Objective To evaluate the effectiveness and safety of Lipo-prostaglandin E1 injection in treating viral hepatitis.Methods We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from 1978 to June 2007. We identified randomized control led trials of Kai Shi injection versus other medicines or blank controlin treating viral hepatitis. The quality of included trials was evaluated independently by two reviewers. Meta-analyses were performed with The Cochrane Collaboration’s RevMan 4.2.7 software. Results Fourteen studies involving 1 218 patients were included, one of these compared lipo-prostaglandin E1 injection versus Mai Anding injection, one compared lipo-prostaglandin E1 injection versus potassium-magnesium aspartate injection, and the other 12 compared Lipo-prostaglandin E1 injection versus blank control. Allincluded studies were assessed in terms of randomization, allocation concealment and blinding; and all were graded C(poor quality). Meta-analyses showed that, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR 1.45, 95%CI (1.29, 1.63)] and the mortality was lower[RR 0.66, 95%CI (0.53, 0.83)] compared with the blank control group, but the incidence of phlebitis was significantlyhigher [RR 7.70, 95%CI (2.57, 23.07)]. There was no significant di f ference between Mai Anding inject ion and lipo-prostaglandin E1 injection in the total effective rate, but Lipo-prostaglandin E1 injection was more effective in improving patients’ liver functions. Compared with potassium-magnesium aspartate injection, the total effective rate was significantly higher in the lipo-prostaglandin E1 injection group[RR1.54, 95%CI (1.14, 2.08)].Conclusion The evidence currently available shows that the effectiveness and safety of lipo-prostaglandin E1 injection are not significantly different from those of Mai Anding injection for patients with viral hepatitis. Compared with potassium-magnesium aspartate injection, Lipo-prostaglandin E1 injection could significantly improve the total effective rate, but since we only include 1 relevant randomized trials, the strength of this evidence is weak. When compared with the blank control, Lipo-prostaglandin E1 injection significantly improved the total effective rate, decreased mortality but increased the incidence of side effects and the existing evidence is insufficiant to show whether Lipo-prostaglandin E1 injection improves patients’ liver functions.
ObjectiveTo evaluate the efficacy of intravenous glutamine on patients with severe acute pancreatitis. MethodsThe Cochrane Library, PubMed, EMbase, CNKI and CBM databases were searched up to January 2013. Randomized controlled trials (RCTs) that compared non-glutamine nutrition with intravenous glutamine supplemented nutrition in patients with severe acute pancreatitis were included. A method recommended by the Cochrane Collaboration was used to perform a meta-analysis of those RCTs. ResultsFour RCTs involving a total of 190 participants were included. Analysis of these RCTs revealed the presence of statistical homogeneity among them. Results showed that glutamine dipeptide had a positive effect on reducing the mortality rate[OR=0.26, 95%CI (0.09, 0.73), P=0.01], length of hospital stay[WMD=-4.85 d, 95%CI (-6.67, -3.03) d, P<0.001], and the rate of complications[OR=0.41, 95%CI (0.22, 0.78), P=0.006]. No serious adverse effects were found. ConclusionCurrent best evidence demonstrates that glutamine is effective for severe acute pancreatitis. Further high quality trials are required and parameters of nutritional condition and hospital cost should be considered in future RCTs with sufficient size and rigorous design.
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Objective To evaluate the effect of neoadjuvant chemotherapy (NAC) on breast conserving surgery and the outcomes of treatment for women with operable breast cancer. Methods We searched The Cochrane Library (Issue 1, 2007), CENTRAL (1970 to 2007), PUBMED (1978 to March 2007), CBM (1978 to 2006), CNKI (1994 to 2007), CMCC (1994 to May 2007) and other relevant databases and journals. We identified randomized controlled trials (RCTs) comparing NAC plus breast conserving therapy (BCT) or mastectomy versus BCT or mastectomy plus postoperative chemotherapy in women with operable breast cancer. Two reviewers independently assessed trial quality and extracted data. Meta-analyses were performed for homogenous studies by using The Cochrane Collaboration’s RevMan 4.2.10. Results Three eligible studies involving 2 391 women were included. The median follow-up in the studies ranged from 17 to 137 months. The methodological quality of the three RCTs was high. Meta-analyses showed that NAC had no significant effect on overall survival (OS) (RR 0.99, 95%CI 0.92 to 1.07), disease-free survival (RR 1.04, 95%CI 0.94 to 1.15) and ipsilateral breast cancer recurrence (RR 1.34, 95%CI 0.84 to 2.13). Two RCTs revealed that NAC significantly increased the rate of BCT in operable breast cancer patients, but the other RCT reported similar rates of BCT in both groups. One RCT indicated that NAC did not increase the incidence of surgery-related local complications. Conclusions NAC is safe for the treatment of women with operable breast cancer, which may increase the rate of BCT and help to evaluate chemosensitivity. There is insufficient evidence to assess the effect of NAC on conserving surgery procedure and survival rate in operable BCT patients. More large-scale RCTs are needed to define further the role of NAC in the treatment of operable breast cancer patients.
Objective To assess the efficacy of medical expulsive therapy for ureteral calculi with tamsulosin. Methods We searched PubMed, MEDLINE, EMBASE, BIOSIS, International Pharmaceutical Abstracts (IPA) Database, The Cochrane Library and Chinese Journal Full-text Database from 1995 to September 2006, as well as the proceedings of urological scientific conferences from 2000 to 2006. Randomized controlled trials(RCTs) comparing tamsulosin and other therapies for ureteral calculi among adults were included. Data were extracted by two reviewers independently and synthesized by STATA 9.0 software. Results A total of 16 studies involving 1521 patients with distal or juxtavesical ureteral calculi were included. Compared with conservative therapy, tamsulosin showed higher expulsion rate [RR 1.50, 95%CI (1.20 to 1.87), Plt;0.0001], shorter expulsion time [SMD –1.29, 95%CI (–2.27, –0.31)] and fewer patients requiring ESWL or ureteroscopy [RR 0.40, 95%CI (0.27, 0.59), Plt;0.05]. Compared with conservative therapy, the combination of tamsulosin plus deflazacort also showed higher expulsion rate [RR 1.59, 95%CI (1.31, 1.93)], shorter expulsion time [SMD –0.8, 95%CI (–1.18, –0.42)] and fewer patients requiring ESWL or ureteroscopy [RR 0.13, 95%CI (0.06, 0.31), Plt;0.05]. Compared with deflazacort alone, the combination of tamsulosin plus deflazacort demonstrated similar expulsion rate [RR 1.31, 95%CI (0.78, 2.23), P=0.31], but significantly reduced the dosage of analgesics [SMD 15.20, 95%CI (14.98, 15.52)] and decreased the proportion of patients requiring ESWL or ureteroscopy [RR 0.09,, 95%CI (0.02, 0.47), Plt;0.05]. Compared with deflazacort plus nifedipine, the combination of tamsulosin plus deflazacort showed higher expulsion rate [RR 1.20, 95%CI (1.07, 1.35), P=0.002], but similar expulsion time [SMD –1.34, 95%CI (–3.47, 0.79)] and proportion of patients requiring ESWL or ureteroscopy [RR 0.34, 95%CI (0.05, 2.22), Pgt;0.05]. As for side effects, tamsulosin-based treatment and conservative therapy were comparable (Pgt;0.05). Conclusions Tamsulosin has a beneficial effect on the expulsion of ureteral calculi, especially for distal and juxtavesical ureteral calculi. Tamsulosin-based medical expulsive therapy at the dosage of 0.4mg daily is effective and safe for patients with distal ureteral calculi. More large-scale studies are required to define the efficacy of combination therapy of tamsulosin plus deflazacort.
Objective To determine the efficacy and safety of external fixation versus intramedulllary nailing in the treatment of adult tibial shaft fracture. Methods We searched the specialized trials register of The Cochrane Collaboration’s Bone, Joint and Muscule Trauma Group, The Cochrane Library (CENTRAL), MEDLINE (1966 to March 2006), EMBASE (1980 to March 2006) and PUBMED (1966 to March 2006). We also handsearched some Chinese orthopedic journals. Randomized controlled trials (RCTs) and quasi-randomized trials (quasi-RCTs) comparing external fixation versus intramedullary nailing for tibial shaft fractures in adults were included. The quality of these trials was critically assessed. We used the Cochrane Collaboration’s RevMan 4.2.8 for data analyses. Result Three RCTs and two quasi-RCTs involving a total of 279 patients were included. The results of meta-analyses showed that external fixation for tibial shaft fractures in adults may increase the infection rate [RR 2.45, 95%CI (1.31,4.61), P=0.005], and the malunion rate [RR 2.85, 95%CI (1.20,6.79), P=0.02] but may reduce the duration of hospitalization [RR –5.50, 95%CI (–6.99,–4.01)]. The nonunion rate, delayed healing rate, and healing time, were comparable between external fixation and intramedulllary nailing. Conclusion The trials available for this systematic review are too few and small for reliable estimates of the relative effects of external fixation and intramedulllary nailing. Further studies are needed to determine these effects , especially for patients who have GustiloШ C fractures.
Objectives To systematically review the efficacy of conservative treatment and open reduction with internal fixation for multiple rib fractures. Methods We searched WanFang Data, CNKI, VIP, PubMed, EMbase, The Cochrane Library and Web of Science from inception to December 2017 to collect studies on conservative treatment and open reduction with internal fixation for multiple rib fractures. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. RevMan 5.3 software was used for meta-analysis. Results A total of 16 studies were included, involving 1 374 patients, 723 patients in the surgical group and 651 patients in the conservative group. The meta-analysis showed that the length of stay in the ICU (MD=–3.41, 95%CI –4.92 to –2.43, P<0.000 01), total length of stay (MD=–7.60, 95 %CI–10.67 to–4.53,P<0.000 01), incidence of pulmonary arylene (RR=0.40, 95%CI 0.29 to 0.54,P<0.000 01), incidence of lung infections (RR=0.43, 95%CI 0.30 to 0.61,P<0.000 01), and incidence of chest wall malformation (RR=0.05, 95%CI 0.03 to 0.11,P<0. 0.000 01) in the surgical group were superior to the conservative group. Conclusions Compared with conservative treatment, open reduction with internal fixation can significantly improve the recovery time of patients with multiple rib fractures, reduce hospitalization time, the incidence of perioperative complications, and significantly enhance the prognosis of patients, which is more conducive to the rehabilitation of patients.
Objective To evaluate the short and long term effectiveness and safety of rapamycin-based immunosuppression regimes with CsA preserving versus CsA withdrawal. Methods We searched MEDLINE, EMBASE, The Cochrane Library and CNKI from Jan. 1995 to Dec. 2005. We identified randomized controlled trials of rapamycin-hased immunosuppression regimes with CsA preserving versus CsA withdrawal for renal transplantation patients. The quality of included trials was evaluated by two reviewers. Meta-analysis was conducted on homogeneous studies. Results Ten studies （1 121 patients） undergoing renal transplantation were included. All included studies were graded in term of randomization, allocation concealment and bhnding. Six studies were graded A and the other 4 were graded B. Meta-analysis results showed CsA withdrawal in sirolimus-based therapy in renal transplantation patients survival rate OR.（95% CI ） values were 0,77（0.17, 3.52）, 1.24（0.48, 3.16）, 1.32（0.57, 3.08）, 1.21（0.60, 2.41） at the end of 6, 12, 24, 36 months respectively; renal allografts survival rate OR. （95% CI） values were 1.79 （0.63, 5.06）, 1.15 （ 0.56, 2.36） , 1.39 （0.68, 2.85）, 1.80（0.99, 3.29）, 2. 13（1.16, 3.89）, 2.01（1.15, 3.51） at the end of 6, 12, 24, 36, 48, 54 months respectively; and acute rejection OP,（95% CI） values were 0.92（0.48, 1.78）, 1.90（1.25, 2.89）, 2. 01 （0.94,4.27）, 1.93（0.93, 4.00）, 1.52（0.77, 3.02） at the end of6, 12, 24, 36, 48 months respectively. Conclusions Available evidence shows that compared with CsA preserving, CsA withdrawal in rapamycin-based immunosuppression regimes can lead to higher incidence rates of acute rejection at the end of one year while there is no statistical difference to survival rate of patients/renal allograft in cases with stabilized renal function post-transplantation. And CsA withdrawal is of benefit to allografts for long term survival rate and is helpful to recovery of renal function. Owing to high possibility of selection bias and measurement bias in included studies, there must be a negative impact on evidence intensity of our results. We expect best evidence from with high quality double blind randomized control trials.
Objective To assess the necessity and safety of ureteral stenting after ureteroscopic lithotripsy in treatment of middle and distal ureteral calculi. Methods We electronically searched MEDLINE, EMbase, Cochrane Library, CBM, VIP and CNKI to collect randomized controlled trials (RCTs) involving men with or without ureteral stenting after ureteroscopic lithotripsy from 2000 to March 2010. The quality of included trials was assessed. Data were extracted and analyzed with RevMan5.0 software. Results Six RCTs involving 543 patients were identified. The results of meta-analysis showed that: a) There was no statistical difference between two groups in stone clearance rate (RR=0.45, 95% CI 0.98 to 1.01, P=0.15), dysuria rate (RR=1.35, 95% CI 0.99 to 1.84, P=0.06), and hematuria rate (RR=2.12, 95% CI 1.00 to 4.49, P=0.05); b) There was statistical difference between two groups in frequent micturition rate (RR=2.17, 95% CI 1.13 to 4.17, P=0.02), the mean visual analog score 3 days postoperatively (WMD=0.94, 95% CI 0.47 to 1.42, P=0.000?1), and the operation time (WMD=3.57, 95% CI 1.40 to 5.72, P=0.001). Without postoperative ureteral stenting can shorten the operation time, decrease the irritation signs of bladder, and can improve quality of postoperative life without influence on stone clearance. Couclusions The routine ureteral stenting after ureteroscopic lithotripsy may be not necessary in order to keep patients from unsafety. More reasonable randomized double blind controlled trails with large sample are required to provide proofs with high quality because the methodology quality of included studies is lower.
ObjectiveTo systematically review the effect of self-management intervention on the prevention and management of lymphedema in breast cancer patients. MethodsThe Cochrane Library, Embase, PubMed, Web of Science, CINAHL, PsycINFO, SinoMed, CNKI, WanFang Data and VIP databases were electronically searched to collect studies on self-management intervention on the prevention and management of lymphedema in breast cancer patients, from inception to June 16. Two reviewers independently screened the literature, extracted data and assessed the risk of bias of the included studies. Meta-analysis was performed using RevMan 5.4 software. ResultsA total of 37 references were included, comprising 25 randomized controlled trials (RCTs), 12 controlled clinical trials (CCTs), and a total of 3 697 patients. There were 26 studies in the meta-analysis, and the results of the meta-analysis showed that, compared with the control group, patients in the intervention group exhibited better performance in lymphedema management-related behaviors (SMD=2.65, 95%CI 1.53 to 3.78, P<0.01), symptoms related to lymphedema (SMD=−2.01, 95%CI −3.66 to −0.37, P<0.05), occurrence of lymphedema (RR=0.37, 95%CI 0.32 to 0.45, P<0.01), upper limb function (SMD=−1.88, 95%CI −2.83 to −0.92, P<0.01), quality of life (SMD=2.79, 95%CI 2.05 to 3.54, P<0.01), and the difference was statistically significant. The intervention mainly included information support, material support, emotional support and decision support. ConclusionThere are currently a variety of self-management interventions, but they mainly focus on information support. Self-management interventions can improve the self-management behavior of breast cancer patients with lymphedema and reduce the impact of lymphedema on patients.