Objective To evaluate the safety of Rongbisu capsule used for treating benign prostatic hyperplasia. Methods A total of 218 patients (average age 63.73±7.50 years old) with phase Ⅰor Ⅱ benign prostatic hyperplasia were treated with oral Rongbisu capsule at a dose of 3 granules twice daily. The therapeutic course was 6 weeks and hepatic function was determined every 2 weeks. Results The median value of ALT in 218 patients rose significantly after the patients took Rongbishu capsule for 6 weeks (P=0.001 7). There were 17 patients whose ALT level rose from normal to abnormal, the incidence was 7.80%. There were 3 patients whose hepatic function was seriously impaired (ALT＞200 IU/L). Conclusions The essential component of Rongbishu capsule is edible tulip which has been recorded in the medical literature as being toxic. Airpotato yam of which the alias is also edible tulip is easily mistaken for edible tulip. Airpotato yam is the tuber of dioscorea bulbifera L. (family dioscoreaceae) which has confirmed hepatotoxcity. Our study result indicates that in order to insure the safety of Chinese crude drug, the origin of Chinese crude drug should be defined in the formulation according to the standard of Chinese drugs preparation. Pharmaceutical enterprises should strictly abide by the standards to identify the origin of Chinese crude drugs when approving the raw materials, especially for species which are poisonous and easily mistaken.
ObjectiveTo systematically review the association between 5α-reductase inhibitors (5ARIs) and risk of sexual dysfunction in subjects with benign prostatic hyperplasia (BPH).MethodsPubMed, Web of Science, The Cochrane Library, EMbase, CNKI, WanFang Data, VIP and CBM databases were electronically searched to collect studies on the association between 5ARIs and risk of sexual dysfunction in subjects with BPH from inception to October 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed by using Stata 12.0 software.ResultsA total of 15 studies involving 17 774 subjects were included. The results of the meta-analysis showed that compared with the placebo group, 5ARIs could significantly increase risk of erectile dysfunction (RR=1.52, 95%CI 1.36 to 1.69, P<0.000 1), while decrease libido (RR=1.79, 95%CI 1.37 to 2.32, P<0.000 1) and ejaculation disorder (RR=2.97, 95%CI 1.82 to 4.83, P<0.000 1) in subjects with BPH. Subgroup analysis of the type of 5ARIs, intervention period, publication year and sample size showed that the 5ARIs had a higher risk of sexual dysfunction than the placebo group.ConclusionsCurrent evidence shows that 5ARIs can increase risk of erectile dysfunction, decrease libido and ejaculation disorder in subjects with BPH. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusions.
Objective To assess the efficacy of finasteride in treating perioperative bleeding in patients undergoing transurethral resection of the prostate (TURP). Methods We searched MEDLINE (1966 to 2005), EMBase (1984 to 2004), CBM (1980 to 2005), The Cochrane Library (Issue 4, 2005) and relevant journals to identify cl inical trials involving finasteride in patients undergoing TURP. We also checked the references in the reports of each included trial. The qual ity of randomized controlled trials (RCTs) was assessed according to the methods recommended by The Cochrane Collaboration, and the qual ity of non-RCTs was assessed based on the methods recommended by Jiang-ping Liu, Stroup and Hailey. Two reviewers extracted data independently and data analyses were conducted with The Cochrane Collaboration’ s RevMan 4.2. Result We included 4 RCTs and 1 non-RCT. The qual ity of 3 RCTs was graded C and the other one was graded B. The quality of the non-RCT was relatively high. Meta-analyses showed that with comparable age, international prostate symptom score, prostate specific antigen, preoperative volume of prostate and excision volume between the two groups (Pgt;0.05), the perioperative bleeding volume (WMD –85.44, 95%CI –117.31 to –53.58), the bleeding volume per gram of resected prostate tissue (WMD –3.5, 95%CI –6.34 to –0.58) and hemoglobin reduction (WMD –1.61, 95%CI –1.96 to –1.26) of the finasteride group were significantly smaller than those of the control group. Conclusion The evidence currently available indicates that preoperative use of finasteride may reduce bleeding in patients undergoing TURP.
ObjectivesTo systematically evaluate the efficacy and safety of the transurethral bipolar plasmakinetic prostatectomy (TUPKP) versus holmium laser enucleation of the prostate (HoLEP) for treatment of benign prostatic hyperplasia (BPH).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of TUPKP and HoLEP for treatment of BPH from inception to January 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Then, the meta-analyses were performed by using RevMan 5.3 software.ResultsA total of 9 RCTs involving 784 patients were included. The results of meta-analyses showed that, in efficacy outcomes, TUPKP was superior to HoLEP in Qmax at 48 months, and was inferior to HoLEP in PVR at 3 months, Qmax in 60 and 72 months, and IIEF-5 at 48 and 72 months. No significant association was found between two groups in Qmax from 1 to 36 months, IPSS from 1 to 72 months, prostate volume, PVR from 6 months, IIEF-5 from 1 to 24 months, QoL at 1 to 36 months, and resected prostate weight. As for safety, TUPKP was superior to HoLEP in operation time, while inferior to HoLEP in blood loss during procedure, hospital stay, catheterization period, bladder irrigation period, irrigation fluid, massive hemorrhage and hematuresis. No significant association was observed between two groups in serum sodium decrease, hemoglobin decrease, PSA, postoperative urine retention, blood transfusion, cystospasm, temporary incontinence, urinary tract infection, TURS, epididymitis, temporary difficulty in urination, urinary tract irritation syndrome, reoperation, retrograde ejaculation, urinary incontinence, ED and urethrostenosis.ConclusionsCurrent evidence shows that the efficacy and safety of TUPKP and HoLEP for treatment of BPH are similar. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
ObjectiveTo systematically evaluate the efficacy and safety of simultaneous transurethral resection of bladder cancer and prostate (TURBT+TURP) in the treatment of bladder cancer with benign prostatic hyperplasia (BPH). MethodsWe searched PubMed, EMbase, The Cochrane Library, Web of Science, CBM, CNKI, WanFang Data and VIP from inception to January 2015, to collect randomized controlled trials (RCTs) and cohort studies investigating the efficacy and safety of TURBT with TURP in the treatment of bladder cancer with BPH. Two reviewers independently screened literature, extracted data, and assessed the risk bias of included studies, and then meta-analysis was performed using RevMan 5.3 software. Results3 A total of 3 RCTs (n=137) and 10 retrospective cohort studies (n=998) were included. The results of meta-analysis showed that there were no significant differences between the simultaneous resection group and the control group in the overall recurrence rate (RCT:OR=0.55, 95% CI:0.24 to 1.24, P=0.15; retrospective cohort study:OR=0.78, 95% CI:0.60 to 1.01, P=0.06), postoperative recurrence rate in the prostatic fossa/urethra (RCT:OR=1.40, 95% CI:0.28 to 7.60, P=0.68; retrospective cohort study:OR=1.36, 95% CI:0.49 to 3.74, P=0.55), progression rate (OR=0.93, 95% CI:0.53 to 1.61, P=0.79) and overall perioperative complication rate (RCT:OR=0.35, 95% CI:0.08 to 1.55, P=0.17; retrospective cohort study:OR=0.1.75, 95% CI:0.44 to 6.98, P=0.43). ConclusionCompared with only TURBT or sequential TURBT and TURP, simultaneous TURBT and TURP do not increase the overall recurrence rate, postoperative recurrence rate in the prostatic fossa/urethra, progression rate and overall postoperative complication rate. However, due to the limited quality and quantity of included studies, larger sample size and higher quality RCTs are needed to verify the above conclusion.
Objectives To evaluate the methodological quality of published clinical practice guidelines for benign prostatic hyperplasia. Methods PubMed, EMbase, CNKI, WanFang Data, VIP and CBM databases, website of Yimaitong, and international authoritative guide platforms were electronically searched to collect the relevant clinical practice guidelines or consensus for benign prostate hyperplasia. The retrieval covered the time up to December 13th, 2016. Literatures were independently screened by 2 reviewers. After data extraction, the methodological quality of included guidelines was evaluated by 4 reviewers using the AGREE Ⅱ. Each domain score was calculated and the intraclass correlation coefficient was used to evaluate the consistency among the reviewers. Results A total of 15 clinical practice guidelines were included. The mean scores for the six domains in AGREE Ⅱ were: 72%, 38%, 30%, 58%, 16%, and 40%, respectively. The intraclass correlation coefficient was larger than 0.87, which indicated the total consistency was well. Conclusions The quality of clinical practice guidelines for benign prostatic hyperplasia is not satisfactory as expected. They are heterogeneous in quality and some requires improvement. Guidelines are required to be further developed in methodology in future, especially in three domains, including participants, preciseness and applicability of the design.
Objective To access the efficacy and safety of Holmium laser prostatectomy technique compared to TURP. Methods We searched MEDLINE (1996 to 2004), EMBASE (1984 to 2004), The Cochrane Library (Issue 4, 2004), CNKI, VIP, CMCC and CBMdisc; and handsearched the relevant Chinese journals. Randomized controlled trials (RCT) were included. The quality of trials was evaluated and meta-analysis was performed. Non-randomized controlled trials were also included to evaluate the safety and efficacy. Results We found 4 randomized controlled trials. A total of 480 participants were in the trials ranging from 60 to 200. There was no statistical difference between the two techniques at 12 or 48 months follow-up in terms of quality of life (QOL) improvement（WMD=-0.19, 95%CI -0.81 to 0.44, Z=0.59, P=0.56; WMD=-0.30, 95%CI -0.90 to 0.30, Z=0.98, P=0.33); Qmax improvement（WMD=1.63 ml/s, 95%CI -0.32 to 3.59, Z=1.64, P=0.10; WMD=3.80 ml/s, 95%CI -1.36 to 8.96,Z=1.44, P=0.15); I-PSS or AUA (WMD=-0.06, 95%CI -1.01 to 0.89, Z=0.12, P=0.91; WMD=-1.40, 95%CI -3.91 to 1.11, Z=1.09, P=0.27) and the urethral stricture complication rate (RR=0.75, 95%CI 0.35 to 1.60, Z=0.74, P=0.46). However hospital stay was significantly shorter in the Holmium laser prostatectomy groups (total WMD=-24.89, 95%CI -28.56 to -21.21, Z=13.27, P＜0.000 01). We can not draw consistent conclusions in terms of blood loss according to the present data. One study indicated Holmium laser prostatectomy technique was more cost-effective than TURP. Conclusions In short period Holmium laser prostatectomy is as safe as TURP in terms of hospital stay, urethral stricture and blood loss complication. This new technique is as effiective as TURP in terms of I-PSS (AUA), Qmax and QOL. More RCTs and more long term follow-up is necessary.
ObjectiesTo investigate the impact of family nursing intervention on the quality of life in postoperative patients with benign prostatic hyperplasia (BPH). MethodsIn total, 60 consecutive patients who underwent BPH surgeries between December 2012 and January 2014 were enrolled and randomly assigned to receive either timely outpatient follow-ups and routine rechecks (control group) or nursing intervention of telephone call follow-ups and family visits by professional nurses (intervention group). Quality of life was assessed by international prostate symptom score (IPSS) and generic quality of life inventory-74 (GQOLI-74), and was compared before and after intervention between the two groups. ResultsThere were no statistically significant differences in GQOLI-74 scores of all dimensions at discharge between the intervention group and the control group (P>0.05). However, six months after discharge, GQOLI-74 scores of all dimensions were significantly different between the two groups (P<0.05), and were also significantly different from the scores at discharge in both groups (P<0.05). At discharge, IPSS scores were not significantly different between the two groups (P>0.05). Six months after discharge, IPSS scores of the intervention group (6.33±1.03) and the control group (7.83±0.94) were significantly different (P<0.05), and were also significantly different from the scores at discharge in the intervention group (7.93±1.31) and the control group (8.10±1.06) (P<0.05). Three patients in the control group (10.0%) were admitted into the hospital again due to bleeding, while there was no bleeding case in the intervention group. No such complications as urethrostenosis or urinary incontinence occurred in both groups. Conclusion Family nursing intervention improves effectively the quality of life in postoperative patients after surgeries for benign prostatic hyperplasia.
ObjectiveTo assess the methodological and reporting quality of systematic reviews/Meta-analyses (SRs/MAs) of transurethral procedure for benign prostatic hyperplasia (BPH). MethodWe electronically searched databases including PubMed, The Cochrane Library (Issue 12, 2014), Sciverse, CNKI, VIP and WanFang Data from inception to December 2014 to collect SRs/MAs of transurethral procedure about BPH. Two reviewers independently screened literature and assessed the methodological and reporting quality of included SRs/MAs by AMSTAR and PRISMA checklists. ResultsA total of 33 SRs/MAs were included. The results of qualitative analysis showed that:the main methodological weakness of included SRs/MAs included the lack of protocol, disappropriate conclusion formulation, the lack of publication bias assessment, and the lack of stating the conflict of interest. The average score of AMSTAR scale was 6.27±2.14. There were 11 items in PRISMA checklist with coincidence rate over 80%, 8 items between 50% to 80%, and 8 items less than 50%. ConclusionThe methodological and reporting quality of SR/MA of transurethral procedure for BHP is low, and that may decrease the reliability and value of results from SRs/MAs in the field. Future SRs/MAs should strictly follow the related reporting guidelines in order to improve the methodological and reporting quality, so as to provide more reliable evidence for clinical decision.