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Nevin Manimala Statistics

Extracorporeal Shockwave for Intermittent Claudication and Quality of Life: A Randomized Clinical Trial

JAMA Surg. 2024 Apr 10. doi: 10.1001/jamasurg.2024.0625. Online ahead of print.

ABSTRACT

IMPORTANCE: Intermittent lower limb claudication limits function and quality of life. Supervised exercise programs are not readily available, and a noninvasive alternative is needed.

OBJECTIVE: To assess extracorporeal corporeal shockwave therapy in improving quality of life in patients with claudication.

DESIGN, SETTING, AND PARTICIPANTS: In this double-blind, placebo-controlled randomized clinical trial, patients in the outpatient setting at a single tertiary center for vascular surgery were randomized in a 1:1 ratio to extracorporeal shockwave therapy or placebo therapy with no shockwaves delivered. Recruitment was between June 2015 and January 2020, with 12-week follow-up ending in March 2020. A convenience sample of patients with claudication and conservative treatment requirements who refused or were unable to participate in supervised exercise were eligible. Patients receiving anticoagulation therapy or with an active cancer were excluded. Of 522 patients screened, 389 were eligible, 138 were enrolled, and 110 completed follow-up and were included in the primary analysis. Statistical analysis was completed by May 2021.

INTERVENTION: In the intervention group, patients received 100 impulses of 0.1mJ/mm/cm2 in an area of the gastrocnemius muscle 3 times weekly for 3 weeks. The steps for treatment were replicated for the control group without delivering the treatment.

MAIN OUTCOMES AND MEASURES: The primary outcome was the Physical Functioning domain of the 36-item Short-Form Quality of Life Questionnaire at 12-week follow-up. Secondary outcomes included walking distances, ankle brachial pressure index, and other quality-of-life measures.

RESULTS: Of 138 patients recruited and randomized, 92 (67%) were male, and the mean (SD) age of the study population was 67 (9.6) years. The intervention group had a significantly higher physical function score at 12 weeks (estimated median difference 3.8; 95% CI, 0.0-7.7; P = .03). However, this significance did not remain when adjusting for covariates. At 12 weeks, the intervention group had significantly longer pain-free and maximum walking distances (pain-free estimated median difference, 34.1, 95% CI, 11.4-56.8; P = .004; maximum estimated median difference, 51.4; 95% CI, 10.7-86.5; P = .01).

CONCLUSIONS AND RELEVANCE: To our knowledge, this is the first double-blind, placebo-controlled, randomized clinical trial to consider extracorporeal shockwave therapy for the management of intermittent claudication. It demonstrated efficacy for walking distances, may have a positive effect on quality of life, and may provide a safe, noninvasive alternative therapy for patients with intermittent claudication.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02652078.

PMID:38598227 | DOI:10.1001/jamasurg.2024.0625

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Nevin Manimala Statistics

Simiaotongzhuo Decoction for the treatment of type III prostatitis: A clinical observation

Zhonghua Nan Ke Xue. 2023 Apr;29(4):348-352.

ABSTRACT

OBJECTIVE: To observe the clinical effect of Simiaotongzhuo Decoction (SMTZD) on the symptoms of type III prostatitis with damp-heat stagnation syndrome.

METHODS: Using the randomized control method, we divided 140 cases of type III prostatitis with damp-heat stagnation syndrome into two groups and treated them orally with SMTZD at 200 ml per time bid (n = 65) and Tamsulosin Hydrochloride Sustained Release Capsules (THSRC) at 0.2 mg per time qd (n = 75), both for 6 weeks. Before and after medication, we recorded the counts of white blood cells (WBC) and lecithin bodies in the prostatic fluid, NIH-CPSI scores and traditional Chinese medicine syndrome (TCMS) scores, and compared them between the two groups of patients.

RESULTS: Compared with the baseline, the WBC count and NIH-CPSI scores were decreased and the number of lecithin bodies increased in both the SMTZD (NIH-CPSI score: [18±6.47] vs [9±5.02]) and THSRC groups after medication, with statistically significant difference only in the former group (P<0.05), the TCMS scores were significantly reduced in both the SMTZD ([21.97±5.12] vs [6.4±4.88], P<0.05) and the THSRC group ([20.73±4.97] vs [11.33±5.93], P<0.05), even more significantly in the former. No statistically significant difference was observed in the incidence of adverse reactions between the SMTZD and THSRC groups (9.2% vs 9.3%, P>0.05), and all the adverse reactions were mild.

CONCLUSION: Simiaotongzhuo Decoction is safe and effective for the treatment of type III prostatitis with damp-heat stagnation syndrome, which can reduce the WBC count in the prostatic fluid, increase the number of lecithin bodies and improve the NIH-CPSI and TCMS scores of the patient.

PMID:38598220

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Nevin Manimala Statistics

Tonglong Kaibi Prescription for the treatment of severe benign prostate hyperplasia: A clinical study

Zhonghua Nan Ke Xue. 2023 Apr;29(4):342-347.

ABSTRACT

OBJECTIVE: To evaluate the clinical effect of the traditional Chinese medicine (TCM) Tonglong Kaibi Prescription (TKP) in the treatment of severe BPH with kidney deficiency and blood stasis combined with damp heat syndrome.

METHODS: We randomly divided 120 cases of severe BPH with kidney deficiency and blood stasis combined with damp heat syndrome into three groups of equal number, treated with TKP, doxazosin mesylate sustained-release tablets (the DM control), and TKP + DM, all for 8 weeks. We obtained the IPSS, TCM symptoms scores, quality of life (QOL) scores, maximum urinary flow rate (Qmax) and postvoid residual urine volume (PVR) from the patients before and after treatment and compared them among the three groups.

RESULTS: After 8 weeks of treatment, the effectiveness rate was significantly higher in the TKP + DM than in the DM control group (P < 0.05). The IPSS, TCM symptoms scores, QOL scores and PVR decreased (P < 0.01), while the Qmax increased dramatically (P < 0.01) in all the three groups. Pairwise comparison showed that the IPSS and QOL scores were lower in the TKP + DM than in the TKP and DM control groups (P < 0.05 or 0.01), and so were the TCM syndrome scores in the TKP + DM and TKP groups than in the DM control (P < 0.01). There were no statistically significant differences in PVR and Qmax among the three groups after treatment (P> 0.05), and no serious adverse events during the treatment.

CONCLUSION: TKP is safe and effective in the treatment of severe BPH, which can improve the TCM symptoms, reduce the IPSS, QOL scores and PVR and increase the Qmax of the patients. TKP is evidently superior to DM alone in improving TCM symptoms of BPH and combined medication of TKP and DM produces even better clinical efficacy.

PMID:38598219

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Efficiency and safety of microsurgical cluster ligation of the spermatic vein

Zhonghua Nan Ke Xue. 2023 Apr;29(4):331-336.

ABSTRACT

OBJECTIVE: To study the effect and safety of microscopic varicocele cluster ligation (MVCL).

METHODS: We selected 28 patients undergoing bilateral microscopic spermatic vein ligation in Xuzhou Central Hospital from July 2021 to June 2023. Using the computerized randomization method, we performed MVCL or microscopic varicocele ligation (MVL) for the right or the left spermatic cord, respectively. We recorded the operation time, intraoperative blood loss, the numbers of the spermatic veins ligated and the arteries and lymphatic vessels preserved in each surgical side. A surgeon unaware of the surgical approach on the operative side collected the Visual Analogue Scale (VAS) pain scores, nodular foreign body sensation, relief of scrotal cramps, complications, and long-term recurrence from the patients.

RESULTS: Compared with the MVL group, the MVCL group showed significantly shorter time for spermatic vein ligation ([56.21±13.96] vs [31.43±10.13] min, P<0.01), lower VAS scores on the 1st postoperative day (P <0.05) and a lower incidence of intra-scrotal nodular foreign body sensation in the 1st postoperative month (P <0.05). There were no statistically significant differences in the intraoperative blood loss, numbers of spermatic veins ligated and arteries and lymphatic vessels preserved, VAS scores at 3 and 7 postoperative days, incidence of complications and long-term recurrence between the two groups (P >0.05).

CONCLUSION: MVCL is superior to MVL in reducing the time of spermatic vein ligation and improving the efficiency, efficacy and safety of the procedure, and therefore worthy of clinical promotion.

PMID:38598217

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Correlation of sperm HDS with sperm DFI and morphology and its influence on in vitro fertilization in infertile males

Zhonghua Nan Ke Xue. 2023 Apr;29(4):317-322.

ABSTRACT

OBJECTIVE: To invest the correlation of sperm high DNA stainability (HDS) with sperm DNA fragmentation index (DFI) and sperm abnormalities and its influence on in vitro fertilization (IVF) in male infertility patients, and assess the clinical value of HDS.

METHODS: Using flow cytometry-assisted sperm chromatin structure assay (SCSA), we examined sperm HDS and sperm DFI in 322 male infertility patients undergoing IVF due to female fallopian tube factors only. Based on sperm HDS, we divided the patients into five groups and compared the semen routine parameters, percentage of morphologically abnormal sperm (MAS), sperm DFI, rates of fertilization, cleavage and high-quality embryos, and pregnancy outcomes among different HDS groups.

RESULTS: Among the 322 male infertility patients, 119 (36.96%) were found with a sperm HDS of 0 - <5%, 117 (36.34%) of 5% - <10%, 50 (15.53%) of 10% - <15%, 23 (7.14%) of 15% - <20%, and 13 (4.03%) of ≥20%. Sperm concentration, motility and progressive motility were decreased with the increase of sperm HDS, but with no statistically significant difference (P > 0.05), so were the rates of fertilization, high-quality embryos and pregnancy (P > 0.05). Sperm DFI and sperm abnormality were correlated positively with sperm HDS (r = 0.236, r = 0.203). The rate of early abortion was remarkably increased in those with sperm HDS greater than 10%.

CONCLUSION: Sperm HDS may be a risk indicator of sperm DFI and sperm abnormality, and can be used as a predictive indicator of early abortion in IVF.

PMID:38598215

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Correlation of serum and seminal plasma HCY levels with semen parameters in men and its effect on recurrent spontaneous abortion

Zhonghua Nan Ke Xue. 2023 Apr;29(4):311-316.

ABSTRACT

OBJECTIVE: To investigate the correlation of serum and seminal plasma homocysteine (Hcy) levels with semen parameters in men and its effect on recurrent spontaneous abortion (RSA) in their spouses.

METHODS: The study included 103 males subjects undergoing preconception examination in the reproduction center from March 2022 to June 2023. According to whether their spouses had a history of RSA or not, we divided their subjects into an RSA (n = 43) and a non-RSA group (NRSA, n = 60), obtained their serum and seminal plasma Hcy levels and semen parameters, and analyzed their correlation.

RESULTS: The serum Hcy level was significantly correlated with the sperm DNA fragmentation index (DFI) (r = 0.316, P = 0.005), but not with the seminal plasma Hcy level (r = -0.041, P = 0.723) and other semen parameters of the subjects (P > 0.05). There was no significant correlation between seminal plasma Hcy and semen parameters (P > 0.05). The median serum Hcy was significantly higher in the RSA than in the NRSA group (18.39 [13.02, 42.84] vs 14.65 [12.00, 18.20] μmol/L), with statistically significant difference in the overall distribution of serum Hcy between the two groups (Z=-2.20, P = 0.028), so was the median sperm DFI in the former than in the latter group (25.00% [12.50%, 37.25%] vs 13.00% [11.00%, 18.50%]), with statistically significant difference in the overall sperm DFI distribution between the two groups (Z=-2.74, P = 0.006).

CONCLUSION: The serum Hcy level was positively correlated with sperm DFI, and both serum Hcy and sperm DFI were significantly elevated in men with spousal RSA, which is expected to be used as a clinical screening indicator for males with spousal RSA.

PMID:38598214

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Nevin Manimala Statistics

Six-sequence-tagged site (STS) versus eight-STS scheme for detection of Y chromosome microdeletions

Zhonghua Nan Ke Xue. 2023 Apr;29(4):306-310.

ABSTRACT

OBJECTIVE: To compare the six-sequence-tagged site (STS) with the eight-STS scheme in the detection of Y chromosome microdeletions.

METHODS: Using real-time quantitative PCR, we compared the results of the six-STS (sY84, sY86, sY127, sY134, sY254, sY255) scheme with those of the eight-STS (sY84, sY86, sY127, sY134, sY254, sY255, sY145, sY152) scheme in detecting Y chromosome microdeletions.

RESULTS: No statistically significant difference was found in the detection rate of the deletion of the azoospermia factor (AZF) regions between the six-STS and eight-STS methods (9.34% [575/6177] vs 8.85% [542/6122], P > 0.05).

CONCLUSION: Though the eight-STS scheme increased the detection of AZFd, its detection rate of the AZF region deletion was not significantly different from that of the six-STS method. From the perspectives of experimental operation, economic cost and clinical strategy guidance, the six-STS is better than the eight-STS scheme for the detection of Y chromosome microdeletions.

PMID:38598213

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Nevin Manimala Statistics

Trajectories of Adolescent Media Use and Their Associations With Psychotic Experiences

JAMA Psychiatry. 2024 Apr 10. doi: 10.1001/jamapsychiatry.2024.0384. Online ahead of print.

ABSTRACT

IMPORTANCE: Adolescent media use is thought to influence mental health, but whether it is associated with psychotic experiences (PEs) is unclear.

OBJECTIVE: To examine longitudinal trajectories of adolescent media use and their associations with PEs at 23 years of age.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study included participants from the Québec Longitudinal Study of Child Development (1998-2021): children who were born in Québec, Canada, and followed up annually or biennially from ages 5 months through 23 years. Data were analyzed between January 2023 and January 2024.

EXPOSURES: Participants reported their weekly amount of television viewing, video gaming, computer use, and reading at ages 12, 13, 15, and 17 years.

MAIN OUTCOME AND MEASURES: Lifetime occurrence of PEs was measured at 23 years of age. Covariables included sociodemographic, genetic, family, and childhood characteristics between ages 5 months and 12 years.

RESULTS: A total of 1226 participants were included in the analyses (713 [58.2%] female, 513 [41.8%] male). For each media type, latent class mixed modeling identified 3 group-based trajectories, with subgroups following trajectories of higher use: television viewing, 128 (10.4%); video gaming, 145 (11.8%); computer use, 353 (28.8%); and reading, 140 (11.4%). Relative to lower video gaming, higher video gaming was preceded by higher levels of mental health and interpersonal problems at age 12 years. Adjusting for these risk factors mitigated the association between higher video gaming and PEs at age 23 years. The curved trajectory of computer use (189 [15.4%] participants), characterized by increasing levels of use until age 15 years followed by a decrease, was associated with higher PEs (estimated difference, +5.3%; 95% CI, +1.5% to +9.3%) relative to lower use (684 [55.8%] participants). This association remained statistically significant after covariable adjustment.

CONCLUSIONS AND RELEVANCE: This study found that longitudinal trajectories of media use during adolescence were modestly associated with PEs at age 23 years, likely reflecting the influence of shared risk factors. Understanding the environmental determinants and psychosocial functions of media use during adolescence may help better integrate digital technologies in the prevention and management of PEs.

PMID:38598210 | DOI:10.1001/jamapsychiatry.2024.0384

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Nevin Manimala Statistics

Usefulness of double plate fixation after failed ORIF for clavicle shaft fracture

Eur J Orthop Surg Traumatol. 2024 Apr 10. doi: 10.1007/s00590-024-03927-5. Online ahead of print.

ABSTRACT

PURPOSE: We aimed to evaluate the clinical and radiological outcomes of double plate fixation for failed clavicle shaft fracture surgery.

MATERIALS AND METHODS: We analyzed 14 patients who underwent double plate fixation due to plate failure after clavicle shaft fracture surgery from March 2016 to March 2021. The study used 3.5 mm locking compression plates for superior clavicle and anterior reconstruction in all patients. In addition, moldable allograft bone was used to fill the bone defect. Clinical and radiological evaluation was performed immediately, at 2 and 4 weeks, and 3, 6, 9, and 12 months postoperatively. The visual analog scale (VAS), University of California at Los Angeles (UCLA) shoulder scale, and American Shoulder and Elbow Surgeons (ASES) scores and range of motion of the shoulder were evaluated as clinical results. For radiological evaluation, anteroposterior, caudal, and cephalad views of both clavicles were used. Successful bone union was defined as complete adjoining of the fracture site through callus formation.

RESULTS: Successful bone union was achieved in all patients, and the mean time to bone union was 16.7 ± 1.2 weeks (range, 12-24 weeks). Statistically significant improvement in forward flexion and external and internal rotation was observed from 135.5° ± 6.3, 45.2° ± 5.3, and 13° ± 2.3 preoperatively to 157.0° ± 9.3, 68.7° ± 6.3, and 9.8° ± 3.1 at the final follow-up, respectively. The VAS score improved from an average of 6.2 ± 2.8 preoperatively to 1.3 ± 0.7 at the final follow-up, which was statistically significant (P = 0.018). In addition, the ASES score significantly increased from a mean of 52.1 ± 6.3 points preoperatively to 83.6 ± 7.8 points at the final follow-up (P = 0.001). The average UCLA shoulder score was 16.7 ± 1.4 and 31.4 ± 2.2 points preoperatively and at the final follow-up, respectively, which was statistically significant (P = 0.001).

CONCLUSION: Double plate fixation has shown good results after failed open reduction and internal fixation (ORIF) for clavicle shaft fractures. Therefore, in complicated situations after ORIF, double plate fixation is considered a surgical treatment option.

PMID:38598169 | DOI:10.1007/s00590-024-03927-5

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Comparing modified USPHS and FDI criteria for the assessment of glass ionomer restorations in primary molars utilising clinical and photographic evaluation

Eur Arch Paediatr Dent. 2024 Apr 10. doi: 10.1007/s40368-024-00892-9. Online ahead of print.

ABSTRACT

PURPOSE: To compare the applicability of modified US Public Health Service (USPHS) and FDI criteria for evaluating glass ionomer cement (GIC) restorations in primary posterior teeth through digital image analysis.

METHODS: This comparative analytic study was conducted at the Children’s Dental Clinic RSKGM FKG UI, involving 40 GIC restorations on lower first primary molars in children aged 4-9 years. After cleaning, the restorations were assessed clinically using modified USPHS and FDI criteria before taking digital images, then the collected images were re-evaluated using both sets of criteria, and the clinical assessment results were compared to the digital image assessment results.

RESULTS: Statistical analysis revealed significant differences between the clinical evaluation of GIC restorations in primary teeth and their corresponding digital photographs when using the modified USPHS criteria, and although the use of FDI criteria yielded different results, these differences were not statistically significant.

CONCLUSION: The assessment of GIC restorations through digital images aligns more closely with clinical assessments using the FDI criteria compared to the modified USPHS criteria.

PMID:38598166 | DOI:10.1007/s40368-024-00892-9