Transmyometrial oocyte recruitment: a safe surgical procedure alternative to the transvaginal retrieval when ovaries are inaccessible

Abstract Background: This study aims to investigate the intra-cytoplasmic semen injection (ICSI) outcomes and the potential complications of transmyometrial oocyte retrieval performed in patients with one or both inaccessible ovaries.Methods: From January 2004 to December 2018 were evaluated 11,273 oocytes retrievals, of which 594 not conventional procedures for inaccessible ovaries through transvaginal retrieval. Despite alternative approaches tested by clinicians during the oocyte pick up (OPU), in 113 of these patients (Group A) were indispensable the needle’s passage through the myometrium, compared to as many controls (Group B) from the 481 remaining women without this necessity. The two resulting groups were matched for their reproductive outcomes and the relative developed complications.Results: No statistically significant differences were found between the two Groups in terms of number of eggs/embryos obtained, ongoing pregnancy rate and spontaneous miscarriage. A complete absence of complications as peritoneal and endometrial bleeding after 4 and 24 hours from the transmyometrial access was reported for the whole cohort.Conclusions: This study shows that the transvaginal transmyometrial oocyte retrieval does not affect the OPU outcome even if the passage of the needle occurs through the endometrium, not inducing significant complications. Thus, here we support both efficacy and safety of transmyometrial follicular aspiration as a valid surgical approach in conditions of inaccessible ovaries.

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A concise infertility work-up results in fewer pregnancies

Human Reproduction Open ◽

10.1093/hropen/hoab033 ◽

2021 ◽

Vol 2021 (4) ◽

Cited By ~ 1

Author(s):

J A M Hamilton ◽

J W van der Steeg ◽

C J C M Hamilton ◽

J P de Bruin

Keyword(s):

Success Rate ◽

Pregnancy Rate ◽

Semen Analysis ◽

Prognostic Score ◽

Ongoing Pregnancy ◽

Ongoing Pregnancy Rate ◽

Group A ◽

Group B ◽

Work Up

Abstract STUDY QUESTION Is pregnancy success rate after a concise infertility work-up the same as pregnancy success rate after the traditional extensive infertility work-up? SUMMARY ANSWER The ongoing pregnancy rate within a follow-up of 1 year after a concise infertility work-up is significantly lower than the pregnancy success rate after the traditional and extensive infertility work-up. WHAT IS KNOWN ALREADY Based on cost-effectiveness studies, which have mainly focused on diagnosis, infertility work-up has become less comprehensive. Many centres have even adopted a one-stop approach to their infertility work-up. STUDY DESIGN, SIZE, DURATION We performed a historically controlled cohort study. In 2012 and 2013 all new infertile couples (n = 795) underwent an extensive infertility work-up (group A). In 2014 and 2015, all new infertile couples (n = 752) underwent a concise infertility work-up (group B). The follow-up period was 1 year for both groups. Complete follow-up was available for 99.0% of couples in group A and 97.5% in group B. PARTICIPANTS/MATERIALS, SETTING, METHODS The extensive infertility work-up consisted of history taking, a gynaecological ultrasound scan, semen analysis, ultrasonographic cycle monitoring, a timed postcoital test, a timed progesterone and chlamydia antibody titre. A hysterosalpingography (HSG) was advised routinely. The concise infertility work-up was mainly based on history taking, a gynaecological ultrasound scan and semen analysis. A HSG was only performed if tubal pathology was suspected or before the start of IUI. Laparoscopy and hormonal tests were only performed if indicated. Couples were treated according to the diagnosis with either expectant management (if the Hunault prognostic score was >30%), ovulation induction (in case of ovulation disorders), IUI in natural cycles (in case of cervical factor), IUI in stimulated cycles (if the Hunault prognostic score was <30%) or IVF/ICSI (in case of tubal factor, advanced female age, severe male factor and if other treatments remained unsuccessful). The primary outcomes were time to pregnancy and the ongoing pregnancy rates in both groups. The secondary outcomes were the number of investigations, the distribution of diagnoses made, the first treatment (started) after infertility work-up and the mode of conception. MAIN RESULTS AND THE ROLE OF CHANCE The descriptive data, such as age, duration of infertility, type of infertility and lifestyle habits, in both groups were comparable. In group A, more than twice the number of infertility investigations were performed, compared to group B. An HSG was made less frequently in group B (33% versus 42%) and at a later stage. A Kaplan–Meier curve shows a shorter time to pregnancy in group A. Also, a significantly higher overall ongoing pregnancy rate within a follow-up of 1 year was found in group A (58.7% versus 46.8%, respectively, P < 0.001). In group A, more couples conceived during the infertility work-up (14.7% versus 6.5%, respectively, P < 0.05). The diagnosis cervical infertility could only be made in group A (9.3%). The diagnosis unexplained infertility differed between groups, at 23.5% in group A and 32.2% in group B (P < 0.001). LIMITATIONS, REASONS FOR CAUTION This was a historically controlled cohort study; introduction of bias cannot be ruled out. The follow-up rate was similar in the two groups and therefore could not explain the differences in pregnancy rate. WIDER IMPLICATIONS OF THE FINDINGS Re-introduction of an extensive infertility work-up should be considered as it may lead to higher ongoing pregnancy rates within a year. The therapeutic effects of HSG and timing of intercourse may improve the fertility chance. This finding should be verified in a randomized controlled trial. STUDY FUNDING/COMPETING INTEREST(S) No funding was obtained for this study. No conflicts of interest were declared. TRIAL REGISTRATION NUMBER N/A.

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P–254 The outcome of artificial reproductive technologies (ART) cycles with transfer of frozen-thawed blastocysts depending on whether expanded on day 5 or day 6

Human Reproduction ◽

10.1093/humrep/deab130.253 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

A Polumiskova ◽

S Tevkin ◽

M Shishimorova ◽

T Jussubaliyeva

Keyword(s):

Pregnancy Rate ◽

Positive Outcome ◽

Reproductive Technologies ◽

Endometrial Receptivity ◽

Ongoing Pregnancy ◽

Miscarriage Rate ◽

Ongoing Pregnancy Rate ◽

Preimplantation Genetic Testing ◽

Group A ◽

Group B

Abstract Study question Is there a difference in ART cycle results after frozen embryo transfer (FET), depending on whether blastocysts were cryopreserved on day 5 or 6? Summary answer There’s no statistical difference in the clinical pregnancy rate (CPR), life birth rate (LBR), miscarriage rate (MR) between embryos frozen on day 5 and 6. What is known already Currently, opinions differ regarding this topic. Previous studies demonstrated no difference in ongoing pregnancy rates between embryos frozen on day 5 (group A) or day 6 (group B) after FET. However, metanalysis (2019) suggested higher CPR and LBR after transferring embryos from group A rather than group B. It has also been established that ovarian stimulation leads to endometrial changes that result in deleterious effects on the implantation window and endometrial receptivity. Consequently, fresh transfers were excluded. Due to hormonal priming of endometrial receptivity, the same pregnancy outcomes should be expected with frozen-thawed blastocysts (day 5 vs 6). Study design, size, duration Retrospective cohort study was conducted between January 2015 and December 2018 with selected group of patients under 40 years of age. Group A consisted of 2275 cryotransfers of blastocyst expanded on day 5; group B included 170 cryotransfers of blastocyst on day 6. Both groups had an average of 1,52 embryos transferred per patient. Participants/materials, setting, methods Embryos were vitrified and warmed with Cryotop method (Kitazato, BioPharma). Blastocysts were scored according to Gardner and Schoolcraft grading system. Only expanded on day or 6 blastocysts of excellent and good (AA, AB, BA, BB) quality were selected. The embryos were cultured in CSC medium (Irvine Scientific) for 2–4 hours prior intrauterine transfer. The cycles with donor gametes, surrogacy and preimplantation genetic testing (PGT) were excluded. Statistical validity was assessed by Pearson’s chi-squared test. Main results and the role of chance The rates of the CPR, the ongoing pregnancy rate (OPR) and the LBR between group A and B were 50,8% (1157/2275) vs 46,5% (79/170) (p = 0,26), 37,4% (852/2275) vs 37,0% (63/170) (p = 0,91), 36,5% (832/2275) vs 35,2% (60/170) (p = 0,73) respectively and no significant differences were found in each category. Moreover, similarly there were no significant differences in the miscarriage rate 26,0% (301/1157) and 21,5% (17/79) (p = 0,37) as well Limitations, reasons for caution The study is limited due to uneven distribution of patients in both groups and by a low number of participants. The grading of blastocysts’ quality is also subjected to a human factor. Wider implications of the findings: This study confirms that frozen-thawed blastocysts do not seem to exhibit a difference in the CPR, OPR, LBR and MR whether they were expanded on day 5 or day 6. The cryopreservation of day 6 blastocyst can increase the chances of the patient for the positive outcome. Trial registration number Not applicable

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P–252 The correlation of first cleavage and blastulation timing to the euploid status of embryos after PGT-A

Human Reproduction ◽

10.1093/humrep/deab130.251 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

E Timotheou ◽

T Chartomatsidou ◽

K Kostoglou ◽

E Papa ◽

C Ioakeimidou ◽

...

Keyword(s):

Pregnancy Rate ◽

Time Lapse ◽

Clinical Pregnancy ◽

Success Rates ◽

Ongoing Pregnancy ◽

Ongoing Pregnancy Rate ◽

Group A ◽

The Mean ◽

Group B ◽

Mean Time

Abstract Study question To examine the correlation of first cleavage and blastulation timing on euploidy rates in IVF cycles after PGT-A. Summary answer The timing of blastulation is observed earlier in the euploid embryos. What is known already Embryo evaluation is one of the most critical processes that affect the clinical outcome in IVF cycles. Conventional morphologic assessment and morphokinetic assessment using time lapse technology are performed in order to select the embryo with the higher implantation potential to be transferred. It is stated that embryos with faster developmental potential, especially early forming blastocysts, show increased euploidy rate and higher implantation potential. Study design, size, duration This study includes ICSI/PGT-A treatments completed between May 2018 and December 2019. 117 blastocysts were biopsied and their euploidy status was analyzed by NGS. These embryos resulted from 32 different ICSI treatments. PGT-A was performed due to: a) repeated IVF failure, b) advanced maternal age, c) recurrent pregnancy loss.ICSI was implemented in all cases and blastocysts were vitrified awaiting the genetic results. Single euploid blastocyst transfer followed and clinical pregnancy rate was monitored. Participants/materials, setting, methods Based on the genetic results, the biopsied embryos were divided into two categories; group A representing the euploid embryos and group B the aneuploid embryos. The timing of 1st cleavage and the timing of blastulation, by means of forming a blastocoel, were investigated and compared between the two groups. The rate of early blastocysts in the two groups was also analysed. Early blastocysts are considered those formed at 96h ±2 of embryo culture post ICSI. Main results and the role of chance After the genetic analysis of the biopsied embryos, 37 blastocysts were included in group A-Euploid embryos and 80 blastocysts in group B-Aneuploid embryos. The mean time of the 1st cleavage division was similar between the two groups, with marginally no statistical significance (group A-euploid:25.9h, group B-aneuploid: 26.9h ,p>0.05). Regarding the blastulation time, it was achieved earlier in group A-Euploid, at a mean time of 102.6h, compared to the mean time of 106h in group B-Aneuploid (p < 0.05). Between the cohort of the Euploid embryos (group A), there was a higher rate of early blastulating embryos, compared to the cohort of aneuploid embryos (Group B) (24% VS 17.5%), although it was not statistically significant (p > 0.05). After transferring 1 euploid blastocyst, the ongoing pregnancy rate was monitored in 76.5%, independently of the 1stcleavage and blastulation time of the transferred embryo. Limitations, reasons for caution Further investigation in larger randomized studies is required, as only a limited number of cases were included in this study. Further analysis of the ongoing pregnancy rate between the euploid blastocysts, depending on other morphokinetic parameters would be of paramount significance, as well. Wider implications of the findings: High clinical pregnancy rates observed independently of the analyzed time points, indicate high success rates obtained after PGT-A/NGS. Additionally, success rates show that trophectoderm biopsy is not hazardous for the embryo viability, if performed properly. Concluding, genetic testing combined with time-lapse microscopy may provide further information to improve IVF outcomes. Trial registration number N/A

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O-200 Frozen embryo transfer: Miscarriage rates depending on the starting day of intramuscular progesterone

Human Reproduction ◽

10.1093/humrep/deab128.011 ◽

2021 ◽

Vol 36 (Supplement_1) ◽

Author(s):

N Kalhorpour ◽

B Martin ◽

O Kulski ◽

J M Mayenga ◽

I Grefenstette ◽

...

Keyword(s):

Pregnancy Rate ◽

Embryo Transfer ◽

Live Birth ◽

Frozen Embryo Transfer ◽

Ongoing Pregnancy ◽

Miscarriage Rate ◽

Ongoing Pregnancy Rate ◽

Group A ◽

Group B ◽

Day Of Embryo Transfer

Abstract Study question Objective was to assess whether adjusting starting day of intramuscular progesterone the day of vaginal supplementation versus day of embryo transfer or later, might affect the outcome of the cycle. Summary answer additional injection of intramuscular progesterone the day of progesterone initiation or later, is not likely to be more effective on live birth and miscarriage rates. What is known already There is no consensus on the most effective method of endometrium preparation prior to FET. However, many studies report that high serum progesterone concentration during the implantation period is associated with optimal live birth rates. Adjusting progesterone treatment the day of embryo transfer seems to be too late and ineffective for rescuing low progesterone levels and should be done before. Study design, size, duration In this single center prospective study from October 2019 to november 2020, 239 patients undergoing hormonal replacement therapy protocol for frozen embryo transfer were randomly divided into two groups: additional injection of intramuscular progesterone the day of progesterone initiation or intramuscular progesterone the day of embryo transfer. We compare these results to our previous protocol beginning intramuscular progesterone day 22 of the treatment. Participants/materials, setting, methods Our frozen embryo transfer protocol consists to initiate GnRH agonist the day 1 of the cycle. After 14 days of estrogens, we introduce vaginal progesterone, prior to embryo transfer. Patients in group A received an additional injection of intramuscular progesterone the day of progesterone initiation. The group B received intramuscular progesterone the day of embryo transfer. For both, intramuscular injection of progesterone was followed every 3 days. Main results and the role of chance 239 patients were enrolled in this study, 125 in the group A and 114 in the group B. The ongoing pregnancy rate in the group A was 26.4 % and miscarriage rate 7.2%, not statistically different from ongoing pregnancy rate and miscarriage rate of women in the group B (22.81 %, p = 0.66/ 6.14%, p = 0.8). The ongoing pregnancy rate in the group D22 was 24.89 % et miscarriage rate 7.2%, not statistically different from ongoing pregnancy rate of women in the group A and B (p = 0.78 and p = 0.31). Limitations, reasons for caution The main limitation of our study is the lack of randomization for the group with additional progesterone IM on day 22. The study is actually followed to enroll more patients in 3 different groups. Wider implications of the findings This study tries to determine optimal adaptive management of hormonal replacement treatment for embryo transfer in patients with potential low progesterone values. Trial registration number no applicable

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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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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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A Comparative Study of Efficacy and Safety Between Tamsulosin and Terazosin in the Treatment of Symptomatic Benign Prostatic Hyperplasia

Chattagram Maa-O-Shishu Hospital Medical College Journal ◽

10.3329/cmoshmcj.v15i1.28755 ◽

2016 ◽

Vol 15 (1) ◽

pp. 17-21

Author(s):

Sakhawat Mahmud Khan ◽

Md Matiar Rahaman Khan ◽

Shahin Akhter ◽

Md Mizanur Rahman

Keyword(s):

Benign Prostatic Hyperplasia ◽

Prostatic Hyperplasia ◽

Common Disease ◽

Efficacy And Safety ◽

College Hospital ◽

Symptomatic Benign Prostatic Hyperplasia ◽

Group A ◽

Group B ◽

A Prospective Study

Background: Lower urinary tract symptoms suggestive of symptomatic Benign Prostatic Hyperplasia (BPH) are a very common disease in elderly men .The incidence of benign prostatic hyperplasia is age related.Objectives: To compare the efficacy and safety of Tamsulosin and Terazosin in the treatment of symptomatic Benign Prostatic Hyperplasia.Methods: This was a prospective study carried out in the Department of Urology, Chittagong Medial College Hospital, Chittagong, Bangladesh during the period of July to December 2014. Total 40 patients of 45-80 years of age were consequently selected according to inclusion criteria. After completion of baseline clinical evaluation and investigations, participants were divided into two groups, group A and group B. Group A (n=20) was given Terazosin 1mg daily for 3 days at bed time and then 2 mg daily at bed time for 2 months. Group B (n=20) was given Tamsulosin, 0.4 mg per day for 2 months. Efficacy was evaluated of each group after 2 month follow up and lastly a comparison was made between them. The parameters monitored were International Prostate Symptoms Score (IPSS) Maximum urine flow rate (Qmax) and Post Voidal Residual Volume (PVR). Tamsulosin 0.4 mg and Terazosin 2 mg once daily for 8 weeks both are effective in relieving symptoms of BPH but Tamsulosin is superior to Terazosin in improvement of total IPSS (p<0.001) and Qmax (p<0.01) PVR (p<0.01) at the end point.Results: Outcome of parameters at follow up after 2 months. Tamsulosin group showed significant improvement of IPSS (p<0.05) PVR (p<0.001) and Qmax (p<0.001) than Terazosin. The incidence of adverse events by administration of Tamsulosin was less than that by Terazosin.Conclusion: Tamsulosin appears to have more efficacy and safety than Terazosin in symptomatic BPH.Chatt Shi Hosp Med Coll J; Vol.15 (1); Jan 2016; Page 17-21

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Results of a Phase I/II-Study on PCR-Based Pre-Emptive Therapy with Valganciclovir or Ganciclovir for Active CMV Infection Following Reduced Intensity Allogeneic Stem Cell Transplantation.

Blood ◽

10.1182/blood.v110.11.5011.5011 ◽

2007 ◽

Vol 110 (11) ◽

pp. 5011-5011

Author(s):

ZiYi Lim ◽

Gordon Cook ◽

Peter R. Johnson ◽

Anne Parker ◽

Mark Zuckerman ◽

...

Keyword(s):

Stem Cell ◽

Efficacy And Safety ◽

Cmv Infection ◽

Reduced Intensity Conditioning ◽

Intravenous Ganciclovir ◽

Group A ◽

Oral Valganciclovir ◽

Group B ◽

Cmv Reactivation ◽

Reduced Intensity

Abstract The advent of reduced intensity conditioning(RIC) protocols for allogeneic haematopoietic stem cell transplantation(HSCT) has reduced the incidence of early transplantation related morbidity largely due to the attenuation of the conditioning intensity. Nevertheless, the incidence of CMV reactivation in these patients remains high. Herein we report the results of a multi-centre randomised prospective study to assess the bioavailability(auc0–12) of ganciclovir in the population of patients undergoing alemtuzumab-based RIC HSCT after oral administration of valganciclovir and secondly, the efficacy and safety of valganciclovir in the treatment of a CMV infection following allogeneic SCT. Recipients of allogeneic bone marrow or peripheral blood stem cell transplants with related or unrelated donors following reduced intensity conditioning, without proven graft versus host disease were eligible for this study. RIC protocols approved for the purposes of this study were FBC(fludarabine, busulphan, alemtuzumab) and FMC(fludarabine, melphalan,alemtuzumab). For inclusion into the study, patients had to have a detectable CMV DNA load in two consecutive blood specimens up to 120 days after transplant. Eligible patients were randomized to 1 of 2 treatment groups: group A received 900 mg oral valganciclovir(2 x 900 mg/d) for 14 days and group B received intravenous ganciclovir 5mg/kg/d twice daily for 14 days. All patients were monitored for 84 days(safety follow-up). pK profiles of ganciclovir were obtained after administration of the study drug in each study arm. pK assessments were scheduled at days 4 and 11. 27 patients were recruited into the study over a 24-month period from Jan 2005 to Dec 2006. The median age was 51 years(range:34–68). The median time to CMV reactivation was 43 days post-HSCT(range:20–114). 18 patients(67%) completed the allocated treatment resulting in CMV DNA load <10 copies/ml at a median of 14 days post-HSCT(range:7–28). In 9 cases, there were changes to the primary treatment regimen. In group A, treatment was modified in 5 cases; 3 due to rising CMV levels, 1 due to drug rash, 1 due to neutropenia. In group B, 4 patients had treatment modification; 3 patients due to rising CMV DNA levels, 1 had neutropenia. None of the patients in the study developed CMV invasive disease. The median value of the systemic clearance of ganciclovir was 11.8 l/h(95%CI: 8–15.6 l/h). The bioavailability of ganciclovir from valganciclovir(expressed as equivalents of ganciclovir) was 73%(95%CI, 34%–112%). The average exposure in the valganciclovir group(36.9 ± 14.9μg.h/ml) was significantly higher than in the ganciclovir cohort(27.9 ±7.5μg.h/ml). As a result, ganciclovir bioavailability in the subjects who received valganciclovir was 79%. In summary, when compared with intravenous ganciclovir, oral valganciclovir had high bioavailability with equivalent efficacy and safety in patients undergoing RIC HSCT. Use of valganciclovir can facilitate the out-patient treatment of patients with CMV reactivation post-HSCT with a potential reduction in hospitalization costs.

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