Study on the Clinical Safe and Effective Methods of Arsenic-Containing Compound-Qinghuang Powder in the Treatment of Myelodysplastic Syndrome

Objective. To establish the clinical safe and effective methods of arsenic-containing compound-Qinghuang Powder (compound-QHP) in the treatment of myelodysplastic syndrome (MDS). Methods. 200 patients with MDS were treated with compound-QHP (daily dose of 0.1 g realgar). The blood arsenic concentrations (BACs) were detected by atomic fluorescence spectrophotometry (HF-AFS). After treatment for 1 month, the patients were randomly divided into group A and group B when the BACs were less than 20 μg/L. Daily dose of realgar was maintained in group A and it was increased to that when the BACs were more than 20 μg/L in group B. The BAC and clinical efficacy and safety in two groups were compared at the end of the treatment with compound-QHP. Results. The average BAC of group B was significantly higher than that of group A (P<0.01). The rates of hematology improvement and reduced transfusion were significantly higher in group B than in group A (P<0.05). The HGB, ANC, and PLT significantly increased in group B after treatment (P>0.05). Conclusions. Monitoring the BAC and adjusting the daily dose of realgar to increase the effective BAC and then improving efficacy without increasing the clinical toxicity are the clinical safe and effective methods in the treatment of MDS.

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Clinical Efficacy and Safety of Joint Butylphthalide and Human Albumin Treatment of PTCI

Journal of Advances in Medicine Science ◽

10.30564/jams.v1i1.19 ◽

2018 ◽

Vol 1 (1) ◽

pp. 1

Author(s):

Jinjian Yang ◽

Deqin Geng

Keyword(s):

Clinical Efficacy ◽

Barthel Index ◽

Conventional Treatment ◽

Effective Rate ◽

Human Albumin ◽

Efficacy And Safety ◽

Nihss Score ◽

Group A ◽

Ginkgo Leaf Extract ◽

Group B

Objective: To observe the clinical efficacy and safety of butylphthalide joint human albumin in the treatment of the progress of type in acute cerebral infarction(PTCI). Methods: 120 patients with PTCI in Department of Neurology of Shuyang People’s Hospital were used to observe the efficacy. These patients were all treated by routine medicine including anti-platelet, statins, edaravone, ginkgo leaf extract and dipyridamole after admission. According to whether used butylphthalide and(or) human albumin in the treatment of PTCI, the patients were divided into A group 30 cases, B group 45 cases, and C group 45 cases.Patients of group C were given conventional treatment. Group B were given conventional treatment and human albumin injection(5g, ivgtt, qd, 3 days in a course); Group A were treated with butylphthalide (first,with butylphthalide and sodium chloride injection 100ml, ivgtt, for 7d, then with butylphthalide soft capsules 0.2g, tid, for 21d ), human albumin(5g, ivgtt, qd, for 3d) and routine medicine. The change of NIHSS score, Barthel Index, and mRS of three groups respectively during progress,1 week, 2 weeks and 90 days after progress were observed and analyzed. Results: NIHSS score, Barthel Index, and mRS of group A, group B and group C all showed no statistically significant (all p > 0.05) on 1 week after treatment; NIHSS score and mRS of group A were both lower than group B and group C on 2 weeks and 90 days after treatment, and both of them showed statistically significant (p<0.05); Barthel Index of group A was higher than group B and group C on 90 days after treatment,it showed statistically significant (p<0.05); The total effective rate of group A（96.7%） > group B（88.9%） > group C（77.8%),showed statistically significant (p<0.05). Conclusions: Butylphthalide joint human albumin treatment of PTCI has good therapeutic effect and safety, it is useful to clinical promotion and further research.

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Clinical Efficacy and Safety Profile of Lurasidone Comparing with Risperidone: Randomized, Open Label, Clinical Study

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i431167 ◽

2021 ◽

pp. 20-27

Author(s):

V. Sreedhar ◽

L. Reddenna ◽

T. Rajavardhana ◽

J. Thippe Rudra ◽

E. Pavan Kumar ◽

...

Keyword(s):

Adverse Drug Reactions ◽

Clinical Efficacy ◽

Safety Profile ◽

Negative Symptoms ◽

Rating Scale ◽

Efficacy And Safety ◽

Drug Reactions ◽

Function Test ◽

Group A ◽

Group B

There are diverse studies which afford evidences that risperidone is as effective as second generation antipsychotics in treating positive symptoms and more effective in treatment of negative symptoms. This study is intended to find the clinical efficacy and safety profile of lurasidone comparing with risperidone, a drug in common use nowadays. Patients aged between 18 to 60yrs, Patients with new onset of symptoms who fulfil the ICD-10 criteria for a primary diagnosis of schizophrenia and Patients having a total PANSS score of ≥80 including a score ≥4 (moderate) on two or more of positive subscale at baseline. Patients with acute exacerbation of schizophrenia who remained drug free for at least last 6 months also included. Demographic data of the patients were collected. Baseline investigations like BP, complete blood count, lipid profile, blood sugar, renal function test and liver function test were done. Severity of schizophrenia at baseline was assessed using positive and negative symptoms scale (PANSS). Patients were randomized by using computer generated random table in 1:1 ratio as group A and group B, with 25 patients in each group. The efficacy of group A and group B was analysed by applying rating scale Positive and negative syndrome scale (PANSS) at the end of 4 and 6 weeks. Adverse drug reactions were recorded and monitored by interviewing with patients, by physical examination and also by necessary lab investigations at the end of 6 weeks. Patients were insisted to maintain a diary to note any new occurrence of adverse drug reactions in between the follow up period. Suspected adverse drug reactions were documented in predesigned reporting form. In PANSS positive scale both groups had significant decrease in PANSS score both at week 4 and week 6 (p<0.05). Lurasidone is as equally efficacious as risperidone in reducing PANSS score, but produces less metabolic syndrome and other adverse effects than risperidone.

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Efficacy and Safety of Halometasone Cream to Treat Chronic Generalized Eczema and the Effects of Halometasone Cream on Serum Cortisol Levels

BioMed Research International ◽

10.1155/2017/3265024 ◽

2017 ◽

Vol 2017 ◽

pp. 1-7 ◽

Cited By ~ 4

Author(s):

Yan Li ◽

Wei Xu ◽

Linfeng Li

Keyword(s):

Adverse Reaction ◽

Serum Cortisol ◽

Efficacy And Safety ◽

Cure Rate ◽

Lesion Area ◽

Effectiveness Rate ◽

Daily Dose ◽

Group A ◽

Cortisol Levels ◽

Group B

The aim of the study was to investigate the efficacy and safety of halometasone cream to treat chronic generalized eczema and the effects of halometasone cream on serum cortisol (COR) levels. Sixty consecutive outpatients diagnosed with chronic generalized eczema between January and April 2017 were included and divided into groups A, B, and C with a lesion area of 30%–40%, 41%–50%, and 51%–60%, respectively. Groups A, B, and C were treated with halometasone cream with a daily dose of 15 g, 20 g, and 30 g for 7–14 days, respectively. Ten patients were randomly selected from each group for serum COR measurement at days 0, 7, and 14. On day 14, group B had significantly higher cure rate (47.1%) than groups A (17.9%) and C (13.3%) and significantly higher effectiveness rate (82.4%) than group C (40.0%) (all P<0.05). Serum COR levels were not affected in group A but were reduced significantly in groups B and C on days 7 and 14 (all P<0.05). No adverse reaction was observed. Halometasone cream appeared to relieve chronic generalized eczema effectively and safely. High dosage (≥20 g daily for 14 days) may temporarily reduce endogenous COR production substantially, although it may be more effective.

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Efficacy and Safety of Oral Ivermectin and Topical Permethrin in the Treatment of Scabies

TAJ Journal of Teachers Association ◽

10.3329/taj.v33i1.49824 ◽

2020 ◽

Vol 33 (1) ◽

pp. 41-47

Author(s):

Mohsena Akhter ◽

Ishrat Bhuiyan ◽

Zulfiqer Hossain Khan ◽

Mahfuza Akhter ◽

Gulam Kazem Ali Ahmad ◽

...

Keyword(s):

Skin Diseases ◽

Close Contact ◽

Randomized Study ◽

Sarcoptes Scabiei ◽

Efficacy And Safety ◽

Common Skin ◽

Group A ◽

The Mean ◽

The Difference ◽

Group B

Background: Scabies is one of the most common skin diseases in our country. It is caused by the mite Sarcoptes scabiei var hominis, which is an ecto-parasite infesting the epidermis. Scabies is highly contagious. Prevalence is high in congested or densely populated areas. Individuals with close contact with an affected person should be treated with scabicidal which is available in both oral and topical formulations. The only oral but highly effective scabicidal known to date is Ivermectin. Amongst topical preparations, Permethrin 5 % cream is the treatment of choice. Objective: To evaluate the efficacy & safety of oral Ivermectin compared to topical Permethrin in the treatment of scabies. Methodology: This prospective, non-randomized study was conducted at the out-patient department of Dermatology and Venereology of Shaheed Suhrawardy Medical College & Hospital over a period of 6 months, from August 2016 to January 2017. The study population consisted of one hundred patients having scabies, enrolled according to inclusion criteria. They were divided into two groups. group A was subjected to oral Ivermectin and the group B to Permethrin 5% cream. Patients were followed up on day 7 and 14 for assessment of efficacy and safety. Result: The mean scoring with SD in group A (Ivermectin) and group B (Permethrin) were 8.26 ± 2.22 and 7.59 ± 2.01 respectively at the time of observation. The difference between the mean score of the two group is not significant (p=0.117) the mean scoring with SD in group A and group B were 4.54 ± 2.05 and 1.64 ± 1.84 respectively at 7thdays. The difference between the mean score of the two group is significant (p<0.001). The mean scoring with SD in group A and group B were 2.68± 2.35 and .36± 1.10 respectively at 14th day difference between the mean score of the group is significant (p<0.001). Conclusion: Topical application of permethrin 5% cream is more effective and safer than oral Ivermectin in the treatment of scabies. TAJ 2020; 33(1): 41-47

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Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Preliminary results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc) for the non-L sarcoma cohort.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.11545 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 11545-11545

Author(s):

Daniel Pink ◽

Dimosthenis Andreou ◽

Anne Flörcken ◽

Alexander Golf ◽

Stephan Richter ◽

...

Keyword(s):

Phase Ii ◽

Single Agent ◽

Primary Efficacy ◽

Primary Efficacy Endpoint ◽

Efficacy And Safety ◽

Disease Stabilization ◽

Group A ◽

Pretreated Patients ◽

Grade 3 ◽

Group B

11545 Background: Single-agent PD-1 inhibitors have modest activity in the treatment of most STS. Potential strategies to increase efficacy include combination therapies targeting the tumor microenvironment. Considering that apart from direct growth inhibition and death of malignant cells, trabectedin (Tr) also induces macrophage depletion and/or different immunologic effects, suggesting a possible synergistic effect of combined Tr plus anti-PD-1 treatment. We therefore aimed to evaluate the efficacy and safety of combined Tr and nivolumab (Ni) as a second-line treatment in STS. Methods: The prospective, explorative, two group, non-randomized phase II NiTraSarc trial enrolled pretreated patients (pt) with advanced STS (Group A: lipo- or leiomyosarcomas, Group B: non-L-sarcomas). Pt were initially treated with 3 cycles of Tr 1.5 mg/m2, followed by the combination of Tr 1.5 mg/m2 + Ni 240 mg (“late combination cohort” (LCC)) for up to 16 cycles. After positive results of a preplanned interim analysis, pt received the combination therapy starting with cycle 2 (“early combination cohort” (ECC)). 92 pt were recruited to the trial (55 in Group A, 37 in Group B). Primary efficacy endpoint is progression-free survival rate after 6 months (PFSR6) according to RECIST v.1.1. This is a first analysis of the primary efficacy endpoint in Group B based on a modified intention-to-treat (mITT) population of evaluable 36 pt: 23 and 13 pt from the LCC and ECC, respectively. Results: The most common Group B subtypes comprised undifferentiated pleomorphic/not otherwise specified sarcoma (UPS/NOS, 13pt) and fibromyxoid sarcoma (FMS, 6pt). After a median follow-up of 5 months (m) PFSR6 was 13.9% for all pt, 8.7% in LCC and 23.1% in ECC. Median duration of disease stabilization (DoDS) was 4m in all pt, the LCC and the ECC. Two pt had a partial response (PR), 10 had disease stabilization (SD), while 13 pt progressed, and 11 had missing data. By subtype: PR- UPS/NOS=2 (DoDS 12.7m/12.5m). SD: UPS/NOS=3, epithelioid=2, synovial=2, FMS=1, fibrosarcoma=1, other=1. All 36 pt experienced at least one adverse event (AE) reaching a total of 579 AEs, 141 (24.4%) of which were considered to be grade ≥3 treatment-related AEs. The main grade ≥3 AEs were: leukopenia (47.2% of pt), neutropenia (41.7% of pt), thrombocytopenia (33.3% of pt), increased ALT (30.6% of pt), and anemia (27.8% of pt). Conclusions: Tr+Ni was well tolerated and showed activity in at least some patients with non-L-sarcomas (mostly UPS/NOS) especially in the ECC. Analyses of the collected data, including PD-L1 expression profile, with the goal to establish whether Tr+Ni should be further pursued in these patients, are ongoing. ClinicalTrials.gov Identifier: NCT03590210; EudraCT: 2017-001083-38. Clinical trial information: NCT03590210.

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Time out: should vitamin D dosing be based on patient's body mass index (BMI): a prospective controlled study

Journal of Nutritional Science ◽

10.1017/jns.2021.100 ◽

2021 ◽

Vol 10 ◽

Author(s):

Mir Sadat-Ali ◽

Khalid W. AlTabash ◽

Haifa A. Al-Turki ◽

Sulaiman A. AlMousa ◽

Hasan N. AlSayed

Keyword(s):

Vitamin D ◽

Vitamin D3 ◽

Standard Dose ◽

Demographic Data ◽

Controlled Study ◽

Daily Dose ◽

Calcium Phosphorus ◽

Group A ◽

Pre Treatment ◽

Group B

Abstract The recommended daily dose of vitamin D is 2000 IU was found to be insufficient in many patients. The objective of the present study is to find whether the daily dose of vitamin D should be based on BMI. Two hundred and thirty patients with an established vitamin D deficiency (serum level of 25 Hydroxy vitamin D3 (25OHD3) of ≤20 ng/ml) and patients with BMI ≥30 kg/m2 were included in the study. Demographic data, comorbidities and BMI were recorded. Pre-treatment and post-treatment serum 25OHD3, calcium, phosphorus and parathyroid hormone (PTH) were tested at 0-, 3- and 6-month periods. Patients were treated with a standard dose of 50 000 IU of vitamin D weekly and 600/1200 mg of calcium a day. Once their level of 25OHD3 reached ≥30 ng/ml, patients were randomised into two groups. Group A received a standard recommended maintenance dose of 2000 IU daily and Group B patients received 125 IU/kg/m2 of vitamin D3. The data were entered in the database and analysed. The mean age of Group A was 50⋅74 ± 7⋅64 years compared to 52⋅32 ± 7⋅21 years in Group B. In both groups, pre-treatment vitamin D level was ≤15 ng/ml and increased to 34⋅6 ± 2⋅6 and 33⋅7 ± 2⋅4 ng/ml at the end of 3 months treatment with a dose 50 000 IU of vitamin D3 and calcium 600/1200 mg once a day for group A and group B, respectively. At 6 months, patients in Group A 25OHD3 level was 22⋅8 ± 3⋅80 and in Group B was 34⋅0 ± 1⋅85 ng/ml (P < 0⋅001). This preliminary study suggests that obese patients need higher dosage of vitamin D than the recommended dose. It is prudent that the dosage should be based on the BMI to maintain normal levels for a healthy musculoskeletal system.

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Comparison of marsupialization under nasal endoscopy versus Lacrimal probing for treatment of congenital dacryocystoceles: a report of 40 cases

10.21203/rs.2.9860/v1 ◽

2019 ◽

Author(s):

Yanhui Cui ◽

Peng Sun ◽

Lixing Tang ◽

Chengyue Zhang ◽

Qian Wu ◽

...

Keyword(s):

Success Rate ◽

Reoperation Rate ◽

Nasal Endoscopy ◽

Efficacy And Safety ◽

Group A ◽

Group B

Abstract Introduction This study was performed to compare the efficacy of marsupialization under nasal endoscopy versus Lacrimal probing in the treatment of congenital dacryocystocele. Methods Forty neonates (43 eyes) diagnosed with congenital dacryocystoceles were divided into Group A (nasal endoscopic marsupialization) and Group B (Lacrimal probing). The patients were followed up for 1 year after surgery. The efficacy, incidence of complications, and reoperation rate were compared between the two groups. Results The male:female ratio was 25:15 patients (27:16 eyes). In Group A, the success rate was 100%, the incidence of complications was 5%, and the reoperation rate was 0%. In Group B, the success rate was 90%, the incidence of complications was 20%, and the reoperation rate was 30%. Conclusion Compared with Lacrimal probing, marsupialization under nasal endoscopy provides greater efficacy and safety for congenital dacryocystoceles.

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The Efficacy and Safety of Nabufen and Sufentanil in the Prevention of Visceral Pain After Gynecological Laparoscopic Surgery: A Randomised Controlled Trial

10.21203/rs.3.rs-125287/v1 ◽

2020 ◽

Author(s):

Xiaoxia Gu ◽

Jingjing Wang ◽

Huihua Liao ◽

Jian Mo ◽

Weiming Huang ◽

...

Keyword(s):

Laparoscopic Surgery ◽

Adverse Reactions ◽

Visceral Pain ◽

Sedation Score ◽

Efficacy And Safety ◽

Significant Difference ◽

Group A ◽

Group B ◽

Group D ◽

Ramsay Sedation Score

Abstract Background: To compare the efficacy and safety of different compatibility schemes in the prevention of visceral pain after gynecological laparoscopic surgery. Methods: from April 2019 to April 2020, patients undergoing elective gynecological laparoscopic surgery in our hospital were randomly divided into four groups: group A: sufentanil 3 μ g / kg; group B: low-dose nalbuphine group: 0.1 mg / kg of nabufen + 3 μ g / kg of sufentanil; group C: medium dose of nabufen group: 1 mg / kg of nabufen + 2 μ g / kg of sufentanil; group D: high-dose nabufen 2 There were 30 cases in each group. The degree of pain and the number of adverse reactions at 2, 4, 8, 12, 24 and 48 hours after operation were observed and recorded. The number and dosage of morphine used as a remedial analgesic were recorded. The pain degree was assessed by visual analogue scale (VAS). The total amount of analgesic pump used, the total number of times of pressing and the effective times of pressing were recorded. The adverse reactions included respiratory depression, nausea and vomiting, drowsiness, restlessness and skin The skin itches. Results: the analgesic effect of group B was similar to that of group A, and there was no significant difference in the number of invalid pressing, total pressing times and rescue analgesia rate (P > 0.05), while the invalid pressing times, total pressing times and remedial analgesia rate of group C and group D were significantly lower than those of group A (P < 0.05). There was no significant difference between group C and group D in the number of invalid compressions, the total number of compressions and the rate of remedial analgesia (P > 0.05), suggesting that increasing the dose of nalbuphine could not significantly increase the analgesic effect. The incidence of postoperative nausea and vomiting, skin pruritus, lethargy and Ramsay Sedation score in group B and group C were significantly lower than those in group A (P < 0.05). Ramsay Sedation score and incidence of drowsiness were lower than those in group D, which indicated that the incidence of adverse reactions was higher in group D than group B and group C.Conclusion: the combination of 1 mg / kg nabufen and 2 μ g / kg sufentanil is a safe and effective combination scheme for the prevention of visceral pain after gynecological laparoscopic surgery with small adverse reactions.Trial registration: http://www.chictr.org.cn/showproj.aspx?proj=40635Registration number：ChiCTR1900025076 . Prospectively registered on 10 August 2019.

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Clinical efficacy of different dosage forms containing vitamin D: design and study outcomes of a randomized, comparative clinical trial

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20203104 ◽

2020 ◽

Vol 7 (3) ◽

pp. 176

Author(s):

Nidhi Sapkal ◽

Gaurav Chhaya ◽

Milan Satya ◽

Dhara Shah

Keyword(s):

Vitamin D ◽

Clinical Efficacy ◽

Dosage Forms ◽

Oral Solution ◽

Blood Levels ◽

Open Label ◽

Soft Gelatin Capsules ◽

25 Hydroxy Vitamin D ◽

Group A ◽

Group B

Background: Different dosage forms of vitamin D like tablets, soft gelatin capsules, oral granules, powders, solutions and thin films are available. The objective of the present study was to evaluate and compare the clinical efficacy of three different dosage forms of vitamin D3 namely, orally disintegrating strips, oral granules and oral solution.Methods: An open label, single centre, prospective, randomized, parallel group, comparative study was conducted for a period of 4 months. The study participants were divided into three groups (A, B, C) and received the respective treatments (orally disintegrating strips, n=20; granules, n=20; oral nano solution, n=10) for the study period. The estimation of blood levels of 25-hydroxy vitamin D [25(OH)D3] in all the subjects at day 0, 60 and 120 was carried out.Results: The normalization level of 25(OH)D3 achieved by the subjects in group A, group B and group C was 100%, 83.3% and 90% respectively after 90 days. Comparison of 25(OH)D3 level in all three groups showed significant increase at day 60. The levels were maintained at day 90 and 120 even after drastic reduction in dosage in Group A and group C. On day 120, the dose reduction was in the order of group A>group C>group B.Conclusions: All the three formulations showed increase in the level of 25(OH)D3. It can be concluded that oral disintegrating strips of 25(OH)D3 are clinically more efficient than other conventional dosage forms.

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THE THROMBOTIC COMPLICATIONS OF TWO GROUPS OF PATIENTS WITH DIFFERENT INR THERAPEUTIC RANGES. THE NECESSITY OF INTENSE ORAL ANTICOAGULANT TREATMENT

10.1055/s-0038-1643263 ◽

1987 ◽

Author(s):

Ir Kontopoulou-Griva ◽

J Spiliotopoulou ◽

L Digenopoulou ◽

J Georgopoulos

Keyword(s):

High Risk ◽

Oral Anticoagulant ◽

Heart Valves ◽

Oral Anticoagulants ◽

Anticoagulant Treatment ◽

Oral Anticoagulant Treatment ◽

Daily Dose ◽

Group A ◽

Thrombotic Complications ◽

Group B

One of the reasons why oral anticoagulants fell into disrepute is the absence of internationally acceptable standarised procedures for controlling the level of anticoagulation. This deplorable situation resulted in over and under coagulation and uncertainty in the therapeutic range. The International Normalised Ratio (INR) can safely be applied in patients on oral anticoagulants.We present two Groups of patients under long term anti coagulation, mainly because of prosthetic heart valves that have recently been added to our outpatients clinic. These patients were till then attended by two cardiologists with different attitudes on the intensity of the anticoagulant treatment. The thromboplastin reagent used is that of ox origin and the results are expressed on INR.The Group A with 32 patients had at the time that we started attending them an INR x = 1,80 ± 0,48 and a daily dose of acenocoumarol x = 1,65 ± 0,51.The Group B with 49 patients had an INR x = 2,75 ± 0,51 and a daily dose of acenocoumarol x = 2,52 ± 1,53.Seven patients of the Group A referred thrombotic complications, while three patients of the Group B referred transiant thrombotic complications.The statistical analysis with the t-test of the INR between the two Groups is p<0,001 while that of the thrombotic complication with the x2 is p<0,05.The introduction of the INR and the acceptance by the medical people of the necessity of the intense oral anticoagulant treatment especially on high risk patients with mechanical heart valves as is the majority of the presented patients, will minimize the thromboembolic complications without high risk of bleeding.

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