MAP), epinephrine, cortisol, self-rating anxiety scale (SAS), Ramsay sedation score (RSS), postoperative bowel sound recovery time, anal exhaust time, and the incidence of gastrointestinal adverse reactions 24 hours after operation were studied pre-and post-24-hour anesthesia induction. Results Following 24-hour operation, the HR and MAP values were largely reduced (p < 0.05). Following 24-hour operation, epinephrine and cortisol became obviously higher (p < 0.05). After 24-hour operation, the levels of epinephrine and cortisol in the research group were greatly lower. The score of the SAS in the study cohort was less than that of the controls (p < 0.05). The RSS of the research group was obviously increased (p < 0.05). The recovery time of intestinal sound and the anal exhaust time of the study cohort became remarkably shorter (p < 0.05). The incidence of gastrointestinal adverse reactions 24 hours after operation of the study cohort was much less common (p < 0.05). Conclusion The ultrasound-guided stellate ganglion block can reduce the fluctuation of blood circulation during radical resection of colorectal cancer, reduce postoperative gastrointestinal dysfunction and stress reaction, relieve patients' anxiety, and contribute to the recovery of gastrointestinal function.

A randomized controlled trial of indobufen versus aspirin in the prevention of bridging restenosis after coronary artery bypass grafting

Objective: To compare the efficacy and safety between indobufen and aspirin in the prevention of restenosis of bridge vessels at 1 year after off-pump coronary artery bypass grafting. Methods: This study was a prospective cohort study. We selected 152 patients who received coronary artery bypass grafting in Beijing Anzhen Hospital from December 2016 to December 2018. Patients were divided into the indobufen group and the aspirin group. Patients in the aspirin group were treated with aspirin and clopidogrel, and patients in the indobufen group were treated with indobufen and clopidogrel. During the 1-year follow-up, the rate of restenosis of saphenous vein bridge and internal mammary artery bridge, the rate of adverse cardiac events and adverse reactions were compared between the two groups. The levels of fibrinogen (FIB), D-dimer (D-D), thrombomodulin (TM) and thrombin-activatable fibrinolysis inhibitor (TAFI) were compared before and after antiplatelet therapy. Results: There were 76 cases in the indobufen group, including 57 males (75.0%), aged (60.3±6.6) years. There were 76 cases in the aspirin group, including 62 males (81.6%), aged (59.7±7.2) years. Baseline data were comparable between the two groups (P>0.05). During the follow-up, 3 cases were lost to follow up. Follow-up was completed in 74 patients in the indobufen group and 75 in the aspirin group. A total of 268 bridging vessels were grafted in the indobufen group and 272 in the aspirin group. One year after surgery, the patency rates of great saphenous vein bridge and internal mammary artery bridge were 94.5% (189/200) and 97.1% (66/68) in the indobuphen group, and 91.3% (189/207) and 96.9% (63/65) in the aspirin group, respectively. There was no significant difference in patency rate of great saphenous vein bridge and internal mammary artery bridge between the two groups (χ²=0.282, 0.345, P>0.05). The total incidence of adverse cardiac events was 5.4% (4/74) in the indobufen group and 6.7% (5/75) in the aspirin group (χ²=0.126, P>0.05). The overall incidence of gastrointestinal adverse reactions was significantly lower in the indobufen group than in the aspirin group (4.1% (3/74) vs. 13.3% (10/75), χ²=4.547, P<0.05). The levels of FIB, D-D, TM and TAFI in the two groups were lower than those before surgery (P<0.05), and there was no statistical significance between the two groups at baseline and post-operation (P>0.05). Conclusion: The efficacy of indobufen combined with clopidogrel in the prevention of 1-year restenosis after coronary artery bypass graft is similar to that of aspirin combined with clopidogrel, but the incidence of adverse reactions is lower, and the safety is higher in patients treated with indobufen combined with clopidogrel compared to aspirin combined with clopidogrel strategy.

Effects of Integrated Chinese Traditional Medicine and Conventional Western Medicine on the Quality of Life of Breast Cancer Patients: A Systematic Review and Meta-Analysis.

Background Traditional Chinese medicine has been widely used, in conjunction with conventional Western medicine, in clinical practice around the world to treat breast cancer. The study systematically reviewed and summarized the quality of life of breast cancer patients treated with integrated treatment method vs. conventional Western medicine. Methods Eight databases including PubMed, EMBASE, Web of Science, the Cochrane Library, Chinese National Knowledge Infrastructure, China Biology Medicine Disc, Chinese Scientific Journal Database, and Wanfang Data knowledge service platform were searched in this study. The retrieval period was set from January 1, 2005, to December 31, 2020. Results Twenty-two high-quality publications were included in this study. The total sample size was 1689 patients including 844 in the intervention group receiving traditional Chinese medicine combined with conventional Western medicine and 845 patients in the control group receiving conventional Western medicine only. Compared with the single-used conventional Western medicine treatment, an integrated approach to treat breast cancer can increase quality of life measured by rating scales (SMD = 1.29, 95% CI (1.07, 1.52) and P=0.01) and ranking scales (RR = 1.53, 95% CI (1.39 1.68) and P=0.02) and also decrease adverse reactions measured by rating scales (Z = 10.89, P < 0.05; Group 1: I2 = 9.0%, P=0.258, SMD = 1.03; and Group 2: I2 = 31.6%, P=0.199, SMD = 1.56). For further analysis, chemotherapy with epirubicin exhibited higher quality of life than the chemotherapy without epirubicin among breast cancer patients [Z = 19.80, P < 0.05; Group 1: I2 = 62.4%, P=0.070, SMD = 1.61; and Group 2: I2 = 9.0%, P=0.359, SMD = 1.04]. Despite the heterogeneity, which was due to a portion of relative low-quality literature or other factors, the results were satisfactory. In terms of secondary results, the patients with lower tumor markers (CEA and CA153) had better efficiency in quality of life with a statistically significant difference (SMD = 1.39, 95% CI: 1.10,1.67) for rating scales. In addition, secondary results related to high incidence of gastrointestinal adverse reactions (RR = 1.33, 95% CI (1.20, 1.48)) and the traditional Chinese medicine syndrome (RR = 1.50, 95% CI (1.28, 1.80))showed lower quality of life in the intervention group than the control group for ranking scales. Conclusion Traditional Chinese medicine, when used in conjunction with the conventional Western medicine, could be an effective way in improving the quality of life and alleviating incidence of associated adverse symptoms such as gastrointestinal adverse reactions, value of tumor markers, and the incidence of traditional Chinese medicine syndrome. Further investigation of larger and methodologically sound trials with longer follow-up periods and appropriate comparison groups is needed.

Effects of enteral nutrition on heart function, inflammatory markers and immune function in elderly patients with chronic heart failure.

ABSTRACTObjectives:To evaluate the effect of enteral nutrition on heart function, inflammatory markers and immune function in elderly patients with chronic heart failure and its clinical significance.Methods:Eighty patients with moderate and severe heart failure admitted to the Cardiology Intensive Care Unit (CCU) of Baoding First Central Hospital from May 2019 to May 2020 were included in this study and randomly divided into two groups: the experimental group and the control group, with 40 patients in each group. The experimental group was given enteral nutrition support therapy on the basis of conventional therapy for one month, while the control group was given restricted salt and water intake on the basis of conventional therapy, and patients were given free diet according to their wishes. The changes in heart function before and after treatment, changes in inflammatory factors such as TNF-a, CRP, IL-6, changes in levels of immunoglobulins such as IgA, IgM, and IgG, and the improvement of the performance status of the two groups were compared and analyzed.Results:After treatment, indicators such as BNP, LVEDD, LVEF and 6min walking distance in the experimental group were significantly improved compared with the control group, with statistically significant differences (p<0.05), and the levels of inflammatory factors such as TNF-a, CRP and IL-6 in the experimental group were significantly reduced compared with those in the control group (p=0.00). The levels of IgG, IgA, IgM and other immunoglobulins in the experimental group improved more significantly after treatment than those in the control group, with statistically significant differences (IgG, IgA, p=0.00; IgM, p=0.01). Moreover, the experimental group was significantly superior to the control group in the improvement rate of performance status score (ECOG) after treatment (p=0.04); The incidence of gastrointestinal adverse reactions in the experimental group was 20%, and that in the control group was 15%. No statistically significant difference can be observed in the gastrointestinal tolerance of both groups (p=0.56).Conclusions:Reasonable enteral nutrition boasts a variety of benefits for the recovery of elderly patients with chronic heart failure. With reasonable enteral nutrition, the heart function of elderly patients with chronic heart failure can be significantly improved, inflammatory factors can be reduced, immunity and performance status can be enhanced, and gastrointestinal tolerance can be ameliorated without obvious gastrointestinal reactions.

Meta-Analysis of Clinical Efficacy and Safety of Tripterygium wilfordii Polyglycosides Tablets in the Treatment of Chronic Kidney Disease.

Objective Tripterygium wilfordii polyglycosides tablet (TGt) is an oral preparation extracted from plant Tripterygium wilfordii. It has the effects of anti-inflammation and inhibition of cellular and humoral immunity. However, many reports of adverse reactions caused by TGt have limited its application. In this paper, the clinical efficacy and safety of TGt in the treatment of chronic kidney disease (CKD) were verified by data mining and analysis, so as to provide theoretical data support for the application and development of TGt. Methods A computer search of the following databases was conducted: PubMed, Web of Science, CBM, VIP, Wanfang Data, and CNKI. The search time limit is from the establishment of the database to September 2020. We searched for clinical randomized controlled trials of TGt in the treatment of CKD. The main types of CKD involved are nephrotic syndrome (NS), primary nephrotic syndrome (PNS), refractory nephrotic syndrome (RNS), and IgA nephropathy (IgAN). RevMan 5.2 and Stata 12.0 software were used to evaluate the literature quality and analyze the data. Finally, GRADEpro software was used to evaluate the quality of evidence. Results According to the inclusion and exclusion criteria, 75 articles with a total of 6418 subjects were included. The results of the meta-analysis showed that TGt could reduce 24-hour urinary protein, increase serum albumin, improve clinical efficacy, and reduce disease recurrence rate in patients (P < 0.05) with CKD compared with adrenocortical hormones or immunosuppressants. TGt could significantly reduce the level of serum creatinine (Scr) in patients with CKD (P < 0.05), but it was not significant in reducing the level of blood urea nitrogen (P > 0.05). In terms of safety evaluation, in patients with CKD, it could significantly reduce the incidence of gastrointestinal adverse reactions and neurogenic dizziness and headache (P < 0.05). However, in terms of adverse reactions such as liver injury, respiratory infection, and leukopenia, TGt was as harmful as corticosteroids or immunosuppressants (P < 0.05). The quality of the evidence was evaluated with GRADEpro software, and the results showed that TGt was strongly recommended for the treatment of CKD. Conclusion TGt has certain efficacy in the treatment of CKD and has fewer side effects in certain types of diseases. The effect of TGt combined with other drugs is better than that of single use. This paper also has some limitations. Due to the limited number of the included studies, with all being from China, there may be methodological differences. Therefore, more high-quality literature data from different countries are needed.

A systematic review and meta-analysis of traditional Chinese medicine with chemotherapy in breast cancer.

With the continuous progression of a new generation of adjuvant chemotherapy, the survival time of breast cancer patients has also been significantly improved. Chemotherapy alone will cause a series of side effects, which will seriously affect the quality of life of breast cancer patients. Chinese medicine combined with neoadjuvant chemotherapy has a unique advantage in the treatment of breast cancer. English databases were searched using combinations of the following search terms: "traditional Chinese medicine", "neoadjuvant hemotherapy", "breast cancer", and "tumor of breast". Publications in which traditional Chinese medicine (TCM) combined with neoadjuvant therapy was the experimental group and chemotherapy alone was the control group were screened. A total of 12 publications were included in the meta-analysis. The efficiency of the performance status score was used to test for heterogeneity, Chi2=2.95, df=5, P=0.71>0.1, I2=0%, Z=3.36, odds ratio (OR) =2.61, and 95% confidence interval (CI), 1.49-4.58. The results of the heterogeneity test of the effective rate of the objective curative effect were as follows: Chi2=1.04, df=7, P=0.99>0.1, I2=0%<50%, Z=2.42, OR =2.00, and 95% CI, 1.14-3.49. The results for the heterogeneity test of the TCM syndrome score were as follows: I2=83%, P<0.00001, mean difference (MD) =8.84, 95% CI, 6.43-11.25, P<0.05. The results for the heterogeneity test of the incidence of adverse reactions in the digestive system after chemotherapy were as follows: Chi2=1.15, df=8, P=1.00>0.1, I2=0%<50%, Z=1.68, OR =0.04, 95% CI, -0.01 to 0.09. The meta-analysis confirmed that using TCM combined with neoadjuvant chemotherapy to treat breast cancer has obvious advantages over chemotherapy alone in terms of the objective curative effect, the performance status score effective rate, the TCM syndrome score change, and the incidence of gastrointestinal adverse reactions after chemotherapy.

Effects of extended nursing combined with traditional Chinese medicine nursing on gastrointestinal function and adverse reactions in patients with tumor chemotherapy

Objective To explore the effect of extended nursing combined with traditional Chinese medicine nursing on gastrointestinal function and adverse reactions in patients with tumor chemotherapy. Methods A total of 100 tumor patients who received chemotherapy in the hospital from February 2016 to May 2018 were selected. According to the random number table method, they were divided into the study group and the control group, 50 patients in each group.The control group received routine nursing, and the research group received extended nursing combined with TCM nursing model.Gastrointestinal function and adverse reaction symptoms were compared between the two groups. Results The improvement of gastrointestinal function in the study group was better than that in the control group(P<0.05), and the incidence of gastrointestinal adverse reactions was lower than that in the control group(P<0.05). Conclusions Extended nursing combined with traditional Chinese medicine nursing model can effectively improve gastrointestinal function and reduce the incidence of gastrointestinal adverse reactions in tumor patients undergoing chemotherapy. Key words: Extended nursing; Traditional Chinese medicine nursing; Cancer patients undergoing chemotherapy; Gastrointestinal function; Adverse symptoms

Effects of alendronate and calcifediol compared to alendronate and cholecalciferol in osteoporotic patients.

Several formulations of vitamin D and alendronate are available for the treatment of osteoporosis. The objective of this study was to examine efficacy and safety of calcifediol (25(OH)D) compared to cholecalciferol (vitamin D3) and also the relationship between different formulations of alendronate and adverse reactions. We observed a population of women diagnosed with postmenopausal osteoporosis or osteopenia treated with alendronate 70 mg weekly associated to vitamin D3 or 25(OH)D at monthly total dose of 625 µg. Data collected both at baseline (T0) and at follow-up after at least 12 months of therapy (T1) were: demographic characteristics, BMI, full medical history, lumbar T-score, femur T-score, calcium, osteocalcin, alkaline phosphatase, PTH and vitamin D blood level. A total of 362 patients were enrolled in the study. Alendronate 70 mg + calcifediol (A+25(OH)D) group consisted of 202 patients while 160 patients were treated with alendronate 70 mg + cholecalciferol (A+D3). In the A+25(OH)D group, we observed a significant increase in lumbar T-score value (0.26±0.35 vs. 0.13±0.3) and serum vitamin D (20.64±20.71 vs. 6.07±7.61 ng/mL) levels compared to the A+D3 group (P<0.05). The lowest incidence of gastrointestinal adverse reactions was observed among patients taking alendronate 70 mg in drinkable solution form (P<0.05). Alendronate 70 mg with calcifediol gives a better outcome in the treatment of osteoporosis according to lumbar T-score and vitamin D serum level observed at one-year follow-up compared to alendronate 70 mg with cholecalciferol. Both vitamin D formulations did not show to cause hypercalcemia in this study. Alendronate 70 mg in drinkable solution form is also associated with lowest incidence of gastrointestinal adverse reactions.

The Traditional Chinese Medicine Kangai Injection as an Adjuvant Method in Combination with Chemotherapy for the Treatment of Breast Cancer in Chinese Patients: A Meta-Analysis.

Objective The traditional Chinese medicine Kangai injection as an adjuvant method in combination with chemotherapy has been widely used for treating breast cancer in clinical practice in China. This study systematically reviewed the clinical effect and safety of traditional Chinese medicine Kangai injection as an adjuvant method in combination with chemotherapy for treating Chinese patients with breast cancer. Methods Seven databases were searched in this study, namely, PubMed, the Cochrane Library, Embase, CNKI, Sino Med, VIP, and Wanfang Data. The timeframe of retrieval was set from the founding date of each database to November 1, 2017. Results Fifteen papers were included in this study. The quality of all the studies included was low. All the studies were carried out among the Chinese population. Meta-analyses showed that, compared with single-use chemotherapy, using a Kangai injection combined with chemotherapy to treat Chinese breast cancer patient can increase the total effective rate [RR = 1.15, 95% CI (1.01, 1.32), and P = 0.033], improve the quality of life [RR = 1.30, 95% CI (1.14, 1.48), and P ≤ 0.001], decrease the incidence of weight loss [RR = 0.49, 95% CI (0.32, 0.77), and P = 0.002], decrease WBC count [RR = 0.78, 95% CI (0.68, 0.89), and P ≤ 0.001], decrease incidence of renal and liver dysfunction [RR = 0.58, 95% CI (0.46, 0.73), and P ≤ 0.001], and decrease cardiac dysfunction [RR = 0.41, 95% CI (0.18, 0.94), and P = 0.035]. For the incidence of gastrointestinal adverse reactions [RR = 0.89, 95% CI (0.65, 1.21), and P = 0.452], decreased platelet count [RR=0.49, 95% CI (0.18, 1.30), and P = 0.150], and alopecia [RR = 1.01, 95% CI (0.89, 1.14), and P = 0.879], these two groups showed no statistically significant differences. Conclusion Kangai injection as an adjuvant method in combination with chemotherapy for treating Chinese breast cancer patients can improve their life quality and physical conditions and reduce the adverse reactions that result from chemotherapy. However, the present conclusion is only suitable for the Chinese population. The long-term, high-quality researches are required to further verify the above conclusions.

Therapy and pharmacological properties of hydroxychloroquine and chloroquine in treatment of systemic lupus erythematosus, rheumatoid arthritis and related diseases.

This review examines the pharmacokinetics, modes of action and therapeutic properties of the anti-malarial drugs, hydroxychloroquine (HCQ) and chloroquine (CQ), in the treatment of systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and related conditions, as well as osteoarthritis (OA). Both HCQ and CQ have historically been employed successfully for the treatment of SLE and RA for over 70 years. HCQ has been used extensively for SLE where it has a good reputation for controlling the dermatological complications in SLE. It has also been reported to effectively control the symptoms of Sjøgren's syndrome, as well as preventing thrombosis in phospholipid antibody (aPL) syndrome. In RA and SLE, HCQ is preferred because of the lower incidence of gastrointestinal adverse reactions compared with CQ and it might have a lower risk of ocular adverse reactions. There is increasing evidence that HCQ may reduce atherosclerosis and risks of cardiovascular disease in rheumatic patients. Both HCQ and CQ have been shown to improve glycaemia and reduce the risks of type II diabetes mellitus. Although both HCQ and CQ are effective in low-moderate RA, HCQ is now preferred as part of combination therapy for more severe disease. The advantages of combination therapy are that the doses of the individual drugs may be lowered so reducing adverse reactions. Both HCQ and CQ are diastereoisomers, have basic properties and are given as the sulphate and phosphate salts. While being relatively well absorbed orally and with good bioavailability, they have long and variable plasma terminal elimination half-lives (approximately 40-60 days). This reflects their high volume of distribution, V D (HCQ 44,000L; CQ 65,000L) which extends into aqueous compartments, long mean residence time (HCQ 1300 h; CQ 900 h) and with about half the drugs (metabolites) undergoing renal clearance. The strong binding to melanin reflects the ocular injury and dermatological properties of these drugs. The consensus is that the occurrence of ocular adverse reactions can be minimised by close attention to the dose (which should be set on a body weight basis) with regular (e.g. quarterly) retinal examination. Although HCQ and CQ can pass through the placenta, the use of these drugs during pregnancy does not appear to risk harm to the baby and might be beneficial to the mother with SLE and her child by controlling the SLE disease activity, which is known to be an important factor affecting pregnancy outcome. The modes of action of HCQ and CQ in these arthritides represent somewhat of an enigma. Undoubtedly, these drugs have multiple actions related, in part, their ability to accumulate in lysosomes and autophagosomes of phagocytic cells as well as affecting MHC Class II expression and antigen presentation; actions of the production of pro-inflammatory cytokines [e.g. interleukin-1 (IL-1) tumour necrosis factor-α (TNFα)]; control of toll-like receptor-9 activation; and leucocyte generation of reactive oxygen species (ROS); i.e. antioxidant activity. The actions of these drugs on T and B cells are less clear but may depend on these leucocyte-mediated actions. Anti-malarials also protect against cytokine-mediated cartilage resorption. This and other actions may underlie the potential benefits in treating OA. The exact relationships of these various actions, mostly determined in vitro, have not been specifically defined in vivo or ex vivo in relation to clinical efficacy. HCQ and CQ have a good reputation for being effective and relatively safe treatments in SLE, mild-moderate RA and Sjøgren's syndrome. There is need for (a) more information on their mode of action in relation to the control of these diseases, (b) scope for developing formulations that have improved pharmacokinetic and therapeutic properties and safety, and (c) further exploring their use in drug combinations not only with other disease modifying agents but also with biologics.

Metformin and rosiglitazone maleate tablets ameliorate insulin resistance and hyperandrogenism in obese and nonobese women with polycystic ovarian syndrome

Objective To evaluate the therapeutic effects of metformin hydrochloride and rosiglitazone maleate tablets on insulin resistance and androgen concentration in obese and nonobese women with polycystic ovarian syndrome (PCOS).Methods Seventy women with PCOS were enrolled into this study according to the diagnostic criteria of Rotterdam conference (2003).The women with PCOS were divided into the over weight/obese group (body mass index ≥ 25 kg/m2,n =34) and the nonobese group (body mass index＜25 kg/m2,n =36).All women with PCOS took metformin hydrochloride and rosiglitazone maleate tablets twice daily for 3 months.The following indexes were measured before and after the treatment:height,weight,waist circumference,hip circumference,fasting plasma glucose,fasting plasma insulin,luteinizing hormone (LH),follicle stimulating hormone (FSH),total testosterone,free testosterone,follicular number and ovarian area,body mass index,waist to hip ratio,and homeostasis model assessment for insulin resistance (HOMA-IR) were calculated.Results (1) Compared with the nonobese group,dramatic increases in HOMA-IR and follicle number were observed in over weight/obese group(P＜0.05),while LH,LH/FSH,total testosterone,free testosterone showed no significant difference between two groups.(2) After the treatment with metformin hydrochloride and rosiglitazone maleate tablets,weight,body mass index,fasting plasma glucose,fasting plasma insulin,HOMA-IR significantly decreased in two groups (P ＜ 0.05).There were also significant declines of LH,LH/FSH,free testosterone,ovarian area,follicular number,especially in the over weight/ obese women with PCOS (P＜0.05),while total testosterone and FSH did not change significantly.(3) The incidence of gastrointestinal adverse reactions in nonobese and over weight/obese group was 9.3％ and 6.3％ respectively,and no liver toxicity,edema,hypoglycemia and other adverse reactions was observed during treatment.Conclusion Compared with the nonobese group,there were severer insulin resistance and more marked polycystic change of ovary in over weight/obese women with PCOS,while total testosterone and free testosterone showed no significant difference between two gruops.Metformin hydrochloride and rosiglitazone maleate tablets can ameliorate insulin resistance and polycystic ovary,and also reduce body mass index and free testosterone in women with PCOS particularly in the over weight/obese individuals. Key words: Polycystic ovary syndrome; Obesity; Metformin ; Rosiglitazone

The Tolerability, Safety and Efficacy of a New Oral Solution of Deferiprone in Children with Transfusional Iron Overload

Although there are 20 yr of clinical experience with deferiprone in treating transfusional iron overload, limited data exist on the safety and efficacy of deferiprone in very young children. Difficulties in swallowing the tablet formulation of deferiprone (Ferriprox®, ApoPharma, Canada), is a limiting factor in the administration of deferiprone in young children. The current study evaluated the tolerability, safety and efficacy of a new liquid formulation of deferiprone (Ferriprox® Oral Solution) in iron-overloaded pediatric patients with transfusion-dependent anemias (≥ 8 transfusions/year). The study also assessed the daily neutrophil count in patients who continued deferiprone therapy during episodes of mild neutropenia. The study was approved by the relevant regulatory authorities and ethics review boards. Informed consent was obtained from the patients' legal representatives. One-hundred children [91Thal major, 8 HbE, 1 Sickle Cell disease; 46 female and 54 male; 76 Caucasian (Egyptian), 24 Asian (9 Chinese, 13 Indonesian, 2 Malay)] ranging from 1 to 10 yr of age (median 5.0 yr) were enrolled. At enrollment, 51 children were being treated with deferoxamine (mean duration 1.82 ± 1.95 years; range 0.1–7.3 yr), 20 with deferiprone (mean duration 0.5 ± 0.6 yr; range 0. 04–2 yr), 8 patients with deferasirox (mean duration 0.4 ± 0.5 yr; range 0.1–1.6 yr) and 21 patients were naïve to chelation therapy.Deferiprone therapy was initiated at 50 mg/kg/day, divided in 3 doses, for the first 2 weeks, and then increased to 75 mg/kg/day. The dose was further increased to 100 mg/kg/day for those patients with ferritin > 2500 μg/L at baseline. Ninety-five children completed 6 months of therapy. One patient was lost to follow-up, 2 patients voluntarily withdrew consent (1 patient disliked the taste, 1 patient did not comply with weekly visits), and 2 were withdrawn due to adverse events. Therapy with the oral solution of deferiprone was not associated with unexpected adverse reactions. The incidence of gastrointestinal adverse reactions was lower than observed for the tablet formulation in older patients (Table).Oral solution in children ≤ 10 yr oldTablet formulation in children > 6 yr old and adultsAdverse Reaction (AR)% Patients with AR% Patients with ARNausea1%16%Abdominal Pain6%14%Vomiting6%12%Arthralgia4%11%Neutropenia (0.5 × 109/L ≤ ANC < 1.5 × 109/L)6%6%Agranulocytosis (0.5 < ANC)2%1%Five patients experienced single episodes of mild neutropenia [absolute neutrophil count (ANC) 1.5 × 109/L but not less than 1.0 × 109/L], which resolved and did not recur, despite continuous deferiprone use. Another patient experienced 2 transient episodes of mild neutropenia and a third episode that progressed to agranulocytosis (ANC < 0.5 × 109/L). Deferiprone was discontinued and the patient was treated with G-CSF. The event resolved (ANC > 1.5 × 109/L) within 9 days upon discontinuation of deferiprone. Another patient experienced a single episode of agranulocytosis, which resolved within 9 days upon discontinuation of deferiprone and therapy with G-CSF.During the 6-month therapy, there was a significant decrease in serum ferritin from a mean baseline value of 2532 ± 1463 to 2176 ± 1144 μg/L (p< 0.0005).The new oral solution of deferiprone was well tolerated and effective in lowering serum ferritin in young children with transfusion dependent anemias and exhibited a safety profile similar or better to that reported for the tablet formulation in older patients. The results also suggest that not all episodes of mild neutropenia progress to agranulocytosis with continued deferiprone therapy, and that further studies are warranted to differentiate those patients from those at risk of developing deferiprone-induced agranulocytosis following neutropenia. This study includes the first report of patients using deferiprone as their first iron chelator.